HK1222109B - Biopsy device with translating valve assembly - Google Patents

Description

Biopsy device with translating valve assembly

Background Art

Various devices have been used to obtain biopsy samples in various ways in various medical procedures. Biopsy devices can be used under stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or other circumstances. For example, some biopsy devices may be fully operable by the user with a single hand and a single insertion to obtain one or more biopsy samples from a patient. In addition, some biopsy devices can be tethered to a vacuum module and/or a control module, such as for communicating fluids (e.g., pressurized air, saline, atmosphere, vacuum, etc.), transmitting power, and/or conveying commands, etc. Other biopsy devices may not need to be tethered or otherwise connected to another device to fully or at least partially operate. Other biopsy devices may not need to be tethered or otherwise connected to another device to fully or at least partially operate.

U.S. Patent No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue”, published on June 18, 1996; U.S. Patent No. 6,086,544, entitled “Control Apparatus for an Automated Surgical Biopsy Device”, published on July 11, 2000; U.S. Publication No. 2003/0109803, entitled “MRI Compatible Surgical Biopsy Device”, published on June 12, 2003; U.S. Publication No. 2006/0074345, entitled “Biopsy Apparatus and Method”, published on April 6, 2006; U.S. Patent No. 2006/0074345, entitled “Remote Thumbwheel for a Surgical Biopsy Device”, published on May 24, 2007; U.S. Publication No. 2007/0118048, entitled “Biopsy Device”, published on September 4, 2008, U.S. Publication No. 2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device”, published on July 2, 2009, U.S. Publication No. 2009/0171242, entitled “Clutch and Valving System for Tetherless Biopsy Device”, published on June 17, 2010, U.S. Publication No. 2010/0152610, entitled “Hand Actuated Tetherless Biopsy Device with Pistol Grip”, published on June 24, 2010, U.S. Publication No. 2010/0160819, entitled “Biopsy Device with Central Thumbwheel”, published on December 16, 2010, U.S. Publication No. 2010/0317997, entitled “Handheld Biopsy Device with Needle Firing,” published on May 3, 2012, and entitled “Needle Assembly and Blade Assembly for Biopsy Device,” published on December 6, 2012, disclose only exemplary biopsy devices. The contents of each of the above-cited U.S. patents, U.S. patent application publications, and U.S. non-provisional patent applications are incorporated herein by reference.

While many systems and methods have been developed and used for obtaining biopsy samples, it is believed that no one prior to the inventors has developed or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While this specification results in claims particularly pointing out and distinctly claiming the biopsy device, it is believed that the biopsy device will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein like reference numerals indicate like elements, and wherein:

FIG1 shows a perspective view of an exemplary biopsy device;

FIG2 illustrates a perspective view of the biopsy device of FIG1 , showing the sheath removed from the probe;

FIG3 shows a schematic diagram of exemplary electrical and/or electromechanical components of the set in FIG2 ;

FIG4 shows an exploded perspective view of the probe in FIG2 ;

FIG5 illustrates a perspective view of an exemplary needle assembly and related components of the probe of FIG2 ;

FIG6 shows a cross-sectional view of the needle assembly of FIG5 taken along line 6-6 in FIG5;

7A illustrates a cross-sectional perspective view of the distal end of the needle assembly of FIG. 5 taken along line 7-7 of FIG. 6 , showing the cutter in a closed position;

7B illustrates a cross-sectional perspective view of the distal end of the needle assembly of FIG. 5 taken along line 7-7 of FIG. 6 , showing the cutter in an open position;

FIG7C illustrates a cross-sectional perspective view of the distal end of the needle assembly of FIG5 taken along line 7-7 of FIG6 showing the cutter in a partially open position;

FIG8 shows an exploded perspective view of the needle assembly in FIG5 ;

FIG9 shows a side cross-sectional perspective view of the valve member of the needle assembly of FIG5 ;

FIG10 shows a perspective view of the valve core body of the valve member in FIG9 when the distal end is oriented away from the observer;

FIG11 shows a perspective view of the valve core body in FIG10 with the proximal end oriented away from the observer;

FIG12 shows a cross-sectional view of the valve core body in FIG10 taken along the center line 12-12 in FIG11;

FIGURE 13A illustrates a cross-sectional perspective view taken along the side of an exemplary needle assembly showing the cutter and valve assembly in a vent position corresponding to the closed cutter position shown in FIGURE 7A;

FIGURE 13B illustrates a cross-sectional perspective view taken along the side of an exemplary needle assembly showing the cutter and valve assembly in a first non-vent position corresponding to the open cutter position shown in FIGURE 7B;

FIGURE 13C illustrates a cross-sectional perspective view taken along the side of an exemplary needle assembly showing the cutter and valve assembly in a second, non-venting position corresponding to the partially open cutter position shown in FIGURE 7C;

FIG14 shows a graph depicting the relationship between valve state and cutter position.

DETAILED DESCRIPTION

The following description of certain examples of the biopsy device should not be construed to limit the scope of the present biopsy device. Other examples, features, aspects, embodiments, and advantages of the biopsy device will become apparent to those skilled in the art from the following description of one of the best modes for conceiving and implementing the biopsy device, which is provided by way of example. As will be appreciated, the biopsy device can include other different and distinct aspects, all without departing from the spirit of the biopsy device. Accordingly, the drawings and detailed description should be regarded as illustrative in nature and not restrictive.

It should be understood that any patent, publication, or other public material incorporated herein in whole or in part by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials given in this invention. Thus, to the extent necessary, the content expressly set forth herein will supersede any conflicting material incorporated herein by reference. Any material or portion thereof stated to be incorporated herein by reference but that conflicts with existing definitions, statements, or other public materials described herein is incorporated herein only to the extent that the incorporated material does not conflict with existing public materials.

I. Overview of Exemplary Biopsy Devices

FIG1 illustrates an exemplary biopsy device 10 comprising a probe 20 and a sheath 30. Probe 20 includes a needle assembly 100 that extends at least partially distally from a housing of probe 20. Needle assembly 100 can be inserted into a patient's tissue to obtain a tissue sample, as described below. Biopsy device 10 also includes a tissue sample holder 40 in which a tissue sample is stored. By way of example only, probe 20 can be a disposable component, while sheath 30 can be a reusable component, to which probe 20 can be coupled, as shown in FIG2 . The term "sheath" as used herein should not be interpreted as requiring that any portion of probe 20 be inserted into any portion of sheath 30. Indeed, in one configuration of biopsy device 10, probe 20 can be simply placed on top of sheath 30. Alternatively, a portion of probe 20 can be inserted into sheath 30 to secure probe 20 to sheath 30. In another configuration, a portion of sheath 30 can be inserted into probe 20. Furthermore, probe 20 and sheath 30 can be integrally formed as a single unit.

In a configuration where the probe 20 and the sleeve 30 are separable components, a port and/or seal 32 may be provided on the sleeve 30 to couple with a second port and/or second seal 26 on the probe 20 so that the vacuum generated within the sleeve 30 by the vacuum pump 50 can be fluidly connected to the probe 20. The sleeve 30 may also provide gears 34, 36 that mate and engage with gears 310, 312 on the probe 20. It should be understood that the configuration shown in FIG2 for communicating vacuum and motive force between the sleeve 30 and the probe 20 is merely exemplary. In some variations, such a construction may be constructed according to at least some of the teachings of U.S. Patent No. 8,206,316, entitled “Tetherless Biopsy Device with Reusable Portion,” issued on June 26, 2012, and/or U.S. Publication No. 2012/0065542, entitled “Biopsy Device Tissue Sample Holder with Removable Tray,” published on March 15, 2012, the contents of which are incorporated herein by reference.

By connecting sheath 30 to probe 20, vacuum pump 50 can create a vacuum within needle assembly 100 via tissue sample holder 40 and tubular cutter 60. However, it should be understood that vacuum can be provided by other means. For example, vacuum pump 50 can be independent of sheath 30 and probe 20 and simply connected to an appropriate port on biopsy device 10 via a vacuum tube. Biopsy device 10 can also be constructed in accordance with at least some of the teachings of U.S. Patent No. 8,764,680, entitled "Handheld Biopsy Device with Needle Firing," issued on July 1, 2014, and/or U.S. Publication No. 2012/0065542, entitled "Biopsy Device Tissue Sample Holder with Removable Tray," published on March 15, 2012, the contents of which are incorporated herein by reference. Other suitable structural and functional combinations of probe 20 and sheath 30 will be apparent to those skilled in the art in light of the teachings herein.

II. Exemplary Sets

As exemplarily shown in FIG3 , the sleeve 30 includes a vacuum pump 50, a motor 70, a control module 1000, a vacuum sensor 52, and any other suitable electrical and/or electromechanical components. The vacuum pump 50 in this example comprises a conventional diaphragm pump mechanically coupled to the motor 70. The vacuum sensor 52 is coupled to the vacuum pump 50 or along any vacuum path from the vacuum pump 50 so that the vacuum sensor 52 can determine the vacuum level generated by the vacuum pump 50. The vacuum sensor 52 is electrically coupled to the control module 1000 so that the vacuum sensor 52 can output a signal indicating the vacuum level to the control module 1000. In the illustrated configuration, the motor 70 is operable to translate and/or rotate the cutter 60, as will be described below, and activate the vacuum pump 50. However, this is optional, and a second motor (not shown) may be provided to operate the vacuum pump 50. Specifically, the motor may be coupled to a cutter drive assembly (not shown). Such a cutter drive assembly (not shown) may simultaneously rotate the gears 34 and 36. As described above, gears 34, 36 mesh with gears 310, 312 in probe 20 to allow motor 70 to translate and/or rotate cutter 60. A person of ordinary skill in the art will readily appreciate that various other configurations of sleeve 30 may be provided based on the teachings of the present invention. By way of example only, the cutter drive assembly (not shown) and/or other features of sleeve 30 may be constructed in accordance with at least some of the teachings of U.S. Patent No. 8,206,316, entitled “Tetherless Biopsy Device with Reusable Portion,” issued June 26, 2012, and/or U.S. Patent No. 8,764,680, entitled “Handheld Biopsy Device with Needle Firing,” issued July 1, 2014, the contents of which are incorporated herein by reference.

III. Exemplary Probes

FIG4 is a partially exploded view of probe 20, showing needle assembly 100, cutter actuator assembly 300, probe housings 22, 24, and tissue sample holder 40. Needle assembly 100 includes needle portion 110 and valve assembly 200. As will be described in detail below, needle assembly 100 is generally operable to pierce tissue where cutter 60 can be positioned, thereby removing a tissue sample from a patient and delivering the tissue sample to tissue sample holder 40. More specifically, needle portion 110 of needle assembly 100 is inserted into the patient's tissue. Cutter actuator assembly 300 is then operable to selectively actuate cutter 60 to an open position. Once cutter 60 is actuated to the open position by cutter actuator assembly 300, tissue prolapses into needle portion 110 by virtue of the vacuum communicated through cutter 60. Cutter 60 can then be selectively actuated to a closed position by cutter actuator assembly 300, severing the prolapsed tissue from the patient. Vent assembly (300) is then operable to selectively vent a portion of needle portion (110) to atmosphere to create a pressure differential between the proximal and distal ends of the prolapsed tissue. The pressure differential then transports the prolapsed tissue through cutter (60) to tissue sample holder (40).

A. Exemplary Cutter Actuation Assembly

Cutter actuation assembly 300 includes a series of gears 310, 320. Gears 310, 320 are capable of translating and/or rotating cutter 60. In the illustrated configuration, when probe 20 is attached to sleeve 30, gears 310, 312 are coupled to motor 70. Specifically, two gears 310, 320 are controlled by motor 70 such that one gear 310 translates cutter 60 while the other gear 312 simultaneously rotates cutter 60. Other configurations can be provided using different arrangements of gears 310. Furthermore, configurations incorporating additional motors 70 can be used. Various suitable motor 70 and gear 310, 312 combinations will readily occur to those skilled in the art, given the teachings of the present invention. In practice, cutter actuation assembly 300 can be constructed in accordance with at least some of the teachings of U.S. Patent No. 8,206,316, entitled "Tetherless Biopsy Device with Reusable Portion," issued June 26, 2012, the contents of which are incorporated herein by reference.

B. Exemplary Needle Portions

Figures 5 to 7 illustrate an exemplary needle portion 110. Needle portion 110 includes a cannula 120, a cannula portion 130, a tissue-piercing tip 140, and a lateral aperture 150. As shown, cannula 120 is positioned atop cannula portion 130. Cannula 120 and cannula portion 130 define a first lumen portion 160 and a second lumen portion 162. As best seen in Figure 6, cannula 120 is generally circular, while cannula portion 130 is semicircular. Cannula 120 and cannula portion 130 may be coextensive, with their proximal ends terminating within valve assembly 200 and their distal ends supporting tissue-piercing tip 140. While needle portion 110 is shown as having a generally oblong cross-sectional shape, it should be understood that other cross-sectional shapes may also be employed. In practice, needle portion 110 may comprise only a circular tube, thereby forming a generally figure-eight cross-section. Alternatively, needle portion 110 may comprise two square tubes, thereby forming a generally square cross-section. In other configurations, any other suitable shape may also be employed.

7A to 7C illustrate needle portion 110 with cutter 60 in various positions. Specifically, cannula 120 is capable of receiving cutter 60 and permitting translation and rotation of cutter 60 within second lumen portion 162. Cannula 120 also includes lateral aperture 150. Lateral aperture 150 is sized to receive prolapsed tissue during operation of biopsy device 10. A sidewall of cannula 120, opposite lateral aperture 150, includes a plurality of openings 170 that provide fluid communication between first lumen portion 160 and second lumen portion 162. In this example, first lumen portion 160 can selectively provide atmospheric air through openings 170 to vent second lumen portion 162. This atmospheric venting of second lumen portion 162 allows excised tissue to be drawn through cutter 60 and into tissue sample holder 40 under the influence of vacuum from vacuum pump 50.

The series of depictions in Figures 7A to 7C shows cutter 60 first in a closed position, then in an open position, and finally in an intermediate position. Each of the illustrated positions may correspond to a specific stage in the tissue sample extraction process. For example, as shown in Figure 7A, cannula 120 can penetrate a patient's tissue when cutter 60 is in the closed position. In the closed position, cutter 60 is in its most distal position relative to lateral aperture 150. Thus, cannula 120 can smoothly penetrate tissue without catching any surrounding tissue that might otherwise impede penetration.

7B shows cutter 60 in an open position, wherein cutter 60 is in its most distal proximal position relative to lateral aperture 150. This state may correspond, for example, to a position in which cannula 120 is oriented within a patient's body at a location where a tissue sample can be extracted. When cutter 60 is in its most distal proximal position relative to lateral aperture 150, a vacuum may be applied to prolapse the patient's tissue through lateral aperture 150.

Finally, FIG. 7C shows cutter 60 in an intermediate position, wherein cutter 60 is positioned between its most distal and proximal positions relative to lateral aperture 150. In this position, cutter 60 can be maneuvered from a closed position or an open position to a closed position or an open position, respectively. For example, cutter 60 can be moved from an open position to a closed position so that cutter 60 can sever a tissue sample. Alternatively, cutter 60 can be moved from a closed position to an open position to allow prolapse of a patient's tissue through lateral aperture 150. As will be described in further detail below, these various positions correspond to various pneumatic states of valve assembly 200. It should be understood that the various positions of cutter 60 and the corresponding stages in the tissue extraction process are merely exemplary, and other suitable combinations will readily occur to those of ordinary skill in the art, given the teachings of the present invention.

The illustrated tissue-piercing tip 140 has a generally conical body with a flat blade protruding from the body. The shape of the tissue-piercing tip 140 is merely illustrative, and a variety of other suitable shapes may be employed. For example, the tissue-piercing tip 140 may be in the shape of a blade protruding from the needle portion 110, independent of the conical body. In other variations, the tissue-piercing tip 140 may have a flat blade portion of various shapes and configurations. Those skilled in the art will readily appreciate various other general configurations of the tissue-piercing tip 140 and needle portion 110 based on the teachings of the present invention. By way of example only, the needle portion 110 may be constructed in accordance with at least some of the teachings of U.S. Patent No. 8,801,742, entitled "Needle Assembly and Blade Assembly for Biopsy Device," issued on August 8, 2014, the contents of which are incorporated herein by reference.

C. Exemplary Valve Assemblies

FIG8 shows an exploded view of an exemplary valve assembly 200. Valve assembly 200 includes a manifold 210, a static seal 240, and a valve core 250. Manifold 210 couples valve assembly 200 to the proximal end of needle portion 110 of needle assembly 100. Specifically, manifold 210 includes a needle coupling end 220 and a vent end 230. As best seen in FIG9 , needle coupling end 220 of manifold 210 is adapted to receive the proximal end of needle portion 110 of needle assembly 100. In this example, coupling occurs at the termination of cannula 120 and a portion of cannula 130. Cutter 60 then continues through valve assembly 200 to tissue sample holder 40. As will be described in greater detail below, needle coupling end 220 forms an airtight seal around cannula 120 and a portion of cannula 130, allowing fluid to flow from vent end 230 through first lumen portion 160. The coupling between the needle portion 110 and the needle coupling end 220 of the manifold 210 may be facilitated by any suitable means, such as adhesive bonding, resilient sealing features, interference fit, or mechanical fastening arrangements.

FIG9 shows the vent end 230 of manifold 210 in place around cutter 60. The valve core 250 is not shown in FIG9 to allow for a detailed view of the vent end 230. The vent end 230 extends proximally from the needle coupling end 220. In this example, the needle coupling end 220 and the vent end 230 are integrally formed as a single unit. In other examples, the needle coupling end 220 and the vent end 230 may be separate components connected together by any suitable fastening means. The vent end 230 terminates at the proximal end of the manifold 210, to which a static seal 240 is attached. The vent end 230 defines a plurality of transverse openings 232 co-located longitudinally with one another. The transverse openings 232 are spaced equidistantly around the circumference of the vent end 230 at their common longitudinal position. As will be described in greater detail below, the transverse openings 232 connect the interior of the vent end 230 to the atmosphere, allowing the atmosphere to fluidically communicate with the first lumen portion 160.

Static seal 240 is attached to the proximal end of manifold 210. Cutter 60 extends through static seal 240. Although cutter 60 can freely rotate and translate through static seal 240, static seal 240 prevents fluid communication at the interface between cutter 60 and static seal 240. Therefore, atmospheric flow can be restricted to the first lumen portion 160 through transverse opening 232 by the seal formed by static seal 240 and the seal formed by needle coupling end 220. Static seal 240 is shown as a separate component of valve assembly 200. This allows valve core body 250 to be inserted into manifold 210. However, it should be understood that static seal 240 can be formed integrally with manifold 210. This is particularly the case where manifold 210 comprises multiple components rather than the integrated design shown in the figures.

10 through 12 provide detailed views of the valve core body 250. The valve core body 250 has O-rings 252 located near the distal and proximal ends of the valve core body 250. As will be described in greater detail below, the O-rings 252 form a seal between the valve core body 250 and the inner diameter surface of the vent end 230 of the manifold 210. Although the valve core body 250 is shown as having two O-rings 252, any number of O-rings may be used.

The valve core body 250 shown in the figure is generally hollow, wherein the inwardly extending cutter engagement member 254 defines a vent passage 256. As can be clearly seen in Figure 12, the cutter engagement member 254 allows the valve core body 250 to be coaxially located on the cutter 60. In this example, there are four cutter engagement members 254 equidistantly oriented around the interior of the valve core body 250. Alternatively, the valve core body 250 may include any suitable number of cutter engagement members 254. The cutter engagement member 254 extends longitudinally from the proximal end of the valve core body 250 toward the distal end of the valve core body 250. It should be understood that the longitudinal extension of the cutter engagement member 254 is merely exemplary, and other configurations may also be employed. For example, the cutter engagement member 254 may extend only a portion of the valve core body 250. In another configuration, the longitudinal extension of the cutter engagement member 254 may be discontinuous, so that it extends a portion of the valve core body 250, interrupts, and then continues to extend another portion.

The vent passages 256 allow fluid communication between the outer diameter of the cutter 60 and the inner diameter of the spool body 250, from the proximal end of the spool body 250 to the distal end of the spool body 250. In this example, four vent passages 256 are defined by four cutter engagement members 254. However, it should be understood that any alternative configuration of the cutter engagement member 254 can provide a corresponding alternative configuration of the vent passages 256. Various other alternative configurations of the cutter engagement member 254 and the vent passages 256 will be readily apparent to those of ordinary skill in the art given the teachings herein.

The distal end of the spool body 250 includes a cutter securing aperture 258 that allows the spool body 250 to be attached to the cutter 60 via a set screw or some other suitable type of fastening member. Thus, the spool body 250 can rotate and translate as the cutter 60 translates and rotates. Two cutter securing apertures 258 are shown. It should be understood that any suitable number of cutter securing apertures 258 may be used. Furthermore, the cutter securing apertures 258 may even be omitted entirely and replaced with some other means of securing the spool body 250 to the cutter 60, as will be apparent to one of ordinary skill in the art in light of the teachings herein.

IV. Exemplary Aerodynamic Conditions

Figures 13A-13C illustrate valve spool body 250 in various exemplary pneumatic states. Figure 13A shows valve spool body 250 in the vent state. In the vent state, valve spool body 250 is in its most distal position relative to manifold 210. As described above, valve spool body 250 is attached to cutter 60. Thus, as seen in Figure 7A, the vent state corresponds to cutter 60 being in its most distal position relative to lateral aperture 150. When valve spool body 250 is in its most distal position relative to manifold 210, transverse opening 232 allows atmospheric fluid to communicate with first lumen portion 160 via vent passage 256 in valve spool body 250. In particular, proximal-most O-ring 252 is located distal to transverse opening 232. Thus, valve spool body 250 provides a clear fluid path between transverse opening 232 and vent passage 256. The atmospheric fluid communication to first lumen portion ( 160 ) correspondingly allows negative pressure to exist behind the severed tissue sample within cutter ( 60 ) at the distal end of cutter ( 60 ). Thus, when a vacuum is applied to cutter ( 60 ), the severed tissue sample is transported proximally through cutter ( 60 ) to tissue sample holder ( 40 ).

FIG13B illustrates valve spool 250 in a non-venting state. In the non-venting state, valve spool 250 is in its furthest proximal position relative to manifold 210. In this furthest proximal position, valve spool 250 is positioned to seal transverse opening 232 in vent end 230 of manifold 210. Specifically, transverse opening 232 is disposed between valve spool 250 and O-ring 252, thereby preventing fluid communication through transverse opening 232 to vent passage 256. FIG13B illustrates the non-venting state, corresponding to the open state of cutter 60. As best seen in FIG7B , the open state of cutter 60 corresponds to cutter 60 being positioned in its furthest proximal position relative to transverse opening 150. In the open state of cutter 60, atmospheric air is not in fluid communication with first lumen portion 160. In other words, valve spool 250 seals first lumen portion 160 from atmospheric air at this stage. Thus, when a vacuum is applied to cutter (60), tissue may prolapse through lateral apertures (150).

FIG13C illustrates valve spool body 250 in an intermediate, non-vented state. In this example, valve spool body 250 includes two O-rings 252 spaced apart by a distance approximately corresponding to the longitudinal length of lateral aperture 150 of cannula 120. Due to the spacing between O-rings 252, and because valve spool body 250 translates with cutter 60, valve spool body 250 remains in the non-vented state as cutter 60 translates between its most proximal and most distal positions relative to lateral aperture 150. Specifically, FIG13C illustrates valve spool body 250 near a transition position from the non-vented state to the vented state. FIG7C illustrates the corresponding position of cutter 60 when valve spool body 250 is in the position shown in FIG13C. It should be understood that the distance between valve spool body 250 and O-rings 252 may be any suitable distance. In practice, the distance may be smaller if it is more desirable for venting to atmosphere when cutter (60) is positioned more proximally relative to lateral aperture (150). Alternatively, needle portion (110) may be configured differently, corresponding to different distances, such that the transition between the non-venting state and the venting state remains constant relative to the position of cutter (60). Other configurations involving different distances between spool body (250) and O-ring (252) will be readily apparent to those of ordinary skill in the art given the teachings herein.

FIG14 illustrates an exemplary pneumatic algorithm 400 that may be executed during use of biopsy device 10. Specifically, FIG14 illustrates the movement of cutter 60 relative to cannula 120, as indicated by diagram 410, which includes diagram 420 representing lateral aperture 150. Line 430 illustrates the movement of cutter 60 throughout its range of travel. Line 440 represents the pneumatic state of valve assembly 200 during tissue extraction, thereby providing the pneumatic state of first lumen portion 160. Line 450 illustrates the pneumatic state of second lumen portion 162 within cutter 60. As shown, vacuum is constantly applied to second lumen portion 162 throughout the entire tissue extraction process. The term "dead head" in FIG14 is intended to indicate that the corresponding first lumen portion 160 is sealed relative to the atmosphere and does not allow vacuum to flow freely from second lumen portion 162 to first lumen portion 160 during this phase.

As shown in Figure 14, cutter 60 starts in the closed position shown in Figure 7A. In this position, line 440 in Figure 14 shows that valve assembly 200 is open to atmosphere, and line 450 shows that vacuum is applied to second lumen portion 162. The corresponding position of valve assembly 200 can be seen in Figure 13A.

As shown by line 430 in FIG. 14 and depicted in FIG. 7C , as cutter 60 translates proximally from the closed state toward the open state, line 440 illustrates the corresponding movement of valve assembly 200 to a "sliding seal" state, in which first lumen portion 160 is sealed from the atmosphere. This transition relative to valve assembly 200 can be best seen in FIG. 13C . In this example, this transition occurs when cutter 60 is in a position relative to lateral aperture 150 in which lateral aperture 150 is effectively open by approximately 24%. However, it should be understood that this transition can occur at other positions of cutter 60 relative to lateral aperture 150.

As shown in FIG7B , once cutter 60 reaches the open position, line 430 in FIG14 indicates that cutter 60 may remain open for a puncture dwell time 460. During puncture dwell time 460, first lumen portion 160 is sealed from the atmosphere. The corresponding position of valve assembly 200 can be best seen in FIG13B . However, as shown by line 450, vacuum is continuously applied to second lumen portion 162 within cutter 60. Thus, vacuum can pass through lateral aperture 150 via second lumen portion 162, allowing tissue to prolapse through lateral aperture 150. In some examples, pneumatic algorithm 400 may include continuously rotating motor 70 at the same speed while cutter 60 is open. In such an example, motor 70 may be disengaged from the cutter drive train during puncture dwell time 460. However, motor 70 may remain coupled to vacuum pump 50 to supply vacuum, as shown by line 450.

Line 430 in FIG. 14 then illustrates the distal movement of cutter 60 from the open position toward the closed position shown in FIG. 7C . As cutter 60 translates distally, severing the prolapsed tissue, line 440 in FIG. 14 illustrates the movement of vent assembly 200 from the sliding seal state to the venting state. For vent assembly 200, this transition occurs immediately after the state shown in FIG. 13C . As described above, this transition occurs when cutter 60 is in a position relative to lateral aperture 150 where lateral aperture 150 is effectively opened by approximately 13%. However, it should also be understood that this position may vary in other embodiments.

Finally, line 430 in FIG. 14 shows cutter 60 returning to the closed position depicted in FIG. 7A , where it remains for a closed-pore dwell time 470. In this state, line 440 in FIG. 14 shows valve assembly 200 in the vented state shown in FIG. 13A . Thus, first lumen 160 can be vented to atmosphere to generate a pressure differential suitable for proximal movement of the severed tissue sample through cutter 60 and into tissue sample holder 40. As similarly described above with respect to open-pore dwell time 460, closed-pore dwell time 470 can include continued rotation of motor 70. However, unlike open-pore dwell time 460, motor 70 can continue to rotate at the same speed while cutter 60 is closed. It should be understood that during this rotation of motor 70, motor 70 may be disengaged from the cutter drive system for the duration of closed-pore dwell time 470. However, motor 70 may remain coupled to vacuum pump 50 to supply the vacuum, as indicated by line 450. Once the obturator dwell time 470 expires, the above-described process may be repeated as necessary to obtain the desired number of tissue samples. Of course, the various states described above are merely exemplary, and those skilled in the art will readily appreciate other relationships between the position of the cutter 60, the ventilation state, and the vacuum, based on the teachings of the present invention.

It should be understood that any patent, publication, or other public material stated to be 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 public material given in this disclosure. Likewise, and to the extent necessary, the disclosure explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, stated to be incorporated herein by reference that conflicts with existing definitions, statements, or other public material described herein is incorporated herein only to the extent that no conflict arises between the incorporated material and the existing public material.

Embodiments of the present invention have applications in traditional endoscopic and open surgical instrumentation as well as in robotic-assisted surgery.

Embodiments of the devices disclosed herein may be designed to be discarded after a single use, or they may be designed to be used multiple times. In either case or both, the embodiments may be repaired for reuse after at least one use. Repair may comprise any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, the device of the embodiments may be disassembled, and any number of specific parts or portions of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacing specific parts, the device of the embodiments may be reassembled at a repair facility or by a surgical team immediately prior to surgery for subsequent use. Those skilled in the art will appreciate that repair of the device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of these techniques and the resulting repair devices are within the scope of this application.

By way of example only, the implementation described herein can be processed before surgery. First, new or used instruments can be obtained and cleaned as necessary. The instruments can then be sterilized. In one sterilization technique, the instruments are placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and instruments can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation can kill bacteria on the instruments and in the container. The sterilized instruments can then be stored in a sterile container. The sealed container can keep the instruments sterile until they are opened in a medical facility. Any other technology known in the art can also be used to sterilize the device, including but not limited to beta radiation or gamma radiation, ethylene oxide, or steam.

Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Several such potential modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. discussed above are exemplary and not required. Therefore, the scope of the present invention should be considered in light of the claims and should be understood not to be limited to the structural and operational details shown and described in the specification and drawings.

Claims (20)

1. A biopsy device, comprising: (a) The main body; (b) A needle extending distally relative to the body, wherein the needle defines a first lumen and a second lumen, wherein the first lumen extends along a first longitudinal axis, wherein the second lumen extends along a second longitudinal axis, wherein the needle includes an opening fluidly connecting the first lumen and the second lumen. (c) a cutter, wherein the cutter is capable of translating relative to the needle to cut tissue; and (d) A valve assembly, the valve assembly comprising: (i) ventilation openings, and (ii) A valve core that is movable relative to a vent opening between a first position and a second position, wherein when the valve core is in the first position, a second cavity is connected to the vent opening, wherein when the valve core is in the second position, the second cavity is sealed relative to the vent opening, wherein the valve core is movable between the first position and the second position by means of a movement that is always proportional to the translation of the cutter. 2. The biopsy device of claim 1, wherein the needle further defines a transverse tissue receiving orifice, wherein the transverse tissue receiving orifice opens into a first lumen, and wherein the cutter is operable to cut off tissue protruding through the tissue receiving orifice. 3. The biopsy apparatus of claim 1, wherein the cutter is capable of translation along a first longitudinal axis. 4. The biopsy device according to claim 3, wherein the cutter is located in the first lumen. 5. The biopsy device according to claim 3, wherein the valve core is movable relative to the vent opening along a first longitudinal axis. 6. The biopsy device according to claim 5, wherein the valve core is connected to the cutter such that the translation of the cutter directly corresponds to the movement of the valve core along the first longitudinal axis. 7. The biopsy device of claim 6, wherein the cutter is translatable between a first position and a second position, wherein the first position of the cutter corresponds to the valve core being in a first position, and wherein the second position of the cutter corresponds to the valve core being in a second position. 8. The biopsy apparatus of claim 7, wherein when the cutter is in the first position, the cutter travels completely distally relative to the needle, and when the cutter is in the second position, the cutter travels completely proximally relative to the needle. 9. The biopsy device of claim 1, wherein the valve assembly further includes a manifold, wherein the ventilation opening is defined by the manifold. 10. The biopsy apparatus of claim 9, wherein the manifold is fixed to the distal end of the body, wherein the manifold extends proximally from the distal end of the body. 11. The biopsy apparatus of claim 10, wherein the needle extends distally from the manifold, and wherein the needle is fluidly sealed relative to the manifold. 12. The biopsy apparatus of claim 11, wherein the valve core is disposed within the manifold, and wherein the valve core is slidable within the manifold relative to the vent opening. 13. The biopsy device of claim 12, wherein the valve core includes a distal end and a proximal end, wherein the distal end and the proximal end each include a seal, wherein the seal is operable to form a fluid seal between the inner surface of the manifold and the outer surface of the valve core. 14. The biopsy device according to claim 13, wherein the seals located at the distal and proximal ends of the valve core body comprise rubber O-rings. 15. The biopsy device according to claim 13, wherein the valve core is arranged coaxially around the cutter. 16. A biopsy device, comprising: (a) The main body; (b) A needle extending distally relative to the body, wherein the needle defines a first lumen and a second lumen, wherein the second lumen is offset from the first lumen, and wherein the needle includes an opening fluidly connecting the first lumen and the second lumen; (c) a cutter, wherein the cutter is movable relative to the needle to cut tissue; and (d) A valve assembly, the valve assembly comprising: (i) ventilation openings, and (ii) A valve component, wherein the valve component is capable of translating relative to the vent opening in direct correspondence with the translation of the cutter, so as to selectively connect and disconnect the vent opening from the second lumen of the needle. 17. The biopsy apparatus of claim 16, further comprising a manifold extending proximally from the distal end of the body, wherein the needle is coaxially positioned relative to the manifold such that the needle extends distally from the manifold, wherein a ventilation opening is defined by the manifold. 18. The biopsy apparatus of claim 17, wherein the valve component is disposed within the manifold, wherein the valve component includes at least two seals capable of sealing between the interior of the manifold and the exterior of the valve component, wherein the valve component is slidable within the manifold such that the seals are movable relative to the vent opening between a first position and a second position. 19. The biopsy device of claim 18, wherein when the seal is in the first position, the vent opening is located between the seals of the valve component, and wherein when the seal is in the second position, the vent opening is located proximal to the seal. 20. A biopsy device, comprising: (a) The main body; (b) A needle extending distally relative to the body, wherein the needle defines a first lumen and a second lumen, wherein the first lumen extends along a first longitudinal axis, wherein the second lumen extends along a second longitudinal axis, wherein the needle includes an opening fluidly connecting the first lumen and the second lumen. (c) A cutter, wherein the cutter is capable of translating relative to the needle to cut tissue; (d) a manifold, wherein the manifold defines a vent opening; and (e) A valve core body fixed longitudinally and coaxially relative to the cutter, wherein the valve core body is translatable within the manifold relative to the vent opening to selectively connect and disconnect the vent opening from the second lumen of the needle.