EP4680123A1

EP4680123A1 - Biopsy devices and methods of performing a biopsy using the same

Info

Publication number: EP4680123A1
Application number: EP23714200.5A
Authority: EP
Inventors: Brian C. BOYLE; Koltin GLASPIE
Original assignee: Bard Peripheral Vascular Inc
Current assignee: Bard Peripheral Vascular Inc
Priority date: 2023-03-13
Filing date: 2023-03-13
Publication date: 2026-01-21
Also published as: CN120957667A; WO2024191454A1; JP2026509881A

Abstract

A biopsy probe assembly includes a sample notch cannula having a distal end and a proximal end and a cutting cannula having a sharpened edge on a distal end and located within the sample notch cannula. A cutter gear-spindle set drives the cutting cannula between an open position and a closed position, and a cutting nut receives the cutter gear-spindle set. A vacuum assembly is connected to the cutting cannula and fluidly coupled to the sample notch cannula. A vent housing connects the proximal end of the sample notch cannula to the vacuum assembly, and a sample basket is fluidly coupled to the cutting cannula. The vent housing further includes a plurality of channels that define a fluid pathway through the plurality of channels between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

Description

BIOPSY DEVICES AND METHODS OF PERFORMING A BIOPSY USING THE SAME

TECHNICAL FIELD

[0001] The present disclosure relates to biopsy devices, and, more particularly, to a single insertion vacuum-assisted biopsy device.

BACKGROUND

[0002] A biopsy may be performed on a subject to obtain tissue for study (e.g., study tissue to determine whether the tissue includes cancerous cells). One biopsy technique used to evaluate breast tissue, for example, involves inserting a biopsy probe into the breast tissue region of interest to capture one or more tissue samples from the region. Such a biopsy technique often utilizes a vacuum to pull the tissue to be sampled into a sample notch of the biopsy probe, after which the tissue is severed and collected. Efforts continue in the art to improve the ability of the biopsy device to sever a tissue sample, to transport the severed tissue sample to a sample basket, and to collect a plurality of samples.

SUMMARY

[0003] An object of the present disclosure is to provide a biopsy device that has the ability to promote effective severing of a tissue sample and effective transport of the tissue sample to a sample basket.

[0004] According to one aspect, a biopsy device is disclosed. The biopsy device includes a sample notch cannula having a distal end and a proximal end, with the distal end including a beveled edge. A cutting cannula having a sharpened edge on a distal end is internally located within the sample notch cannula. A cutter gear-spindle set drives the cutting cannula between an open position and a closed position, and a cutting nut receives the cutter gear-spindle when the cutting cannula is in the open position. A vacuum assembly is connected to the cutting cannula and fluidly coupled to the sample notch cannula generates a vacuum in the sample notch cannula when the cutting cannula is in the open position. A vent housing connects the proximal end of the sample notch cannula to the vacuum assembly, and a sample basket is fluidly coupled to the cutting cannula. The vent housing further includes a plurality of channels that define a fluid pathway through the plurality of channels between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0005] In another embodiment, a biopsy probe assembly is disclosed. The biopsy assembly includes a vacuum assembly and a probe having a sample notch cannula and a cutting cannula, the cutting cannula being internally located within the sample notch cannula and capable of moving between an open position, wherein the sample notch cannula is open to an external environment, and a closed position, wherein the cutting cannula extends across an opening of the sample notch cannula. A vent housing connects the probe to the vacuum assembly, the vacuum assembly being fluidly coupled to the sample notch cannula to generate a vacuum in the sample notch cannula when the cutting cannula is in the open position. The vent housing defines a plurality of channels allowing the vacuum assembly to draw fluid in a space between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0006] In yet another embodiment, a method of performing a biopsy is disclosed. The method involves inserting a biopsy device having a probe comprising a sample notch cannula, a cutting cannula, a cutter gear-spindle, and a cutting nut into a tissue sample, wherein the cutting cannula is located internally to the sample notch cannula and the cutter gear-spindle is coupled to the cutting cannula. The method further involves moving the cutting cannula into an open position by threading the cutter gear-spindle into the cutting nut to expose the sample notch cannula, and creating a vacuum using the vacuum assembly located on a proximal end of the probe to draw the tissue sample into the sample notch cannula. Once the tissue sample is drawn into the sample notch cannula, the method includes moving the cutting cannula into a closed position by threading the cutter gear-spindle out of the cutting nut to close the cutting cannula and cut the tissue sample drawn into the sample notch cannula. The method then involves ventilating a space between the cutting cannula and the sample notch cannula, such that the vacuum can transport the tissue sample into a sample basket located on a proximal end of the probe while the cutting cannula is in the closed position.

[0007] 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

[0008] 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:

[0009] FIG. 1 is a front-side view of an illustrative biopsy device with a driver assembly attached to a probe assembly, according to one or more embodiments described herein;

[0010] FIG. 2 is a bottom-side view of the driver assembly of FIG. 1, according to one or more embodiments described herein;

[0011] FIG. 3 A is a perspective view of the probe assembly within a housing of the biopsy device of FIG. 1, according to one or more embodiments described herein;

[0012] FIG. 3B is a cross-sectional view of FIG. 3A, according to one or more embodiments described herein;

[0013] FIG. 4 is a cross-sectional view of the probe assembly of FIG. 1, according to one or more embodiments described herein;

[0014] FIG. 5 is a front-side cross sectional view of the probe assembly of the biopsy device of FIG. 1 along line 5-5, according to one or more embodiments described herein;

[0015] FIG. 6A is a partial cross-sectional view of an illustrative cutting cannula of the probe assembly of the biopsy device of FIG. 1 in an open position, according to one or more embodiments described herein;

[0016] FIG. 6B is a partial cross-sectional view of the cutting cannula of the probe of the biopsy device of FIG. 1 in a closed position, according to one or more embodiments described herein; and

[0017] FIG. 7 depicts a flow diagram of an illustrative method of performing a biopsy, according to one or more embodiments described herein.

[0018] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment of the present disclosure, and such exemplifications are not to be construed as limiting the scope of the present disclosure in any manner.

DETAILED DESCRIPTION

[0019] Embodiments disclosed herein relate to biopsy devices and methods of performing biopsy procedures. For example, in embodiments, a biopsy device includes a driver assembly, a probe assembly, and a vacuum assembly. The driver assembly may include a cutter module, a rotation module, and a piercing module. The driver assembly may be operably connected to the probe assembly, which may include a sample notch cannula, a cutting cannula, a cutter gearspindle set, a cutting nut, a sample notch gear, a vent housing, a seal, a probe housing, and a sample basket. The vacuum assembly may be operably connected to a proximal end of the probe assembly, such that tissue samples acquired by the probe assembly may be transported to the sample basket with the assistance of vacuum generated by the vacuum assembly. The cutter gearspindle set may provide simultaneous rotational and linear movement of the cutting cannula, which may alleviate the need for multiple motors and/or valves to operate the cutting cannula and perform a tissue cutting sequence.

[0020] The vent housing may further include a plurality of channels, which may allow for the vacuum generated by the vacuum assembly to operate in a space between the sample notch cannula and the cutting cannula when the cutting cannula is in a closed (e.g., forward) position. By allowing the vacuum to flow through the plurality of channels, the vacuum may act to transport a tissue sample through the cutting cannula and into the sample basket. When the cutting cannula is in an open (e.g., retracted) position, the seal may act to seal the cutting cannula to the vent housing, such that the vacuum generated by the vacuum assembly may draw a tissue sample into the sample notch cannula. In these embodiments, the seal may be operably coupled to the cutter gear-spindle, such that movement of the cutter gear-spindle in the longitudinal direction translates to similar longitudinal movement of the seal. By moving the seal along with the cutter gearspindle, fluid flow from the vacuum assembly may travel through the plurality of channels and around the seal when the cutting cannula is in the closed position, while the seal may force air flow through the cutting cannula when the cutting cannula is in the open position.

[0021] Notably, traditional sealing mechanisms may require spring-loaded operation, which can complicate operation of the biopsy device. By integrating the seal into the cutter gearspindle set, and providing a plurality of channels on the vent housing, the rotational and linear movement of the cutter gear-spindle set may simultaneously act to translate the seal between a sealing position and a venting position. The translation of the seal via the cutter gear-spindle set may further alleviate the need for additional motors and/or valves which are commonly utilized in biopsy devices to obtain tissue samples.

[0022] Referring now to the drawings, and more particularly to FIG. 1, there is shown a vacuum assisted biopsy device 10 including a biopsy probe assembly which may generally include a non-invasive biopsy driver assembly 100 and an invasive probe assembly 200. As used herein, the term “non-invasive” is used to refer to a device that is not inserted into the body of a subject. As a result, non-invasive devices may be further considered non-disposable devices that are intended for use on multiple subjects during the lifetime of the device. In contrast, the term “invasive” is used to refer to a device that is inserted into the body of a patient. Invasive devices may further be considered “disposable,” as these devices are intended to be disposed of after use on a single subject. The biopsy driver assembly 100 may be releasably attached to the probe assembly 200. As used herein, the term “releasably attached” means a configuration that facilitates an intended temporary connection followed by selective detachment involving a manipulation of disposable probe assembly 200 relative to biopsy driver assembly 100, without the need for tools. As further illustrated in FIG. 1, the biopsy device 10 may also include a vacuum assembly 300, which may be releasably coupled to the disposable probe assembly 200.

[0023] Referring now to FIG. 2, an underside (or coupling side) of the biopsy driver assembly 100 is generally depicted. The biopsy driver assembly 100 may include a driver housing 110 and a plurality of modules (e.g., structures, gears, motors, etc.) for mechanically driving one or more functions of the biopsy device 10. For example, the biopsy driver assembly 100 may include, for example, a cutter module 122, a rotation module 124, and a piercing module 126. The cutter module 122 may include an electrical motor 122a having a shaft to which a drive gear 122b is attached. In these embodiments, the drive gear 122b may be attached to the shaft via any suitable connection, such that rotation of the shaft results in rotation of the drive gear 122b. The rotation module 124 includes an electrical motor 124a having a shaft to which a drive gear 124b is attached. Piercing module 126 may include an electrical motor 126a, a drive spindle 126b, and a piercing drive 126c. Each electrical motor 122a, 124a, 126a may be, for example, a direct current (DC) motor or stepper motor. As an alternative, to the arrangement described above, each of the cutter module 122, rotation module 124, and piercing module 126 may include one or more of a gear, gear train, belt/pulley arrangement, etc., interposed between the respective motor and drive gear or drive spindle. Furthermore, although the cutter module 122, the rotation module 124 and the piercing module 126 are depicted as being electromechanically driven, it should be further understood that, in some embodiments, the cutter module 122, the rotation module 124 and the piercing module 126 may be manually actuated. As depicted, in embodiments, openings may be formed within the driver housing 110 to allow for coupling to the probe assembly 200.

[0024] Referring still to FIG. 2, the piercing module 126, when assembled to the probe assembly 200, is operable to pull one or more components of the probe assembly 200 in a proximal (-x) direction and fire the probe assembly 200 into a tissue site. For example, the piercing drive 126c may engage one or more portions of the biopsy probe assembly 200 connected to the sample notch cannula, to retract and drive forward the sample notch cannula. The piercing drive 126c, accordingly, may be any structure which may extend into and engage one or more portions of the biopsy probe assembly for retracting and firing the sample notch cannula. For example, the piercing drive 126c may include one or more projections 126d (e.g., forks), which are configured to extend into the biopsy probe assembly 200 to the operably engaged sample notch cannula. The operation of the piercing module 126 will be described in additional detail herein.

[0025] Turning now to FIG. 3, a perspective view of the probe assembly 200 is illustrated. In these embodiments, the probe assembly 200 may include a probe housing 210, the sample notch cannula 220, a sample notch gear 222, a cutting cannula 230, a cutter gear-spindle set 232 for rotary and linear cutter translation, a cutting nut 233, a seal 234 (see FIG. 4), a vent housing 236 and a vent cap 240. In the embodiments described herein, rotational movement of the cutter gearspindle 232 may result in longitudinal movement of the cutting cannula 230 in a proximal or distal direction, as will be described in greater detail herein.

[0026] Referring now to FIGS. 2 and 3 A, in embodiments where the probe housing 210 is provided, the probe housing 210 may be formed as an elongate member 212 having a front plate 214. The elongate member 212 may further comprise a plurality of retaining clips 212a, which may be configured to engage with a plurality of openings in the driver housing. When the probe assembly 200 is attached to biopsy driver assembly 100, the driver assembly 100 may be initially positioned above the probe assembly 200 such that a front surface of the biopsy driver assembly 100 is aligned with the front plate 214 of the probe assembly 200. Once the biopsy driver assembly 100 is appropriately positioned, the front surface of the biopsy driver assembly 100 may be lowered such that the surface comes into contact with the probe assembly 200. As the biopsy driver assembly 100 is lowered, the plurality of openings of the biopsy driver assembly 100 may engage the plurality of retaining clips 212a of the probe assembly 200 to lock the biopsy driver assembly 100 to the probe assembly 200.

[0027] Referring now to FIG. 3A and 3B, the sample notch cannula 220 may include a proximal end 220b and distal end 220a. In these embodiments, the distal end 220a may include a sample notch 224. Attached to distal end 220a may be piercing tip 226, which may form part of the sample notch cannula 220. It should be noted that in some embodiments, the piercing tip 226 may be integrated into the distal end 220a of the sample notch cannula 220. The sample notch 224 is formed as an elongate opening in a side wall 220c of the sample notch cannula 220 to facilitate reception of tissue into a lumen of the sample notch cannula 220. More specifically, when the sample notch cannula 220 is inserted into a target area, the sample notch 224 may receive tissue samples drawn into the sample notch cannula 224. The sample notch 224 may extend in a longitudinal direction along longitudinal axis L. In embodiments, the sample notch 224 may include cutting edges around the perimeter of the opening formed by the sample notch 224.

[0028] In some embodiments, the sample notch cannula 220 may be linearly translatable between an engaged position and a disengaged position via the piercing module 126. In an engaged position, rotation of the piercing module 126 causes the sample notch cannula and piercing drive 126c to be translated in unison in the proximal direction to position piercing drive 126c and sample notch cannula 220 in the ready, i.e., cocked (primed) position. The sample notch cannula 220 may then be released to effect a piercing shot, in which the piercing module 126 may rapidly propel the sample notch cannula 220 and piercing drive 126c in unison in the distal direction such that the sample notch cannula 220 pierces tissue within the subject. This firing of the sample notch cannula 220 may be particularly useful when biopsying dense tissue, specifically where manual or slow advancement of the sample notch cannula would be difficult due to variations in tissue type and density.

[0029] Referring still to FIGS. 3A and 3B, the sample notch cannula 220 may be rotated about its longitudinal axis L by activation of the rotation module 124, discussed above. For example, when the probe assembly 200 and the biopsy driver assembly 100 have been attached, drive gear 124b may engage the sample notch gear 222 such that rotation of the drive gear 124b in turn rotates the sample notch gear 222. In these embodiments, the sample notch cannula 220 may be rotated to a plurality of angular positions by sample notch gear 222 in order to allow the biopsy device 10 to obtain tissue from a plurality of target sites around sample notch cannula 220 without requiring the user to manually rotate the position of biopsy driver assembly 100. Turning now to FIGS. 3B and 4, cuting cannula 230 may be positioned coaxially within the sample notch cannula and may include a proximal end 230a and a distal end 230b. The distal end 230b may further include a sharpened edge for severing a tissue sample. The cutter gear-spindle set 232 may include a driven gear 232a, a cutting spindle 232b, and a non-threaded shoulder 232c. The cutting spindle 232b may be positioned on a proximal end of the cutter gear-spindle set 232, while the non-threaded shoulder 232c may be positioned on a distal end of the cutter gear-spindle set 232, whereas in other embodiments the components of the gear-spindle set 232 may be positioned in a different order along the length of the device. In these embodiments, the driven gear 232a may be positioned between the cutting spindle 232b and the non-threaded shoulder 232c, as is most clearly illustrated in FIG. 4. The cutter gear-spindle set 232 may be a unitary device having the driven gear 232a fixedly attached to the cutting spindle 232b and non-threaded shoulder 232c. In some embodiments, the cutter gear-spindle set 232 may be formed as a single molded component, while in other embodiments, the components may be formed separately.

[0030] The cutter gear-spindle set 232 may be fixedly attached (e.g., glued, welded, staked, etc.) to the proximal end 230a of the cutting cannula. In these embodiments, the cutting cannula 230 may be actuatable between an open position and a closed position by activation of cutter module 122 of biopsy driver assembly 100, with the drive gear 122b of the cutter module 122 engaging the driven gear 232a of the cutter gear-spindle set 232. To position the cutting cannula 230 in the open position, the drive gear 122b of the cutter module 122 may rotate the driven gear 232a of the cutter gear-spindle set 232 in a first direction such that the cutting spindle 232b is driven in the proximal direction into the cutting nut 233. To move the cutting cannula 230 to the closed position, the cutter module may rotate the driven gear 232a of the cutter gear-spindle set 232 in a second direction opposite the first direction, such that the cutting spindle 232b is driven in the distal direction and out of the cutting nut 233. Thus, cutting cannula 230 has a rotational cutting motion and is translated axially along the longitudinal axis L. In these embodiments, the pitch of the threads of cutting spindle 232b may determine the number of revolutions per axial distance that cutting cannula 230 moves axially.

[0031] Referring still to FIGS. 3B and 4, the probe assembly 200 may also include a vent housing 236. The vent housing 236 may have a first end 236a and a second end 236b, and may further define a passageway 237 which extends in the longitudinal direction from the first end 236a to the second end 236b of the vent housing 236. In these embodiments, the passageway 237 of the vent housing 236 may receive the non-threaded shoulder 232c of the cutter gear-spindle set 232. The vent cap 240 may be coupled to the second end 236b of the vent housing 236, such that the vent cap 240 encloses the passageway 237 and creates a fluid-tight seal between the sample notch cannula 220 and the vent housing 236. In these embodiments, the vent cap 240 may include a vent cap opening 241 through which the sample notch cannula 220 passes.

[0032] Referring now to FIGS. 4 and 5, the vent housing 236 may further include a plurality of channels 238 which may extend circumferentially around the passageway 237 of the vent housing 236. The plurality of channels 238 may have a length CL which extends in the longitudinal direction from the second end 236b of the vent housing 236 towards the first end 236a of the vent housing 236. As illustrated in FIG. 5, the vent housing 236 may include six channels 238, but it should be understood that the vent housing 236 may include any number of channels 238. Furthermore, FIG. 5 illustrates that the plurality of channels 238 may be spaced 60 degrees apart from one another in the circumferential direction. However, it should be understood that the plurality of channels 238 may include any circumferential spacing, having rotational symmetry or no rotational symmetry, so long as there are a plurality of channels 238. For example, in some embodiments the vent housing 236 may include twelve channels. In these embodiments, the twelve channels may be spaced 30 degrees apart from one another in the circumferential direction around the passageway 237.

[0033] Referring now to FIGS. 4 and 5, the sample notch cannula 220 and cutting cannula 230 may be coaxially arranged along the longitudinal axis L in a nested tube arrangement, with cutting cannula 230 being the innermost tube and sample notch cannula 220 being the outermost tube. The cutting cannula 230 may be coaxially arranged within the sample notch cannula 220 such that a fluid pathway 250 exists between the cutting cannula 230 and the sample notch cannula 220. The fluid pathway 250 may allow a fluid, such as air, saline, or anesthetics, to pass between the sample notch cannula 220 and the cutting cannula 230.

[0034] The fluid pathway 250 may be most clearly illustrated in FIG. 4. For ease of illustration, the fluid pathway 250 is depicted via a plurality of arrows. As demonstrated, the fluid pathway extends from atmospheric inlets 260 positioned on the proximal end 220b of the sample notch cannula 220, through passageways 237 and the plurality of channels 238, and into a space between the cutting cannula 230 and the sample notch cannula 220.

[0035] Referring again to FIGS. 4 and 5, the assembly may be configured to receive a seal 234, such as an O-ring, which may be used to control the passage of fluid through the fluid pathway 250. As illustrated in FIG. 4, the seal 234 may be disposed on the non-threaded shoulder 232c of the cutter gear-spindle set 232, such that the seal 234 extends into the plurality of channels 238 of the vent housing 236. Because the seal 234 is disposed on the non-threaded shoulder 232c of the cutter gear-spindle set 232, the seal 234 may move in the longitudinal direction (e.g., in the +/- x direction as shown in the coordinate axis of FIG. 4) along with the cutter gear-spindle set 232 when the cutter gear-spindle set 232 is actuated between the open position and the closed position, as described in greater detail herein below with respect to FIGS. 6A-6B.

[0036] Turning now to FIG. 6A, the cutting cannula 230 is illustrated in the open position. In the open position, the cutter gear-spindle set 232 may be fully retracted, such that cutting cannula 230 is retracted and the sample notch 224 of the sample notch cannula 220 is exposed. In this position, the seal 234 may contact the vent housing 236 such that the seal 234 obstructs the fluid pathway 250. In these embodiments, when the seal 234 contacts the vent housing 236, the seal 234 prevents fluid from passing between the passageway 237 and the plurality of channels 238. As a result, the seal 234 may block the fluid pathway 250 from atmosphere such that fluid is not able to traverse the fluid pathway 250 from atmosphere and between the passageway 237, the cutting cannula 230, and the sample notch cannula 220.

[0037] With the fluid pathway 250 obstructed by the seal 234, any fluid applied to the biopsy device 10 by the vacuum assembly 300 may be forced through the cutting cannula 230 and into the exposed sample notch 224 of the sample notch cannula 220, thereby creating negative pressure within the sample notch 224. In these embodiments, the negative pressure acting in the sample notch 224 when the cutting cannula 230 is in the open position may cause a tissue sample to be drawn into the sample notch 224 of the sample notch cannula 220.

[0038] Once the tissue sample has been obtained, the cutting cannula 230 may be actuated to the closed position, as illustrated in FIG. 6B. In the closed position, the cutter spindle-gear set 232 may be moved forward, such that the cutting cannula 230 may advance towards the sample notch 224 of the sample notch cannula 220. The cutting cannula 230 may continue to advance across the sample notch 224, such that the sharpened edge of the cutting cannula 230 severs the tissue sample drawn into the sample notch 224.

[0039] As further illustrated in FIG. 6B, as the cutting cannula 230 advances towards the distal end 220a of the sample notch cannula 220, the seal 234 may similarly move in the longitudinal direction towards the distal end 220a of the sample notch cannula 220. As the seal 234 moves towards the distal end 220a of the sample notch cannula 220, the seal 234 may become disconnected from the vent housing 236. The disconnect between the seal 234 and the vent housing 236 may expose the passageway 237 to the plurality of channels 238, which may in turn open the fluid pathway 250 which runs through the plurality of channels 238 and into the space between the sample notch cannula 220 and the cutting cannula 230.

[0040] With the fluid pathway 250 opened, fluid may flow from atmosphere via the atmospheric inlets 260 and into the passageway 237, As the fluid traverses the passageway, the fluid may flow around the seal 234, through the fluid pathway 250, and into the space between the sample notch cannula 220 and the cutting cannula 230. The fluid passing through the space between the sample notch cannula 220 and the cutting cannula 230 may cause the tissue sample severed by the cutting cannula 230 to be transported through the cutting cannula 230 and into the sample basket fluidly coupled to the proximal end 230b of the cutting cannula 230.

[0041] Referring now to FIG. 7, an illustrative method 400 of performing a biopsy using biopsy device is depicted. Initially, a biopsy driver assembly, such as the biopsy driver assembly 100 may be coupled to a probe assembly, such as probe assembly 200, as shown at block 410. With the biopsy device assembled and coupled to the vacuum assembly, the method may move to block 420, where the biopsy device may be inserted or fired (as described above) into a target site. For example, the piercing tip 226 of the sample notch cannula 220 may pierce tissue until the biopsy device 10 is positioned at the target site. Once the biopsy device has been appropriately positioned, a cutter module is activated to drive a cutting cannula in the proximal direction and expose a sample notch. For example, the cutter module 122 may be activated, such that the drive gear 122b of the cutter module 122 drives the cutter gear-spindle set 232 backwards, as shown at block 430. Specifically, drive gear 122b may rotate in a clockwise direction, which in turn may drive driven gear 232a in the opposite, counterclockwise direction. As the driven gear 232a rotates in the counterclockwise direction, the spindle 232b may move in a proximal direction such that the cutter gear-spindle set 232 and cutting cannula 230 move in the proximal direction. As the cutter gear-spindle set 232 is driven backwards, the cutting cannula 230 retracts within the sample notch cannula 220, such that the sample notch 224 of the sample notch cannula 220 is opened.

[0042] The cutter gear-spindle set may be driven backwards until the cutting cannula 230 is fully retracted within the sample notch cannula 220, such that the cutting cannula is in the open position. With the cutting cannula 230 in the open position, the seal 234 may be in contact with the vent housing 236 such that the fluid pathway 250 through the plurality of channels 238 and into the space between the cutting cannula 230 and the sample notch cannula 220 is blocked. In this position, the sample notch 224 of the sample notch cannula 220 may be fully exposed.

[0043] Once the sample notch has been exposed, a vacuum assembly may be activated, as shown at block 440. For example, vacuum assembly 300 may be activated such that a vacuum is applied to the biopsy device 10. With the fluid pathway 250 blocked, the vacuum may act through the cutting cannula 230 and into the sample notch 224, such that a tissue sample is drawn into the sample notch 224.

[0044] The method may then move to block 450, in which the cutting cannula is driven forward to sever the tissue sample. For example, cutter module 122 may drive drive gear 122b in the reverse direction, such that the cutter gear-spindle set 232 is driven forward or distally, thereby moving the cutting cannula 230 in the distal direction towards the sample notch 224. As the cutting cannula 230 moves across the sample notch 224, the tissue sample is excised from the target site. The seal 234 may move away from the vent housing 236, which may allow fluid to pass through the plurality of channels 238 and into the fluid pathway 250 between the sample notch cannula 220 and cutting cannula 230. As fluid travels into the fluid pathway 250, the vacuum may pull the excised tissue through the cutting cannula 230 in a proximal direction such that the excised tissue sample traverses the length of the cutting cannula 230 and is deposited in the sample basket 270. The sample basket 270 may store excised tissue samples transported through the cutting cannula 230 until the desired number of tissue samples have been excised. For example, in some embodiments, multiple tissue samples may be obtained from the same target site during a single procedure. In these embodiments, the method may further include rotating the sample notch cannula 220 about its longitudinal axis L such that the sample notch 224 is directed towards a different circumferential position within the target site. Once the sample notch cannula 220, an additional tissue sample may be obtained. The sample notch cannula 220 may be rotated and repositioned as many times as is required to obtain the desired number of tissue samples. Once the desired number of tissue samples are obtained, the vacuum assembly may be deactivated and the tissue samples may be collected from the sample basket, as shown at block 460.

[0045] As may be appreciated in view of the foregoing, embodiments herein relate to biopsy devices and methods of performing biopsy procedures. A biopsy device may include a driver assembly, a probe assembly, and a vacuum assembly. The driver assembly may be operably connected to the probe assembly, which may include a sample notch cannula, a cutting cannula, a cutter gear-spindle set, a cutting nut, a sample notch gear, a vent housing, a seal, a probe housing, and a sample basket. The vent housing may further include a plurality of channels, which may allow for the vacuum generated by the vacuum assembly to operate in a space between the sample notch cannula and the cutting cannula when the cutting cannula is in a closed (e.g., forward) position. The seal may be operably coupled to the cutter gear-spindle, such that movement of the cutter gear-spindle in the longitudinal direction translates to similar longitudinal movement of the seal. By integrating the seal into the cutter gear-spindle set, and providing a plurality of channels on the vent housing, the rotational and linear movement of the cutter gear-spindle set may simultaneously act to translate the seal between a sealing position and a venting position.

[0046] Embodiments may be further described with references to the following numbered clauses:

[0047] 1. A biopsy device, comprising: a sample notch cannula having a distal end and a proximal end; a cutting cannula having a sharpened edge on a distal end and being internally located within the sample notch cannula; a cutter gear-spindle set that drives the cutting cannula between an open position and a closed position; a cutting nut that receives the cutter gear-spindle set when the cutting cannula is in the open position; a vacuum assembly connected to the cutting cannula and fluidly coupled to the sample notch cannula to generate a vacuum within the sample notch cannula when the cutting cannula is in the open position; a vent housing connecting the proximal end of the sample notch cannula to the vacuum assembly; and a sample basket fluidly coupled to the proximal end of the cutting cannula; the vent housing comprising a plurality of channels that define a fluid pathway through the plurality of channels between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0048] 2. The biopsy device of item 1, wherein the cutter gear-spindle set further comprises a seal that seals the cutting cannula to the vent housing.

[0049] 3. The biopsy device of item 2, wherein the seal contacts the vent housing when the cutting cannula is in the open position such that the fluid pathway defined through the plurality of channels is blocked by the seal.

[0050] 4. The biopsy device of item 2 or 3, wherein the seal does not contact the vent housing when the cutting cannula is in the closed position, such that the fluid pathway defined through the plurality of channels is open. [0051] 5. The biopsy device of any of items 2-4, wherein the fluid pathway extends from an atmosphere inlet at the proximal end of the sample notch cannula, around the seal of the cutter gear-spindle set, and distally into a space between the cutting cannula and the sample notch cannula.

[0052] 6. The biopsy device of any of items 2-5, wherein the seal is an O-ring

[0053] 7. The biopsy device of any of items 1-6, wherein the plurality of channels are circumferentially positioned around the cutting cannula.

[0054] 8. The biopsy device of any of items 1-7, further comprising a piercing module coupled to the sample notch cannula to fire the sample notch cannula into an area of dense tissue.

[0055] 9. A biopsy probe assembly comprising: a vacuum assembly; a probe having a sample notch cannula and a cutting cannula, the cutting cannula being internally located within the sample notch cannula and capable of moving between an open position, wherein the sample notch cannula is open to an external environment, and a closed position, wherein the cutting cannula extends across an opening of the sample notch cannula; and a vent housing connecting the probe to the vacuum assembly, the vacuum assembly fluidly coupled to the sample notch cannula to generate a vacuum in the sample notch cannula when the cutting cannula is in the open position, the vent housing defining a plurality of channels allowing the vacuum assembly to draw fluid in a space between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0056] 10. The biopsy probe assembly of item 9, further comprising a cutter gear-spindle rotatable to drive the cutting cannula between the open position and the closed position.

[0057] 11. The biopsy probe assembly of item 10, wherein the cutter gear-spindle further comprises a seal to seal the cutting cannula to the vent housing.

[0058] 12. The biopsy probe assembly of item 11, wherein the seal contacts the vent housing when the cutting cannula is in the open position, such that a fluid pathway defined through the plurality of channels is blocked by the seal.

[0059] 13. The biopsy probe assembly of item 11 or 12, wherein the seal does not contact the vent housing when the cutting cannula is in the closed position, such that a fluid pathway defined through the plurality of channels is open. [0060] 14. The biopsy probe assembly of any of item 11-13, wherein the plurality of channels define a fluid pathway which extends from an atmosphere inlet at a proximal end of the sample notch cannula, around the seal of the cutter gear-spindle, and distally into a space between the cutting cannula and the sample notch cannula.

[0061] 15. The biopsy probe assembly of any of items 9-14, wherein the plurality of channels are circumferentially positioned around the cutting cannula.

[0062] 16. A method of performing a biopsy comprising: inserting a biopsy device having a probe comprising a sample notch cannula, a cutting cannula, a cutter gear-spindle set, and a cutting nut into a tissue sample, wherein the cutting cannula is located internally to the sample notch cannula and the cutter gear-spindle set is coupled to the cutting cannula; moving the cutting cannula into an open position by threading the cutter gear-spindle set into the cutting nut to expose the sample notch cannula; creating a vacuum using a vacuum assembly located on a proximal end of the probe to draw the tissue sample into the sample notch cannula; moving the cutting cannula into a closed position by threading the cutter gear-spindle set out of the cutting nut to close the cutting cannula and cut the tissue sample drawn into the sample notch cannula; and ventilating a space between the cutting cannula and the sample notch cannula to draw vacuum through the space and transport the tissue sample into a sample basket located on a proximal end of the probe while the cutting cannula is in the closed position.

[0063] 17. The method of item 16, further comprising sealing the cutting cannula to a vent housing using the cutter gear-spindle set.

[0064] 18. The method of item 17, wherein the cutting cannula is sealed to the vent housing in the open position, such that the space between the cutting cannula and the sample notch cannula is not ventilated.

[0065] 19. The method of item 18, wherein the cutting cannula is not sealed to vent housing in the closed position, such that the space between the cutting cannula and the sample notch cannula is ventilated.

[0066] 20. The method of any of items 16-19, further comprising driving the cutter gearspindle set with a motor to move the cutting cannula between the open position and the closed position. [0067] 21. The method of any of items 16-19 wherein the tissue sample is a first tissue sample and the method further comprises rotating the sample notch cannula to align with a second tissue sample after the step of ventilating the space between the cutting cannula and the sample notch cannula.

[0068] The terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms, including “at least one,” unless the content clearly indicates otherwise. “Or” means “and/or.” As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. It will be further understood that the terms “comprises” and/or “comprising,” or “includes” and/or “including” when used in this specification, specify the presence of stated features, regions, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and/or groups thereof. The term “or a combination thereof’ means a combination including at least one of the foregoing elements.

[0069] It is noted that the terms "substantially" and "about" may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0070] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. A biopsy device, comprising: a sample notch cannula comprising a sample notch and having a distal end and a proximal end; a cutting cannula having a sharpened edge on a distal end and being internally located within the sample notch cannula; a cutter gear-spindle set that drives the cutting cannula between an open position and a closed position; a cutting nut that receives the cutter gear-spindle set when the cutting cannula is in the open position; a vacuum assembly connected to the cutting cannula and fluidly coupled to the sample notch cannula to generate a vacuum within the sample notch cannula when the cutting cannula is in the open position; a vent housing connecting the proximal end of the sample notch cannula to the vacuum assembly; and a sample basket fluidly coupled to the proximal end of the cutting cannula; the vent housing comprising a plurality of channels that define a fluid pathway through the plurality of channels between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

2. The biopsy device of claim 1, wherein the cutter gear-spindle set further comprises a seal that seals the cutting cannula to the vent housing.

3. The biopsy device of claim 2, wherein the seal contacts the vent housing when the cutting cannula is in the open position such that the fluid pathway defined through the plurality of channels is blocked by the seal.

4. The biopsy device of claim 2 or 3, wherein the seal does not contact the vent housing when the cutting cannula is in the closed position, such that the fluid pathway defined through the plurality of channels is open.

5. The biopsy device of any of claims 2-4, wherein the fluid pathway extends from an atmosphere inlet at the proximal end of the sample notch cannula, around the seal of the cutter gear-spindle set, and distally into a space between the cutting cannula and the sample notch cannula.

6. The biopsy device of any of claims 2-5, wherein the seal is an O-ring.

7. The biopsy device of any of claims 1-6, wherein the plurality of channels are circumferentially positioned around the vent housing.

8. The biopsy device of any of claims 1-7, further comprising a piercing module coupled to the sample notch cannula to fire the sample notch cannula into an area of dense tissue.

9. A biopsy probe assembly comprising: a vacuum assembly; a probe having a sample notch cannula and a cutting cannula, the cutting cannula being internally located within the sample notch cannula and capable of moving between an open position, wherein the sample notch cannula is open to an external environment, and a closed position, wherein the cutting cannula extends across an opening of the sample notch cannula; and a vent housing connecting the probe to the vacuum assembly, the vacuum assembly fluidly coupled to the sample notch cannula to generate a vacuum in the sample notch cannula when the cutting cannula is in the open position, the vent housing defining a plurality of channels allowing the vacuum assembly to draw fluid in a space between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

10. The biopsy probe assembly of claim 9, further comprising a cutter gear-spindle rotatable to drive the cutting cannula between the open position and the closed position.

11. The biopsy probe assembly of claim 10, wherein the cutter gear-spindle further comprises a seal to seal the cutting cannula to the vent housing.

12. The biopsy probe assembly of claim 11, wherein the seal contacts the vent housing when the cutting cannula is in the open position, such that a fluid pathway defined through the plurality of channels is blocked by the seal.

13. The biopsy probe assembly of claim 11 or 12, wherein the seal does not contact the vent housing when the cutting cannula is in the closed position, such that a fluid pathway defined through the plurality of channels is open.

14. The biopsy probe assembly of any of claim 11-13, wherein the plurality of channels define a fluid pathway which extends from an atmosphere inlet at a proximal end of the sample notch cannula, around the seal of the cutter gear-spindle, and distally into a space between the cutting cannula and the sample notch cannula.

15. The biopsy probe assembly of any of claims 9-14, wherein the plurality of channels are circumferentially positioned around the vent housing.

16. A method of performing a biopsy comprising: inserting a biopsy device having a probe comprising a sample notch cannula, a cutting cannula, a cutter gear-spindle set, and a cutting nut into a tissue sample, wherein the cutting cannula is located internally to the sample notch cannula and the cutter gear-spindle set is coupled to the cutting cannula; moving the cutting cannula into an open position by threading the cutter gear-spindle set into the cutting nut to expose the sample notch cannula; creating a vacuum using a vacuum assembly located on a proximal end of the probe to draw the tissue sample into the sample notch cannula; moving the cutting cannula into a closed position by threading the cutter gear-spindle set out of the cutting nut to close the cutting cannula and cut the tissue sample drawn into the sample notch cannula; and ventilating a space between the cutting cannula and the sample notch cannula to draw vacuum through the space and transport the tissue sample into a sample basket located on a proximal end of the probe while the cutting cannula is in the closed position.

17. The method of claim 16, further comprising sealing the cutting cannula to a vent housing using the cutter gear-spindle set.

18. The method of claim 17, wherein the cutting cannula is sealed to the vent housing in the open position, such that the space between the cutting cannula and the sample notch cannula is not ventilated.

19. The method of claim 18, wherein the cutting cannula is not sealed to vent housing in the closed position, such that the space between the cutting cannula and the sample notch cannula is ventilated.

20. The method of any of claims 16-19, further comprising driving the cutter gear-spindle set with a motor to move the cutting cannula between the open position and the closed position.

21. The method of any of claims 16-19 wherein the tissue sample is a first tissue sample and the method further comprises rotating the sample notch cannula to align with a second tissue sample after the step of ventilating the space between the cutting cannula and the sample notch cannula.