Biopsy device and method for performing a biopsy using the same

Abstract

The biopsy probe assembly includes a sample notch cannula having a distal and proximal end, and a cutting cannula having a sharp edge at its distal end and positioned within the sample notch cannula. A cutter gear spindle set drives the cutting cannula between an open and closed position, and a cutting nut receives the cutter gear spindle set. A vacuum assembly is connected to the cutting cannula and fluid-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 fluid-coupled to the cutting cannula. The vent housing further includes multiple channels, which define fluid pathways through the multiple channels between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

Description

Technical Field

[0001]

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

Background Art

[0002]

[0002] Biopsies can be performed on a subject to obtain tissue for investigation (e.g., to investigate tissue to determine whether the tissue contains cancerous cells). One biopsy technique used to evaluate breast tissue involves, for example, inserting a biopsy probe into a target breast tissue region and capturing one or more tissue samples from that region. Such biopsy techniques often utilize a vacuum to draw the tissue into the sample notch of the biopsy probe so that the tissue can then be cut and collected. Efforts continue in the art to improve the capabilities of biopsy devices for cutting tissue samples, transporting the cut tissue samples to a sample basket, and collecting multiple samples.

Summary of the Invention

Problems to be Solved by the Invention

[0003]

[0003] An object of the present disclosure is to provide a biopsy device having the ability to facilitate effective cutting of tissue samples and effective transport of the tissue samples to a sample basket.

Means for Solving the Problems

[0004]

[0004] According to one embodiment, a biopsy apparatus is disclosed. The biopsy apparatus includes a sample notch cannula having a distal end and a proximal end, the distal end having an oblique edge. A cutting cannula having a sharp edge at the distal end is located internally 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 when the cutting cannula is in the open position. A vacuum assembly is connected to and fluid-coupled to the cutting cannula to generate a vacuum within 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 fluid-coupled to the cutting cannula. The vent housing further includes multiple channels, which define fluid pathways through the channels between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0005]

[0005] In another embodiment, a biopsy probe assembly is disclosed. The biopsy assembly comprises a vacuum assembly and a probe having a sample notch cannula and a cutting cannula, the cutting cannula being located internally within the sample notch cannula and movable between an open position where the sample notch cannula is open to the external environment and a closed position where the cutting cannula extends across the opening of the sample notch cannula. A vent housing connects the probe to the vacuum assembly, which is fluid-coupled to the sample notch cannula to create a vacuum within the sample notch cannula when the cutting cannula is in the open position. The vent housing defines a plurality of channels that allow the vacuum assembly to draw fluid into the space between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0006]

[0006] In yet another embodiment, a method for performing a biopsy is disclosed. This method involves inserting a biopsy apparatus having a probe including 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 inside the sample notch cannula and the cutter gear spindle is coupled to the cutting cannula. This method further involves moving the cutting cannula to an open position by passing the cutter gear spindle through the cutting nut to expose the sample notch cannula, and creating a vacuum using a vacuum assembly located at the 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, this method includes moving the cutting cannula to a closed position by moving 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. This method further involves venting the space between the cutting cannula and the sample notch cannula so that a vacuum can be applied while the cutting cannula is in the closed position, allowing the tissue sample to be transported into the sample basket located at the proximal end of the probe.

[0007]

[0007] These and additional features provided by the embodiments described herein will be better understood in conjunction with the drawings from the following detailed description.

[0008] The embodiments shown in the drawings are illustrative and illustrative in nature and are not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood in conjunction with the following drawings, and the same structures are shown using the same reference numerals. [Brief explanation of the drawing]

[0008] [Figure 1]

[0009] This is a front view of an illustrative biopsy apparatus in which the driver assembly is mounted on the probe assembly, according to one or more embodiments described herein. [Figure 2]

[0010] This is a bottom view of the driver assembly shown in Figure 1, according to one or more embodiments described herein. [Figure 3A]

[0011] This is a perspective view of the probe assembly within the housing of the biopsy apparatus shown in Figure 1, according to one or more embodiments described herein. [Figure 3B]

[0012] This is a cross-sectional view of Figure 3A according to one or more embodiments described herein. [Figure 4]

[0013] This is a cross-sectional view of the probe assembly shown in Figure 1, according to one or more embodiments described herein. [Figure 5]

[0014] This is a front cross-sectional view of the probe assembly of the biopsy apparatus of Figure 1, along line 5-5, according to one or more embodiments described herein. [Figure 6A]

[0015] This is an illustrative partial cross-sectional view of an exemplary cut cannula of the probe assembly of the biopsy device of Figure 1 in the open position, according to one or more embodiments described herein. [Figure 6B]

[0016] This is a partial cross-sectional view of the cut cannula of the probe of the biopsy apparatus of Figure 1 in the closed position, according to one or more embodiments described herein. [Figure 7]

[0017] This is a flowchart illustrating an illustrative method for performing a biopsy according to one or more embodiments described herein. [Modes for carrying out the invention]

[0009]

[0018] Similar reference letters indicate similar parts in several drawings. The descriptions provided herein illustrate at least one embodiment of the present disclosure, and such descriptions should not be construed as limiting the scope of the present disclosure in any way.

[0010]

[0019] Embodiments disclosed herein relate to biopsy apparatuses and methods for performing biopsy procedures. For example, in embodiments, the biopsy apparatus includes a driver assembly, a probe assembly, and a vacuum assembly. The driver assembly may include a cutter module, a rotary module, and a puncture module. 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 vacuum assembly may be operably connected to the proximal end of the probe assembly so that the tissue sample taken by the probe assembly can be transported to the sample basket with the help of the vacuum generated by the vacuum assembly. The cutter gear spindle set may provide simultaneous rotational and linear motion of the cutting cannula, thereby mitigating the need for multiple motors and / or valves to operate the cutting cannula and perform the tissue cutting sequence.

[0011]

[0020] The vent housing may further include multiple channels, which may allow the vacuum generated by the vacuum assembly to operate in the 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 multiple channels, the vacuum may act to transport the tissue sample through the cutting cannula 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 against the vent housing so that the vacuum generated by the vacuum assembly draws the tissue sample into the sample notch cannula. In these embodiments, the seal may be operably coupled to the cutter gear spindle such that the longitudinal movement of the cutter gear spindle leads to a similar longitudinal movement of the seal. By moving the seal together with the cutter gear spindle, the fluid flow from the vacuum assembly can travel through multiple channels and around the seal when the cutting cannula is in the closed position, while the seal can force the airflow through the cutting cannula when the cutting cannula is in the open position.

[0012]

[0021] In particular, conventional sealing mechanisms may require spring-loaded action, which can complicate the operation of the biopsy apparatus. By integrating the seal into the cutter gear spindle set and providing multiple channels on the vent housing, the rotational and linear motion of the cutter gear spindle set can simultaneously act to translate the seal between a sealed position and a vented position. Translation of the seal via the cutter gear spindle set can further reduce the need for additional motors and / or valves commonly used in biopsy apparatuses to acquire tissue samples.

[0013]

[0022] Referring hereto to the drawings, and more specifically to Figure 1, a vacuum-assisted biopsy apparatus 10 is shown, which includes a biopsy probe assembly that 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, a non-invasive device may further be considered a non-disposable device intended for use in multiple subjects over the lifespan of the device. In contrast, the term “invasive” is used to refer to a device that is inserted into the body of a patient. An invasive device may further be considered “disposable” because these devices are intended to be discarded after use in a single subject. The biopsy driver assembly 100 may be releasably mounted to the probe assembly 200. As used herein, the term “releasably mounted” means a configuration that facilitates an intended temporary connection and subsequent selective disconnection, involving the operation of the disposable probe assembly 200 to the biopsy driver assembly 100 without the need for tools. As further illustrated in Figure 1, the biopsy apparatus 10 may also include a vacuum assembly 300 that can be releasably coupled to a disposable probe assembly 200.

[0014]

[0023] Referring now to Figure 2, the lower (or connected) side of the biopsy driver assembly 100 is depicted in its entirety. The biopsy driver assembly 100 may include a driver housing 110 and several 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 rotary module 124, and a puncture module 126. The cutter module 122 may include an electric motor 122a having a shaft on which a drive gear 122b is mounted. In these embodiments, the drive gear 122b may be mounted on the shaft via any suitable connection such that the rotation of the shaft results in the rotation of the drive gear 122b. The rotary module 124 includes an electric motor 124a having a shaft on which a drive gear 124b is mounted. The puncture module 126 may include an electric motor 126a, a drive spindle 126b, and a puncture drive 126c. Each of the electric motors 122a, 124a, and 126a may be, for example, a direct current (DC) motor or a stepper motor. As an alternative to the arrangement described above, each of the cutter module 122, the rotary module 124, and the puncture module 126 may include one or more of the following: gears, gear trains, belt / pulley arrangements, etc., intervening between their respective motors and the drive gear or drive spindle. Furthermore, although the cutter module 122, the rotary module 124, and the puncture module 126 are described as being electromechanically driven, it should be further understood that in some embodiments, the cutter module 122, the rotary module 124, and the puncture module 126 may be manually operated. As described, in embodiments, an opening may be formed within the driver housing 110 to allow coupling to the probe assembly 200.

[0015]

[0024] Still referring to FIG. 2, when the piercing module 126 is assembled to the probe assembly 200, it is operable to pull one or more components of the probe assembly 200 in the proximal (-x) direction and fire the probe assembly 200 into the tissue site. For example, the piercing drive 126c may engage one or more portions of the biopsy probe assembly 200 that are connected to the sample notch cannula to retract and drive forward the sample notch cannula. The piercing drive 126c can thus extend to and engage one or more portions of the biopsy probe assembly to retract and fire the sample notch cannula. For example, the piercing drive 126c may include one or more protrusions 126d (e.g., forks) configured to extend into the biopsy probe assembly 200 to the operably engaged sample notch cannula. The operation of the piercing module 126 is described in further detail herein.

[0016]

[0025] Moving 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, a sample notch cannula 220, a sample notch gear 222, a cutting cannula 230, a cutter gear - spindle set 232 for rotational and linear cutter translation, a cutting nut 233, a seal 234 (see FIG. 4), a vent (alternatively, ventilation) housing 236, and a vent cap 240. In the embodiments described herein, the rotational movement of the cutter gear - spindle 232 can result in a longitudinal movement of the cutting cannula 230 in the proximal or distal direction, as will be described in more detail herein.

[0017]

[0026] Referring now to FIGS. 2 and 3A, in an embodiment in which a probe housing 210 is provided, the probe housing 210 may be formed as an elongated member 212 having a front plate 214. The elongated member 212 may further include a plurality of retaining clips 212a configured to engage a plurality of openings within the driver housing. When the probe assembly 200 is attached to the biopsy driver assembly 100, the driver assembly 100 may first be positioned over the probe assembly 200 such that the front face 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 accurately positioned, the front face of the biopsy driver assembly 100 may be lowered such that the front face contacts 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.

[0018]

[0027] Referring now to FIGS. 3A and 3B, the sample notch cannula 220 may include a proximal end 220b and a distal end 220a. In these embodiments, the distal end 220a may include a sample notch 224. Attached to the distal end 220a may be a piercing tip 226 that may form a 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 elongated opening within the sidewall 220c of the sample notch cannula 220 to facilitate the receipt of tissue into the lumen of the sample notch cannula 220. More particularly, when the sample notch cannula 220 is inserted into the target region, the sample notch 224 may receive a tissue sample drawn into the sample notch cannula 224. The sample notch 224 may extend longitudinally along the longitudinal axis L. In an embodiment, the sample notch 224 may include a cutting edge around the periphery of the opening formed by the sample notch 224.

[0019]

[0028] In some embodiments, the sample notch cannula 220 may be linearly translatable between an engaged position and an unengaged position via the puncture module 126. In the engaged position, rotation of the puncture module 126 causes the sample notch cannula and puncture drive 126c to simultaneously translate proximal to position the puncture drive 126c and the sample notch cannula 220 to a ready position, i.e., a cock (prime) position. The sample notch cannula 220 may then be released to cause a puncture ejection, in which the puncture module 126 rapidly and simultaneously propels the sample notch cannula 220 and puncture drive 126c distally, so that the sample notch cannula 220 punctures tissue within the subject. Such ejection of the sample notched cannula 220 can be particularly useful when biopsying dense tissue, specifically when manual or slow advancement of the sample notched cannula is difficult due to variations in tissue type and density.

[0020]

[0029] Still referring to Figures 3A and 3B, the sample notch cannula 220 can be rotated around its longitudinal axis L by activating the rotation module 124 discussed above. For example, when the probe assembly 200 and biopsy driver assembly 100 are mounted, the drive gear 124b can engage with the sample notch gear 222, and as a result, the rotation of the drive gear 124b in turn rotates the sample notch gear 222. In these embodiments, the sample notch cannula 220 can be rotated by the sample notch gear 222 to multiple angular positions, enabling the biopsy device 10 to acquire tissue from multiple target sites around the sample notch cannula 220 without requiring the user to manually rotate the position of the biopsy driver assembly 100. Moving on to Figures 3B and 4, the cutting cannula 230 can 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 sharp edge for cutting tissue samples. 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 at the proximal end of the cutter gear-spindle set 232, while the non-threaded shoulder 232c may be positioned at the distal end of the cutter gear-spindle set 232, while 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 best illustrated in Figure 4. The cutter gear-spindle set 232 may also be a single device that fixates the driven gear 232a onto the cutting spindle 232b and the non-threaded shoulder 232c. In some embodiments, the cutter gear spindle set 232 may be formed as a single molded product, while in other embodiments, the components may be formed separately.

[0021]

[0030] The cutter gear spindle set 232 can be fixedly attached (e.g., by gluing, welding, or staking) to the proximal end 230a of the cutting cannula. In these embodiments, the cutting cannula 230 may be operable between an open position and a closed position by activating the cutter module 122 of the biopsy driver assembly 100, with the drive gear 122b of the cutter module 122 engaged with 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 proximal to 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 to the first direction, such that the cutting spindle 232b is driven distally and exits the cutting nut 233. Thus, the 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 the cutting spindle 232b may determine the number of rotations per axial distance the cutting cannula 230 moves axially.

[0022]

[0031] Referring still to Figures 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 a passage 237 extending longitudinally from the first end 236a to the second end 236b may be further defined. In these embodiments, the passage 237 of the vent housing 236 may receive the non-threaded shoulder 232c of the cutter gear spindle set 232. A vent cap 240 may be coupled to the second end 236b of the vent housing 236 such that the vent cap 240 surrounds the passage 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.

[0023]

[0032] Referring now to Figures 4 and 5, the vent housing 236 may further include a plurality of channels 238 that may extend circumferentially around the passage 237 of the vent housing 236. The plurality of channels 238 extend longitudinally from the second end 236b of the vent housing 236 toward the first end 236a of the vent housing 236 with a length C L It is possible to have the following. As illustrated in Figure 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, Figure 5 illustrates that the multiple channels 238 may be spaced 60 degrees apart from each other in the circumferential direction. However, it should be understood that the multiple channels 238 may have any circumferential spacing, with or without rotational symmetry, as long as the multiple channels 238 exist. 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 each other in the circumferential direction around the passage 237.

[0024]

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

[0025]

[0034] The fluid path 250 can be most clearly illustrated in Figure 4. For ease of illustration, the fluid path 250 is depicted by multiple arrows. As demonstrated, the fluid path extends from the air inlet 260 located at the proximal end 220b of the sample notch cannula 220, through the passage 237 and multiple channels 238, into the space between the cutting cannula 230 and the sample notch cannula 220.

[0026]

[0035] Referring again to Figures 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 path 250. As illustrated in Figure 4, the seal 234 may be positioned on the non-threaded shoulder 232c of the cutter gear spindle set 232 such that the seal 234 extends into a plurality of channels 238 of the vent housing 236. Because the seal 234 is positioned on the non-threaded shoulder 232c of the cutter gear spindle set 232, the seal 234 may move longitudinally (e.g., in the + / -x directions as shown in the coordinate axes of Figure 4) with respect to the cutter gear spindle set 232 when the cutter gear spindle set 232 is operated between an open position and a closed position, as will be described in more detail below herein with respect to Figures 6A and 6B.

[0027]

[0036] Moving on to Figure 6A, the cutting cannula 230 is illustrated in the open position. In the open position, the cutter gear spindle set 232 can be fully retracted, as a result of which the cutting cannula 230 is retracted and the sample notch 224 of the sample notch cannula 220 is exposed. In this position, the seal 234 can contact the vent housing 236 such that the seal 234 obstructs the fluid path 250. In these embodiments, when the seal 234 contacts the vent housing 236, the seal 234 prevents fluid from passing between the passage 237 and the multiple channels 238. As a result, the seal 234 can block (in other words, seal) the fluid path 250 from the atmosphere, so that fluid cannot traverse between the passage 237, the cutting cannula 230, and the sample notch cannula 220.

[0028]

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

[0029]

[0038] Once a tissue sample is obtained, the cutting cannula 230 can be moved to the closed position, as illustrated in Figure 6B. In the closed position, the cutter spindle-gear set 232 can be moved forward so that the cutting cannula 230 can advance toward the sample notch 224 of the sample notch cannula 220. The cutting cannula 230 can continue to advance beyond the sample notch 224 so that the sharp edge of the cutting cannula 230 cuts the tissue sample that has been drawn into the sample notch 224.

[0030]

[0039] As further illustrated in Figure 6B, as the cutting cannula 230 advances toward the distal end 220a of the sample notch cannula 220, the seal 234 may similarly move longitudinally toward the distal end 220a of the sample notch cannula 220. As the seal 234 moves toward the distal end 220a of the sample notch cannula 220, the seal 234 may be detached from the vent housing 236. Detachment of the seal 234 from the vent housing 236 may expose the passage 237 to a plurality of channels 238, thereby opening a fluid path 250 through the plurality of channels 238 to the space between the sample notch cannula 220 and the cutting cannula 230.

[0031]

[0040] With the fluid path 250 open, fluid can flow from the atmosphere into the passage 237 via the air inlet 260. As the fluid crosses the passage, it can flow around the seal 234 through the fluid path 250 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 cut by the cutting cannula 230 to be transported through the cutting cannula 230 into a sample basket that is fluid-coupled to the proximal end 230b of the cutting cannula 230.

[0032]

[0041] Referring now to Figure 7, a method 400 for performing a biopsy using a biopsy device is depicted. Initially, a biopsy driver assembly, such as a biopsy driver assembly 100, may be coupled to a probe assembly, such as a probe assembly 200, as shown in block 410. With the biopsy device assembled and coupled to the vacuum assembly, the method may proceed to block 420, where the biopsy device may be inserted into or launched into the target site (as described above). For example, the puncture tip 226 of the sample notch cannula 220 may puncture the tissue until the biopsy device 10 is positioned at the target site. Once the biopsy device is properly positioned, the cutter module is activated to drive the cutting cannula proximal to expose the sample notch. For example, the cutter module 122 may be activated so that the drive gear 122b of the cutter module 122 drives the cutter gear spindle set 232 backward, as shown in block 430. Specifically, the drive gear 122b can rotate clockwise, thereby driving the driven gear 232a in the opposite counterclockwise direction. When the driven gear 232a rotates counterclockwise, the spindle 232b can move proximal, as a result of the cutter gear-spindle set 232 and the cutting cannula 230 moving proximal. When the cutter gear-spindle set 232 is driven backward, the cutting cannula 230 retracts within the sample notch cannula 220, as a result of the sample notch 224 of the sample notch cannula 220 opening.

[0033]

[0042] The cutter gear spindle set can be driven backward until the cutting cannula 230 is fully retracted within the sample notch cannula 220, so 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, thereby blocking the fluid path 250 into the space between the cutting cannula 230 and the sample notch cannula 220 through multiple channels 238. In this position, the sample notch 224 of the sample notch cannula 220 may be fully exposed.

[0034]

[0043] Once the sample notch is exposed, a vacuum assembly can be activated, as shown in block 440. For example, the vacuum assembly 300 can be activated so that a vacuum is applied to the biopsy apparatus 10. With the fluid path 250 blocked, the vacuum can act into the sample notch 224 through the cutting cannula 230, thereby drawing the tissue sample into the sample notch 224.

[0035]

[0044] The method then moves to a block 450, which drives the cutting cannula forward to cut the tissue sample. For example, the cutter module 122 may drive the drive gear 122b in the reverse direction so that the cutter gear spindle set 232 is driven forward or distally, thereby moving the cutting cannula 230 distally toward the sample notch 224. Once the cutting cannula 230 has moved beyond the sample notch 224, the tissue sample is excised from the target site. The seal 234 may move away from the vent housing 236, thereby allowing fluid to pass through multiple channels 238 into the fluid path 250 between the sample notch cannula 220 and the cutting cannula 230. As the fluid moves into the fluid path 250, the vacuum can pull the excised tissue proximal through the cutting cannula 230, resulting in the excised tissue sample traversing the length of the cutting cannula 230 and being placed in the sample basket 270. The sample basket 270 can hold the excised tissue samples transported through the cutting cannula 230 until a desired number of tissue samples have been excised. For example, in some embodiments, multiple tissue samples may be obtained from the same target site in a single procedure. In these embodiments, the method may further include rotating the sample notch cannula 220 around its longitudinal axis L so that the sample notch 224 is oriented toward different circumferential positions within the target site. Once the sample notch cannula 220 is rotated, additional tissue samples may be obtained. The sample notch cannula 220 may be rotated and repositioned as many times as necessary to obtain a desired number of tissue samples. Once the desired number of tissue samples have been obtained, the vacuum assembly may be deactivated, and the tissue samples may be collected from the sample basket, as shown in block 460.

[0036]

[0045] As can be understood in consideration of the foregoing, the embodiments herein relate to a biopsy apparatus and a method for carrying out a biopsy procedure. The biopsy apparatus may include a driver assembly, a probe assembly, and a vacuum assembly. The driver assembly may be operably connected to the probe assembly, and the probe assembly 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 the vacuum generated by the vacuum assembly to operate in the 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 the longitudinal motion of the cutter gear spindle leads to similar longitudinal motion of the seal. By integrating the seal into the cutter gear spindle set and providing multiple channels on the vent housing, the rotational and linear motion of the cutter gear spindle set can simultaneously act to translate the seal between a sealed position and a vented position.

[0037]

[0046] Embodiments may be further described with reference to the following numbered clauses.

[0047] 1. A biopsy apparatus comprising: a sample notch cannula having a distal end and a proximal end; a cutting cannula having a sharp edge at its distal end and located internally within the sample notch cannula; a cutter gear spindle set for driving the cutting cannula between an open position and a closed position; a cutting nut for receiving the cutter gear spindle set when the cutting cannula is in the open position; a vacuum assembly connected to and fluid-coupled to the cutting 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 fluid-coupled to the proximal end of the cutting cannula, wherein the vent housing includes a plurality of channels, the plurality of channels defining a fluid path through the plurality of channels between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0038]

[0048] 2. The biopsy apparatus as described in Clause 1, further comprising a cutter gear spindle set, which includes a seal for sealing the cutting cannula against the vent housing.

[0049] 3. The biopsy apparatus according to Clause 2, wherein the seal contacts the vent housing when the cutting cannula is in the open position, such that the fluid path defined through multiple channels is blocked by the seal.

[0039]

[0050] 4. The biopsy apparatus according to Clause 2 or 3, wherein the seal does not contact the vent housing when the cutting cannula is in the closed position, so that a fluid path defined through multiple channels is opened.

[0040]

[0051] 5. The biopsy apparatus according to any of clauses 2 to 4, wherein the fluid path extends distally from the air inlet at the proximal end of the sample notch cannula, around the seal of the cutter gear spindle set, and into the space between the cutting cannula and the sample notch cannula.

[0041]

[0052] 6. The seal is an O-ring, as described in any of clauses 2 to 5 of the biopsy apparatus.

[0053] 7. A biopsy apparatus according to any of clauses 1 to 6, wherein multiple channels are positioned circumferentially around the cutting cannula.

[0042]

[0054] 8. A biopsy apparatus according to any one of the clauses 1 to 7, further comprising a puncture module coupled to a sample notch cannula for launching the sample notch cannula into an area of ​​dense tissue.

[0043]

[0055] 9. A biopsy probe assembly comprising: a vacuum assembly; a probe having a sample notch cannula and a cutting cannula, wherein the cutting cannula is located internally within the sample notch cannula and is movable between an open position in which the sample notch cannula is exposed to the external environment and a closed position in which the cutting cannula extends across the opening of the sample notch cannula; and a vent housing connecting the probe to the vacuum assembly, wherein the vacuum assembly is fluid-coupled to the sample notch cannula to generate a vacuum within the sample notch cannula when the cutting cannula is in the open position, and the vent housing defines a plurality of channels that allow the vacuum assembly to draw fluid into the space between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0044]

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

[0057] 11. The biopsy probe assembly described in Clause 10 further includes a cutter gear spindle, which further includes a seal for sealing the cutting cannula against the vent housing.

[0045]

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

[0046]

[0059] 13. The seal does not contact the vent housing when the cutting cannula is in the closed position, so that the fluid pathway defined through multiple channels is opened, as described in Clause 11 or 12 of the biopsy probe assembly.

[0047]

[0060] 14. A biopsy probe assembly according to any one of clauses 11-13, wherein multiple channels define fluid pathways extending distally from an air inlet at the proximal end of the sample notch cannula, around the seal of the cutter gear spindle, and into the space between the cutting cannula and the sample notch cannula.

[0048]

[0061] 15. A biopsy probe assembly as described in any of clauses 9-14, wherein multiple channels are positioned circumferentially around the cutting cannula.

[0062] 16. A method for performing a biopsy, comprising the steps of inserting a biopsy device having a probe equipped with 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 inside the sample notch cannula and the cutter gear spindle set is coupled to the cutting cannula; moving the cutting cannula to an open position by passing the cutter gear spindle set through the cutting nut in order to expose the sample notch cannula; and placing the tissue sample inside the sample notch cannula. A method comprising the steps of: creating a vacuum using a vacuum assembly located at the proximal end of the probe in order to draw in; moving the cutting cannula to a closed position by moving the cutter gear spindle set out of the cutting nut in order to close the cutting cannula and cut the tissue sample drawn into the sample notch cannula; and venting the space between the cutting cannula and the sample notch cannula to draw a vacuum through this space and transport the tissue sample into a sample basket located at the proximal end of the probe while the cutting cannula is in the closed position.

[0049]

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

[0064] 18. The method according to clause 17, wherein the cutting cannula is sealed to the vent housing in the open position so that the space between the cutting cannula and the sample notch cannula is not permeable.

[0050]

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

[0051]

[0066] 20. The method according to any one of the clauses 16 to 19, further comprising the step of driving a cutter gear spindle set using a motor to move the cutting cannula between an open position and a closed position.

[0052]

[0067] 21. The tissue sample is a first tissue sample, and the method further comprises the step of rotating the sample notch cannula to align it with a second tissue sample, after the step of ventilating the space between the cutting cannula and the sample notch cannula.

[0053]

[0068] The terms used herein are intended to describe only specific aspects and are not intended to be limiting. Where used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form, which includes “at least one,” unless the context indicates otherwise. “Or” means “and / or.” Where used herein, the term “and / or” includes one or any combination of the associated enumerated items. It should be further understood that the terms “equip” and / or “equip,” or “include” and / or “include,” when used herein, specify the presence of the described features, regions, integers, steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, actions, elements, components, and / or groups thereof. The term “or combination thereof” means a combination that includes at least one of the preceding elements.

[0054]

[0069] It should be noted that the terms “substantially” and “about” may be used herein to express the essential degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other expression. These terms may also be used herein to express the degree to which a quantitative expression may deviate from the stated standard without altering the fundamental function of the subject matter in question.

[0055]

[0070] While specific embodiments are illustrated and described herein, it should be understood that other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Furthermore, while various aspects of the claimed subject matter are described herein, such aspects do not need to be used in combination. Accordingly, the appended claims are intended to cover all such changes and modifications that fall within the scope of the claimed subject matter.

Claims

1. A sample notch cannula, which includes a sample notch and has a distal end and a proximal end, A cutting cannula having a sharp edge at its distal end and located internally within the sample notched cannula, A cutter gear spindle set that drives the cutting cannula between an open position and a closed position, When the cutting cannula is in the open position, the cutting nut that receives the cutter gear spindle set, 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 in order to generate a vacuum within the sample notch cannula, A vent housing connects the proximal end of the sample notched cannula to the vacuum assembly, A sample basket is fluid-coupled to the proximal end of the cutting cannula, Equipped with, A biopsy apparatus comprising a vent housing including a plurality of channels, the plurality of channels defining a fluid path through the plurality of channels between the sample notched cannula and the cutting cannula when the cutting cannula is in the closed position.

2. The biopsy apparatus according to claim 1, wherein the cutter gear spindle set further includes a seal that seals the cutting cannula against the vent housing.

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

4. The biopsy apparatus according to claim 2 or 3, wherein the seal does not contact the vent housing when the cutting cannula is in the closed position, so that the fluid path defined through the plurality of channels is opened.

5. The biopsy apparatus according to any one of claims 2 to 4, wherein the fluid path extends distally from the air inlet at the proximal end of the sample notch cannula, around the seal of the cutter gear spindle set, and into the space between the cutting cannula and the sample notch cannula.

6. The biopsy apparatus according to any one of claims 2 to 5, wherein the seal is an O-ring.

7. The biopsy apparatus according to any one of claims 1 to 6, wherein the plurality of channels are positioned circumferentially around the vent housing.

8. The biopsy apparatus according to any one of claims 1 to 7, further comprising a puncture module coupled to the sample notched cannula for launching the sample notched cannula into an area of ​​dense tissue.

9. Vacuum assembly and, A probe having a sample notch cannula and a cutting cannula, wherein the cutting cannula is located internally within the sample notch cannula and can move between an open position in which the sample notch cannula is exposed to the external environment and a closed position in which the cutting cannula extends across the opening of the sample notch cannula. A vent housing for connecting the probe to the vacuum assembly, wherein the vacuum assembly is fluid-coupled to the sample notch cannula to generate a vacuum within the sample notch cannula when the cutting cannula is in the open position, and the vent housing defines a plurality of channels that allow the vacuum assembly to draw fluid into the space between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position. A biopsy probe assembly comprising:

10. The biopsy probe assembly according to 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 according to claim 10, wherein the cutter gear spindle further includes a seal for sealing the cutting cannula against the vent housing.

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

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

14. The biopsy probe assembly according to any one of claims 11 to 13, wherein the plurality of channels define fluid pathways extending distally from an air inlet at the proximal end of the sample notch cannula, around the seal of the cutter gear spindle, and into the space between the cutting cannula and the sample notch cannula.

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

16. A method for performing a biopsy, A biopsy device having a probe including a sample notch cannula, a cutting cannula, a cutter gear spindle set, and a cutting nut is inserted into a tissue sample, wherein the cutting cannula is located inside the sample notch cannula, and the cutter gear spindle set is coupled to the cutting cannula. In order to expose the sample notched cannula, the cutter gear spindle set is passed through the cutting nut to move the cutting cannula to the open position. The steps include creating a vacuum using a vacuum assembly located at the proximal end of the probe in order to draw the tissue sample into the sample notched cannula, The steps include moving the cutting cannula to the closed position by extending the cutter gear spindle set outside the cutting nut, closing the cutting cannula, and cutting the tissue sample that has been drawn into the sample notched cannula, The steps include: ventilating the space between the cutting cannula and the sample notch cannula, creating a vacuum through the space, and transporting the tissue sample into the sample basket located at the proximal end of the probe while the cutting cannula is in the closed position; Methods that include...

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

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

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

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

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

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