JP2025514206A - Core needle biopsy device for obtaining multiple samples with a single insertion - Patents.com - Google Patents

Abstract

The core needle biopsy device includes a needle assembly, a cutter drive assembly, a puncturator drive assembly, and an actuation mechanism. The needle assembly includes a puncturator and a hollow cutter. The puncturator includes a sharp distal tip and a notch. The puncturator is slidably disposed within the cutter to sever tissue into the notch. The cutter drive assembly is configured to move the cutter. The puncturator drive assembly is configured to move the puncturator. The puncturator drive assembly includes a lead screw, the lead screw configured to translate axially within a portion of the biopsy device to move both a portion of the cutter drive assembly and a portion of the puncturator drive assembly. The actuation mechanism is configured to engage both the cutter drive assembly and the puncturator drive assembly and to initiate sequential firing of the puncturator and the cutter using the cutter drive assembly and the puncturator drive assembly.
[Selection] Figure 26

Description

A biopsy is the removal of a tissue sample from a patient so that the tissue can be examined for signs of cancer or other disorders. Tissue samples can be obtained in a variety of ways using a variety of medical procedures involving a variety of sample collection devices. For example, a biopsy can be an open procedure (surgical removal of tissue after making an incision) or a percutaneous procedure (e.g., by fine needle aspiration, core needle biopsy, or aspiration biopsy). After the tissue sample is collected, it is typically analyzed in a laboratory (e.g., a pathology laboratory, a biomedical laboratory, etc.) that is set up to perform the appropriate tests (such as histological analysis).

Biopsy samples have been obtained in a variety of ways in a variety of medical procedures, including open and percutaneous methods using a variety of devices. For example, some biopsy devices may be fully operable by a user using one hand and with a single insertion to obtain one or more biopsy samples from a patient. Additionally, some biopsy devices may be tethered to a vacuum module and/or a control module for communication of fluids (e.g., pressurized air, saline, atmosphere, vacuum, etc.), for transmission of power, and/or for transmission of commands, etc. Other biopsy devices may be fully or at least partially operable without being tethered or otherwise coupled to another device.

One technique for collecting breast biopsies involves the use of a core needle biopsy device. One such device is the MAX-CORE disposable core biopsy instrument manufactured by Bard Biopsy Systems. Core needle biopsy devices often use a sharp, solid piercer with a lateral tissue-receiving notch located adjacent the distal end of the piercer. Once tissue is received within the notch, an elongated, hollow cutting sheath translates over the notch to sever the tissue sample. The severing tissue sample is then stored within the notch until both the piercer and the cutting sheath are removed from the patient. Thus, core needle biopsy devices are capable of collecting only one tissue sample per insertion of the piercer and cutting sheath.

Another technique for performing a breast biopsy is to perform the breast biopsy with a vacuum breast biopsy device. In contrast to a core needle breast biopsy procedure, a vacuum breast biopsy device allows the probe to extract multiple samples without the need to remove the probe from the breast after each sample collection. For example, a vacuum breast biopsy device uses a hollow needle to penetrate tissue. The hollow needle includes a lateral opening adjacent to a sharp distal tip. A hollow cutter is disposed within the hollow needle, and to sever the tissue sample, the hollow cutter is moved axially relative to the lateral opening of the needle. Once the tissue sample is severed by the hollow cutter, the tissue sample is transported axially within the cutter and collected in a tissue collection feature.

Examples of suction biopsy devices and biopsy system components are described in U.S. Patent No. 5,526,822, issued June 18, 1996, entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue," U.S. Patent No. 6,086,544, issued July 11, 2000, entitled "Control Apparatus for an Automated Surgical Biopsy Device," U.S. Patent No. 6,086,544, issued December 19, 2000, entitled "Fluid Collection Apparatus for a Surgical Biopsy Device," and U.S. Patent No. 6,086,544, issued December 19, 2000, entitled "Control Apparatus for an Automated Surgical Biopsy Device." No. 6,162,187, issued on Aug. 13, 2002 and entitled "Method for Using a Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Patent No. 6,432,065, issued on June 22, 2004 and entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Patent No. 6,752,768, issued on Oct. 8, 2008 and entitled "Remote Control of a Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Patent No. 6,52 ... No. 7,442,171 entitled "Thumbwheel for a Surgical Biopsy Device," U.S. Patent No. 7,854,706 issued on December 1, 2010 and entitled "Clutch and Valving System for Tetherless Biopsy Device," U.S. Patent No. 7,914,464 issued on March 29, 2011 and entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Patent No. 7,914,464 issued on May 10, 2011 and entitled "Vacuum Timing Algorithm," U.S. Patent No. 7,854,706 issued on December 1, 2010 and entitled "Clutch and Valving System for Tetherless Biopsy Device," U.S. Patent No. 7,914,464 issued on March 29, 2011 and entitled "Vacuum Timing Algorithm for a Surgical Biopsy Device," U.S. Patent No. 7,854,706 issued on December 1, 2010 and entitled "Clutch and Valving System for Tetherless Biopsy Device," U.S. Patent No. 7,914,464 issued on May 10, 2011 and entitled "Vacuum Timing Algorithm for a Surgical Biopsy Device," U.S. Patent No. 7,854,706 issued on December 1, 2010 and entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Patent No. No. 7,938,786 entitled "Tissue Biopsy Device with Rotatably Linked Thumbwheel and Tissue Sample Holder" issued on December 21, 2011; U.S. Patent No. 8,083,687 entitled "Tissue Biopsy Device with Rotatably Linked Thumbwheel and Tissue Sample Holder" issued on February 1, 2012; U.S. Patent No. 8,118,755 entitled "Biopsy Sample Storage" issued on June 26, 2012; No. 8,206,316 entitled "Biopsy Device with Discrete Tissue Chambers" issued on April 22, 2014; U.S. Patent No. 8,702,623 entitled "Biopsy Device with Motorized Needle Firing" issued on October 14, 2014; and U.S. Patent No. 8,858,465 entitled "Biopsy Device with Motorized Needle Firing" issued on May 3, 2016. No. 9,326,755, entitled "Methods for Producing a High-Performance Electrostatically Conductive Tube with a Fluorescent Lamp," issued to the same assignee as the present application, the disclosures of which are incorporated herein by reference.

Additional examples of suction biopsy devices and biopsy system components are described in U.S. Publication No. 2006/0074345, published April 6, 2006, now abandoned, entitled "Biopsy Apparatus and Method," U.S. Publication No. 2009/0131821, published May 21, 2009, now abandoned, entitled "Graphical User Interface for Biopsy System Control Module," U.S. Publication No. 2009/0131821, published June 17, 2010, now abandoned, entitled "Hand Actuated Tetherless Biopsy Device with Pistol," and U.S. Publication No. 2009/0131822, published June 17, 2010, now abandoned, entitled "Hand Actuated Tetherless Biopsy Device with Pistol," and U.S. Publication No. 2009/0131823, published June 17, 2010, now abandoned, entitled "Hand Actuated Tetherless Biopsy Device with Pistol," and U.S. Publication No. 2009/0131824, published May 21, 2009, now abandoned, entitled "Graphical User Interface for Biopsy System Control Module." No. 2010/0152610, entitled "Biopsy Device with Central Thumbwheel", published on June 24, 2010 and now abandoned, U.S. Publication No. 2010/0160819, entitled "Biopsy Device with Central Thumbwheel", published on December 5, 2013, and U.S. Publication No. 2013/0324882, entitled "Control for Biopsy Device". The disclosures of each of the above U.S. patent application publications are incorporated herein by reference.

Exemplary core needle biopsy devices are disclosed in U.S. Patent No. 5,560,373, issued October 1, 1996 and entitled "Needle Core Biopsy Instrument with Durable or Disposable Cannula Assembly," U.S. Patent No. 5,817,033, issued October 6, 1998 and entitled "Needle Core Biopsy Device," U.S. Patent No. 5,971,939, issued October 26, 1999 and entitled "Needle Core Biopsy Device," and U.S. Patent No. 5,971,939, issued April 30, 1996 and entitled "Needle Core Biopsy Device." No. 5,511,556, entitled "A Novel Instrument for a Microwave Oscilloscope," the disclosures of which are incorporated herein by reference.

While this specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the invention will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which like reference characters identify the same elements, and in which some components or portions of components are shown in phantom, as depicted by dashed lines.

1 illustrates a perspective view of an exemplary core needle biopsy device. 2 shows an exploded view of the needle assembly of the core needle biopsy device of FIG. 1; FIG. 3 shows a perspective view of the needle assembly of FIG. 2 . 2 shows a perspective view of a drive assembly of the core needle biopsy device of FIG. 1; 5 shows an exploded view of the drive assembly of FIG. 4. FIG. 5 illustrates an exploded view of the needle cocking assembly of the drive assembly of FIG. FIG. 7 shows a perspective view of the lead screw of the needle cocking assembly of FIG. FIG. 7 shows a perspective view of the carriage nut of the needle cocking assembly of FIG. 9 illustrates a side cross-sectional view of the needle cocking assembly of FIG. 6, the cross-section being taken along line 9-9 of FIG. 5 shows an exploded view of the cutter drive assembly of the drive assembly of FIG. 4 . 10B shows a cross-sectional view of the cocking member of the cutter drive assembly of FIG. 10A, the cross-section being taken along line BB of FIG. 10A. 5 illustrates an exploded view of the lancing device drive assembly of the drive assembly of FIG. 4. FIG. 11B shows a cross-sectional view of the cocking member of the piercer drive assembly of FIG. 11A, the cross-section being taken along line BB of FIG. 11A. 5 shows an exploded view of the release assembly of the drive assembly of FIG. 4; FIG. 5 shows a bottom view of the release assembly of FIG. 4 . 5 illustrates another perspective view of the drive assembly of FIG. 4, the drive assembly being in an initial position. 5 illustrates yet another perspective view of the drive assembly of FIG. 4, the drive assembly being in a cocked position. 5 illustrates yet another perspective view of the drive assembly of FIG. 4, the drive assembly being in the ready position. 5 illustrates yet another perspective view of the drive assembly of FIG. 4, with the lancing device drive assembly in the fired position. 5 illustrates yet another perspective view of the drive assembly of FIG. 4 with the cutter drive assembly in the fired position. FIG. 3 illustrates a partial front view of the needle assembly of FIG. 2, the needle assembly positioned adjacent to a lesion. 3 illustrates another partial front view of the needle assembly of FIG. 2 with the piercer fired through the lesion; 3 illustrates yet another partial front view of the needle assembly of FIG. 2 with the cutter fired through the lesion; 5 illustrates yet another perspective view of the drive assembly of FIG. 4 with the lancing device retraction assembly retracted to an intermediate position. 5 illustrates yet another perspective view of the drive assembly of FIG. 4 with the piercer retraction assembly retracted to a proximal position. 3 shows a detailed perspective view of the tissue collection feature of the needle assembly of FIG. 2, the tissue collection feature being in a closed position; 3 illustrates another detailed perspective view of the tissue collection feature of the needle assembly of FIG. 2, the tissue collection feature in an open position; 2 shows a perspective view of an alternative drive assembly that may be incorporated into the core needle biopsy device of FIG. 1; 27 shows an exploded perspective view of the lancing device drive assembly of the drive assembly of FIG. 26; FIG. FIG. 28 shows a perspective view of the lead screw drive shaft of the lancing device drive assembly of FIG. 27 . 28 shows a perspective view of the lead screw latch of the lancing device drive assembly of FIG. 27; 30 shows another perspective view of the lead screw latch of FIG. 29 . 30 shows yet another perspective view of the lead screw latch of FIG. 29 . FIG. 28 shows a detailed perspective view of the external lead screw of the piercer drive assembly of FIG. 27 . 33 illustrates a partial perspective cross-sectional view of the external lead screw of FIG. 32 with a distal end of the external lead screw engaged with the lead screw latch of FIG. 29 . 33 illustrates a front cross-sectional view of the external lead screw of FIG. 32 with a distal end of the external lead screw engaged with the lead screw latch of FIG. 29. 28 shows a perspective view of a spring guide of the lancing device drive assembly of FIG. 27; 27 shows a cross-sectional side view of the piercer drive assembly of FIG. 27 with the piercer spring in an expanded configuration, the cross-section being taken along line 36-36 of FIG. 26. 36A shows another cross-sectional side view of the piercer drive assembly of FIG. 27, with the piercer spring of FIG. 36A in a compressed position. FIG. 27 illustrates an exploded perspective view of the cutter drive assembly of the drive assembly of FIG. 26 . FIG. 38 shows a perspective view of the cutter carriage of the cutter drive assembly of FIG. 37 . A side view of the cutter carriage of Figure 38 is shown. FIG. 27 shows a perspective view of a control shaft of the drive assembly of FIG. 26 . 27 illustrates a cutaway perspective view of the drive assembly of FIG. 26 being used with the core needle biopsy device of FIG. 1, the drive assembly being in an initialization position. 32. A detailed perspective view of the piercer drive assembly of FIG. 27 is shown with the piercer carriage engaging the hard stop of the external lead screw of FIG. 40 shows a detailed perspective view of the cutter drive assembly of FIG. 37, with the control shaft of FIG. 40 engaging the hard stop protrusion of the cutter drive assembly. 27 illustrates another cutaway perspective view of the drive assembly of FIG. 26 being used with the core needle biopsy device of FIG. 1 , the drive assembly in a cocked configuration; 27 illustrates yet another cutaway perspective view of the drive assembly of FIG. 26 being used with the core needle biopsy device of FIG. 1, the drive assembly in a piercer firing configuration; 27, with the control shaft of FIG. 40 rotating to actuate the lead screw latch of FIG. 29. 40 shows a detailed perspective view of the cutter drive assembly of FIG. 37 with the control shaft of FIG. 40 rotating to hold the cutter carriage of FIG. 38 in a predetermined axial position. 27 illustrates yet another cutaway perspective view of the drive assembly of FIG. 26 being used with the core needle biopsy device of FIG. 1 , the drive assembly in a cutter firing configuration; 27 illustrates yet another cutaway perspective view of the drive assembly of FIG. 26 being used with the core needle biopsy device of FIG. 1 , the drive assembly in a piercer retracted configuration; 40 shows another rear view of the lancing device drive assembly of FIG. 27 with the control shaft of FIG. 40 rotating to actuate the lead screw latch of FIG. 29. 40 shows another detailed perspective view of the cutter drive assembly of FIG. 37 with the control shaft of FIG. 40 rotating to extract a tissue sample from the notch in the lancing device of FIG. 20;

The drawings are not intended to be limiting in any way, and it is envisioned that various embodiments of the invention may be practiced in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention. It will be understood, however, that the invention is not limited to the precise configurations shown.

The following description of certain examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is, by way of example, one of the best modes contemplated for carrying out the present invention. As will be understood, the present invention is capable of other different and obvious aspects, all without departing from the present invention. Thus, the drawings and description should be regarded as illustrative in nature and not limiting.

Biopsy devices may be utilized to collect tissue samples in a variety of ways. For example, in some cases, tissue samples are collected in a single tissue basket, such that all tissue samples collected during a given biopsy procedure accumulate in the single tissue sample basket. In some other instances, tissue samples are collected in a tissue sample holder having a separate compartment for each tissue sample collected. Such multi-compartment tissue sample holders may further include a tray or strip that holds each tissue sample separately from the other tissue samples. Such a tray or strip may be removable or otherwise separable from the tissue sample holder upon the conclusion of the biopsy procedure.

Regardless of the structure in which the tissue sample is stored, the tissue sample may be collected using a biopsy device under the guidance of a variety of imaging modalities, such as ultrasound imaging guidance, stereotactic (X-ray) guidance, MRI guidance, positron emission mammography ("PEM") guidance, and breast specific gamma imaging ("BSGI") guidance. Each procedure has its own methodology based on the type of imaging guidance used. The following text provides a brief description of ultrasound imaging guided biopsy procedures, stereotactic guided biopsy procedures, and MRI guided biopsy procedures.

In an ultrasound image-guided breast biopsy procedure, an operator positions an ultrasound transducer on a patient's breast and, while viewing an ultrasound image display screen, can manipulate the transducer to identify suspicious tissue in the patient's breast. Once the operator has identified the suspicious tissue, the operator can anesthetize the target area of the breast. Once the breast is anesthetized, the operator can use a scalpel to create an initial incision at a location on the outside of the breast that is offset from the transducer. The needle of a breast biopsy probe, which is coaxially positioned within an introducer cannula, is then inserted into the breast through the initial incision. The operator continues to hold the ultrasound transducer with one hand while manipulating the biopsy probe with the other. While viewing an ultrasound image on a display screen, the operator guides the needle to a location adjacent to the suspicious tissue. A cutter within the needle of the probe is used to remove tissue, which is then transported to either a manual take location or a tissue sample chamber in the breast biopsy device. The needle of the breast biopsy device is then removed while the introducer cannula remains positioned within the breast. The introducer cannula can then be used to introduce a biopsy marker cannula to place a biopsy site marker at the biopsy site. Once the marker is placed at the biopsy site, both the biopsy marker cannula and the introducer cannula are removed from the breast and the incision is closed using a medically accepted method for closing cuts in the skin.

In a stereotactic image-guided breast biopsy procedure, the patient is first positioned relative to an x-ray device that includes a breast stereotactic assembly. In some procedures, the patient is positioned in a prone position, lying face down on the treatment table with at least one breast hanging through an opening in the treatment table. The breast is then compressed between a compression plate and an x-ray receptor of the stereotactic assembly that is located under the treatment table. The breast biopsy device is positioned on an automated guide between the breast and the x-ray source, in front of the compression plate. Once the patient is positioned and the breast is localized, a scout image is acquired with the x-ray receptor in a zero degree angular position (i.e., x-rays are emitted along an axis perpendicular to the x-ray receptor). If the scout image indicates that the patient is positioned in the desired position, the procedure may proceed with acquiring a stereotactic image pair. Stereotactic image pairs are acquired by orienting the x-ray source at various complementary angular positions (e.g., +15° and −15°) relative to the x-ray receptor and acquiring at least one x-ray image at each position.

Furthermore, in a stereotactic image-guided breast biopsy procedure, once a suitable stereotactic image pair has been acquired, the operator can identify the target site where biopsy sampling is desired by examining the stereotactic image pair. The target site is marked on each stereotactic image, and an image processing module is used to calculate the exact location of the target site in a Cartesian coordinate system. The calculated location of the target site is then communicated to an automated guidance device, which in response to this information positions the breast biopsy probe in a position that is in line with the target site. With the breast biopsy device in position, the operator can then fire the needle of the biopsy probe into the patient's breast, thereby placing the needle at the target site. A cutter within the needle of the probe is used to remove tissue, which is then transported to either a manual pick-up position or a tissue sample chamber of the breast biopsy device. After the biopsy tissue is removed, a biopsy marker cannula is inserted into the needle and used to deploy a biopsy site marker at the biopsy site. Once the marker is in place at the biopsy site, the needle is removed from the breast and the incision is closed using a medically accepted method for closing skin breaks.

In an MRI-guided breast biopsy procedure, after the patient is properly positioned on the table and a targeting device (e.g., a grid and cube combination or a pillar, post and cradle support combination) is deployed and used, a baseline MRI image is taken to verify the target location. A scalpel is then used to incise the skin of the breast. An assembly formed by an obturator placed in a sleeve is then inserted through the incision and penetrates the breast tissue beneath the skin. In some accepted surgical techniques, the obturator is removed and an imaging rod is inserted into the sleeve in its place. An imaging rod is simply defined as a properly shaped rod that contains features detectable by the imaging technique being used for the biopsy procedure. An MRI image of the imaging rod is used to identify the site penetrated by the sleeve/obturator assembly. In some other accepted surgical techniques, the obturator cooperates with the breast tissue to produce a visually noticeable artifact in the MRI image. After both of these techniques have been used to verify the location within the breast where the biopsy should be performed, the obturator or imaging rod is removed.

Furthermore, in an MRI-guided breast biopsy procedure, the obturator or imaging rod is removed and then replaced in the sleeve with the needle of a breast biopsy probe. A cutter inside the needle of the probe is used to remove tissue which is then transported either to a manual location in the breast biopsy device or to a sample chamber in the breast biopsy device. After the biopsy tissue is removed, a biopsy marker cannula is inserted into the needle and used to place a biopsy site marker at the biopsy site. The needle is then removed from the sleeve. Optionally, the imaging rod or obturator is placed back into the breast for re-imaging of the biopsy site. The imaging rod or obturator and sleeve are then removed.

Both suction and core needle biopsy devices may have various advantages over the other, depending on the situation. For example, one advantage of suction biopsy devices is that suction allows for the extraction of multiple tissue samples with a single insertion. However, core needle biopsy devices do not have this feature, but it may be desirable to use a core needle biopsy device nonetheless. For example, core needle biopsy devices may generally include a smaller needle than core needle biopsy devices, which may reduce patient anxiety and increase the ability of the needle to penetrate a lesion. Thus, in some cases, it may be desirable to incorporate the multiple sample extraction feature of a suction biopsy device into a core needle biopsy device in order to obtain the benefits found in both styles of biopsy devices.

A desirable feature of the device described herein is that it is a core needle biopsy device, and that it allows for the acquisition of multiple samples with a single insertion while still using a core needle type device. Currently, only suction biopsy devices are believed to have this capability.

I. Exemplary Core Needle Biopsy Device FIG. 1 illustrates an exemplary core needle biopsy device (10) for use in a breast biopsy procedure. The core needle biopsy device (10) of this example includes a body (12) and a needle assembly (20) extending distally from the body (12). The body (12) includes an outer housing (14) and an actuation member (16) disposed on the outer housing (14). As described in more detail below, the outer housing (14) encases the various components of the biopsy device (10), which are used to drive the needle assembly (20) through cutting and tissue collection cycles. To this end, the outer housing (14) of this example is sized and shaped to be grasped by an operator in one hand. Although not illustrated, it should be understood that in some examples, the outer housing (14) may include multiple sections, each section interconnecting to form the outer housing (14).

2 and 3 show the needle assembly (20) in more detail. As shown in FIG. 2, the needle assembly (20) comprises an elongated piercer (22) and an elongated cutter (40). As described in more detail below, the piercer (22) is generally movable relative to the cutter (40) to pierce the tissue and collect a tissue sample, while the cutter is generally movable relative to the piercer (22) to sever the tissue sample. The piercer (22) comprises a generally cylindrical rod having a sharp distal tip (24) and a notch (26) disposed adjacent the distal tip (24). As described in more detail below, the distal tip (24) is generally configured to penetrate the tissue of a patient. Also, as described in more detail below, the notch (26) is generally configured to receive tissue therein such that the tissue sample may be collected in the notch (26) after it has been severed by the cutter (40).

The end (30) is disposed at the proximal end of the puncture device (22). In this example, the end (30) is overmolded onto the proximal end of the puncture device (22) and is generally configured to enhance maneuverability of the puncture device (22). Specifically, the end (30) includes a receiving feature (32) in the form of a latch notch. The receiving feature (32) is configured to receive a portion of the puncture device drive assembly (300). As described in more detail below, this feature enables the puncture device drive assembly (300) to drive the movement of the puncture device (22) through a predetermined movement sequence.

The cutter (40) includes a generally hollow cylindrical tube configured to receive the puncture tool (22) therein. The cutter (40) includes an open distal end (42), a cannula portion (44), and an end portion (50). The open distal end (42) is configured to allow at least a portion of the puncture tool (22) to protrude from the cutter (40) when the puncture tool (22) is moved relative to the cutter (40). As described in more detail below, this configuration allows the needle assembly (20) to move through cutting and tissue collection cycles by allowing the notch (26) of the puncture tool (22) to move relative to the distal end (42) of the cutter (40).

The open distal end (42) of this example includes a tapered edge (43). The tapered edge (43) is generally configured to bite into tissue and separate a tissue sample when the cutter (40) is moved relative to the notch (26) of the lancet (22). It should be understood, therefore, that the tapered edge (43) is generally configured to function as a blade. While this example is described and illustrated as using a tapered configuration, it should be understood that in other examples, various alternative configurations can be used. For example, in some examples, the tapered edge (43) includes a plurality of serrated edges in addition to or in place of the taper illustrated. In still other examples, the tapered edge (43) can include any other additional or alternative cutting surface as would be apparent to one of ordinary skill in the art in view of the teachings herein.

The cannula portion (44) of the cutter (40) extends proximally from the distal end (42) through the end (50) so that the puncture device (22) can be received at the proximal end of the cutter (40). Unlike the end (30) of the puncture device (22), the end (50) of the cutter (40) is generally elongated such that at least a portion of the end (50) extends distally relative to the outer housing (14). As described in more detail below, this distal extension relative to the outer housing (14) allows an operator to reach a portion of the end (50) for tissue sample collection purposes.

The end (50) of the cutter (40) includes a receiving feature (52) and a tissue collection feature (54). Similar to the receiving feature (32) of the lancet (22), the receiving feature (52) of the end (50) includes a lateral slot or other receiving feature configured to receive at least a portion of the cutter drive assembly (200). As described in more detail below, the receiving feature (52) is configured to receive at least a portion of the cutter drive assembly (200) to enable the cutter drive assembly (200) to move the cutter (40) in a predetermined motion sequence.

The tissue collection feature (54) is disposed distally relative to the receiving feature (52). The tissue collection feature (54) generally defines an elongated notch that opens into the cannula portion (44) of the cutter (40). Correspondingly, the cannula portion (44) includes a cutout portion (46) adjacent the tissue collection feature (54). It should be understood that the tissue collection feature (54) is thus in communication with the hollow interior, or lumen, defined by the cannula portion (44). As will be explained in more detail below, this relationship between the tissue collection feature (54) and the cannula portion (44) allows an operator to remove the tissue sample from the cutter (40) when the tissue sample is collected by the lancing device (22).

FIG. 3 shows the puncture device (22) disposed within the cutter (40). As shown, the cutter (40) is generally configured to receive the puncture device (22) such that the puncture device (22) is coaxial with the cutter (40). Additionally, the puncture device (22) is generally movable relative to the open distal end (42) of the cutter (40). It should be understood that in some circumstances, the puncture device (22) moves relative to the cutter (40) while the cutter (40) remains stationary. In other circumstances, the cutter (40) moves relative to the puncture device (22) while the puncture device (22) remains stationary. In either case, it should be understood that the lancet (22) and cutter (40) are generally configured such that the notch (26) of the lancet (22) can be moved into and out of the cutter (40) such that the notch (26) can be positioned distally or proximally relative to the open distal end (42) of the cutter (40). As described in more detail below, this configuration allows the lancet (22) and cutter (40) to operate in concert to penetrate tissue, sever tissue samples, and withdraw tissue samples for collection by an operator via the tissue collection feature (54).

4 and 5 show the internal components of the body (12) of the biopsy device (10) with the outer housing (14) removed. As shown, within the outer housing (14), the body (12) includes a drive assembly (100). The drive assembly (100) is generally configured to engage the needle assembly (20) and drive the lancet (22) and cutter (40) through a predetermined sequence of movements to penetrate tissue and obtain multiple tissue samples with a single insertion of the needle assembly (20) into the patient. Although not shown, it should be understood that the outer housing (14) defines various internal geometries that support or otherwise engage the drive assembly (100). It should be understood that such internal geometries are used to provide relative motion of various components of the drive assembly (100) with respect to other components of the drive assembly (100) and/or the outer housing (14).

The drive assembly (100) includes a needle cocking assembly (110), a cutter drive assembly (200), a puncture drive assembly (300), and a release assembly (400). In general, as described in more detail below, the needle cocking assembly (110) engages the cutter drive assembly (200) and the puncture drive assembly (300) to cock the cutter (40) and the puncture drive assembly (22) in response to cocking the cutter drive assembly (200) and the puncture drive assembly (300). The release assembly (400) also engages the cutter drive assembly (200) and the puncture drive assembly (300) to selectively release and fire the cutter drive assembly (200) and the puncture drive assembly (300), thereby selectively releasing and firing the cutter (40) and the puncture drive assembly (22).

The needle cocking assembly (110) is best shown in Figures 6-9. As can be seen, the needle cocking assembly (110) includes a lead screw (112), a carriage nut (130), a drive member (150), and a motor assembly (160). The lead screw (112) is best shown in Figure 7. As can be seen, the lead screw (112) is a generally elongated, multi-threaded rod. The lead screw (112) includes a distal end (114), a first threaded portion (116), a slide stop portion (118), a non-threaded portion (120), a keyway (122), a second threaded portion (124), and a proximal end (126).

The distal end (114) of the lead screw (112) generally has a cylindrical shape extending distally from the first threaded portion (116). The distal end (114) is configured to be received by at least a portion of the outer housing (14) or another intermediate coupling member, such as a bearing, to allow the lead screw (112) to rotate about a fixed axis. It should therefore be understood that the distal end (114) generally functions as a boss or locating feature that allows the lead screw (112) to rotate.

The first threaded portion (116) is disposed proximally of the distal end (114). The first threaded portion (116) includes a thread (117) having a relatively fine pitch. As described in more detail below, the thread (117) is generally configured to engage a portion of the cutter drive assembly (200) and convert rotational motion of the lead screw (112) into translational motion of at least a portion of the cutter drive assembly (200). This conversion of motion generally cocks the cutter drive assembly (200) when proximal and distal translational motion of at least a portion of the cutter drive assembly (200) occurs.

The slide stop portion (118) is disposed proximally of the first threaded portion (116) and distally of the keyway (122), the second threaded portion (124), and the proximal end (126). The slide stop portion (118) includes a generally cylindrical shape. The diameter of the slide stop portion (118) generally corresponds to the major effective diameter of the first threaded portion (116). As described in more detail below, these size and shape characteristics of the slide stop portion (118) enable the slide stop portion (118) to coaxially support at least a portion of the cutter drive assembly (200) as the cutter drive assembly (200) moves relative to the lead screw (112).

The diameter of the slide stop portion (118) is also generally larger than the diameter of the non-threaded portion (120) of the lead screw (112). As will be appreciated, this difference in diameter between the slide stop portion (118) and the non-threaded portion (120) allows the slide stop portion (118) to function as a mechanical stop feature. As will be explained in more detail below, this mechanical stop feature is configured to limit distal translational motion of the carriage nut (130) as it moves along the lead screw (112).

Between the slide stop portion (118) and the first threaded portion (116), the lead screw (112) defines a recess (119). As described in more detail below, the recess (119) is generally configured to allow a portion of the cutter drive assembly (200) to "freewheel" when the cutter drive assembly (200) is disposed in axial alignment with the recess (119). It should be understood that the term "freewheel" as used herein refers to the ability of the lead screw (112) to continue to rotate without further proximal translational motion of the cutter drive assembly (200) and without interfering between the lead screw (112) and at least a portion of the cutter drive assembly (200). It should be understood that during freewheeling, at least a portion of the cutter drive assembly (200) is generally disengaged from the first threaded portion (116) of the lead screw (112). However, it should be understood that the length of the recess (119) is limited sufficiently so that at least a portion of the cutter drive assembly (200) re-engages with the first threaded portion (116) of the lead screw (112) if the rotational motion of the lead screw (112) is reversed. Further details of the relationship between the recess (119), the first threaded portion (116), and the cutter drive assembly (200) are described in more detail below.

As shown in FIG. 7, the non-threaded portion (120) is proximally adjacent to the slide stop portion (118). The non-threaded portion (120) is also distally adjacent to the second threaded portion (124) and is disposed distally of the proximal end (126). The non-threaded portion (120) is generally cylindrical without threads or other features. However, as seen in FIG. 7, the keyway (122) extends through the non-threaded portion (120) and through the second threaded portion (124). As previously described with respect to the slide stop portion (118), the non-threaded portion (120) has a diameter generally smaller than the diameter defined by the slide stop portion (118). Also as noted above, this diametric difference between the non-threaded portion (120) and the slide stop portion (118) allows the non-threaded portion (120) to provide a mechanical stop function for the carriage nut (130), as described in more detail below.

The second threaded portion (124) is disposed between the non-threaded portion (120) and the proximal end (126), with the non-threaded portion (120) distal to the second threaded portion (124) and the proximal end (126) proximal to the non-threaded portion (120). The second threaded portion (124) includes a plurality of relatively coarse threads (125). The threads (125) are generally coarse relative to the threads (117) of the first threaded portion (116). It should thus be understood that both threads (125, 117) function to transfer rotational motion to axial translational motion, with the threads (125) of the second threaded portion (124) generally providing a higher rate of translational motion from the same rotational input relative to the threads (117) of the first threaded portion (116).

The second threaded portion (124) of the present example is configured to engage at least a portion of the piercer drive assembly (300). As described in more detail below, the threads (125) of the second threaded portion (124) are generally configured to convert rotational motion of the lead screw (112) into axial translational motion of at least a portion of the piercer drive assembly (300). Converting this rotational motion into translational motion enables the piercer drive assembly to translate the piercer (22) for tissue collection via the tissue collection feature (54).

In this example, the second threaded portion (124) and the non-threaded portion (120) are arranged such that the non-threaded portion (120) defines a length. The length of the non-threaded portion (120) is generally slightly greater than the approximate length of the carriage nut (130). As will be appreciated, the length of the non-threaded portion allows the carriage nut (130) to be translated axially by the puncture drive assembly (300) until stopped by the slide stop portion (120). Although the translational motion is stopped by the slide stop portion (120), the non-threaded portion (120) allows the lead screw (112) to "freewheel" relative to the puncture drive assembly (300). It should be understood that the term "freewheel" as used herein refers to the ability of the lead screw (112) to continue to rotate without further translational motion of the puncture drive assembly (300) and without binding between the lead screw (112) and the puncture drive assembly (300). During freewheel operation, the puncture drive assembly (300) is normally disengaged from the second threaded portion (124). However, it should be understood that the length of the non-threaded portion remains limited to such an extent that the puncture drive assembly (300) re-engages with the second threaded portion (124) if the rotational motion of the lead screw (112) is reversed. Further details of the relationship between the non-threaded portion (120), the second threaded portion (124), and the puncture drive assembly (300) are described in more detail below.

Returning to FIG. 6, the rotational motion of the lead screw (112) is provided by a drive member (150) and a motor assembly (160). In particular, the drive member (150) in this example is configured to be rigidly fixed to the proximal end (126) of the lead screw (112). The drive member (150) includes a rotational transmission feature (152) configured to transmit rotational motion from a rotational transmission feature (162) of the motor assembly (160) to the lead screw (112). In this example, the rotational transmission features (152, 162) are configured as a belt drive such that the rotational motion is transmitted via a belt (not shown). Although the rotational transmission features (152, 162) are shown as using a belt drive, it should be understood that any other suitable rotational transmission feature may be used. For example, in some examples, the rotational transmission features (152, 162) may include one or more gears with various gear ratios to transmit the rotational motion from the motor assembly (160) to the lead screw (112). Of course, in other examples, the rotational transmission features (152, 162) can be omitted entirely, such that the motor assembly (160) includes a direct drive that transmits rotational motion directly to the lead screw (112).

As described above, the motor assembly (160) includes a rotary transmission feature (162). Additionally, the motor assembly (160) includes a rotary power source (164). In this example, the rotary power source (164) includes an electric motor. In other examples, the rotary power source (164) may include any other suitable power source, such as a pneumatic motor, a piezoelectric motor, etc.

Figure 8 shows the carriage nut (130) in more detail. As can be seen, the carriage nut (130) has a generally cylindrical shape with a bore (132) extending completely therethrough. A key (134) extends inwardly into the bore (132). The key (134) extends axially through at least a portion of the length of the carriage nut (130). As will be described in more detail below, the key (134) is generally configured to engage a keyway (122) of the lead screw (112) such that the carriage nut (130) is generally configured to rotate in conjunction with the lead screw (112).

On the exterior of the carriage nut (130), the carriage nut (130) defines a threaded portion (136) and a sliding portion (140). The threaded portion (136) includes a plurality of threads (138). The threads (138) generally include a pitch that is relatively fine relative to and approximately equal to the pitch of the threads (117) of the first threaded portion (116) previously described with respect to the lead screw (112). As will be described in more detail, the threads (138) of the threaded portion (136) are generally configured to engage at least a portion of the puncture drive assembly (300) and move at least a portion of the puncture drive assembly (300) through various positions adjacent which the puncture drive assembly (22) is cocked and fired.

The sliding portion (140) defines a generally cylindrical shape having an outer diameter that corresponds approximately to the outer diameter of the threaded portion (136). As described in more detail below, this diametric correspondence allows at least a portion of the cutter drive assembly (200) to slide freely over both the sliding portion (140) and the threaded portion (136) while remaining approximately coaxial with the carriage nut (130).

Adjacent to the proximal end of the carriage nut (130), the slide portion (140) defines an annular channel (142). As described in more detail below, the annular channel (142) is configured to receive at least a portion of the puncture drive assembly (300) to axially secure at least a portion of the puncture drive assembly (300) to the carriage nut (130). However, as described in more detail below, none of the portions of the cutter drive assembly (300) axially secured to the carriage nut (130) via the cannula channel (142) are rotatably secured such that the carriage nut (130) can rotate relative to the puncture drive assembly (300).

The carriage nut (130) defines a recess (144) disposed between the sliding portion (140) and the threaded portion (136). The recess (144) is defined by an outer diameter that is generally smaller than the outer diameter of the threaded portion (136) and the outer diameter of the sliding portion (140). Additionally, the recess (144) defines a length. As described in more detail below, the length of the recess (144) is generally approximately equal to at least a portion of the puncture drive assembly (300) and allows the portion of the puncture drive assembly (300) to freewheel relative to the carriage nut (130).

As will be described in more detail below, the recess (144) is generally configured to allow a portion of the puncture drive assembly (300) to "freewheel" when the puncture drive assembly (300) is disposed in axial alignment with the recess (144). As described above with respect to the non-threaded portion (120) of the lead screw (112), the term "freewheel" as used herein refers to the ability of the carriage nut (130) to continue to rotate without further proximal translational movement of the puncture drive assembly (300) and without pinching between the carriage nut (130) and at least a portion of the puncture drive assembly (300). It should be understood that during freewheeling, at least a portion of the puncture drive assembly (300) is generally disengaged from the threaded portion (136) of the carriage nut (130). However, it should be understood that the length of the recess (144) is limited sufficiently so that at least a portion of the piercer drive assembly (300) re-engages with the threaded portion (136) of the carriage nut (130) if the rotational motion of the carriage nut (130) is reversed. Further details of the relationship between the recess (144), the threaded portion (136), and the piercer drive assembly (300) are described in more detail below.

9 shows the carriage nut (130) coaxially disposed on the lead screw (112). As can be seen, when the carriage nut (130) is disposed on the lead screw (112), the key (134) extends into the keyway (122) of the lead screw (112). It should therefore be understood that the keyway (122) of the lead screw (112) engages the key (134) such that rotation of the lead screw (112) results in corresponding rotational movement of the carriage nut (130). It should be appreciated that the keyway (122) extends through both the second threaded portion (124) and the non-threaded portion (120) of the lead screw (112) such that the keyway (122) is configured to engage the key (134) of the carriage nut (130) as the carriage nut (130) moves axially around the second threaded portion (124) and the non-threaded portion (120) of the lead screw (112).

10A shows the cutter actuation assembly (200) in more detail. In particular, the cutter actuation assembly (200) comprises a cocking member (210), an actuation member (230), and a resilience member (202). The cocking member (210) comprises a stop portion (212), a slide portion (216), and a bore (220) extending axially through the cocking member (210). The stop portion (212) is generally configured to function as a mechanical stop for the actuation member (230). As such, the stop portion (212) forms a shape resembling a partially cylindrical flange or another similar feature. As will be described in more detail below, this mechanical stop function of the stop portion (212) is generally configured to manipulate the motion of the actuation member (230) when the actuation member (230) moves the cutter (40) through a predetermined motion sequence.

The stop portion (212) further defines an alignment tab (214) that extends upwardly relative to the bore (220). The alignment tab (214) has a generally rectangular or cubic shape. In other examples, the alignment tab (214) may include any other suitable shape, such as a cylindrical shape, a ball shape, a triangular shape, and the like. Although not shown, it should be understood that the alignment tab (214) is configured to be received within a corresponding channel or track disposed within the outer housing (14) or the intermediate housing (not shown). Such a channel or track is configured to restrict the motion of the cocking member (210) to a particular predetermined axial path. Such a channel or track is further configured to prevent rotational motion of the cocking member (210) relative to the lead screw (112) to allow the lead screw (112) to transmit axial motion of the cocking member (210), as described in more detail below.

The slide portion (216) of the cocking member (210) extends proximally from the stop portion (212). The slide portion (216) includes a generally cylindrical outer surface configured to receive the actuating member (230). As described in more detail below, the actuating member (230) is generally coaxially slidable on the slide portion (216) to actuate the cutter (40) through a predetermined motion sequence. However, the slide portion (216) has a diameter that is smaller than the size or diameter of the stop portion (212). Thus, it should be understood that the actuating member (230) is generally coaxially slidable on the slide portion (216) until the actuating member (230) reaches the stop portion (212). At that point, any further distal sliding relative to the slide portion (216) is stopped by the stop portion (212).

As described above, the hole (220) of the cocking member (210) extends through both the stop portion (212) and the slide portion (216). The hole (220) defines a plurality of threads (222) that extend inwardly of the hole (220). As best seen in FIG. 10B, the threads (222) of the hole (220) extend only through a length of the hole (220) that corresponds to the length of the stop portion (212). It should be understood that while the threads (222) in this example extend only partially through the hole (220), in other examples, the threads (222) can extend the entire length of the hole (220). However, it should be understood that in such examples, certain complementary features of the lead screw (112) may require length/size adjustment to accommodate the additional length of the threads (222).

The bore (220) is configured to receive at least a portion of the lead screw (112). In particular, the bore (220) is configured to receive the first threaded portion (116), the recess (119), and/or the slide stop portion (118) of the lead screw (112) during various stages during the cutting and tissue acquisition cycles, as described in more detail below. As will be appreciated, the threads (222) are configured to engage the threads (117) of the first threaded portion (116). It will thus be appreciated that rotational movement of the lead screw (112) relative to the cocking member (210) generally results in axial translational movement of the cocking member (210) relative to the lead screw (112).

As noted above, the threads (222) of the hole (220) are generally limited to the length of the stop portion (212). It should be understood that because a portion of the hole (220) in this example (e.g., the portion corresponding to the sliding portion (216)) is not threaded, the hole (220) can receive at least a portion of the sliding stop portion (118) of the lead screw (112). However, it should be understood that, because the sliding stop portion (118) defines a diameter approximately equal to the outer diameter of the first threaded portion (116) of the lead screw (112), as the cocking member (210) moves proximally relative to the lead screw (112), such relative movement is only possible until the threads (222) reach the sliding stop portion (118) of the lead screw (112). When the threads (222) reach the slide stop portion (118) of the lead screw (112), the interference between the outer diameter of the threads (222) and the outer diameter of the slide stop portion (118) prevents further proximal movement of the cocking member (210). Furthermore, the threads (222) at this stage are adjacent to the target portion (119) and therefore disengage from the threads (117) of the first threaded portion (116).

The actuating member (230) includes a body (232), an alignment tab (236), and an actuating tab (240). The body (232) has a shape generally similar to the stop portion (212) described above with respect to the cocking member (210). Like the stop portion (212), the body (232) defines a hole (234) extending through the body (232). The hole (234) of the body (232) is configured to receive the slide portion (216) of the cocking member (210). It should be understood that the actuating member (230) is therefore slidable generally coaxially with the slide portion (216) of the cocking member (210).

An alignment tab (236) extends upward from the body (232). Similar to the alignment tab (214) of the cocking member (210), the alignment tab (236) of the actuating member (230) is configured to engage a channel or track disposed in the outer housing (14) or intermediate housing (not shown). As above, this arrangement generally allows such a channel or track to restrict the movement of the actuating member (230) to a predetermined path. However, unlike the alignment tab (214) described above, the alignment tab (236) of the actuating member (230) extends only a relatively short distance from the body (232). Instead of the alignment tab (236) extending to its full extent as seen with the alignment tab (214), a portion of the alignment tab (236) of the actuating member (230) is replaced with a release member (238). The release member (238) has a generally cylindrical shape. As described in more detail below, the release member (238) is generally configured to be received by the release assembly (400) to temporarily hold the actuating member (230) in a cocked position and then selectively release the actuating member (230) by actuation of the release assembly (400).

The actuation tab (240) extends downwardly from the body (232). The actuation tab (240) includes an upper portion (242) and a lower portion (244). The upper portion (242) has a generally rectangular shape. Although not shown, it should be understood that in some examples, the upper portion (242) can be configured to be received within a channel or track in the outer housing (14) or an intermediate inner housing (not shown). In such examples, the upper portion (242) functions to restrict the movement of the actuation member (230) to a predetermined path.

The lower portion (244) of the actuation tab (240) extends downward from the upper portion (242). The lower portion (244) is generally configured to be received within the receiving feature (52) of the cutter (40). As described in more detail below, when the lower portion (244) is received within the receiving feature (52) of the cutter (40), the actuation member (230) is generally enabled to drive the cutter (40) through a predetermined sequence of motions via the lower portion (244). Although not shown, in examples where the upper portion (242) is received within a channel or track of the outer housing (14) or the intermediate inner housing, it should be understood that such channel or track may include an opening or additional channel to prevent the lower portion (244) from extending through such channel or track to the receiving feature (52) of the cutter (40).

When the cutter drive assembly (200) is assembled (e.g., as seen in FIG. 4), the spring (202) is disposed adjacent to the proximal end of the actuating member (230). Additionally, the spring (202) is coaxially disposed about the sliding portion (216) of the cocking member (210) and/or about the sliding stop portion (118) of the lead screw (112) depending on the particular stage of operation of the drive assembly (100). As described in more detail below, the spring (202) is generally configured to drive the actuating member (230) distally after the actuating member (230) is released by the release assembly (400). The spring (202) generally defines an outer diameter that generally corresponds to an outer diameter of the sliding portion (216) of the cocking member (210). While the spring (202) in this example is shown as a coil spring, it should be understood that any other suitable resilience member may be used, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

11A shows the piercer drive assembly (300) in more detail. As can be seen, the piercer drive assembly (300) comprises a cocking member (310), an actuating member (330), a piercer retraction assembly (350), and a spring (302). The cocking member (310) of the piercer drive assembly (300) is similar to the cocking member (210) of the cutter drive assembly (200). Specifically, like the cocking member (210), the cocking member (310) comprises a stop portion (312), a slide portion (316), and a bore (320) extending axially through the cocking member (310). The stop portion (312) is generally configured to function as a mechanical stop for the actuating member (330). As such, the stop portion (312) forms a shape resembling a partially cylindrical flange or another similar feature. As described in more detail below, this mechanical stop feature of the stop portion (312) is generally configured to manipulate the motion of the actuating member (330) as the actuating member (330) moves the puncture device (22) through a predetermined motion sequence.

The stop portion (312) further defines an alignment tab (314) that extends upwardly relative to the bore (320). The alignment tab (314) has a generally rectangular or cubic shape. In other examples, the alignment tab (314) may include any other suitable shape, such as a cylindrical shape, a ball shape, a triangular shape, and the like. Although not shown, it should be understood that the alignment tab (314) is configured to be received within a corresponding channel or track disposed within the outer housing (14) or the intermediate housing (not shown). Such a channel or track is configured to restrict the motion of the cocking member (310) to a particular predetermined axial path. Such a channel or track is further configured to allow the lead screw (112) and the carriage nut (130) to transmit axial motion of the cocking member (310) by preventing rotational motion of the cocking member (310) relative to the lead screw (112) and the carriage nut (130), as described in more detail below.

The slide portion (316) of the cocking member (310) extends proximally from the stop portion (312). The slide portion (316) includes a generally cylindrical outer surface configured to receive the actuating member (330). As described in more detail below, the actuating member (330) is generally coaxially slidable on the slide portion (316) to actuate the cutter (40) through a predetermined motion sequence. However, the slide portion (316) has a diameter that is smaller than the size or diameter of the stop portion (312). Thus, it should be understood that the actuating member (330) is generally coaxially slidable on the slide portion (316) until the actuating member (330) reaches the stop portion (312). At that point, any further distal sliding relative to the slide portion (316) is stopped by the stop portion (312).

As mentioned above, the hole (320) of the cocking member (310) extends through both the stop portion (312) and the slide portion (316). The hole (320) defines a plurality of threads (322) that extend inwardly of the hole (320). As best seen in FIG. 11B, the threads (322) of the hole (320) extend only through a longitudinal length of the hole (320) that corresponds to the length of the stop portion (312). In other examples, the threads (322) can instead extend the entire length of the hole (320). However, in such examples, it should be understood that certain complementary features of the carriage nut (130) may require length/size adjustment to accommodate the additional length of the threads (322).

The bore (320) is configured to receive at least a portion of the carriage nut (130). In particular, the bore (320) is configured to receive the threaded portion (136), the recess (144), and/or the sliding portion (140) of the carriage nut (130) during various stages during the cutting and tissue acquisition cycles, as described in more detail below. As will be appreciated, the threads (322) are configured to engage the threads (138) of the threaded portion (136) of the carriage nut (130). It will thus be appreciated that rotational movement of the carriage nut (130) by the lead screw (112) relative to the cocking member (310) generally results in axial translational movement of the cocking member (310) relative to the carriage nut (130) and the lead screw (112).

As noted above, the threads (322) of the hole (320) are generally limited to the length of the stop portion (312). It should be understood that because a portion of the hole (320) in this example (e.g., the portion corresponding to the sliding portion (316)) is not threaded, the hole (320) can receive at least a portion of the sliding portion (140) of the carriage nut (130). However, it should be understood that, because the sliding portion (140) defines a diameter approximately equal to the outer diameter of the threaded portion (136) of the carriage nut (130), as the cocking member (310) moves proximally relative to the carriage nut (130) and the lead screw (112), such relative movement is only possible until the threads (322) reach the sliding portion (140) of the carriage nut (130). When the threads (322) reach the sliding portion (140) of the carriage nut (130), the interference between the outer diameter of the threads (322) and the outer diameter of the sliding portion (140) prevents further proximal movement of the cocking member (310). Furthermore, the threads (322) at this stage are adjacent to the target portion (144) and therefore disengage from the threads (138) of the threaded portion (136).

The actuating member (330) includes a body (332), an alignment tab (336), and an actuating tab (340). The body (332) has a shape generally similar to the stop portion (312) described above with respect to the cocking member (310). Like the stop portion (312), the body (332) defines a hole (334) extending through the body (332). The hole (334) of the body (332) is configured to receive the slide portion (316) of the cocking member (310). It should thus be understood that the actuating member (330) is slidable generally coaxially with the slide portion (316) of the cocking member (310).

An alignment tab (336) extends upward from the body (332). Similar to the alignment tab (314) of the cocking member (310), the alignment tab (336) of the actuating member (330) is configured to engage a channel or track disposed in the outer housing (14) or intermediate housing (not shown). As above, this arrangement generally allows such a channel or track to restrict the movement of the actuating member (330) to a predetermined path. However, unlike the alignment tab (314) described above, the alignment tab (336) of the actuating member (330) extends only a relatively short distance from the body (332). Instead of the alignment tab (336) extending to its full extent as seen with the alignment tab (314), a portion of the alignment tab (336) of the actuating member (330) is replaced with a release member (338). The release member (338) has a generally cylindrical shape. As described in more detail below, the release member (338) is generally configured to be received by the release assembly (400) to temporarily hold the actuating member (330) in a cocked position and then selectively release the actuating member (330) upon actuation of the release assembly (400).

The actuation tab (340) extends downwardly from the body (332). The actuation tab (340) includes an upper portion (342) and a lower portion (344). The upper portion (342) has a generally rectangular shape. Although not shown, it should be understood that in some examples, the upper portion (342) can be configured to be received within a channel or track in the outer housing (14) or an intermediate inner housing (not shown). In such examples, the upper portion (342) functions to restrict the movement of the actuation member (330) to a predetermined path.

The lower portion (344) of the actuation tab (340) extends downwardly from the upper portion (342). The lower portion (344) is generally configured to be received within the receiving feature (32) of the puncture device (22). As described in more detail below, when the lower portion (344) is received within the receiving feature (32) of the puncture device (22), the actuation member (330) is generally enabled to drive the puncture device (22) through a predetermined sequence of motion via the lower portion (344). Although not shown, in examples where the upper portion (342) is received within a channel or track of the outer housing (14) or the intermediate inner housing, it should be understood that such channel or track may include an opening or additional channel to prevent the lower portion (344) from extending through such channel or track to the receiving feature (32) of the puncture device (22).

The puncture retraction assembly (350) is disposed proximally of the cocking member (310) and the actuation member (330). As described in more detail below, the puncture retraction assembly (350) is generally configured to axially translate the puncture drive assembly (300) relative to the lead screw (112). The puncture retraction assembly (350) includes a first retraction member (352) and a second retraction member (370), and a retainer (390) disposed between the first retraction member (352) and the second retraction member (370).

The first retraction member (352) comprises a body (354) and a support arm (360). The body (354) defines a bore (356) extending entirely through the body (354). The body (354) further includes a counterbore (358) disposed adjacent the bore (356). The counterbore (358) extends distally only partially through the body (354) from its proximal end. As described in more detail below, the bore (356) and the counterbore (358) are generally sized to receive the sliding portion (316) of the cocking member (310) and the sliding portion (140) of the carriage nut (130). The hole (356) defines a diameter that is generally smaller than the diameter defined by the retainer (390), and the counterbore (358) defines a diameter that is generally larger than the diameter defined by the retainer (390). As will be described in more detail below, this difference in diameter between the hole (356) and the counterbore (358) is configured to secure the retainer (390) between the first retraction member (352) and the second retraction member (370).

The support arm (360) of the first retraction member (352) extends distally from the body (354). The distal extension of the support arm (360) defines a length generally equal to that of the spring (302) in a compressed state. On a distal end of the support arm (360), the support arm (360) defines a receiving recess (362). The receiving recess (362) is generally configured to receive at least a portion of the release member (338) of the actuation member (330). As described in more detail below, the receiving recess (362) is generally configured to operate in conjunction with at least a portion of the release assembly (400) to selectively hold the release member (338) in a predetermined position relative to the first retraction member (352).

The second retraction member (370) comprises a body (372) having a generally rectangular shape. The body (372) defines a hole (374) and a counterbore (376) coaxially disposed with the hole (374). The hole (374) extends entirely through the body (372), while the counterbore (376) extends distally from its distal end through only a portion of the body (372). Both the hole (374) and the counterbore (376) are configured to receive at least a portion of the lead screw (112), such that the lead screw (112) can extend entirely through the second retraction member (370). However, the diameter defined by the counterbore (376) is larger than the diameter defined by the hole (374) in order to accommodate the retainer (390) within the counterbore (376). It should be appreciated that this difference in diameter of the hole (374) and the countersunk hole (376) is configured to prevent proximal movement of the retainer (390) relative to the second retracting member (370), such that the retainer (390) is generally held between the first retracting member (352) and the second retracting member (370).

Additionally, bore (374) includes a protrusion (378) that extends downwardly within the space defined by bore (374). Protrusion (378) includes a generally cylindrical shape, although any other suitable shape may be used. As described in more detail below, protrusion (378) is configured to engage threads (125) of lead screw (112) to transmit translational motion of second retraction member (370) in response to rotational motion of lead screw (112).

As described above, the retainer (390) is disposed between the first retraction member (352) and the second retraction member (370). The retainer (390) generally has a circular shape similar to a washer or other similar structure. The retainer (390) includes a hole (392) extending entirely through the retainer (390). The hole (392) in the retainer (390) is sized to allow the retainer (390) to fit within the annular channel (142) of the carriage nut (130). It should be understood that because the retainer (390) is secured between the first retraction member (352) and the second retraction member (370), the engagement between the retainer (390) and the annular channel (142) may cause the retainer (390) to generally axially secure the movement of the carriage nut (130) relative to the perforator retraction assembly (350). It should therefore be appreciated that axial movement of the carriage nut (130) generally results in axial movement of the lancet retraction assembly (350). As will be described in more detail below, this motional relationship between the carriage nut (130) and the lancet retraction assembly (350) generally results in the lancet (22) being retracted during a tissue acquisition cycle.

It should be understood that the retainer (390) axially fixes the movement of the carriage nut (130) relative to the puncture retraction assembly (350), but the carriage nut (130) is rotatably movable relative to the puncture retraction assembly (350). In other words, the retainer (390) fixes only the axial movement of the carriage nut (130), but not the rotational movement. Although not shown, it should be understood that in some examples, the retainer (390) is adjacent to one or more bearings, which can be disposed in the counterbores (358, 376) of one or both of the first retraction member (352) and the second retraction member (370), respectively. In such examples, the bearings can be used to facilitate the rotatability of the carriage nut (130) relative to the puncture retraction assembly (350). Additionally, while retainer (390) is shown as having a generally circular shape, it should be understood that in some examples, retainer (390) may include a variety of other shapes. For example, in other examples, retainer (390) comprises a c-washer, a snap-on washer, a circlip, a Jesus clip, and/or any other suitable retention feature that would be apparent to one of ordinary skill in the art in view of the teachings herein.

When the piercer drive assembly (300) is assembled (e.g., as seen in FIG. 4), the spring (302) is disposed between the proximal end of the actuating member (330) and the distal end of the body (354) of the first retraction member (352). Additionally, the spring (302) is disposed coaxially around the sliding portion (316) of the cocking member (310) and/or around the sliding portion (140) of the carriage nut (130) depending on the particular stage of operation of the drive assembly (100). As described in more detail below, the spring (302) is generally configured to drive the actuating member (330) in a distal direction after the actuating member (330) is released by the release assembly (400). The spring (302) generally defines an outer diameter that generally corresponds to an outer diameter of the sliding portion (316) of the cocking member (310). While the spring (302) in this example is shown as a coil spring, it should be understood that any other suitable resilience member may be used, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

12 and 13 show the release assembly (400) in more detail. As can be seen, the release assembly (400) comprises a nut member (410), a second lead screw (420), a motor assembly (430), a first latch member (440), and a second latch member (450). The nut member (410) comprises a body (412) through which extends a longitudinally elongated bore (414). Although not shown, it should be understood that the bore (414) comprises a threaded portion (not shown) in the body (412) that includes a thread (not shown) extending into the bore (414). As will be described in more detail below, the threaded portion of the bore (414) is configured to engage at least a portion of the second lead screw (420) to enable the second lead screw (420) to transmit proximal and distal translational motion of the nut member (410).

The nut member (410) further includes a first latch actuator (416) and a second latch actuator (418) extending downwardly from the body (412). Both the first latch actuator (416) and the second latch actuator (418) have a generally cylindrical shape, although any other suitable shape may be used. The first latch actuator (416) is coupled to the first latch member (440), and the second latch actuator (418) is coupled to the second latch member (450). As described in more detail below, the latch actuators (416, 418) are generally configured to engage the corresponding latch members (440, 450) to release the cutter drive assembly (200) and the piercer drive assembly (300) to fire the cutter (40) and the piercer (22), respectively.

The second lead screw (420) comprises a drive rod (422) and a drive member (426). The drive rod (422) defines a generally cylindrical shape with a plurality of threads (424) extending along at least a portion of the length of the drive rod (422). The threads (424) are configured to engage corresponding threads disposed within the nut member (410). This engagement between the threads (424) of the drive rod (422) and the threads of the nut member (410) generally translates rotational motion of the second lead screw (420) into translational motion of the nut member (410). As described in more detail below, this motion of the nut member (410) via the lead screw (420) is generally configured to selectively initiate firing of the cutter (40) and the piercer (22).

The drive member (426) of the second lead screw (420) is rigidly fixed to the proximal end of the drive rod (422). The drive member (426) is configured to transmit rotational motion from the motor assembly (430) to the drive rod (422). Specifically, the drive member (426) includes a plurality of teeth (428). As described in more detail below, the teeth (428) are configured to engage at least a portion of the motor assembly (430) such that the rotational motion imparted by the motor assembly (430) is transmitted to the drive rod (422) via the teeth (428) of the drive member (426).

The motor assembly (430) includes a rotary power source (432) and a drive member (434) that transmits rotation from the rotary power source (432). In this example, the rotary power source (432) is configured as an electric motor. In other examples, the rotary power source (432) can be configured as a variety of other rotary power sources, such as a pneumatic motor, a piezoelectric motor, etc.

The drive member (434) of the motor assembly (430) is configured to transmit rotational power from the rotary power source (432) to the second lead screw (420). Specifically, the drive member (434) includes a plurality of teeth (436) configured to engage with the teeth (428) of the drive member (426) described above with respect to the second lead screw (420). The engagement between the teeth (428, 436) and the drive member (426, 434) rotates to transmit rotational power from the motor (432) to the drive member (426) of the second lead screw (420). Although the drive members (426, 434) are described herein as essentially toothed gears (428, 436), it should be understood that in other examples, any other suitable rotary transmission may be used. By way of example only, suitable rotary transmissions may include belt drives, drives with additional gears to provide a gear ratio between the motor (432) and the drive rod (422), etc.

The first latch member (440) includes a lever portion (442), a pivot portion (444), and a catch portion (446). The lever portion (442), the pivot portion (444), and the catch portion (446) are all connected together to form an L-shaped structure. The lever portion (442) and the catch portion (446) each define one leg of the L-shape, and the pivot portion (444) is disposed between the lever portion (442) and the catch portion (448). The pivot portion (444) includes an opening (445) extending entirely through the latch member (440) such that a pin or other similar structure can be received by the opening (445) to pivot the first latch member (440) about an axis defined by the opening (445). As described in more detail below, this pivoting action generally enables the first latch member (440) to selectively capture and release the member (238) of the cutter drive assembly (200).

The catch portion (446) defines a ramp feature (448) and a concave feature (449). The ramp feature (448) is generally triangular in shape and the adjacent concave feature (449) is generally semicircular in shape. Both the ramp feature (448) and the concave feature (449) are configured to engage the release member (238) of the cutter drive assembly (200). For example, as described in more detail below, the ramp feature (448) functions to pivot the first latch member (440) away from the release member (238) to a receiving or released position so that the release member (238) can enter the concave feature (449). Similarly, the concave feature (449) captures or otherwise selectively secures the release member (238) when the first latch member (440) pivots to a cocked position. Although not shown herein, it should be understood that in some examples, the first latch member (440) may include a resilience feature such that when the release member (238) is received by the recessed feature (449), it may resiliently bias the first latch member (440) toward the cocked position.

The second latch member (450) includes a lever portion (452), a pivot portion (454), and a catch portion (456). The lever portion (452), the pivot portion (454), and the catch portion (456) are all connected together to form an L-shaped structure. The lever portion (452) and the catch portion (456) each define one leg of the L-shape, and the pivot portion (454) is disposed between the lever portion (452) and the catch portion (458). The pivot portion (454) includes an opening (455) extending entirely through the latch member (450) such that a pin or other similar structure can be received by the opening (455) to pivot the second latch member (450) about an axis defined by the opening (455). As described in more detail below, this pivoting action generally enables the second latch member (450) to selectively capture and release the member (338) of the piercer drive assembly (300).

The catch portion (456) defines a ramp feature (458) and a concave feature (459). The ramp feature (458) is generally triangular in shape and the adjacent concave feature (459) is generally semicircular in shape. Both the ramp feature (458) and the concave feature (459) are configured to engage the release member (238) of the piercer drive assembly (300). For example, as described in more detail below, the ramp feature (458) functions to pivot the second latch member (450) away from the release member (338) to a receiving or released position so that the release member (338) can enter the concave feature (459). Similarly, the concave feature (459) captures or otherwise selectively secures the release member (338) when the second latch member (450) pivots to a cocked position. Although not shown herein, it should be understood that in some examples, the first latch member (450) may include a resilience feature such that when the release member (338) is received by the recessed feature (459), it may resiliently bias the first latch member (450) toward the cocked position.

FIGS. 14-26 illustrate an exemplary use of the biopsy device (10) described above. In particular, in such use, using the drive assembly (100), the lancet (22) and cutter (40) are generally cocked and fired in a predetermined sequence to penetrate a suspected lesion and then sever a tissue sample thereof. Once the lancet (22) and cutter (40) are actuated, the lancet (22) is retracted relative to the cutter (40) to allow collection of the severed tissue by an operator. The cocking and firing process may then be repeated as many times as desired to collect as many tissue samples as desired by the user.

14-16 show an exemplary cocking sequence that results in the preparation of the puncture device (22) and the cutter (40) for firing. In the cocking sequence, the drive assembly (100) can start in an initial position as shown in FIG. 15. Alternatively, as described in more detail below, the drive assembly (100) may start in a cocked position as shown in FIG. 15. In the initial position, the puncture device (22) and the cutter (40) are each in a distal position. Correspondingly, the cutter drive assembly (200) and the puncture device drive assembly (300) are also in a distal unlocked position. The release assembly (400) is disengaged from both the cutter drive assembly (200) and the puncture device drive assembly (300) when the cutter drive assembly (200) and the puncture device drive assembly (300) are in the distal position.

When the cutter drive assembly (200) is in the distal position, the cocking member (210) is positioned on the distal end of the first threaded portion (116) of the lead screw (112). The actuating member (230) is positioned adjacent to the stop portion (212) of the cocking member (210) via the spring (202). In particular, the release member (238) of the actuating member (230) is disengaged from the release assembly (400) so that the release member (238) is free to move along the axis of the lead screw (112). Even though the actuating member (230) is free to move along the axis of the lead screw (112), the spring (202) resiliently biases the actuating member (230) to push the actuating member (230) distally to the position shown in FIG. 14. Thus, the actuating member (230) is biased adjacent to the cocking member (210) by the spring (202).

When the puncture drive assembly (300) is in the distal position, the cocking member (310) is positioned on the distal end of the threaded portion (136) of the carriage nut (130). The carriage nut (130) is correspondingly positioned on the distal end of the second threaded portion (124) of the lead screw (112) such that the cocking member (310) is in a distal-most position relative to both the carriage nut (130) and the lead screw (112). The actuating member (330) is positioned adjacent to the stop portion (312) of the cocking member (310) via the spring (302). In particular, the release member (338) of the actuating member (330) is disengaged from the release assembly (400) so that the release member (338) is freely movable along the axis of the lead screw (112) and the carriage nut (130). Although the actuating member (330) is free to move along the axis of the lead screw (112) and the carriage nut (130), the spring (302) resiliently biases the actuating member (330) distally to the position shown in FIG. 14. Thus, the actuating member (330) is biased adjacent to the cocking member (310) by the spring (302).

In the initial position, the puncture retraction assembly (350) of the puncture drive assembly (300) is also in a distal position. However, when the puncture retraction assembly (350) is in the distal position, the puncture retraction assembly (350) is generally separated from the cocking member (310) and the actuation member (330). As described above, the puncture retraction assembly (350) is axially fixed relative to the carriage nut (130) by the engagement between the retainer of the retraction assembly (350) and the annular channel (142) of the carriage nut (130). Thus, the puncture retraction assembly (350) is axially fixed near the distal end of the carriage nut (130) solely by the axial movement of the puncture retraction assembly (350) due to the axial movement of the carriage nut (130).

To move the drive assembly (100) to the cocked position, an operator may actuate the actuating member (16) on the exterior of the outer housing (14). Actuation of the actuating member (16) in turn provides a signal to the rotary power source (164) of the needle cocking assembly (110). Upon receiving such a signal, the rotary power source (164) begins to rotate the lead screw (112) in a first direction via the rotary transmission features (152, 162), as shown in FIG. 15.

Rotation of the lead screw (112) in a first direction generally translates the cutter drive assembly (200) and the piercer drive assembly (300) in a proximal direction. Specifically, rotation of the lead screw (112) causes the threads (117) of the first threaded portion (118) to engage the threads (222) of the cocking member (210). This engagement between the threads (117, 222) causes the cocking member (210) to translate in a proximal direction. As the cocking member (210) translates in a proximal direction, the stop portion (212) of the cocking member (210) urges the actuating member (230) in a proximal direction in response to engaging the actuating member (230). The actuating member (230) then acts on the spring (202) to compress the spring (202).

The proximal translation of the cocking member (210) and the actuating member (230) continues until the release member (238) contacts the first latch member (440) of the release assembly (410). When such contact is made, the release member (238) of the actuating member (230) engages the ramp feature (448) of the first latch member (440) when the actuating member (230) is driven proximally, causing the first latch member (440) to pivot outward (e.g., into the page of FIG. 15). The proximal translation of the actuating member (230) and the pivoting of the first latch member (440) continue until the release member (238) is adjacent the concave feature (449) of the first latch member (440).

When the release member (238) of the actuating member (230) abuts the concave feature (449) of the first latch member (440), the rotational movement of the lead screw (112) and the corresponding proximal translational movement of the actuating member (230) via the cocking member (210) are stopped. At this stage, the first latch member (440) pivots inward (e.g., out of the page of FIG. 15) to capture the release member (238) of the actuating member (230) within the concave feature (449) of the first latch member (440). With the release member (238) captured within the concave feature (449), the actuating member (230) is generally held in the axial position shown in FIG. 15 via the first latch member (440).

The rotational motion of the lead screw (112) also rotates the carriage nut (130) via the key (134) of the carriage nut (130) and the keyway (122) of the lead screw (112). As the carriage nut (130) rotates, the puncture drive assembly (300) generally translates in a proximal direction. Specifically, as the carriage nut (130) rotates, the threads (138) of the carriage nut (130) engage threads (322) disposed within the bore (320) of the cocking member (310). This engagement between the threads (138, 322) causes the cocking member (310) to translate in a proximal direction. As the cocking member (310) translates proximally, the stop portion (312) of the cocking member (310) engages the actuating member (330) and pushes the actuating member (330) proximally. The actuating member (330) then acts on the spring (302) to compress the spring (302).

The proximal translation of the cocking member (310) and the actuating member (330) continues until the release member (338) contacts the second latch member (450) of the release assembly (410). When such contact is made, the release member (338) of the actuating member (330) engages the ramp feature (458) of the second latch member (450) when the actuating member (330) is driven proximally, causing the second latch member (450) to pivot outward (e.g., into the page of FIG. 15). The proximal translation of the actuating member (330) and the pivoting of the second latch member (450) continue until the release member (338) is adjacent the concave feature (459) of the second latch member (450).

When the release member (338) of the actuating member (330) abuts the concave feature (459) of the second latch member (450), the rotational movement of the carriage nut (130) via the lead screw (112) and the corresponding proximal translational movement of the actuating member (330) via the cocking member (310) are stopped. At this stage, the second latch member (450) pivots inward (e.g., out of the page of FIG. 15) to capture the release member (338) of the actuating member (330) within the concave feature (459) of the second latch member (450). With the release member (338) captured within the concave feature (459), the actuating member (330) is generally held in the axial position shown in FIG. 15 via the second latch member (450).

When both the cutter drive assembly (200) and the puncture drive assembly (300) are translated to the proximal position shown in FIG. 15, the drive assembly (100) is in the cocked position. Although the drive assembly (100) is shown and described herein as initially transitioning from an initial position to the cocked position, it should be understood that in some instances, a procedure may begin with the drive assembly (100) in the cocked position. In the cocked position, the springs (202, 302) are still compressed for firing. However, the cutter (40) and puncture (22) cannot be fired because the respective cocking members (210, 310) are adjacent to the respective actuation members (230, 330). Therefore, it should be understood that when the drive assembly (100) is in the cocked position, the cutter (40) and puncture (22) are merely in position for firing, and the drive assembly (100) is not yet fully armed.

While the drive assembly (100) is in the cocked position, the operator may not be able to move the needle assembly (20) within the patient's tissue. As shown in FIG. 19, insertion may be performed to position the needle assembly (20) adjacent to the suspected lesion (LE). In some applications, it may be desirable to insert the needle assembly (20) into the patient's tissue to prevent accidental firing of the perforator (22) or cutter (40). Of course, it should be understood that the operator may position the needle assembly (20) when the drive assembly (100) is in other positions, as described in more detail below.

To prepare the needle assembly (20) for firing, the operator may transition the drive assembly (100) from the cocked position shown in FIG. 15 to the ready position shown in FIG. 16. To initiate transition of the drive assembly (100) from the cocked position to the ready position, the operator may depress the actuation member (16) a second time. Depressing the actuation member (16) a second time sends a signal to the rotary power source (164) of the needle cocking assembly (110) to initiate rotational movement of the lead screw (112) in a second direction opposite the first direction.

Rotational movement of the lead screw (112) in the opposite direction generally translates the cocking member (210) of the cutter drive assembly (200) and the cocking member (310) of the puncture drive assembly (300) in a distal direction relative to the lead screw (112). Specifically, the threads (117) of the first threaded portion (116) again engage the threads (222) of the cocking member (210). However, due to the rotational movement of the lead screw (112) in the second direction, this engagement translates the cocking member (210) in a distal direction. Because the actuating member (230) and the spring (202) are not rigidly fixed to the cocking member (210), the actuating member (230) and the spring (202) remain held in place by the first latch member (440) of the release assembly (400). The translational movement of the cocking member (210) continues until the cocking member (210) reaches the distal end of the first threaded portion (116) of the lead screw (112), as shown in FIG. 16.

Similarly, with respect to the puncture drive assembly (300), the threads (138) of the carriage nut (130) again engage the threads (322) of the cocking member (310). As described above, rotational movement of the lead screw (112) results in rotation of the carriage nut (130) due to the engagement between the key (134) and the keyway (122). Thus, rotational movement of the lead screw (112) rotates the carriage nut (130) in a second direction. Rotation of the carriage nut (130) in the second direction causes the cocking member (310) to translate distally due to the engagement of the threads (138, 322). Because the actuating member (330) and the spring (302) are not rigidly fixed to the cocking member (310), the actuating member (330) and the spring (302) remain held in place by the second latch member (450) of the release assembly (400). The translational movement of the cocking member (310) continues until the cocking member (310) reaches the distal end of the threaded portion (136) of the carriage nut (130), as shown in FIG.

When the cocking member (210) of the cutter drive assembly (200) and the cocking member (310) of the puncture drive assembly (300) are positioned in the distal position as shown in FIG. 16, the drive assembly (100) is in the armed position. Once the drive assembly (100) is in the armed position, the operator may, if not already done so, position the needle assembly (20) in the patient's tissue adjacent the suspected lesion (LE), as shown in FIG. 19, before transitioning the drive assembly (100) from the cocked position to the armed position.

With the drive assembly (100) in the ready position (FIG. 16) and the needle assembly (20) positioned near the suspected lesion (SE) (FIG. 19), the operator may then initiate the firing sequence. FIGS. 17-18 and 19-21 show the firing sequence in more detail. To initiate the firing sequence, the operator may depress the actuation member (16) on the outer housing (14) three times. When the actuation member (16) is depressed, a signal is now sent to the motor (432) of the release assembly (400). This signal causes the motor (432) to rotate the second lead screw (420) by providing rotational power to the second lead screw (420) via the drive members (426, 434). As the second lead screw (420) rotates, the threads (424) of the second lead screw (420) engage the threads disposed within the body (412) of the nut member (410).

Engagement between the threads (424) of the second lead screw (420) and the threads of the nut member (410) during rotation of the second lead screw (420) causes the nut member (410) to retract proximally. As the nut member (410) retracts proximally, the second latch actuator (418) first comes into contact with the lever portion (452) of the second latch member (450). It should be appreciated that due to the spacing between the first latch actuator (416) and the second latch actuator (418), only the second latch actuator (418) initially contacts the second latch member (450). As will be described in more detail below, further proximal actuation of the nut member (410) is required for the first latch actuator (416) to engage the lever portion (442) of the first latch member (440).

As the nut member (410) continues to translate proximally, the second latch actuator (418) engages the lever portion (452) of the second latch member (450) and begins to pivot the second latch member (450) away from the release member (338) of the piercer drive assembly (300). Further proximal translation of the nut member (410) eventually results in the second latch member (450) fully pivoting to disengage the release member (338) from the recessed feature (459) of the second latch member (450), as shown in FIG. 17.

When the release member (338) is disengaged from the recessed feature (459) of the second latch member (450), the actuating member (330) is free to translate axially relative to the lead screw (112). Because the spring (302) was previously compressed during cocking, the spring (302) now biases the actuating member (330) in a rapid distal direction. As described above, the actuating member (330) includes an actuating tab (340) that is secured to the receiving feature (32) of the puncture device (22). It should therefore be understood that rapid translation of the actuating member (330) results in a corresponding rapid translation of the puncture device (22). As the puncture device (22) rapidly translates, the distal tip (24) and notch (26) of the puncture device (22) penetrate the suspected lesion (LE), as shown in FIG. 20.

Once firing of the puncture device (22) occurs, the motor (432) of the release assembly (400) stops, thereby stopping further proximal movement of the nut member (410) via the second lead screw (420). In this application, the proximal translational movement of the nut member (410) stops before the first latch actuator (416) reaches the first latch member (440) to fire the cutter (40). In other words, after the puncture device (22) is fired, the firing sequence is paused before firing the cutter (40). Alternatively, in some applications, the motor (432) may continue to rotate without stopping after firing of the puncture device (22). In these applications, the puncture device (22) is initially fired, followed by a relatively short delay, and then the cutter (40) is fired using the sequence described below.

To fire the cutter (40) in this application, the operator may resume the rotational motion of the motor (432) and the corresponding proximal translational motion of the nut member (410) by depressing the actuation member (16) on the outer housing (14) four times. This causes the motor (432) of the release assembly (400) to continue the rotational motion of the second lead screw (420). As also described above, the engagement between the threads (424) of the second lead screw (420) and the threads of the nut member (410) during rotation of the second lead screw (420) retracts the nut member (410) proximally. As the nut member (410) continues to retract proximally, the first latch actuator (416) engages the lever portion (442) of the first latch member (440). As the nut member (410) translates further proximally, the first latch actuator (416) depresses the lever portion (442) to pivot the first latch member (440) away from the release member (238) of the actuation member (230), as shown in FIG. 18. This pivoting movement of the first latch member (440) ultimately results in disengagement of the release member (238) of the actuation member (230) from the first latch member (440).

When the release member (238) of the actuating member (230) is disengaged from the first latch member (440), the actuating member (230) is free to translate axially relative to the lead screw (112). Because the spring (202) was previously compressed during cocking, the spring (302) now biases the actuating member (230) in a rapid distal direction. As described above, the actuating member (230) includes an actuating tab (240) that is secured to a receiving feature (52) of the cutter (40). It should therefore be understood that rapid translation of the actuating member (230) results in a corresponding rapid translation of the cutter (40). As a result of the rapid translation of the cutter (40), the distal end (42) of the cutter (40) penetrates the suspected lesion (LE) and severs the tissue sample within the notch (26) of the lancing device (22), as shown in FIG. 21.

22-25 show an exemplary sequence for retracting the lancet (22) relative to the cutter (40) to collect a tissue sample after the tissue sample has been obtained using the firing sequence described above. As described in more detail below, the retraction sequence of the lancet (22) generally involves retracting the lancet (22) relative to the cutter (40) to expose the lancet notch (26) within the tissue collection feature (54) of the cutter (40). When the lancet (22) is so retracted, the operator may extract a tissue sample from the notch (26) for further analysis and processing.

The retraction sequence of the lancet (22) begins by returning the drive assembly (100) to the cocked position described above with respect to FIG. 15. When the drive assembly (100) is in the cocked position shown in FIGS. 4 and 15, the lancet (22) is correspondingly positioned in a distal position. As can be seen in FIG. 24, when the lancet is in the distal position, the tissue collection feature (54) of the cutter (40) is generally blocked by the lancet (22). To return the drive assembly (100) to the cocked position, the operator may depress the actuation member (16) on the outer housing (14) five times. As described above, the drive assembly (100) is generally moved to the cocked position by rotating the lead screw (112) in a first direction to translate the cocking members (210, 310) of the cutter drive assembly (200) and the puncture drive assembly (300) proximally relative to the lead screw (112).

When the drive assembly (100) is returned to the cocked position as shown in FIGS. 4 and 15, the lead screw (112) continues to rotate in a first direction. As the rotation continues, the cocking members (210, 310) of the cutter drive assembly (200) and the puncture drive assembly (300) begin to freewheel relative to the lead screw (112). In particular, as the cocking member (210) of the cutter drive assembly (200) transitions adjacent to the recess (119) of the lead screw (112), the cocking member (210) disengages from the first threaded portion (116) of the lead screw (112). Similarly, as the cocking member (310) of the cutter drive assembly (300) transitions adjacent to the recess (144) of the carriage nut (130), the cocking member (310) disengages from the threaded portion (136) of the carriage nut (130).

As the cocking members (210, 310) begin to freewheel as described above, the puncture retraction assembly (350) begins to engage the second threaded portion (124) of the lead screw (112). Specifically, the protrusion (378) of the second retraction member (370) is received by the threads (125) of the second threaded portion (124). As the lead screw (112) rotates, the engagement between the protrusion (378) and the threads (125) pulls the second retraction member (370) proximally, as shown in FIG. 22. Because the second retraction member (370) is fixed to the first retraction member (352), the proximal movement of the second retraction member (370) also pulls the first retraction member (352) proximally. Moreover, since the retainer (390) is positioned between the first retraction member (352) and the second retraction member (370) to axially secure the carriage nut (130) to the piercer retraction assembly (350), the proximal movement of the first retraction member (352) and the second retraction member (370) causes a corresponding proximal movement of the carriage nut (130). When the piercer drive assembly (300) is disposed on the carriage nut (130), the translation of the carriage nut (130) also causes the piercer drive assembly (300) to translate. It should therefore be understood that when the piercer retraction assembly (350) is driven proximally by the rotational movement of the lead screw (112), the piercer drive assembly (300) in addition to the piercer (22) translates accordingly.

The proximal translation of the puncture retraction assembly (350), the puncture drive assembly (300), and the puncture (22) continues until the puncture retraction assembly (350) reaches the distal position shown in FIG. 23. Once the puncture retraction assembly (350) reaches the distal position, further proximal translation of the puncture retraction assembly (350) is stopped by halting the rotational motion of the lead screw (112).

When the lancet drive assembly (300) is in the distal position, the lancet (22) is also in the distal position as shown in FIG. 25. As can be seen in FIG. 25, when the lancet (22) is in the distal position, the notch (26) of the lancet (22) is aligned with the tissue collection feature (54) of the cutter (40). This alignment provides access to the notch (26) through the cutout (46) in the cutter (40). At this stage, the operator may obtain a tissue sample from the notch (26) for further examination, analysis, investigation, etc.

After obtaining the tissue sample, the operator may complete the biopsy procedure by removing the biopsy device (10) from the patient. Alternatively, in some cases, the operator may wish to obtain additional samples using a single insertion of the needle assembly (20) into the patient. In such a case, the operator may depress the actuation member (16) on the outer housing (14) six times. This re-actuates the rotary transmission feature (162) of the needle cocking assembly, which returns the drive assembly (100) to its initial or cocked position via the rotary motion of the lead screw (112). The operator may then repeat the same procedure described above one or more times until the desired number of tissue samples have been obtained.

II. EXAMPLES OF ALTERNATIVE DRIVE ASSEMBLY FOR A CORE NEEDLE BIOPSY DEVICE In some versions of biopsy device 10 described above, it may be desirable for structure similar to body 12 to have a compact size. For example, one desirable aspect of a core needle biopsy device as opposed to a suction biopsy device is the compact size of the core needle biopsy device as compared to a suction biopsy device.

In some circumstances, the compact size may be a function of the internal components of a particular device and the functionality of the device. For example, in some core needle biopsy devices (10), the movement of the puncturator (22) and/or cutter (40) and similar structures may be facilitated by a spring-loaded mechanism. Such movement of the puncturator (22) and cutter (40) together may be restricted to a predetermined sequence relative to one another. Such spring-loaded mechanisms may therefore be relatively compact to facilitate such movement. In contrast, suction biopsy devices may utilize more complex movement of cutter (40) and similar structures, which may result in relatively complex drive mechanisms. Such relatively complex drive mechanisms may therefore occupy a larger footprint, and some suction biopsy devices are less compact than some core needle biopsy devices.

In some situations, an operator may prefer a relatively small biopsy device. For example, in ultrasound-guided procedures, a small biopsy device may be preferred because operation of the biopsy device may be performed with one hand. In other situations, a small biopsy device may be desirable for ease of use, even when operation cannot be performed entirely by hand. For example, in some stereotactic or MRI-guided procedures, space near the patient may be limited by other ancillary components such as the patient table, imaging equipment, fixtures, etc. Thus, a small size biopsy device may be desirable in a variety of situations.

As noted above, it may be desirable for biopsy device (10) to also provide the characteristics of a core needle biopsy device, but with the capability of obtaining multiple samples with a single insertion. However, one aspect of such capability is that in some versions, a structure similar to the puncture device (22) may retract the length of a structure similar to the cutter (40) for obtaining each tissue sample. Such retraction of the puncture device (22) may be accomplished by a variety of mechanisms, but when combined with the cocking and firing capabilities, such mechanisms may be large in size. Thus, in some versions of biopsy device (10), it may be desirable to incorporate a drive assembly similar to drive assembly (100) that has the capabilities of cocking, firing, and retracting the puncture device, but with a relatively small size.

26 and 27 show an example of an alternative drive assembly (1100) that may be incorporated into the biopsy device (10) in place of the drive assembly (100) described above. Similar to the drive assembly (100) described above, this version of the drive assembly is generally configured to drive the lancet (22) and cutter (40) through a predetermined sequence for cocking, firing, and sampling. Like the drive assembly (100) described above, the drive assembly (1100) of this example includes a lancet drive assembly (1300) and a cutter drive assembly (1200). As described in more detail below, the lancet drive assembly (1300) and the cutter drive assembly (1200) are generally interconnected to interact with each other to generally reduce the overall size of the drive assembly (1100).

The puncture drive assembly (1300) may be in communication with the puncture device (22), such that the puncture drive assembly (1300) may be configured to drive the puncture device (22) through a predetermined motion sequence, either independently of the cutter (40), in cooperation with the cutter (40), or both. Additionally, as described in more detail below, the puncture drive assembly (1300) may be in communication with one or more elements of the cutter drive assembly (1200) to drive elements of the cutter drive assembly (1200) and/or the cutter (40). As best seen in FIG. 27, the puncture drive assembly (1300) includes a lead screw drive shaft (1310), a lead screw latch (1320), an external lead screw (1340) (also referred to as a first lead screw, a dual-thread lead screw, or a driver), and a puncture device carriage (1370). In general, the lancet drive assembly (1300) is configured to move the lancet (22) via the lancet carriage (1370) by moving the lancet carriage (1370) either directly via rotational motion of the external lead screw (1340) or indirectly via translational motion of the external lead screw (1340).

The lead screw drive shaft (1310) is generally configured to drive the rotational motion of the external lead screw (1340) and, in some circumstances, also allow translational motion of at least a portion of the external lead screw (1340) relative to the lead screw drive shaft (1310). As best seen in FIG. 28, the lead screw drive shaft (1310) includes a shaft (1312) having a keyed portion (1314) and a drive gear (1318). The shaft (1312) is generally configured to be slidably received within a portion of the external lead screw (1340) and drive the rotational motion of the external lead screw (1340) via the keyed portion (1314). The drive gear (1318) may thus be fastened to or integral with the shaft (1312) to drive the rotational motion of the shaft (1312), which in turn drives the rotational motion of the external lead screw (1340). Although not shown, it should be understood that the drive gear (1314) may mesh with other components of the biopsy device (10), such as a motorized assembly, to drive the rotational movement of the shaft (1312).

The keyed portion (1314) in this version includes a pair of outwardly extending elongated projections or wings. Specifically, each projection or wing defines a rectangular cross-section extending along its axial length of the shaft (1312). As described in more detail below, the keyed portion (1314) is generally configured to be received within a complementary portion of the external lead screw (1340) and to transmit rotational motion from the shaft (1312) to the external lead screw (1340). Furthermore, as described in more detail below, the elongated nature of the keyed portion (1314) is configured to allow for the transmission of rotational motion from the shaft (1312) to the external lead screw (1340) while still allowing for some axial motion of the external lead screw (1340) relative to the shaft (1312). Thus, it should be understood that in other versions, various alternative configurations of the keyed portion (1314) may be used. For example, in some versions, the keyed portion (1314) may include a hexagonal feature, an octagonal feature, an oval feature, a single key, etc.

The shaft (1312) further includes one or more sawtooth features (1316) extending outwardly from the keyed portion (1314). Each sawtooth feature (1316) is generally configured to engage a portion of the lead screw latch (1320) to provide additional surface area at the engagement point between the shaft (1312) and the lead screw latch (1320). As described in more detail below, such engagement may be used in some versions to releasably hold a relatively large spring force. Thus, the additional material and surface area provided by each sawtooth feature (1316) may be desirable in some versions to promote stiffness of the shaft (1312) and avoid unintended movement of the shaft (1312) and/or the lead screw latch (1320).

The lead screw latch (1320) is generally configured to be selectively fastened to the lead screw drive shaft (1310) to selectively hold the external lead screw (1340) in a predetermined axial position. Although not shown, it should be understood that the lead screw drive shaft (1310) may be axially fixed to a portion of the biopsy device (10), such as a portion of the outer housing (14) or body (12). It should be further understood that such axial fixation of the lead screw drive shaft (1310) is only possible with respect to axial (e.g., proximal-distal) movement of the lead screw drive shaft (1310). In other words, the lead screw drive shaft (1310) may still be free to rotate within the outer housing (14) or body (12). Additionally, the lead screw latch (1320) may also be rotatable within the outer housing (14) or body (12), but may also be free to move axially within the outer housing (14) or body (12) along with the external lead screw (1340). As described in more detail below, such rotational movement of the lead screw latch (1320) may be desirable to facilitate selective disengagement of the lead screw latch (1320) from the lead screw drive shaft (1310) to allow axial movement of the lead screw latch (1320) along with the external lead screw (1340).

As best seen in FIGS. 29-31, the lead screw latch (1320) includes a latch body (1322) having an actuation protrusion (1324) and a location protrusion (1336) extending proximally and distally, respectively, from the latch body (1322). In this version, the latch body (1322) defines a generally cylindrical shape. However, it should be understood that in other versions, various alternative configurations for the latch body (1322) may be used.

The actuation protrusion (1324) provides one or more radially extending surfaces. As described in more detail below, such radially extending surfaces of the actuation protrusion (1324) are generally configured to engage other components of the drive assembly (1100) to permit rotational movement of the lead screw latch (1320) from the lead screw drive shaft (1310) and release movement of the lead screw latch (1320).

As best seen in FIG. 29, the actuation projection (1324) defines a drive shaft bore (1326) centered within the latch body (1322). The drive shaft bore (1326) defines a shape complementary to the shape of the keyed portion (1314) of the lead screw drive shaft (1310). Specifically, as described above, the present version of the keyed portion (1314) includes a pair of wings. Thus, the drive shaft bore (1326) includes a generally circular opening with an outward projection to accommodate the shape of the pair of wings. Thus, the drive shaft bore (1326) is generally configured to slidably receive the keyed portion (1314) of the drive shaft bore (1326). Thus, in versions in which the specific configuration of the keyed portion (1314) is changed, it should be understood that the specific configuration of the drive shaft bore (1326) may be similarly changed to achieve such functionality.

The interior of the latch body (1322) is generally hollow and includes various features to facilitate interaction between the lead screw latch (1320), the lead screw drive shaft (1310), and the external lead screw (1340). Specifically, the interior of the latch body (1322) defines an interior proximal surface (1328), one or more locating arms (1330), and an interior distal surface (1332) opposite the interior proximal surface (1328). The interior proximal surface (1328) is configured to abut a proximal end of the keyed portion (1314) of the lead screw drive shaft (1310) to selectively couple the lead screw latch (1320) to the lead screw drive shaft (1310). Specifically, each sawtooth feature (1316) of the keyed portion (1314) may abut against an interior proximal surface (1328) of the latch body (1322) to retain the keyed portion (1314) within the lead screw latch (1320). Additionally, the drive shaft bore (1326) communicates with the interior of the latch body (1322) because the drive shaft bore (1326) extends through the interior proximal surface (1328). Thus, the engagement between the interior proximal surface (1328) and the wings of the keyed portion (1314) may be released by rotational movement of the lead screw latch (1320) to align the drive shaft bore (1326) and the wings of the keyed portion (1314) rather than the interior proximal surface (1328).

As best seen in FIG. 31, the location arm (1330) extends into the hollow interior of the latch body (1322). Additionally, the location arm (1330) extends inwardly into the hollow interior of the latch body (1322). As described in more detail below, the location arm (1330) is generally configured to locate the lead screw latch (1320) relative to the external lead screw (1340) to facilitate insertion of the lead screw drive shaft (1310) into the external lead screw (1340). Also, as described in more detail below, the location arm (1330) is further configured to allow at least some rotation of the lead screw latch (1320) relative to the external lead screw (1340) to facilitate actuation of the lead screw latch (1320) and release of the lead screw latch (1320) from the lead screw drive shaft (1310).

The internal distal surface (1332) is generally configured to engage and/or abut at least a portion of the external lead screw (1340) to hold the lead screw latch (1320) on a proximal portion of the external lead screw (1340). As described in more detail below, the lead screw latch (1320) is generally configured to move axially with the external lead screw (1340). Thus, the engagement between the internal distal surface (1332) and at least a portion of the external lead screw (1340) may be used to transfer axial motion of the external lead screw (1340) to the lead screw latch (1320). Additionally, in some circumstances, the lead screw latch (1320) may be used to hold the external lead screw (1340) in a predetermined axial position, utilizing the engagement between the internal distal surface (1322) and at least a portion of the external lead screw (1340). It should be appreciated that such engagement between the inner distal surface (1332) and at least a portion of the external lead screw (1340) may still be configured to allow rotation of at least a portion of the lead screw latch (1320) relative to the external lead screw (1340). As described below, such relative rotational motion between the lead screw latch (1320) and the external lead screw (1340) may be used to allow selective decoupling of the lead screw latch (1320) from the lead screw drive shaft (1310).

As best seen in FIGS. 30 and 31 , the actuation protrusion (1324) extends distally from the latch body (1322). The actuation protrusion (1324) includes a square or rectangular cross-section that extends around a portion of the latch body (1322) forming a semicircular pattern. In this version, the semicircular pattern of the actuation protrusion (1324) is c-shaped or semicircular. Regardless of the particular shape of the actuation protrusion (1324), the actuation protrusion (1324) can be configured to position the lead screw latch (1320) relative to the external lead screw (1340). As described in more detail below, it may be desirable to align the external lead screw (1340), the lead screw latch (1320), and the lead screw drive shaft (1310) for purposes of inserting the lead screw drive shaft (1310) into the lead screw latch (1320) and the external lead screw (1340). The actuation protrusion (1324) may thus facilitate such alignment by locating the lead screw latch (1320) relative to the external lead screw (1340).

The latch body (1322) further defines a lead screw hole (1334) located in a distal portion of the latch body (1322) and positioned at the center of curvature of the actuation protrusion (1324). As described in more detail below, the lead screw hole (1334) can be sized and shaped to correspond to at least a portion of the external lead screw (1340) and to retain at least a portion of the external lead screw (1340) within the latch body (1322). Thus, the inner distal surface (1328) and the lead screw hole (1334) can be configured to cooperate to retain at least a portion of the external lead screw (1340) within the latch body (1322). Optionally, a portion of the lead screw hole (1334) may be larger than a portion of the external lead screw (1340). Such a large portion of the lead screw hole (1334) may be used in some versions of the lead screw hole (1334) to allow the external lead screw (1340) to be inserted into the latch body (1322) during assembly. Furthermore, a specific location of such a large portion of the lead screw hole (1334) may correspond to other features of the latch body (1322) (e.g., the locating arm (1330) or other geometric features) so that a portion of the external lead screw (1340) may be coupled to the latch body (1322) for operation of the drive assembly (1100) once assembly is complete.

As best seen in FIGS. 27 and 32, the external lead screw (1340) includes an open distal end (1342), an elongated threaded portion (1346), and an engagement end (1350) opposite the open distal end (1342). The open distal end (1342) is configured to receive an insert (1360) and a piercer spring (1364) that may extend through the hollow interior of the external lead screw (1340). As described in more detail below, the insert (1360) and the piercer spring (1364) may be used to interact with the cutter drive assembly (1200) to drive the movement of one or more portions of the cutter drive assembly (1200) based on the movement of the external lead screw (1340).

The elongated threaded portion (1346) extends distally from the open distal end (1342) to near the location of the engagement end (1350). The elongated threaded portion (1346) includes relatively coarse threads (1347) configured to engage a portion of the puncture carriage (1370). As described in more detail below, the elongated threaded portion (1346) is generally configured to translate rotational motion of the external lead screw (1340) into axial motion of the puncture carriage (1370) via the threads (1347). Additionally, as will be appreciated, axial motion of the external lead screw (1340) itself may also be transmitted to the puncture carriage (1370) via the threads (1347).

As best seen in FIG. 32, the threaded portion (1346) further includes a hard stop (1348) positioned near the proximal end of the threaded portion. The hard stop (1348) in this version is formed by an axially extending solid portion of the threaded portion (1347). The hard stop (1348) is generally configured to prevent rotational motion of the external lead screw (1340) from being translated into axial motion of the puncture carriage (1370). As described in more detail below, such functionality of the hard stop (1348) may be used in some versions in conjunction with an initialization sequence to establish a home position of the puncture carriage (1370) relative to the external lead screw (1340).

While the present version of the hard stop (1348) is shown as being integral with the threaded portion (1346), it should be understood that in other versions the hard stop (1348) may be incorporated into other components. For example, in some versions the hard stop (1348) may be configured as a rib or ledge near the proximal end of the threaded portion (1346). In such a configuration, the hard stop (1348) may be configured to engage a receiving component integrated into the piercer carriage (1370). Such a configuration may be desirable in some versions to provide a more robust hard stop (1348) for use in general operation of the drive assembly (1100), and not just during initialization.

Additionally or alternatively, the external lead screw (1340) may include multiple hard stops (1348) in some versions. For example, in some versions, hard stops (1348) may be positioned on both the proximal and distal ends of the threaded portion (1346). Such a configuration may be desirable in some versions to facilitate control of the external lead screw (1340) solely through such hard stops (1348) rather than relying on electronic control of the motor. Controlling the position of the external lead screw (1340) via hard stops (1348) instead of electronic motor control may increase the speed of the drive assembly (1100) without reducing the motor speed.

The engagement end (1350) is disposed at a proximal end of the external lead screw (1340) opposite the open distal end (1342). The engagement end (1350) includes a cylindrical portion (1352) having a proximal bore (1354), a pair of mounting projections (1356), and a key receiving portion (1358). The cylindrical portion (1352) defines a diameter smaller than the diameter of the threaded portion (1346) and is configured to be received within the lead screw bore (1334) of the lead screw latch (1320).

33 and 34, each mounting protrusion (1356) is positioned adjacent to a proximal end of cylindrical portion (1352) such that each mounting protrusion (1356) may abut an interior distal surface (1328) of lead screw latch (1320). Specifically, cylindrical portion (1352) may extend through drive shaft bore (1326) of lead screw latch (1320) to position each mounting protrusion (1356) within a hollow interior of latch body (1322). When each mounting protrusion (1356) is received within the latch body (1322), the locating arm (1330) may also abut each mounting protrusion (1356) to hold each mounting protrusion (1356) in engagement with the inner distal surface (1332), yet still allow at least some relative rotational movement between the lead screw latch (1320) and the external lead screw (1340). Although not shown, it should be understood that during insertion of the mounting protrusion (1356) into the latch body (1322), the locating arm (1330) may flex or be moved outwardly, away from the mounting protrusion (1356), to allow attachment of the lead screw latch (1322) to the external lead screw (1340). Once attachment of the lead screw latch (1320) to the external lead screw (1340) is complete, the attachment protrusion (1356) and the location arm (1330) may prevent disengagement until an operator physically manipulates the location arm (1330) to enable disengagement.

The proximal bore (1354) and the key receiving portion (1358) are both configured to slidably receive at least a portion of the lead screw drive shaft (1310). Specifically, the proximal bore (1354) is configured to correspond to the size and shape of the shaft (1312) (e.g., cylindrical). Similarly, the key receiving portion (1358) is configured to correspond to the size and shape of the keyed portion (1314). Thus, the key receiving portion (1358) can be configured to receive the keyed portion (1314) to transmit rotational motion from the lead screw drive shaft (1310) to the external lead screw (1340). As described above, the keyed portion (1314) in this version includes rectangular wings or protrusions. Thus, in this version, the key receiving portion (1358) includes a slot that can be complementary to the size and shape of the wings or protrusions of the keyed portion (1314). However, it should be understood that in versions in which the configuration of the keyed portion (1314) is altered, the configuration of the key-receiving portion (1358) may likewise be altered to complement the size and shape of the keyed portion (1314).

35 shows the insert (1360) and piercer spring (1364) in more detail. As described above, the insert (1360) and piercer spring (1364) can be disposed as an assembly within the hollow interior of the external lead screw (1340). The insert (1360) in this example comprises a brass insert with 10-32 threads therein. As described in more detail below, the insert (1360) can be rigidly secured adjacent the open distal end (1342) of the external lead screw (1340) to drive or otherwise interact with the motion of one or more components of the cutter drive assembly (1200).

The puncturator spring (1364) in this example comprises a coil spring, although various alternative resilience features may be used in other versions. The puncturator spring (1364) is generally configured to apply an axial force to the external lead screw (1340) and the lead screw drive shaft (1310), which may be used to drive the external lead screw (1340) in a distal direction. As described in more detail below, the puncturator spring (1364) may be used to fire the puncturator (22) via the external lead screw (1340) during a firing sequence.

In some versions, the puncturator spring (1364) may be used in conjunction with a spring guide (1366). For example, in this example, the spring guide (1366) is configured to receive the puncturator spring (1364) and hold the puncturator spring (1364) within a predetermined length and with a known preload. Thus, the spring guide (1366) may be used in some versions to control the specific load applied to a feature of the drive assembly (1100).

The present version of the spring guide (1366) includes a pin member (1368) and a sheath member (1369). Both the pin member (1368) and the sheath member (1369) are configured to fit within and extend through the interior of the piercer spring (1364). The pin member (1368) is configured to nest within the sheath member (1369) and includes a distal end having a flat surface for engaging other features of the drive assembly (1100). Similarly, the sheath member (1369) includes a sheath configured to receive at least a portion of the pin member (1368) and includes a proximal end having a flat surface for engaging other features of the drive assembly (1100). As can be appreciated, the pin member (1368) and the sheath member (1369) are configured to act in concert to limit compression of the piercer spring (1364), thereby controlling the amount of force that can be introduced into the piercer spring (1364).

36A and 36B, the insert (1360), puncturator spring (1364), and spring guide (1366) may all be disposed within the interior of the external lead screw (1340). In particular, the insert (1360) may be rigidly secured within a distal portion of the interior of the external lead screw (1340), such that the puncturator spring (1364) and spring guide (1366) may be retained within the external lead screw (1340) between the insert (1360) and the lead screw drive shaft (1310) and/or the proximal end of the external lead screw (1340). As described in more detail below, the insert (1360) may be configured to threadably engage a portion of the cutter drive assembly (1200) such that the portion of the cutter drive assembly (1200) may enter the interior of the external lead screw (1340) and compress the piercer spring (1364) against the lead screw drive shaft (1310). In other words, the insert (1360) may be used to facilitate compression of the piercer spring (1364) against the lead screw drive shaft (1310) using a portion of the cutter drive assembly (1200).

37 shows the cutter drive assembly (1200) in more detail. As can be seen, the cutter drive assembly (1200) includes a cutter carriage (1210), a cutter driver (1250), and a cutter spring (1280). The cutter carriage (1210), cutter driver (1250), and cutter spring (1280) are generally configured to operate cooperatively to move the cutter (40) through a predetermined sequence, including cocking and firing. As described in more detail below, the cutter carriage (1210), cutter driver (1250), and cutter spring (1280) are further generally configured to interact with features of the lancet drive assembly (1300) such that both the cutter drive assembly (1200) and the lancet drive assembly (1300) may be driven by a single motor.

As best seen in FIGS. 38 and 39, the cutter carriage (1210) includes a cutter collar (1214), a tissue manipulator (1216), and a carriage body (1212) defining a proximal receiving end (1220). The cutter collar (1214) is configured to receive the proximal end of the cutter (40) such that the cutter (40) may extend distally from the cutter collar (1214). In this version, the cutter (40) may be rigidly secured to the cutter collar (1214). Alternatively, in other versions, the cutter collar (1214) may be threaded, keyed, or otherwise structured to allow the cutter (40) to be removably secured to the cutter collar (1214). The cutter collar (1214) is of a generally hollow configuration to facilitate access to the proximal end of the cutter (40) by the piercer (22) and/or other structures.

The tissue manipulator (1216) is disposed between the cutter collar (1214) and the proximal receiving end (1220). The tissue manipulator (1216) is generally configured to direct tissue from the piercer (22) into a tissue sample chamber or other structure during operation of the drive assembly (1100). Thus, the tissue manipulator (1216) is configured to receive at least a portion of the piercer (22) such that the piercer (22) may extend and move through the tissue manipulator (1216). As described in more detail below, in some versions, the tissue manipulator (1216) may be used in conjunction with other features, such as flexible members, wipers, or blade features.

The proximal receiving end (1220) of the carriage body (1212) is generally configured to engage various components of the drive assembly (1100) to drive movement of the cutter (40) by movement of the cutter carriage (1210). Specifically, the proximal receiving end (1220) defines a driver bore (1222), a shaft bore (1226), and a piercer bore (1240). The driver bore (1222) is generally circular and configured to slidably receive at least a portion of the cutter driver (1250). As best seen in FIG. 39, the driver bore (1222) includes a channel (1224) that extends along the axis of the driver bore (1222). As described in more detail below, the channels (1224) are generally configured to engage corresponding features of the cutter driver (1250) such that the cutter driver (1250) can be keyed relative to the carriage body (1212). While the driver hole (1222) in this version includes a pair of channels (1224), it should be understood that in other versions, any other suitable number of channels (1224) can be used. Alternatively, in some versions, the channels (1224) can assume various other geometric configurations that correspond to features of the cutter driver (1250).

The shaft bore (1226) is generally configured to receive one or more components of the drive assembly (1100) to lock the cutter carriage (1210) in one or more predetermined axial positions. As best seen in FIGS. 38 and 39, the shaft bore (1226) defines a generally cylindrical shape that may correspond to other structures of the drive assembly (1100). Additionally, the shaft bore (1226) includes one or more channels (1228). As described in more detail below, the channels (1228) may be configured to receive one or more structures protruding from the shaft to release the movement of the cutter carriage (1210) when the shaft is in some positions and to lock the position of the cutter carriage (1210) when the shaft is in other positions.

Adjacent to the shaft bore (1226), the proximal receiving end (1220) further defines a hard stop protrusion (1230). The hard stop protrusion (1230) extends from a proximal face of the proximal receiving end (1220) and is positioned adjacent to the channel (1228) of the shaft bore (1226). As described in more detail below, the hard stop protrusion (1230) may be used in some versions to initialize the drive assembly (1100). In other words, in some versions, the hard stop protrusion (1230) may be used to establish a known home or initial position of one or more components of the drive assembly (1100) coupled to the shaft bore (1226).

The puncture hole (1240) is configured to slidably receive at least a portion of the puncture device (22). Thus, the puncture hole (1240) defines a size and shape that corresponds to the cross-sectional size and shape of the puncture device (22). Furthermore, the puncture hole (1240) is aligned with an axis defined by the cutter (40) and the cutter collar (1214) such that the puncture device (22) can be oriented within the cutter (40).

Returning to FIG. 37, there is a cutter driver (1250), a threaded portion (1252) and a sliding portion (1256). The threaded portion (1252) includes a relatively fine threaded portion (1254) as compared to the threaded portion (1347) of the external lead screw (1340). The threaded portion (1254) is also of a reverse threaded configuration relative to the threaded portion (1347) of the external lead screw (1340). In other words, the threaded portion (1254) of the cutter driver (1250) may be of a right-hand threaded configuration and the threaded portion (1347) of the external lead screw (1340) may be of a left-hand threaded configuration. Of course, in other versions, the opposite configuration may be used, where the threaded portion (1254) is of a left-hand threaded configuration and the threaded portion (1347) is of a right-hand threaded configuration.

The threaded portion (1254) is generally configured to engage an insert (1360) disposed within the external lead screw (1340) such that the rotational motion of the external lead screw (1340) may be used to drive the translational motion of the cutter driver (1250). Furthermore, such engagement between the insert (1360) and the threaded portion (1254) may also be configured to convert the translational motion of the external lead screw (1340) into a corresponding translational motion of the cutter driver (1250). As described in more detail below, such engagement between the insert (1360) and the threaded portion (1254) may be used in combination with other components of the drive assembly (1100) to facilitate cocking and firing of the cutter (40).

The sliding portion (1256) extends distally from the threaded portion (1252) along a common longitudinal axis. The sliding portion (1256) defines a generally smooth cylindrical cross-section and includes one or more outwardly extending projections (1258) and a distal engagement end (1260). The projections (1258) in this version are configured as a key that corresponds to the shape of the channel (1224) of the driver bore (1222) in the cutter carriage (1210). Thus, the projections (1258) and the channel (1224) may act in cooperation to fix the rotational position of the cutter driver (1250) relative to the cutter carriage (1210), yet still allow sliding movement of the cutter driver (1250) relative to the cutter carriage (1210). It should be understood that while this version uses a key-keyway arrangement to facilitate such functionality, in other examples, various alternative alignment features may be used. For example, in some versions, the slider portion (1256) may define a cross-section of an irregular shape, such as a hexagon, and the driver hole (1222) may define a hole having a complementary shape. Still other configurations of the protrusion (1258) and the channel (1224) will be apparent to those of skill in the art in view of the teachings herein.

The distal engagement end (1260) is disposed at the distal end of the cutter driver (1250). In this version, the distal engagement end (1260) is configured to engage a distal surface of the receiving end (1220) of the cutter carriage (1210). Thus, the distal engagement end (1260) is generally configured as a flange having a larger diameter compared to the diameter defined by the sliding portion (1256) and/or the threaded portion (1252). As described in more detail below, such engagement between the distal engagement end (1260) and the receiving end (1220) can be used as a stop to prevent at least some relative motion between the cutter carriage (1210) and the cutter driver (1250).

The present version of the cutter spring (1280) is a coil spring configured to receive the cutter driver (1250) such that the cutter driver (1250) may extend through the cutter spring (1280). Thus, the cutter spring (1280) may be guided by the cutter driver (1250) for compression of the cutter spring (1280) by the cutter carriage (1210). As described in more detail below, the cutter spring (1280) is generally configured to drive distal translational motion of the cutter carriage (1210) to fire the cutter (40). Thus, the distal end of the cutter spring (1280) is configured to engage the receiving end (1220) of the cutter carriage (1210). Meanwhile, the proximal end of the cutter spring (1280) is configured to engage a journal, protrusion, or other structure on the outer housing (14) such that the cutter spring (1280) can be compressed between the cutter carriage (1210) and the outer housing (14).

The drive assembly (1100) further includes a control shaft (1150) (also referred to as an actuation mechanism, control, or trip mechanism) that may be configured to interact with the cutter drive assembly (1200) and the piercer drive assembly (1300) to initiate movement of the cutter (40) and the piercer (22) through a predetermined movement sequence. As best seen in FIG. 40, the control shaft (1150) includes an elongated shaft (1152) having a drive gear (1154), a latch portion (1160), a release portion (1170), and a tissue manipulation portion (1180). The elongated shaft (1152) defines a generally cylindrical cross-section and is configured to extend from the piercer drive assembly (1300) to the cutter drive assembly (1200).

The drive gear (1154) is configured to engage a gear coupled to a motor or other drive mechanism to drive the rotational movement of the control shaft (1150). In some versions, the drive gear (1154) may be driven by the same motor used to drive the gear (1318) of the puncture drive assembly (1300) using a transmission, gearing, and/or other mechanism. In other versions, the drive gear (1154) may be driven by a dedicated motor. In still other versions, the drive gear (1154) may be manually driven by a knob, thumb wheel, crank, or other manual drive mechanism.

The latch portion (1160) is adjacent to the drive gear (1154) and the proximal end of the control shaft (1150). The latch portion (1160) is generally configured to engage the puncture drive assembly (1300) to control one or more operations of the puncture drive assembly (1300). Specifically, the latch portion (1160) includes an actuator (1162) that protrudes outwardly from the elongate shaft (1152). As described in more detail below, the actuator (1162) is configured to engage an actuation protrusion (1324) of the lead screw latch (1320) to selectively release the lead screw latch (1320) from the lead screw drive shaft (1310).

The actuator (1162) extends outwardly from a particular point on the elongate shaft (1152) such that engagement of the actuator (1162) with the piercer drive assembly (1300) can occur at particular rotational positions of the control shaft (1150). As described in more detail below, the particular point of extension of the actuator (1162) may correspond to particular positions of other features of the control shaft (1150). Such relationships between features of the control shaft (1150) may be desirable to facilitate sequential control of the cutter drive assembly (1200) and the piercer drive assembly (1300) through continuous rotational motion of the control shaft (1150).

The release portion (1170) is disposed along the elongate shaft (1152) between the latch portion (1160) and the tissue manipulation portion (1180) and includes a pair of wings (1172). The wings (1172) extend outwardly in opposite directions from the elongate shaft (1152) and define a square or rectangular cross-section. The wings (1172) further extend a predetermined distance along the length of the elongate shaft (1152). As described in more detail below, the particular length of the wings (1172) may correspond to a travel distance of the cutter carriage (1210).

Each wing (1172) is configured to be received within a corresponding channel (1228) of the shaft bore (1226) of the cutter carriage (1210). Thus, the shape of each wing (1172) is complementary to the shape of each channel (1228). In this version, a square or rectangular shape is used for the wings (1172) and the channel (1228), but it should be understood that in other examples, various alternative shapes may be used in other versions.

The particular location of the release portion (1170) along the elongated shaft (1152) is generally configured to allow the release portion (1170) to engage one or more portions of the cutter drive assembly (1200). Specifically, the elongated shaft (1152) is sized to fit within the shaft bore (1226) of the cutter carriage (1210). Similarly, as described above, the wings (1172) are sized to fit within the channel (1228) of the shaft bore (1226). As will be described in more detail below, the control shaft (1150) can be used to rotate the release portion (1170) to selectively lock on and unlock the position of the cutter carriage (1210) relative to the length of the control shaft (1150). As will be appreciated, such functionality can be used to facilitate the release of the cutter carriage (1210) to fire the cutter (40).

The tissue manipulation portion (1180) is disposed proximate the distal end of the elongate shaft (1152). The tissue manipulation portion (1180) is generally configured to manipulate the tissue sample out of the lancing device (22) and into the tissue chamber in response to rotation of the control shaft (1150).

Figures 41-51 show a use version of the biopsy device (10) coupled to the drive assembly (1100) described above. In particular, in such use, the drive assembly (1100) is used to generally cock and then fire the lancet (22) and cutter (40) in a predetermined sequence to penetrate a suspected lesion and then sever a tissue sample thereof. Once the lancet (22) and cutter (40) are actuated, the lancet (22) is retracted relative to the cutter (40) to allow the operator to collect the severed tissue. The cocking and firing process can then be repeated as many times as desired to collect as many tissue samples as the user desires.

FIGS. 41-43 show the initial operation of the drive assembly (1100) to initialize the drive assembly (1100). During initialization, home positions of various components such as the external lead screw (1340), the piercer carriage (1370), the control shaft (1150), and the cutter carriage (1210) are established. Initialization may be used in this version to establish a common initial position of the drive assembly (1100) before starting other manipulation procedures, so that such manipulation procedures proceed sequentially based on predetermined movements performed in coordination.

As best seen in FIG. 41, initialization begins with rotational movement of the lead screw drive shaft (1310) in a clockwise (relative to the view of FIG. 41) direction, which causes a corresponding rotation of the external lead screw (1340). While the external lead screw (1340) rotates in a clockwise direction, the engagement between the threaded portion (1347) of the external lead screw (1340) and the puncture carriage (1370) causes the puncture carriage (1370) to translate proximally down the length of the external lead screw (1340), which causes a corresponding translation of the puncture (22). Also, while the external lead screw (1340) rotates in a clockwise direction, the engagement between the threaded portion (1254) of the cutter driver (1250) and an insert (1360) disposed within the external lead screw (1340) causes the cutter driver (1250) to translate distally relative to the external lead screw (1340). Distal translation of the cutter driver (1250) enables corresponding distal movement of the cutter carriage (1210) via the cutter spring (1280), resulting in corresponding distal translation of the cutter (40).

The rotational movement of the external lead screw (1340) may continue until the puncture carriage (1370) reaches the hard stop (1348) of the external lead screw (1340), as shown in FIG. 42. At this stage, the external lead screw (1340) is physically prevented from rotating further clockwise by the hard stop (1348) of the external lead screw (1340). In some versions, this point may be identified by a control circuit coupled to the motor or other driver of the drive gear (1318) by a current spike or other electrical characteristic in response to an increase in the mechanical load applied to the drive gear (1318). Upon reaching the hard stop (1348), the puncture tool (22) is at its furthest proximal position, corresponding to the home position of the puncture tool (22). Similarly, the cutter (40) is at its furthest distal position, corresponding to the home position of the cutter (40).

In some versions, the home position of the external lead screw (1340) identified by the hard stop (1348) may be slightly offset from the true initialization position identified by the hard stop (1348). In other words, the home position of the external lead screw (1340) may be a different position from the initialization position of the external lead screw (1340). Such an offset may be facilitated by the control circuitry and/or motor control described above. In some versions, this offset may be desirable to reduce wear on the motor used to drive the external lead screw (1340). However, as described above, the hard stop (1348) may be of a more robust configuration in some versions to facilitate control directly via the hard stop (1348) rather than via motor control. In such versions, the initialization position of the external lead screw (1340) may be substantially similar to the home position of the external lead screw (1340).

Also, during initialization, a home position of the control shaft (1150) may be established. In particular, as seen in FIG. 41, the control shaft (1150) may rotate in a clockwise direction. Such clockwise rotational motion of the control shaft (1150) may continue until one or more wings (1172) of the release portion (1170) engage a hard stop protrusion (1230) of the cutter carriage (1210). Once the one or more wings (1172) engage the hard stop protrusion (1230), further clockwise rotational motion may be physically prevented by the hard stop protrusion (1230). In some versions, this point may be identified by a control circuit coupled to the motor or other driver of the drive gear (1154) by a current spike or other electrical characteristic in response to an increase in mechanical load applied to the drive gear (1154).

After the home position of the control shaft (1150) is established by the rotational motion to engage one or more wings (1172) with the hard stop protrusion (1230), the rotational motion of the control shaft (1150) may be reversed to rotate in a counterclockwise direction. In some versions, this reversal of the rotational motion may be used to ensure that the lead screw latch (1320) is positioned to couple to the external lead screw (1340). In particular, the control shaft (1150) may rotate through a full 360° rotation. During this rotational motion, the actuator (1162) of the control shaft (1150) may engage the lead screw latch (1320) and rotate the lead screw latch (1320) into position. Such actuation versions are described in more detail below in connection with FIGS. 46 and 50.

In some versions, the initialization operations described above may be performed in a predetermined sequence. For example, as described above, the wings (1172) of the control shaft (1150) may engage the channel (1228) of the shaft bore (1226) depending on the position of the cutter carriage (1210) relative to the control shaft (1150). Thus, in this example, initialization of the control shaft (1150) may be performed after initialization of the piercer (22) and cutter (40) to establish a position of the cutter carriage (1210) that may allow rotation of the control shaft (1150) and engagement between one or more wings (1172) and the hard stop protrusion (1230). In this version, the drive assembly (1100) is configured such that the cutter carriage (1210) is in its farthest distal position when initialization of the control shaft (1150) may be performed. However, in other versions, various alternative initialization sequences may be used.

After initialization has been performed, both the puncture tool (22) and the cutter (40) may be cocked for firing. As seen in FIG. 44, cocking is performed by rotating the lead screw drive shaft (1310) in a counterclockwise (relative to the view of FIG. 44) direction. Rotational motion of the lead screw drive shaft (1310) may cause a corresponding counterclockwise rotation of the external lead screw (1340). As the external lead screw (1340) rotates in a counterclockwise direction, the puncture tool carriage (1370) translates distally due to engagement between the threaded portion (1347) of the external lead screw (1340) and the puncture tool carriage (1370). This motion advances the puncture tool (22) from the home position described above to a cocked or pre-fire position.

Also, as the external lead screw (1340) rotates in a counterclockwise direction, the engagement between the threaded portion (1254) of the cutter driver (1250) and the insert (1360) disposed within the external lead screw (1340) causes the cutter driver (1250) to translate proximally relative to the external lead screw (1340). This translational movement of the external lead screw (1340) draws at least a portion of the cutter driver (1250) into the hollow interior of the external lead screw (1340), compressing the puncture spring (1364) between the cutter driver (1250) and the lead screw drive shaft (1310). Such compression of the puncture spring (1364) may load the puncture spring (1364) for subsequent firing of the puncture (22).

Also, as the cutter driver (1250) translates relative to the external lead screw (1340), the engagement between the distal engagement end (1260) of the cutter driver (1250) and the receiving end (1220) of the cutter carriage (1210) may correspondingly translate the cutter carriage (1210) in a proximal direction. This proximal translation of the cutter carriage (1210) compresses the cutter spring (1280) between the cutter carriage (1210) and a portion of the outer housing (14). This compression of the cutter spring (1280) may load the cutter spring (1280) for subsequent firing of the cutter (40).

Once cocking is complete, the drive assembly (1100) may be used to sequentially fire the puncture device (22) and cutter (40). As shown in FIG. 45, firing may be initiated by rotating the control shaft (1150) in a counterclockwise direction (relative to the view of FIG. 45). As the control shaft (1150) rotates, engagement between elements of the control shaft (1150), the lead screw latch (1320), and the cutter carriage (1210) may cause the sequential firing of the puncture device (22) and then the cutter (40).

As best seen in FIG. 46, during rotation of the lead screw latch (1320), the actuator (1162) first engages the actuation protrusion (1324) of the lead screw latch (1320). Such engagement causes the lead screw latch (1320) to rotate at least somewhat to align the drive shaft bore (1326) with the lead screw drive shaft (1310) and allow the keyed portion (1314) of the lead screw drive shaft (1310) to slide through the drive shaft bore (1326). Once proper alignment is achieved, compression of the puncture spring (1364) pushes the lead screw drive shaft (1310) outward from the external lead screw (1340), causing the lead screw latch (1320), external lead screw (1340), puncture carriage (1370), puncture (22), and cutter driver (1250) to protrude distally, allowing the puncture (22) to be fired.

45 and 47, and as the control shaft (1150) rotates in a clockwise direction, the wings (1172) of the release portion (1170) move out of alignment with the channel (1228) of the shaft bore (1226). Such misalignment may occur prior to engagement between the actuator (1162) and the actuation protrusion (1324). As a result, distal advancement of the cutter carriage (1210) may be prevented by the wings (1172) of the release portion (1170) despite distal movement of the cutter driver (1250) described above.

As shown in FIG. 48, after firing of the puncture tool (22) is completed, firing of the cutter (40) can be initiated by reversing the rotational motion of the control shaft (1150) in a counterclockwise direction (relative to the view shown in FIG. 48). Such counterclockwise rotation of the control shaft (1150) can realign the wings (1172) of the release portion (1170) with the channel (1228) of the shaft bore (1226) in the cutter carriage (1210). When such realignment occurs, the distal movement of the cutter carriage (1210) is released so that the cutter carriage (1210) can be driven distally by the cutter spring (1280) to fire the cutter (40).

After firing the lancet (22) and cutter (40), a tissue collection sequence may be used to obtain a tissue sample from the lancet (22) and reset the drive assembly (1100) for subsequent tissue collection. Specifically, as best seen in FIG. 49, the lead screw drive shaft (1310) may rotate in a clockwise direction (relative to the view of FIG. 49). Due to the length of the lead screw drive shaft (1310), such rotational motion may result in the external lead screw (1340) rotating clockwise. As the external lead screw (1340) rotates clockwise, the lancet carriage (1370) translates proximally through engagement with the threaded portion (1347) of the external lead screw (1340), retracting the lancet (22) proximally.

Simultaneously with the restriction of the puncture device (22) by the rotational movement of the external lead screw (1340), the external lead screw (1340) itself is also retracted or translated in the proximal direction, further retracting the puncture device (22). Specifically, as the external lead screw (1340) rotates, the insert (1360) also rotates relative to the cutter driver (1250), pushing a portion of the cutter driver (1250) out of the hollow interior of the external lead screw (1340). At this stage, the cutter driver (1250) is in its most distal position, so the cutter driver (1250) pushes the external lead screw (1340) in the proximal direction. This proximal movement of the external lead screw (1340) returns the external lead screw (1340) to the initial home position described above.

During a tissue acquisition sequence, the control shaft (1150) may also rotate in a counterclockwise direction (relative to the view of FIG. 49). As shown in FIG. 50, this rotational motion of the control shaft (1150) may be used to actuate the lead screw latch (1320) to recouple the lead screw latch (1320) with the lead screw drive shaft (1310). In particular, as the control shaft (1150) rotates, the actuator (1162) of the latch portion (1160) may rotate. The actuator (1162) may then engage the actuation protrusion (1324) of the lead screw latch (1320) to rotate the lead screw latch (1320). As the lead screw latch (1320) rotates, the drive shaft bore (1326) may move relative to the keyed portion (1314) of the lead screw drive shaft (1310) to engage the keyed portion (1314) with the inner proximal surface (1328) of the lead screw latch (1320).

Further counterclockwise rotation of the control shaft (1150) may also rotate the tissue manipulation portion (1180). As shown in FIG. 51, rotation of the tissue manipulation portion (1180) may move the severed tissue sample from the notch (26) of the lancet (22) into the tissue chamber by engagement of the cutter carriage (1210) with the tissue manipulator (1216).

After the tissue collection sequence is completed, the drive assembly (1100) may be returned to the home position described above for initialization. Collection of one or more additional tissue samples may then be optionally performed by repeating the cocking, firing, and tissue collection sequence described above. Such a sequence may be repeated as many times as desired to collect any suitable number of tissue samples.

III. EXEMPLARY COMBINATIONS The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any "claims" that may be presented at any time in this application or in any subsequent application following this application. No disclaimers are intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features referenced in the examples below. Thus, unless expressly indicated otherwise later by the inventor or by the intended inventor's successors, etc., none of the aspects or features referenced below should be considered critical. If any "claims" are presented in this application or in any subsequent application related to this application that include additional features beyond those referenced below, those additional features should not be presumed to have been added for any reason related to patentability.

Example 1
1. The core needle biopsy device comprising: a needle assembly including a puncture and a hollow cutter, the puncture including a sharp distal tip and a notch proximal to the distal tip, the puncture being slidably disposed within the cutter to sever a tissue sample within the notch of the puncture; a cutter drive assembly configured to move the cutter; a puncture drive assembly configured to move the puncture, the puncture drive assembly including a lead screw, the lead screw configured to move both a portion of the cutter drive assembly and a portion of the puncture drive assembly; and an actuation mechanism configured to engage both the cutter drive assembly and the puncture drive assembly and to initiate sequential firing of the puncture and the cutter using the cutter drive assembly and the puncture drive assembly.

Example 2
2. The core needle biopsy device of claim 1, wherein the puncture device drive assembly further includes a drive shaft configured to rotate the lead screw, the lead screw configured to translate relative to the drive shaft to fire the puncture device.

Example 3
3. The core needle biopsy device of claim 1 or 2, wherein the lead screw includes a first threaded portion and a second threaded portion, the first threaded portion includes a thread having a first pitch, and the second threaded portion includes a thread having a second pitch, the first pitch being different from the second pitch.

Example 4
4. The core needle biopsy device of example 3, wherein the first threaded portion is configured to engage the cutter drive assembly and the second threaded portion is configured to engage a puncture carriage coupled to the puncture.

Example 5
A core needle biopsy device as described in any one or more of Examples 1 to 4, wherein the lead screw of the puncture drive assembly includes an external lead screw and the cutter drive assembly includes an internal lead screw, and the external lead screw of the puncture drive assembly is configured to threadably receive the internal lead screw of the cutter drive assembly.

Example 6
6. The core needle biopsy device of example 5, wherein rotational movement of the external lead screw relative to the internal lead screw is configured to simultaneously compress a cutter spring and a piercer spring.

Example 7
The core needle biopsy device of Example 6, wherein the internal lead screw is configured to compress the puncture spring within a hollow interior of the external lead screw between a proximal end of the internal lead screw and a portion of the puncture drive assembly disposed within the external lead screw.

Example 8
A core needle biopsy device as described in any one or more of Examples 5 to 7, wherein the cutter drive assembly includes a cutter carriage coupled to the cutter, and the internal lead screw is configured to translate the cutter via the cutter carriage.

Example 9
A core needle biopsy device as described in any one or more of Examples 5 to 8, wherein the puncture drive assembly further includes a latch mechanism configured to be selectively released from a portion of the puncture drive assembly to enable translational movement of the external lead screw.

Example 10
10. The core needle biopsy device of example 9, wherein the latch mechanism is axially fixed to the external lead screw such that the latch mechanism is configured to translate with the external lead screw.

Example 11
The core needle biopsy device of example 9 or 10, wherein the actuation mechanism includes an elongate shaft defining a latch portion and a release portion, the latch portion configured to actuate the latch mechanism to selectively fire the puncture instrument using the external lead screw, and the release portion configured to engage a portion of the cutter drive assembly to selectively fire the cutter.

Example 12
12. The core needle biopsy device of example 11, wherein the actuation mechanism further comprises a tissue manipulation portion, a portion of the tissue manipulation portion configured to manipulate tissue from the notch of the piercer into a tissue chamber.

Example 13
13. The core needle biopsy device of claim 11 or 12, wherein the latch portion includes a protrusion configured to drive rotational movement of the latch mechanism, and the release portion includes a pair of wings.

Example 14
The core needle biopsy device of any one or more of Examples 1-13, wherein at least a portion of the lancing device drive assembly is driven by a motor.

Example 15
The core needle biopsy device of any one or more of Examples 1-14, wherein the lancet drive assembly is configured to retract at least a portion of the cutter drive assembly when the lancet is retracted.

Example 16
13. The core needle biopsy device comprising: a body; a cutter extending from the body, the cutter including an open distal end defined by a sharp edge; a puncture disposed within the cutter, the puncture defining a notch, the puncture movable relative to the cutter to sever a tissue sample in the notch via the sharp edge; a drive assembly including a cutter drive assembly having a cutter carriage and a cutter driver extending from the cutter carriage, a puncture drive assembly having a puncture carriage, a lead screw, and a release mechanism, the release mechanism configured to release axial translational motion of the lead screw relative to the body to fire the puncture; and an actuation mechanism configured to selectively engage the cutter carriage and the release mechanism.

Example 17
17. The core needle biopsy device of example 16, wherein the cutter driver is configured to be received within a portion of the lead screw and to transfer translational motion of the lead screw to the cutter drive assembly.

Example 18
The core needle biopsy device of example 17 or 18, wherein the puncture driver assembly further includes a drive shaft, the drive shaft configured to rotate the lead screw.

Example 19
18. The core needle biopsy device of example 17, wherein the release mechanism is configured to engage the drive shaft to selectively couple the lead screw to the drive shaft.

Example 20
The core needle biopsy device of example 18 or 19, wherein the drive shaft includes an elongated shaft, and the lead screw has a hollow interior configured to receive a portion of the elongated shaft of the drive shaft.

Example 21
The core needle biopsy device of example embodiment 20, wherein the elongated shaft includes a keyed portion, the keyed portion configured to transfer rotational motion from the drive shaft to the lead screw.

Example 22
22. The core needle biopsy device of claim 20 or 21, wherein the lead screw is configured to drive compression of a piercer spring between the cutter driver and the drive shaft.

Example 23
11. A method for obtaining a tissue sample using a core needle biopsy device, the method comprising: distally translating a lead screw to fire a puncture tool from a cocked position to a distal position, the puncture tool being disposed within a hollow cutter, the puncture tool including a notch movable relative to a distal end of the cutter; firing the cutter distally from a cocked position to a distal position after firing the puncture tool to cut a first tissue sample in the notch of the puncture tool; rotating the lead screw to retract the puncture tool while the cutter remains in the distal position to obtain the first tissue sample cut in the notch of the puncture tool; and obtaining the first tissue sample from the notch of the puncture tool.

Example 24
24. The method of claim 23, wherein the step of distally translating the lead screw includes rotating a control shaft a first distance to disengage the lead screw from a drive shaft.

Example 25
25. The method of example 24, wherein the step of firing the cutter distally includes rotating the control shaft a second distance to disengage a cutter carriage from a portion of the control shaft.

Example 26
26. The method of example 25, wherein the step of obtaining the first tissue sample includes rotating the control shaft a third distance to remove the first tissue sample from the notch of the lancing device.

Example 27
The method of any one or more of Examples 23-26, wherein steps (a)-(d) are repeated to obtain a second tissue sample.

Example 28
13. The core needle biopsy device comprising: a needle assembly including a puncture and a hollow cutter, the puncture including a sharp distal tip and a notch proximal to the distal tip, the puncture being slidably disposed within the cutter to sever a tissue sample within the notch of the puncture; a cutter drive assembly configured to move the cutter; a puncture drive assembly configured to move the puncture, the puncture drive assembly including a lead screw, the lead screw configured to translate axially within a portion of the biopsy device to move both a portion of the cutter drive assembly and a portion of the puncture drive assembly; and an actuation mechanism configured to engage both the cutter drive assembly and the puncture drive assembly and to initiate sequential firing of the puncture and the cutter using the cutter drive assembly and the puncture drive assembly.

Example 29
The core needle biopsy device of Example 28, wherein the puncture device drive assembly further includes a drive shaft configured to rotate the lead screw, the lead screw configured to translate relative to the drive shaft to fire the puncture device.

Example 30
The core needle biopsy device of Example 28 or 29, wherein the lead screw includes a first threaded portion and a second threaded portion, the first threaded portion includes a thread having a first pitch, and the second threaded portion includes a thread having a second pitch, the first pitch being different from the second pitch.

Example 31
The core needle biopsy device of example embodiment 30, wherein the first threaded portion is configured to engage the cutter drive assembly and the second threaded portion is configured to engage a puncture carriage coupled to the puncture.

Example 32
A core needle biopsy device as described in any of Examples 28 to 31, wherein the lead screw of the puncture drive assembly includes an external lead screw and the cutter drive assembly includes an internal lead screw, and the external lead screw of the puncture drive assembly is configured to threadably receive the internal lead screw of the cutter drive assembly.

Example 33
33. The core needle biopsy device of example 32, wherein rotational movement of the external lead screw relative to the internal lead screw is configured to simultaneously compress a cutter spring and a piercer spring.

Example 34
The core needle biopsy device of Example 33, wherein the internal lead screw is configured to compress the puncture spring within a hollow interior of the external lead screw between a proximal end of the internal lead screw and a portion of the puncture drive assembly disposed within the external lead screw.

Example 35
A core needle biopsy device described in any of Examples 32 to 34, wherein the cutter drive assembly includes a cutter carriage coupled to the cutter, and the internal lead screw is configured to translate the cutter via the cutter carriage.

Example 36
A core needle biopsy device as described in any of Examples 32 to 35, wherein the puncture drive assembly further includes a latch mechanism configured to be selectively released from a portion of the puncture drive assembly to enable translational movement of the external lead screw.

Example 37
10. The core needle biopsy device of example 9, wherein the latch mechanism is axially fixed to the external lead screw such that the latch mechanism is configured to translate with the external lead screw.

Example 38
The core needle biopsy device of example 36 or 37, wherein the actuation mechanism includes an elongate shaft defining a latch portion and a release portion, the latch portion configured to actuate the latch mechanism to selectively fire the puncture instrument using the external lead screw, and the release portion configured to engage a portion of the cutter drive assembly to selectively fire the cutter.

Example 39
The core needle biopsy device of Example 38, wherein the actuation mechanism further includes a tissue manipulation portion, a portion of the tissue manipulation portion configured to manipulate tissue from the notch of the piercer into a tissue chamber.

Example 40
The core needle biopsy device of example 38 or 39, wherein the latch portion includes a protrusion configured to drive rotational movement of the latch mechanism, and the release portion includes a pair of wings.

Example 41
A core needle biopsy device as described in any of Examples 28 to 40, wherein at least a portion of the piercer drive assembly is driven by a motor.

Example 42
A core needle biopsy device as described in any of Examples 28 to 41, wherein the puncture driver assembly is configured to retract at least a portion of the cutter driver assembly when the puncture driver is retracted.

Example 43
13. The core needle biopsy device comprising: a body; a cutter extending from the body, the cutter including an open distal end defined by a sharp edge; a puncture disposed within the cutter, the puncture defining a notch, the puncture movable relative to the cutter to sever a tissue sample in the notch via the sharp edge; a drive assembly including a cutter drive assembly having a cutter carriage and a cutter driver extending from the cutter carriage, a puncture drive assembly having a puncture carriage, a lead screw, and a release mechanism, the release mechanism configured to release axial translational motion of the lead screw relative to the body to fire the puncture; and an actuation mechanism configured to selectively engage the cutter carriage and the release mechanism.

Example 44
44. The core needle biopsy device of example 43, wherein the cutter driver is configured to be received within a portion of the lead screw and to transmit translational motion of the lead screw to the cutter drive assembly.

Example 45.18
The core needle biopsy device of example 43 or 44, wherein the puncture drive assembly further includes a drive shaft, the drive shaft configured to rotate the lead screw.

Example 46
45. The core needle biopsy device of claim 44, wherein the release mechanism is configured to engage the drive shaft to selectively couple the lead screw to the drive shaft.

Example 47
11. A method for obtaining a tissue sample using a core needle biopsy device, the method comprising: distally translating a lead screw to fire a puncture tool from a cocked position to a distal position, the puncture tool being disposed within a hollow cutter, the puncture tool including a notch movable relative to a distal end of the cutter; firing the cutter distally from a cocked position to a distal position after firing the puncture tool to cut a first tissue sample in the notch of the puncture tool; rotating the lead screw to retract the puncture tool while the cutter remains in the distal position to obtain the first tissue sample cut in the notch of the puncture tool; and obtaining the first tissue sample from the notch of the puncture tool.

While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Some such potential modifications have been mentioned, but others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. described above are illustrative and not required. Accordingly, it is understood that the scope of the present invention should be considered in conjunction with the following "claims" and is not limited to the details of structure and operation shown and described in the specification and drawings.

It should be understood that any of the variations of the devices described herein may include various other features in addition to or in place of those described above. Also, by way of example only, any of the devices described herein may include one or more of the various features disclosed in any of the various references incorporated by reference herein. It should be understood that the teachings herein may be readily applied to any of the devices described in any of the other references cited herein, and thus the teachings herein may be readily combined in numerous ways with the teachings of any of the references cited herein. Other types of devices that may incorporate the teachings herein will be apparent to those skilled in the art.

It should be recognized that any patent, publication, or other disclosure material referred to as being incorporated herein by reference in whole or in part is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. Thus, and to the extent necessary, the disclosure as expressly set forth herein takes precedence over any conflicting material incorporated herein by reference. Any material, or portion thereof, referred to as being incorporated herein by reference but which conflicts with existing definitions, statements, or other disclosure material set forth herein, is incorporated only to the extent that no conflict arises between the incorporated material and the existing disclosure material.

[Embodiment]
(1) A core needle biopsy device, comprising:
(a) a needle assembly including a piercer and a hollow cutter, the piercer including a sharp distal tip and a notch proximal to the distal tip, the piercer slidably disposed within the cutter to sever a tissue sample into the notch of the piercer;
(b) a cutter drive assembly configured to move the cutter; and
(c) a puncture drive assembly configured to move the puncture, the puncture drive assembly including a lead screw, the lead screw configured to translate axially within a portion of the biopsy device to move both a portion of the cutter drive assembly and a portion of the puncture drive assembly;
(d) an actuation mechanism configured to engage both the cutter drive assembly and the puncture drive assembly and to initiate sequential firing of the puncture and the cutter using the cutter drive assembly and the puncture drive assembly;
The core needle biopsy device.
2. The core needle biopsy device of claim 1, wherein the puncture driver assembly further comprises a drive shaft configured to rotate the lead screw, the lead screw configured to translate relative to the drive shaft to fire the puncture.
3. The core needle biopsy device of claim 1, wherein the lead screw includes a first threaded portion and a second threaded portion, the first threaded portion including a thread having a first pitch, the second threaded portion including a thread having a second pitch, and the first pitch is different from the second pitch.
4. The core needle biopsy device of claim 3, wherein the first threaded portion is configured to engage the cutter drive assembly and the second threaded portion is configured to engage a puncture carriage coupled to the puncture.
(5) The core needle biopsy device of any one of claims 1 to 4, wherein the lead screw of the puncture drive assembly includes an external lead screw and the cutter drive assembly includes an internal lead screw, and the external lead screw of the puncture drive assembly is configured to threadably receive the internal lead screw of the cutter drive assembly.

6. The core needle biopsy device of claim 5, wherein rotational movement of the external lead screw relative to the internal lead screw is configured to simultaneously compress a cutter spring and a piercer spring.
7. The core needle biopsy device of claim 6, wherein the internal lead screw is configured to compress the piercer spring within a hollow interior of the external lead screw between a proximal end of the internal lead screw and a portion of the piercer drive assembly disposed within the external lead screw.
(8) The core needle biopsy device of any one of claims 5 to 7, wherein the cutter drive assembly includes a cutter carriage coupled to the cutter, and the internal lead screw is configured to translate the cutter via the cutter carriage.
9. The core needle biopsy device of any one of claims 5 to 8, wherein the puncturator drive assembly further includes a latch mechanism, the latch mechanism configured to selectively release from a portion of the puncturator drive assembly to allow translational movement of the external lead screw.
10. The core needle biopsy device of claim 9, wherein the latch mechanism is configured to be axially secured to the external lead screw such that the latch mechanism translates with the external lead screw.

11. The core needle biopsy device of claim 9 or 10, wherein the actuation mechanism includes an elongate shaft defining a latch portion and a release portion, the latch portion configured to actuate the latch mechanism to selectively fire the puncture instrument using the external lead screw, and the release portion configured to engage a portion of the cutter drive assembly to selectively fire the cutter.
12. The core needle biopsy device of claim 11, wherein the actuation mechanism further comprises a tissue manipulation portion, a portion of the tissue manipulation portion configured to manipulate tissue from the notch of the piercer into a tissue chamber.
13. The core needle biopsy device of claim 11 or 12, wherein the latch portion includes a protrusion configured to drive rotational movement of the latch mechanism, and the release portion includes a pair of wings.
14. The core needle biopsy device of any one of claims 1 to 13, wherein at least a portion of the piercer drive assembly is driven by a motor.
(15) The core needle biopsy device of any preceding claim, wherein the puncturator drive assembly is configured to retract at least a portion of the cutter drive assembly when the puncturator is retracted.

(16) A core needle biopsy device, comprising:
(a) a main body;
(b) a cutter extending from the body, the cutter including an open distal end defined by a sharp edge; and
(c) a piercer disposed within the cutter, the piercer defining a notch, the piercer movable relative to the cutter to sever a tissue sample via the sharp edge within the notch;
(d) a drive assembly comprising:
(i) a cutter drive assembly having a cutter carriage and a cutter driver extending from the cutter carriage;
(ii) a puncture drive assembly having a puncture carriage, a lead screw, and a release mechanism configured to release axial translation of the lead screw relative to the body to fire the puncture; and
(iii) an actuation mechanism configured to selectively engage the cutter carriage and the release mechanism; and
the drive assembly including:
The core needle biopsy device.
17. The core needle biopsy device of claim 16, wherein the cutter driver is configured to be received within a portion of the lead screw and to transfer translational motion of the lead screw to the cutter drive assembly.
18. The core needle biopsy device of claim 16 or 17, wherein the piercer drive assembly further includes a drive shaft, the drive shaft configured to rotate the lead screw.
19. The core needle biopsy device of claim 17, wherein the release mechanism is configured to engage the drive shaft to selectively couple the lead screw to the drive shaft.
20. A method for collecting a tissue sample using a core needle biopsy device, comprising:
(a) distally translating a lead screw to distally fire a puncture device from a cocked position to a distal position, the puncture device being disposed within a hollow cutter, the puncture device including a notch movable relative to a distal end of the cutter;
(b) firing the lancing instrument and then firing the cutter distally from a cocked position to a distal position to sever a first tissue sample within the notch of the lancing instrument;
(c) rotating the lead screw to retract the lancing device while the cutter remains in the distal position and collect the first tissue sample severed within the notch of the lancing device;
(d) collecting the first tissue sample from the notch of the lancing device;
The method comprising:

Claims (20)

1. A core needle biopsy device comprising:
(a) a needle assembly including a piercer and a hollow cutter, the piercer including a sharp distal tip and a notch proximal to the distal tip, the piercer slidably disposed within the cutter to sever a tissue sample into the notch of the piercer;
(b) a cutter drive assembly configured to move the cutter; and
(c) a puncture drive assembly configured to move the puncture, the puncture drive assembly including a lead screw, the lead screw configured to translate axially within a portion of the biopsy device to move both a portion of the cutter drive assembly and a portion of the puncture drive assembly;
(d) an actuation mechanism configured to engage both the cutter drive assembly and the puncture drive assembly and to initiate sequential firing of the puncture and the cutter using the cutter drive assembly and the puncture drive assembly;
The core needle biopsy device. The core needle biopsy device of claim 1, wherein the puncture device drive assembly further includes a drive shaft configured to rotate the lead screw, the lead screw configured to translate relative to the drive shaft to fire the puncture device. The core needle biopsy device of claim 1 or 2, wherein the lead screw includes a first threaded portion and a second threaded portion, the first threaded portion includes a thread having a first pitch, the second threaded portion includes a thread having a second pitch, and the first pitch is different from the second pitch. The core needle biopsy device of claim 3, wherein the first threaded portion is configured to engage the cutter drive assembly and the second threaded portion is configured to engage a lancet carriage coupled to the lancet. The core needle biopsy device of claim 1, wherein the lead screw of the puncture drive assembly includes an external lead screw and the cutter drive assembly includes an internal lead screw, and the external lead screw of the puncture drive assembly is configured to threadably receive the internal lead screw of the cutter drive assembly. The core needle biopsy device of claim 5, wherein rotational movement of the external lead screw relative to the internal lead screw is configured to simultaneously compress a cutter spring and a piercer spring. 7. The core needle biopsy device of claim 6, wherein the internal lead screw is configured to compress the piercer spring within a hollow interior of the external lead screw between a proximal end of the internal lead screw and a portion of the piercer drive assembly disposed within the external lead screw. The core needle biopsy device of claim 5, wherein the cutter drive assembly includes a cutter carriage coupled to the cutter, and the internal lead screw is configured to translate the cutter via the cutter carriage. The core needle biopsy device of claim 5, wherein the piercer drive assembly further includes a latch mechanism configured to be selectively released from a portion of the piercer drive assembly to permit translational movement of the external lead screw. The core needle biopsy device of claim 9, wherein the latch mechanism is configured to be axially fixed to the external lead screw such that the latch mechanism translates with the external lead screw. The core needle biopsy device of claim 9 or 10, wherein the actuation mechanism includes an elongate shaft defining a latch portion and a release portion, the latch portion configured to actuate the latch mechanism to selectively fire the puncture instrument using the external lead screw, and the release portion configured to engage a portion of the cutter drive assembly to selectively fire the cutter. The core needle biopsy device of claim 11, wherein the actuation mechanism further includes a tissue manipulation portion, a portion of the tissue manipulation portion configured to manipulate tissue from the notch of the piercer into a tissue chamber. The core needle biopsy device of claim 11, wherein the latch portion includes a protrusion configured to drive rotational movement of the latch mechanism, and the release portion includes a pair of wings. The core needle biopsy device of claim 1, wherein at least a portion of the lancet drive assembly is driven by a motor. The core needle biopsy device of claim 1, wherein the lancet drive assembly is configured to retract at least a portion of the cutter drive assembly when the lancet is retracted. 1. A core needle biopsy device comprising:
(a) a main body;
(b) a cutter extending from the body, the cutter including an open distal end defined by a sharp edge; and
(c) a piercer disposed within the cutter, the piercer defining a notch, the piercer movable relative to the cutter to sever a tissue sample via the sharp edge within the notch;
(d) a drive assembly comprising:
(i) a cutter drive assembly having a cutter carriage and a cutter driver extending from the cutter carriage;
(ii) a puncture drive assembly having a puncture carriage, a lead screw, and a release mechanism configured to release axial translation of the lead screw relative to the body to fire the puncture; and
(iii) an actuation mechanism configured to selectively engage the cutter carriage and the release mechanism; and
the drive assembly including:
The core needle biopsy device. The core needle biopsy device of claim 16, wherein the cutter driver is configured to be received within a portion of the lead screw and to transmit translational motion of the lead screw to the cutter drive assembly. The core needle biopsy device of claim 16 or 17, wherein the piercer drive assembly further includes a drive shaft, the drive shaft configured to rotate the lead screw. The core needle biopsy device of claim 17, wherein the release mechanism is configured to engage the drive shaft to selectively couple the lead screw to the drive shaft. 1. A method for collecting a tissue sample using a core needle biopsy device, comprising:
(a) distally translating a lead screw to distally fire a puncture device from a cocked position to a distal position, the puncture device being disposed within a hollow cutter, the puncture device including a notch movable relative to a distal end of the cutter;
(b) firing the lancing instrument and then firing the cutter distally from a cocked position to a distal position to sever a first tissue sample within the notch of the lancing instrument;
(c) rotating the lead screw to retract the lancing device while the cutter remains in the distal position and collect the first tissue sample severed within the notch of the lancing device;
(d) collecting the first tissue sample from the notch of the lancing device;
The method comprising:

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