Biopsy device with multiple air paths for venting - Patent application

Abstract

The biopsy device includes a biopsy probe assembly having a cutter cannula, a vacuum cannula, and a stylet cannula arranged coaxially. The vacuum cannula is positioned inside the stylet cannula to define a first intermediate lumen. The stylet cannula is positioned within the cutter cannula to define a second intermediate lumen. The stylet cannula is movable relative to the vacuum cannula and the cutter cannula between an extended position and a retracted position. The stylet cannula has a longitudinal vent slot. The seal has a proximal seal portion. When the stylet cannula is moved from the extended position toward the retracted position, the longitudinal vent slot is positioned longitudinally below the proximal seal portion to open a seal bypass pathway across the proximal seal portion to establish a first air pathway in the first intermediate lumen and a second air pathway in the second intermediate lumen.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of co-pending U.S. Provisional Patent Application No. 63 / 135256, filed January 8, 2021, for "Biopsy Apparatus Having Multiple Air Paths for Venting," which is incorporated herein by reference in its entirety.

[0002]

[0002] The present disclosure relates to biopsy devices, and more particularly to single-insertion multiple-sample biopsy apparatus. [Background technology]

[0003]

[0003] A biopsy may be performed on a patient to help determine whether tissue within a region of interest contains cancer cells. For example, one biopsy technique used to evaluate breast tissue involves inserting a biopsy probe into the breast tissue region of interest and capturing one or more tissue samples from that region. Such biopsy techniques often utilize a vacuum to draw the tissue to be sampled into a sample notch in the biopsy probe, after which the tissue is cut and collected. There is a continuing effort in the art to improve the ability of biopsy devices to cut tissue samples and to transport the cut tissue samples to a sample collection container.

[0004] What is needed in the art is a biopsy device that has the ability to facilitate effective cutting of a tissue sample and effective transport of the tissue sample to a sample collection container. Summary of the Invention [Means for solving the problem]

[0005] In one embodiment, a biopsy device includes a biopsy probe assembly having a cutter cannula, a vacuum cannula, and a stylet cannula coaxially arranged along a longitudinal axis. The vacuum cannula is positioned inside the stylet cannula to define a first intermediate lumen therebetween. The stylet cannula is positioned within the cutter cannula to define a second intermediate lumen therebetween. The vacuum cannula has a vacuum lumen. The stylet cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position. The stylet cannula has a plurality of vent openings, the plurality of vent openings including at least one longitudinal vent slot. The biopsy device also includes a seal having a proximal seal portion and a distal seal portion, the distal seal portion having a distal seal lip positioned to radially engage an outer diameter of the cutter cannula, and the proximal seal portion having a proximal seal lip positioned to radially engage an outer diameter of the stylet cannula. When the stylet cannula is moved from the first extended position toward the first retracted position, the at least one longitudinal vent slot is positioned longitudinally below the proximal seal lip of the proximal seal portion of the seal to open a seal bypass pathway across the longitudinal extension of the proximal seal lip of the proximal seal portion of the seal to establish both a first air pathway in a first intermediate lumen between the outer diameter of the vacuum cannula and the inner diameter of the stylet cannula, and a second air pathway in a second intermediate lumen between the inner diameter of the cutter cannula and the outer diameter of the stylet cannula. The first and second air pathways are in fluid communication with the proximal region of the seal.

[0006] In another embodiment, a method includes applying a vacuum to a lumen of a stylet cannula of a biopsy device at a sample notch of the stylet cannula via a vacuum cannula of the biopsy device. The cutter cannula, vacuum cannula, and stylet cannula of the biopsy device are coaxially arranged along a longitudinal axis. The vacuum cannula is positioned inside the stylet cannula to define a first intermediate lumen therebetween, and the stylet cannula is positioned within the cutter cannula to define a second intermediate lumen therebetween, and the vacuum cannula has a vacuum lumen. The stylet cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position. The stylet cannula has a plurality of vent openings, the plurality of vent openings including at least one longitudinal vent slot. The biopsy device includes a seal having a proximal seal portion and a distal seal portion, the distal seal portion having a distal seal lip positioned to radially engage an outer diameter of the cutter cannula, and the proximal seal portion having a proximal seal lip positioned to radially engage an outer diameter of the stylet cannula. The method also includes moving the stylet cannula toward a first retracted position to move the cut tissue sample into the vacuum cannula. When the stylet cannula is moved toward the first retracted position, at least one longitudinal vent slot is positioned longitudinally below the proximal seal lip of the proximal seal portion of the seal to open a seal bypass pathway across a longitudinal extension of the proximal seal lip of the proximal seal portion of the seal to establish both a first air pathway in a first intermediate lumen between the outer diameter of the vacuum cannula and an inner diameter of the stylet cannula, and a second air pathway in a second intermediate lumen between the inner diameter of the cutter cannula and the outer diameter of the stylet cannula. The first air pathway and the second air pathway are in fluid communication with a proximal region of the seal.

[0007]

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

[0008]

[0008] The above and other features and advantages of the present disclosure, as well as the manner in which they are obtained, will become more apparent and the present disclosure will be better understood by referring to the following description of embodiments of the present disclosure, together with the accompanying drawings. [Brief explanation of the drawings]

[0009] [Figure 1]

[0009] FIG. 1 is a perspective view of a biopsy device configured in accordance with one embodiment of the present disclosure, with a biopsy probe assembly attached to a biopsy driver assembly. [Figure 2]

[0010] 2 is a perspective view of the biopsy device of FIG. 1 with the biopsy probe assembly detached from the biopsy driver assembly and the top cover of the biopsy driver assembly removed to expose the puncture module of the biopsy driver assembly. [Figure 2A]

[0011] 3 is a bottom view of the biopsy driver assembly of FIG. 2 with the biopsy driver assembly inverted from the orientation shown in FIG. 2. [Figure 3]

[0012] FIG. 2 is a block representation of the biopsy driver assembly of FIG. 1. [Figure 4]

[0013] FIG. 2 is an exploded view of the biopsy probe assembly of FIG. 1. [Figure 5A]

[0014] 5A is a cross-sectional view of the biopsy probe assembly of FIG. 1 taken along line 5A-5A of FIG. 2. [Figure 5B]

[0015] FIG. 5B shows an enlarged portion of the vacuum cannula shown in FIG. 5A. [Figure 5C]

[0016] FIG. 5B shows an enlarged portion of the stylet cannula shown in FIG. 5A. [Figure 6A]

[0017] 10A-10C illustrate the relative positions of the vacuum cannula, stylet cannula, and cutter cannula before, during, and immediately after the puncture shot. [Figure 6B]

[0018] FIG. 10 illustrates the relative positions of the vacuum cannula, stylet cannula, and cutter cannula with the cutter cannula retracted to expose the sample notch in the stylet cannula. [Figure 6C]

[0019] FIG. 10 shows the relative positions of the vacuum cannula, stylet cannula, and cutter cannula, illustrating shaking of the sample notch by alternating proximal and distal movement of the stylet cannula over short distances. [Figure 6D]

[0020] FIG. 10 shows the relative positions of the vacuum cannula, stylet cannula, and cutter cannula, with the cutter cannula rotated and translated distally to cut a tissue sample from tissue received in the sample notch. [Figure 6E]

[0021] FIG. 10 shows the relative positions of the vacuum cannula, stylet cannula, and cutter cannula, where the stylet cannula is moved proximally through the cutter cannula to mechanically assist in moving the tissue sample into the flared portion of the vacuum cannula. [Figure 6F]

[0022] FIG. 10 shows the relative positions of the vacuum cannula, stylet cannula, and cutter cannula, with the stylet cannula being moved distally through the cutter cannula to release the projection member from the flared portion of the vacuum cannula. [Figure 6G]

[0023] FIG. 10 shows the relative positions of the vacuum cannula, stylet cannula, and cutter cannula with the stylet cannula again moved proximally through the cutter cannula and the protruding member re-engaging the flared portion of the vacuum cannula. [Figure 6H]

[0024] FIG. 10 shows the relative positions of the vacuum cannula, stylet cannula, and cutter cannula, with the stylet cannula again moved distally through the cutter cannula to release the protrusion member from the flared portion of the vacuum cannula and return to the extended position. [Figure 7]

[0025] 6A-6H are (normalized) vacuum / time graphs showing baseline vacuum pressure at several different locations during the tissue sample cutting and transport sequence as shown in FIGS. 6A-6H. [Figure 8]

[0026] FIG. 10 is a perspective view of a stylet cannula showing two diametrically opposed longitudinal vent slots. [Figure 8A]

[0027] 8A is a cross-sectional view of the stylet cannula taken along line 8A-8A of FIG. 8, showing the arrangement of vent openings including two diametrically opposed longitudinal vent slots and a plurality of circular vent holes. [Figure 9]

[0028] 6E is a side view of the biopsy probe assembly of FIG. 2 including an introducer cannula and with a stylet cannula positioned substantially as in FIG. 6D. [Figure 10]

[0029] 10 is an enlarged cross-sectional view of a portion of the biopsy probe assembly taken along line 10-10 of FIG. 9. [Figure 11]

[0030] 11 is a further enlarged view of a portion of the cross-sectional view of FIG. 10 showing the first and second air paths. [Figure 12]

[0031] 6F is a side view of the biopsy probe assembly of FIG. 2 including an introducer cannula and with a stylet cannula positioned substantially as in FIG. 6E. [Figure 13]

[0032] 13 is an enlarged cross-sectional view of a portion of the biopsy probe assembly taken along line 13-13 of FIG. 12. [Figure 14]

[0033] FIG. 14 is a further enlarged view of a portion of the cross-sectional view of FIG. 13 showing the first and second air paths. [Figure 15]

[0034] 6E is a cross-sectional view of a portion of the biopsy probe assembly of FIG. 2 with the protruding member of the piercing tip of the stylet cannula positioned slightly distal to the retracted position shown in FIG. 6E and showing the combined air flow formed from the combination of air flows from the first and second air paths. DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0035] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications presented herein illustrate at least one embodiment of the present disclosure, and such exemplifications should not be construed as limiting the scope of the present application in any way.

[0011]

[0036] 1 and 2, there is shown a biopsy device 10 that generally includes a non-invasive (e.g., non-disposable) biopsy driver assembly 12 and an invasive (e.g., disposable) biopsy probe assembly 14. As used herein, the term "non-disposable" is used to describe a device intended for use on multiple patients over the device's lifetime, and the term "disposable" is used to describe a device intended to be discarded after use on a single patient. The biopsy driver assembly 12 includes a driver housing 16 that is configured and ergonomically designed to be grasped by a user.

[0012]

[0037] 2 and 3, biopsy driver assembly 12 includes, within driver housing 16, controller circuitry 18, electromechanical power source 20, vacuum source 22, vacuum sensor 24, and battery 26 (or alternatively, an AC adapter). A user interface 28 (see FIG. 1), such as a keypad, is positioned to be attached to driver housing 16 and is externally accessible with respect to driver housing 16 by a user. Battery 26 can be, for example, a rechargeable battery, which can be charged by an electromagnetic induction charging device coupled to induction coil 29 or, alternatively, by an electrical connection to a power source. Battery 26 is electrically coupled to controller circuitry 18, electromechanical power source 20, vacuum source 22, and user interface 28.

[0013]

[0038] 3 , user interface 28 may include control buttons and visual / auditory indicators that provide user control over various functions of biopsy device 10 and visual / auditory indicators that provide visual / auditory feedback of the status of one or more conditions and / or positions of components of biopsy device 10. The control buttons may include a sample button 28-1 and a prime / puncture button 28-2. The visual indicators may include a display screen 28-3 and / or one or more light-emitting diodes (LEDs) 28-4. The auditory indicators may include a buzzer 28-5. The control buttons may include tactile feedback to the user when activated.

[0014]

[0039] Controller circuit 18 is electrically and communicatively coupled, for example, by one or more wires or circuit traces, to electromechanical power source 20, vacuum source 22, vacuum sensor 24, and user interface 28. Controller circuit 18 may be assembled on an electrical circuit board and includes, for example, processor circuit 18-1 and memory circuit 18-2.

[0015]

[0040] Processor circuit 18-1 has one or more programmable microprocessors and associated circuits, such as input / output interfaces, clocks, buffers, memory, etc. Memory circuit 18-2 is communicatively coupled to processor circuit 18-1, for example, via bus circuits, and is non-transitory electronic memory, which can include volatile memory circuits, such as random access memory (RAM), and non-volatile memory circuits, such as read-only memory (ROM), electronically erasable programmable ROM (EEPROM), NOR flash memory, NAND flash memory, etc. Controller circuit 18 can be formed as one or more application-specific integrated circuits (ASICs).

[0016]

[0041] Controller circuit 18 is configured, via software and / or firmware present in memory circuit 18-2, to execute program instructions that perform functions associated with retrieving a biopsy tissue sample, such as functions to control and / or monitor one or more components of electromechanical power source 20, vacuum source 22, and vacuum sensor 24.

[0017]

[0042] The electromechanical power source 20 may include, for example, a cutter module 30, a transport module 32, and a lancing module 34, each of which is electrically coupled to the battery 26. Each of the cutter module 30, the transport module 32, and the lancing module 34 is electrically and controllably coupled to the controller circuit 18 by one or more electrical conductors, e.g., wires or circuit traces.

[0018]

[0043] The cutter module 30 may include an electric motor 30-1 having a shaft, with a drive gear 30-2 attached to the shaft. The transport module 32 may include an electric motor 32-1 having a shaft, with a drive gear 32-2 attached to the shaft. The puncture module 34 may include an electric motor 34-1, a drive spindle 34-2, and a puncture shot drive 34-3. Each electric motor 30-1, 32-1, 34-1 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 30, transport module 32, and puncture module 34 may include one or more gears, gear trains, belt / pulley arrangements, etc., interposed between the respective motors and the drive gear or drive spindle.

[0019]

[0044] The lancing module 34 is configured such that actuation of the electric motor 34-1 and drive spindle 34-2 causes the puncture shot drive 34-3 to move in a proximal direction 36-1 to compress a firing spring, e.g., one or more coil springs, and to latch the puncture shot drive 34-3 into the ready position. Actuation of the prime / puncture button 28-2 on the user interface 28 propels, or fires, the puncture shot drive 34-3 in a distal direction 36-2 (see FIG. 1 ).

[0020]

[0045] The vacuum source 22 is electrically and controllably coupled to the battery 26 by one or more electrical conductors, e.g., wires or circuit traces. The vacuum source 22 may include, for example, an electric motor 22-1 that drives a vacuum pump 22-2. The vacuum source 22 has a vacuum source port 22-3 that is coupled to the vacuum pump 22-2 for establishing a vacuum within the biopsy probe assembly 14. The electric motor 22-1 may be, for example, a rotary DC motor, a linear DC motor, or an oscillating DC motor. The vacuum pump 22-2 may be, for example, a peristaltic pump or a diaphragm pump, or one or more of each connected in series or parallel.

[0021]

[0046] Vacuum sensor 24 is electrically coupled to controller circuit 18 by one or more electrical conductors, e.g., wires or circuit traces. Vacuum sensor 24 can be a differential pressure sensor, which provides a vacuum (negative pressure) feedback signal to controller circuit 18. In some implementations, vacuum sensor 24 can be integrated into vacuum source 22.

[0022]

[0047] 1 and 2, the biopsy probe assembly 14 is configured for releasable attachment to the biopsy driver assembly 12. As used herein, the term "releasable attachment" refers to a configuration that facilitates an intended temporary connection followed by selective detachment with manipulation of the disposable biopsy probe assembly 14 relative to the biopsy driver assembly 12 without the need for tools.

[0023]

[0048] Referring to the exploded view of FIG. 4 , biopsy probe assembly 14 includes a probe housing 40, a probe sub-housing 42, a vacuum cannula 44, a stylet cannula 46, a stylet gear-spindle set 48 for linear stylet translation, a cutter cannula 50, a cutter gear-spindle set 52 for rotational and linear cutter translation, a sample manifold 54, and a sample cup 56.

[0024]

[0049] 2, 4, and 5A, the probe housing 40 is formed as an L-shaped structure having an elongated portion 40-1 and a front plate 40-2. When the biopsy probe assembly 14 is attached to the biopsy driver assembly 12, the front plate 40-2 is positioned adjacent to and distal to the entire front surface 16-1 of the driver housing 16, i.e., shielding the entire front surface 16-1 of the non-disposable driver assembly from contact with the patient.

[0025]

[0050] Vacuum cannula 44, stylet cannula 46, and cutter cannula 50 are coaxially arranged along longitudinal axis 58 in a nested tube arrangement, with vacuum cannula 44 being the innermost tube, cutter cannula 50 being the outermost tube, and stylet cannula 46 being an intermediate tube interposed between vacuum cannula 44 and cutter cannula 50. In other words, vacuum cannula 44 is positioned inside stylet cannula 46, which is positioned inside cutter cannula 50.

[0026]

[0051] Vacuum cannula 44 is mounted stationarily relative to probe sub-housing 42. Vacuum cannula 44 is coupled in fluid communication with vacuum source 22 via sample manifold 54.

[0027]

[0052] 4, 5A, and 5B, the vacuum cannula 44 includes an elongated portion 44-1, a flared portion 44-2 extending distally from the elongated portion 44-1, and a vacuum lumen 44-3. The elongated portion 44-1 has a first outer diameter D1. The flared portion 44-2 flares from the elongated portion 44-1 in two stages, a first flared portion 45-1 and a second flared portion 45-2. The first flared portion 45-1 diverges from the elongated portion 44-1 at a first acute angle A1, and the second flared portion 45-2 diverges from the first flared portion 45-1 at a second acute angle A2 relative to the elongated portion 44-1, the acute angle A2 being greater than the acute angle A1. The distal outer diameter D2 of the second flared portion 45-2 is selected to be received within and in sliding contact with the lumen 46-4 of the stylet cannula 46. The first and second flared portions 45-1, 45-2 of the flared portion 44-2 each have a distally and gradually increasing diameter that is greater than the diameter D1 of the elongated portion 44-1.

[0028]

[0053] 4 and 5A, the stylet cannula 46 includes a proximal portion 46-1 and a distal portion 46-2. The distal portion 46-2 includes a sample notch 60. Attached to the distal portion 46-2 is a piercing tip 62, which forms part of the stylet cannula 46. The stylet gear-spindle set 48 threadably engages the external threads of a transport spindle 46-5, which is fixedly attached (e.g., glued, welded, or staked) to the proximal portion 46-1 of the stylet cannula 46. The stylet gear-spindle set 48 is a unitary gear having a driven gear 48-1 fixedly attached to a threaded spindle 48-2, and may be formed as a single molded component. The stylet cannula 46 is retracted or extended along the longitudinal axis 58 by actuation of the transport module 32 of the biopsy probe assembly 14, with the drive gear 32-2 of the transport module 32 of the biopsy driver assembly 12 engaged with the driven gear 48-1 of the stylet gear-spindle set 48.

[0029]

[0054] 5C, 6A, and 6B, the sample notch 60 is formed as an elongated opening in the sidewall 46-3 of the stylet cannula 46 to facilitate receipt of tissue 66 into the lumen 46-4 of the stylet cannula 46. The sample notch 60 has a longitudinal extension 60-1 extending along the longitudinal axis 58. The sample notch 60 does not extend into the sidewall 46-3 below the diametric centerline of the stylet cannula 46 and may include cutting edges around the periphery of the opening formed by the sample notch 60, with the cutting edges of the elongated (straight) portions of the sample notch 60 each having cutting edges that diverge from the cutting edge along the sidewall 46-3 to the diametric centerline of the stylet cannula 46.

[0030]

[0055] The puncture tip 62 has a tip portion 62-1, an attachment portion 62-2, and a protrusion member 62-3. The puncture tip 62 is inserted into the lumen 46-4 of the stylet cannula 46 at its distal portion 46-2, and the attachment portion 62-2 is attached to the distal portion 46-2 of the stylet cannula 46, such as by adhesive or welding. As such, the tip portion 62-1 extends distally from the distal portion 46-2 of the stylet cannula 46, and the protrusion member 62-3 extends proximally (i.e., in the proximal direction 36-1) into the lumen 46-4 along a portion of the longitudinal extension 60-1 of the sample notch 60. 6E and 6G, when the stylet cannula 46 is fully retracted in the proximal direction 36-1, the projection member 62-3 is received into the flared portion 44-2 of the vacuum cannula 44. At least a proximal tip portion of the projection member 62-3 has a proximally decreasing diameter.

[0031]

[0056] Referring again to FIG. 4 , cutter cannula 50 includes a proximal portion 50-1 and a distal portion 50-2. Distal portion 50-2 includes an annular cutting edge 64. Cutter gear-spindle set 52 is fixedly attached (e.g., glued, welded, or pinned) to proximal portion 50-1 of cutter cannula 50. Cutter gear-spindle set 52 is a unitary gear having driven gear 52-1 fixedly attached to threaded spindle 52-2 and may be formed as a single molded component. Cutter cannula 50 is retracted or extended along longitudinal axis 58 by actuation of cutter module 30 of biopsy probe assembly 14, with drive gear 30-2 of cutter module 30 of biopsy driver assembly 12 engaged with driven gear 52-1 of cutter gear-spindle set 52. Cutter cannula 50 therefore has a rotational cutting motion and is translated axially along longitudinal axis 58. The pitch of the threads on threaded spindle 52-2 determines the number of rotations per axial distance (in millimeters (mm)) that cutter cannula 50 moves axially.

[0032]

[0057] 4 and 5A, the sample manifold 54 is configured as an L-shaped structure having a vacuum chamber portion 54-1 and a collection chamber portion 54-2. The vacuum chamber portion 54-1 includes a vacuum input port 54-3 that is positioned to sealably engage the vacuum source port 22-3 of the vacuum source 22 of the biopsy driver assembly 12 when the biopsy probe assembly 14 is attached to the biopsy driver assembly 12. The vacuum chamber portion 54-1 is connected in fluid communication with the collection chamber portion 54-2. The proximal end of the elongated portion 44-1 of the vacuum cannula 44 passes through the vacuum chamber portion 54-1 and is in direct fluid communication with the collection chamber portion 54-2. Collection chamber portion 54-2 has a cavity sized and positioned to removably receive sample cup 56 such that sample cup 56 is in direct fluid communication with elongated portion 44-1 of vacuum cannula 44 and also in direct fluid communication with vacuum input port 54-3 of vacuum chamber portion 54-1. Blotter paper is placed within vacuum chamber portion 54-1 in the region between vacuum input port 54-3 and collection chamber portion 54-2.

[0033]

[0058] Thus, a tissue sample cut by cutter cannula 50 at sample notch 60 of stylet cannula 46 can be transported through vacuum cannula 44 and into sample cup 56 by the vacuum applied by vacuum source 22 at sample cup 56.

[0034]

[0059] 2, 4, and 5A, the probe sub-housing 42 (e.g., a probe carrier body portion) is a sub-housing that is slidably coupled to the probe housing 40, for example, using a rail and slot arrangement. The probe sub-housing 42 includes a proximal threaded portion 42-1 and a distal threaded portion 42-2. The probe sub-housing 42 is also configured to be drivably coupled to the puncture module 34. In other words, when the biopsy driver assembly 12 is coupled to the biopsy probe assembly 14 to form the biopsy device 10, the puncture module 34 is drivably coupled to the probe sub-housing 42.

[0035]

[0060] The probe sub-housing 42 includes one or more lancing module engagement openings (e.g., slots). In this embodiment, referring to FIGS. 2 and 2A , the probe sub-housing 42 includes a lancing module engagement opening 42-3 and a lancing module engagement opening 42-4, each of which is configured, e.g., in terms of size and shape, to receive a respective drive protrusion 34-5, 34-6 of the puncturing shot drive 34-3 of the puncturing module 34, thereby realizing longitudinal movement of the probe sub-housing 42 in unison with longitudinal movement of the puncturing shot drive 34-3 during a puncturing shot (firing) operation. For example, each of the lancing module engagement openings 42-3 and 42-4 can be a respective rectangular slot. While this embodiment includes two lancing module engagement openings for symmetry and / or redundancy, alternative embodiments can have, for example, only one lancing module engagement opening (e.g., the lancing module engagement opening 42-3).

[0036]

[0061] The threaded proximal portion 42-1 in the probe sub-housing 42 has a threaded bore that threadably receives the threaded spindle 48-2 of the stylet gear-spindle set 48 such that rotation of the driven gear 48-1 of the stylet gear-spindle set 48 results in linear translation of the stylet cannula 46 along the longitudinal axis 58, the direction of rotation correlating with the direction of translation of the stylet cannula 46 in one of the proximal and distal directions 36-1, 36-2. The driven gear 48-1 of the stylet gear-spindle set 48 engages the drive gear 32-2 of the transport module 32 when the biopsy probe assembly 14 is attached to the biopsy driver assembly 12 (see FIG. 1 ).

[0037]

[0062] Similarly, the threaded distal portion 42-2 of the probe sub-housing 42 has a threaded bore that threadably receives the threaded spindle 52-2 of the cutter gear-spindle set 52, such that rotation of the driven gear 52-1 of the cutter gear-spindle set 52 results in combined rotation and linear translation of the cutter cannula 50 along a longitudinal axis 58, the direction of rotation correlating with the direction of translation of the cutter cannula 50. The driven gear 52-1 of the cutter gear-spindle set 52 engages the drive gear 30-2 of the cutter module 30 when the biopsy probe assembly 14 is attached to the biopsy driver assembly 12 (see FIG. 1).

[0038]

[0063] 2 and 3, when the biopsy probe assembly 14 is attached to the biopsy driver assembly 12, the probe sub-housing 42 is connected to the puncture shot drive 34-3 of the puncture module 34. As such, upon a first actuation of the prime / puncture button 28-2, the probe sub-housing 42 and the puncture shot drive 34-3 are translated in unison in the proximal direction 36-1 to position the puncture shot drive 34-3 and the probe sub-housing 42, carrying the stylet cannula 46 and the cutter cannula 50, in a cocked position, and upon a second actuation of the prime / puncture button 28-2 to deliver the puncture shot, the probe sub-housing 42 and the puncture shot drive 34-3 are rapidly propelled in unison in the distal direction 36-2 to position the stylet cannula 46 and the cutter cannula 50 at the distal-most position of the combined elements, e.g., within the patient.

[0039]

[0064] Figures 6A-6H collectively depict the tissue sample cutting and transport sequence. Figures 6E and 6G show the stylet cannula 46 in its retracted position 68-1. Figures 6A, 6B, and 6H show the stylet cannula 46 in its extended position 68-2, sometimes referred to as the zero position. Figures 6C, 6D, and 6F show the stylet cannula 46 in various positions intermediate the retracted position 68-1 and the extended position 68-2. Figures 6B and 6C show the cutter cannula 50 in its retracted position 70-1, which exposes the sample notch 60 of the stylet cannula 46 when the stylet cannula 46 is at or near its extended position 68-2. 6A and 6D-6H show the cutter cannula 50 in its extended position 70-2, sometimes referred to as the zero position, in which the cutter cannula 50 covers the sample notch 60 of the stylet cannula 46.

[0040]

[0065] To achieve the described movement of the stylet cannula 46, the controller circuit 18 executes program instructions and sends respective control signals to the transport module 32 of the biopsy driver assembly 12, which transmits motion to the stylet gear-spindle set 48 of the biopsy probe assembly 14. Similarly, to achieve the described movement of the cutter cannula 50, the controller circuit 18 executes program instructions and sends respective control signals to the cutter module 30 of the biopsy driver assembly 12, which transmits motion to the cutter gear-spindle set 52 of the biopsy probe assembly 14. The controller circuit 18 can determine the axial positions of the stylet cannula 46 and the cutter cannula 50 relative to their respective zero positions by counting the respective number of motor drive pulses or, alternatively, the respective number of motor shaft rotations.

[0041]

[0066] 6A shows the relative positions of vacuum cannula 44, stylet cannula 46, and cutter cannula 50 before, during, and immediately after a puncture shot achieved by puncture module 34. As shown, distal portion 50-2 of cutter cannula 50 is extended over sample notch 60.

[0042]

[0067] 6B , the vacuum source 22 is actuated to deliver vacuum via the vacuum cannula 44 to the lumen 46-4 of the stylet cannula 46 at the sample notch 60, and the cutter cannula 50 is retracted by actuation of the cutter module 30, exposing the sample notch 60 and allowing tissue 66 to be drawn through the sample notch 60 and into the lumen 46-4 of the stylet cannula 46. In this embodiment, to expose the sample notch 60, the cutter cannula 50 is rotated counterclockwise, achieving linear translation of the cutter cannula 50 in the proximal direction 36-1 over a distance of approximately 23 millimeters (mm), defining the opening length of the sample notch 60. As used herein, the relative term “approximately” means plus or minus 5 percent of a base value in the units (if any) indicated, unless otherwise stated. The actual opening size in the sample notch 60 (corresponding to the desired sample size) can be user-selected in the user interface 28, and the distance that the cutter cannula 50 is retracted from the extended position 70-2 toward the retracted position 70-1 is controlled by the controller circuit 18 to correspond to the sample size selected by the user.

[0043]

[0068] 6C and 6D illustrate the cutting sequence.

[0069] In the sequence step illustrated in FIG. 6C , to increase the size of the tissue sample collected, the stylet cannula 46 may be alternately moved proximally 36-1 and distally 36-2 a short distance, e.g., 2 to 5 mm, to shake (i.e., vibrate) the sample notch 60, thereby increasing the amount of tissue 66 passing through the sample notch 60 and into the lumen 46-4 of the stylet cannula 46. The final shaking movement is defined to maintain the sample notch 60 in a 1 mm retracted position (see FIG. 6C ) compared to the zero position of the stylet cannula 46 as shown in FIG. 6A . This is to ensure that the cutter cannula 50 closes the sample notch 60 and cuts an additional 1 mm during the cutting sequence (see FIG. 6D ), thus ensuring that the connective tissue or string is completely cut during the cutting sequence step illustrated in FIG. 6D .

[0044]

[0070] 6D, cutter cannula 50 is rotated and translated in distal direction 36-2 to sever tissue sample 66-1 from tissue 66. In this embodiment, cutter cannula 50 is rotated clockwise to cut the tissue and to return to the zero position, achieving linear translation of the cutter cannula in distal direction 36-2 over a distance of approximately 23 mm.

[0045]

[0071] 6E-6H illustrate the tissue sample transport sequence.

[0072] 6E , vacuum is applied by vacuum cannula 44, and stylet cannula 46 is moved proximally 36-1 through cutter cannula 50, mechanically assisting in moving tissue sample 66-1 into flared portion 44-2 of vacuum cannula 44. More specifically, as stylet cannula 46 is moved proximally 36-1 through cutter cannula 50, protruding member 62-3 of piercing tip 62 engages tissue sample 66-1 and assists tissue sample 66-1 into vacuum cannula 44. Protruding member 62-3 then engages flared portion 44-2 of vacuum cannula 44, blocking the inflow of air into flared portion 44-2 of vacuum cannula 44.

[0046]

[0073] In the sequence step illustrated in FIG. 6F, with vacuum being applied by vacuum cannula 44, stylet cannula 46 is moved distally 36-2 through cutter cannula 50, releasing protruding member 62-3 from flared portion 44-2 of vacuum cannula 44 and causing a sudden change in air flow into vacuum cannula 44, thereby assisting in vacuum transport of tissue sample 66-1 through vacuum cannula 44.

[0047]

[0074] The sequence steps illustrated in Figures 6G and 6H are essentially repeats of sequence steps 6E and 6F.

[0048]

[0075] In the sequence step illustrated in FIG. 6G, with vacuum being applied to vacuum cannula 44 by vacuum source 22, stylet cannula 46 is again moved in the proximal direction 36-1 through cutter cannula 50, causing protruding member 62-3 of piercing tip 62 to re-engage with flared portion 44-2 of vacuum cannula 44, again blocking the flow of air into flared portion 44-2 of vacuum cannula 44.

[0049]

[0076] In the sequence steps illustrated in Figure 6H, with vacuum applied to vacuum cannula 44 by vacuum source 22, stylet cannula 46 is moved distally 36-2 through cutter cannula 50, again releasing protruding member 62-3 from flared portion 44-2 of vacuum cannula 44 and causing an abrupt change in air flow into vacuum cannula 44, thereby assisting in vacuum transport of tissue sample 66-1 through vacuum cannula 44 (if not already delivered by the sequence steps of Figures 6E and 6F). At the end of the sequence of Figure 6H, stylet cannula 46 is repositioned to the tissue-receiving position, i.e., extended position 68-2 (also referred to as the zero position), ready to receive tissue for the next tissue sample, at which the sequence steps of Figures 6A-6H are repeated.

[0050]

[0077] It is noted that the sample transport sequence illustrated in Figures 6E and 6F may be repeated as many times as necessary to complete vacuum transport of tissue sample 66-1 through vacuum cannula 44. Also, the rearward movement of protruding member 62-3 of piercing tip 62 of stylet cannula 46 in the proximal direction 36-1 may be implemented as incremental steps, alternating between rearward and then forward movement (the forward distance being less than the rearward distance) until a final position (retracted position 68-1) is reached, as shown by Figures 6E and 6G.

[0051]

[0078] FIG. 7 is a (normalized) vacuum graph showing baseline vacuum pressure at different positions during the tissue sample cutting and transport sequence shown in FIGS. 6A-6H.

[0052]

[0079] Referring to the vacuum graph of FIG. 7, it is noted that vacuum is applied throughout the entire sequence shown in FIGS. 6A-6H. At time T0, vacuum source 22 is activated and a vacuum (negative pressure) builds up in vacuum cannula 44. At time T1, maximum vacuum is achieved, which corresponds to the end of the cutting sequence step shown in FIG. 6D. At time T2, the tissue packing sequence of FIGS. 6E-6F begins, with a sudden drop in vacuum pressure due to the moment when vent opening 80 in stylet cannula 46 is unrestricted. Vacuum begins to build and maximizes before time T3, as protruding member 62-3 of puncture tip 62 approaches flared portion 44-2 of vacuum cannula 44, marking the end of the first packing sequence shown in FIG. 6E. At time T3, the vacuum pressure drops suddenly due to the protruding member 62-3 of the piercing tip 62 being moved away from the flared portion 44-2, as shown in FIG. 6F. In some cases, the tissue sample 66-1 may be delivered to the sample cup 56. At time T4, the second packing sequence, as shown in FIGS. 6G and 6H, begins. Time T5 corresponds to the end of the second packing sequence, as shown in FIG. 6G. At time T6, the vacuum pressure drops due to the protruding member 62-3 of the piercing tip 62 being moved again away from the flared portion 44-2 and returned to the tissue-receiving (zero) position, as shown in FIG. 6H.

[0053]

[0080] By comparing the actual vacuum pressure at different stages of the tissue cutting and transport sequence shown in Figures 6A-6H with the baseline vacuum graph shown in Figure 7, cutting or tissue transport anomalies can be identified and corrective action can be attempted.

[0054]

[0081] According to aspects of the present disclosure, vacuum sensor 24 provides a vacuum pressure feedback signal to controller circuit 18, which executes program instructions to determine whether the actual vacuum pressure provided by vacuum sensor 24 deviates from the baseline pressure of the vacuum graph of FIG. 7 at the corresponding point in the tissue cutting and transport sequence by more than a predetermined amount. The predetermined amount can be, for example, plus or minus 10 percent of the baseline vacuum pressure. If the deviation is outside an acceptable range of deviations, corrective action can be taken depending on when in the tissue cutting and transport sequence the anomaly occurred.

[0055]

[0082] For example, if the vacuum pressure falls below the baseline by more than an acceptable deviation during the time period between time T1 and time T2, this may be an indication of an incomplete cut, and thus controller circuit 18 may repeat the cutting sequence shown in Figures 6C and 6D without user intervention, rather than immediately proceeding to an error condition. Similarly, if the vacuum pressure rises above the baseline by more than an acceptable deviation between times T3 and T5, this may be an indication of incomplete tissue transport through vacuum cannula 44, and thus controller circuit 18 may increase the number of repetitions of sequence steps 6E and 6F without user intervention.

[0056]

[0083] Referring again to FIG. 5A , along with FIGS. 10 and 13 , vacuum is maintained within the biopsy probe assembly 14 by a series of seals. Seal 72 (e.g., a sleeve-type seal) is positioned to provide a seal between the cutter cannula 50 and the stylet cannula 46. Seal 74 (e.g., an O-ring seal) is positioned to provide a seal between the stylet cannula 46 and the vacuum cannula 44. Seal 76 (e.g., a sleeve-type seal or an O-ring arrangement) is positioned to provide a seal between the vacuum cannula 44 and the vacuum chamber portion 54-1 of the sample manifold 54. Alternatively, seal 78 may be positioned within the collection chamber portion 54-2 of the sample manifold 54 and the sample cup 56. Finally, a seal is installed at the vacuum input port 54-3 at the vacuum interface between the biopsy probe assembly 14 and the biopsy driver assembly 12.

[0057]

[0084] During operation, vacuum pump 22-2 of vacuum source 22 establishes a vacuum (negative pressure) in the vacuum reservoir formed by sample manifold 54 and sample cup 56. More specifically, the volume of sample cup 56 and sample manifold 54 determines the strength of the "vacuum boost" and the cycle time for vacuum pump 22-2 of vacuum source 22. In this embodiment, for example, the volume is approximately 25 milliliters.

[0058]

[0085] With regard to "vacuum boost," the stylet cannula 46 has one or more vent openings 80 longitudinally separated from the sample notch 60. The vent openings 80 may be annularly positioned a predetermined distance proximal from the sample notch 60 and tip portion 62-1, and these vent openings 80 (see FIG. 4) are exposed to the atmosphere when the stylet cannula 46 is retracted to the retracted position 68-1 (see FIGS. 6E and 6G), with the vent openings 80 sliding beneath the seal 72 between the cutter cannula 50 and the stylet cannula 46. Once these vent openings 80 are exposed to the atmosphere, the system is "open," and the built-up vacuum pressure is equalized with ambient pressure, creating a vacuum boost effect in addition to the continuous flow delivered by the vacuum pump 22-2 of the vacuum source 22.

[0059]

[0086] 8 and 8A, in this embodiment, the vent opening 80 in the stylet cannula 46 includes at least one longitudinal vent slot 82, which in this embodiment may include a plurality of longitudinal vent slots 84 (e.g., longitudinal vent slot 82 and longitudinal vent slot 86) and a plurality of circular vent holes 88 (e.g., two or more circular vent holes). In this embodiment, the longitudinal vent slot 82 and the longitudinal vent slot 86 are diametrically opposed. Also, in this embodiment, the proximal ends of the plurality of longitudinal vent slots 84 (e.g., proximal end 82-1 of longitudinal vent slot 82 and proximal end 86-1 of longitudinal vent slot 86 (see also FIG. 11)) are longitudinally aligned with the plurality of circular vent holes 88.

[0060]

[0087] 11 and 14 , in particular, seal 72 includes a proximal seal portion 90 and a distal seal portion 92. Distal seal portion 92 of seal 72 includes a distal seal lip 92-1 that is positioned to radially engage the outer diameter (OD) of cutter cannula 50. Proximal seal portion 90 of seal 72 includes a proximal seal lip 90-1 that is positioned to radially engage the outer diameter (OD) of stylet cannula 46.

[0061]

[0088] Each longitudinal vent slot (e.g., multiple longitudinal vent slots 84) of stylet cannula 46 is configured with a size and shape that promotes increased air flow into vacuum lumen 44-3 of vacuum cannula 44 over a corresponding number of circular vent holes to aid in the proximal movement 36-1 of cut tissue sample 66-1 (see also FIGS. 6E-6G ). In this embodiment, for example, each longitudinal vent slot 82, 86 of multiple longitudinal vent slots 84 of stylet cannula 46 can have a longitudinal length of 21 millimeters and a width of 0.75 millimeters.

[0062]

[0089] More particularly, with reference to FIGS. 9-14, when the stylet cannula 46 is retracted in the proximal direction 36-1 toward the retracted position 68-1 (see FIGS. 6D-6E), each of the plurality of longitudinal vent slots 84 of the stylet cannula 46 opens a seal bypass pathway 94 (see FIGS. 11 and 14) across the longitudinal extension of the proximal seal lip 90-1 of the proximal seal portion 90 of the seal 72 to establish both a first air pathway 94-1 in an intermediate lumen 96 between the outer diameter (OD) of the vacuum cannula 44 and the inner diameter (ID) of the stylet cannula 46, and a second air pathway 94-2 in an intermediate lumen 98 between the ID of the cutter cannula 50 and the OD of the stylet cannula 46. Each of the first air path 94-1 and the second air path 94-2 is fluidly connected to the atmosphere in the proximal region of the seal 72 when the seal bypass path 94 is established, i.e., by positioning at least one longitudinal vent slot (e.g., longitudinal vent slot 82 and / or longitudinal vent slot 86) of the stylet cannula 46 to bridge longitudinally across the proximal seal lip 90-1 of the proximal seal portion 90 of the seal 72.

[0063]

[0090] With further reference to FIG. 15 , the first air path 94-1 and the second air path 94-2 converge at the sample notch 60 of the stylet cannula 46, establishing a combined air flow 100 of the first air path 94-1 and the second air path 94-2 into the vacuum lumen 44-3 of the vacuum cannula 44, thus facilitating increased air flow into the vacuum lumen 44-3 of the vacuum cannula 44 over the use of multiple circular vent holes 88 (e.g., six) without the use of a longitudinal vent slot. 15 shows that the use of at least one longitudinal vent slot 82 and (in this embodiment) multiple longitudinal vent slots 84 allows more air to flow through and from both intermediate lumen 96 and intermediate lumen 98, and the combined air flow 100 reaches tissue sample 66-1 and then moves tissue sample 66-1 through vacuum lumen 44-3 of vacuum cannula 44, resulting in much faster and more powerful pressure equalization, due to the additional (second) air path 94-2 allowing more air to be moved into vacuum lumen 44-3 of vacuum cannula 44. Without at least one longitudinal slot 82 and / or longitudinal vent slot 86 in stylet cannula 46, the additional (second) air path 94-2 would not be established by the arrangement of the components of this embodiment.

[0064]

[0091] The following items also pertain to this disclosure:

[0092] 1. A biopsy device comprising:

[0093] a driver assembly having an electromechanical power source and a vacuum source;

[0094] a biopsy probe assembly releasably attached to the driver assembly, the biopsy probe assembly having a cutter cannula, a vacuum cannula, and a stylet cannula coaxially arranged along a longitudinal axis, the vacuum cannula positioned inside the stylet cannula to define a first intermediate lumen therebetween, the stylet cannula positioned within the cutter cannula to define a second intermediate lumen therebetween, and the vacuum cannula having a vacuum lumen;

[0095] the vacuum lumen of the vacuum cannula is coupled in fluid communication with a vacuum source;

[0096] the stylet cannula is coupled in driving communication with the electromechanical power source, the stylet cannula being movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position, the stylet cannula having a proximal portion and a distal portion, the distal portion having a sample notch;

[0097] a biopsy probe assembly, the stylet cannula having a plurality of vent openings disposed proximal to the sample notch, the plurality of vent openings including at least one longitudinal vent slot;

[0098] a seal having a proximal seal portion and a distal seal portion, the distal seal portion having a distal seal lip positioned to radially engage an outer diameter of the cutter cannula, and the proximal seal portion having a proximal seal lip positioned to radially engage an outer diameter of the stylet cannula;

[0099] The biopsy device is configured such that when the stylet cannula is moved from the first extended position toward the first retracted position, the at least one longitudinal vent slot is positioned longitudinally beneath the proximal seal lip of the proximal seal portion of the seal to open a seal bypass pathway across a longitudinal extension of the proximal seal lip of the proximal seal portion of the seal to establish both a first air pathway in a first intermediate lumen between an outer diameter of the vacuum cannula and an inner diameter of the stylet cannula and a second air pathway in an intermediate lumen between the inner diameter of the cutter cannula and an outer diameter of the stylet cannula, the first air pathway and the second air pathway being in fluid communication with a proximal region of the seal. Equipped with.

[0065]

[0100] The cutter cannula is coupled in driving communication with an electromechanical power source, and the cutter cannula is movable relative to the stylet cannula between a second extended position for covering the sample notch and a second retracted position for exposing the sample notch when the stylet cannula is in the first extended position.

[0066]

[0101] Embodiments may be described with reference to the following numerical clauses:

[0102] 1. A biopsy device comprising: a biopsy probe assembly having a cutter cannula, a vacuum cannula, and a stylet cannula coaxially arranged along a longitudinal axis, the vacuum cannula positioned inside the stylet cannula to define a first intermediate lumen therebetween, the stylet cannula positioned within the cutter cannula to define a second intermediate lumen therebetween, the vacuum cannula having a vacuum lumen, the stylet cannula being movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position, the stylet cannula having a plurality of vent openings, the plurality of vent openings including at least one longitudinal vent slot; and a seal having a proximal seal portion and a distal seal portion, the distal seal portion radially extending from the outer diameter of the cutter cannula. the proximal seal portion has a distal seal lip positioned to radially engage an outer diameter of the stylet cannula, and the proximal seal portion has a proximal seal lip positioned to radially engage an outer diameter of the stylet cannula, and when the stylet cannula is moved from the first extended position toward the first retracted position, the at least one longitudinal vent slot is positioned longitudinally below the proximal seal lip of the proximal seal portion of the seal to open a seal bypass pathway across the longitudinal extension of the proximal seal lip of the proximal seal portion of the seal to establish both a first air pathway in a first intermediate lumen between the outer diameter of the vacuum cannula and the inner diameter of the stylet cannula and a second air pathway in a second intermediate lumen between the inner diameter of the cutter cannula and the outer diameter of the stylet cannula, the first air pathway and the second air pathway being in fluid communication with a proximal region of the seal.

[0067]

[0103] 2. The biopsy device described in clause 1, further comprising a driver assembly having an electromechanical power source and a vacuum source, the biopsy probe assembly being releasably attached to the driver assembly.

[0068]

[0104] 3. The biopsy device of clause 1 or 2, further comprising a driver assembly having an electromechanical power source and a vacuum source, wherein the vacuum lumen of the vacuum cannula is connected in fluid communication with the vacuum source.

[0069]

[0105] 4. A biopsy device described in any one of clauses 1 to 3, further comprising a driver assembly having an electromechanical power source and a vacuum source, wherein the stylet cannula is coupled in driving communication with the electromechanical power source.

[0070]

[0106] 5. A biopsy device described in any one of clauses 1 to 4, further comprising a driver assembly having an electromechanical power source and a vacuum source, the cutter cannula being coupled in driving communication with the electromechanical power source.

[0071]

[0107] 6. A biopsy device described in any one of clauses 1 to 5, wherein the cutter cannula is movable relative to the stylet cannula between a second extended position for covering the sample notch of the stylet cannula and a second retracted position for exposing the sample notch when the stylet cannula is in the first extended position.

[0072]

[0108] 7. A biopsy device according to any one of clauses 1 to 6, wherein the stylet cannula has a proximal portion and a distal portion, the distal portion defining a sample notch.

[0073]

[0109] 8. The biopsy device of any one of clauses 1 to 7, wherein the plurality of vent openings are located proximal to the sample notch.

[0074]

[0110] 9. The biopsy device of any one of clauses 1 to 8, wherein the first air path and the second air path converge at a sample notch.

[0075]

[0111] 10. The biopsy device of any one of clauses 1 to 9, wherein the plurality of vent openings includes at least two longitudinal vent slots.

[0076]

[0112] 11. The biopsy device of any one of clauses 1 to 10, wherein the first longitudinal vent slot and the second longitudinal vent slot are diametrically opposed.

[0077]

[0113] 12. The biopsy device of any one of clauses 1 to 11, wherein the plurality of vent openings includes at least one circular vent hole.

[0078]

[0114] 13. The biopsy device of any one of clauses 1 to 12, wherein a proximal end of the at least one longitudinal vent slot is aligned with at least one circular vent hole.

[0079]

[0115] 14. A method, comprising the steps of applying a vacuum to a lumen of a stylet cannula of a biopsy device at a sample notch of the stylet cannula via a vacuum cannula of a biopsy device, wherein the cutter cannula, vacuum cannula, and stylet cannula of the biopsy device are coaxially arranged along a longitudinal axis, the vacuum cannula being positioned inside the stylet cannula to define a first intermediate lumen therebetween, and the stylet cannula being positioned within the cutter cannula. and a second intermediate lumen therebetween, the vacuum cannula having a vacuum lumen, the stylet cannula being movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position, the stylet cannula having a plurality of vent openings, the plurality of vent openings including at least one longitudinal vent slot, and the biopsy device includes a seal having a proximal seal portion and a distal seal portion, the distal seal portion radially extending from an outer diameter of the cutter cannula. the proximal seal portion having a distal seal lip positioned to radially engage an outer diameter of the stylet cannula; and moving the stylet cannula toward a first retracted position to move the cut tissue sample into the vacuum cannula, wherein as the stylet cannula is moved toward the first retracted position, at least one longitudinal vent slot is positioned longitudinally below the proximal seal lip of the proximal seal portion of the seal to open a seal bypass pathway across a longitudinal extension of the proximal seal lip of the proximal seal portion of the seal to establish both a first air pathway in a first intermediate lumen between the outer diameter of the vacuum cannula and an inner diameter of the stylet cannula and a second air pathway in a second intermediate lumen between the inner diameter of the cutter cannula and the outer diameter of the stylet cannula, wherein the first air pathway and the second air pathway are in fluid communication with a proximal region of the seal.

[0080]

[0116] 15. The method of clause 14, wherein the cutter cannula is movable relative to the stylet cannula between a second extended position for covering the sample notch and a second retracted position for exposing the sample notch when the stylet cannula is in the first extended position.

[0081]

[0117] 16. The method of clause 14 or 15, further comprising the steps of moving the stylet cannula toward a first extended position to puncture tissue with the stylet cannula and moving the cutter cannula toward a second retracted position to expose a sample notch in the stylet cannula, wherein applying vacuum via the vacuum cannula draws tissue through the sample notch and into the lumen of the stylet cannula.

[0082]

[0118] 17. The method of any one of clauses 14 to 16, further comprising the step of moving the cutter cannula to a second extended position to sever the cut tissue sample from the tissue.

[0083]

[0119] 18. The method of any one of clauses 14 to 17, wherein the first air path and the second air path converge at a sample notch.

[0084]

[0120] 19. The method of any one of clauses 14 to 18, further comprising applying a vacuum through the vacuum cannula during the step of moving the stylet cannula toward the first retracted position to move the cut tissue sample into the vacuum cannula.

[0085]

[0121] 20. The method of any one of clauses 14 to 19, wherein the plurality of vent openings includes at least two longitudinal vent slots, a first longitudinal vent slot and a second longitudinal vent slot being diametrically opposed.

[0086]

[0122] As used herein, the terms "substantially," "slightly," "approximately," and other degrees of degree are relative modifiers intended to indicate acceptable variations from the property so modified. They are not intended to be limited to the absolute value or property that they modify, but rather to address more of a physical or functional property than the opposite, and to approach or approximate such a physical or functional property.

[0087]

[0123] Also, as used herein, the term "coupled" and its derivatives are intended to encompass any operatively functional connection, i.e., a direct connection or an indirect connection.

[0088]

[0124] While this application has been described with respect to at least one embodiment, this application may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the claimed subject matter using its general principles.

Claims

1. 1. A biopsy device comprising: a biopsy probe assembly having a cutter cannula, a vacuum cannula, and a stylet cannula coaxially arranged along a longitudinal axis, the vacuum cannula positioned inside the stylet cannula to define a first intermediate lumen therebetween, the stylet cannula positioned within the cutter cannula to define a second intermediate lumen therebetween, and the vacuum cannula having a vacuum lumen; the stylet cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position; the stylet cannula having a plurality of vent openings, the plurality of vent openings including at least one longitudinal vent slot; a biopsy probe assembly; a seal having a proximal seal portion and a distal seal portion, the distal seal portion having a distal seal lip positioned to radially engage an outer diameter of the cutter cannula, and the proximal seal portion having a proximal seal lip positioned to radially engage an outer diameter of the stylet cannula; a seal and a proximal region of the seal, the proximal region of the seal being in fluid communication with the proximal region of the seal; a seal having a first air passage in the first intermediate lumen between an outer diameter of the vacuum cannula and an inner diameter of the stylet cannula, the first air passage in the first intermediate lumen being in fluid communication with the proximal region of the seal; a proximal region of the seal being in fluid communication with the proximal region of the seal; a seal having a second air passage in the second intermediate lumen between an inner diameter of the cutter cannula and an outer diameter of the stylet cannula, the first air passage in the first intermediate lumen being in fluid communication with the proximal region of the seal; A biopsy device comprising:

2. The biopsy device of claim 1 , further comprising a driver assembly having an electromechanical power source and a vacuum source, the biopsy probe assembly being releasably attached to the driver assembly.

3. The biopsy device of claim 1 , further comprising a driver assembly having an electromechanical power source and a vacuum source, the vacuum lumen of the vacuum cannula coupled in fluid communication with the vacuum source.

4. The biopsy device of claim 1 , further comprising a driver assembly having an electromechanical power source and a vacuum source, the stylet cannula coupled in driving communication with the electromechanical power source.

5. The biopsy device of claim 1 , further comprising a driver assembly having an electromechanical power source and a vacuum source, the cutter cannula coupled in driving communication with the electromechanical power source.

6. 2. The biopsy device of claim 1, wherein the cutter cannula is movable relative to the stylet cannula between a second extended position for covering a sample notch of the stylet cannula and a second retracted position for exposing the sample notch when the stylet cannula is in the first extended position.

7. The biopsy device of claim 1 , wherein the stylet cannula has a proximal portion and a distal portion, the distal portion defining a sample notch.

8. The biopsy device of claim 7 , wherein the plurality of vent openings are located proximal to the sample notch.

9. The biopsy device of claim 7 , wherein the first air path and the second air path converge at the sample notch.

10. The biopsy device of claim 1 , wherein the plurality of vent openings includes at least two longitudinal vent slots.

11. The biopsy device of claim 10 , wherein the first longitudinal vent slot and the second longitudinal vent slot are diametrically opposed.

12. The biopsy device of claim 1 , wherein the plurality of vent openings includes at least one circular vent hole.

13. The biopsy device of claim 12 , wherein a proximal end of the at least one longitudinal vent slot is aligned with the at least one circular vent hole.

Images