Biopsy device and method of performing biopsy therewith

Abstract

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

Description

Technical Field

[0001] This disclosure relates to biopsy devices, and more specifically, to single-insertion vacuum-assisted biopsy devices. Background Technology

[0002] Biopsies can be performed on subjects to obtain tissue for research (e.g., to determine if the tissue contains cancer cells). One biopsy technique for evaluating chest tissue involves, for example, inserting a biopsy sampler into a region of chest tissue of interest to obtain one or more tissue samples from that region. This biopsy technique often utilizes a vacuum to pull the tissue to be sampled into the sample notch of the biopsy sampler, then excises and collects the tissue. Efforts in the art continue to improve the biopsy apparatus's ability to excise tissue samples, transport the excised tissue samples to a sample basket, and collect multiple samples. Summary of the Invention

[0003] The purpose of this disclosure is to provide a biopsy apparatus that facilitates the efficient cutting and transport of tissue samples to a sample basket.

[0004] According to one aspect, a biopsy apparatus is disclosed. The biopsy apparatus includes a sample notch sleeve having a distal end and a proximal end, wherein the distal end includes a beveled edge. A cutting sleeve having a sharp edge at the distal end is located inside the sample notch sleeve. A cutter gear-spindle assembly drives the cutting sleeve between an open position and a closed position, and when the cutting sleeve is in the open position, a cutting nut receives the cutter gear-spindle. A vacuum assembly is connected to the cutting sleeve and fluidly coupled to the sample notch sleeve, and when the cutting sleeve is in the open position, the vacuum assembly generates a vacuum in the sample notch sleeve. A vent housing connects the proximal end of the sample notch sleeve to the vacuum assembly, and a sample basket is fluidly coupled to the cutting sleeve. The vent housing also includes a plurality of channels that define a fluid path through the sample notch sleeve and the cutting sleeve when the cutting sleeve is in the closed position.

[0005] In another embodiment, a biopsy sampler assembly is disclosed. The biopsy assembly includes a vacuum assembly and a sampler having a sample notch cannula and a cutting cannula. The cutting cannula is located inside the sample notch cannula and is movable between an open position and a closed position. In the open position, the sample notch cannula is open to the external environment, and in the closed position, the cutting cannula extends across the opening of the sample notch cannula. A vent housing connects the sampler to a 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 defines multiple channels that allow the vacuum assembly to aspirate fluid from the space between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0006] In another embodiment, a method for performing a biopsy is disclosed. The method involves inserting a biopsy device having a sampler into a tissue sample, the sampler including a sample notch cannula, a cutting cannula, a cutter gear-spindle, and a cutting nut, wherein the cutting cannula is located inside the sample notch cannula, and the cutter gear-spindle is coupled to the cutting cannula. The method further involves moving the cutting cannula to an open position to expose the sample notch cannula by screwing the cutter gear-spindle into the cutting nut, and generating a vacuum using a vacuum assembly located at the proximal end of the sampler to aspirate the tissue sample into the sample notch cannula. After the tissue sample has been aspirated into the sample notch cannula, the method includes moving the cutting cannula to a closed position by screwing the cutter gear-spindle out of the cutting nut to close the cutting cannula and cut the tissue sample aspirated into the sample notch cannula. The method then involves venting the space between the cutting cannula and the sample notch cannula such that, when the cutting cannula is in the closed position, the vacuum can transport the tissue sample to a sample basket located at the proximal end of the sampler.

[0007] These and additional features provided by the embodiments described herein will be more fully understood in light of the following detailed description taken in conjunction with the accompanying drawings. Attached Figure Description

[0008] The embodiments illustrated in the accompanying drawings are illustrative and exemplary in nature and are not intended to limit the subject matter as defined in the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, wherein similar structures are indicated by similar reference numerals, and in the drawings:

[0009] Figure 1 This is a front view of an illustrative biopsy apparatus according to one or more embodiments described herein, the biopsy apparatus having a driver assembly attached to a sampler assembly;

[0010] Figure 2 According to one or more embodiments described herein Figure 1 Bottom side view of the driver component;

[0011] Figure 3A According to one or more embodiments described herein Figure 1 A three-dimensional view of the sampler assembly inside the housing of the biopsy device;

[0012] Figure 3B According to one or more embodiments described herein Figure 3A Cross-sectional view;

[0013] Figure 4 According to one or more embodiments described herein Figure 1 A cross-sectional view of the sampler assembly;

[0014] Figure 5 According to one or more embodiments described herein Figure 1 A front cross-sectional view of the sampler assembly of the biopsy device along line 5-5;

[0015] Figure 6A It is in the open position according to one or more embodiments described herein. Figure 1 A partial cross-sectional view of the illustrative cutting sleeve of the sampler assembly of the biopsy device;

[0016] Figure 6B It is in a closed position according to one or more embodiments described herein. Figure 1 A partial cross-sectional view of the cutting sleeve of the sampler in a biopsy device;

[0017] Figure 7 A flowchart is provided illustrating an illustrative method for performing a biopsy according to one or more embodiments described herein.

[0018] Throughout the various views, corresponding reference numerals indicate the corresponding parts. The examples set forth herein illustrate at least one embodiment of this disclosure, and these examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0019] The embodiments disclosed herein relate to biopsy apparatuses and methods for performing biopsy procedures. For example, in some embodiments, the biopsy apparatus includes an actuator assembly, a sampler assembly, and a vacuum assembly. The actuator assembly may include a cutter module, a rotation module, and a puncture module. The actuator assembly may be operatively connected to the sampler assembly, which may include a sample notch cannula, a cutting cannula, a cutter gear-spindle assembly, a cutting nut, a sample notch gear, a vent housing, a seal, a sampler housing, and a sample basket. The vacuum assembly may be operatively connected to the proximal end of the sampler assembly such that tissue samples collected by the sampler assembly can be transported to the sample basket with the aid of a vacuum generated by the vacuum assembly. The cutter gear-spindle assembly provides synchronized rotation and linear motion of the cutting cannula, which reduces the need for multiple motors and / or valves used to operate the cutting cannula and perform tissue cutting sequences.

[0020] The vent housing may also include multiple channels that, when the cutting sleeve is in the closed (e.g., forward) position, allow a vacuum generated by the vacuum assembly to operate in the space between the sample notch sleeve and the cutting sleeve. By allowing vacuum flow through the multiple channels, the vacuum can be used to transport tissue samples through the cutting sleeve and into the sample basket. When the cutting sleeve is in the open (e.g., retracted) position, a seal can be used to seal the cutting sleeve to the vent housing, such that the vacuum generated by the vacuum assembly can aspirate tissue samples into the sample notch sleeve. In these embodiments, the seal may be operatively coupled to the cutter gear-spindle such that longitudinal movement of the cutter gear-spindle is translated into similar longitudinal movement of the seal. By moving the seal together with the cutter gear-spindle, fluid flow from the vacuum assembly can pass through the multiple channels and travel around the seal when the cutting sleeve is in the closed position, while the seal can force air to flow through the cutting sleeve when the cutting sleeve is in the open position.

[0021] It is worth noting that traditional sealing mechanisms may require spring-loaded operation, which can complicate the operation of biopsy devices. By integrating the seal into the cutter gear-spindle assembly and providing multiple channels on the venting housing, the rotational and linear motion of the cutter gear-spindle assembly can be used simultaneously to translate the seal between sealed and venting positions. Translating the seal via the cutter gear-spindle assembly further reduces the need for additional motors and / or valves commonly used in biopsy devices to obtain tissue samples.

[0022] Now refer to the attached diagram, or more specifically, refer to... Figure 1 The illustration shows a vacuum-assisted biopsy device 10 including a biopsy sampler assembly, which generally includes a non-invasive biopsy driver assembly 100 and an invasive sampler 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. Thus, a non-invasive device can be further considered as a non-disposable device used on multiple subjects during the device's lifetime. Conversely, the term "invasive" is used to refer to a device inserted into the body of a patient. Invasive devices can be further considered as "disposable" because these devices are designed to be discarded after use on a single subject. The biopsy driver assembly 100 can be releasably attached to the sampler assembly 200. As used herein, the term "releasably attached" means a configuration that facilitates a intended temporary connection followed by selective detachment, involving manipulation of the disposable sampler assembly 200 relative to the biopsy driver assembly 100 without the need for tools. Figure 1 As further shown, the biopsy device 10 may also include a vacuum assembly 300, which can be releasably coupled to the disposable sampler assembly 200.

[0023] Now for reference Figure 2 The image generally depicts the lower (or connecting) side of the biopsy driver assembly 100. The biopsy driver assembly 100 may include a driver housing 110 and multiple 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 puncture module 126. The cutter module 122 may include an electric 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 connector such that rotation of the shaft causes rotation of the drive gear 122b. The rotation module 124 includes an electric motor 124a having a shaft to which the drive gear 124b is attached. The puncture module 126 may include an electric motor 126a, a drive spindle 126b, and a puncture drive 126c. Each electric motor 122a, 124a, 126a can be, for example, a direct current (DC) motor or a stepper motor. Alternatively to the above arrangement, each of the cutter module 122, the rotation module 124, and the puncture module 126 may include one or more gears, gear trains, belt / pulley arrangements, etc., inserted between the respective motor and the drive gear or drive shaft. Furthermore, although the cutter module 122, the rotation module 124, and the puncture module 126 are described as electromechanically driven, it should be further understood that in some embodiments, the cutter module 122, the rotation module 124, and the puncture module 126 can be manually actuated. As depicted, in some embodiments, an opening may be formed within the actuator housing 110 to allow coupling to the sampler assembly 200.

[0024] Still referencing Figure 2 The puncture module 126, when assembled to the sampler assembly 200, is operable to pull one or more components of the sampler assembly 200 in a proximal (-x) direction and fire the sampler assembly 200 into the tissue site. For example, the puncture actuator 126c may engage one or more portions of the biopsy sampler assembly 200 connected to the sample notch cannula to retract and drive the sample notch cannula forward. Therefore, the puncture actuator 126c can be any structure that can extend into and engage with one or more portions of the biopsy sampler assembly for retracting and firing the sample notch cannula. For example, the puncture actuator 126c may include one or more protrusions 126d (e.g., forks) configured to extend into the biopsy sampler assembly 200 to the operably engaged sample notch cannula. The operation of the puncture module 126 will be described herein in additional detail.

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

[0026] Now for reference Figure 2 and Figure 3A In embodiments providing a sampler housing 210, the sampler housing 210 may be formed as an elongated member 212 having a front plate 214. The elongated member 212 may also include a plurality of retaining clips 212a, which may be configured to engage with a plurality of openings in the actuator housing. When the sampler assembly 200 is attached to the biopsy actuator assembly 100, the actuator assembly 100 may be initially positioned above the sampler assembly 200 such that the front surface of the biopsy actuator assembly 100 is aligned with the front plate 214 of the sampler assembly 200. Once the biopsy actuator assembly 100 is properly positioned, the front surface of the biopsy actuator assembly 100 may be lowered such that the surface contacts the sampler assembly 200. As the biopsy actuator assembly 100 is lowered, the plurality of openings of the biopsy actuator assembly 100 may engage the plurality of retaining clips 212a of the sampler assembly 200 to lock the biopsy actuator assembly 100 to the sampler assembly 200.

[0027] Now for reference Figure 3A and Figure 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 puncture tip 226, which may form a portion of the sample notch cannula 220. It should be noted that in some embodiments, the puncture 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 in the sidewall 220c of the sample notch cannula 220 to facilitate the reception of tissue into the lumen of the sample notch cannula 220. More specifically, when the sample notch cannula 220 is inserted into a target region, the sample notch 224 may receive a tissue sample aspirated into the sample notch cannula 224. The sample notch 224 may extend longitudinally along a longitudinal axis L. In some embodiments, the sample notch 224 may include a cut edge surrounding the periphery of the opening formed by the sample notch 224.

[0028] In some embodiments, the sample notch cannula 220 can be linearly translated between an engaged position and a disengaged position via the puncture module 126. In the engaged position, rotation of the puncture module 126 causes the sample notch cannula and the puncture actuator 126c to translate proximally in a consistent manner to position the puncture actuator 126c and the sample notch cannula 220 in a ready (i.e., cocked) position. The sample notch cannula 220 can then be released to achieve puncture firing, wherein the puncture module 126 can advance the sample notch cannula 220 and the puncture actuator 126c rapidly and consistently in a distal direction, such that the sample notch cannula 220 punctures tissue within the subject. This firing of the sample notch cannula 220 is particularly useful when performing biopsies on dense tissue, specifically where it is difficult to manually or slowly advance the sample notch cannula due to variations in tissue type and density.

[0029] Still referencing Figure 3A and Figure 3B As discussed above, by activating the rotation module 124, the sample notch 220 can be rotated about its longitudinal axis L. For example, when the sampler assembly 200 and the biopsy driver assembly 100 are attached, the drive gear 124b can engage the sample notch gear 222, such that rotation of the drive gear 124b subsequently rotates the sample notch gear 222. In these embodiments, the sample notch 220 can be rotated to multiple angular positions via the sample notch gear 222 to allow the biopsy device 10 to obtain tissue from multiple target sites around the sample notch 220 without requiring the user to manually rotate the position of the biopsy driver assembly 100. Now turning to Figure 3B and Figure 4 The cutting sleeve 230 can be coaxially positioned within the sample notch sleeve and may include a proximal end 230a and a distal end 230b. The distal end 230b may also include a sharp edge for cutting a tissue sample. The cutter gear-spindle assembly 232 may include a driven gear 232a, a cutting spindle 232b, and a threadless shoulder 232c. The cutting spindle 232b may be positioned on the proximal end of the cutter gear-spindle assembly 232, while the threadless shoulder 232c may be positioned on the distal end of the cutter gear-spindle assembly 232. In other embodiments, the components of the gear-spindle assembly 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 threadless shoulder 232c, such as... Figure 4 The cutter gear-spindle assembly 232 is most clearly illustrated here. It can be an integral assembly having a driven gear 232a fixedly attached to the cutting spindle 232b and a threadless shoulder 232c. In some embodiments, the cutter gear-spindle assembly 232 can be formed as a single molded component, while in other embodiments, the component can be formed separately.

[0030] The cutter gear-spindle assembly 232 can be fixedly attached (e.g., glued, welded, studded, etc.) to the proximal end 230a of the cutting sleeve. In these embodiments, the cutting sleeve 230 can be actuated between an open and closed position by activating the cutter module 122 of the biopsy actuator assembly 100, wherein the drive gear 122b of the cutter module 122 engages the driven gear 232a of the cutter gear-spindle assembly 232. To position the cutting sleeve 230 in the open position, the drive gear 122b of the cutter module 122 can rotate the driven gear 232a of the cutter gear-spindle assembly 232 in a first direction, such that the cutting spindle 232b is driven into the cutting nut 233 in the proximal direction. To move the cutting sleeve 230 to the closed position, the cutter module can rotate the driven gear 232a of the cutter gear-spindle assembly 232 in a second direction opposite to the first direction, causing the cutting spindle 232b to be driven in the distal direction and disengaged from the cutting nut 233. Therefore, the cutting sleeve 230 has a rotational cutting motion and axial translation along the longitudinal axis L. In these embodiments, the pitch of the thread of the cutting spindle 232b determines the number of revolutions per axial distance of axial movement of the cutting sleeve 230.

[0031] Still referencing Figure 3B and Figure 4 The sampler 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 passage 237 extending longitudinally from the first end 236a to the second end 236b. In these embodiments, the passage 237 of the vent housing 236 may receive a threadless shoulder 232c of the cutter gear-spindle assembly 232. A vent cap 240 may be coupled to the second end 236b of the vent housing 236 such that the vent cap 240 closes the passage 237 and creates a fluid-impermeable seal between the sample notch sleeve 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 sleeve 220 passes.

[0032] Now for reference Figure 4 and Figure 5 The vent housing 236 may also include a plurality of channels 238 that extend circumferentially around the passage 237 of the vent housing 236. The plurality of channels 238 may have a length C. L It extends longitudinally from the second end 236b of the vent housing 236 toward the first end 236a of the vent housing 236. For example... Figure 5As illustrated, the vent housing 236 may include six channels 238; however, it should be understood that the vent housing 236 may include any number of channels 238. Furthermore, Figure 5 The illustration shows multiple channels 238 that can be spaced 60 degrees apart in the circumferential direction. However, it should be understood that as long as multiple channels 238 exist, the multiple channels 238 can include any circumferential spacing, whether rotationally symmetric or not. For example, in some embodiments, the vent housing 236 can include twelve channels. In these embodiments, the twelve channels can be spaced 30 degrees apart in the circumferential direction surrounding channel 237.

[0033] Now for reference Figure 4 and Figure 5 The sample notch cannula 220 and the cutting cannula 230 can be arranged coaxially along the longitudinal axis L in a nested tube arrangement, wherein the cutting cannula 230 is the innermost tube and the sample notch cannula 220 is the outermost tube. The cutting cannula 230 can be coaxially arranged 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 allows fluids (such as air, saline, or anesthetic) to pass between the sample notch cannula 220 and the cutting cannula 230.

[0034] Fluid path 250 can be Figure 4 The clearest illustration is shown below. For ease of illustration, the fluid path 250 is depicted by multiple arrows. As shown, the fluid path extends from the atmospheric inlet 260 located on the proximal end 220b of the sample notch sleeve 220, passes through the passage 237 and multiple channels 238, and enters the space between the cutting sleeve 230 and the sample notch sleeve 220.

[0035] Refer again Figure 4 and Figure 5 The component can be configured to receive a seal 234, such as an O-ring, which can be used to control the passage of fluid through fluid path 250. Figure 4 As illustrated, a seal 234 can be disposed on the unthreaded shoulder 232c of the cutter gear-spindle assembly 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 unthreaded shoulder 232c of the cutter gear-spindle assembly 232, when the cutter gear-spindle assembly 232 is actuated between the open and closed positions, the seal 234 can move together with the cutter gear-spindle assembly 232 in the longitudinal direction (e.g., in…). Figure 4 The motion (in the + / -x direction as shown on the coordinate axes) is as described below in this article. Figures 6A to 6B A more detailed description.

[0036] Now go to Figure 6A The cutting sleeve 230 is illustrated in the open position. In the open position, the cutter gear-spindle assembly 232 can be fully retracted, causing the cutting sleeve 230 to retract and exposing the sample notch 224 of the sample notch sleeve 220. In this position, the seal 234 can contact the vent housing 236, thereby blocking 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 plurality of channels 238. Therefore, the seal 234 can block the communication between the fluid path 250 and the atmosphere, preventing fluid from crossing the fluid path 250 from the atmosphere and between the path 237, the cutting sleeve 230, and the sample notch sleeve 220.

[0037] In the event that the fluid path 250 is blocked by the seal 234, any fluid applied to the biopsy device 10 by the vacuum assembly 300 may be forced through the cutting sleeve 230 and into the exposed sample notch 224 of the sample notch sleeve 220, thereby creating a negative pressure within the sample notch 224. In these embodiments, when the cutting sleeve 230 is in the open position, the negative pressure acting on the sample notch 224 may cause tissue samples to be aspirated into the sample notch 224 of the sample notch sleeve 220.

[0038] Once a tissue sample has been obtained, the cutting cannula 230 can be actuated to the closed position, such as Figure 6B As illustrated in the diagram. In the closed position, the cutter spindle-gear set 232 can move forward, allowing the cutting sleeve 230 to move forward toward the sample notch 224 of the sample notch sleeve 220. The cutting sleeve 230 can continue to move forward across the sample notch 224, causing the sharp edge of the cutting sleeve 230 to cut off the tissue sample aspirated into the sample notch 224.

[0039] like Figure 6B As further illustrated, as the cutting sleeve 230 moves forward toward the distal end 220a of the sample notch sleeve 220, the seal 234 can similarly move longitudinally toward the distal end 220a of the sample notch sleeve 220. As the seal 234 moves toward the distal end 220a of the sample notch sleeve 220, the seal 234 can become disengaged from the vent housing 236. This disengagement of the seal 234 from the vent housing 236 exposes the passage 237 to the plurality of channels 238, which in turn opens the fluid path 250, which extends through the plurality of channels 238 and into the space between the sample notch sleeve 220 and the cutting sleeve 230.

[0040] With fluid path 250 open, fluid can flow from the atmosphere through atmospheric inlet 260 and into passage 237. As the fluid traverses the passage, it can flow around seal 234, through fluid path 250, and into the space between sample notch sleeve 220 and cutting sleeve 230. The fluid flowing through the space between sample notch sleeve 220 and cutting sleeve 230 can cause tissue samples cut by cutting sleeve 230 to be transported through cutting sleeve 230 and into the sample basket fluidly connected to the proximal end 230b of cutting sleeve 230.

[0041] Now for reference Figure 7 This describes an illustrative method 400 for performing a biopsy using a biopsy device. Initially, a biopsy driver assembly (such as biopsy driver assembly 100) may be coupled to a sampler assembly (such as sampler assembly 200), as shown in box 410. With the biopsy device assembled and coupled to a vacuum assembly, the method can proceed to box 420, where the biopsy device can be inserted or fired (as described above) into the target site. For example, the puncture tip 226 of the sample notch cannula 220 can puncture the tissue until the biopsy device 10 is positioned at the target site. Once the biopsy device is properly positioned, a cutter module is activated to drive the cutting cannula in a proximal direction and expose the 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 assembly 232 rearward, as shown in box 430. Specifically, the drive gear 122b can rotate clockwise, which in turn drives the driven gear 232a in the opposite counterclockwise direction. As the driven gear 232a rotates counterclockwise, the main shaft 232b can move in the proximal direction, causing the cutter gear-main shaft assembly 232 and the cutting sleeve 230 to move in the proximal direction. When the cutter gear-main shaft assembly 232 is driven backward, the cutting sleeve 230 retracts within the sample notch sleeve 220, opening the sample notch 224 of the sample notch sleeve 220.

[0042] The cutter gear-spindle assembly can be driven rearward until the cutting sleeve 230 is fully retracted within the sample notch sleeve 220, placing the cutting sleeve in the open position. With the cutting sleeve 230 in the open position, the seal 234 can contact the vent housing 236, blocking the fluid path 250 through the multiple channels 238 and into the space between the cutting sleeve 230 and the sample notch sleeve 220. In this position, the sample notch 224 of the sample notch sleeve 220 is fully exposed.

[0043] Once the sample gap has been exposed, the vacuum assembly can be activated, as shown in box 440. For example, vacuum assembly 300 can be activated to apply a vacuum to biopsy device 10. In the event that fluid path 250 is blocked, the vacuum can act through cutting sleeve 230 and enter sample gap 224, allowing tissue sample to be drawn into sample gap 224.

[0044] The method can then proceed to frame 450, where the cutting sleeve is driven forward to cut a tissue sample. For example, the cutter module 122 can drive the drive gear 122b in the opposite direction, causing the cutter gear-spindle assembly 232 to be driven forward or distally, thereby moving the cutting sleeve 230 distally toward the sample notch 224. As the cutting sleeve 230 moves across the sample notch 224, the tissue sample is removed from the target site. The seal 234 can move away from the vent housing 236, which allows fluid to pass through multiple channels 238 and into the fluid path 250 between the sample notch sleeve 220 and the cutting sleeve 230. As the fluid travels into the fluid path 250, a vacuum can be created proximally to pull the excised tissue through the cutting sleeve 230, causing the excised tissue sample to traverse the length of the cutting sleeve 230 and deposit in the sample basket 270. The sample basket 270 can store the excised tissue sample transported through the cutting sleeve 230 until a desired number of tissue samples have been removed. For example, in some embodiments, multiple tissue samples can be obtained from the same target site in a single procedure. In these embodiments, the method may further include rotating the sample notch sleeve 220 about its longitudinal axis L, such that the sample notch 224 is guided toward different circumferential positions within the target site. Once the sample notch sleeve 220 is actuated, additional tissue samples can be obtained. The sample notch sleeve 220 may be rotated and repositioned multiple times as needed to obtain a desired number of tissue samples. Once the desired number of tissue samples has been obtained, the vacuum assembly can be stopped, and the tissue samples can be collected from the sample basket, as shown in box 460.

[0045] As will be understood from the foregoing, embodiments herein relate to biopsy apparatuses and methods of performing biopsy procedures. A biopsy apparatus may include a driver assembly, a sampler assembly, and a vacuum assembly. The driver assembly may be operatively connected to the sampler assembly, which may include a sample notch sleeve, a cutting sleeve, a cutter gear-spindle assembly, a cutting nut, a sample notch gear, a vent housing, a seal, a sampler housing, and a sample basket. The vent housing may also include multiple channels that, when the cutting sleeve is in a closed (e.g., forward) position, allow a vacuum generated by the vacuum assembly to operate in the space between the sample notch sleeve and the cutting sleeve. The seal may be operatively coupled to the cutter gear-spindle such that longitudinal movement of the cutter gear-spindle is translated into similar longitudinal movement of the seal. By integrating the seal into the cutter gear-spindle assembly and providing multiple channels on the vent housing, rotational and linear movement of the cutter gear-spindle assembly can be used simultaneously to translate the seal between a sealed position and a vented position.

[0046] The embodiments can be further described with reference 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 sharp edge at its distal end and located within the sample notch cannula; a cutter gear-spindle assembly driving the cutting cannula between an open position and a closed position; a cutting nut receiving the cutter gear-spindle assembly 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 venting 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 venting housing including a 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.

[0048] 2. The biopsy apparatus according to Item 1, wherein the cutter gear-spindle assembly further includes a seal that seals the cutting sleeve to the vented housing.

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

[0050] 4. The biopsy apparatus according to item 2 or 3, wherein when the cutting sleeve is in the closed position, the seal does not contact the vent housing, such that the fluid path defined through the plurality of channels is open.

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

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

[0053] 7. The biopsy apparatus according to any one of items 1 to 6, wherein the plurality of channels are circumferentially positioned around the cutting sleeve.

[0054] 8. The biopsy device according to any one of items 1 to 7 further includes a puncture module connected to the sample notch cannula to fire the sample notch cannula into a region of dense tissue.

[0055] 9. A biopsy sampler assembly comprising: a vacuum assembly; a sampler having a sample notch cannula and a cutting cannula, the cutting cannula being located within the sample notch cannula and movable between an open position and a closed position, wherein in the open position the sample notch cannula is open to the external environment, and in the closed position the cutting cannula extends across an opening in the sample notch cannula; and a vent housing connecting the sampler 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 defining a plurality of channels that allow the vacuum assembly to aspirate fluid in the space between the sample notch cannula and the cutting cannula when the cutting cannula is in the closed position.

[0056] 10. The biopsy sampler assembly according to item 9 further includes a cutter gear-spindle rotatable to drive the cutting sleeve between an open position and a closed position.

[0057] 11. The biopsy sampler assembly according to item 10, wherein the cutter gear-spindle further includes a seal for sealing the cutting sleeve to the vented housing.

[0058] 12. The biopsy sampler assembly according to item 11, wherein when the cutting sleeve is in the open position, the seal contacts the vent housing such that the fluid path defined through the plurality of channels is blocked by the seal.

[0059] 13. The biopsy sampler assembly according to item 11 or 12, wherein when the cutting sleeve is in the closed position, the seal does not contact the vent housing, such that the fluid path defined through the plurality of channels is open.

[0060] 14. The biopsy sampler assembly according to any one of items 11 to 13, wherein the plurality of channels define a fluid path extending from an atmospheric inlet at the proximal end of the sample notch cannula, around the seal of the cutter gear-spindle, and distally extending into the space between the cutting cannula and the sample notch cannula.

[0061] 15. The biopsy sampler assembly according to any one of items 9 to 14, wherein the plurality of channels are circumferentially positioned around the cutting sleeve.

[0062] 16. A method of performing a biopsy, comprising: inserting a biopsy device having a sampler into a tissue sample, the sampler including a sample notch cannula, a cutting cannula, a cutter gear-spindle assembly, and a cutting nut, wherein the cutting cannula is located inside the sample notch cannula and the cutter gear-spindle assembly is coupled to the cutting cannula; moving the cutting cannula to an open position by screwing the cutter gear-spindle assembly into the cutting nut to expose the sample notch cannula; generating a vacuum using a vacuum assembly located at a proximal end of the sampler to draw the tissue sample into the sample notch cannula; moving the cutting cannula to a closed position by unscrewing the cutter gear-spindle assembly out of the cutting nut to close the cutting cannula and cut the tissue sample drawn into the sample notch cannula; and, when the cutting cannula is in the closed position, venting the space between the cutting cannula and the sample notch cannula to evacuate the space and transport the tissue sample to a sample basket located at a proximal end of the sampler.

[0063] 17. The method according to item 16 further includes sealing the cutting sleeve to the vent housing using the cutter gear-spindle assembly.

[0064] 18. The method according to item 17, wherein the cutting sleeve is sealed to the vented housing in the open position such that the space between the cutting sleeve and the sample notch sleeve is airtight.

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

[0066] 20. The method according to any one of items 16 to 19 further includes driving the cutter gear-spindle assembly with a motor to move the cutting sleeve between an open position and a closed position.

[0067] 21. The method according to any one of items 16 to 19, wherein the tissue sample is a first tissue sample, and the method further comprises, after venting the space between the cutting sleeve and the sample notch sleeve, rotating the sample notch sleeve to align with a second tissue sample.

[0068] The terminology used herein is for descriptive purposes only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” are also intended to include the plural forms, including “at least one,” unless the context explicitly states 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 should also be understood that “comprising” and / or “including,” when used in this specification, specify the presence of the described features, ranges, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, ranges, integers, steps, operations, elements, components, and / or groups thereof. The term “or a combination thereof” means a combination that includes at least one of the foregoing elements.

[0069] Note that the terms “substantially” and “approximately” may be used herein to indicate inherent uncertainty attributable to any quantitative comparison, value, measurement, or other representation. These terms are also used herein to indicate the extent to which a quantitative representation may differ from the stated reference without causing a fundamental change in the subject matter under discussion.

[0070] While specific embodiments have been shown 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. Furthermore, although various aspects of the claimed subject matter have been described herein, these aspects need not be used in combination. Therefore, the appended claims are intended to cover all such changes and modifications within the scope of the claimed subject matter.

Claims

1. A biopsy device, comprising: A sample notch sleeve, the sample notch sleeve including a sample notch and having a distal end and a proximal end; A cutting sleeve having a sharp edge at its distal end and located inside the sample notch sleeve; A cutter gear-spindle assembly that drives the cutting sleeve between an open position and a closed position; The cutting nut receives the cutter gear-spindle assembly when the cutting sleeve is in the open position. A vacuum assembly connected to the cutting sleeve and fluidly coupled to the sample notch sleeve to generate a vacuum within the sample notch sleeve when the cutting sleeve is in the open position; A vented housing that connects the proximal end of the sample notch sleeve to the vacuum assembly; as well as A sample basket, which is fluidly coupled to the proximal end of the cutting sleeve; The vented housing includes multiple channels that define a fluid path between the sample notch sleeve and the cutting sleeve when the cutting sleeve is in the closed position.

2. The biopsy device according to claim 1, wherein, The cutter gear-spindle assembly also includes a seal that seals the cutting sleeve to the vent housing.

3. The biopsy device according to claim 2, wherein, When the cutting sleeve is in the open position, the seal contacts the vent housing, thereby blocking the fluid path defined by the plurality of channels.

4. The biopsy device according to claim 2 or 3, wherein, When the cutting sleeve is in the closed position, the seal does not contact the vent housing, so that the fluid path defined by the plurality of channels is open.

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

6. The biopsy device according to any one of claims 2 to 5, wherein, The sealing element 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 device according to any one of claims 1 to 7, further comprising a puncture module connected to the sample notch cannula to fire the sample notch cannula into a region of dense tissue.

9. A biopsy sampler assembly, comprising: Vacuum components; A sampler having a sample notch sleeve and a cutting sleeve, the cutting sleeve being located inside the sample notch sleeve and movable between an open position and a closed position, wherein in the open position the sample notch sleeve is open to the external environment, and in the closed position the cutting sleeve extends across the opening of the sample notch sleeve; as well as A vent housing connects the sampler to the vacuum assembly, which is fluidly coupled to the sample notch sleeve to generate a vacuum in the sample notch sleeve when the cutting sleeve is in the open position. The vent housing defines a plurality of channels that allow the vacuum assembly to aspirate fluid from the space between the sample notch sleeve and the cutting sleeve when the cutting sleeve is in the closed position.

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

11. The biopsy sampler assembly of claim 10, wherein, The cutter gear-spindle also includes a seal for sealing the cutting sleeve to the vent housing.

12. The biopsy sampler assembly of claim 11, wherein, When the cutting sleeve is in the open position, the seal contacts the vent housing, thereby blocking the fluid path defined by the plurality of channels.

13. The biopsy sampler assembly according to claim 11 or 12, wherein, When the cutting sleeve is in the closed position, the seal does not contact the vent housing, so that the fluid path defined by the plurality of channels is open.

14. The biopsy sampler assembly according to any one of claims 11 to 13, wherein, The plurality of channels define a fluid path that extends from an atmospheric inlet at the proximal end of the sample notch sleeve, around the seal of the cutter gear-spindle, and extends distally into the space between the cutting sleeve and the sample notch sleeve.

15. The biopsy sampler 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, comprising: A biopsy device with a sampler is inserted into a tissue sample. The sampler includes a sample notch sleeve, a cutting sleeve, a cutter gear-spindle assembly, and a cutting nut. The cutting sleeve is located inside the sample notch sleeve, and the cutter gear-spindle assembly is connected to the cutting sleeve. The cutting sleeve is moved to the open position by screwing the cutter gear-spindle assembly into the cutting nut to expose the sample notch sleeve; A vacuum is generated using a vacuum assembly located at the proximal end of the sampler to aspirate tissue samples into the sample notch cannula. The cutting sleeve is moved to the closed position by unscrewing the cutting nut from the cutter gear-spindle assembly, thereby closing the cutting sleeve and cutting the tissue sample aspirated into the sample notch sleeve; and When the cutting sleeve is in the closed position, the space between the cutting sleeve and the sample notch sleeve is vented to create a vacuum through the space and transport the tissue sample to the sample basket located on the proximal end of the sampler.

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

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

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

20. The method according to any one of claims 16 to 19, further comprising driving the cutter gear-spindle assembly with a motor to move the cutting sleeve between an open position and a 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 includes, after venting the space between the cutting sleeve and the sample notch sleeve, rotating the sample notch sleeve to align it with a second tissue sample.

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