Biopsy device with translating shuttle valve assembly

Abstract

A biopsy device includes a body, a needle, a cutter, and a valve assembly. The needle extends distally relative to the body and defines a first lumen, a second lumen, and an opening fluidically coupling the first lumen to the second lumen. The cutter is configured to translate relative to the needle. The valve assembly includes a manifold and a spool valve body. The manifold includes a proximal exhaust port. The spool valve body is movable between a first position and a second position relative to the proximal exhaust port. When the spool valve body is in the first position, the second lumen is coupled to the proximal exhaust port. When the spool valve body is in the second position, the second lumen is sealed relative to the proximal exhaust port. The spool valve body is configured to transition between the first position and the second position by moving in proportion to the translation of the cutter.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 779,636, filed on December 14, 2018, entitled “BIOPSY DEVICE WITH TRANSLATION SHUTTLE VALVE ASSEMBLY,” the disclosure of which is incorporated herein by reference. Background Art

[0003] A variety of devices have been used to obtain biopsy samples in various medical procedures in a variety of ways. Biopsy devices can be used under stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or other guidance. For example, some biopsy devices can be fully capable of being operated by a user using a single hand and capture one or more biopsy samples from a patient's body with a single insertion. In addition, some biopsy devices can be tethered to a vacuum module and / or a control module, such as for the transmission of fluids (e.g., compressed air, saline, atmosphere, vacuum, etc.), for the transmission of electricity, and / or for the transmission of commands, etc. Other biopsy devices can be fully or at least partially operable without being tethered or otherwise connected to another device. Other biopsy devices can be fully or at least partially operable without being tethered or otherwise connected to another device.

[0004] Exemplary biopsy devices are shown in U.S. Patent No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy and Soft Tissue Collection,” issued on June 18, 1996; U.S. Patent No. 6,086,544, entitled “Control Apparatus for Automated Surgical Biopsy Device,” issued on July 11, 2000; U.S. Patent No. 6,626,849, entitled “MRI Compatible Surgical Biopsy Device,” issued on September 30, 2003; and U.S. Patent No. 6,626,849, entitled “MRI Compatible Surgical Biopsy Device,” issued on September 30, 2008. U.S. Patent No. 7,442,171, titled “Remote Control Thumbwheel for Surgical Biopsy Device,” issued on October 28, 2010; U.S. Patent No. 7,854,706, titled “Clutch and Valve System for Cordless Biopsy Device,” issued on December 21, 2010; U.S. Patent No. 8,206,316, titled “Cordless Biopsy Device with Reusable Portion,” issued on June 26, 2012; and U.S. Patent No. 8,206,316, titled “Cordless Biopsy Device with Reusable Portion,” issued on July 1, 2014. No. 8,764,680, entitled “Handheld biopsy device with a needle firing member”; No. 8,801,742, issued on August 12, 2014, entitled “Needle assembly and blade assembly for a biopsy device”; No. 9,345,457, issued on May 24, 2016, entitled “Presentation of a biopsy sample by a biopsy device”; No. 9,345,457, issued on August 8, 2017, entitled “Biopsy device with a translating valve assembly”; and No. 9,345,457, issued on August 8, 2017, entitled “Biopsy device with a translating valve assembly”. No. 724,074, entitled “Biopsy Apparatus and Method,” published on April 6, 2006; U.S. Publication No. 2006 / 0074345, entitled “Biopsy Apparatus and Method,” published on April 6, 2006; U.S. Publication No. 2010 / 0152610, entitled “Hand-Actuated Cordless Biopsy Device with Pistol Grip,” published on June 17, 2010; and U.S. Publication No. 2010 / 0160819, entitled “Biopsy Device with Central Fingerwheel,” published on June 24, 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 hereby incorporated by reference.

[0005] While several systems and methods have been made and used to obtain biopsy samples, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] While the specification concludes with claims particularly pointing out and distinctly claiming the present biopsy device, it is believed that the present biopsy device will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings in which like reference numerals identify like elements, and wherein:

[0007] Figure 1 depicts a perspective view of an exemplary biopsy device;

[0008] Figure 2 Depicts Figure 1 A perspective view of the biopsy device showing the housing removed from the probe;

[0009] Figure 3 Depicts Figure 2 A schematic diagram of exemplary electrical and / or electromechanical components of a housing;

[0010] Figure 4 Depicts Figure 2 An exploded perspective view of the probe;

[0011] Figure 5 Depicts Figure 2 A perspective view of an exemplary needle assembly and associated components of a probe;

[0012] Figure 6 Depicts the Figure 5 The line 6-6 intercepts Figure 5 a cross-sectional view of a needle assembly;

[0013] Figure 7A Depicts the Figure 6 The line 7-7 is intercepted Figure 5 a cross-sectional perspective view of the distal end of the needle assembly showing the cutter in a closed position;

[0014] Figure 7B Depicts the Figure 6 The line 7-7 is intercepted Figure 5 a cross-sectional perspective view of the distal end of the needle assembly showing the cutter in an open position;

[0015] Figure 7C Depicts the Figure 6 The line 7-7 is intercepted Figure 5 a cross-sectional perspective view of the distal end of the needle assembly showing the cutter in a partially open position;

[0016] Figure 8 depiction Figure 5 An exploded perspective view of a needle assembly;

[0017] Figure 9 Depicts Figure 5 a side cross-sectional perspective view of a valve component of a needle assembly;

[0018] Figure 10 Depicts Figure 9 A perspective view of a spool valve body of a valve component oriented with the distal end facing outward;

[0019] Figure 11 Depicts Figure 10 A perspective view of a spool valve body oriented with the proximal end facing outward;

[0020] Figure 12 Depicts Figure 10 A cross-sectional view of the spool valve body, Figure 7A The cutter is arranged in the slide valve body;

[0021] Figure 13A Depicted is a cross-sectional perspective view taken along the side of an exemplary needle assembly showing the cutter and valve assembly in a position corresponding to Figure 7A The exhaust position of the closed cutter position is depicted in FIG;

[0022] Figure 13B Depicted is a cross-sectional perspective view taken along the side of an exemplary needle assembly showing the cutter and valve assembly in a position corresponding to Figure 7B The open cutter position depicted in the non-venting position; and

[0023] Figure 14 A graph showing the relationship between valve state and cutter position is depicted. DETAILED DESCRIPTION

[0024] The following description of certain examples of biopsy devices 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, which is provided by way of illustration and is intended to be one of the best modes for implementing the biopsy device. As will be appreciated, the biopsy device can have other different and distinct aspects, all without departing from the spirit of the biopsy device. Accordingly, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0025] It should be understood that any patent, publication, or other public material that is alleged 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 materials set forth in this disclosure. Therefore, and to the extent necessary, the disclosure as expressly set forth herein takes precedence over any conflicting material incorporated herein by reference. Any material or portion thereof that is alleged to be incorporated herein by reference but conflicts with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.

[0026] I. Overview of Exemplary Biopsy Devices

[0027] Figure 1An exemplary biopsy device (10) is shown that includes a probe (20) and a housing (30). The probe (20) includes a needle assembly (100) that extends at least partially distally from a housing of the probe (20). The needle assembly (100) can be inserted into tissue of a patient to obtain a tissue sample, as described below. The biopsy device (10) also includes a tissue sample holder (40) in which the tissue sample is placed. By way of example only, the probe (20) can be a disposable component and the housing (30) can be a reusable component to which the probe (20) can be coupled, such as Figure 2 As shown. The use of the term "housing" herein should not be understood as requiring that any portion of the probe (20) be inserted into any portion of the housing (30). Indeed, in one configuration for the biopsy device (10), the probe (20) may simply be positioned on top of the housing (30). Alternatively, a portion of the probe (20) may be inserted into the housing (30) to secure the probe (20) to the housing (30). In yet another configuration, a portion of the housing (30) may be inserted into the probe (20). Still further, the probe (20) and housing (30) may be integrally formed as a single unit.

[0028] In a configuration where the probe (20) and housing (30) are separable components, a port and / or seal (32) may be provided on the housing (30) to couple with a second port and / or seal (26) on the probe (20) so that a vacuum generated by a vacuum pump (50) within the housing (30) may be fluidly connected to the probe (20). The housing (30) may also provide gears (34, 36) that mate and mesh with gears (310, 312) on the probe (20). It should be understood that Figure 2 The configuration depicted in the drawings for transmitting vacuum and power between housing (30) and probe (20) is exemplary only. In some versions, such a configuration may be constructed in accordance with at least some of the teachings of U.S. Patent No. 8,206,316, issued June 26, 2012, entitled “Cordless Biopsy Device with Reusable Portion,” and / or U.S. Publication No. 2012 / 0065542, published March 15, 2012, entitled “Biopsy Device Tissue Sample Holder with Removable Tray,” the disclosures of which are incorporated herein by reference.

[0029] With the housing (30) and probe (20) connected, the vacuum pump (50) can generate a vacuum within the needle assembly (100) via the tissue sample holder (40) and the tubular cutter (60). However, it should be understood that the vacuum can be provided in other ways. For example, the vacuum pump (50) can be independent of the housing (30) and probe (20) and can simply be connected to an appropriate port on the biopsy device (10) via a vacuum tube. The 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, the disclosures of which are incorporated herein by reference; and / or U.S. Publication No. 2012 / 0065542, entitled "Biopsy Device Tissue Sample Holder with Removable Tray," published on March 15, 2012. Other suitable structural and functional combinations for probe (20) and housing (30) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0030] II. Exemplary Cases

[0031] exist Figure 3The housing (30) schematically shown in FIG. 1 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) of 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 of the vacuum pump 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 actuate the vacuum pump (50), but this is merely optional and a second motor (not shown) can be provided to operate the vacuum pump (50). In particular, the motor can be coupled to a cutter drive assembly (not shown). Such a cutter drive assembly (not shown) can simultaneously rotate gears (34, 36). As described above, gears (34, 36) mesh with gears (310, 312) in probe (20), thereby allowing motor (70) to translate and / or rotate cutter (60). In view of the teachings herein, one of ordinary skill in the art will appreciate that various other configurations for housing (30) can be provided. By way of example only, the cutter drive assembly (not shown) and / or other features of housing (30) can be constructed in accordance with at least some of the teachings of U.S. Patent No. 8,206,316, issued on June 26, 2012, entitled “Cordless Biopsy Device with Reusable Portion”; and / or U.S. Patent No. 8,764,680, issued on July 1, 2014, entitled “Handheld Biopsy Device with Needle Firing Element,” the disclosures of which are incorporated herein by reference.

[0032] III. Exemplary Probes

[0033] Figure 4A partially exploded view of the probe (20) is depicted, showing a needle assembly (100), a cutter actuator assembly (300), a probe housing (22, 24), and a tissue sample holder (40). The needle assembly (100) includes a needle portion (110) and a valve assembly (200). As will be described in more detail below, the needle assembly (100) is generally operable to pierce tissue, wherein a cutter (60) can be placed to cut a tissue sample from a patient and transport the tissue sample to the tissue sample holder (40). More specifically, the needle portion (110) of the needle assembly (100) is inserted into the patient's tissue. The cutter actuator assembly (300) is then operable to selectively actuate the cutter (60) to an open position. Once the cutter (60) is actuated to the open position by the cutter actuator assembly (300), tissue can be prolapsed into the needle portion (110) by means of a vacuum transmitted through the cutter (60). The cutter (60) can then be selectively actuated to a closed position by means of the cutter actuation assembly (300), thereby removing prolapsed tissue from the patient. The valve assembly (200) can then be operated to selectively vent a portion of the needle portion (110) to atmosphere, thereby creating a pressure differential between the proximal and distal ends of the prolapsed tissue. The pressure differential then transports the prolapsed tissue through the cutter (60) to the tissue sample holder (40).

[0034] A. Exemplary Cutter Assemblies

[0035] The cutter actuator assembly (300) includes a series of gears (310, 312). The gears (310, 312) are configured to translate and / or rotate the cutter (60). In the illustrated configuration, when the probe (20) is attached to the housing (30), the gears (310, 312) are coupled to the motor (70). In particular, two gears (310, 312) are controlled by the motor (70) such that one gear (310) translates the cutter (60) while the other gear (312) simultaneously rotates the cutter (60). Other configurations can be provided using different gear (310) arrangements. In addition, configurations involving additional motors (70) can be used. In view of the teachings herein, one of ordinary skill in the art will appreciate various suitable motor (70) and gear (310, 312) combinations. Indeed, cutter actuation assembly (300) may be constructed in accordance with at least some of the teachings of U.S. Patent No. 8,206,316, entitled “Cordless Biopsy Device Having Reusable Portion,” issued June 26, 2012, the disclosure of which is incorporated herein by reference.

[0036] B. Exemplary Needle Portions

[0037] Figure 5FIG7 shows an exemplary needle portion (110). Needle portion (110) includes a cannula (120), a partial cannula (130), a tissue piercing tip (140), and a lateral orifice (150). As shown, cannula (120) is located on top of partial cannula (130). Cannula (120) and partial cannula (130) define a first lumen portion (160) and a second lumen portion (162). As shown in FIG7, Figure 6 As best seen in the figures, the cannula (120) is generally circular in shape, while the partial cannula (130) is semicircular in shape. The cannula (120) and the partial cannula (130) can extend together, with their proximal ends terminating within the valve assembly (200) and their distal ends supporting the tissue piercing tip (140). Although the needle portion (110) is shown as having a generally oval cross-section, it should be understood that other cross-sectional shapes may be used. In fact, the needle portion (110) may be composed solely of a circular tube, thereby forming a generally figure eight shaped cross-section. Alternatively, the needle portion (110) may be composed of two square tubes, thereby forming a generally square cross-section. In other configurations, the partial cannula (130) is omitted, and only the cannula (120) is used to form the generally circular cross-section. In other configurations, any other suitable shape may be used.

[0038] 7A to 7C The needle portion (110) is depicted with the cutter (60) in various states. In particular, the cannula (120) is configured to receive the cutter (60) and allow the cutter (60) to translate and rotate within the second lumen portion (162). The cannula (120) also includes a lateral orifice (150). The lateral orifice (150) is sized to receive prolapsed tissue during operation of the biopsy device (10). The sidewall of the cannula (120) opposite the lateral orifice (150) includes a plurality of openings (170) that provide fluid communication between the first lumen portion (160) and the second lumen portion (162). In this example, the first lumen portion (160) can selectively provide atmospheric air to ventilate the second lumen portion (162) through the plurality of openings (170). This atmospheric venting in second lumen portion (162) allows severed tissue to be drawn through cutter (60) and into tissue sample holder (40) under the influence of the vacuum from vacuum pump (50).

[0039] 7A to 7C The series depicted in FIG shows the cutter (60) first in a closed position, then in an open position, and finally in an intermediate position. Each of the depicted positions may correspond to a particular stage in the tissue sample extraction process. For example, Figure 7AAs depicted, cannula (120) can penetrate a patient's tissue when cutter (60) is in a closed position. In the closed position, cutter (60) is in its furthest distal position relative to lateral orifice (150). Thus, cannula (120) can smoothly penetrate tissue without catching any surrounding tissue that could impede penetration.

[0040] Figure 7B Cutter (60) is shown in an open position, wherein cutter (60) is in its most distal proximal position relative to lateral orifice (150). This state may correspond, for example, to a position in which cannula (120) is oriented within a patient, in which a tissue sample may be collected. With cutter (60) in its most distal proximal position relative to lateral orifice (150), a vacuum may be applied through lateral orifice (150) to prolapse tissue of the patient.

[0041] at last, Figure 7C The cutter (60) is depicted in an intermediate position, wherein the cutter (60) is in a position between its most distal position and its most proximal position relative to the lateral orifice (150). In this position, the cutter (60) can be in a state of motion from a closed position or an open position to a closed or open position, respectively. For example, the cutter (60) can be moved from an open position to a closed position so that the cutter (60) can cut a tissue sample. Alternatively, the cutter can be moved from a closed position to an open position to allow the patient's tissue to prolapse through the lateral orifice (150). As will be described in further detail below, these various positions correspond to various pneumatic states of the valve assembly (200). It should be understood that the various positions of the cutter (60) and the corresponding stages in the tissue extraction process are merely exemplary, and based on the teachings herein, one of ordinary skill in the art will understand other suitable combinations.

[0042] The tissue piercing tip (140) is shown as having a generally conical body with a flat blade protruding therefrom. The shape of the tissue piercing tip (140) is exemplary only, and many other suitable shapes may be used. For example, the tissue piercing tip (140) may be in the shape of a blade protruding from the needle portion (110), regardless of the conical body. In still further variations, the tissue piercing tip (140) may have a flat blade portion of varying shapes and configurations. In view of the teachings herein, one of ordinary skill in the art will appreciate that various other configurations may be provided for the tissue piercing tip (140) and for the needle portion (110) generally. 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, issued August 8, 2014, entitled "Needle Assembly and Blade Assembly for Biopsy Device," the disclosure of which is incorporated herein by reference.

[0043] C. Example Valve Assemblies

[0044] In some cases, it may be desirable to have a compact and simple valve assembly for a biopsy device. For example, as described above, the biopsy device (10) is configured as a handheld, cordless biopsy device. In such a configuration, it is generally desirable to reduce the size and complexity of the components used in the biopsy device (10) to improve the hand-holdability of the device. Therefore, if certain valve assemblies have minimal components and can be easily integrated with other components of the biopsy device (10), such valve assemblies may be desirable. Although various examples of suitable valve assemblies are described below, it should be understood that a person of ordinary skill in the art will understand that various alternative valve assemblies may be used without departing from the nature and spirit of the various examples described herein.

[0045] Figure 8 An exploded view of an exemplary valve assembly (200) is depicted. The valve assembly (200) includes a manifold (210), a static seal (240), and a spool valve body (250) or shuttle valve. In this example, the manifold (210) is constructed as a single, integrated plastic and / or polycarbonate component. The manifold (210) couples the valve assembly (200) to the proximal end of the needle portion (110) of the needle assembly (100). In particular, the manifold (210) includes a needle coupling end (220) and a vent end (230). As shown in Figure 9 As best seen in FIG, the needle coupling end (220) of the manifold (210) is configured to receive the proximal end of the needle portion (110) of the needle assembly (100). In this example, the coupling is made at the distal ends of the cannula (120) and the partial cannula (130). The cutter (60) then continues through the valve assembly (200) to the tissue sample holder (40). As will be described in more detail below, the needle coupling end (220) forms an airtight seal around the cannula (120) and the partial cannula (130) to allow fluid to flow from the exhaust end (230) through the first lumen portion (160). The coupling between the needle portion (110) and the needle coupling end (220) of the manifold (210) can be facilitated by any suitable means, such as adhesive bonding, resilient sealing features, interference fit, or mechanical fastening.

[0046] Figure 9 The exhaust end (230) of the manifold (210) is shown positioned around the cutter (60). The spool valve body (250) is not positioned Figure 9, so that details of the exhaust end (230) are visible. The exhaust end (230) extends proximally from the needle coupling end (220). In this example, the needle coupling end (220) and the exhaust end (230) are integrally formed as a single unit. In other examples, the needle coupling end (220) and the exhaust end (230) can be separate components joined together by any suitable fastening means. The exhaust end (230) terminates at the proximal end of the manifold (210), at which a static seal (240) is attached. The exhaust end (230) of this example includes a lip (232), a flange, a channel, or other fastening feature. It will be understood that the lip (232) is generally configured to engage the interior of the static seal (240), thereby securing the static seal (240) to the exhaust end (230) and promoting a seal between the static seal (240) and the exhaust end (230).

[0047] A static seal (240) is attached to the proximal end of the manifold (210). The cutter (60) extends through the static seal (240). As can be seen, the static seal (240) defines a proximal exhaust port (242) therein. The exhaust port (242) is generally circular and defines a diameter that is oversized relative to the outer diameter of the cutter (60). Thus, the cutter (60) is free to rotate and translate through the static seal (240), while fluid generally freely passes through the exhaust port (242) above the exterior of the cutter (60). As will be described in more detail below, this configuration generally allows the exhaust port (242) to permit atmospheric air to flow through the static seal (240), into the exhaust end (230), and then to the first lumen portion (160). However, as will be described in more detail below, in certain circumstances, such fluid flow may be blocked by the spool valve body (250).

[0048] Positioning the proximal vent (242) proximally and centered within the static seal (240) can have certain advantages. For example, in some configurations of the valve assembly (200), one or more vent openings similar to the proximal vent opening (242) can be integrated into the manifold (210) near the center of the manifold (210). However, in such configurations, as fluid, such as blood and / or saline, flows from the first lumen portion (160), some circumstances can cause fluid to overflow from the one or more vents. It may be desirable to reposition such one or more vents to the location of the proximal vent (242) to accommodate at least some of this fluid overflow. For example, due to the centered positioning of the proximal vent (242), a lip or container is provided by the static seal (240) that would otherwise not be present in examples having one or more vents in the manifold (210).

[0049] The static seal (240) is shown as a separate component of the valve assembly (200). This allows the sliding valve body (250) to be inserted into the manifold (210). To facilitate ease of assembly, in this example, the static seal (240) is an elastomeric, rubber, or silicone rubber material so that the static seal (240) can be stretched onto the exhaust end (230). As will be described in more detail below, such a material can also facilitate the interaction between the sliding valve body (250) and the static seal (240). However, it should be understood that the static seal (240) can be formed integrally with the manifold (210). This is particularly the case if the manifold (210) is composed of more than one component rather than the integral design shown.

[0050] Figures 10 to 12 A detailed view of the spool body (250) is provided. As can be seen, the spool body (250) generally defines an elongated cylindrical body. The proximal end of the spool body (250) (e.g., extending outward) Figure 10 The end of the page in the figure) includes a tapered portion (252) that defines a generally truncated conical shape. As will be described in more detail below, the tapered portion (252) is generally configured to engage the static seal (240) to promote sealing between the sliding valve body (250) and the static seal (240). In addition, in some examples, the tapered portion (252) can also be configured to flex or otherwise displace the static seal (240) to further promote sealing. Although the tapered portion (252) is shown as having a particular shape in this example, it should be understood that in other examples, the shape of the tapered portion (252) can be changed. For example, in some examples, the tapered portion (252) can have a larger taper angle or a smaller taper angle. In other examples, the tapered portion (252) can have a concave curvature or a convex curvature. In view of the teachings herein, one of ordinary skill in the art will understand other suitable configurations.

[0051] The distal end of the spool valve body (250) (eg, extending Figure 11 60 ).

[0052] The spool body (250) further includes an inner cavity (256) extending completely through the body of the spool body (250) from the proximal end to the distal end. The inner cavity (256) is generally cylindrical, with a diameter generally corresponding to the outer diameter of the cutter (60). This configuration generally allows the inner cavity (256) to receive the cutter (60) while forming a fluid-tight seal between the cutter (60) and the spool body (250). It will be appreciated that this configuration generally allows the spool body (250) to seal the first inner cavity portion (160) relative to the static seal (240) during certain operating stages.

[0053] from Figure 12 As best seen in the drawings, when assembled, the spool body (250) is coaxially positioned on the cutter (60) with the cutter (60). Additionally, the spool body (250) abuts the outer surface of the cutter (60) such that no gap is formed between the interior of the spool body (250) and the cutter (60). As described above, the fastening openings (254) allow for the placement of glue or adhesive to secure the spool body (250) to the cutter (60). Thus, it should be understood that in operation, movement of the cutter (60) is immediately transmitted to the spool body (250), such that the spool body (250) and the cutter (60) always move in unison. Thus, the spool body (250) can rotate and translate with the translation and rotation of the cutter (60).

[0054] IV. Exemplary Aerodynamic Conditions

[0055] 13A to 13B The spool valve body (250) is shown in various exemplary pneumatic states. Figure 13A , the spool body (250) is shown in the vented state. In the vented state, the spool body (250) is in its most distal position relative to the manifold (210). As described above, the spool body (250) is attached to the cutter (60). Thus, the vented state corresponds to the cutter (60) being in its most distal position relative to the lateral orifice (150), as shown. Figure 7AWhen the spool body (250) is in its most distal position relative to the manifold (210), the proximal exhaust port (242) allows atmospheric air to pass through the static seal (240), into the manifold (210), and around the outer surface of the spool body (250) to the first lumen portion (160). The spool body (250) thus provides an unobstructed fluid path between the proximal exhaust port (242) and the first lumen portion (160). The fluid communication of atmospheric air with the first lumen portion (160) accordingly allows negative pressure to exist behind the severed tissue sample inside the cutter (60) at the distal end of the cutter (60). Thus, when a vacuum is applied to the cutter (60), the severed tissue sample can be transported proximally through the cutter (60) to the tissue sample holder (40).

[0056] Furthermore, when spool body (250) is in its furthest distal position relative to manifold (210), spool body (250) may act as a hard stop to prevent distal translation of cutter (60). Figure 13A As can be seen in FIG, spool body (250) may engage certain features (such as an internal step) within manifold (210) to prevent further distal translation of spool body (250) within the manifold. While this generally prevents further distal translation of cutter (60), it should be understood that at least some rotation of cutter (60) may continue for a predetermined period of time—a configuration referred to as “lost motion.”

[0057] Figure 13BThe spool valve body (250) is depicted in a non-vented state. In the non-vented state, the spool valve body (250) is at its furthest proximal portion relative to the manifold (210). In the furthest proximal position, the spool valve body (250) is positioned to seal the proximal vent (242) within the static seal (240). In particular, the spool valve body (250) typically occupies the entire open space between the static seal (240) and the cutter (60), thereby sealing the manifold (210) and the first lumen portion (160). In this configuration, the engagement between the spool valve body (250) and the static seal (240) to provide a seal to the first lumen portion (160) can provide a more robust valve assembly (200). For example, in some forms of the valve assembly (200), the spool valve body (250) includes one or more O-rings to seal within the interior of the manifold (210) relative to one or more vents in the manifold (210). In this configuration, the engagement between the O-ring and the manifold (210) may cause the O-ring to degrade over time. However, in the current configuration having the proximal exhaust port (242) in the static seal (240), the O-ring may be omitted entirely, thereby preventing degradation and improving robustness. Additionally, removing the O-ring may provide greater flexibility in the material used for the manifold (210). For example, in versions of the valve assembly using O-rings, at least a portion of the manifold (210) is typically constructed of metal to reduce friction between the O-ring and the manifold (210). However, in the current configuration in which the O-rings are removed, the manifold (210) may comprise a unitary polycarbonate component formed by injection molding.

[0058] In this example, the sealing configuration includes at least some displacement of the static seal (240) to facilitate a consistent seal between the static seal (240) and the spool body (250). However, it will be appreciated that in other examples, alternative configurations may be used. For example, in other examples, the static seal (240) may be comprised of a generally rigid material, while the spool body (250) may be comprised of an elastomeric material. Thus, in some examples, a portion of the spool body (250) rather than a portion of the static seal (240) may be displaced. In other examples, neither the static seal (240) nor the spool body (250) may be displaced, relying instead on a compression fit between the two for sealing. In other examples, both the static seal (240) and the spool body (250) may be displaced relative to each other.

[0059] Figure 13B The non-venting state corresponding to the open state of the cutter (60) is depicted. Figure 7BAs best seen in FIG, the open state of cutter (60) corresponds to cutter (60) being positioned in its furthest proximal position relative to lateral orifice (150). In the open state of cutter (60), atmospheric air does not communicate fluid through first lumen portion (160). In other words, at this stage, spool valve body (250) seals first lumen portion (160) from atmospheric air. Thus, when vacuum is applied to cutter (60), tissue can prolapse through lateral orifice (150).

[0060] exist Figure 13A and Figure 13B Between the positions shown, the spool body (250) can travel through intermediate non-venting states. In this example, the spool body (250) generally defines a longitudinal length. Due to this longitudinal length, and because the spool body (250) translates with the cutter (60), the spool body (250) can remain engaged with the static seal (240) and in the non-venting state as the cutter (60) translates between its furthest proximal position and furthest distal position relative to the lateral orifice (150). The valve assembly (200) can remain in this non-venting state until, for example, the cutter (60) reaches Figure 7C As will be appreciated, the specific transition point between the vented and non-vented states of valve assembly (200) can vary based on a variety of factors. For example, some factors that can influence the transition point are the specific axial position of spool valve body (250) on cutter (60) and / or the longitudinal length of spool valve body (250). Additionally, by varying the longitudinal length of spool valve body (250), the amount of time valve assembly (200) remains in the non-vented state can be readily varied (as long as the cutter translation speed remains constant). For example, if venting to atmosphere is desired when cutter (60) is in a more proximal position relative to lateral orifice (150), the longitudinal length can be shorter. Alternatively, needle portion (110) can have a different configuration requiring a different distance so that the transition between the non-vented and vented states remains the same relative to the position of cutter (60). Other configurations involving different distances between spool valve bodies (250), the positioning of spool valve bodies (250), and the longitudinal length of spool valve bodies (250) will be apparent to one of ordinary skill in the art based on the teachings herein.

[0061] Figure 14 An exemplary pneumatic algorithm (400) that may be executed during use of the biopsy device (10) is depicted. In particular, Figure 14The movement of the cutter (60) relative to the cannula (120) is shown by a graphical representation (410) including a graphical representation (420) of the lateral orifice (150). The movement of the cutter (60) is shown in line (430) for the entire range of travel of the cutter (60). Line (440) represents the pneumatic state of the valve assembly (200) during the tissue extraction process; thereby indicating the pneumatic state of the first lumen portion (160). The pneumatic state of the second lumen portion (162) within the cutter (60) is shown by line (450). It can be seen that vacuum is continuously applied to the second lumen portion (162) throughout the tissue extraction process. Figure 14 The term "dead end" in the is intended to mean that the corresponding first cavity portion (160) is sealed with respect to the atmosphere and does not allow vacuum to flow freely from the second cavity portion (162) to the first cavity portion (160) during this phase.

[0062] like Figure 14 As shown in FIG, the cutter (60) starts at Figure 7A In this position, Figure 14 Line (440) shows the valve assembly (200) vented to atmosphere, and line (450) shows the second lumen portion (162) having a vacuum applied thereto. The corresponding position of the valve assembly (200) may be Figure 13A Seen in.

[0063] As the cutter (60) translates proximally from the closed position toward the open position, Figure 14 As shown by line (430) and as Figure 7C As depicted, line (440) illustrates valve assembly (200) correspondingly transitioning to a "dead end" state, wherein first lumen portion (160) is sealed to atmosphere. In the present example, this transition occurs when cutter (60) is positioned relative to lateral orifice (150) in a position wherein lateral orifice (150) is effectively open by approximately 24%. However, it should be understood that such a transition may occur at other cutter (60) positions relative to lateral orifice (150).

[0064] Once the cutter (60) reaches the open position, Figure 7B As shown, Figure 14 The line (430) in FIG. 4 shows that the cutter (60) can remain open for an open orifice dwell time (460). During the open orifice dwell time (460), the first lumen portion (160) is sealed relative to the atmosphere. The corresponding position of the valve assembly (200) is Figure 13B. However, as indicated by line (450), vacuum remains applied to the second lumen portion (162) inside the cutter (60). Thus, vacuum can travel through the lateral orifice (150) via the second lumen portion (162), allowing tissue to prolapse through the lateral orifice (150). In some examples, the pneumatic algorithm (400) can include the motor (70) continuing to rotate at the same speed as when the cutter (60) was opened. In such an example, the motor (70) can be decoupled from the cutter drive train during the duration of the open orifice dwell time (460). However, as indicated by line (450), the motor (70) can remain coupled to the vacuum pump (50) to supply vacuum.

[0065] Figure 14 Line (430) then depicts the movement of the cutter (60) from the open position distally toward Figure 7C The closed position shown is transformed. When the cutter (60) is translated distally, severing the prolapsed tissue, Figure 14 Line (440) shows the transition of the valve assembly (200) from the dead-end state to the vented state. As described above, this transition occurs when the cutter (60) is positioned relative to the lateral orifice (150) in a position where the lateral orifice (150) is effectively open by approximately 13%. However, it should also be understood that this position may vary in other versions.

[0066] at last, Figure 14 Line (430) shows the return of the cutter (60) to the closed position, as shown in FIG. Figure 7A As shown, in this position, the cutter will maintain a closed orifice dwell time (470). In this state, Figure 14 The line (440) depicts the Figure 13AThe valve assembly (200) is shown in a vented state. Thus, the first lumen (160) can be vented to the atmosphere to create a pressure differential suitable for the proximal movement of the cut tissue sample through the cutter (60) and into the tissue sample holder (40). As described above with respect to the open orifice dwell time (460), the closed orifice dwell time (470) can include continued rotation of the motor (70). However, unlike the open orifice dwell time (460), the motor (70) can continue to rotate at the same speed as when the cutter (60) is closed. It should be understood that during this rotation of the motor (70), the motor (70) can be decoupled from the cutter drive train for the duration of the closed orifice dwell time (470). However, as indicated by line (450), the motor (70) can remain coupled to the vacuum pump (50) to supply vacuum. Once the closed orifice dwell time (470) expires, the above process can then be repeated as needed to obtain the desired number of tissue samples. Of course, the various states described above are merely exemplary, and other relationships between the position of cutter (60), exhaust states, and vacuum will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0067] V. Exemplary Combinations

[0068] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be filed at any time in this application or a subsequent application hereof. No disclaimer. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered critical unless otherwise expressly indicated by the inventor or a successor subsequently associated with the inventor. If any claims are filed in this application or a subsequent application related to this application that include features other than those mentioned below, it shall not be assumed that these additional features have been added for any reason related to patentability.

[0069] Example 1

[0070] A biopsy device comprising: (a) a body; (b) a needle extending distally relative to the body, wherein the needle defines a first lumen and a second lumen, wherein the needle includes an opening fluidically coupling the first lumen and the second lumen; (c) a cutter, wherein the cutter is configured to translate relative to the needle to sever tissue; and (d) a valve assembly comprising: (i) a manifold including a proximal exhaust port; and (ii) a spool valve body movable relative to the proximal exhaust port between a first position and a second position, wherein when the spool valve body is in the first position, the second lumen of the needle is coupled to the proximal exhaust port, wherein when the spool valve body is in the second position, the second lumen is sealed relative to the proximal exhaust port, wherein the spool valve body is configured to transition between the first position and the second position by moving in proportion to translation of the cutter.

[0071] Example 2

[0072] A biopsy device according to embodiment 1, wherein the needle further defines a transverse tissue receiving aperture, wherein the transverse tissue receiving aperture opens into the first lumen, and wherein the cutter is operable to sever tissue protruding through the tissue receiving aperture.

[0073] Example 3

[0074] The biopsy device of any one or more of Examples 1-2, wherein the first lumen extends along a first longitudinal axis, wherein the second lumen extends along a second longitudinal axis, and wherein the cutter is configured to translate along the first axis.

[0075] Example 4

[0076] The biopsy device of any one or more of embodiments 1-3, wherein the cutter is located in the first lumen.

[0077] Example 5

[0078] The biopsy device according to any one or more of embodiments 1-4, wherein the spool body is movable along an axis defined by the cutter or the first lumen.

[0079] Example 6

[0080] The biopsy device of any one or more of embodiments 1-5, wherein the spool body is coupled to the cutter such that translation of the cutter directly corresponds to movement of the spool body along an axis defined by the cutter.

[0081] Example 7

[0082] A biopsy device according to any one or more of Examples 1 to 6, wherein the cutter is translatable between a first position and a second position, wherein the first position of the cutter corresponds to the sliding valve body being in the first position, and wherein the second position of the cutter corresponds to the sliding valve body being in the second position.

[0083] Example 8

[0084] A biopsy device according to Example 7, wherein when the cutter is in the first position, the cutter is fully advanced distally relative to the needle, and wherein when the cutter is in the second position, the cutter is fully advanced proximally relative to the needle.

[0085] Example 9

[0086] The biopsy device of any one or more of embodiments 1-8, wherein the proximal exhaust port is defined by the manifold.

[0087] Example 10

[0088] The biopsy device according to any one or more of embodiments 1 to 8, wherein the valve assembly further comprises a seal, wherein the seal defines the proximal exhaust port and is secured to the manifold.

[0089] Example 11

[0090] A biopsy device according to any one or more of embodiments 1 to 10, wherein the manifold is fixedly secured to the distal end of the body, wherein the manifold extends proximally from the distal end of the body, wherein the needle extends distally from the manifold, and wherein the needle is fluidly sealed relative to the manifold.

[0091] Example 12

[0092] The biopsy device according to any one or more of embodiments 1 to 11, wherein the sliding valve body is disposed within the manifold, wherein the sliding valve body is slidable relative to the proximal exhaust port within at least a portion of the manifold.

[0093] Example 13

[0094] The biopsy device according to any one or more of Examples 1 to 12, wherein the sliding valve body defines an open space between an outer surface of the sliding valve body and an inner surface of the manifold, wherein the open space is configured to allow atmospheric air to flow around the sliding valve body.

[0095] Example 14

[0096] The biopsy device according to any one or more of Examples 1 to 13, wherein the sliding valve body defines an inner cavity for receiving the cutter, wherein the sliding valve body is configured to receive the cutter such that an inner surface of the sliding valve body is directly adjacent to the cutter.

[0097] Example 15

[0098] The biopsy device according to any one or more of Examples 1-14, wherein the sliding valve body is configured to plug the proximal exhaust port to seal the second lumen relative to the proximal exhaust port.

[0099] Example 16

[0100] A biopsy device comprising: (a) a body; (b) a needle extending distally relative to the body, wherein the needle defines a first lumen and a second lumen, wherein the needle includes an opening fluidically coupling the first lumen to the second lumen; (c) a cutter, wherein the cutter is movable relative to the needle to sever tissue; and (d) a valve assembly comprising: (i) a static seal defining a proximal exhaust port; and (ii) a valve member, wherein the valve member is configured to translate relative to the proximal exhaust port in correspondence with translation of the cutter to selectively couple and decouple the proximal exhaust port from the second lumen of the needle.

[0101] Example 17

[0102] According to embodiment 16, the biopsy device also includes a manifold extending proximally from the distal end of the body, wherein the needle is coaxially positioned relative to the manifold so that the needle extends distally from the manifold, and wherein the static seal is fixed to the proximal end of the manifold.

[0103] Example 18

[0104]

[00106] The biopsy device of Example 17, wherein the valve member is disposed within the manifold, wherein the valve member is slidable within the manifold such that an exterior of the valve member is configured to be pluggable to the proximal exhaust port.

[0105] Example 19

[0106] The biopsy device of any one or more of Examples 16 to 18, wherein the valve member includes a tapered portion, wherein the tapered portion is configured to engage the static seal to deform at least a portion of the static seal.

[0107] Example 20

[0108] A biopsy device according to any one or more of Examples 16 to 18, wherein the valve member includes an elastomeric portion, wherein the static seal is substantially rigid, and wherein the elastomeric portion of the valve member is configured to deform in response to engagement between the valve member and the static seal.

[0109] Example 21

[0110] The biopsy device of any one or more of Examples 16-20, wherein the valve member is configured to prevent distal translation of the cutter beyond a predetermined point.

[0111] Example 22

[0112] 24. The biopsy device of any one or more of Examples 16-21, wherein the valve member is fixedly secured to the cutter.

[0113] Example 23

[0114] A biopsy device comprising: (a) a body; (b) a needle extending distally relative to the body, wherein the needle defines a first lumen and a second lumen, wherein the needle includes an opening fluidically coupling the first lumen and the second lumen; (c) a cutter, wherein the cutter is configured to translate relative to the needle to sever tissue; (d) a manifold having a seal defining a vent; and (e) a spool body fixed relative to the cutter, wherein the spool body is translatable within the manifold relative to the seal to selectively plug the vent.

[0115] It should be understood that any patent, publication, or other public material that is alleged 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 materials set forth in this disclosure. Therefore, and to the extent necessary, the disclosure as expressly set forth herein takes precedence over any conflicting material incorporated herein by reference. Any material or portion thereof that is alleged to be incorporated herein by reference but conflicts with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.

[0116] Embodiments of the present invention have application to conventional endoscopic and open surgical instrumentation as well as robotic-assisted surgery.

[0117] Embodiments of the devices disclosed herein can be designed to be cleared away after a single use, or they can be designed to be used multiple times. In either case or both, the embodiments can be restored for reuse after at least one use. Restoration can include any combination of steps such as disassembling the device, subsequently cleaning or replacing specific parts, and subsequently reassembling. In particular, embodiments of the device can be disassembled, and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific components, embodiments of the device can be reassembled for subsequent use in a restoration facility, or can be used by the surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that restoration of the device can use a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting restored device are all within the scope of this application.

[0118] By way of example only, the embodiments described herein can be processed before surgery. First, new or used instruments can be obtained and cleaned as needed. The instruments can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container (such as a plastic or TYVEK bag). The container and instrument can then be placed in a radiation field that can penetrate the container, such as gamma rays, x-rays, or high-energy electrons. The radiation can kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container can keep the instrument sterile until the sealed container is opened in the medical device. The device can also be sterilized using any other technology known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0119] While various embodiments of the present invention have been shown and described, other adaptations of the methods and systems described herein may be accomplished 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 others will be apparent to those skilled in the art. For example, the foregoing examples, embodiments, geometries, materials, dimensions, proportions, steps, and the like are illustrative and not required. Accordingly, the scope of the present invention should be determined in accordance with the appended claims and should be understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

1. A biopsy device comprising: (a) subject; (b) a needle extending distally relative to the body, wherein the needle defines a first lumen and a second lumen, wherein the needle includes an opening fluidly coupling the first lumen and the second lumen; (c) a cutter, wherein the cutter is configured to translate relative to the needle to sever tissue; as well as (d) a valve assembly, the valve assembly comprising: (i) a manifold including a proximal exhaust port; (ii) a static seal attached to the manifold and defining a proximal exhaust port therein, the cutter extending through the static seal, the proximal exhaust port being circular and defining a diameter that is oversized relative to an outer diameter of the cutter; and (iii) a spool valve body configured to move relative to the proximal exhaust port between a first position and a second position, wherein when the spool valve body is in the first position, the second lumen of the needle is coupled to the proximal exhaust port, and the proximal exhaust port allows fluid communication of atmospheric air through the static seal, into the manifold, and around an outer surface of the spool valve body to the second lumen, wherein when the spool valve body is in the second position, the second lumen is sealed relative to the proximal exhaust port, wherein the spool valve body is configured to transition between the first and second positions by moving in proportion to translation of the cutter, and wherein, in the second position, the spool body is received within the proximal exhaust port, passes through the proximal exhaust port and occupies the entire open space between the static seal and the cutter, thereby sealing the proximal exhaust port in the static seal, wherein the cutter is translatable between a first position and a second position, wherein the first position of the cutter corresponds to the spool valve body being in the first position, and wherein the second position of the cutter corresponds to the spool valve body being in the second position, Wherein, the spool valve body is configured to remain engaged with the static seal and in a non-venting state when the cutter translates between its second position and its first position.

2. The biopsy device of claim 1 , wherein the needle further defines a transverse tissue receiving aperture, wherein the transverse tissue receiving aperture opens into the first lumen, and wherein the cutter is operable to sever tissue protruding through the tissue receiving aperture.

3. The biopsy device of claim 1 or 2, wherein the first lumen extends along a first longitudinal axis, wherein the second lumen extends along a second longitudinal axis, and wherein the cutter is configured to translate along the first longitudinal axis. The biopsy device of claim 1 , wherein the cutter is located in the first lumen.

5. The biopsy device of claim 1 or 2, wherein the spool body is movable along an axis defined by the cutter or the first lumen.

6. The biopsy device of claim 1 or 2, wherein the spool body is coupled to the cutter such that translation of the cutter corresponds directly to movement of the spool body along an axis defined by the cutter.

7. The biopsy device of claim 1 , wherein when the cutter is in the first position, the cutter is fully advanced distally relative to the needle, and wherein when the cutter is in the second position, the cutter is fully advanced proximally relative to the needle.

8. The biopsy device of claim 1 or 2, wherein the proximal exhaust port is defined by the manifold.

9. The biopsy device of claim 1 or 2, wherein the manifold is fixedly secured to the distal end of the body, wherein the manifold extends proximally from the distal end of the body, wherein the needle extends distally from the manifold, and wherein the needle is fluidly sealed relative to the manifold.

10. The biopsy device of claim 1 or 2, wherein the spool body is disposed within the manifold, wherein the spool body is slidable relative to the proximal exhaust port within at least a portion of the manifold.

11. The biopsy device of claim 1 or 2, wherein the spool body defines an open space between an outer surface of the spool body and an inner surface of the manifold, wherein the open space is configured to allow atmospheric air to flow around the spool body.

12. The biopsy device of claim 1 or 2, wherein the spool body defines an inner cavity for receiving the cutter, wherein the spool body is configured to receive the cutter such that an inner surface of the spool body directly abuts the cutter.

13. The biopsy device of claim 1 or 2, wherein the spool body is configured to plug the proximal exhaust port to seal the second lumen relative to the proximal exhaust port.

14. The biopsy device of claim 1, wherein the seal is located at a proximal end of the manifold, wherein the proximal exhaust port is defined between the cutter and the seal.

15. A biopsy device comprising: (a) subject; (b) a needle extending distally relative to the body, wherein the needle defines a first lumen and a second lumen, wherein the needle includes an opening fluidly coupling the first lumen and the second lumen; (c) a cutter, wherein the cutter is movable relative to the needle to sever tissue; as well as (d) a valve assembly, the valve assembly comprising: (i) a static seal defining a proximal exhaust port, the cutter extending through the static seal, the proximal exhaust port being circular and defining a diameter that is oversized relative to an outer diameter of the cutter; and (ii) a valve member, wherein the valve member is configured to translate into and through the proximal vent in response to translation of the cutter to occupy the entire open space between the static seal and the cutter, thereby sealing the proximal vent in the static seal to selectively couple and decouple the proximal vent from the second lumen of the needle, wherein the valve member is configured to remain engaged with the static seal and in a non-venting state when the cutter translates between a position in which the proximal vent is decoupled from the second lumen of the needle and another position in which the proximal vent is coupled to the second lumen of the needle, wherein when the valve member is in the position in which the proximal vent is coupled to the second lumen of the needle, the proximal vent permits atmospheric air to pass through the static seal and around an outer surface of the valve member to fluid communication with the second lumen.

16. The biopsy device of claim 15, 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 the static seal is secured to the proximal end of the manifold.

17. The biopsy device of claim 16, wherein the valve member is disposed within the manifold, wherein the valve member is slidable within the manifold such that an exterior of the valve member is configured to be pluggable to the proximal exhaust port.

18. The biopsy device of any one or more of claims 15 to 17, wherein the valve member comprises a tapered portion, wherein the tapered portion is configured to engage the static seal to deform at least a portion of the static seal.

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