Single-insertion multi-sample biopsy device

Abstract

A biopsy device comprising a driver assembly and a biopsy probe assembly having a vacuum sleeve, a cutter sleeve and a stylet sleeve coaxially arranged along a longitudinal axis, the vacuum sleeve being connected in fluid communication with a vacuum source, the stylet sleeve having a proximal portion and a distal portion, the distal portion having a sample recess and a protruding member extending proximally in a lumen of the stylet sleeve along a portion of the longitudinal length of the sample recess, wherein: the stylet sleeve is movable relative to the vacuum sleeve between a first extended position and a first retracted position in accordance with control signals of a controller circuit, the protruding member being received within a flared portion of the vacuum sleeve when the stylet sleeve is in the first retracted position; and the cutter sleeve is movable relative to the stylet sleeve by an electromechanical power source in accordance with control signals of the controller circuit to selectively cover or expose the sample recess.

Description

[0001] This divisional application is based on the Chinese Patent Application No. 201780080429.8 (with International Application No. PCT / US2017 / 062961), filed on November 22, 2017, entitled "Single Insertion Multi-Specimen Biopsy Device".

[0002] Cross Reference to Related Applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 425,974, filed on November 23, 2016, which is hereby incorporated by reference herein. TECHNICAL FIELD

[0004] The present invention relates to biopsy devices, and more particularly, to a single insertion multi-specimen biopsy device. BACKGROUND

[0005] Biopsies can be performed on patients in order to help determine whether tissue in a region of interest includes cancerous cells. For example, one biopsy technique for evaluating breast tissue involves inserting a biopsy probe into a region of breast tissue of interest in order to capture one or more tissue specimens from the region. This biopsy technique typically utilizes a vacuum to draw the tissue to be sampled into a specimen recess of the biopsy probe, after which the tissue is severed and collected. There has been an ongoing effort in the art to improve the ability of biopsy devices to sever tissue specimens and to transport severed tissue specimens to a specimen collection container.

[0006] There is a need in the art for a biopsy device that facilitates effective severing of tissue specimens and effective transport of the tissue specimens to a specimen collection container. SUMMARY

[0007] The present invention provides a biopsy device that facilitates effective severing of tissue specimens and effective transport of the tissue specimens to a specimen collection container.

[0008] In one form, the present disclosure is directed to a biopsy device including a driver assembly and a biopsy probe assembly. The driver assembly has a motor and a vacuum source. The biopsy probe assembly is releasably attached to the driver assembly. The biopsy probe assembly has a vacuum sleeve and a stylet sleeve coaxially arranged along a longitudinal axis, with the vacuum sleeve inside the stylet sleeve. The vacuum sleeve is fluidly connected to the vacuum source. The vacuum sleeve has an elongated portion and a flared portion extending distally from the elongated portion. The stylet sleeve is drivingly connected to the motor. The stylet sleeve is movable relative to the vacuum sleeve between a first extended position and a first retracted position. The stylet sleeve has a proximal portion and a distal portion. The distal portion has a sample recess and a protruding member extending proximally in a lumen of the stylet sleeve along a portion of a longitudinal length of the sample recess, with the protruding member received within the flared portion of the vacuum sleeve when the stylet sleeve is in the first retracted position.

[0009] The biopsy device can further include a controller circuit having a virtual energy reservoir that executes program instructions to control current to the motor when engaging dense tissue.

[0010] In another form, the present disclosure is directed to a biopsy device including a driver assembly and a biopsy probe assembly. The driver assembly has a motor, a vacuum source, and a controller circuit. The controller circuit is electrically connected and in communication with the motor and the vacuum source. The biopsy probe assembly is releasably attached to the driver assembly. The biopsy probe assembly has a vacuum sleeve, a stylet sleeve, and a cutter sleeve coaxially arranged along a longitudinal axis. The vacuum sleeve is inside the stylet sleeve, which is inside the cutter sleeve. The vacuum sleeve is fluidly connected to the vacuum source. The vacuum sleeve has an elongated portion and a flared portion extending distally from the elongated portion. The stylet sleeve is drivingly connected to the motor. The stylet sleeve is movable relative to the vacuum sleeve between a first extended position and a first retracted position. The stylet sleeve has a proximal portion and a distal portion. The distal portion has a sample recess and a protruding member extending proximally in a lumen of the stylet sleeve along a portion of a longitudinal length of the sample recess. The protruding member is received within the flared portion of the vacuum sleeve when the stylet sleeve is in the retracted position. The cutter sleeve is drivingly connected to the motor. The cutter sleeve is movable relative to the stylet sleeve between a second extended position for covering the sample recess and a second retracted position for exposing the sample recess when the stylet sleeve is in the first extended position.

[0011] The present application relates to a biopsy device comprising a driver assembly having an electromechanical power source, a vacuum source, and a controller circuit in electrical connection and communication with the electromechanical power source, and a biopsy probe assembly releasably attached to the driver assembly, the biopsy probe assembly having a vacuum sleeve, a cutter sleeve, and a stylet sleeve coaxially arranged along a longitudinal axis, wherein the vacuum sleeve is interior to the stylet sleeve, the vacuum sleeve is in fluid communication with the vacuum source, the vacuum sleeve has an elongated portion and a flared portion extending distally from the elongated portion, the stylet sleeve and the cutter sleeve are in driving communication with the electromechanical power source, the stylet sleeve has a proximal portion and a distal portion, the distal portion has a sample recess and a protruding member extending proximally in a lumen of the stylet sleeve along a portion of the longitudinal length of the sample recess, wherein the stylet sleeve is movable relative to the vacuum sleeve between a first extended position and a first retracted position by the electromechanical power source in accordance with a control signal from the controller circuit, wherein the protruding member is received within the flared portion of the vacuum sleeve when the stylet sleeve is in the first retracted position. BRIEF DESCRIPTION OF DRAWINGS

[0012] The above-mentioned and other features and advantages of this application, and the manner of attaining them, will become more apparent and the application will be better understood by reference to the following description of embodiments of the application taken together with the accompanying drawings, wherein:

[0013] Figure 1 is a perspective view of a biopsy device configured in accordance with an embodiment of the present application, wherein a biopsy probe assembly is attached to a driver assembly;

[0014] Figure 2 is a perspective view of the biopsy device of Figure 1 , wherein the biopsy probe assembly is detached from the driver assembly and the driver assembly is inverted so as to expose a drive member of the driver assembly;

[0015] Figure 3 is a block diagram of the driver assembly of Figure 1 ;

[0016] Figure 4 is an exploded view of the biopsy probe assembly of Figure 1 ;

[0017] Figure 5A is a cross-sectional view of the biopsy probe assembly of Figure 1 along line 5A-5A in Figure 2 ;

[0018] Figure 5B is an enlarged portion of the vacuum sleeve shown in Figure 5A ;

[0019] Figure 5C is Figure 5A an enlarged portion of the trocar sleeve shown in

[0020] Figure 6A illustrates the relative positions of the vacuum sleeve, the trocar sleeve, and the cutter sleeve prior to, during, and immediately after the firing launch;

[0021] Figure 6B illustrates the relative positions of the vacuum sleeve, the trocar sleeve, and the cutter sleeve, with the cutter sleeve retracted to expose the sample notch of the trocar sleeve.

[0022] Figure 6C illustrates the relative positions of the vacuum sleeve, the trocar sleeve, and the cutter sleeve, illustrating the rocking of the sample notch by alternately moving the trocar sleeve a short distance in the proximal and distal directions;

[0023] Figure 6D illustrates the relative positions of the vacuum sleeve, the trocar sleeve, and the cutter sleeve, with the cutter sleeve rotated and translated in the distal direction to sever the tissue sample from the tissue received in the sample notch.

[0024] Figure 6E illustrates the relative positions of the vacuum sleeve, the trocar sleeve, and the cutter sleeve, with the trocar sleeve moved in the proximal direction within the cutter sleeve to mechanically assist the movement of the tissue sample into the flared portion of the vacuum sleeve;

[0025] Figure 6F illustrates the relative positions of the vacuum sleeve, the trocar sleeve, and the cutter sleeve, with the trocar sleeve moved in the distal direction within the cutter sleeve to disengage the tab from the flared portion of the vacuum sleeve;

[0026] Figure 6G illustrates the relative positions of the vacuum sleeve, the trocar sleeve, and the cutter sleeve, with the trocar sleeve again moved in the proximal direction within the cutter sleeve to re-engage the tab with the flared portion of the vacuum sleeve;

[0027] Figure 6H illustrates the relative positions of the vacuum sleeve, the trocar sleeve, and the cutter sleeve, with the trocar sleeve again moved in the distal direction within the cutter sleeve to disengage the tab from the flared portion of the vacuum sleeve and return to the extended position;

[0028] Figure 7 is a vacuum / time plot illustrating the baseline vacuum pressure at a plurality of different positions in the tissue sample cutting and delivery sequence as shown in Figures 6A-6H

[0029] Figure 8A ​is Figure 1 a plot of actual motor winding current (I) of the motor of the driver assembly to be combined with Figure 8B a plot; and

[0030] Figure 8B is Figure 1 a plot of energy state of the virtual energy reservoir established in the memory circuit of the driver assembly to be combined with Figure 8A a plot.

[0031] Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein represent at least one embodiment of the present application and are not intended to represent limitations of the scope of the present application. DETAILED DESCRIPTION

[0032] Reference will now be made to the drawings, more particularly to Figure 1 and Figure 2 , which depict a biopsy device 10 that generally includes a non-invasive (e.g., non-disposable) driver assembly 12 and an invasive (e.g., disposable) biopsy probe assembly 14. As used herein, the term "non-disposable" is used to mean a device that will be used for multiple patients over the life of the device, while the term "disposable" is used to mean a device that will be discarded after use for a single patient. The driver assembly 12 includes a driver housing 16 that is structured and ergonomically designed to be grasped by a user.

[0033] Referring to Figure 2 and 3 , the driver assembly 12 includes a controller circuit 18, an electromechanical power source 20, a vacuum source 22, a vacuum sensor 24, and a battery 26 (or an optional AC adapter) within the driver housing 16. A user interface 28 (see Figure 1 ) such as a keypad is disposed on the driver housing 16 and is externally accessible by a user relative to the driver housing 16. The battery 26 can be, for example, a rechargeable battery that can be charged by an inductive charging device connected to an inductive coil 29, or alternatively, by an electrical connection to a power source. The battery 26 is electrically connected to the controller circuit 18, the electromechanical power source 20, the vacuum source 22, and the user interface 28.

[0034] Referring to Figure 3The user interface 28 can include control buttons and visual / audible indicators, where the control buttons provide user control over various functions of the biopsy device 10 and the visual / audible indicators provide visual / audible feedback of the status of one or more conditions and / or positions of components of the biopsy device 10. The control buttons can include a sample button 28-1 and a prime / puncture start button 28-2. The visual indicators can include a display screen 28-3 and / or one or more light emitting diodes (LEDs) 28-4. The audible indicator can include a buzzer 28-5. The control buttons can include haptic feedback to the user upon actuation.

[0035] The controller circuit 18 is in electrical and communicative connection with the electromechanical power source 20, the vacuum source 22, the vacuum sensor 24, and the user interface 28, such as through one or more conductors or circuit traces. The controller circuit 18 can be mounted on a circuit board and include, for example, a processor circuit 18-1 and a memory circuit 18-2.

[0036] The processor circuit 18-1 is one or more programmable microprocessors and associated circuitry, such as input / output interfaces, clocks, buffers, memory, etc. The memory circuit 18-2 is in communicative connection with the processor circuit 18-1, such as through a bus circuit, and is a non-transitory electronic memory that can include volatile memory circuits, such as random access memory (RAM), and non-volatile memory circuits, such as read only memory (ROM), electrically erasable programmable ROM (EEPROM), NOR flash, NAND flash, etc. The controller circuit 18 can be formed as one or more application specific integrated circuits (ASICs).

[0037] The controller circuit 18 is configured to execute program instructions through software and / or firmware resident in the memory circuit 18-2 to perform functions associated with the retrieval of a biopsy tissue sample, such as controlling and / or monitoring one or more components of the electromechanical power source 20, the vacuum source 22, and the vacuum sensor 24.

[0038] The electromechanical power source 20 can include, for example, a cutter module 30, a transport module 32, and a puncture module 34, each in electrical connection with the battery 26. The cutter module 30, the transport module 32, and the puncture module 34 are each in electrical and control connection with the controller circuit 18 through one or more electrical conductors, such as conductors or circuit traces.

[0039] The cutter module 30 can include an electric motor 30-1 having a shaft to which a drive gear 30-2 is attached. The delivery module 32 can include an electric motor 32-1 having a shaft to which a drive gear 32-2 is attached. The piercing module 34 can include an electric motor 34-1, a drive arbor 34-2, and a piercing launch driver 34-3. Each of the electric motors 30-1, 32-1, 34-1 can be, for example, a direct current (DC) motor or a stepper motor. As an alternative to the above-described arrangement, each of the cutter module 30, the delivery module 32, and the piercing module 34 can include one or more gears, gear sets, belt / pulley arrangements, etc., interposed between the respective motor and drive gear or drive arbor.

[0040] The piercing module 34 is arranged such that actuation of the electric motor 34-1 and drive arbor 34-2 causes the piercing launch driver 34-3 to move in the proximal direction 36-1 to compress a firing spring, such as one or more coil springs, and to lock the piercing launch driver 34-3 in a cocked position. Upon actuation of the prime / pierce button 28-2 of the user interface 28, the piercing launch driver 34-3 is advanced in the distal direction 36-2, i.e., fired (see Figure 2 ).

[0041] The vacuum source 22 is electrically and control connected to the battery 26 by one or more electrical conductors, such as wires or circuit traces. The vacuum source 22 can 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 connected to the vacuum pump 22-2, which is used to establish a vacuum in the biopsy probe assembly 14. The electric motor 22-1 can be, for example, a rotary, linear, or oscillating DC motor. The vacuum pump 22-2 can be, for example, a peristaltic or diaphragm pump, or one or more connected in series or in parallel.

[0042] The vacuum sensor 24 is electrically connected to the controller circuit 18 by one or more electrical conductors, such as wires or circuit traces. The vacuum sensor 24 can be a differential pressure sensor that provides a vacuum (negative pressure) feedback signal to the controller circuit 18. In some embodiments, the vacuum sensor 24 can be incorporated into the vacuum source 22.

[0043] Referring to Figure 1 and Figure 2 , the biopsy probe assembly 14 is arranged to be releasably connected to the driver assembly 12. The term "releasably connected" as used herein means a structure that facilitates a predetermined temporary connection, followed by selective disconnection, involving manipulation of the disposable biopsy probe assembly 14 relative to the driver assembly 12 without the need for tools.

[0044] Referring to Figure 4FIG. 4 is an exploded view of the biopsy probe assembly 14, which includes a probe housing 40, a probe sub-housing 42, a vacuum sleeve 44, a stylet sleeve 46, a stylet gear-spindle set 48 for linear stylet translation, a cutter sleeve 50, a cutter gear-spindle set 52 for rotation and linear cutter translation, a sample manifold 54, and a sample cup 56.

[0045] Referring to Figure 2 , 4 and 5A, the probe housing 40 is formed as an L-shaped structure having an elongated portion 40-1 and a forward plate 40-2. When the biopsy probe assembly 14 is attached on the driver assembly 12, the forward plate 40-2 is positioned to be adjacent to the entire forward surface 16-1 of the driver housing 16 distally, i.e., so as to shield the entire forward surface 16-1 of the non-disposable driver assembly from contact with the patient.

[0046] The vacuum sleeve 44, the stylet sleeve 46, and the cutter sleeve 50 are coaxially arranged along a longitudinal axis 58 in a nested tube configuration, wherein the vacuum sleeve 44 is the innermost tube, the cutter sleeve 50 is the outermost tube, and the stylet sleeve 46 is the intermediate tube disposed between the vacuum sleeve 44 and the cutter sleeve 50. In other words, the vacuum sleeve 44 is inside the stylet sleeve 46, and the stylet sleeve 46 is inside the cutter sleeve 50.

[0047] The vacuum sleeve 44 is mounted stationary relative to the probe sub-housing 42. The vacuum sleeve 44 is connected in fluid communication with the vacuum source 22 through the sample manifold 54.

[0048] Referring to Figure 4 , 5A and 5B, the vacuum sleeve 44 includes an elongated portion 44-1 and a flared portion 44-2 extending distally from the elongated portion 44-1. The elongated portion 44-1 has a first outer diameter Dl. The flared portion 44-2 flares from the elongated portion 44-1 in two segments, i.e., a first flared segment 45-1 and a second flared segment 45-2. The first flared segment 45-1 diverges from the elongated portion 44-1 at a first acute angle Al, and the second flared segment 45-2 diverges from the first flared segment 45-1 at a second acute angle A2 relative to the elongated portion 44-1, wherein the acute angle A2 is greater than the acute angle Al. The distal outer diameter D2 of the second flared segment 45-2 is selected to be received within and in sliding contact with the lumen 46-4 of the stylet sleeve 46. The first flared segment 45-1 and the second flared segment 45-2 of the flared portion 44-2 each have a diameter that increases distally, which is greater than the diameter Dl of the elongated portion 44-1.

[0049] Referring again to Figure 4The 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. A piercing tip 62 is attached to the distal portion 46-2, which in turn forms part of the stylet cannula 46. A stylet gear-spindle assembly 48 is threadably engageable with the delivery spindle 42-3, 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 assembly 48 is an integral gear having a driven gear 48-1 fixedly attached to a threaded spindle 48-2, and can be formed as a single molded component. The stylet cannula 46 is retracted or extended along the longitudinal axis 58 by the delivery module 32 of the biopsy probe assembly 14, wherein the drive gear 32-2 of the delivery module 32 of the driver assembly 12 engages the driven gear 48-1 of the stylet gear-spindle assembly 48.

[0050] Reference is also made to Figure 5C Figs. 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 the receipt of tissue 66 into the lumen 46-4 of the stylet cannula 46. The sample notch 60 has a longitudinal length 60-1 extending along the longitudinal axis 58. The sample notch 60 does not extend below the centerline of the diameter of the stylet cannula 46 in the sidewall 46-3, and can include a cut edge that circumscribes the periphery of the opening formed by the sample notch 60, wherein the cut edges of the elongated (linear) portions of the sample notch 60 each have a cut edge 46-5 that diverges from the cut edge along the sidewall 46-3 toward the centerline at the diameter of the stylet cannula 46.

[0051] The piercing tip 62 has a tip portion 62-1, a mounting portion 62-2, and a protruding component 62-3. The piercing tip 62 is inserted into the lumen 46-4 of the stylet cannula 46 at the distal portion 46-2, wherein the mounting portion 62-2 is attached to the distal portion 46-2 of the stylet cannula 46, such as by an adhesive or a weld. In this manner, the tip portion 62-1 extends distally from the distal portion 46-2 of the stylet cannula 46, and the protruding component 62-3 extends proximally (i.e., in the proximal direction 36-1) in the lumen 46-4 along a portion of the longitudinal length 60-1 of the sample notch 60. Thus, as shown in Figs. 6A and 6B, when the stylet cannula 46 is fully retracted in the proximal direction 36-1, the protruding component 62-3 is received into the flared portion 44-2 of the vacuum cannula 44. At least the proximal tip portion of the protruding component 62-3 has a diameter that decreases proximally. Figure 6E and 6G When the stylet cannula 46 is fully retracted in the proximal direction 36-1, the protruding component 62-3 is received into the flared portion 44-2 of the vacuum cannula 44. At least the proximal tip portion of the protruding component 62-3 has a diameter that decreases proximally.

[0052] Reference is also made to Figure 4The cutter cannula 50 includes a proximal portion 50-1 and a distal portion 50-2. The distal portion 50-2 includes an annular cutting edge 64. The cutter gear-spindle assembly 52 is fixedly attached (e.g., glued, welded, or staked) to the proximal portion 50-1 of the cutter cannula 50. The cutter gear-spindle assembly 52 is a unitary gear having a driven gear 52-1 that is fixedly attached to a threaded spindle 52-2. The cutter module 30 is retracted or extended along the longitudinal axis 58 by the cutter module 30 of the driver probe assembly 14, wherein the drive gear 30-2 of the cutter module 30 of the driver assembly 12 engages the driven gear 52-1 of the cutter gear-spindle assembly 52. Thus, the cutter cannula 50 has rotational cutting motion and axial translation along the longitudinal axis 58. The pitch of the threaded spindle 52-2 determines the number of revolutions per axial distance (in millimeters (mm)) of axial movement of the cutter cannula 50.

[0053] Referring to Figure 4 and 5A The sample manifold 54 is provided in an L-shaped configuration 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 arranged to sealingly engage the vacuum source port 22-3 of the vacuum source 22 of the driver assembly 12 when the biopsy probe assembly 14 is attached to the driver assembly 12. The vacuum chamber portion 54-1 is fluidly connected in 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. The collection chamber portion 54-2 has a cavity sized and configured to removably receive the sample cup 56 such that the sample cup 56 is in direct fluid communication with the elongated portion 44-1 of the vacuum cannula 44 and the sample cup 56 is also in direct fluid communication with the vacuum input port 54-3 of the vacuum chamber portion 54-1. A blotter paper is placed in the vacuum chamber portion 54-1 and in the area between the vacuum input port 54-3 and the collection chamber portion 54-2.

[0054] Thus, the tissue sample severed by the cutter cannula 50 at the sample notch 60 of the stylet cannula 46 can be transported through the vacuum cannula 44 into the sample cup 56 by the vacuum applied by the vacuum source 22 at the sample cup 56.

[0055] Referring again to Figure 2 , 4 and 5A, the probe sub-housing 42 is a sub-housing that is slidably connected to the probe housing 40, e.g., using a rail / slot arrangement. The probe sub-housing 42 includes a proximal threaded portion 42-1 and a distal threaded portion 42-2.

[0056] The proximal threaded portion 42-1 of the probe sub-housing 42 has a threaded bore that threadably receives the threaded spindle 48-2 of the stylet gear-spindle assembly 48 such that rotation of the driven gear 48-1 of the stylet gear-spindle assembly 48 results in linear translation of the stylet cannula 46 along the longitudinal axis 58, where the direction of rotation is correlated to the direction of translation of the stylet cannula 46 (in one of the proximal direction 36-1 and the distal direction 36-2). When the biopsy probe assembly 14 is attached to the driver assembly 12 (see Figure 1 ), the driven gear 48-1 of the stylet gear-spindle assembly 48 is engaged with the drive gear 32-2 of the delivery module 32.

[0057] Likewise, the distal threaded 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 assembly 52 such that rotation of the driven gear 52-1 of the cutter gear-spindle assembly 52 results in combined rotation and linear translation of the cutter cannula 50 along the longitudinal axis 58, where the direction of rotation is correlated to the direction of translation of the cutter cannula 50. When the biopsy probe assembly 14 is attached to the driver assembly 12 (see Figure 1 ), the driven gear 52-1 of the cutter gear-spindle assembly 52 is engaged with the drive gear 30-2 of the cutter module 30.

[0058] Also, when the biopsy probe assembly 14 is attached to the driver assembly 12, the probe sub-housing 42 is connected with the puncture launch driver 34-3 of the puncture module 34, with reference also to Figure 2 and 3 . In this way, when the prime / puncture button 28-2 is actuated for the first time, the probe sub-housing 42 and the puncture launch driver 34-3 are collectively translated in the proximal direction 36-1 so as to position the puncture launch driver 34-3 and the probe sub-housing 42 (which carries the stylet cannula 46 and the cutter cannula 50) in a ready (i.e., ready to fire) position, and when the prime / puncture button 28-2 is actuated for the second time so as to effect a puncture launch, the probe sub-housing 42 and the puncture launch driver 34-3 are collectively rapidly advanced in the distal direction 36-2 so as to position the stylet cannula 46 and the cutter cannula 50 at the distal-most position of the assembly, e.g., within the patient.

[0059] Figures 6A-6H Collectively represent the tissue sample severing and delivery sequence. Figure 6E and 6G represent the stylet cannula 46 in its retracted position 68-1. Figure 6A , 6B and 6H represent the stylet cannula 46 in its extended position 68-2, also sometimes referred to as the zero position. Figure 6C , 6Dand 6F indicate various positions of the stylet sleeve 46 between the retracted position 68-1 and the extended position 68-2. Figure 6B and 6C indicates the cutter sleeve 50 in its retracted position 70-1, which exposes the sample recess 60 of the stylet sleeve 46 when the stylet sleeve 46 is in its extended position 68-2 or near thereto. Figure 6A and 6D - 6H indicates the cutter sleeve 50 in its extended position 70-2, also sometimes referred to as the zero position, in which the cutter sleeve 50 covers the sample recess 60 of the stylet sleeve 46.

[0060] To effect the described movements of the stylet sleeve 46, the controller circuit 18 executes program instructions and sends corresponding control signals to the delivery module 32 of the driver assembly 12, which in turn imparts movement to the stylet gear-spindle set 48 of the biopsy probe assembly 14. Likewise, to effect the described movements of the cutter sleeve 50, the controller circuit 18 executes program instructions and sends corresponding control signals to the cutter module 30 of the driver assembly 12, which in turn imparts movement to the cutter gear-spindle set 52 of the biopsy probe assembly 14. The controller circuit 18 can determine the axial position of the stylet sleeve 46 and the cutter sleeve 50, respectively, relative to the respective zero positions by counting the respective number of motor drive pulses or, alternatively, the respective number of motor shaft revolutions.

[0061] Figure 6A indicates the relative positions of the vacuum sleeve 44, the stylet sleeve 46, and the cutter sleeve 50 prior to, during, and immediately after the firing of the puncture by the puncture module 34. As shown, the distal portion 50-2 of the cutter sleeve 50 extends over the sample recess 60.

[0062] In Figure 6BIn the sequence steps shown, vacuum source 22 is activated to deliver vacuum through vacuum sleeve 44 to the lumen 46-4 of stylet sleeve 46 at sample notch 60, and cutter sleeve 50 is retracted by activation of cutter module 30 to expose sample notch 60 to enable tissue 66 to be drawn through sample notch 60 into lumen 46-4 of stylet sleeve 46. In the present embodiment, to expose sample notch 60, cutter sleeve 50 is rotated counterclockwise to effect linear translation of cutter sleeve 50 in proximal direction 36-1 by a distance of approximately 23 millimeters (mm) to define the open length of sample notch 60. The term "approximately" as used herein means the base value of the unit indicated (when present) plus or minus 5% (unless otherwise stated). The actual aperture size at sample notch 60 (corresponding to the desired sample size) can be selected by the user at user interface 28, with the distance of retraction of cutter sleeve 50 from extended position 70-2 to retracted position 70-1 being controlled by controller circuit 18 to correspond to the sample size selected by the user.

[0063] Figure 6C and 6D represents the cutting sequence.

[0064] In Figure 6C the sequence steps shown, to increase the size of the tissue sample to be collected, stylet sleeve 46 can be alternately moved in proximal direction 36-1 and distal direction 36-2 by a short distance, e.g., 2 to 5 mm, to rock sample notch 60 to increase the amount of tissue 66 entering through sample notch 60 into lumen 46-4 of stylet sleeve 46. The last movement of the rocking is defined to hold sample notch 60 at a 1 mm retracted position (see Figure 6A ) compared to the zero position of stylet sleeve 46 (as shown in Figure 6C ). This is to ensure that cutter sleeve 50 closes sample notch 60 in the cutting sequence (see Figure 6D ) and cuts an additional 1 mm to ensure complete cutting of the connective tissue or string in the cutting sequence steps shown in Figure 6D .

[0065] In Figure 6D the cutting sequence steps shown, cutter sleeve 50 is rotated and translated in distal direction 36-2 to sever tissue sample 66-1 from tissue 66. In the present embodiment, cutter sleeve 50 is rotated clockwise to effect linear translation of cutter sleeve in distal direction 36-2 by a distance of approximately 23 mm to cut the tissue and return to the zero position.

[0066] Figures 6E-6H represents the tissue sample delivery sequence.

[0067] InFigure 6E In the illustrated sequence of steps, a vacuum is applied through a vacuum sleeve 44, and a mandrel sleeve 46 moves proximally 36-1 within a cutter sleeve 50 to mechanically facilitate the movement of the tissue sample 66-1 into the flared portion 44-2 of the vacuum sleeve 44. More specifically, as the mandrel sleeve 46 moves proximally 36-1 within the cutter sleeve 50, a protrusion 62-3 of the puncture tip 62 engages with the tissue sample 66-1 to facilitate its entry into the vacuum sleeve 44. The protrusion 62-3 then engages with the flared portion 44-2 of the vacuum sleeve 44 to close the airflow into the flared portion 44-2 of the vacuum sleeve 44.

[0068] exist Figure 6F In the sequence of steps shown, by applying a vacuum by the vacuum sleeve 44, the core needle sleeve 46 moves in the distal direction 36-2 within the cutter sleeve 50, causing the protruding part 62-3 to disengage from the flared portion 44-2 of the vacuum sleeve 44, thereby causing a sudden change in the airflow into the vacuum sleeve 44, which helps to vacuum transport the tissue sample 66-1 through the vacuum sleeve 44.

[0069] Figure 6G and 6H The sequence steps shown are essentially a repetition of sequence steps 6E and 6F.

[0070] exist Figure 6G In the sequence of steps shown, by applying a vacuum to the vacuum sleeve 44 from the vacuum source 22, the core needle sleeve 46 moves again in the proximal direction 36-1 within the cutter sleeve 50, so that the protruding part 62-3 of the puncture tip 62 re-engages with the flared portion 44-2 of the vacuum sleeve 44, thereby closing the air flow into the flared portion 44-2 of the vacuum sleeve 44 again.

[0071] exist Figure 6H In the sequence of steps shown, by applying a vacuum to the vacuum sleeve 44 from the vacuum source 22, the mandrel sleeve 46 moves distally 36-2 within the cutter sleeve 50, so as to disengage the protruding part 62-3 from the flared portion 44-2 of the vacuum sleeve 44 again, thereby causing a sudden change in the airflow into the vacuum sleeve 44, thus facilitating the vacuum transport of the tissue sample 66-1 through the vacuum sleeve 44 (when it has not yet passed through) Figure 6E and 6F (During the sequential steps of transmission). Figure 6H At the end of the sequence, the core needle cannula 46 is repositioned in the tissue receiving position, i.e., the extended position 68-2, also known as the zero position, and is ready to receive tissue for the next tissue sample, wherein the process will be repeated. Figures 6A-6H The sequential steps.

[0072] It should be noted thatFigure 6E and 6F The sample delivery sequence shown can be repeated multiple times as needed to complete the vacuum delivery of tissue sample 66-1 through vacuum sleeve 44. Furthermore, the rearward movement of the protruding part 62-3 of the puncture tip 62 of the mandrel sleeve 46 in the proximal direction 36-1 can be implemented as incremental steps, alternating between rearward movement and then forward movement (the forward distance being less than the rearward distance) until the final position (retracted position 68-1) is reached, as shown. Figure 6E and 6G As shown in the image.

[0073] Figure 7 It means in Figures 6A-6H The diagram shows the vacuum curves of baseline vacuum pressure at different locations during the tissue sample cutting and transport sequence.

[0074] refer to Figure 7 The vacuum curve should be noted that vacuum is... Figures 6A-6H The entire sequence shown is applied. At time T0, vacuum source 22 is activated, and a vacuum (negative pressure) is established in vacuum sleeve 44. At time T1, the maximum vacuum is achieved, which corresponds to... Figure 6D The cutting sequence shown in the diagram ends at time T2. Figures 6E-6F The tissue filling sequence begins, and because the timing is not limited to the vent 80 in the mandrel cannula 46, the vacuum pressure suddenly drops. Vacuum is established before time T3 because the protrusion 62-3 of the puncture tip 62 approaches the flared portion 44-2 of the vacuum cannula 44, maximizing the vacuum. Figure 6E The first filling sequence shown ends. At time T3, due to the movement of the protruding part 62-3 of the puncture tip 62 away from the flared part 44-2, as... Figure 6F As shown, the vacuum pressure suddenly drops. In some cases, tissue sample 66-1 may have already been transferred to sample cup 56. At time T4, it begins... Figure 6G and 6H The second filling order is shown. Time T5 corresponds to... Figure 6G The second filling sequence shown is complete. At time T6, the protruding part 62-3 of the puncture tip 62 moves away from the flared portion 44-2 again (as shown). Figure 6H (As shown in the diagram) and return to the tissue receiving (zero) position, thus the vacuum pressure drops.

[0075] Through Figures 6A-6H The different stages of the tissue cutting and delivery sequence shown make the actual vacuum pressure and Figure 7 By comparing the baseline vacuum curves shown, it is possible to identify abnormalities in cutting or tissue delivery and to attempt corrective actions.

[0076] According to one aspect of the application, the vacuum sensor 24 provides a vacuum pressure feedback signal to the controller circuit 18, and the controller circuit 18 executes program instructions to determine whether the actual vacuum pressure provided by the vacuum sensor 24 deviates from the baseline pressure of the vacuum profile at the corresponding point in the tissue cutting and transport sequence by more than a predetermined amount. The predetermined amount can be, for example, 10% above or below the baseline vacuum pressure. When the deviation is outside the acceptable deviation range, corrective action can be taken depending on the time at which the anomaly occurs in the tissue cutting and transport sequence. Figure 7

[0077] For example, when the vacuum pressure drops below the baseline by more than the allowed deviation during the time period between times Tl and T2, this can be an indication of incomplete cutting, so the controller circuit 18 can repeat the cutting sequence shown in Figure 6C and 6D without user intervention, rather than immediately entering an error state. Similarly, when the vacuum pressure rises above the baseline by more than the allowed deviation between times T3 and T5, this can be an indication of incomplete tissue transport through the vacuum sleeve 44, so the controller circuit 18 can increase the number of repetitions of sequence steps 6E and 6F without user intervention.

[0078] Referring again to Figure 5A , the vacuum is maintained in the biopsy probe assembly 14 by a series of seals. A seal 72, such as a sleeve type seal or O-ring arrangement, is arranged to provide a seal between the cutter sleeve 50 and the stylet sleeve 46. A seal 74, such as an O-ring, is arranged to provide a seal between the stylet sleeve 46 and the vacuum sleeve 44. A seal 76, such as a sleeve type seal or O-ring arrangement, is arranged to provide a seal between the vacuum sleeve 44 and the vacuum chamber portion 54-1 of the sample manifold 54. Also, a seal 78 can be arranged in the collection chamber portion 54-2 of the sample manifold 54 and the sample cup 56. Finally, a seal is arranged at the vacuum input port 54-3 at the vacuum interface between the biopsy probe assembly 14 and the driver assembly 12.

[0079] During operation, the vacuum pump 22-2 of the vacuum source 22 will establish a vacuum (negative pressure) in the vacuum reservoir formed by the sample manifold 54 and the sample cup 56. More particularly, the volume of the sample cup 56 and the sample manifold 54 will determine the strength of the "vacuum boost", and also the cycle time for the vacuum pump 22-2 of the vacuum source 22. In the present embodiment, for example, the volume is approximately 10 milliliters.

[0080] With regard to the "vacuum boost", the stylet sleeve 46 has one or more vent openings 80, such as an annular arrangement, at a predetermined distance proximal of the tip portion 62-1, and these vent openings 80 (see Figure 4 ​The cannula 46 will retract to the retracted position 68-1 (reference). Figure 6E and 6G When exposed to the atmosphere, the system has vent openings 80 that slide beneath a seal 72 between the cutter sleeve 50 and the core needle sleeve 46. Once these vent openings 80 are exposed to the atmosphere, the system will “open” and the accumulated vacuum pressure will equal the ambient pressure in order to produce a vacuum boosting effect (in addition to the continuous flow delivered by the vacuum pump 22-2 of the vacuum source 22).

[0081] See again Figure 3 When the cutter motor 30-1 is driven by the moving cutter sleeve 50 for cutting tissue, or when the transport motor 32-1 is driven by the moving mandrel sleeve 46 for transporting tissue, each motor draws current from the battery 26. This current increases linearly with the load on the respective motor. Therefore, the amount of current consumed can be converted into a load. When working on dense tissue, the load may increase, which is detected by monitoring the current using a current monitoring program executed by the controller circuit 18.

[0082] The cutter motor 30-1 and the conveyor motor 32-1 each have a maximum continuous current rating (load). The motors can operate indefinitely at their maximum continuous current rating, but when the corresponding motor exceeds this continuous current (load), it can only operate for a limited time before motor failure (e.g., winding burns in the motor), with the time decreasing as the load increases. A current monitoring program executed by the controller circuit 18 monitors the current for each motor, and when the current exceeds the maximum continuous current level for the corresponding motor, it determines that the motor has entered a dense structure mode, and the drive assembly enters a dense structure mode.

[0083] When encountering dense tissue, the controller circuit 18 controls the current supplied to the corresponding motor according to the state (virtual energy level) of the virtual energy storage device in order to provide motor protection and allow the motor current to exceed the maximum continuous current rating for a short period of time. The state of the virtual energy storage device is established in the memory circuit 18-2 of the controller circuit 18.

[0084] This concept is to apply as much motor force as possible without damaging the motor windings when encountering such challenging dense tissue. Once the motor (e.g., cutter motor 30-1 and / or feed motor 32-1) starts to run in any phase, the motor speed (revolutions per minute (rpm)) is set to 100% according to the voltage set in the controller circuit 18 (e.g., equal to 6 volts). Then, an increase in load (torque) will increase the current draw and can slow down the motor until it stops rotating. The controller circuit 18 can choose to increase the voltage from 6 volts to, for example, 9 volts and thereby increase the speed (rpm) and stall torque to overcome more dense tissue. In this example, it is assumed that each motor has three individual windings or phases. It is recognized, however, that some very dense tissue can stall the motor from rotating, in which case only one motor phase or winding is in an on state, which will cause a sharp increase in temperature in that single phase and cause the motor to burn out. The virtual energy reservoir is used to monitor the heat when running between the sustained torque level and the stall torque level, in which there is a risk of the motor winding burning out.

[0085] According to one aspect of the present invention, it is possible to exceed the sustained current level, for example, when encountering dense tissue, and still protect the motor without compromising motor performance.

[0086] It is assumed that each motor is initialized at rest and the ambient temperature is normal room temperature. By tracking the instantaneous current draw over time of operation, it is possible to predict the corresponding increase in motor winding temperature. Therefore, for dense tissue detection / motor protection, a virtual energy reservoir is established in the memory circuit 18-2 for each motor (cutter motor 30-1 and feed motor 32-1). The virtual energy reservoir can be filled or depleted while running according to the integral of the difference between the actual motor winding current and the rated motor winding current (maximum sustained current) over a period of time. When the actual motor winding current is higher than the rated motor winding current (maximum sustained current), the motor winding temperature starts to increase and vice versa.

[0087] Therefore, the controller circuit 18 executes program instructions in order to predict the time when the winding temperature is above its thermal limit, and when this is determined, the controller circuit 18 sends a control signal to the corresponding cutter module 30 or feed module 32 in order to reduce the torque of the motor before the corresponding motor gets too hot. The algorithm executed by the controller circuit 18 as program instructions is as follows:

[0088] ∫(I 2 -In 2 )t

[0089] where: “I” represents the actual motor winding current;

[0090] “In” represents the rated current of the motor winding; and

[0091] "t" denotes time.

[0092] Figure 8A is a plot of the actual motor winding current (I), Figure 8B is a plot of the energy state of the virtual energy reservoir established in the memory circuit 18-2. In Figure 8B the plot, STH denotes the upper threshold, and STL denotes the lower threshold of the virtual energy reservoir.

[0093] Referring to Figure 8A and 8B the combination, when the motor is started at tO, there is a large current spike for the motor to accelerate, and at the same time, the virtual energy reservoir starts to fill, although it does not exceed the upper threshold. The virtual energy reservoir is empty at tl, and the virtual energy reservoir continues to be zero until the current again increases suddenly at t2. When the energy accumulation in the virtual energy reservoir first exceeds the upper threshold STH at t3, the controller circuit 18 immediately takes action so that the current supplied to the corresponding motor is reduced to a (predetermined) safe level. The virtual energy reservoir level starts to drop from that time, even though the virtual energy reservoir level has experienced a very short overshoot. When the energy accumulation of the virtual energy reservoir level drops below the lower threshold STL at t4, the controller circuit 18 immediately takes action to again increase, i.e., increase the current. The same process can be repeated three times before the controller circuit 18 specifies the condition as an error condition, which means that the organization is significantly dense, i.e., too dense to be cut. The number of three repetitions before the error is predetermined in the software executed by the controller circuit 18. The number of repetitions can be varied, if necessary, based at least in part on the length of the cycle time (e.g., the time of t5-t3).

[0094] In the present embodiment, the dense tissue mode is entered automatically when the driver assembly 12 is powered on and runs all the time after the driver assembly 12 is powered on.

[0095] The following also relates to the present invention:

[0096] In one form, the present disclosure is directed to a biopsy device including a driver assembly and a biopsy probe. The driver assembly has an electromechanical power source and a vacuum source. The biopsy probe assembly is releasably attachable to the driver assembly. The biopsy probe assembly has a vacuum sleeve and a stylet sleeve coaxially arranged along a longitudinal axis. The vacuum sleeve is positioned inside the stylet sleeve. The vacuum sleeve is connected in fluid communication with the vacuum source. The vacuum sleeve has an elongated portion and a flared portion extending distally from the elongated portion. The stylet sleeve is connected in driving communication with the electromechanical power source. The stylet sleeve is movable relative to the vacuum sleeve between a first extended position and a first retracted position. The stylet sleeve has a proximal portion and a distal portion. The distal portion has a sample recess and a protruding member extending proximally in a lumen of the stylet sleeve along a portion of a longitudinal length of the sample recess. When the stylet sleeve is in the first retracted position, the protruding member is received within the flared portion of the vacuum sleeve.

[0097] The flared portion of the vacuum sleeve can have a first flared segment diverging from the elongated portion at a first acute angle relative thereto and a second flared segment diverging from the first flared segment at a second acute angle relative thereto. Optionally, the second acute angle is greater than the first acute angle.

[0098] The biopsy probe assembly can further include a cutter sleeve coaxial with the stylet sleeve and the vacuum sleeve, wherein the stylet sleeve is positioned within the cutter sleeve. The cutter sleeve is movable relative to the stylet sleeve between a second extended position for covering the sample recess and a second retracted position for exposing the sample recess when the stylet sleeve is in the first extended position.

[0099] In any embodiment, the driver assembly optionally includes a driver housing having a front surface. The biopsy probe assembly has a probe housing having an elongated portion and, in any embodiment, can include a front panel. When the biopsy probe assembly is attached to the driver assembly, the front panel is distally positioned proximate to the entire front surface of the driver housing so as to shield the entire front surface of the driver assembly from contact with a patient.

[0100] In any embodiment, the driver assembly can include a controller circuit and an electromechanical power source. The controller circuit is in electrical and communicative connection with the electromechanical power source. The electromechanical power source has a cutter module and a delivery module. The cutter module has a first motor and the delivery module has a second motor. The cutter module is in driving connection with the cutter cannula when the biopsy probe assembly is attached to the driver assembly and the delivery module is in driving connection with the stylet cannula. The first motor and the second motor each have a maximum continuous current rating at which the respective motor can run indefinitely. The controller circuit is configured to execute program instructions to control current to each of the first motor and the second motor. The controller circuit is configured to determine that a motor is in dense tissue when the current exceeds the maximum continuous level of the respective motor.

[0101] In any embodiment having a controller circuit, the controller circuit can include a processor circuit and a memory circuit and can have a virtual energy reservoir established in the memory circuit for each of the first motor and the second motor. The processor is configured to execute program instructions to control current to the respective motor to provide motor protection and to allow the respective motor current to exceed the maximum continuous current rating for a short period of time (depending on the state of the virtual energy reservoir).

[0102] In any embodiment having at least one virtual energy reservoir, each virtual energy reservoir is capable of being filled or depleted. The controller circuit can be configured to integrate the difference between the actual motor winding current for the respective motor and the maximum continuous current rating over a period of time. The controller circuit can be configured to take action to decrease current to the respective motor when the energy accumulation level in the virtual energy reservoir exceeds an upper threshold. The controller circuit can be configured to take action to increase current to the respective motor when the energy accumulation level in the virtual energy reservoir falls below a lower threshold. The apparatus can be configured such that the controller circuit takes further action to decrease current to the respective motor when the energy accumulation level in the virtual energy reservoir exceeds the upper threshold. The apparatus can be configured such that the controller circuit takes further action to increase current to the respective motor when the energy accumulation level in the virtual energy reservoir falls below the lower threshold.

[0103] In any embodiment having a controller circuit, the controller circuit can be configured to execute program instructions to repeatedly cause the protruding member of the stylet cannula to move into and out of the flared portion of the vacuum cannula to assist in the transfer of the tissue sample into the flared portion of the vacuum cannula. The apparatus can be configured such that vacuum is continuously applied to the vacuum cannula while the protruding member of the stylet cannula repeatedly moves into and out of the flared portion of the vacuum cannula.

[0104] In another form, the present invention relates to a biopsy device having a driver assembly with a motor, a vacuum source, and a controller circuit in electrical communication with the motor and the vacuum source. A biopsy probe assembly is releasably attached to the driver assembly. The biopsy probe assembly has a vacuum sleeve, a stylet sleeve, and a cutter sleeve coaxially arranged along a longitudinal axis. The vacuum sleeve is inside the stylet sleeve. The stylet sleeve is inside the cutter sleeve. The vacuum sleeve is in fluid communication with the vacuum source. The vacuum sleeve has an elongated portion and a flared portion extending distally from the elongated portion. The stylet sleeve is in driving communication with the motor. The stylet sleeve is movable relative to the vacuum sleeve between a first extended position and a first retracted position. The stylet sleeve has a proximal portion and a distal portion. The distal portion has a sample recess and a protruding member extending proximally in a lumen of the stylet sleeve along a portion of a longitudinal length of the sample recess. The protruding member is received within the flared portion of the vacuum sleeve when the stylet sleeve is in the retracted position. The cutter sleeve is in driving communication with the motor. The cutter sleeve is movable relative to the stylet sleeve between a second extended position for covering the sample recess and a second retracted position for exposing the sample recess when the stylet sleeve is in the first extended position.

[0105] The controller circuit can be configured to execute program instructions to control the device such that the protruding member of the stylet sleeve is repeatedly moved into and out of the flared portion of the vacuum sleeve to help deliver a tissue sample into the flared portion of the vacuum sleeve. The device can be controlled such that the vacuum is continuously applied to the vacuum sleeve during the repeated movement of the protruding member of the stylet sleeve into and out of the flared portion of the vacuum sleeve.

[0106] The motor can include a cutter module and a transport module. The cutter module has a first motor and the transport module has a second motor. The cutter module is in driving connection with the cutter sleeve and the transport module is in driving connection with the stylet sleeve when the biopsy probe assembly is attached to the driver assembly.

[0107] The first motor and the second motor each have a maximum continuous current rating at which the respective motor can run indefinitely. The controller circuit is configured to execute program instructions to control the current for each of the first motor and the second motor. The controller circuit can be configured to determine that the motor has entered dense tissue when the current exceeds the maximum continuous level for the respective motor.

[0108] The controller circuit can include a processor circuit and a memory circuit. The controller circuit can have a virtual energy reservoir established in the memory circuit for each first motor and second motor. The processor can be configured to execute program instructions to control the current supplied to the respective motor in accordance with the state of the virtual energy reservoir to provide motor protection and to allow the respective motor current to exceed the maximum continuous current rating for a short period of time.

[0109] In any embodiment having at least one virtual energy reservoir, each virtual energy reservoir can be capable of being filled or depleted. The controller circuit can be configured to integrate the difference between the actual motor winding current for the respective motor and the maximum continuous current rating over a period of time. The controller circuit can be configured to decrease the current supplied to the respective motor when the energy accumulation level in the virtual energy reservoir exceeds an upper threshold. The controller circuit can be configured to increase the current supplied to the respective motor when the energy accumulation level in the virtual energy reservoir falls below a lower threshold. The apparatus can be configured such that the controller circuit takes further action to decrease the current supplied to the respective motor when the energy accumulation level in the virtual energy reservoir exceeds the upper threshold. The apparatus can be configured such that the controller circuit takes further action to increase the current supplied to the respective motor when the energy accumulation level in the virtual energy reservoir falls below the lower threshold.

[0110] The flared portion of the vacuum jacket can have a first flared segment diverging from the elongated portion at a first acute angle relative to the elongated portion and a second flared segment diverging from the first flared segment at a second acute angle relative to the elongated portion. Optionally, the second acute angle is greater than the first acute angle.

[0111] While the application has been described with respect to at least one embodiment, the application can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the application using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which the application pertains and fall within the limits of the appended claims.

Claims

1. A biopsy device comprising: a driver assembly having an electromechanical power source, a vacuum source and a controller circuit in electrical connection and communication with the electromechanical power source; and a biopsy probe assembly releasably attachable to the driver assembly, the biopsy probe assembly having a vacuum sleeve, a cutter sleeve and a stylet sleeve coaxially arranged along a longitudinal axis, wherein the vacuum sleeve is located inside the stylet sleeve, the vacuum sleeve is in fluid communication with the vacuum source, the vacuum sleeve has an elongated portion and a flared portion extending distally from the elongated portion, the stylet sleeve and the cutter sleeve are in driving communication with the electromechanical power source, the stylet sleeve has a proximal portion and a distal portion, the distal portion has a sample recess and a protruding member extending proximally in a lumen of the stylet sleeve along a portion of a longitudinal length of the sample recess, wherein: the stylet sleeve is movable relative to the vacuum sleeve between a first extended position and a first retracted position by the electromechanical power source in accordance with control signals of the controller circuit, wherein the protruding member is received within the flared portion of the vacuum sleeve when the stylet sleeve is in the first retracted position. the flared portion of the vacuum sleeve has a first flared segment diverging from the elongated portion at a first acute angle relative to the elongated portion; and a second flared segment diverging from the first flared segment at a second acute angle relative to the elongated portion, wherein the second acute angle is greater than the first acute angle.

2. The biopsy device of claim 1, wherein: the stylet sleeve is located within the cutter sleeve, the cutter sleeve is movable relative to the stylet sleeve between a second extended position for covering the sample recess and a second retracted position for exposing the sample recess by the electromechanical power source in accordance with control signals of the controller circuit when the stylet sleeve is in the first extended position.

3. The biopsy device of claim 1 or 2, wherein: the driver assembly includes a driver housing having a front surface, the biopsy probe assembly has a probe housing having an elongated portion and a front plate, wherein the front plate is located distally adjacent to the entire front surface of the driver housing when the biopsy probe assembly is attached to the driver assembly so as to shield the entire front surface of the driver assembly. the electromechanical power source has a cutter module in driving connection with the cutter sleeve and a delivery module in driving connection with the stylet sleeve, the cutter module has a first motor, the delivery module has a second motor, wherein the first motor and the second motor each has a maximum continuous current rating, the respective motor is capable of running indefinitely at the maximum continuous current rating, 4. The biopsy device of claim 1 or 2, wherein: the current supplied to the respective motor is controlled by a processor circuit of the controller circuit based on a state of a virtual energy reservoir established in a memory circuit of the controller circuit for each first motor and second motor in order to provide motor protection and to allow the current of the respective motor to exceed the maximum continuous current rating for a short time.

5. The biopsy device of claim 1 or 2, wherein: each virtual energy reservoir is capable of being filled or emptied, ​ 6. The biopsy device of claim 5, wherein: ​ By the controller circuit, a difference between an actual motor winding current for the respective motor and a maximum continuous current rating is integrated over a period of time, wherein the controller circuit is set to reduce the current supplied to the respective motor when an energy accumulation level in the virtual energy store exceeds an upper threshold value and to increase the current supplied to the respective motor when the energy accumulation level of the virtual energy store falls below a lower threshold value.

7. The biopsy device of claim 5, comprising: Based on a control signal of the controller circuit, the protruding member of the stylet cannula is repeatedly movable into and out of the flared portion of the vacuum cannula by the electromechanical power source.

8. The biopsy device of claim 7, wherein: The controller circuit is in electrical connection and communication with the vacuum source, The vacuum source is controlled by the controller circuit such that the vacuum is continuously applied to the vacuum cannula during the time the protruding member of the stylet cannula is repeatedly moved into and out of the flared portion of the vacuum cannula.

Images