Biopsy device with a puncture module

Abstract

A biopsy device includes a piercing module having a probe drive slider coupled to a probe carrier body of a biopsy probe assembly, and the biopsy device has a ready position and a fired position. A nut housing has an initial position and an extended position. A drive spindle is drivably coupled to a motor drive shaft and is coupled to the nut housing. A firing spring is disposed between the motor housing and the probe drive slider. A release arm is pivotally coupled to the piercing module frame. When the probe drive slider is in the ready position and the release arm is in the latched position, the release arm is positioned to engage the probe drive slider to hold the probe drive slider in the ready position. When the nut housing moves from the initial position to the extended position, a release slider releases the release arm from the latched position.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 939,342, filed on November 22, 2019, entitled "Piercing Module / Firing Mechanism For Multiple Sample Biopsy Apparatus", which is incorporated herein by reference. Technical Field

[0003] The present invention relates to a biopsy device, and more particularly, the present invention relates to a biopsy device having a piercing module, which is sometimes referred to in the art as a firing mechanism. Background Art

[0004] A biopsy can be performed on a patient to help determine whether the tissue in the area of interest includes cancer cells. For example, a biopsy technique for evaluating breast tissue involves inserting a biopsy probe into the area of breast tissue of interest to capture one or more tissue samples from that area. This biopsy technique typically uses a vacuum to draw the tissue to be sampled into a sample notch of the biopsy probe, and then cuts and collects the tissue. In the art, there is a continuing effort to improve the ability of biopsy devices to insert into the tissue of a patient to be biopsied, cut tissue samples, and transport the cut tissue samples to a sample collection container. Such tissue can be, for example, dense and / or fibrous tissue.

[0005] There is a need in the art for a biopsy device having a piercing module that can facilitate the effective insertion of the needle portions (e.g., trocar and cutter cannula) of a biopsy probe assembly into the tissue of a patient. Summary of the Invention

[0006] The present invention provides a biopsy device having a piercing module that can facilitate the effective insertion of the needle portions (e.g., trocar and cutter cannula) of a biopsy probe assembly into the tissue of a patient.

[0007] In one form, the present invention relates to a biopsy device that includes a biopsy probe assembly and a piercing module. The biopsy probe assembly has a probe carrier body, a stylet cannula, and a cutter cannula coaxial with the stylet cannula. Each of the stylet cannula and the cutter cannula is coupled to the probe carrier body. The piercing module is drivably coupled to the probe carrier body. The piercing module includes a piercing module frame having a proximal portion and a distal portion. A probe drive slider is slidably coupled to the piercing module frame. The probe drive slider is drivably coupled to the probe carrier body of the biopsy probe assembly. The probe drive slider has a ready position and a fired position. A nut housing is movably coupled to the piercing module frame. The nut housing has a cocked position, an initial position, and an extended position. A motor assembly has a motor and a motor housing. The motor housing is configured to mount the motor to the piercing module frame. The motor has a rotatable drive shaft. A drive spindle is drivably coupled to the rotatable drive shaft of the motor. The drive spindle is rotatable and drivably coupled to the nut housing. A firing spring is disposed between the motor housing and the probe drive slider. The firing spring is configured to bias the probe drive slider toward the fired position. A release arm has a mounting end portion and a head. The mounting end portion is pivotally coupled to the piercing module frame. The release arm has a latching position in which, when the probe drive slider is in the ready position and the release arm is in the latching position, the head of the release arm is positioned to engage the probe drive slider to hold the probe drive slider in the ready position. A release slider is slidably coupled to the piercing module frame. The release slider is configured to engage the nut housing. The release slider is configured to release the release arm from the latching position when the nut housing is moved from the initial position to the extended position by rotation of the drive spindle.

[0008] In another form, the present invention relates to a biopsy device having a biopsy probe assembly and a piercing module. The biopsy probe assembly has a probe carrier body, a stylet cannula, and a cutter cannula coaxial with the stylet cannula. Each of the stylet cannula and the cutter cannula is movably coupled to the probe carrier body. The piercing module is drivingly coupled to the probe carrier body. The piercing module includes a piercing module frame having a proximal portion and a distal portion. A probe drive slider is slidably coupled to the piercing module frame. The probe drive slider is configured to be drivingly coupled to the probe carrier body of the biopsy probe assembly. The probe drive slider is longitudinally translatable along the piercing module frame. The probe drive slider has a ready position and a fired position. A nut housing is movably coupled to the piercing module frame. The nut housing contains an internal thread. The nut housing is longitudinally translatable along the piercing module frame. The nut housing has a cocked position, an initial position, and an extended position. A motor assembly has a motor and a motor housing. The motor housing is configured to mount the motor to the proximal portion of the piercing module frame. The motor has a rotatable drive shaft. The drive spindle has a proximal end, a distal end, and an elongated threaded portion. The proximal end of the drive spindle is drivingly coupled to the rotatable drive shaft of the motor. The elongated threaded portion is rotatably engaged with the internal thread of the nut housing. A firing spring is disposed between the motor housing and the probe drive slider. The firing spring is configured to bias the probe drive slider toward the fired position. A release arm has a distal mounting end portion and a proximal head. The proximal head is longitudinally spaced from the distal mounting end portion. The distal mounting end portion is pivotally coupled to the distal portion of the piercing module frame. The release arm is biased by a first biasing spring toward a latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the proximal head of the release arm is positioned to engage the probe drive slider to hold the probe drive slider in the ready position. A release slider is slidably coupled to the piercing module frame and is biased in the proximal direction by a second biasing spring. The release slider has an engagement portion configured to engage the nut housing. The release slider is configured to release the release arm from the latched position when the nut housing moves from the initial position to the extended position by rotation of the drive spindle.

[0009] In another form, the present invention relates to a biopsy driver for drivingly coupling to a biopsy probe assembly having a probe carrier body carrying a stylet cannula. The biopsy driver includes a piercing module frame having a proximal portion and a distal portion. A probe drive slider is slidably coupled to the piercing module frame. The probe drive slider is configured to drivingly couple to the probe carrier body of the biopsy probe assembly. The probe drive slider has a ready position and a fired position. A nut housing is movably coupled to the piercing module frame. The nut housing has a cocked position, an initial position, and an extended position. A motor assembly has a motor and a motor housing. The motor housing is configured to mount the motor to the piercing module frame. The motor has a rotatable drive shaft. A drive spindle is drivingly coupled to the rotatable drive shaft of the motor. The drive spindle is rotatably coupled to the nut housing. A firing spring is disposed between the motor housing and the probe drive slider. The firing spring is configured to bias the probe drive slider toward the fired position. A release arm has a mounting end portion and a head. The mounting end portion is pivotally coupled to the distal portion of the piercing module frame. The release arm is biased by a biasing member toward a latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the head of the release arm is configured to engage the probe drive slider to hold the probe drive slider in the ready position. A release slider is slidably coupled to the piercing module frame. The release slider has an engagement portion configured to engage the nut housing. The release slider is configured to release the release arm from the latched position when the motor rotates the drive spindle to move the nut housing from the initial position to the extended position. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The features and advantages of the present invention and the manner of achieving them will become more apparent and will be better understood by referring to the following description of embodiments of the invention in conjunction with the accompanying drawings, in which:

[0011] Figure 1 is a perspective view of a biopsy device constructed in accordance with an embodiment of the present invention, wherein the biopsy probe assembly is attached to the biopsy driver;

[0012] Figure 2 is Figure 1 a perspective view of the biopsy device of, wherein the biopsy probe assembly is separated from the biopsy driver and the upper cover of the biopsy driver is removed to expose the piercing module of the biopsy driver;

[0013] Figure 2A is Figure 2 a bottom view of the biopsy driver of, wherein the biopsy driver is inverted from the direction shown in Figure 2 ;

[0014] Figure 3 is Figure 1 a block diagram of the biopsy driver of;

[0015] Figure 4 is Figure 1 an exploded view of a biopsy probe assembly;

[0016] Figure 5 is a sectional view of the biopsy probe assembly taken along Figure 2 line 5-5 of Figure 1 and Figure 2 ;

[0017] Figure 6 is Figure 2 a top view of the piercing module of

[0018] Figure 7 is Figure 2 a side view of the piercing module of

[0019] Figure 8 is Figure 2 a bottom view of the piercing module of Figure 6 which is opposite to the top view of

[0020] Figure 9 and shows the probe drive slider in the fired position and the nut housing in the initial position; Figure 8 a distal view of the piercing module in the direction depicted in

[0021] Figure 10 is Figure 2 opposite to the direction of the piercing module of Figure 2 and Figures 6 - 9 a perspective view of the piercing module of Figure 8 showing the probe drive slider in the fired position and the nut housing in the initial position, as also shown in

[0022] Figure 11 is Figure 2 and Figure 6 -10 an exploded view of the piercing module;

[0023] Figure 12 is a sectional view of the piercing module taken along Figure 8 line 12-12 showing the probe drive slider in the fired position and the nut housing in the initial position and showing the pivot latch of the nut housing which engages with the slider body of the probe drive slider to lock the nut housing and the probe drive slider together;

[0024] Figure 13 is a bottom view of the piercing module showing the probe drive slider in the ready position and the nut housing in the cocked position;

[0025] Figure 14 is alongFigure 13 A cross-sectional view of the piercing module taken along line 14-14, which shows the probe drive slider in the ready position and the nut housing in the cocked position, and shows the pivot latch of the nut housing disengaged from the slider body of the probe drive slider to unlock the nut housing from the probe drive slider;

[0026] Figure 15 is along Figure 13 A cross-sectional view of the piercing module taken along line 15-15, which shows the release arm in the latched position, and the head of the release arm engages with the shoulder of the probe drive slider to hold the probe drive slider in the ready position;

[0027] Figure 16 A bottom view of the piercing module, which shows the probe drive slider in the ready position and the nut housing in the initial position;

[0028] Figure 17 A bottom view of the piercing module, which shows the probe drive slider in the ready position and the nut housing in the extended position;

[0029] Figure 18 is along Figure 17 A cross-sectional view of the piercing module taken along line 18-18, which shows the probe drive slider in the ready position and the nut housing in the extended position;

[0030] Figure 19 is along Figure 17 A cross-sectional view of the piercing module taken along line 19-19, which shows the cantilever release member of the release slider engaging and pressing on the release arm to move the release arm to the release position;

[0031] Figure 20 is Figure 19 An enlarged view of a part of the cross-sectional view;

[0032] Figure 21 is along Figure 17 A cross-sectional view of the piercing module taken along line 21-21, which shows the release arm in the release position, and the head of the release arm disengages from the shoulder of the probe drive slider to release the probe drive slider from the ready position; and

[0033] Figure 22 is Figure 21 An enlarged view of a part of the cross-sectional view.

[0034] Corresponding reference numerals indicate corresponding parts in multiple views. The examples listed herein illustrate at least one embodiment of the present invention, and these examples should not be construed as limiting the scope of the present invention in any way. Detailed Description

[0035] Now referring to the accompanying drawings, and more particularly to Figure 1 and Figure 2 , a biopsy device 10 is shown, which includes a non-invasive (e.g., non-disposable) biopsy driver 12 and an invasive (e.g., disposable) biopsy probe assembly 14. As used herein, the term "non-disposable" is used to refer to a device intended to be used for multiple patients during the life cycle of the device, and the term "disposable" is used to refer to a device intended to be disposed of after use on a single patient. The biopsy driver 12 includes a driver housing 16 that is configured and ergonomically designed to be grasped by a user.

[0036] Referring to Figure 2 and Figure 3 , the biopsy driver 12 includes a controller circuit 18, an electromechanical power supply 20, a vacuum source 22, a vacuum sensor 24, and a battery 26 (or optionally an AC adapter) within the driver housing 16. A user interface 28 such as a keypad (see Figure 1 ) is positioned to be mounted to the driver housing 16 and can be accessed by the user from the outside 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 coupled to an induction 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 supply 20, the vacuum source 22, and the user interface 28.

[0037] Referring to Figure 3 , the user interface 28 can include control buttons and visual / auditory indicators, where the control buttons provide the user with control over various functions of the biopsy device 10, and the visual / auditory indicators provide visual / auditory feedback on the status of one or more conditions of the biopsy device 10 and / or the position of components. The control buttons can include a sample button 28-1 and a prime / puncture button 28-2. The visual indicator can include a display screen 28-3 and / or one or more light-emitting diodes (LEDs) 28-4. The auditory indicator can include a buzzer 28-5. The control buttons can include tactile feedback to the user when actuated.

[0038] The controller circuit 18 is electrically and communicatively connected to the electromechanical power supply 20, the vacuum source 22, the vacuum sensor 24, and the user interface 28, for example, by one or more wires or circuit traces. The controller circuit 18 can be assembled on a circuit board and includes, for example, a processor circuit 18-1 and a memory circuit 18-2.

[0039] The processor circuit 18-1 has one or more programmable microprocessors and associated circuitry, such as input / output interfaces, clocks, buffers, memories, etc. The memory circuit 18-2 is communicatively coupled to the processor circuit 18-1, for example, via a bus circuit, and is a non-transitory electronic memory, which may include volatile memory circuits (such as random access memory (RAM)) and non-volatile memory circuits (e.g., read-only memory (ROM), electrically erasable programmable ROM (EEPROM), NOR flash memory, NAND flash memory, etc.). The controller circuit 18 may be formed as one or more application-specific integrated circuits (ASICs).

[0040] The controller circuit 18 is configured to execute program instructions, which are resident in the memory circuit 18-2, to perform functions associated with retrieving a biopsy tissue sample, such as controlling and / or monitoring one or more components of the electromechanical power supply 20, the vacuum source 22, and the vacuum sensor 24.

[0041] The electromechanical power supply 20 of the biopsy driver 12 may include, for example, a cutter module 30, a transport module 32, and a piercing module 34 (see also Figure 2 ), each module being electrically coupled to the battery 26 separately. Each of the cutter module 30, the transport module 32, and the piercing module 34 is electrically and controllably coupled to the controller circuit 18 via one or more electrical conductors (e.g., wires or circuit traces). The piercing module 34 may also be sometimes referred to as a "firing mechanism" in the art.

[0042] The cutter module 30 may include an electric motor 30-1 having a shaft with a drive gear 30-2 attached thereto. The transport module 32 may include an electric motor 32-1 having a shaft with a drive gear 32-2 attached thereto. The piercing module 34 may include a motor 35 (e.g., an electric motor), a drive spindle 36, and a probe drive slider 38. Each of the electric motors 30-1, 32-1, 35 may be, for example, a direct current (DC) motor or a stepper motor.

[0043] Referring to Figure 2 and Figure 3 , the piercing module 34 of the biopsy driver 12 is configured such that a first actuation of the start / pierce button 28-2 of the user interface 28 actuates the motor 35 to rotate the drive spindle 36, so as to move the probe drive slider 38 in the proximal direction 39-1 to compress a firing spring (e.g., one or more helical springs), and lock the probe drive slider 38 in a ready position. Upon a second actuation of the start / pierce button 28-2 of the user interface 28, the probe drive slider 38 is advanced in the distal direction 39-2, i.e., fired. The piercing module 34 will be described in more detail below.

[0044] The vacuum source 22 is electrically and controllably coupled to the battery 26 via one or more electrical conductors (such as 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 coupled to the vacuum pump 22-2 for establishing a vacuum in the biopsy probe assembly 14. The electric motor 22-1 may be, for example, a rotary, linear, or vibrating DC motor. The vacuum pump 22-2 may be, for example, a peristaltic pump or a diaphragm pump, or one or more of each in series or parallel.

[0045] The vacuum sensor 24 is electrically coupled to the controller circuit 18 via one or more electrical conductors (such as, wires or circuit traces). The vacuum sensor 24 may 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 may be incorporated into the vacuum source 22.

[0046] Referring Figure 1 and Figure 2 , the biopsy probe assembly 14 is configured to be releasably attached to the biopsy driver 12. As used herein, the term "releasably attached" refers to a configuration that facilitates an intended temporary connection, the intended temporary coupling being followed by a selective detachment of the disposable biopsy probe assembly 14 relative to the biopsy driver 12 without the use of tools.

[0047] Referring Figure 4 to the exploded view of, the biopsy probe assembly 14 includes a probe housing 40, a probe carrier body 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. Each of the stylet cannula 46 and the cutter cannula 50 is coupled (such as, movably coupled) to the probe carrier body 42.

[0048] Referring Figure 2 and Figure 4 , 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 12, the front plate 40-2 is positioned distally adjacent to the entire front surface 16-1 of the driver housing 16, that is, to shield the entire front surface 16-1 of the non-disposable biopsy driver from contact with the patient.

[0049] The vacuum cannula 44, the stylet cannula 46, and the cutter cannula 50 are coaxially arranged in a nested cannula arrangement along the longitudinal axis 58, where the vacuum cannula 44 is the innermost tube, the cutter cannula 50 is the outermost tube, and the stylet cannula 46 is the intermediate tube between the vacuum cannula 44 and the cutter cannula 50. In other words, the vacuum cannula 44 is located inside the stylet cannula 46, and the stylet cannula 46 is located inside the cutter cannula 50.

[0050] The vacuum cannula 44 is mounted stationary relative to the probe carrier body 42. The vacuum cannula 44 is fluidly connected to the vacuum source 22 through the sample manifold 54.

[0051] Referring Figure 4 and Figure 5 Referring to FIGS. and, 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. The piercing tip 62 is attached to the distal portion 46-2, which in turn forms part of the stylet cannula 46. The stylet gear-spindle assembly 48 is threadedly engaged with the external thread of the transmission spindle 46-5, and the transmission spindle is fixedly attached (e.g., glued, welded, or riveted) 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 the threaded spindle 48-2 and can be formed as a single molded part. By actuating the transmission module 32 of the biopsy probe assembly 14, the stylet cannula 46 is retracted or extended along the longitudinal axis 58, where the drive gear 32-2 of the transmission module 32 of the biopsy driver 12 is engaged with the driven gear 48-1 of the stylet gear-spindle assembly 48.

[0052] The sample notch 60 is formed as an elongated opening in the sidewall of the stylet cannula 46 to facilitate the reception of tissue into the lumen 46-4 of the stylet cannula 46. The sample notch 60 has a longitudinal extent extending along the longitudinal axis 58. The sample notch 60 does not extend in the sidewall below the centerline of the diameter of the stylet cannula 46 and may include a cutting edge surrounding the perimeter of the opening formed by the sample notch 60, where the cutting edges of the elongated (linear) portion of the sample notch 60 each have a cutting edge that diverges from the cutting edge along the sidewall to the centerline of the diameter of the stylet cannula 46.

[0053] Referring again to Figure 4, the 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 riveted) to the proximal portion 50-1 of the cutter cannula 50. The cutter gear-spindle assembly 52 is an integral gear having a driven gear 52-1 fixedly attached to a threaded spindle 52-2 and may be formed as a single molded part. By actuating the cutter module 30 of the biopsy probe assembly 14, the cutter cannula 50 retracts or extends along the longitudinal axis 58, wherein the drive gear 30-2 of the cutter module 30 of the biopsy driver 12 meshes with the driven gear 52-1 of the cutter gear-spindle assembly 52. Thus, the cutter cannula 50 has a rotary cutting motion and translates axially along the longitudinal axis 58. The pitch of the threads of the threaded spindle 52-2 determines the number of revolutions per axial distance (in millimeters (mm)) that the cutter cannula 50 moves axially.

[0054] 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 arranged to sealingly engage the vacuum source port 22-3 of the vacuum source 22 of the biopsy driver 12 when the biopsy probe assembly 14 is attached to the biopsy driver 12. The vacuum chamber portion 54-1 is fluidly connected to 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 that is sized and arranged to removably receive a 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. Absorbent paper is placed in the vacuum chamber portion 54-1 in the region between the vacuum input port 54-3 and the collection chamber portion 54-2.

[0055] Thus, the tissue sample cut by the cutter cannula 50 at the sample notch 60 of the trocar cannula 46 can be transported through the vacuum cannula 44 and into the sample cup 56 by the vacuum applied at the sample cup 56 by the vacuum source 22.

[0056] Referring again to Figure 2 , Figure 4 and Figure 5, the probe carrier body 42 is slidably coupled to (e.g., using a rail / slot arrangement) the probe housing 40. The probe carrier body 42 carries a proximal threaded portion 42-1 and a distal threaded portion 42-2. Additionally, the probe carrier body 42 is configured to be drivably coupled to the piercing module 34. In other words, when the biopsy driver 12 is coupled to the biopsy probe assembly 14 to form the biopsy device 10, the piercing module 34 is drivably coupled to the probe carrier body 42.

[0057] The probe carrier body 42 includes one or more piercing module engagement openings, such as slots. In the present embodiment, with reference to Figure 2 , the probe carrier body 42 includes a piercing module engagement opening 42-3 and a piercing module engagement opening 42-4, each of which is configured, for example, in size and shape to receive a respective drive protrusion of the piercing module 34 as will be described in more detail below. For example, each of the piercing module engagement opening 42-3 and the piercing module engagement opening 42-4 can be a respective rectangular slot. Although the present embodiment includes two piercing module engagement openings for symmetry and / or redundancy purposes, alternative embodiments can have, for example, only one piercing module engagement opening, such as the piercing module engagement opening 42-3.

[0058] The proximal threaded portion 42-1 in the probe carrier body 42 has a threaded hole 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 causes linear translation of the stylet cannula 46 along the longitudinal axis 58, where the direction of rotation is related to the direction of translation of the stylet cannula 46 in one of the proximal direction 39-1 and the distal direction 39-2. When the biopsy probe assembly 14 is attached to the biopsy driver 12 (see Figure 1 ), the driven gear 48-1 of the stylet gear-spindle assembly 48 meshes with the drive gear 32-2 of the transmission module 32.

[0059] Similarly, the distal threaded portion 42-2 of the probe carrier body 42 has a threaded hole 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 causes a combined rotation and linear translation of the cutter cannula 50 along the longitudinal axis 58, where the direction of rotation is related to the direction of translation of the cutter cannula 50. When the biopsy probe assembly 14 is attached to the biopsy driver 12, the driven gear 52-1 of the cutter gear-spindle assembly 52 meshes with the drive gear 30-2 of the cutter module 30 (see Figure 1 ).

[0060] Additionally, when the biopsy probe assembly 14 is attached to the biopsy driver 12, also with reference to Figure 2 and Figure 3As shown, the probe carrier body 42 is drivably coupled to the probe drive slider 38 of the piercing module 34. Thus, upon a first actuation of the start / pierce button 28-2, the probe carrier body 42 and the probe drive slider 38 translate in unison in the proximal direction 39-1 to position the probe drive slider 38 and the probe carrier body 42 carrying the stylet cannula 46 and the cutter cannula 50 in a ready position (i.e., a cocking position), and upon a second actuation of the start / pierce button 28-2 to effect a piercing launch, the probe carrier body 42 and the probe drive slider 38 are advanced rapidly in unison in the distal direction 39-2 to position the stylet cannula 46 and the cutter cannula 50 at the most distal position of the combined elements (e.g., within the patient).

[0061] Reference will now be made to Figures 6 to 22 describe the structure of the piercing module 34.

[0062] In Figures 6 - 10 and 12, the piercing module 34 is shown with the probe drive slider 38 in the fired position 70. Figure 11 is an exploded view showing the various components of the piercing module 34.

[0063] In particular, referring to Figure 11 , the piercing module 34 includes a piercing module frame 72; a motor assembly 74; guide rods 76, 78; a probe drive slider 38; a nut housing 80; a drive spindle 36; a release arm 82; release sliders 84, firing springs 86, 88; and pivot latches 90, 92. The motor assembly 74 includes a motor housing 94 that is configured (e.g., in size and shape) to mount the motor 35 to the piercing module frame 72. The rotational drive shaft 35-1 of the motor 35 and the longitudinal extent of the drive spindle 36 are disposed on and along a longitudinal axis 95. The motor 35 includes a flexible cable 35-2, such as a multi-conductor cable, that supplies electrical power and / or control signals from the controller circuit 18 to the motor 35.

[0064] The piercing module frame 72 has a proximal portion 96, a distal portion 98, and an intermediate section 100. The intermediate section 100 extends longitudinally between the proximal portion 96 and the distal portion 98. The proximal portion 96 is configured as a flat plate having holes to facilitate mounting of the motor housing 94 to the proximal portion 96 by screws 102.

[0065] The motor housing 94 extends perpendicular to the intermediate section 100. The motor housing 94 includes a motor aperture 104 configured (e.g., in size and shape) to mount the motor 35. The motor housing 94 may include threaded holes to facilitate connection to the proximal portion 96 of the puncture module frame 72 via screws 102 to mount the motor 35 to the proximal portion 96 of the puncture module frame 72.

[0066] The puncture module frame 72 has a distal block 106 at the distal portion 98. The distal block 106 extends perpendicular to the intermediate section 100. The distal block 106 is longitudinally spaced from the motor housing 94. The distal block 106 has a bearing seat 108, which may be configured as a bearing hole. For example, buffers 109-1, 109-2 made of rubber may be attached to the proximal face of the distal block 106 to provide an impact absorbing surface for engagement with the probe drive slider 38.

[0067] The guide rods 76, 78 are positioned to extend parallel from the motor housing 94 to the distal block 106. Opposite ends of each of the guide rods 76 and 78 are respectively mounted to each of the motor housing 94 and the distal block 106 of the puncture module frame 72.

[0068] The probe drive slider 38 is slidably coupled to the puncture module frame 72 by the guide rods 76, 78. Thus, the probe drive slider 38 is longitudinally translatable along the puncture module frame 72. As described above, when the biopsy driver 12 is coupled to the biopsy probe assembly 14, the probe drive slider 38 is drivingly coupled to the probe carrier body 42 of the biopsy probe assembly. The probe drive slider 38 includes a slider body 110 and probe engagement protrusions 112, 114 (see also Figure 2A ). The probe engagement protrusions 112, 114 extend perpendicular to the slider body 110. Each of the probe engagement protrusion 112 and the probe engagement protrusion 114 is configured to be received in a corresponding puncture module engagement opening of the probe carrier body 42 (see Figure 12 ) (e.g., the puncture module engagement opening 42-3 and the puncture module engagement opening 42-4) to align the longitudinal movement of the probe carrier body 42 with the longitudinal movement of the probe drive slider 38.

[0069] In the present embodiment, the slider body 110 includes a through hole 116 through which the drive spindle 36 can pass without engaging therewith. In addition, the slider body 110 includes guide holes 118, 120 (e.g., a pair of guide holes) for receiving bearings 122, 124 in a press-fit manner, respectively. In other words, the guide holes 118, 120 are configured to receive guide rods 76, 78 in a sliding engagement manner, respectively, wherein the bearing 122 is radially interposed between the guide rod 76 and the guide hole 118 of the slider body 110 of the probe drive slider 38, and the bearing 124 is radially interposed between the guide rod 78 and the guide hole 120 of the slider body 110 of the probe drive slider 38. Each of the bearings 122 and 124 can be, for example, a cylindrical bushing having a corresponding hole configured to slidably receive the guide rod 76 and the guide rod 78 (e.g., in terms of size and shape). Thus, the probe drive slider 38 can be longitudinally translated slidably along the guide rods 76, 78.

[0070] The positioning pin 125 can be used as an alignment device to provide releasable alignment of the probe drive slider 38 and the nut housing 80 about the longitudinal axis 95 when the nut housing 80 is coupled to the probe drive slider 38.

[0071] In Figures 8 - 10 and 12, the nut housing 80 is shown in the initial position 126. The initial position 126 is also considered the "zero" position from which other positions can be determined, e.g., based on the counted number of revolutions and / or partial revolutions of the drive spindle 36 and / or the motor drive shaft 35-1 and converting the number of revolutions to a linear distance, e.g., as performed by the controller circuit 18. The nut housing 80 is movably coupled to the puncture module frame 72 and can be longitudinally translated along the puncture module frame 72. For example, the nut housing 80 can slide along the intermediate section 100 of the puncture module frame 72. The nut housing 80 contains internal threads. In the present embodiment, the nut housing 80 includes a nut hole 127 configured to fixedly mount a nut 128 in a press-fit or threaded fit manner (e.g., in terms of size and shape), wherein the nut 128 has a hole including internal threads. In Figure 11 the nut 128 is shown with its internal threads threadedly engaged with the external threads of the drive spindle 36. The nut housing 80 is longitudinally translated (e.g., slid) along the intermediate section 100 of the puncture module frame 72 by the rotation of the drive spindle 36.

[0072] The drive spindle 36 is longitudinally stationary relative to the puncture module frame 72, and the drive spindle 36 will rotate clockwise or counterclockwise only according to a commanded cocking (ready-to-fire) operation or a puncturing (firing) operation. Of course, there is a small longitudinal sluggishness due to component tolerances.

[0073] The drive spindle 36 has a proximal end 130, an elongated threaded portion 132, and a distal end 134. The drive spindle 36 can be, for example, a lead screw spindle, such as a ball screw spindle. The proximal end 130 of the drive spindle 36 is drivingly coupled (e.g., in a keyed arrangement) to a rotatable drive shaft 35-1 of the motor 35. The elongated threaded portion 132 of the drive spindle 36 is rotatably and drivingly coupled to the nut housing 80 via a nut 128, such as meshing with the nut housing 80. In other words, the elongated threaded portion 132 rotatably meshes with an internal thread contained in the nut housing 80. The distal end 134 of the drive spindle 36 is rotatably coupled to a distal block 106 of the frame of the piercing module 34 via a bearing 136. For example, in the present embodiment, the distal end 134 of the drive spindle 36 is received in a bearing seat 108 located at the distal portion 98 of the piercing module frame 72, where the bearing 136 is radially interposed between the distal end 134 of the drive spindle 36 and the bearing seat 108 of the distal block 106 of the piercing module frame 72. The bearing 136 can be, for example, a ball bearing having an outer race received in the bearing seat 108 of the distal block 106 in a tight fit manner (e.g., a press fit), and the ball bearing having an inner race received on the distal end 134 of the drive spindle 36 in a tight fit manner.

[0074] Each of the firing springs 86, 88 is interposed between the motor housing 94 and the probe drive slider 38. Each of the firing spring 86 and the firing spring 88 is configured (e.g., in size and shape) to bias the probe drive slider 38 in the distal direction 39-2 towards the fired position 70. In other words, each of the firing spring 86 and the firing spring 88 is configured (e.g., in size and shape) to bias the probe drive slider 38 in the distal direction 39-2 towards the distal block 106 of the piercing module frame 72. In the present embodiment, each of the firing springs 86, 88 is a helical spring, where the firing spring 86 is received on the guide rod 76 and the firing spring 88 is received on the guide rod 78, and the combined spring force generated by the firing springs 86, 88 is approximately 70 Newtons.

[0075] Although the present embodiment includes two firing springs 86, 88 for symmetry and / or redundancy purposes, alternative embodiments can have, for example, only one firing spring, such as the firing spring 86.

[0076] The release arm 82 is pivotally coupled to the piercing module frame 72 and configured to pivot about a pivot axis 138. The release arm 82 has a mounting end portion 140 and a head 142. The mounting end portion 140 is pivotally coupled to the piercing module frame 72 via a pin 144. The head 142 of the release arm 82 is longitudinally spaced from the mounting end portion 140 of the release arm 82. An arm biasing member 146 (such as a coil spring) is located between the mounting end portion 140 of the release arm 82 and the piercing module 34 to apply a biasing force to the mounting end portion 140 of the release arm 82 so as to tend to rotate the release arm 82 about the pivot axis 138.

[0077] The release slider 84 is slidably coupled to the piercing module frame 72 for longitudinal movement along the ramp surface 100-1 of the intermediate section 100 of the piercing module frame 72. The release slider 84 is configured to engage the nut housing 80. Release slider biasing members 148, 150 (such as coil springs) are configured to slidably bias the release slider 84 in the proximal direction 39-1. The release slider biasing members 148, 150 are inserted through corresponding holes in the distal block 106, which are in turn closed by screws 152. The release slider biasing members 148, 150 extend from the distal block 106 in the proximal direction 39-1.

[0078] Although this embodiment includes two release slider biasing members 148, 150 for symmetry and / or redundancy purposes, alternative embodiments may have, for example, only one release slider biasing member, such as release slider biasing member 148.

[0079] In this embodiment, the release slider 84 has an open planar frame 154, an engagement portion 156, and a cantilever release member 158. The engagement portion 156 extends perpendicularly from the open planar frame 154 and is positioned between the nut housing 80 and the distal block 106. The engagement portion 156 is configured (such as in size and shape) to engage the nut housing 80 when the nut housing 80 moves in the distal direction 39-2. The cantilever release member 158 extends inwardly from the open planar frame 154, for example, inwardly in the distal direction 39-2. The cantilever release member 158 is configured (such as in size and shape) to engage the head 142 of the release arm 82.

[0080] Refer to Figure 12, the release slider biasing members 148, 150 extend from the distal block 106 in the proximal direction 39-1 to contact the engagement portion 156 of the release slider 84 so as to bias the proximal end 84-1 of the release slider 84 in the proximal direction 39-1 into contact with the shoulder 72-1 of the puncture module frame 72, which is located in the proximal range of the intermediate section 100 of the puncture module frame 72. In other words, the release slider biasing members 148, 150 engage with the engagement portion 156 to bias the release slider 84 in the proximal direction 39-1 (i.e., towards the nut housing 80).

[0081] Referring to Figure 11 and 12 , the pivot latches 90, 92 are pivotally mounted to the nut housing 80 to pivot about a pivot axis 160. Each of the pivot latch 90 and the pivot latch 92 is pivotally mounted to the nut housing 80 by a pivot pin 162 and a pivot pin 164 respectively. The pivot latch 90 has a hook end 90-1 and a tail end 90-2. The pivot latch 92 has a hook end 92-1 and a tail end 92-2. A biasing spring 166 (such as a helical spring) is disposed between the nut housing 80 and the tail end 90-2 of the pivot latch 90. Similarly, a biasing spring 168 (such as a helical spring) is disposed between the nut housing 80 and the tail end 92-2 of the pivot latch 92.

[0082] Although the present embodiment includes two pivot latches 90, 92 for symmetry and / or redundancy purposes, alternative embodiments may have, for example, only one pivot latch, such as the pivot latch 90.

[0083] Referring again to Figure 12 the cross-sectional view of, the puncture module 34 is constructed such that when the nut housing 80 is in the initial position 126 and the probe drive slider 38 is in the fired position 70, the nut housing 80 is releasably latched to the probe drive slider 38 (shown in the latched position) by the pivot latches 90, 92, so that the probe carrier body 42 of the biopsy probe assembly 14 (see Figure 2 ) is held in the fully extended position (i.e., the puncture tip 62 of the stylet cannula 46 of the biopsy probe assembly 14 is held in a fixed position regardless of the force applied to the puncture tip 62). In other words, the function of the pivot latches 90, 92 is to lock the probe drive slider 38 to the nut housing 80 when the probe drive slider 38 is in the initial position 126. This is accomplished by the pivot latches 90, 92 engaging the hook-shaped edge on the bottom side of the slider body 110 of the probe drive slider 38, as Figure 12 shown.

[0084] As Figure 12As shown, the nut housing 80 also has an extended position 182, which is distal to the initial position 126. Figures 13 - 15 An assembled configuration of the piercing module 34 is shown, where the nut housing 80 is in the cocked position 184 and the probe drive slider 38 is in the ready position 186.

[0085] Electrically, referring to Figure 3 , the piercing module 34 can include an initial position detector 170 and a ready position detector 172. The initial position detector 170 can be, for example, a current / torque sensing circuit and / or a rotation counting circuit, or alternatively a proximity detector, which is configured to determine the position of the nut housing 80 (e.g., in the initial position 126) either alone or in combination with the controller circuit 18. The ready position detector 172 can be, for example, a current / torque sensing circuit and / or a rotation counting circuit, or alternatively a proximity sensor, which is configured to determine the position of the probe drive slider 38 (e.g., the ready position 186) either alone or in combination with the controller circuit 18. Although the initial position detector 170 and the ready position detector 172 are depicted as part of the piercing module 34 for convenience, when separately configured as current / torque sensing circuits and / or revolution counting circuits, the initial position detector 170 and the ready position detector 172 can be incorporated, in whole or in part, into the controller circuit 18.

[0086] Optionally, the piercing module 34 can also include a side cover 174, a foam insulation block 176, and / or a threaded ring piercing motor coupler 178.

[0087] The side cover 174 can be attached to the motor housing 94 and the distal block 106 by screws 180.

[0088] The foam insulation block 176 (or blocks of foam) can be attached to the proximal end of the motor 35. The function of the foam insulation block 176 is to reduce operating noise. The foam insulation block 176 can be made of, for example, foam rubber.

[0089] The threaded ring piercing motor coupler 178 can be used as an interface between the motor 35 and the motor housing 94. The motor 35 has a threaded distal end, which is used to mount the threaded ring piercing motor coupler 178 on the motor 35. The motor coupler 178 can be positioned at a plurality of rotational angular positions around the longitudinal axis 95, for example, eight different rotational angular positions (spaced 45 degrees apart). The purpose is to ensure that during assembly, the flexible cable 35-2 from the motor 35 is positioned relatively in the same direction and thus does not get twisted, so as not to damage the flexible cable 35-2.

[0090] Referring to Figures 13 - 15, the piercing module 34 is shown in a tightened configuration, wherein the nut housing 80 and the probe drive slider 38 have been retracted in the proximal direction 39-1 by the rotation of the drive spindle 36 so as to position the nut housing 80 in the tightened and ready position 184 and the probe drive slider 38 in the ready position 186. The nut housing 80 is configured to engage the probe drive slider 38 and longitudinally move it to the ready position 186, thereby compressing the firing springs 86, 88. The ready position detector 172 can be configured to determine the position of the probe drive slider 38 and generate a ready position signal when the probe drive slider 38 is in the ready position 186. The ready position signal can be provided to the controller circuit 18 (see Figure 3 ) to control the rotation of the motor 35 and thus the rotation of the drive spindle 36.

[0091] In conjunction with Figure 11 and Figure 12 for reference Figure 14 , when the nut housing 80 is longitudinally translated in the proximal direction 39-1 from the initial position 126 (see Figure 12 ), the pivot latches 90, 92 ride along the intermediate section 100 of the piercing module frame 72 and the corresponding ramp surfaces 100-1 so as to rotate the pivot latches 90, 92 about the pivot axis 138 against the biasing forces of the biasing springs 166, 168, thereby unlocking the nut housing 80 from the probe drive slider 38. In other words, the piercing module 34 is configured such that when the nut housing 80 is in the tightened and ready position 184 and the probe drive slider 38 is in the ready position 186, the pivot latches 90, 92 are released so as to release the nut housing 80 from the probe drive slider 38 to facilitate the return of the nut housing 80 to the initial position 126 while the probe drive slider 38 remains in the ready position 186.

[0092] In conjunction with Figure 11 for reference Figure 15 , the arm biasing member 146 is configured to bias the release arm 82 towards the latch position 188. When the probe drive slider 38 is in the ready position 186 and the release arm 82 is in the latch position 188, the release arm 82 is biased by the arm biasing member 146 such that the head 142 of the release arm 82 is positioned to engage the shoulder 190 of the probe drive slider 38 so as to hold the probe drive slider 38 in the ready position 186. In addition, in the ready position 186, the firing springs 86, 88 are compressed by the proximal movement of the probe drive slider 38 from the fired position 70 (see Figure 8 ) to the ready position 186 (see Figure 13 ).

[0093] Refer to Figure 16, the piercing module 34 is shown in a pre-firing configuration, in which the nut housing 80 has been returned to the initial position 126 by the rotation of the drive spindle 36, while the probe drive slider 38 is held in the ready position 186 by the release arm 82. In other words, after the probe drive slider 38 is in the ready position 186, by first returning the nut housing 80 to the initial position 126, the piercing module 34 is ready for firing of the probe drive slider 38, as Figure 16 shown. The initial position detector 170 (see also Figure 3 ) can determine the position of the nut housing 80 and can generate an initial position signal when the nut housing 80 is in the initial position 126. The initial position signal can be provided to the controller circuit 18, which in turn stops the rotation of the motor 35. When the nut housing 80 is in the initial position 126, the engaging portion 156 of the nut housing 80 engages the release slider 84.

[0094] Referring to Figures 17 - 22 , the piercing module 34 is shown in a configuration released to firing, in which the nut housing 80 has moved from the initial position 126 (see Figure 16 ) to the extended position 182 (see Figure 17 and 18 ). In this embodiment, the release slider 84 is configured to release the release arm 82 from the latched position 188 when the nut housing 80 moves from the initial position 126 to the extended position 182 by the rotation of the drive spindle 36 and thus moves the release slider 84 distally (see Figure 15 ).

[0095] Referring to Figure 19 and 20 , the cantilever release member 158 of the release slider 84 is configured to engage the head 142 of the release arm 82 such that when the nut housing 80 moves from the initial position 126 to the extended position 182, the release arm 82 is released from the latched position 188. In this embodiment, referring to Figure 20 , the cantilever release member 158 of the release slider 84 has a distal inclined end surface 158-1, which is configured (e.g., in terms of size, shape, and position) to engage the corresponding proximal ramp surface 142-1 of the head 142 of the release arm 82. Thus, when the nut housing 80 moves from the initial position 126 to the extended position 182, the nut housing 80 (engaging the engaging portion 156 of the release slider 84) causes the release slider 84 to move in the distal direction 39-2. As the release slider 84 moves in the distal direction 39-2, the distal inclined end surface 158-1 of the cantilever release member 158 of the release slider 84 engages the proximal ramp surface 142-1 of the head 142 of the release arm 82 to force the release arm 82 to rotate about the pivot axis 138 (see Figure 11 , 19and 21) and further forces the head 142 out of engagement with the shoulder 190 of the probe drive slider 38 (see Figure 15 , 21 and 22), so as to position the head 142 of the release arm 82 at the release position 192 (as Figure 21 and 22 shown), thereby allowing the firing springs 86, 88 to decompress, which in turn fires (i.e., rapidly propels) the probe drive slider 38 in the distal direction 39-2 until the probe drive slider 38 reaches the firing position 70 (e.g., see Figure 8 ).

[0096] In operation, the first actuation of the start / puncture button 28-2 initiates the start (cocking) operation and actuates the motor 35 to rotate the drive spindle 36, which in turn causes the puncture firing drive (nut housing 80, probe drive slider 38) to move in the proximal direction 39-1 to compress the firing springs 86, 88 and lock the probe drive slider 38 in the ready position 186 via the release arm 82. The second actuation of the start / puncture button 28-2 initiates the puncture (firing) operation and releases the release arm 82 from the probe drive slider 38 so as to fire (distally propel) the probe drive slider 38 and the interface probe carrier body 42 of the biopsy probe assembly 14. The entire start / puncture function is driven by the motor 35, which is actuated by the start / puncture button 28-2, and the motion / position is specified / programmed in software. The start / puncture button 28-2 acts electrically on the components, rather than mechanically on the components. Program instructions (e.g., software) are executed by the controller circuit 18 to recognize the button press of the start / puncture button 28-2 and send a control signal to the puncture motor 35. A very small amount of rotational movement from the motor 35 is required, and in turn a rotational movement of the drive spindle 36 is required to distally drive the release slider 84 only a little (e.g., 2-5 mm) in the distal direction 39-2, which causes the release arm 82 to disengage from the probe drive slider 38, thereby allowing the firing springs 86, 88 to decompress and fire (distally propel) the probe drive slider 38 forward. In this embodiment, in order to perform the start / puncture operation to operate the puncture module 34, the user does not need to perform any operation while pressing the start / puncture button 28-2.

[0097] In this embodiment, there are two piercing firing springs 86, 88 which drive the probe drive slider 38 forward to perform a piercing operation. The motor 35 pulls the probe drive slider 38 backward by driving the movement of the drive spindle 36. Among them, the nut 128 on the drive spindle 36 drives the nut housing 80 in the proximal direction 39-1 to pull the probe drive slider 38 backward. The probe drive slider 38 is held in place by the release arm 82 and is released by the distal movement of the release slider 84 in the distal direction 39-2 through the distal movement of the nut housing 80. Once the firing springs 86, 88 are compressed, the probe drive slider 38 is longitudinally fixed (in the ready position 186) by the release arm 82. The nut housing 80 and the nut 128 on the drive spindle 36 then move longitudinally back to the initial position 126 (i.e., the zero position) because they are used to actuating the piercing (firing) operation once the user presses the start / piercing button 28-2 for the second time.

[0098] Therefore, the nut housing 80 retracts during the start operation, thereby pulling the probe drive slider 38 proximally until it has moved approximately 20 millimeters and is locked in the ready position 186 by the release arm 82.

[0099] In the ready position 186, the release arm 82 is slightly moved upward (e.g., pivoted about the pin 144) by the force from the arm biasing member 146 to engage / tap the probe drive slider 38 after being ready. After the release arm 82 holds the probe drive slider 38 in the ready position 186, the rotation of the motor 35 and the drive spindle 36 is reversed to move the nut housing 80 back to the initial position 126. The release arm 82 holds the probe drive slider 38 on, for example, two small edges located on each side of the head 142 of the release arm 82. Between these two small edges is an inclined surface, i.e., the proximal ramp surface 142-1 of the head 142. This inclined surface contacts the inclined surface of the release slider 84 (i.e., the distal inclined end surface 158-1) such that these surfaces are in contact.

[0100] When the piercing (firing) operation is actuated by a second press of the start / pierce button 28-2, the motor 35 actuates (rotates) the drive spindle 36, and the nut housing 80 moves a few millimeters (e.g., 2-5 mm) in the distal direction 39-2 (the direction opposite to start). As the nut housing 80 moves, the release slider 84 correspondingly moves a few millimeters (e.g., 2-5 mm). Moving the release slider 84 a few millimeters (e.g., 2-5 mm) means that the inclined surface (i.e., the distal bevel end surface 158-1) contacts the inclined surface (i.e., the proximal ramp surface 142-1 of the head 142 of the release arm 82), and further the distal inclined end surface 158-1 of the release slider 84 slides over the proximal ramp surface 142-1 of the release arm 82 and thus presses on the release arm 82, causing the release arm 82 to disengage the head 142 of the release arm 82 (e.g., two small edges thereon) from the probe drive slider 38. The probe drive slider 38 acted upon by the two compressed firing springs 86, 88 is then released and fires approximately 20 mm in the proximal direction 39-1 (in this embodiment) until it is stopped at the fired position 70 by the buffers 109-1, 109-2.

[0101] Due to the release slider biasing members 148, 150 near the distal end of the piercing module frame 72, the release slider 84 is essentially always moved (i.e., biased) to the right end / proximal end. In this embodiment, this means that the release slider 84 will contact the release arm 82 on the inclined surface, unless as described above when the inclined sliding surfaces of the release slider 84 and the release arm 82 slide past each other.

[0102] It should be noted that when the piercing module 34 is actuated (the firing springs 86, 88 are compressed), the motor 35 is not used to move the longitudinal position of the probe carrier body 42 of the biopsy probe assembly 14 while the firing springs 86, 88 remain compressed. However, due to the movement of the probe drive slider 38 of the piercing module 34, the probe carrier body 42 will move when the piercing module 34 is fired.

[0103] The following is an exemplary operation sequence using the controller circuit 18 together with the initial position detector 170 and the ready position detector 172. Also refer to Figure 3 , the electric actuator button (e.g., the start / pierce button 28-2) is configured to generate a first actuation signal and a second actuation signal. The controller circuit 18 is communicatively coupled to each of the start / pierce button 28-2, the initial position detector 170, the ready position detector 172, and the motor 35.

[0104] The first actuation of the start / puncture button 28-2 sends a first actuation signal to the controller circuit 18. The controller circuit 18 is configured to execute program instructions to receive and process the first actuation signal to cause the motor 35 to rotate the drive spindle 36 in a first rotational direction to longitudinally move the nut housing 80 upward to the cocked position 184, and the nut housing 80 is configured to engage the probe drive slider 38 and longitudinally move it to the ready position 186, thereby compressing the firing springs 86, 88. When the probe drive slider 38 is in the ready position 186 (e.g., as determined by the ready position detector 172): (a) the head 142 of the release arm 82 is positioned to hold the probe drive slider 38 in the ready position 186; (b) the controller circuit 18 executes program instructions to receive and process the ready position signal and cause the motor 35 to rotate the drive spindle 36 in a second rotational direction opposite to the first rotational direction to longitudinally move the nut housing 80 from the cocked position 184 to the initial position; and (c) the controller circuit 18 is configured to execute program instructions to receive and process the initial position signal to stop the motor 35 from rotating the drive spindle 36 when the nut housing 80 has reached the initial position 126.

[0105] The second actuation of the start / puncture button 28-2 sends a second actuation signal to the controller circuit 18. The controller circuit 18 is configured to execute program instructions to receive and process the second actuation signal to cause the motor 35 to rotate the drive spindle 36 in the second rotational direction to longitudinally move the nut housing 80 from the initial position 126 toward the extended position 182 such that the nut housing 80 moves to release the slider 84. As described in more detail above, the release slider 84 is configured to operate the release arm 82 to disengage the head 142 of the release arm 82 from the probe drive slider 38 to release the firing springs 86, 88 to decompress, thereby causing the probe drive slider 38 to longitudinally move (i.e., fire) to the fired position 70. The longitudinal movement of the probe drive slider 38 causes corresponding longitudinal movement of the probe carrier body 42, the stylet cannula 46, and the cutter cannula 50 to the extended position to complete the puncture operation.

[0106] The following items are also related to the present invention:

[0107] In one embodiment, the present invention relates to a biopsy device that includes a biopsy probe assembly and a piercing module. The biopsy probe assembly may have a probe carrier body, a stylet cannula, and a cutter cannula coaxial with the stylet cannula. Each of the stylet cannula and the cutter cannula may be coupled to the probe carrier body. The piercing module may be (configured to be) drivably coupled to the probe carrier body. The piercing module includes a piercing module frame having a proximal portion and a distal portion. A probe drive slider may be slidably coupled to the piercing module frame. The probe drive slider may be drivably coupled to the probe carrier body of the biopsy probe assembly. The probe drive slider may have a ready position and a fired position. A nut housing may be (configured to be) movably coupled to the piercing module frame. (The device may be configured such that) the nut housing may be configured to have / assume a cocked position, an initial position, and an extended position. A motor assembly may have a motor and a motor housing. (The device may be configured such that) the motor housing may be configured to mount the motor to the piercing module frame. The motor may have a rotatable drive shaft. A drive spindle may be (configured to be) drivably coupled to the rotatable drive shaft of the motor. The drive spindle may be rotatably and drivably coupled to the nut housing. One or more firing springs may be (configured to be) interposed between the motor housing and the probe drive slider. (The device may be configured such that) one or more firing springs may be configured to bias the probe drive slider toward the fired position. A release arm may have a mounting end portion and a head. The mounting end portion may be pivotally coupled to the piercing module frame. The release arm may be configured to have / assume a latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the head of the release arm is positioned to engage the probe drive slider to hold the probe drive slider in the ready position. A release slider may be (configured to be) slidably coupled to the piercing module frame. (The device may be configured such that) the release slider may be configured to engage the nut housing. (The device may be configured such that) the release slider is configured to release the release arm from the latched position when the nut housing moves from the initial position to the extended position by rotation of the drive spindle.

[0108] In any embodiment, the probe drive slider may translate longitudinally along the piercing module frame. The nut housing may translate longitudinally along the piercing module frame. The nut housing includes internal threads. The motor may be (configured to be) mounted to the proximal portion of the piercing module frame. The drive spindle has a proximal end, a distal end, and an elongate threaded portion. The proximal end may be (configured to be) drivably coupled to the rotatable drive shaft of the motor. The elongate threaded portion may be rotatably engaged with the internal threads of the nut housing.

[0109] In any embodiment, the head of the release arm is longitudinally spaced from the mounting end portion of the release arm. The arm biasing member is configured to bias the release arm toward the latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the release arm is biased by the arm biasing member such that the head is positioned to engage the probe drive slider to hold the probe drive slider in the ready position.

[0110] In any embodiment, (the device may be constructed such that) the release slider biasing member may be constructed to bias the release slider in the proximal direction. The release slider has an engagement portion configured to engage the nut housing. The release slider may have a cantilever release member, and (the device may be constructed such that the cantilever release member) is configured to engage the head of the release arm to release the release arm from the latched position when the nut housing moves from the initial position to the extended position.

[0111] In some embodiments, the probe carrier body may have one or more puncture module engagement openings. The probe drive slider may have one or more probe engagement protrusions. (The device may be constructed such that) the one or more probe engagement protrusions may be configured to be received in the one or more puncture module engagement openings of the probe carrier body to align the longitudinal movement of the probe carrier body with the longitudinal movement of the probe drive slider.

[0112] In any embodiment, the pivot latch may be pivotally mounted to the nut housing. (The device may be constructed such that) the puncture module may be constructed such that when the nut housing is in the initial position and the probe drive slider is in the fired position, the nut housing is releasably locked to the probe drive slider by the pivot latch to hold the biopsy probe assembly in the fully extended position.

[0113] In any embodiment having a pivot latch, (the device may be constructed such that) the puncture module may be constructed such that when the nut housing is in the cocked position and the probe drive slider is in the ready position, the pivot latch is released to release the nut housing from the probe drive slider to facilitate movement of the nut housing to the initial position while the probe drive slider remains in the ready position.

[0114] In any embodiment, the puncture module may further include a pair of guide rods. The probe drive slider may have a pair of guide holes configured to slidably receive the pair of guide rods, respectively. The puncture module frame may have a distal block at the distal portion. The distal block may be longitudinally spaced from the motor housing, wherein the pair of guide rods are positioned to extend parallel from the motor housing to the distal block.

[0115] In any embodiment having a distal block, the distal block of the piercing module frame may have a bearing housing. The distal end of the drive spindle may be received in the bearing housing at the distal portion of the piercing module frame.

[0116] In any embodiment, the electric actuator button may be configured to generate a first actuation signal and a second actuation signal. The controller circuit may be communicatively coupled to each of the electric actuator button and the motor. (The controller circuit may be configured such that) a first actuation of the electric actuator button sends the first actuation signal to the controller circuit. The controller circuit may be configured to execute program instructions to receive and process the first actuation signal to cause the motor to rotate the drive spindle in a first rotational direction, thereby causing the nut housing to longitudinally move toward the cocked position, and (wherein) the nut housing may in turn (be configured to) engage the probe drive slider and longitudinally move it to the ready position, thereby compressing the one or more firing springs. (The device is configured such that) when the probe drive slider is in the ready position, the head of the release arm is positioned to hold the probe drive slider in the ready position, and the controller circuit may be configured to execute program instructions to cause the motor to rotate the drive spindle in a second rotational direction opposite to the first rotational direction to longitudinally move the nut housing from the cocked position toward the initial position. The controller circuit may be configured to execute program instructions to stop the motor from rotating the drive spindle when the nut housing has reached the initial position. (The controller circuit may be configured such that) a second actuation of the electric actuator button sends the second actuation signal to the controller circuit. The controller circuit may be configured to execute program instructions to receive and process the second actuation signal to cause the motor to rotate the drive spindle in the second rotational direction so as to longitudinally move the nut housing from the initial position toward the extended position, such that the nut housing moves to release the slider. (The device may be configured such that) the release slider may be configured to operate the release arm to disengage the head of the release arm from the probe drive slider, so as to release the firing springs to decompress, and further longitudinally move the probe drive slider to the fired position.

[0117] In any embodiment, (the device may be configured such that) when the probe drive slider is drivably coupled to the probe carrier body of the biopsy probe assembly, longitudinal movement of the probe drive slider causes corresponding longitudinal movement of the stylet cannula and the cutter cannula of the biopsy probe assembly.

[0118] In another embodiment, the present invention relates to a biopsy device that includes a biopsy probe assembly and a piercing module. The biopsy probe assembly may have a probe carrier body, a stylet cannula, and a cutter cannula coaxial with the stylet cannula. Each of the stylet cannula and the cutter cannula may be movably coupled to the probe carrier body. The piercing module may be drivably coupled to the probe carrier body. The piercing module may include a piercing module frame that may have a proximal portion and a distal portion. A probe drive slider may be slidably coupled to the piercing module frame. The probe drive slider may be configured to be drivably coupled to the probe carrier body of the biopsy probe assembly. The probe drive slider may be longitudinally translatable along the piercing module frame. The probe drive slider may be configured to have a ready position and a fired position. A nut housing may be movably coupled to the piercing module frame. The nut housing may contain internal threads. The nut housing may be longitudinally translatable along the piercing module frame. The nut housing may be configured to have a cocked position, an initial position, and an extended position. A motor assembly may have a motor and a motor housing. The motor housing may be configured to mount the motor to the proximal portion of the piercing module frame. The motor may have a rotatable drive shaft. The drive spindle may have a proximal end, a distal end, and an elongate threaded portion. The proximal end may be drivably coupled to the rotatable drive shaft of the motor. The elongate threaded portion may be rotatably engaged with the internal threads of the nut housing. A firing spring may be interposed between the motor housing and the probe drive slider. The firing spring may be configured to bias the probe drive slider toward the fired position. A release arm may have a distal mounting end portion and a proximal head. The proximal head may be longitudinally spaced from the distal mounting end portion. The distal mounting end portion may be pivotally coupled to the distal portion of the piercing module frame. The release arm may be biased toward a latched position by a first biasing spring, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the proximal head of the release arm may be positioned to engage the probe drive slider to hold the probe drive slider in the ready position. A release slider may be slidably coupled to the piercing module frame and may be biased in the proximal direction by a second biasing spring. The release slider may have an engagement portion configured to engage the nut housing. The release slider may be configured to release the release arm from the latched position when the nut housing is moved from the initial position to the extended position by rotation of the drive spindle.

[0119] In any embodiment, the probe carrier body may have a puncture module engagement opening. The probe drive slider may have a probe engagement protrusion. (The device may be configured such that) the probe engagement protrusion may be configured to be received in the puncture module engagement opening of the probe carrier body to align the longitudinal movement of the probe carrier body with the longitudinal movement of the probe drive slider.

[0120] In any embodiment, the pivot latch may be pivotally mounted to the nut housing. (The device may be configured such that) the puncture module may be configured such that when the nut housing may be in an initial position and the probe drive slider may be in a fired position, the nut housing may be releasably locked to the probe drive slider by the pivot latch to hold the biopsy probe assembly in a fully extended position.

[0121] In an embodiment according to the foregoing paragraph, (the device may be configured such that) the puncture module may be configured such that when the nut housing may be in a cocked position and the probe drive slider may be in a ready position, the pivot latch may be released to release the nut housing from the probe drive slider to facilitate movement of the nut housing to the initial position while the probe drive slider remains in the ready position.

[0122] In any embodiment, the puncture module may further include at least one, and possibly a pair of, guide rods. The probe drive slider may have a pair of guide holes that may be configured to receive the pair of guide rods in a sliding engagement respectively (and the device may be configured accordingly). The puncture module frame may have a distal block at a distal portion. The distal block may be longitudinally spaced from the motor housing, wherein the pair of guide rods are positioned to extend parallel from the motor housing to the distal block.

[0123] In an embodiment according to the foregoing paragraph, the distal block of the puncture module frame may have a bearing seat, and the distal end of the drive spindle may be received in the bearing seat at the distal portion of the puncture module frame.

[0124] In any embodiment, the electric actuator button can be configured to generate a first actuation signal and a second actuation signal. The initial position detector can be configured to generate an initial position signal when the nut housing is in the initial position. The ready position detector can be configured to generate a ready position signal when the probe drive slider can be in the ready position. The controller circuit can be communicatively coupled to each of the electric actuator button, the initial position detector, the ready position detector, and the motor. The controller circuit can be configured to receive and process the first actuation signal, the second actuation signal, the initial position signal, and the ready position signal, and execute program instructions to control the operation of the motor. (The controller circuit can be configured such that) the first actuation of the electric actuator button sends the first actuation signal to the controller circuit to cause the motor to rotate the drive spindle in a first rotational direction, thereby causing the nut housing to longitudinally move toward the cocked position, and the nut housing can in turn be configured to engage the probe drive slider and longitudinally move it to the ready position, thereby compressing the firing spring. (The device can be configured such that) after the probe drive slider is in the ready position determined by the ready position detector, the proximal head of the release arm can be positioned by a first biasing spring to hold the probe drive slider in the ready position. The controller circuit executes program instructions to cause the motor to rotate the drive shaft in a second rotational direction opposite to the first rotational direction, (wherein) as the drive shaft of the motor rotates the drive spindle, the nut housing can / will longitudinally move from the cocked position toward the initial position, and then when the nut housing has reached the initial position determined by the initial position detector, the controller circuit stops the motor from rotating the drive shaft. (The device can be configured such that) the second actuation of the electric actuator button sends the second actuation signal to the controller circuit to cause the motor to further rotate the drive spindle in the second rotational direction, thereby longitudinally moving the nut housing from the initial position toward the extended position, wherein the nut housing in turn longitudinally moves to release the slider. (The device can be configured such that) the release slider can be configured to disengage the proximal head of the release arm from the probe drive slider, such that the firing spring decompresses to longitudinally move the probe drive slider to the fired position.

[0125] In another embodiment, the present invention relates to a biopsy driver for drivingly coupling to a biopsy probe assembly, which may have a probe carrier body carrying a stylet cannula. The biopsy driver includes a piercing module frame having a proximal portion and a distal portion. A probe drive slider may be slidably coupled to the piercing module frame. (The biopsy driver may be configured such that) the probe drive slider may be configured for drivingly coupling to the probe carrier body of the biopsy probe assembly. (The biopsy driver may be configured such that) the probe drive slider is configured to have / assume a ready position and a fired position. A nut housing may be movably coupled to the piercing module frame. (The biopsy driver may be configured such that) the nut housing is configured to have / assume a cocked position, an initial position, and an extended position. A motor assembly may have a motor and a motor housing. The motor housing may be configured to mount the motor to the piercing module frame. The motor has a rotatable drive shaft. A drive spindle may be drivingly coupled to the rotatable drive shaft of the motor. The drive spindle may be rotatably coupled to the nut housing. One or more firing springs may be interposed between the motor housing and the probe drive slider. (The biopsy driver may be configured such that) the one or more firing springs may be configured to bias the probe drive slider toward the fired position. A release arm may have a mounting end portion and a head. (The biopsy driver may be configured such that) the mounting end portion may be pivotally coupled to the distal portion of the piercing module frame. (The biopsy driver may be configured such that) the release arm may be biased by a biasing member toward a latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the head of the release arm is configured to engage the probe drive slider to hold the probe drive slider in the ready position. (The biopsy driver may be configured such that) a release slider may be slidably coupled to the piercing module frame. The release slider has an engagement portion configured to engage the nut housing. (The biopsy driver may be configured such that) the release slider may be configured to release the release arm from the latched position when the nut housing is moved from the initial position to the extended position by rotating the drive spindle by the motor.

[0126] In an embodiment according to the foregoing paragraph, (the biopsy driver may be configured such that) one or more release slider biasing members may be configured to slidably bias the release slider in the proximal direction. The release slider may have an engagement portion configured to engage the nut housing. The release slider may have a cantilever release member extending in the distal direction, and (the biopsy driver may be configured such that the cantilever release member) may be configured to engage the head of the release arm to release the release arm from the latched position when the nut housing is moved from the initial position to the extended position in the distal direction.

[0127] As used herein, "slightly", "about", and other degree words are relative modifiers that are intended to indicate the allowable variation from the feature so modified. It is not intended to be limited to the absolute value or property being modified, but rather has more of a physical or functional property and approaches or approximates such a physical or functional property.

[0128] In addition, as used herein, the term "coupled" and its derivatives are intended to cover any operative functional connection, i.e., direct connection or indirect connection.

[0129] Although the invention has been described for at least one embodiment, the invention may be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or modifications of the invention using its general principles. In addition, this application is intended to cover departures from the present disclosure that come within known or customary practice in the art to which this invention pertains and fall within the limitations of the appended claims.

Claims

1. A biopsy device, the biopsy device comprising: a biopsy probe assembly having a probe carrier body, a stylet cannula, and a cutter cannula coaxial with the stylet cannula, wherein each of the stylet cannula and the cutter cannula is coupled to the probe carrier body; and a biopsy driver having a driver housing, the biopsy driver including a piercing module that is drivingly coupled to the probe carrier body, the piercing module comprising: a piercing module frame disposed within the driver housing, the piercing module frame having a proximal portion and a distal portion, a probe drive slider slidably coupled to the piercing module frame and drivingly coupled to the probe carrier body of the biopsy probe assembly, the probe drive slider having a ready position and a fired position, a nut housing movably coupled to the piercing module frame, the nut housing having a cocked position, an initial position, and an extended position, a motor assembly having a motor and a motor housing configured to mount the motor to the piercing module frame, the motor having a rotatable drive shaft, a drive spindle drivingly coupled to the rotatable drive shaft of the motor, the drive spindle being rotatably and drivingly coupled to the nut housing; a firing spring interposed between the motor housing and the probe drive slider and configured to bias the probe drive slider toward the fired position; a release arm having a mounting end portion and a head, the mounting end portion pivotally coupled to the piercing module frame, the release arm having a latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the head of the release arm is positioned to engage the probe drive slider to hold the probe drive slider in the ready position; and a release slider slidably coupled to the piercing module frame and configured to engage the nut housing, the release slider configured to release the release arm from the latched position when the nut housing moves from the initial position to the extended position by rotation of the drive spindle.

2. The biopsy device according to claim 1, wherein: the probe drive slider is longitudinally translatable along the piercing module frame; the nut housing is longitudinally translatable along the piercing module frame and includes an internal thread; the motor is mounted to the proximal portion of the piercing module frame; and the drive spindle has a proximal end, a distal end, and an elongate threaded portion, the proximal end of the drive spindle being drivingly coupled to the rotatable drive shaft of the motor and the elongate threaded portion being rotatably engaged with the internal thread of the nut housing.

3. The biopsy device according to any one of claims 1 to 2, wherein, The head of the release arm is longitudinally spaced from the mounting end portion of the release arm, and the biopsy device further includes an arm biasing member configured to bias the release arm toward the latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the release arm is biased by the arm biasing member such that the head of the release arm is positioned to engage the probe drive slider to hold the probe drive slider in the ready position.

4. The biopsy device according to any one of claims 1 to 2, the biopsy device including a release slider biasing member configured to slidably bias the release slider in the proximal direction, the release slider having an engagement portion configured to engage the nut housing, and the release slider having a cantilever release member configured to engage the head of the release arm to release the release arm from the latched position when the nut housing moves from the initial position to the extended position.

5. The biopsy device according to any one of claims 1 to 2, wherein: the probe carrier body has a puncture module engagement opening; and the probe drive slider has a probe engagement protrusion configured to be received in the puncture module engagement opening of the probe carrier body to align the longitudinal movement of the probe carrier body with the longitudinal movement of the probe drive slider.

6. The biopsy device according to any one of claims 1 to 2, the biopsy device including a pivot latch pivotally mounted to the nut housing, the puncture module configured such that when the nut housing is in the initial position and the probe drive slider is in the fired position, the nut housing is releasably latched to the probe drive slider by the pivot latch to hold the biopsy probe assembly in the fully extended position.

7. The biopsy device according to claim 6, the puncture module configured such that when the nut housing is in the cocked position and the probe drive slider is in the ready position, the pivot latch is released to release the nut housing from the probe drive slider to facilitate moving the nut housing to the initial position while the probe drive slider remains in the ready position.

8. The biopsy device according to any one of claims 1 to 2, the puncture module further comprising: a pair of guide rods; the probe drive slider having a pair of guide holes configured to respectively receive the pair of guide rods in a sliding engagement manner; and the puncture module frame having a distal block at the distal portion, the distal block being longitudinally spaced from the motor housing, wherein the pair of guide rods are positioned to extend parallel from the motor housing to the distal block.

9. The biopsy device according to claim 8, wherein, The distal block of the piercing module frame has a bearing housing, and the distal end of the drive spindle is received in the bearing housing at the distal portion of the piercing module frame.

10. The biopsy device according to any one of claims 1 to 2, the biopsy device comprising: an electric actuator button configured to generate a first actuation signal and a second actuation signal; a controller circuit communicatively coupled to each of the electric actuator button and the motor, wherein: a first actuation of the electric actuator button sends the first actuation signal to the controller circuit, the controller circuit being configured to execute program instructions to receive and process the first actuation signal to cause the motor to rotate the drive spindle in a first rotational direction to longitudinally move the nut housing towards the cocked position, the nut housing further configured to engage the probe drive slider and longitudinally move the probe drive slider to the ready position, thereby compressing the firing spring, wherein, when the probe drive slider is in the ready position: the head of the release arm is positioned to hold the probe drive slider in the ready position, and the controller circuit is configured to execute program instructions to cause the motor to rotate the drive spindle in a second rotational direction opposite to the first rotational direction to longitudinally move the nut housing from the cocked position towards the initial position, and the controller circuit is configured to execute program instructions to cause the motor to stop rotating the drive spindle when the nut housing has reached the initial position; and a second actuation of the electric actuator button sends a second actuation signal to the controller circuit, the controller circuit being configured to execute program instructions to receive and process the second actuation signal to cause the motor to rotate the drive spindle in the second rotational direction to longitudinally move the nut housing from the initial position towards the extended position such that the nut housing moves the release slider, the release slider being configured to operate the release arm to disengage the head of the release arm from the probe drive slider to release the firing spring to decompress and thereby longitudinally move the probe drive slider to the fired position.

11. The biopsy device according to any one of claims 1 to 2, wherein, when the probe drive slider is drivingly coupled to the probe carrier body of the biopsy probe assembly, longitudinal movement of the probe drive slider causes corresponding longitudinal movement of the stylet cannula and the cutter cannula of the biopsy probe assembly.

12. A biopsy device, the biopsy device comprising: a biopsy probe assembly having a probe carrier body, a stylet cannula, and a cutter cannula coaxial with the stylet cannula, each of the stylet cannula and the cutter cannula being movably coupled to the probe carrier body; and A biopsy driver having a driver housing, the biopsy driver including a piercing module, the piercing module being drivably coupled to the probe carrier body, the piercing module including: A piercing module frame disposed within the driver housing, the piercing module frame having a proximal portion and a distal portion; A probe drive slider slidably coupled to the piercing module frame, the probe drive slider configured to be drivably coupled to the probe carrier body of the biopsy probe assembly, the probe drive slider being longitudinally translatable along the piercing module frame, the probe drive slider having a ready position and a fired position; A nut housing movably coupled to the piercing module frame, the nut housing including an internal thread, the nut housing being longitudinally translatable along the piercing module frame, the nut housing having a cocked position, an initial position, and an extended position; A motor assembly having a motor and a motor housing, the motor housing configured to mount the motor to the proximal portion of the piercing module frame, the motor having a rotatable drive shaft; A drive spindle having a proximal end, a distal end, and an elongate threaded portion, the proximal end of the drive spindle being drivably coupled to the rotatable drive shaft of the motor, the elongate threaded portion rotatably engaging the internal thread of the nut housing; A firing spring interposed between the motor housing and the probe drive slider, the firing spring configured to bias the probe drive slider toward the fired position; A release arm having a distal mounting end portion and a proximal head, the proximal head being longitudinally spaced from the distal mounting end portion, the distal mounting end portion pivotally coupled to the distal portion of the piercing module frame, the release arm being biased by a first biasing spring toward a latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the proximal head of the release arm is positioned to engage the probe drive slider to hold the probe drive slider in the ready position; A release slider slidably coupled to the piercing module frame and biased in a proximal direction by a second biasing spring, the release slider having an engagement portion configured to engage the nut housing, the release slider configured to release the release arm from the latched position when the nut housing moves from the initial position to the extended position by rotation of the drive spindle.

13. The biopsy device according to claim 12, wherein: The probe carrier body has a piercing module engagement opening; and The probe drive slider has a probe engagement protrusion configured to be received in the piercing module engagement opening of the probe carrier body to align longitudinal movement of the probe carrier body with longitudinal movement of the probe drive slider.

14. The biopsy device according to any one of claims 12 to 13, wherein the biopsy device includes a pivot latch pivotally mounted to the nut housing, and the piercing module is configured such that when the nut housing is in the initial position and the probe drive slider is in the fired position, the nut housing is releasably latched to the probe drive slider by the pivot latch to hold the biopsy probe assembly in the fully extended position.

15. The biopsy device according to claim 14, wherein the piercing module is configured such that when the nut housing is in the cocked position and the probe drive slider is in the ready position, the pivot latch is released to release the nut housing from the probe drive slider to facilitate moving the nut housing to the initial position while the probe drive slider remains in the ready position.

16. The biopsy device according to any one of claims 12 to 13, wherein the piercing module further comprises: a pair of guide rods; the probe drive slider has a pair of guide holes configured to respectively receive the pair of guide rods in a sliding engagement manner; the piercing module frame has a distal block at the distal portion, the distal block being longitudinally spaced from the motor housing, wherein the pair of guide rods are positioned to extend parallel from the motor housing to the distal block.

17. The biopsy device according to claim 16, wherein, the distal block of the piercing module frame has a bearing seat, and the distal end of the drive spindle is received in the bearing seat at the distal portion of the piercing module frame.

18. The biopsy device according to any one of claims 12 to 13, wherein the biopsy device comprises: an electric actuator button configured to generate a first actuation signal and a second actuation signal; an initial position detector configured to generate an initial position signal when the nut housing is in the initial position; a ready position detector configured to generate a ready position signal when the probe drive slider is in the ready position; a controller circuit communicatively coupled to each of the electric actuator button, the initial position detector, the ready position detector, and the motor, the controller circuit being configured to receive and process the first actuation signal, the second actuation signal, the initial position signal, and the ready position signal, and execute program instructions to control the operation of the motor, wherein: The first actuation of the electric actuator button sends the first actuation signal to the controller circuit to cause the motor to rotate the drive spindle in a first rotational direction, thereby longitudinally moving the nut housing towards the cocked position, the nut housing being further configured to engage the probe drive slider and longitudinally move the probe drive slider to the ready position, thereby compressing the firing spring, wherein after the probe drive slider is in the ready position determined by the ready position detector: the proximal head of the release arm is positioned by the first biasing spring to hold the probe drive slider in the ready position, and the controller circuit executes program instructions to cause the motor to rotate the drive shaft in a second rotational direction opposite to the first rotational direction, wherein when the drive spindle is rotated by the drive shaft of the motor, the nut housing longitudinally moves from the cocked position towards the initial position, and then, when the nut housing reaches the initial position determined by the initial position detector, the controller circuit causes the motor to stop rotating the drive shaft; and the second actuation of the electric actuator button sends the second actuation signal to the controller circuit to cause the motor to further rotate the drive spindle in the second rotational direction so as to longitudinally move the nut housing from the initial position towards the extended position, wherein the nut housing in turn longitudinally moves the release slider, the release slider being configured to disengage the proximal head of the release arm from the probe drive slider, such that the firing spring is decompressed to longitudinally move the probe drive slider to the fired position.

19. A biopsy driver for drivingly coupling to a biopsy probe assembly, the biopsy probe assembly having a probe carrier body carrying a stylet cannula, the biopsy driver comprising: a driver housing; a puncture module frame disposed within the driver housing, the puncture module frame having a proximal portion and a distal portion; a probe drive slider slidably coupled to the puncture module frame, the probe drive slider configured to drivingly couple to the probe carrier body of the biopsy probe assembly, the probe drive slider having a ready position and a fired position; a nut housing movably coupled to the puncture module frame, the nut housing having a cocked position, an initial position, and an extended position; a motor assembly having a motor and a motor housing, the motor housing configured to mount the motor to the puncture module frame, the motor having a rotatable drive shaft; a drive spindle drivingly coupled to the rotatable drive shaft of the motor, the drive spindle rotatably coupled to the nut housing; a firing spring interposed between the motor housing and the probe drive slider, the firing spring configured to bias the probe drive slider towards the fired position; A release arm having a mounting end portion and a head, the mounting end portion being pivotally coupled to the distal portion of the piercing module frame, the release arm being biased by a biasing member toward a latched position, wherein when the probe drive slider is in the ready position and the release arm is in the latched position, the head of the release arm is configured to engage the probe drive slider to hold the probe drive slider in the ready position; and A release slider slidably coupled to the piercing module frame, the release slider having an engagement portion configured to engage the nut housing, the release slider being configured to release the release arm from the latched position when the nut housing moves from the initial position to the extended position due to rotation of the drive spindle by the motor.

20. The biopsy driver according to claim 19, the biopsy driver including a release slider biasing member configured to slidably bias the release slider in a proximal direction, the release slider having an engagement portion configured to engage the nut housing, and the release slider having a cantilever release member extending in a distal direction and configured to engage the head of the release arm to release the release arm from the latched position when the nut housing moves from the initial position to the extended position in the distal direction.

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