Automatic biopsy devices for fine needle aspiration biopsy

The automatic biopsy device addresses inefficiencies in FNAB procedures by incorporating a reusable assembly with a plunger lock mechanism and cam system, enabling semi-automated axial and rotational movements for improved specimen collection efficiency and cost-effectiveness.

WO2025085082A1PCT designated stage expired Publication Date: 2025-04-24BARD PERIPHERAL VASCULAR INC
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Patent Information

Application Number
PCT/US2023/077261
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-10-19
Publication Date
2025-04-24

AI Technical Summary

Technical Problem

Current fine needle aspiration biopsy (FNAB) procedures are inefficient due to the need for multiple punctures, insufficient specimen collection, and the requirement for manual suction and needle rotation, which can be cumbersome and costly, especially with the use of disposable biopsy devices.

Method used

The development of an automatic biopsy device with a reusable assembly that includes a plunger lock mechanism, actuation members, and a cam and follower surface system, allowing for semi-automated operation with axial and rotational movements to facilitate efficient specimen collection.

Benefits of technology

The automatic biopsy device enhances sampling efficiency and quality by reducing the need for manual suction and needle rotation, improving specimen collection with fewer punctures, and offering a cost-effective solution through the combination of disposable and reusable components.

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Abstract

A biopsy device includes a reusable assembly that includes an outer housing and a plunger lock mechanism located in the outer housing. The plunger lock mechanism includes an actuation member accessible outside the outer housing that moves relative to the outer housing and includes a cam surface. A release flange is configured to move axially in the outer housing and includes a follower surface. A gripping finger is configured to move laterally with axial movement of the release flange. The cam and follower surfaces are configured to cooperate such that movement of the actuation member relative to the outer housing moves the release flange axially relative to the gripping finger. The release flange is configured to move the gripping finger from a locked configuration engaged with a plunger of a syringe to an unlocked configuration disengaged with the plunger of the syringe.
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Description

AUTOMATIC BIOPSY DEVICES FOR FINE NEEDLE ASPIRATION BIOPSYTECHNICAL FIELD

[0001] The present specification generally relates to biopsy devices and, more specifically, to automatic biopsy devices for fine needle aspiration biopsy procedures having both reusable and disposable portions.BACKGROUND

[0002] Fine needle aspiration biopsy (FNAB) is the standard of care for thyroid pathology diagnosis. During the FNAB procedure, the needle punctures the skin and is navigated to the target nodule under the guidance of ultrasound equipment, then the inner stylet will be removed, the needle tip will thrust back and forth inside of nodule to scratch and cut off cells sample for pathological diagnosis. Multiple punctures (2-5 needles) and repeated thrusting of each FN are typically performed due to insufficient specimen collected from each puncture alone. For insufficient blood supply, density and hard, calcified nodules, aspiration may be applied to the needle to increase the sampling volume. If needed, the needle may be manually rotated during the sampling procedure to allow the needle tip to cut / crush more cells off for pathology diagnosis. To apply suction, a third hand may be needed to generate the suction. Further, the biopsy device may be disposable, which can be relatively costly.

[0003] What is needed are other biopsy devices for fine needle aspiration.SUMMARY

[0004] According to a first embodiment, a biopsy device includes a reusable assembly that includes an outer housing and a plunger lock mechanism located in the outer housing. The plunger lock mechanism includes an actuation member accessible outside the outer housing that moves relative to the outer housing and includes a cam surface. A release flange is configured to move axially in the outer housing and includes a follower surface. A gripping finger is configured to move laterally with axial movement of the release flange. The cam and follower surfaces are configured to cooperate such that movement of the actuation member relative to the outer housing moves the release flange axially relative to the gripping finger. The release flange is configured to move the gripping finger from a locked configuration engaged with a plunger of a syringe with axial movement of the release flange away from the gripping finger to an unlocked configurationdisengaged with the plunger of the syringe with axial movement of the release flange toward the gripping finger.

[0005] According to a second embodiment, a method of operating a biopsy device is provided. The method includes inserting a plunger of a syringe into a plunger lock mechanism of the biopsy device. The plunger lock mechanism includes a gripping finger that moves laterally to interlock with and release the plunger. The plunger is retracted with the plunger lock mechanism interlocked with the plunger by sliding an actuation member relative to an outer housing of the biopsy device.

[0006] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0008] FIG. 1 schematically depicts a perspective view of a biopsy device with a disposable assembly connected to a reusable assembly, according to one or more embodiments shown and described herein;

[0009] FIG. 2 schematically depicts a side view of the biopsy device of FIG. 1 with the disposable assembly disconnected from the reusable assembly, according to one or more embodiments shown and described herein;

[0010] FIG. 3 schematically depicts the disposable assembly of FIG. 2 partially disassembled, according to one or more embodiments shown and described herein;

[0011] FIG. 4 schematically depicts a perspective view of the reusable assembly of FIG. 2, according to one or more embodiments shown and described herein;

[0012] FIG. 5 schematically depicts a side perspective detail view of the biopsy device of FIG. 1 with an outer housing removed for illustration, according to one or more embodiments shown and described herein;

[0013] FIG. 6 schematically depicts a portion of a plunger lock mechanism in isolation in an unlocked configuration, according to one or more embodiments shown and described herein;

[0014] FIG. 7 schematically depicts the portion of the plunger lock mechanism of FIG. 6 in a locked configuration, according to one or more embodiments shown and described herein;

[0015] FIG. 8 schematically depicts the plunger lock mechanism of FIGS. 6 and 7 in use within the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0016] FIG. 9 schematically depicts a section view of a portion of the plunger lock mechanism of FIGS. 6 and 7 in use, according to one or more embodiments shown and described herein;

[0017] FIG. 10 schematically depicts a partial detail view of a sliding assembly of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0018] FIG. 11 schematically depicts operation of the sliding assembly of FIG. 10, according to one or more embodiments shown and described herein;

[0019] FIG. 12 schematically depicts a perspective view of a stand assembly for use with the sliding assembly of FIG. 10, according to one or more embodiments shown and described herein;

[0020] FIG. 13 schematically depicts operation of a rotation assembly of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0021] FIG. 14 schematically illustrates operation of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0022] FIG. 15 schematically illustrates operation of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0023] FIG. 16 schematically illustrates operation of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein;

[0024] FIG. 17 schematically illustrates operation of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein; and

[0025] FIG. 18 schematically illustrates operation of the biopsy device of FIG. 1, according to one or more embodiments shown and described herein.DETAILED DESCRIPTION

[0026] Embodiments described herein are generally directed to a biopsy device that includes a reusable assembly. The reusable assembly includes an outer housing and a plunger lock mechanism that is located in the outer housing. The plunger lock mechanism includes a actuation member that is accessible outside the outer housing that moves relative to the outer housing and includes a cam surface. A release flange is configured to move axially in the outer housing and includes a follower surface. A gripping finger is configured to move laterally with axial movement of the release flange. The cam and follower surfaces are configured to cooperate such that movement of the actuation member relative to the outer housing moves the release flange axially toward the gripping finger. The release flange is configured to engage the gripping finger such that the gripping finger moves from a locked configuration engaged with a plunger of a syringe with axial movement of the release flange away from the gripping finger to an unlocked configured disengaged with the plunger of the syringe with axial movement of the release flange toward the gripping finger.

[0027] As used herein, the terms “distal” and “proximal” are with respect to a person using the biopsy device. In particular, the term “distal” is farther from the user and the term “proximal” is nearer to the user. Further, the term “axial direction” or “longitudinal direction” are used interchangeably to refer to the elongated direction of the biopsy device parallel to a biopsy needle and the term “lateral direction” is the direction transverse to the longitudinal direction.

[0028] Referring to FIGS. 1 and 2, a biopsy device 10 includes a disposable assembly 12 and a reusable assembly 14. By “disposable,” it is meant that the assembly 12 is intended for only a single use after which it is disposed of as waste. By “reusable,” it is meant that the assembly 14 is intended for multiple uses with multiple ones of the disposable assemblies 12, one after the other for multiple fine needle aspiration biopsy (FNAB) procedures. As can be seen in FIG. 1, the disposable assembly 12 is configured to interlock with the reusable assembly 14 to form an assembled biopsy device 10.

[0029] Referring to particularly to FIGS. 2 and 3, the disposable assembly 12 includes a head shell 16, a syringe sleeve 18 and a syringe 20, which may be any suitable medical syringe that includes a barrel 22, a plunger 24 and a fine needle 26 suitable for FNAB (e.g., 22-gauge or smaller). The head shell 16 may be generally frustoconical in shape and includes a larger proximal end 28 and a distal end 30 that can be smaller in diameter than the proximal end 28. The proximal end 28 may be larger in diameter to facilitate insertion of the barrel 22 into an opening 32 through the head shell 16. The distal end 30 may be smaller in diameter to engage a perimeter 34 of the barrel 22 and inhibit its side-to-side or transverse movement within the opening 32.

[0030] Referring to FIG. 3, the syringe sleeve 18 includes a proximal interlock portion 36 and a distal barrel engaging portion 38 that extends outward from the proximal interlock portion 36. The proximal interlock portion 36 includes interlock arms 40 and 42 that extend proximally from a hub 43 and serve as male connectors that can be inserted into a rotation socket 44 of the reusable assembly 14 (FIG. 4) that serves as a female connector. The interlock arms 40 and 42 may include beveled sides 48 that extend at oblique angles to one another forming a hex-type connector that interlock with corresponding beveled sides 50 of the rotation socket 44 (FIG. 4) in order to force rotation of the disposable assembly 12, as will be described in greater detail below. The syringe sleeve 18 further includes stabilization arms 52 that extend outward from the hub 43 in the transverse direction. The stabilization arms 52 can have a length to engage an inner surface 54 around the opening 32 at the proximal end 28. The stabilization arms 52 can also limit side-to- side movement of the barrel 22 in the opening 32. The distal barrel engaging portion 38 includes engagement arms 56 that extend distally from the hub 43 and are shaped to engage around portions of the barrel 22. This engagement between the engagement arms 56 and barrel 22 may provide a friction fit arrangement, however, other engagement arrangements are possible, such as an interlocking engagement.

[0031] Referring to FIGS. 1, 2 and 4, the reusable assembly 14 includes an outer housing 60 that is connected to a motor housing 62. The motor housing 62 is, in turn, connected to an electrical connector that provides electrical power from a power source to a motor 64 (FIG. 5). Actuation members 66 in the form of slide buttons may be provided at opposite sides of the outer housing 60. While two actuation members 66 are shown, there may be less or more than two actuation members 66. The actuation members 66 slide within tracks 68 that allow for axial movement of the actuation members 66 relative to the outer housing 60. Each actuation member 66 carries another actuation member 70 that may be in the form of push buttons. The actuationmembers 70 are provided in openings 72 through the actuation members 66 that allow for transverse movement of the actuation members 70 relative to the actuation members 66 and the outer housing 60. A trigger 74 is pivotally connected to the outer housing 60. The trigger 74 includes a distal depress portion 76 on one side of a pivot location and a proximal lock portion 78 on the other side of the pivot location. The lock portion 78 may include a locking hook 80 that can engage a mating interlock location 82 provided on the actuation member 66. The trigger 74 may be spring biased toward an interlocked configuration shown in FIGS. 1, 2 and 4 such that the locking hook 80 can remain engaged with the interlock location 82 of the actuation member 66 until the depress portion 76 is pressed down thereby releasing the locking hook 80 from the interlock location 82 and allowing the actuation members 66 to slide proximally relative to the outer housing 60.

[0032] Referring now to FIG. 5, a detail view of a portion of the biopsy device 10 is illustrated with the outer housing 60 and motor housing 62 removed to illustrate internal components of a core mechanism 90 of the biopsy device 10. The core mechanism 90 generally includes a plunger lock mechanism 92, a sliding mechanism 94 and a rotation mechanism 96.

[0033] The plunger lock mechanism 92 may be a cam linkage structure that is controlled by the actuation members 70. The plunger lock mechanism 92 includes a flange assembly 100 including a plunger lock device 102, a base flange 104 and a release flange 106. The plunger lock device 102 includes a slidable plunger 108 (FIG. 9) that moves in the longitudinal direction relative to the base flange 104 and the release flange 106 and includes an engaging head 110 that engages the plunger 24 of the syringe 20 and opposing gripping fingers 112 and 114, each having a gripping flange 116 that engage around an edge of the plunger of the syringe in a locked configuration.

[0034] FIG. 6 illustrates the gripping fingers 112 and 114 in an open configuration with the gripping fingers 112 and 114 farther apart in the transverse direction to release the plunger 24 and FIG. 7 illustrates the gripping fingers 112 and 114 in the locked configuration with the gripping fingers 112 and 114 closer together in the transverse direction to interlock with the plunger 24. A biasing member 118, such as a spring, is used to bias the gripping fingers 112 and 114 toward the locked configuration.

[0035] Referring to FIGS. 5-7 and also FIG. 8 showing a detail view of the plunger lock mechanism 92 and FIG. 9 showing a schematic section view of the flange assembly 100, the baseflange 104 interlocks with the actuation members 66 to slide with the actuation members 66 as they are moved axially. In the illustrated example, the base flange 104 is received within notches 120 that are provided in the actuation members 66 to interlock therewith (FIG. 8). When the actuation members 66 are moved axially, the base flange 104 provides a connection hub that causes the plunger lock device 102 and release flange 106 to move axially therewith, which, when in use, causes the plunger 24 of the syringe 20 to also move axially.

[0036] The release flange 106 includes a follower surface 122 that is beveled between distal and proximal surfaces 124 and 126. The actuation members 70 include cooperating cam surfaces 128 (FIG. 8) that are beveled between distal and proximal surfaces 130 and 132. Moving the actuation members 70 in the transverse direction, as represented by arrows 134 in FIGS. 8 and 9 cause the follower and cam surfaces 122 and 128 to engage, which creates an axial force, represented by arrow 136, on the release flange 106. The release flange 106 can move axially relative to the gripping fingers 112 and 114 and axial movement of the release flange 106 distally relative to the gripping fingers 112 and 114 causes a release wedge 140 as a cam element on a face 115 of the release flange 106 to wedge between the gripping fingers 112 and 114 and force the gripping fingers 112 and 114 apart by overcoming the bias provided by the biasing member 118. Forcing the gripping fingers 112 and 114 apart moves the gripping fingers 112 and 114 to the unlocked configuration and releases the plunger 111. When the actuation members 70 are released, the biasing member 118 forces the gripping fingers 112 and 114 closer together toward the locked configuration and moves the release flange 106 proximally.

[0037] Referring to FIGS. 5, 10 and 11, the sliding mechanism 94 is connected to the plunger lock mechanism 92 so that the plunger lock mechanism 92 can slide axially along the sliding mechanism 94. The sliding mechanism 94 includes the actuation members 66 that slide along the tracks 68 (FIG. 1) as discussed above. The actuation members 66 include the notches 120 that receive an edge of the base flange 104 to interlock sliding movement of the actuation members 66 and the base flange 104 and, in turn, the plunger lock mechanism 92 together. The plunger lock mechanism 92 is slidably supported by a stand assembly 144 that may include support rods 146. In the illustrated example, two support rods 146 are shown, but there may be any suitable number of support rods, such as one, three, four support rods, etc. The actuation members 66 including sliding members 150 (FIG. 11) that slide along the support rods 146. The slide members 150 may include, for example, linear bearings that facilitate sliding movement of the actuation members 66 along the support rods 146.

[0038] Another biasing member 152 (e.g., a spring) is connected to the plunger 108 of the plunger lock mechanism 92. For example, the plunger 108 may include a plunger rod 154 having a hook 156 located at a proximal end (see also FIG. 9) that receives a loop 158 at a distal end of the biasing member 152. The biasing member 152 can apply a biasing force to the plunger lock mechanism 92 and actuation members 66 interlocked therewith to bias the plunger lock mechanism 92 from an extended configuration, as shown by FIG. 11 toward a retracted configuration, as shown by FIG. 10. Movement of the plunger lock mechanism 92 toward the retracted configuration moves the plunger 24 of the syringe 20 proximally in the barrel 22 (FIG. 2) thereby generating a negative pressure therein such that a suction is generated through the fine needle 26 (FIG. 1) suitable for FNAB.

[0039] The biopsy device 10 may further include the trigger 74 that can be used to releasably lock the actuation members 66 and the plunger lock mechanism 92 interlocked therewith in the extended configuration shown by FIG. 11. The trigger 74 includes the distal depress portion 76 on one side of the pivot location 160 and the proximal lock portion 78 on the other side of the pivot location. The lock portion 78 may include the locking hook 80 that can engage the mating interlock location 82 provided on the actuation member 66. The trigger 74 may be spring biased about the pivot location 160 toward the interlocked configuration shown in FIG. 11 such that the locking hook 80 can remain engaged with the interlock location 82 of the actuation member 66 until the depress portion 76 is pressed down. Pressing down on the depress portion 76 releases the locking hook 80 from the interlock location 82 and allows the actuation members 66 to slide proximally relative to the outer housing 60 due to the bias provided by the biasing member 152. Further, a motor actuation member 162 may also be provided beneath the depress portion 76. Pressing down on the depress portion 76 may also actuate the motor actuation member 162, which can activate the motor 64 operably connected to the stand assembly 144.

[0040] Referring particularly to FIG. 12, the rotation mechanism 96 also utilizes the stand assembly 144 which includes the rotation socket 44 fixed to a distal end of the support rods 146 and a rotation stand 164 fixed to a proximal end of the support rods 146. The rotation stand 164 includes longitudinally-extending legs 166, each connecting to a respective one of the support rods 146 and a hub portion 168 that extends between the legs 166 connecting the legs 166 and the support rods 146 in the lateral direction. Referring also to FIG. 13, a connecting shaft 170 extends through the hub portion 168 and is fixedly mounted thereto. The connecting shaft 170 is configured to connect the stand assembly 144 to the motor 64, which can then rotate the standassembly 144 and the plunger lock mechanism 92. This rotation of the stand assembly 144, including the rotation socket 44 which is connected to the syringe sleeve 18, and the plunger lock mechanism 92 can cause the syringe 20 (FIG. 1) to rotate for FNAB as represented by arrows 172, 174 and 176 of FIG. 13. The rotation can be clockwise, counterclockwise, or combined, depending on clinical needs, which can be achieved by a controller, such as provided by a printed circuit board (PCB) that is operably connected to or part of the motor 64.

[0041] FIGS. 14-18 illustrate operation of the biopsy device 10 including the plunger lock mechanism, sliding mechanism 94 and rotation mechanism 96. Referring first to FIG. 14, at step 200, the actuation members 66 are slid distally to the extended configuration until the trigger 74 automatically interlocks with the interlock location 82 of the actuation member 66 using the locking hook 80 and the bias provided at the pivot location. As discussed above, in the extended configuration, the biasing member 152 is extended thereby providing increase potential energy for retracting the plunger 24 of the syringe 20 (FIG. 15).

[0042] Referring to FIG. 15, with the syringe 20 in the head shell 16 and the syringe sleeve 18 around the barrel 22, the plunger 24 is inserted into the rotation socket 44 and the syringe sleeve 18 is interlocked with the rotation socket 44 at step 202. In some embodiments, the syringe 20 and syringe sleeve 18 may be inserted into the rotation socket 44 first and then the head shell 16 may be slid over the syringe 20 and interlocked with the outer housing 60 using interlocking elements 204 at step 206 of FIG. 16.

[0043] Referring to FIG. 17, a needle tip 208 of the needle 26 is inserted into the biopsy target location 210 at step 212. The depress portion 76 of the trigger 74 is pressed, represented by arrow 214, which releases the lock portion 78 from the interlock location 82 and allows the tension in the biasing member 152 to pull back the plunger 24 of the syringe 20, represented by arrow 216, and generate a suction in the syringe 20. Meanwhile continued pressure on the trigger 74 actuates the motor actuation member 162, which activates the motor 64 for the rotation function, as represented by arrow 218.

[0044] Referring to FIG. 18, once the sample is collected, the actuation members 70 can be pressed down, represented by arrow 220, to place the plunger lock mechanism 92 in the unlock configuration and unlock the plunger 24. Unlocking the plunger 24 can allow the plunger 24 to move and release extra suction at step 222. The needle 26 can be removed from the target location and the plunger 24 can be pushed to the front end of the barrel 22 using the actuation member 66to collect the sample in a sample container. The head shell 16 can be disassembled from the outer housing 60 and the syringe sleeve 18 can be removed from the rotation socket 44. The head shell 16, syringe 20 and syringe sleeve 18 can be disposed as the disposable assembly 12 and the reusable assembly 14 can be stored for next use.

[0045] The above-described biopsy devices are semi-automated with electric power-driven equipment providing functions to improve sampling efficiency and quality. The biopsy devices can apply a suction during FNAB and rotate the needle during the FNAB. The biopsy devices combine disposable and reusable assemblies for cost-efficiency and infection control purposes. The disposable part includes a syringe assembled with a syringe sleeve and covered with a head shell. The syringe assembly can be a medical syringe or a customized syringe for FNAB. The syringe sleeve is locked on the syringe barrel as an adapter and may have a selected shape, such as a hexagon or cross, for orientation and to transfer the rotational force. The head shell is for syringe fixturing, assembling and hand-holding purposes. The reusable part is the core structure for functions and control and includes a plunger lock mechanism where the syringe plunger can be inserted and locked when rotating.

[0046] Embodiments can be described with reference to the following numbered clauses, with certain features laid out in the dependent clauses:

[0047] Clause 1 : A biopsy device comprising: a reusable assembly comprising: an outer housing; a plunger lock mechanism located in the outer housing, the plunger lock mechanism comprising: an actuation member accessible outside the outer housing that moves relative to the outer housing and comprising a cam surface; a release flange configured to move axially in the outer housing and comprising a follower surface; and a gripping finger configured to move laterally with axial movement of the release flange; the cam and follower surfaces are configured to cooperate such that movement of the actuation member relative to the outer housing moves the release flange axially relative to the gripping finger, the release flange configured to move the gripping finger from a locked configuration engaged with a plunger of a syringe with axial movement of the release flange away from the gripping finger to an unlocked configuration disengaged with the plunger of the syringe with axial movement of the release flange toward the gripping finger.

[0048] Clause 2: The biopsy device of clause 1, wherein the gripping finger is a first gripping finger, the reusable assembly further comprising a second gripping finger that opposes the firstgripping finger, the second gripping finger configured to move laterally with axial movement of the release flange.

[0049] Clause 3: The biopsy device of clause 2 further comprising a biasing member operatively connected to the first and second gripping fingers, the biasing member biasing the first and second gripping fingers toward the locked configuration.

[0050] Clause 4: The biopsy device of clause 3, wherein the release flange comprises a face that faces distally, the release flange comprising a cam element on the face, the cam element comprising ramp surfaces that are configured to engage the first and second gripping fingers such that the first and second gripping fingers move from the locked configuration to the unlocked configuration with axial movement of the release flange toward the first and second gripping fingers.

[0051] Clause 5: The biopsy device of claim 4, wherein the biasing member is configured to bias the first and second gripping members toward the locked configuration and the actuation member toward an initial position.

[0052] Clause 6: The biopsy device of any of clauses 1-5, wherein the actuation member comprises a button that moves laterally relative to the outer housing and comprising the cam surface.

[0053] Clause 7: The biopsy device of clause 6, wherein the actuation member is a first actuation member, the biopsy device further comprising a second actuation member of a sliding mechanism that is configured to move axially relative to the outer housing with the gripping finger in the locked configuration, the second actuation member operably connected to the second actuation member to move axially therewith.

[0054] Clause 8: The biopsy device of clause 7, wherein the second actuation member comprises the button such that the button moves axially with the second actuation member.

[0055] Clause 9: The biopsy device of clause 7 or 8 further comprising a biasing member operatively connected to the release flange, the biasing member configured to bias the release flange proximally toward a retracted configuration.

[0056] Clause 10: The biopsy device of any of clauses 7-9, wherein the sliding mechanism comprises: the second actuation member; and a third actuation member accessible outside theouter housing and operatively connected to the gripping finger, the third actuation member configured to move axially relative to the outer housing with the gripping finger in the locked configuration.

[0057] Clause 11 : The biopsy device of clause 10, wherein the button is a first button that is carried by the second actuation member, the biopsy device further comprising a second button accessible outside the outer housing that moves relative to the outer housing and comprising another cam surface, wherein the another cam surface and the follower surface are configured to cooperate such that movement of the second button relative to the outer housing moves the release flange axially toward the gripping finger.

[0058] Clause 12: The biopsy device of any of clauses 1-11, wherein the reusable assembly comprises a stand assembly that extends axially through the outer housing and is operatively connected to the release flange, the stand assembly comprising: a rotation stand comprising a connecting shaft that extends axially from the rotation stand and is configured to operatively connect to a motor; a support rod that extends axially from the rotation stand and through the release flange; and a rotation socket connected to the support rod; wherein the support rod and rotation socket rotate with the rotation stand relative to the outer housing due to activation of the motor.

[0059] Clause 13: The biopsy device of clause 12 further comprising a disposable assembly comprising a syringe sleeve that interlocks with the rotation socket.

[0060] Clause 14: The biopsy device of clause 13 further comprising a head shell that receives the syringe sleeve and connects to the outer housing with the syringe sleeve interlocked with the rotation socket.

[0061] Clause 15: A method of operating a biopsy device, the method comprising: inserting a plunger of a syringe into a plunger lock mechanism of the biopsy device, wherein the plunger lock mechanism comprises a gripping finger that moves laterally to interlock with and release the plunger; and retracting the plunger with the plunger lock mechanism interlocked with the plunger by sliding an actuation member relative to an outer housing of the biopsy device.

[0062] Clause 16. The method of clause 15 further comprising inserting a barrel of the syringe into a syringe sleeve.

[0063] Clause 17: The method of clause 16 further comprising inserting the plunger and syringe sleeve into a rotation socket, the syringe sleeve configured to interlock with the rotation socket.

[0064] Clause 18: The method of any of clauses 15-17 further comprising rotating the syringe using a motor operatively coupled to the syringe.

[0065] Clause 19: The method of any of clauses 15-18, wherein the actuation member is a first actuation member, the method further comprising releasing the plunger from the plunger lock mechanism by actuating a second actuation member

[0066] Clause 20: The method of clause 19, wherein the first actuation member carrying the second actuation during sliding the first actuation member relative to the outer housing.

[0067] It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments described herein without departing from the spirit and scope of the claimed subject matter. Thus it is intended that the specification cover the modifications and variations of the various embodiments described herein provided such modification and variations come within the scope of the appended claims and their equivalents.

Claims

CLAIMS1. A biopsy device comprising: a reusable assembly comprising: an outer housing; a plunger lock mechanism located in the outer housing, the plunger lock mechanism comprising: an actuation member accessible outside the outer housing that moves relative to the outer housing and comprising a cam surface; a release flange configured to move axially in the outer housing and comprising a follower surface; and a gripping finger configured to move laterally with axial movement of the release flange; wherein the cam and follower surfaces are configured to cooperate such that movement of the actuation member relative to the outer housing moves the release flange axially relative to the gripping finger, the release flange configured to move the gripping finger from a locked configuration engaged with a plunger of a syringe with axial movement of the release flange away from the gripping finger to an unlocked configuration disengaged with the plunger of the syringe with axial movement of the release flange toward the gripping finger.

2. The biopsy device of claim 1, wherein the gripping finger is a first gripping finger, the reusable assembly further comprising a second gripping finger that opposes the first gripping finger, the second gripping finger configured to move laterally with axial movement of the release flange.

3. The biopsy device of claim 2 further comprising a biasing member operatively connected to the first and second gripping fingers, the biasing member biasing the first and second gripping fingers toward the locked configuration.

4. The biopsy device of claim 3, wherein the release flange comprises a face that faces distally, the release flange comprising a cam element on the face, the cam element comprising ramp surfaces that are configured to engage the first and second gripping fingers such that the first and second gripping fingers move from the locked configuration to the unlocked configuration with axial movement of the release flange toward the first and second gripping fingers.

5. The biopsy device of claim 4, wherein the biasing member is configured to bias the first and second gripping members toward the locked configuration and the actuation member toward an initial position.

6. The biopsy device of claim 1, wherein the actuation member comprises a button that moves laterally relative to the outer housing and comprising the cam surface.

7. The biopsy device of claim 6, wherein the actuation member is a first actuation member, the biopsy device further comprising a second actuation member of a sliding mechanism that is configured to move axially relative to the outer housing with the gripping finger in the locked configuration, the second actuation member operably connected to the second actuation member to move axially therewith.

8. The biopsy device of claim 7, wherein the second actuation member comprises the button such that the button moves axially with the second actuation member.

9. The biopsy device of claim 7 further comprising a biasing member operatively connected to the release flange, the biasing member configured to bias the release flange proximally toward a retracted configuration.

10. The biopsy device of claim 7, wherein the sliding mechanism comprises: the second actuation member; and a third actuation member accessible outside the outer housing and operatively connected to the gripping finger, the third actuation member configured to move axially relative to the outer housing with the gripping finger in the locked configuration.

11. The biopsy device of claim 10, wherein the button is a first button that is carried by the second actuation member, the biopsy device further comprising a second button accessible outside the outer housing that moves relative to the outer housing and comprising another cam surface, wherein the another cam surface and the follower surface are configured to cooperate such that movement of the second button relative to the outer housing moves the release flange axially toward the gripping finger.

12. The biopsy device of claim 1, wherein the reusable assembly comprises a stand assembly that extends axially through the outer housing and is operatively connected to the release flange, the stand assembly comprising: a rotation stand comprising a connecting shaft that extends axially from the rotation stand and is configured to operatively connect to a motor; a support rod that extends axially from the rotation stand and through the release flange; and a rotation socket connected to the support rod; wherein the support rod and rotation socket rotate with the rotation stand relative to the outer housing due to activation of the motor.

13. The biopsy device of claim 12 further comprising a disposable assembly comprising a syringe sleeve that interlocks with the rotation socket.

14. The biopsy device of claim 13 further comprising a head shell that receives the syringe sleeve and connects to the outer housing with the syringe sleeve interlocked with the rotation socket.

15. A method of operating a biopsy device, the method comprising: inserting a plunger of a syringe into a plunger lock mechanism of the biopsy device, wherein the plunger lock mechanism comprises a gripping finger that moves laterally to interlock with and release the plunger; and retracting the plunger with the plunger lock mechanism interlocked with the plunger by sliding an actuation member relative to an outer housing of the biopsy device.

16. The method of claim 15 further comprising inserting a barrel of the syringe into a syringe sleeve.

17. The method of claim 16 further comprising inserting the plunger and syringe sleeve into a rotation socket, the syringe sleeve configured to interlock with the rotation socket.

18. The method of claim 15 further comprising rotating the syringe using a motor operatively coupled to the syringe.

19. The method of claim 15, wherein the actuation member is a first actuation member, the method further comprising releasing the plunger from the plunger lock mechanism by actuating a second actuation member.

20. The method of claim 19, wherein the first actuation member carrying the second actuation during sliding the first actuation member relative to the outer housing.

Citation Information

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