HK1191204B - Biopsy device with motorized needle firing - Google Patents

Description

Biopsy device with motorized needle firing

Background

Biopsy samples have been obtained in a variety of medical procedures using a variety of devices and in a variety of ways. The biopsy device may be used under stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or other guidance. For example, some biopsy devices may be fully operable by a user using a single hand and with a single insertion to obtain one or more biopsy samples from a patient. Further, some biopsy devices may be cabled with a vacuum module and/or a control module, such as for the passage of fluids (e.g., compressed air, saline, atmospheric air, vacuum, etc.), for the transmission of power and/or instructions, and so forth. Other biopsy devices may operate fully or at least partially without being cabled or otherwise connected to another device.

Exemplary biopsy devices are disclosed in the following patents: U.S. Pat. No. 5,526,822 entitled "method and apparatus for automatic Biopsyand Collection of Soft tissue", issued at 18.6.1996; U.S. patent No. 6,086,544 entitled "control apparatus for and automatic surgery biopsydevice" issued at 11.7.2000; U.S. publication No. 2003/0109803 entitled "mricompatibles neurocathip biopsydevice" published on 12.6.2003; U.S. publication No. 2006/0074345 entitled "biopsy apparatus and method" published on 6.4.2006; U.S. publication No. 2007/0118048 entitled "remotethumb bweelformaturcal biopsydevice" published 24/5/2007; U.S. publication No. 2008/0214955 entitled "presentationo f biopsysamplebeybiopsydevice" published on 9/4 of 2008; U.S. publication No. 2009/0171242 entitled "clutchandvallingsystemforthetherlessbiopsydevice" published on 7/2/2009; U.S. publication No. 2010/0152610 entitled "handactuatedtherlessbiopsydevicewithpistolgrip" published on 6/17/2010; U.S. publication No. 2010/0160819 entitled "biopsydevicewithcentralthimbwheel" published 24/6/2010; U.S. publication No. 2010/0317997 entitled "tetherlessbiopsydevicewithreusable port" published on day 16, 12/2010; and U.S. non-provisional patent application No. 12/953,715 entitled "handedbydevicewithneedlefile" filed on 24.11.2010. The disclosures of each of the above-referenced U.S. patents, U.S. patent application publications, and U.S. non-provisional patent applications are incorporated herein by reference.

While some systems and methods have been made and used to obtain biopsy samples, the inventors believe that the invention described in the appended claims has not been made or used before.

Brief Description of Drawings

While the specification concludes with claims particularly pointing out and distinctly claiming the present invention, it is believed that the present invention will be better understood from the following description of certain embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements throughout the drawings, and in which some features or portions of features are shown in phantom (phantom) drawn in phantom lines.

FIG. 1 depicts a block schematic diagram showing various components of an exemplary biopsy device;

FIG. 2 depicts a perspective view of a probe and a holster of an exemplary biopsy device coupled together;

FIG. 3 depicts a perspective view of the biopsy device of FIG. 2 with the probe separated from the sheath to expose a bottom surface of the probe and a top surface of the sheath;

FIG. 4A depicts a side elevational view of the biopsy device of FIG. 2 with the needle in an armed (armed) position;

FIG. 4B depicts a side elevational view of the biopsy device of FIG. 2 with the needle in a fired position;

FIG. 5 depicts a top plan view of the holster of the biopsy device of FIG. 2 with the top housing cover removed;

FIG. 6 depicts an exploded perspective view of the needle firing mechanism of the holster of FIG. 5;

FIG. 7 depicts a side view of the lead screw and firing tube of the needle firing mechanism of FIG. 6;

FIG. 8 depicts a cross-sectional end view of the cam rail of the holster of FIG. 5 engaged with the firing tube of FIG. 7;

FIG. 9A depicts a top plan view of the sleeve of FIG. 5 with the needle firing mechanism in a pre-armed configuration;

FIG. 9B depicts a top plan view of the sleeve of FIG. 5 with the needle firing mechanism in an armed configuration;

FIG. 9C depicts a top plan view of the sleeve of FIG. 5 with the needle firing mechanism in a firing configuration;

FIG. 9D depicts a top plan view of the sleeve of FIG. 5 with the needle firing mechanism in a fired configuration; and is

FIG. 10 depicts a partial perspective view of components of the needle firing mechanism of FIG. 6 with the needle firing mechanism in the firing configuration of FIG. 9C.

The drawings are not intended to be limiting in any way and it is contemplated that various embodiments of the invention can be practiced in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention; it should be understood, however, that the invention is not limited to the precise arrangements shown.

Detailed Description

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

I. Overview of an exemplary biopsy device

Fig. 1-4 illustrate an exemplary biopsy device (10). The biopsy device (10) of this embodiment includes a probe (100) and a sheath (700). A needle (110) extends distally from the probe (100) and is inserted into tissue of a patient to obtain a tissue sample, as described in more detail below. These tissue samples are deposited in a tissue sample holder (300) at the proximal end of the probe (100), as also described in more detail below. It should also be understood that the use of the term "sheath" herein should not be read as requiring any portion of the probe (100) to be inserted into any portion of the sheath (700). While in the present embodiment, the fork arms (102) are used to removably secure the probe (100) to the holster (700), it should be appreciated that a variety of other types of structures, components, features, etc. (e.g., bayonet mounts, latches, clamps, clips, snap fittings, etc.) may be used to provide removable attachment of the probe (100) and holster (700). Further, in some biopsy devices (10), the probe (100) and the holster (700) may be of unitary or integral construction such that the two components cannot be separated. By way of example only, in versions where the probe (100) and the case (700) are provided as separable components, the probe (100) may be provided as a disposable component and the case (700) may be provided as a reusable component. Other suitable structural and functional relationships between the probe (100) and the case (700) will be apparent to those of ordinary skill in the art in view of the teachings herein.

Some variations of biopsy device (10) may include one or more sensors (not shown) in probe (100) and/or holster (700) configured to detect when probe (100) is coupled with holster (700). Such sensors or other features may be further configured to allow only certain types of probes (100) and sleeves (700) to be joined together. In addition or in the alternative, such sensors may be configured to disable one or more functions of the probe (100) and/or the case (700) until the appropriate probe (100) and case (700) are joined together. Of course, such sensors and features may be changed or omitted as desired.

In some versions as shown in fig. 1, biopsy device (10) includes a vacuum source (800), such as a vacuum pump. By way of example only, the vacuum source (800) may be incorporated into the probe (100), into the casing (700), and/or be a completely separate component. In versions where the vacuum source (800) is separate from the probe (100) and the case (700), the vacuum source (800) may be coupled to the probe (100) and/or the case (700) via one or more conduits, such as flexible tubing. As shown in fig. 1, vacuum source (800) is in fluid communication with tissue sample holder (300) and needle (110). Accordingly, the vacuum source (800) may be activated to draw tissue into the lateral aperture (114) of the needle (110). The tissue sample holder (300) is also in fluid communication with the cutter (200). Accordingly, the vacuum source (800) may also be activated to draw the severed tissue sample through the hollow interior of the cutter (200) and into the tissue sample holder (300). Other suitable ways of using the vacuum source (800) will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that the vacuum source (800) may simply be omitted, if desired.

In some versions, the vacuum source (800) is provided in accordance with the teachings of U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. In addition or in the alternative, the vacuum source (800) may be provided in accordance with the teachings of U.S. non-provisional patent application No. 12/953,715, the disclosure of which is incorporated herein by reference. As yet another merely illustrative example, the vacuum source (800) may be provided in accordance with the teachings of U.S. non-provisional patent application No. 12/709,695 entitled "BiopsyDeviceWith AuxiliaryVacuumSource," filed on 2/22/2010, the disclosure of which is incorporated herein by reference. Other suitable ways in which vacuum source (800) may be provided will be apparent to those of ordinary skill in the art in view of the teachings herein.

The biopsy device (10) of the present embodiment is configured to be mounted to a table or fixture and used under stereotactic guidance. Of course, biopsy device (10) may alternatively be used under ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or other guidance. It should also be understood that biopsy device (10) may be sized and configured such that biopsy device (10) may be operated by a single hand of a user. Specifically, the user can accomplish all of the following with only one hand: the biopsy device (10) is grasped, the needle (110) is inserted into the patient's chest, and one or more tissue samples are collected from within the patient's chest. Alternatively, the user may grasp biopsy device (10) with more than one hand and/or with any desired assistance. In some cases, a user can obtain multiple tissue samples with only one needle (110) insertion into the patient's chest. Such tissue samples may be pneumatically deposited in the tissue sample holder (300) and subsequently retrieved from the tissue sample holder (300) for analysis. While the embodiments described herein often relate to taking a biopsy sample from a patient's chest, it should be understood that biopsy device (10) may be used in a variety of other procedures for a variety of other purposes and in a variety of other portions of a patient's anatomy (e.g., prostate, thyroid, etc.). Various exemplary components, features, configurations, and operability of biopsy device (10) will be described in more detail below; and other suitable components, features, configurations and operability will be apparent to those of ordinary skill in the art in view of the teachings herein.

Exemplary Probe

As shown in fig. 2-4, the probe (100) of the present embodiment includes a distally extending tip (110). The probe (100) further includes a bottom chassis (120) and a top housing (130) fixedly secured together. As best seen in fig. 3, the gear (140) is exposed through an opening (142) in the chassis (120) and is operable to drive a cutter actuation mechanism (202) in the probe (100). As also seen in fig. 3, another gear (144) is exposed through another opening (146) in the chassis (120) and is operable to rotate the needle (110), as described in more detail below. When the probe (100) and the case (700) are coupled together, the gear (140) of the probe (100) meshes with the exposed gear (740) of the case (700). Similarly, when the probe (100) and the case (700) are coupled together, the gear (144) of the probe (100) meshes with the exposed gear (744) of the case (700).

A. Exemplary needle

The needle (110) of the present embodiment includes a piercing tip (112), a lateral aperture (114) positioned proximal to the tip (112), and a hub member (150). The tissue piercing tip (112) is configured to pierce and penetrate tissue without requiring a significant amount of force, and without requiring a pre-formed opening in the tissue prior to insertion of the tip (112). Alternatively, the tip (112) may be blunt (e.g., rounded, flat, etc.) if desired. The tip (112) may also be configured to provide greater echogenicity than other portions of the needle (110), thereby providing enhanced visibility of the tip (112) under ultrasound imaging. By way of example only, the tip (112) may be constructed in accordance with any of the teachings in U.S. non-provisional patent application No. 12/875,200 entitled "echogenic needle for biopsydevice," filed on 9/3/2010, the disclosure of which is incorporated herein by reference. Other suitable configurations for the tip (112) will be apparent to those of ordinary skill in the art in view of the teachings herein.

The lateral aperture (114) is sized to receive prolapsed tissue during operation of the device (10). A hollow tubular cutter (200) having a sharpened distal edge (not shown) is positioned within needle (110). The cutter (200) is operable to rotate and translate relative to the needle (110) and move through the lateral aperture (114) to sever a tissue sample from tissue protruding through the lateral aperture (114). For example, cutter (200) may be moved from an extended position to a retracted position, thereby "opening" lateral aperture (114) to allow tissue to protrude therethrough; and then from the retracted position back to the extended position to sever the protruding tissue. Although the lateral aperture (114) is shown in fig. 1 as being oriented in an upward position, it should be understood that the needle (110) may be rotated to orient the lateral aperture (114) at any desired angular position about the longitudinal axis of the needle (110). This rotation of the needle (110) is facilitated in this embodiment by a hub member (150).

The hub member (150) of the present embodiment is overmolded around the needle (110) such that the hub member (150) and the needle (110) rotate and translate integrally with each other. By way of example only, the needle (110) may be formed of metal and the hub member (150) may be formed of a plastic material that is overmolded around the needle (110) to integrally secure and form the hub member (150) on the needle (110). The hub member (150) and needle (110) may alternatively be formed of any other suitable material and may be secured together in any other suitable manner. The hub member (150) includes an annular flange (152) and a thumbwheel (154). The gear (144) is slidably and coaxially arranged on the proximal end portion (150) of the hub member (150) and keyed to the hub member (150) such that rotation of the gear (144) will rotate the hub member (150) and the needle (110); the hub member (150) and needle (110) may also translate relative to the gear (144). Gear (144) is rotatably driven by gear (744), as described in more detail below. Alternatively, the needle (110) may be rotated by rotating the thumbwheel (154). Various other suitable ways in which manual rotation of the needle (110) may be provided will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that rotation of the needle (110) may be automated in a variety of ways, including but not limited to various forms of automatic needle rotation described in the various references cited herein. Embodiments of how the needle (110) may be translated longitudinally relative to the chassis (120) and the top housing (130), particularly by a needle firing mechanism (400), will be described in more detail below.

It should be understood that needle (110), as with the other components described herein, may be changed, modified, replaced, or supplemented in a number of ways; and the needle (110) may have a variety of alternative features, components, configurations and functions. A plurality of external openings (not shown) may also be formed in the needle (110) and may be in fluid communication with the second lumen (162). For example, such an external opening may be constructed in accordance with the teachings of U.S. publication No. 2007/0032742 entitled "biopsydevice with vacuum system b deledingcontrol" published on 8.2.2007, the disclosure of which is incorporated herein by reference. The cutter (150) may also include one or more side openings (not shown). Of course, such external openings in the needle (110) and cutter (150) are only optional, as are the other components described herein. As yet another merely illustrative example, the needle (110) may be constructed in accordance with the teachings of U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference, and/or in accordance with the teachings of any other reference cited herein.

The probe (100) may also include a valve assembly in fluid communication with at least a portion of the needle (110) that selectively changes the pneumatic state of at least a portion of the needle (110) based on any suitable condition, such as the longitudinal position of the cutter (200). Such a valve assembly may be constructed in accordance with the teachings of U.S. publication No. 2010/0317997, the disclosure of which is incorporated herein by reference, in accordance with the teachings of U.S. non-provisional patent application No. 12/953,715, the disclosure of which is incorporated herein by reference, or otherwise. In addition or in the alternative, valving may be provided by a vacuum source (800) and/or a vacuum tank as taught in U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. Other suitable alternatives, features, components, configurations and functions of the needle (110) will be apparent to those of ordinary skill in the art in view of the teachings herein.

B. Exemplary cutter drive mechanism

As mentioned above, the cutter (200) is operable to rotate and translate relative to the needle (110) and move through the lateral aperture (114) to sever a tissue sample from tissue protruding through the lateral aperture (114). This action of the cutter (200) is provided by a cutter actuation mechanism (202). Although in the present embodiment, the cutter actuation mechanism (202) is primarily positioned in the probe (100), it should be understood that the cutter actuation mechanism (202) may be primarily positioned in the case (700) and/or in both the probe (100) and the case (700). The cutter actuation mechanism (202) includes meshing gears (140, 740), wherein the gears (740) are driven by the motor (204). Although in the present embodiment, the motor (204) is positioned in the casing (700), it should be understood that the motor (204) may alternatively be positioned in the probe (100) and/or other locations.

By way of example only, the cutter actuation mechanism (202) may be constructed in accordance with the teachings of U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. As another merely illustrative example, the cutter actuation mechanism (202) may be constructed in accordance with the teachings of U.S. publication No. 2010/0317997, the disclosure of which is incorporated herein by reference. As yet another merely illustrative example, cutter actuation mechanism (202) may be constructed in accordance with the teachings of U.S. publication No. 2010/0292607 entitled "TetherlessBiopsiyDeviceWithSelf-reversing cutterDriveMechanism", published on 11/18/2010, the disclosure of which is incorporated herein by reference. Alternatively, the cutter actuation mechanism (202) may be constructed in accordance with the teachings of any of the other references cited herein. It should also be understood that biopsy device (10) may be configured such that cutter (200) does not translate (e.g., such that cutter (200) only rotates, etc.); or such that cutter (200) does not rotate (e.g., such that cutter (200) only translates, etc.). As another merely illustrative example, cutter (200) may be pneumatically actuated in addition to or instead of being actuated by mechanical components. Other suitable alternatives, features, components, configurations, and functions of the cutter actuation mechanism (202) will be apparent to those of ordinary skill in the art in view of the teachings herein.

C. Exemplary tissue sample holder

The tissue sample holder (300) of the present embodiment includes a plurality of chambers (not shown) configured to receive a tissue sample severed by the cutter (200) and conveyed proximally through the hollow interior of the cutter (200). The tissue sample holder (300) also includes one or more removable trays (not shown) that allow a user to remove a severed tissue sample from the tissue sample holder (300) without having to remove the tissue sample holder (300) from the chassis (120). The tissue sample holder (130) further includes a rotatable manifold (not shown) in fluid communication with the vacuum source (800) and the cutter (200) and rotatable to sequentially index the chambers to the cutter (200). Specifically, the manifold is rotated by a tissue sample holder rotation mechanism (302) that is driven by a motor (304). It should be understood that at least a portion of the tissue sample holder rotation mechanism (302) and/or the motor (304) may be incorporated into the probe (100), into the holster (700), or into both the probe (100) and holster (700).

By way of example only, tissue sample holder (300) may be constructed in accordance with the teachings of U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. As another merely illustrative example, the tissue sample holder (300) may be constructed and operated in accordance with the teachings of U.S. publication No. 2010/0160824 entitled "biopsydevice with dispenser properties chambers," published 24/6/2010, the disclosure of which is incorporated herein by reference. As yet another merely illustrative example, tissue sample holder (300) may be constructed and operated in accordance with the teachings of U.S. publication No. 2008/0221480 entitled "biopsy samplestorage," published 9/11 2008, the disclosure of which is incorporated herein by reference.

In some other versions, tissue sample holder (300) does not include a rotatable manifold. In some such embodiments, the tissue sample holder (300) may be constructed in accordance with the teachings of U.S. non-provisional patent application No. 61/381,466 entitled "biopsydevicetissue sample holder with removablebaset," filed on 9/10 2010, the disclosure of which is incorporated herein by reference. Other suitable ways in which tissue sample holder (300) may be constructed and operated will be apparent to those of ordinary skill in the art in view of the teachings herein.

Exemplary case

As shown in fig. 2-10, the case (700) of the present embodiment includes a top housing cover (702), side panels (704), and a housing base (706) that are fixedly secured together. As best seen in fig. 3 and as mentioned above, the gears (740, 744) are exposed through the top housing cover (702) and mesh with the gears (140, 144) of the probe (100) when the probe (100) and the case (120) are joined together. Specifically, the gears (740, 140) drive the cutter actuation mechanism (202); and gears (744, 144) are used to rotate the needle (110). The holster (700) also includes a firing bar (730) and prongs (732) that are coupled to the needle (110) and that fire the needle (110) distally, as described in more detail below.

All of the motors (204,304,402) mentioned herein are housed within the case (700) of the present embodiment and receive power from an external power source via a cable (720). In addition or in the alternative, data may be transmitted from case (700) and/or to case (700) via cable (720) as desired. In some other versions, the motor (204,304,402) may be powered by one or more batteries positioned within the case (700) and/or the probe (100). It should therefore be understood that, as with the other components described herein, cable (720) is only optional. As yet another merely illustrative variation, the motor (204,304,402) may be pneumatically powered so that the cable (720) may be replaced with a conduit that delivers pressurized fluid medium to the casing (700). As other merely illustrative variations, cable (720) may include one or more rotational drive cables that may be driven by a motor (204,304,402) positioned outside of case (700). It should also be understood that two or three of the motors (204,304,402) may be combined into a single motor. Other suitable ways in which the various mechanisms (202, 302, 400) may be actuated will be apparent to those of ordinary skill in the art in view of the teachings herein.

A. Exemplary needle rotation mechanism

As mentioned above, rotation of the gear (744) provides rotation of the needle (110) relative to the probe (100). In this embodiment, the gear (744) is rotated by rotating the knob (710). Specifically, the knob (710) is coupled to the gear (744) through a series of gears (not shown) and shafts (not shown) such that rotation of the knob (710) rotates the gear (744). A second knob (710) extends from the other side of the case (700). By way of example only, such a needle rotation mechanism may be constructed in accordance with the teachings of U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. As another merely illustrative example, the needle rotation mechanism may be constructed in accordance with the teachings of U.S. publication No. 2010/0160819, the disclosure of which is incorporated herein by reference. In some other versions, the needle (110) is rotated by a motor. In other versions, the needle (110) is simply rotated by rotating the thumbwheel (154). Various other suitable ways of providing rotation of the needle (110) will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that some versions may not provide for rotation of the needle (110).

B. Exemplary needle firing mechanism

The holster (700) of the present embodiment further includes a needle firing mechanism (400) operable to fire the needle (110) from the loaded position shown in FIG. 4A to the fired position shown in FIG. 4B. By way of example only, such firing may be applicable where biopsy device (10) is mounted to a stereotactic table fixture or other fixture, where tip (112) is adjacent to the chest of a patient, such that needle firing mechanism (400) may be activated to drive needle (110) into the chest of the patient. The needle firing mechanism (400) may be configured to drive the needle (110) along any suitable range of motion to drive the tip (112) to any suitable distance relative to the fixed components of the probe (100). The needle firing mechanism (400) of the present embodiment is actuated by an actuation button (760) and an arming button (750). The activation button (760) comprises a membrane switch provided on the side panel (704) of the case (700). In some versions, the activation button (760) is located on both sides of the case (700), while in other versions the activation button (760) is located on only one side of the case (700) or at other locations (e.g., away from the user interface, at the vacuum source (800), or other locations, etc.). The activation button (760) is operable to selectively activate the motor (402), as described in more detail below. In this embodiment, arming buttons (750) are also provided on both sides of the case (700) and are mechanically movable laterally with respect to the side panels (704). Each arming button (750) includes a bellows (752) that provides a fluid-tight seal with the side panel (704). Of course, either type of button (750, 760) may have various other features, characteristics, configurations, and operability.

In this embodiment, the needle firing mechanism (400) is coupled to the needle (110) via a firing bar (732) and a firing fork (732). The firing bar (732) and the firing fork (734) are integrally secured together by complementary flat surfaces (736, 737) and a pin (738). Firing fork (732) includes a pair of prongs (734) that receive hub member (150) of needle (110) therebetween. The fork arm (734) is positioned between the annular flange (152) and the thumbwheel (154) such that the needle (110) will translate integrally with the firing bar (730) and the fork (732). Nevertheless, the fork arms (734) removably receive the hub member (150) so that the prongs (732) can be easily fastened to the hub member (150) when the probe (100) is joined with the case (700); and such that the hub member (150) can be easily removed from the prongs (732) when the probe (100) is disengaged from the case (700). The prongs (734) are also configured to allow the hub member (150) to rotate between the prongs (734), as in the case of rotating the knob (710) to change the angular orientation of the lateral aperture (114). Other suitable components, configurations, and relationships will be apparent to those of ordinary skill in the art in view of the teachings herein.

Fig. 5-10 illustrate the components of the needle firing mechanism (400) in more detail. As best seen in FIG. 6, the needle firing mechanism (400) of the present embodiment includes a motor (402), a firing tube (420), a coupling (440), and a coil spring (460). As described in greater detail below, the motor (402) is operable to selectively connect the firing tube (420) with the coupling (440), thereby compressing the coil spring (460). The motor (402) is further operable to retract the needle (110) to the loaded position shown in fig. 4A. The motor (402) is then operable to disengage the coupling (440) from the firing tube (420), allowing the coil spring (460) to fire the needle (110) distally to the fired position shown in FIG. 4B. Of course, a variety of other types of resilient or biasing members may be used in addition to or in place of the coil spring (460).

Still referring to fig. 6, the motor (402) includes an integral drive gear (404) such that the motor (402), when activated, rotates the drive gear (404). The drive gear (404) meshes with an intermediate gear (406) which is supported in a recess (770) in the housing base (706) by means of a bushing (408). The intermediate gear (406) meshes with a nut gear (410) that is supported in a recess (772) of the housing base (706) by a bushing (412). The nut gear (410) includes an internal thread (414) and is coaxially disposed about a shaft (422) that extends proximally and integrally from the firing tube (420). Specifically, the shaft (422) includes external threads (424) that are complementary to the internal threads (414) of the nut gear (410). As described in more detail below, in this embodiment, the shaft (422) does not rotate relative to the housing base (706). It will thus be appreciated that rotation of the nut gear (410) causes the firing tube (420) to translate longitudinally. In other words, depending on the direction in which the motor (402) rotates the drive gear (404), the motor (402) may be activated to translate the firing tube (420) distally or proximally. A retainer (780) is secured to the housing base (706) to retain the motor (402), gears (404, 406, 410), and bushings (408, 412) relative to the housing base (706).

As best seen in fig. 7, the firing tube (420) further includes a proximal inner wall (430), a pair of opposed elongate slots (432), a pair of pawl notches (434) associated with the slots (432), and an alignment notch (436). As best seen in fig. 8, the housing base (706) includes a pair of opposing inwardly projecting cam rails (782) disposed in the elongate slot (432) of the firing tube (420). The rail (782) allows the firing tube (420) to translate relative to the housing base (706) but prevents the firing tube (420) from rotating relative to the housing base (706). Of course, a variety of other types of structures, components, features, etc. may be used to provide such operability, as desired.

The coupling (440) is secured to the firing rod (730) and the pin (738) such that the coupling (440) translates integrally with the rod (730), the pin (738), the fork (732), and the needle (110). The coupling (440) includes an annular flange (442) and a cap member (444). The cap member (444) includes an alignment tab (446) that is complementary to the alignment notch (436) of the firing tube (420). The coupling (440) further includes a pair of pawls (450) resiliently biased by springs (452) to project oppositely outwardly. Of course, a variety of other types of resilient or biasing members may be used in addition to or in place of the coil spring (452). A cap member (444) secures the pawl (450) and spring (452) to the coupling while allowing the pawl (450) to move laterally as the spring (452) is compressed and decompressed. Specifically and as described in more detail below, the pawl (450) is sized, positioned, and configured to snap into a pawl notch (434) of the firing tube (420) as the firing tube (420) is advanced distally; the pawls are then deflected inward by rails (782) as the firing tube (420) is retracted proximally.

Referring back to FIG. 6, the needle firing mechanism (400) of the present embodiment further includes a crossbar (470) positioned between the buttons (750) and movable laterally relative to the housing base (706). A pair of spacers (472) are positioned between the crossbar (470) and the free ends of the buttons (750). Each free end of the cross-bar (470) includes a post (474) that is received in a respective recess (476) of the spacer (472). A pair of coil springs (478) are positioned coaxially around the cross-bar (470). Each helical spring (478) bears resiliently against the respective spacer (472) and housing base (706). The coil spring (478) is thus configured to bias the cross-bar (470) into a laterally centered position relative to the housing base (706). Of course, a variety of other types of resilient or biasing members may be used in addition to or in place of the coil spring (478). As also shown in fig. 6, the crossbar (470) includes a pair of upper grooves (480a, 480b) and a pair of lower grooves (484a, 484 b). The upper grooves (480a, 480b) are separated by an upper protrusion (482) and the lower grooves (484a, 484b) are separated by a lower protrusion (486). As shown in fig. 5, 9A-9B, and 9D, the crossbar (470) is configured to center the bosses (482, 486) on a vertical plane (out of the page) that is aligned with the longitudinal axes of the shaft (422), firing tube (420), coupling (440), firing bar (730), and pin (738) when the crossbar (470) is centered by the relative resilient bias of the coil spring (478).

In an exemplary operation of the needle firing mechanism (400), components of the needle firing mechanism (400) are initially in the position shown in FIG. 5. The user then activates one of the buttons (760) to arm the needle firing mechanism (400). This causes the motor (402) to rotate the drive gear (404) in a first direction, which rotation, via the intermediate gear (406), causes the nut gear (410) to rotate in the same first direction. This rotation of the nut gear (410) advances the firing tube (420) distally due to the interaction between the internal threads (414) of the nut gear (410) and the external threads (424) of the shaft (422). The firing tube (420) eventually reaches the position shown in FIG. 9A. As the firing tube (420) advances from the position shown in fig. 5 to the position shown in fig. 9A, the coil spring (460) is compressed between the proximal inner wall (430) of the firing tube (420) and the coupling (440). Additionally, as the firing tube (420) advances from the position shown in fig. 5 to the position shown in fig. 9A, the pawl (450) is deflected inward by the distal end of the firing tube (420) and then snaps outward into the pawl notch (434) of the firing tube (420) once the firing tube (420) reaches the position shown in fig. 9A. This inward deflection and outward snapping is facilitated by a coil spring (452) that provides an outward bias to the pawls (450) while still allowing the pawls (450) to move inward toward each other. It should also be appreciated that as the firing tube (420) advances from the position shown in fig. 5 to the position shown in fig. 9A, the interaction between the alignment notch (436) and the alignment boss (446) ensures that the firing tube (420) is properly rotationally aligned with the coupling (440), thereby ensuring that the pawl (450) reaches the pawl notch (434) when the firing tube (420) reaches the distal-most position shown in fig. 9A.

Upon reaching the configuration shown in FIG. 9A in which the firing tube (420) has engaged the coupling (440), operation of the motor (402) is reversed such that the drive gear (404) and the nut gear (410) rotate in a second direction opposite the first direction. In some versions, this requires separate actuation of at least one button (760). In some other versions, a single actuation of button (760) causes motor (402) to drive firing tube (420) to the position in fig. 9A and automatically reverses direction as soon as the firing tube reaches that position. As another merely illustrative example, the user must hold at least one button (760) for the entire time that the motor (402) is activated to drive the firing tube (420) to the position in FIG. 9A and automatically reverses direction as soon as the firing tube reaches that position. In versions where the motor (402) automatically reverses direction as soon as the firing tube (420) reaches the position shown in FIG. 9A, there are various ways in which such automatic reversal may be provided. By way of example only, an encoder, a proximity sensor, a motor load detection algorithm, and/or various other components/techniques may be used to provide automatic reversal of the motor (402). It should also be appreciated that a sensor may be used to detect latching of the pawl (450) to the firing tube (420), and this data may be used to trigger reversal of the motor (402). As yet another merely illustrative example, biopsy device (10) may alert a user when firing tube (420) reaches the position shown in fig. 9A (e.g., beep, light, loud click, etc. when pawl (450) snaps into engagement with firing tube (420) so that the user must then provide input (e.g., via one or more buttons (750, 760) and possibly via another mechanical safety, etc.) to reverse motor (402) in order to continue the firing process.

With the nut gear (410) rotated in the second direction, the firing tube (420) is proximally retracted due to the interaction between the internal threads (414) of the nut gear (410) and the external threads (424) of the shaft (422). The firing tube (420) eventually reaches the armed position shown in FIG. 9B. In this configuration, the coil spring (460) remains compressed between the proximal inner wall (430) of the firing tube (420) and the coupling (440), storing the large potential energy that is resisted by the engagement of the pawl (450) with the firing tube (420). The pawl (450) is just distal of the rail (782) and still engages the firing tube (420) in the configuration shown in FIG. 9B. Additionally, a cross bar (470) is positioned and configured to limit further proximal movement of the firing tube (420). Specifically, with the cross bar (470) centered by the spring (478), the lower projection (486) is positioned directly adjacent to the proximal end (426) of the shaft (422); and along a longitudinal axis through the shaft (422). Although only the upper boss (482) may be seen in fig. 9B, it should be understood that the lower boss (486) is just below the upper boss (482). Of course, in some other versions, the upper boss (482) may be positioned immediately adjacent to the proximal end (426) of the shaft (422); and along a longitudinal axis through the shaft (422). In the event that the motor (402) is inadvertently activated to continue to translate the firing tube (420) proximally, the proximal end (426) of the shaft (422) will extend almost immediately into the lower lobe (486), which will prevent further proximal movement of the firing tube (420). In other words, the firing tube (420) cannot move further proximally until the lower lobe (486) moves away, as described in further detail below. It should also be appreciated that these components are configured such that the pawl (450) remains engaged with the firing tube (420) until the lower lobe (486) is removed, as described in further detail below.

After the needle firing mechanism (400) reaches the armed configuration shown in FIG. 9B, the needle firing mechanism (400) is ready to be fired. Biopsy device (10) may include one or more user feedback features (e.g., one or more lights, one or more speakers or other audible components, etc.) to alert the user that needle firing mechanism (400) has reached the armed configuration. To fire the needle firing mechanism (400), the user must hold one of the buttons (750) while activating the other button (760). This will allow firing of the needle firing mechanism (400) as shown in FIG. 9C. While the button (750) on the right hand side of the case (700) is shown being pressed in fig. 9C, it is understood that the same operation may be provided by pressing the button (750) on the left hand side of the case (700). This pressing of the button (750) pushes the crossbar (470) so that the crossbar (470) moves laterally with respect to the case (700). This lateral movement of the cross-bar (470) moves the lower projection (486) away from the proximal end (426) of the shaft (422). This can be better seen in fig. 10, which shows the lower groove (484a) which provides clearance for further proximal movement of the proximal end (426) of the shaft (422). With such clearance provided, the motor (402) is activated to further translate the firing tube (420) proximally to the position shown in fig. 9C and 10. With the firing tube (420) in this position, the pawls (450) are brought into contact with the rail (782), thereby urging the pawls (450) inwardly toward one another. Specifically, the guide rails (782) push the pawls (450) inward far enough so that the pawls (450) disengage from the pawl notches (434). With the pawl (450) disengaged from the pawl notch (434), the coupling (440) is disengaged from the firing tube (420). With the coupling (440) disengaged from the firing tube (420), there is no obstruction to the coil spring (460) decompression. The coil spring (460) therefore immediately and forcefully decompresses, rapidly pushing the coupling (440) distally to fire the needle (110) via the firing bar (730) and prongs (732), as shown in fig. 9D. Once the coupling (440) reaches the fired position shown in FIG. 9D, the annular flange (442) and retainer (790) cooperate to prevent distal movement of the coupling (440).

In some versions, the biopsy device allows the user to "soft fire" the needle (110). For example, in some such versions, the motor (402) is activated to move distally to translate the firing tube (420) distally to the position shown in fig. 9A to engage the pawl (450). The motor (402) is then reversed to translate the firing tube (420), prongs (732), needle (110), and associated components proximally to the position shown in fig. 9B. However, instead of continuing to rotate in the direction to continue further proximally translating the firing tube (420), to release the pawl (450) and allow the coil spring (460) to distally fire the prongs (732) and needle (110), the motor (402) is again reversed to advance these components distally back to the configuration shown in FIG. 9A. In other words, rather than using a coil spring (460) to drive the fork (732) and needle (110) distally, the motor (402) is used to drive the fork (732) and needle (110). It should be appreciated that such operation may allow for selective control of the distal translation speed of prong (732) and needle (110), and may also allow for interruption, slowing or acceleration or otherwise control of the distal movement of prong (732) and needle (110) as prong (732) and needle (110) traverse the distal range of movement. Of course, such "soft fire" control may be provided via one or more buttons (750, 760) and/or via any other suitable form of control. It should be appreciated that in some versions, the "soft fire" firing of the needle (110) is less audible to the patient than the firing of the needle (110) by the coil spring (460).

With the needle (110) already fired as shown in fig. 9D (or as shown in the "soft fire" operation in fig. 9A, etc.), the user may then activate the cutter actuation mechanism (202) to take one or more biopsy samples from the patient's chest. In some versions, just after the needle firing mechanism (400) has fired the needle (110) distally, the motor (402) automatically reverses direction again to move the components from the configuration shown in FIG. 9D back to the configuration shown in FIG. 9A,

thereby preparing for a subsequent firing stroke. Alternatively, the needle firing mechanism (400) may wait for the user to press the arm button (760) before the motor (402) reverses direction to move the components from the configuration shown in fig. 9D back to the configuration shown in fig. 9A. Other suitable ways in which biopsy device (10) may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

It should be understood that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein 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 where necessary, the disclosure as explicitly set forth herein takes precedence over any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein is only incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

Embodiments of the present invention may be applied to conventional endoscopic and open surgical instruments as well as in robotic-assisted surgery.

Embodiments of the devices disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either or both cases, the embodiments can be reconstituted for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, subsequent cleaning or replacement of particular pieces, and subsequent reassembly. In particular, embodiments of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular components, embodiments of the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of these techniques and the resulting reconstitution devices are all within the scope of the present application.

By way of example only, embodiments described herein may be performed prior to surgery. First, new or used instruments can be obtained and cleaned (if necessary). The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container (e.g., a plastic or TYVEK bag). The container and instrument may then be placed in a field of radiation that can penetrate the container, such as gamma rays, x-rays, or high energy electrons. The radiation may kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container may keep the instrument sterile until the sealed container is opened in the medical facility. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

While various embodiments of the present invention have been shown and described, the methods and systems described herein may be further modified by those of ordinary skill in the art with appropriate modifications without departing from the scope of the present invention. Some of these possible modifications have already been mentioned, and others will be apparent to those skilled in the art. For example, the above examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. are illustrative and not required. The scope of the present invention should, therefore, be determined with reference to the appended claims, and should not be limited to the details of construction and operation shown and described in the specification and drawings.

Claims (17)

1. A biopsy device, comprising:

(a) a needle having a tissue piercing tip;

(b) a body portion, wherein the needle is longitudinally movable relative to the body portion; and

(c) a needle firing assembly, wherein the needle firing assembly comprises:

(i) a resilient member configured to urge the needle distally relative to the body portion when the resilient member is in a loaded configuration,

(ii) a translating member operable to load the resilient member when the translating member moves distally, an

(iii) A motor, wherein the motor is operable to drive the translating member distally relative to the body portion to load the resilient member, wherein the motor is further operable to drive the translating member proximally relative to the body portion to unload the resilient member to fire the needle distally.

2. The biopsy device of claim 1, wherein the resilient member comprises a coil spring.

3. The biopsy device of claim 1, the needle firing assembly further comprising a firing bar and prongs, wherein the prongs are secured to the needle, wherein the prongs are also secured to the firing bar, wherein the firing bar is translatable relative to the body portion.

4. The biopsy device of claim 3, wherein the resilient member is coaxial with the firing bar, wherein the resilient member and the firing bar are both parallel to but lateral to the needle.

5. The biopsy device of claim 3, wherein the needle firing assembly further comprises a coupling, wherein the coupling is secured to the firing bar, wherein the coupling is removably secured to the translating member.

6. The biopsy device of claim 5, wherein the coupling includes at least one resiliently biased detent configured to selectively secure the coupling to the translating member.

7. The biopsy device of claim 5, wherein the translating member and the coupling are positioned and configured to cooperate to compress the resilient member when the translating member is driven distally by the motor.

8. The biopsy device of claim 7, wherein the coupling is configured to travel proximally with the translating member when the coupling and translating member are secured together, wherein the coupling and translating member are configured to maintain the resilient member in a compressed state when the coupling and translating member travel proximally together relative to the body portion.

9. The biopsy device of claim 8, wherein the body portion comprises a feature configured to cause the coupling to loosen from the translating member when the coupling and the translating member reach a proximal position, wherein the loosening of the coupling from the translating member allows the resilient member to decompress to fire the needle distally.

10. The biopsy device of claim 9, wherein the feature configured to release the coupling from the translating member comprises a cam track, wherein the translating member comprises an elongated slot, wherein the cam track is disposed in the elongated slot.

11. The biopsy device of claim 1, wherein the needle firing assembly further comprises a movable restraining member configured to restrain proximal movement of the translating member to selectively prevent firing of the needle firing assembly.

12. The biopsy device of claim 11, wherein the restraining member comprises a crossbar, wherein the crossbar comprises a barrier feature and a clearance feature, wherein the barrier feature is configured to prevent proximal movement of the translating member when the crossbar is in a first position and when the translating member reaches a first proximal position, wherein the clearance feature is configured to provide clearance for movement of the translating member to a second longitudinal position when the crossbar is in a second position, wherein the second longitudinal position is proximal to the first proximal position.

13. The biopsy device of claim 12, wherein the restraining member further comprises at least one resilient member configured to bias the cross-bar to the first position.

14. The biopsy device of claim 1, wherein the translating member comprises a firing tube.

15. The biopsy device of claim 14, wherein at least a portion of the resilient member is disposed within the firing tube.

16. The biopsy device of claim 1, wherein the translating member comprises a threaded region, the needle firing assembly further comprising a nut rotatably coupled with the motor, wherein the nut has threads complementary to the threaded region of the translating member.

17. The biopsy device of claim 1, wherein the needle further comprises a transverse aperture proximal to the tip, wherein the biopsy device further comprises a cutter configured to sever tissue protruding through the aperture.