WO2023229578A1

WO2023229578A1 - Advanceable and steerable biopsy devices and systems

Info

Publication number: WO2023229578A1
Application number: PCT/US2022/030660
Authority: WO
Inventors: Angela Jensen; Gabrielle PORTI
Original assignee: Bard Peripheral Vascular, Inc.
Priority date: 2022-05-24
Filing date: 2022-05-24
Publication date: 2023-11-30

Abstract

A biopsy device includes an outer housing defining an interior, a drive disposed within the interior, and a variable length needle configured to be coupled to the drive. The variable length needle extends distally from the outer housing. The variable length needle has a plurality of coaxially arranged telescoping needle segments including an outer coaxial needle segment, an inner coaxial needle segment, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment. The drive causes linear translation of the variable length needle such that each of the at least one intermediate coaxial needle segment and the inner coaxial needle segment is telescopically movable relative to the outer coaxial needle segment. The at least one intermediate coaxial needle segment has a first intermediate coaxial needle segment radially adjacent to the inner coaxial needle segment having a distal cutting edge.

Description

ADVANCEABLE AND STEERABLE BIOPSY DEVICES AND SYSTEMS

TECHNICAL FIELD

[0001] The present disclosure relates to biopsy devices and systems of using biopsy devices, and more particularly, to a biopsy device and system for fine precision positioning of a distal tip of a biopsy device to a target site.

BACKGROUND

[0002] Biopsy devices and systems may be used for removing tissue from a subject so that the tissue can be examined and a diagnosis and treatment plan can be formulated. Fine needles may be very long to reach very deep soft tissue for biopsies taken under imaging guidance. Biopsy devices with long fine needles may have limitations, including, but not limited to, being lengthy, being difficult to steer a distal tip thereof to a target site within a subject and requiring repositioning that necessitates backing out the distal tip from the tissue and reentering into the tissue of the subject.

SUMMARY

[0003] According to an embodiment of the present disclosure, a biopsy device includes an outer housing defining an interior, a drive disposed within the interior, and a variable length needle coupled to the drive. The variable length needle extends distally from the outer housing. The variable length needle has a plurality of coaxially arranged telescoping needle segments that includes an outer coaxial needle segment, an inner coaxial needle segment, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment. The drive causes linear translation of the variable length needle such that each of the at least one intermediate coaxial needle segment and the inner coaxial needle segment is telescopically movable relative to the outer coaxial needle segment.

[0004] In another embodiment, a biopsy system includes a biopsy device, an imaging system, and a controller circuit. The biopsy device includes an outer housing defining an interior, a drive located within the interior, and a variable length needle coupled to the drive. The variable length needle extends distally from the outer housing. The variable length needle has a plurality of coaxially arranged telescoping needle segments. The plurality of coaxially arranged telescoping needle segments includes an outer coaxial needle segment, an inner coaxial needle segment having a distal penetrating tip, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment. The drive is drivably coupled to the inner coaxial needle segment. The imaging system is configured to generate an image containing a visualization of the variable length needle with respect to a target site in a subject. The controller circuit is communicatively coupled with the drive and the imaging system. The drive effectuates linear translation of the variable length needle such that each of the at least one intermediate coaxial needle segment and the inner coaxial needle segment is telescopically movable relative to the outer coaxial needle segment. The controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site in the subject.

[0005] In yet another embodiment, the disclosure includes a method for advancing and steering a distal penetrating tip of a biopsy device to a target site in a subject. The method includes providing a biopsy device. The biopsy device includes an outer housing, a drive located within the outer housing, and a variable length needle coupled to the outer housing. The variable length needle extends distally from the outer housing. The variable length needle has a plurality of coaxially arranged telescoping needle segments including an outer coaxial needle segment, an inner coaxial needle segment, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment. The inner coaxial needle segment has the distal penetrating tip. The drive is operatively coupled to the inner coaxial needle segment. Each of the plurality of coaxially arranged telescoping needle segments is pivotally and slidably coupled to at least one coaxial needle segment of the plurality of coaxially arranged telescoping needle segments. The method also includes communicatively coupling a controller circuit with the drive, communicatively coupling an imaging system to the controller circuit, generating an image containing a visualization of the variable length needle with respect to a target site in a subject, determining a depth to reach the target site in the subject, and controlling the drive to advance the distal penetrating tip to the target site.

[0006] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0008] FIG. 1 illustrates a perspective view of an illustrative biopsy device, wherein an exemplary drive and a mechanical drive train are housed within an interior defined by an outer housing, according to one or more embodiments shown and described herein;

[0009] FIG. 2 schematically depicts an illustrative system for implementing computer- and software-based methods for steering and varying a length of a variable length needle of a biopsy device in a subject, according to one or more embodiments shown and described herein;

[0010] FIG. 3 is a schematic side view of the mechanical drive train of a biopsy device, according to one or more embodiments shown and described herein;

[0011] FIG. 4 is a side cross-sectional view of the biopsy device of FIG. 1 with the variable length needle in a fully extended configuration, wherein a sample notch is fully exposed, according to one or more embodiments shown and described herein;

[0012] FIG. 5 is a side cross-sectional view of the biopsy device of FIG. 1 with the variable length needle with an inner needle coaxial needle segment fully retracted into a first intermediate coaxial needle segment, wherein the sample notch is fully closed and the variable length needle is in a partially retracted configuration, according to one or more embodiments shown and described herein;

[0013] FIG. 6 shows a distal portion of the variable length needle enlarged and in a side cross- sectional view, wherein the variable length needle is in a partially retracted configuration and with a partially exposed sample notch, according to one or more embodiments shown and described herein;

[0014] FIG. 7 is a schematic side view of the biopsy device of FIG. 1, wherein the variable length needle is in an exemplary fully retracted configuration with a reduced working length, according to one or more embodiments shown and described herein;

[0015] FIG. 8 is a cross-sectional view of the biopsy device of FIG. 7 taken across line 8, according to one or more embodiments shown and described herein; [0016] FIG. 9 is a side cross-sectional view of a ball joint pivotally coupling a first intermediate coaxial needle segment with a second intermediate coaxial segment, according to one or more embodiments shown and described herein;

[0017] FIG. 10 is a perspective view of an illustrative steering system having an articulation system used to steer the variable length needle of the biopsy device, according to one or more embodiments shown and described herein;

[0018] FIG. 11 is a schematic view of a biopsy device in use in a subject, and FIG. 11 depicts schematically five illustrative positions of the variable length needle, according to one or more embodiments shown and described herein;

[0019] FIG. 12 depicts schematically a biopsy device in use in a subject, wherein FIG. 12 is the biopsy device of FIG. 11 drawn from a perspective that is rotated ninety degrees from the perspective taken in FIG. 11, and FIG. 12 depicts schematically five illustrative positions of the variable length needle, according to one or more embodiments shown and described herein; and [0020] FIG. 13 depicts a flowchart of an exemplary method for electronically steering and advancing a distal tip of a biopsy device to a target site.

[0021] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment, and such exemplifications are not to be construed as limiting the scope of the present disclosure in any manner.

DETAILED DESCRIPTION

[0022] Embodiments of the apparatuses and systems of the present disclosure include a biopsy device having a variable length needle with a distal tip that is steerable to a target site within a subject. The disclosed variable length needle is flexible and has a plurality of coaxially arranged telescoping needle segments. In embodiments, each of the plurality of coaxially arranged telescoping needle segments is pivotally coupled to at least one adjacent coaxially arranged telescoping needle segment. With the disclosed variable length needle, the operator of the apparatus may steer or the disclosed biopsy system may control the steering of the distal tip of the variable length needle to avoid the chest wall or blood vessels by selectively articulating any or all of the plurality of coaxially arranged telescoping needle segments along a first pivot axis, a second pivot axis, or both the first and second pivot axes relative to the longitudinal axis of the biopsy device. [0023] Referring now to the drawings, FIGS. 1 and 2 collectively illustrate an embodiment of a biopsy device 12 designed to advance and steer a distal end 73 of a variable length needle 220 to a target site 14 in a subject 16. The biopsy device 12 includes an outer housing 18 having a distal face 182 and defining an interior 22, a drive 20 disposed within the interior 22 of the biopsy device 12, and the variable length needle 220 coupled to the drive 20. The variable length needle 220 is couplable to the drive 20. FIG. 1 illustrates the variable length needle 220 extending in a distal direction 36 from the distal face 182 of the outer housing 18. However, in other configurations, the variable length needle 220 may be fully retracted into the interior 22. The variable length needle 220 has a plurality of coaxially arranged telescoping needle segments 240, each of a different gauge (measured by exterior diameter), including an outer coaxial needle segment 260 having the largest exterior diameter, an inner coaxial needle segment 280, and at least one intermediate coaxial needle segment 30 radially interposed between the outer coaxial needle segment 260 and the inner coaxial needle segment 280. A length of each of the plurality of coaxially arranged telescoping needle segments 240 may be equal to or different from the length of each of the other coaxially arranged telescoping needle segments. As shown in FIG. 1, the inner coaxial needle segment 280 may be the innermost coaxial needle segment of the plurality of coaxially arranged telescoping needle segments 240 and the outer coaxial needle segment 260 may be the outermost coaxial needle segment of the plurality of coaxially arranged telescoping needle segments 240. The inner coaxial needle segment 280 has the smallest exterior diameter of the plurality of coaxially arranged telescoping needle segments 240 and may have a distal penetrating tip 288. The plurality of coaxially arranged telescoping needle segments 240 may nest within one another in retracted configurations. In embodiments, the inner coaxial needle segment 280 may have a sample notch 282 formed in a surface thereof. The sample notch 282 has a maximum sample notch length 283 defined by the distance between a sample notch distal end 284 and a sample notch proximal end 286. In other embodiments, any or all of the plurality of coaxially arranged telescoping needle segments 240 may have a sample notch formed in a surface thereof. In embodiments, any or all of the plurality of coaxially arranged telescoping needle segments 240 may have a distal cutting edge, for example, a first distal end 311 has a first distal cutting edge 310.

[0024] The drive 20 may include a motor 116 and a mechanical drive train 50. The mechanical drive train 50 may be coupled to receive rotary power from the motor 116. The motor 116 may be, for example, a stepper motor or a DC (direct current) motor. The drive 20 causes linear translation 32 of the variable length needle 220 such that each of the at least one intermediate coaxial needle segment 30 and the inner coaxial needle segment 280 is telescopically movable relative to the outer coaxial needle segment 260. Linear translation 32 of various segments of the plurality of coaxially arranged telescoping needle segments 240 may be in a proximal direction 34 to retract and the distal direction 36 to extend. In embodiments, the drive 20 may cause the variable length needle 220 to achieve rotational movement 48 in 360° about a longitudinal axis 46 thereof. The rotational movement 48 includes clockwise and counterclockwise around the longitudinal axis 46 of the variable length needle 220.

[0025] The interior 22 may or may not include an electrical power source 61. The drive 20 may include the electrical power source 61, the motor 116, a gear assembly 117, and the mechanical drive train 50. In embodiments, the mechanical drive train 50 includes the steering system 68, which will be described in greater detail below. It will be appreciated that any combination of components of the drive 20 may be slidably engaged or rotatably and slidably engaged with the outer housing 18 with the remaining components of the drive 20 remaining stationary. As shown in FIG. 1, the drive 20 may include a drive shaft 21 having threads 26 that engage with interior threads (not shown) on a spindle nut 24 that is drivably engaged with a gear assembly 117 that is rotationally driven by a motor 116. As shown in FIG. 1, the drive shaft 21 may be coaxial with the spindle nut 24. As the motor 116 drives the gear assembly 117, the gear assembly drives the spindle nut, which engages with the threads 26 on the drive shaft 21 to drive the drive shaft 21 in the distal direction 36 with the turn of the motor 116 in one rotational direction and to drive the drive shaft 21 in the proximal direction 34 with the opposition rotational direction. The distal end of the drive shaft 21 is drivably engaged with the inner coaxial needle segment 280 to linearly translate the inner coaxial needle segment 280 in either the proximal direction 34 or the distal direction 36.

[0026] In still other embodiments, the drive shaft 21 may be arranged to be parallel to a different embodiment of the spindle nut 24, which has exterior threads, and a drivable key (not shown), engaged with the exterior threads of the spindle nut 24, couples the drive shaft 21 with the spindle nut, such that as the spindle nut rotates, the drivable key longitudinally translates the drive shaft 21 in either the proximal direction 34 or the distal direction 36, depending on the rotational direction being applied to the gear assembly 117 by the motor 116.

[0027] As best seen in the schematic depiction of the mechanical drive train 50 of FIG. 3, the drive shaft 21 may include a plurality of drive shaft segments 25. The plurality of drive shaft segments 25 are fluidly coupled to one another and define the drive shaft lumen 23. Each of the plurality of drive shaft segments 25 is coupled together via a pin or a hinge with at least one immediately adjacent segment. For example, FIG. 3 shows a proximal-most drive shaft segment 27 flexibly coupled with a first intermediate drive shaft segment 35 via a proximal-most drive shaft pin 29. A first intermediate drive shaft pin 37 flexibly couples the first intermediate drive shaft segment 35 with a second intermediate drive shaft segment 39. A second intermediate drive shaft pin 41 is shown at the distal end of the second intermediate drive shaft segment 39. A distal- most drive shaft segment 55 of the plurality of drive shaft segments 25 is coupled at its distal end with a proximal end 250 of the inner coaxial needle segment 280. The pattern of drive shaft segments is followed to the distal-most drive shaft segment 55. Since the plurality of drive shaft segments 25 are fluidly coupled together to define the drive shaft lumen 23 and the distal-most drive shaft segment 55 is directly connected to the inner coaxial needle segment 280, which has an innermost lumen 248, the sample notch 282 is fluidly coupled through the drive shaft 21 and the drive shaft lumen 23 to the interior 22 of the outer housing 18, and more specifically to a sample collection canister 44 and a vacuum 45, shown in FIGS. 1 and 2.

[0028] In embodiments, a number of the plurality of drive shaft segments 25 may greater than a number of the plurality of coaxially arranged telescoping needle segments 240. Each drive shaft pin, such as the proximal -most drive shaft pin 29 provides flexibility to the drive shaft 21 and may snap to lock straight the two adjoining drive shaft segments, which, in this example, are the proximal -most drive shaft segment 27 and the first intermediate drive shaft segment 35, so that the drive shaft 21 may provide greater driving force to the inner coaxial needle segment 280. Each of the plurality of drive shaft segments 25 has the same exterior diameter so that the drive shaft 21 has a consistent diameter across a longitudinal length L50 of the drive shaft 21, best seen in FIGS. 4 and 5. The drive shaft 21 is divided into the plurality of drive shaft segments 25 to permit the variable length needle 220 to extend, retract, and pivot relative to the outer housing 18 while also preventing the rotary and pivoting forces applied to the variable length needle 220 from being transferred in the proximal direction 34 to the motor 116, which would ultimately destroy the motor 116.

[0029] Referring again to FIG. 1, the outer housing 18 may include a controller interface 70. The controller interface 70 may include a window 122 for accessing a user interface circuit 124. In addition, the outer housing 18 includes a coupling interface 102 and may have a socket 104. The socket 104 defines a distal bore 314 into the interior 22 of the biopsy device 12. An outer coaxial needle segment 260 has a proximal portion 265 that is directly coupled with the socket 104. The proximal portion 265 is sized to be received within the socket 104 to retain the proximal portion 265 within the socket 104 even as the drive 20 linearly advances the outer coaxial needle segment 260 in the distal direction 36 from within the interior 22.

[0030] The at least one intermediate coaxial needle segment 30 may include at least a first intermediate coaxial needle segment 210 and a second intermediate coaxial needle segment 230. It should be appreciated that any number of intermediate coaxial needle segments could be coupled to, coaxial with, and extending between the outer coaxial needle segment 260 and the inner coaxial needle segment 280 following the pattern of the first intermediate coaxial needle segment 210 and the second intermediate coaxial needle segment 230.

[0031] As illustrated in FIG. 1, the first intermediate coaxial needle segment 210 is radially adjacent to the inner coaxial needle segment 280. The first intermediate coaxial needle segment 210 is arranged to be immediately proximal and adjacent to the inner coaxial needle segment 280, and the first intermediate coaxial needle segment 210 is arranged to be immediately distal and adjacent to the second intermediate coaxial needle segment 230. As shown in FIG. 1, the second intermediate coaxial needle segment 230 is coaxially arranged between the outer coaxial needle segment 260 and the first intermediate coaxial needle segment 210. The second intermediate coaxial needle segment 230 is arranged to be radially adjacent to the first intermediate coaxial needle segment 210 and the outer coaxial needle segment 260. The second intermediate coaxial needle segment 230 is arranged to be immediately proximal and adjacent to the first intermediate coaxial needle segment 210, and the second intermediate coaxial needle segment 230 is arranged to be immediately distal and adjacent to the outer coaxial needle segment 260.

[0032] In embodiments, the first intermediate coaxial needle segment 210 has the first distal cutting edge 310 and a first intermediate coaxial needle segment proximal end 252. The second intermediate coaxial needle segment 230 has a second distal end 231 and a second intermediate coaxial needle segment proximal end 254. In embodiments, the second distal end 231 may have a cutting edge 31. The outer coaxial needle segment 260 has an outer coaxial needle segment distal end 262 that may or may not have a cutting edge and a proximal portion 265 that extends from the distal face 182 of the outer housing 18.

[0033] FIG. 1 shows that the inner coaxial needle segment 280 has an inner segment length 208. The first intermediate coaxial needle segment 210 has a first intermediate coaxial needle segment length 212. The second intermediate coaxial needle segment 230 has a second intermediate coaxial needle segment length 232. The outer coaxial needle segment 260 has an outer coaxial needle segment length 264, measured from the distal face 182 of the outer housing 18 to the outer coaxial needle segment distal end 262 when the outer coaxial needle segment 260 is in its extended-most positon, as shown in FIG. 1. When the variable length needle 220 is in a fully extended configuration such that each of the plurality of coaxially arranged telescoping needle segments 240 are in their respective extended-most positions, as shown in FIG. 1, a working needle length W of the variable length needle 220 is about equal to the sum of the inner segment length 208, the first intermediate coaxial needle segment length 212, the second intermediate coaxial needle segment length 232, and the outer coaxial needle segment length 264.

[0034] In embodiments, a proximal portion 265 of the outer coaxial needle segment 260 may include an enlarged portion 312 coupled with and extending in the proximal direction 34 from the distal face 182 of the outer housing 18. In particular, the enlarged portion 312 pivotally couples the outer coaxial needle segment 260 with the interior 22 and, more particularly, a distal bore 314 of the outer housing 18. In some embodiments, the enlarged portion 312 is a fourth ball joint 225 that flexibly and pivotally couples the outer coaxial needle segment 260 to the outer housing 18 and interior 22 and, in embodiments, to the coupling interface 102 having the socket 104. In embodiments including the socket 104, the socket 104 defines the distal bore 314 of the biopsy device 12. As shown in FIG. 10, the socket 104 may include a distal lip 106, having a smaller diameter than the maximum diameter of the enlarged portion 312, to aid in the retention of the proximal portion 265 of the variable length needle 220 within the interior 22 of the biopsy device 12.

[0035] Referring to FIG. 2, a system 10 for advancing and steering biopsy devices may include a console 52 having a controller circuit 54, a graphical user interface (e.g., GUI) 56, which may include a screen 58, and an imaging system 60. In embodiments, the imaging system 60 may include the controller circuit 54 and the GUI 56.

[0036] An electrical power source (not shown) is electrically coupled to the console 52 to receive electrical power. The electrical power source 61 is electrically coupled to the drive 20 to receive electrical power therefrom. In embodiments having the controller interface 70 part of the biopsy device 12, the electrical power source 61 is electrically coupled to the controller interface 70 to receive electrical power therefrom. Those skilled in the art will recognize that each of the drive 20 and the controller interface 70 may receive power via the console 52, or alternatively, from electrical power source 61. The electrical power source 61 may be, for example, a rechargeable battery sized to have electrical capacity sufficient to supply the electrical power requirements of the drive 20 and the controller interface 70.

[0037] The controller circuit 54 may be communicatively coupled to and, thus, in communication with the drive 20 via a drive input/output (VO) interface circuit 62, a first internal bus structure 64, and a first communication link 66, which may be wired or wireless. The controller circuit 54 may be communicatively coupled to and, thus, in communication with the controller interface 70, such as, but not limited to handles, knobs, thumb screws, ball controls, and/or joysticks, via the drive element I/O interface circuit, the first internal bus structure, and a third communication link 72, which may be wired or wireless. The controller interface 70, which may be incorporated into the biopsy device 12 or may be an independent handheld device, is depicted as a joystick 71 in the embodiment of FIG. 1. In use, as the joystick 71 pivots from left to right and forward to backward and through the third communication link 72, the operator of the system 10 controls the linear and pivot positions of a distal end 73 of the variable length needle 220 within the subject 16. Additionally or alternatively, the controller interface 70 may include the window 122 for accessing the user interface circuit 124, as shown in FIG. 1. The user interface circuit 124 is configured to receive a user input and generate a user output signal. In the present embodiment, user interface circuit 124 may be a simple touch pad having a plurality of control buttons 126, which may include a needle extend button 128 and a needle retract button 130. Additionally or alternatively, it is contemplated that user interface circuit 124 may be a digital touch screen display.

[0038] The controller circuit 54 communicates drive instructions to the drive 20 to effectuate linear translation 32 of the variable length needle 220 such that each of the at least one intermediate coaxial needle segment 30 and the inner coaxial needle segment 280 is telescopically movable relative to the outer coaxial needle segment 260. Furthermore, the controller circuit 54 is configured to execute program instructions to generate motor control signals to control the drive 20 to linearly translate the inner coaxial needle segment 280 to the target site 14 in the subject 16. The program instructions may control the drive 20 to extend or retract the variable length needle 220.

[0039] The controller circuit 54 is an electrical circuit that has data processing capability and command generating capability. In the present embodiment, the controller circuit 54 has a controller processor 74 and a controller memory 76, which is an associated non-transitory electronic memory. The controller processor 74 may be in the form of a single microprocessor, or two or more parallel microprocessors. The controller memory 76 may include multiple types of digital data memory, such as random access memory (RAM), non-volatile RAM (NVRAM), read only memory (ROM), and/or electrically erasable programmable read-only memory (EEPROM). The controller memory 76 may further include mass data storage in one or more of the electronic memory forms described above, or on a computer hard drive or optical disk. Alternatively, controller circuit 54 may be assembled as one or more Application Specific Integrated Circuits (ASIC).

[0040] The controller memory 76 may store data on various tissues, tissue types, and tissue densities. The controller processor 74 may be configured to execute program instructions stored in the controller memory 76 to execute one or more control schemes described herein. The controller circuit 54 is configured to instruct the drive 20 and, more specifically, the motor 116 to linearly translate each of the plurality of coaxially arranged telescoping needle segments 240 and the inner coaxial needle segment 280 with respect to the outer coaxial needle segment 260 and the outer housing 18.

[0041] The imaging system 60 is an electrical circuit that has data processing capability and command generating capability. The imaging system 60 may include an imaging processor 80 and an imaging memory 82. The imaging memory 82 is an associated non-transitory electronic memory. The imaging processor 80 may be in the form of a single microprocessor, or two or more parallel microprocessors. The imaging memory may include multiple types of digital data memory, such as random access memory (RAM), non-volatile RAM (NVRAM), read only memory (ROM), and/or electrically erasable programmable read-only memory (EEPROM). The imaging memory may further include mass data storage in one or more of the electronic memory forms described above, or on a computer hard drive or optical disk. Alternatively, the imaging system 60 may be assembled as one or more Application Specific Integrated Circuits (ASIC). In embodiments, the imaging system 60 may be configured to generate an image containing a visualization, e.g. visual data, of the variable length needle 220 with respect to the target site 14 in the subject 16. The imaging system 60 may display the visualization on the GUI 56 or, more specifically, on the screen 58 for the operator of the system to assess. In embodiments, the GUI 56 may include the screen 58 which may be a display screen or a touch-screen configured to accommodate user input.

[0042] The imaging system 60 may be communicatively coupled to an imaging field generator 84. The imaging system 60 may be communicatively coupled to the imaging field generator 84 via an imaging field generator input/output (VO) interface circuit 86, a third internal bus structure 88, and a fourth communication link 90, which may be wired or wireless. In some embodiments, the imaging field generator 84 may be located in an ultrasound probe configured to produce an ultrasound field-of-view volume. However, in still other embodiments, the imaging field generator 84 may be an X-ray device or another known imaging modality for providing accurate imaging data. The imaging field generator 84 may be internal or external to the console 52. The imaging system 60 may be configured to produce the imaging data concerning the location of the variable length needle 220 relative to the target site 14.

[0043] In embodiments, the imaging system 60 may be configured to provide a real time image data to the controller circuit 54, and the controller circuit 54 may be configured to process the real time image data to control the drive 20 to control the mechanical drive train 50 to linearly translate the inner coaxial needle segment 280 to the target site 14. In embodiments, the imaging system 60 may be configured to provide the real time image data to the controller circuit 54, and the controller circuit 54 may be configured to process the real time image data to control the drive 20 to control the mechanical drive train 50 and, more particularly, the steering system 68 to pivot any or all of the plurality of coaxially arranged telescoping needle segments 240 in order to steer the inner coaxial needle segment 280 to the target site 14. In still other embodiments, the imaging system 60 may be configured to provide an on demand image data to the controller circuit 54. The controller circuit 54 may be configured to control the drive 20 to linearly translate the inner coaxial needle segment 280 to the target site 14 via the on demand image data.

[0044] The controller circuit 54 is communicatively coupled to the imaging system 60 via a second internal bus structure 78. The imaging system 60 is configured to generate an image (e.g., imaging data) that contains a visualization of the variable length needle 220 and target site 14. In embodiments, the controller circuit 54 being configured to process the image, e.g., imaging data, such as, the real time image data or the on demand image data, to identify the target site 14 within the image. In embodiments, the controller circuit 54 may be configured to estimate the working needle length W of the variable length needle 220 to reach the target site 14, and the controller circuit 54 may be configured to control the drive with drive instructions to linearly translate the inner coaxial needle segment 280 to the target site 14. In embodiments, the controller circuit 54 is configured to control the drive 20 and, more specifically, the motor 116 to automatically advance the variable length needle 220 to the target site 14. In still other embodiments, the controller circuit 54 is configured to receive user input, e.g., drive instructions, from the controller interface 70, as previously discussed.

[0045] For linear translation 32, the motor 116 may receive electrical power, in the form of control signals, from the controller circuit 54, and in turn provide rotary power to drive 20, as directed by the controller circuit 54. As will be further discussed below, the drive 20, which is an electromechanical drive mechanism, is configured to convert the rotary power received from the motor 116 into linear power, which may or may not be supplied to a hydraulic drive assembly (not shown). [0046] In embodiments, the variable length needle 220 is extendable to have a working needle length W of about 10 cm to about 20 cm measured from the distal face 182 of the outer housing to the distal end 73. An exposed length of the sample notch 282 and the working needle length W may be tuned during advancement by the user as appropriate for the lesion shape and location. For example, if the target site 14 is 6 cm deep and 1 cm wide, the controller circuit 54 can send drive instructions to the drive to linearly translate the variable length needle 6 cm in the distal direction and set the sample notch to be opened so that the sample notch is 1 cm long near the distal penetrating tip 288 of the variable length needle 220. In embodiments, the controller circuit 54 is configured to process the imaging data, which may be real time image data or on demand image data, to control the drive 20 to linearly translate the first intermediate coaxial needle segment 210 with respect to the sample notch 282 of the inner coaxial needle segment 280 to control an exposed sample notch length L, such as the maximum exposed sample notch length 283, shown in FIG. 1, the exposed sample notch length L, shown in FIG. 6, and the closed configuration shown in FIG. 5.

[0047] In use, the user or the controller circuit 54 may select to cover or uncover the sample notch 282 of the inner coaxial needle segment 280 by linear movement 32 of the inner coaxial needle segment 280 within the first intermediate coaxial needle segment 210. Alternatively, the user or the controller circuit 54 may select to cover or uncover the sample notch 282 of the inner coaxial needle segment 280 by linear movement 32 of the first intermediate coaxial needle segment 210. In some embodiments, in the covered condition, the inner coaxial needle segment 280, including the distal penetrating tip 288, is entirely contained within the first intermediate coaxial needle segment 210. In still other embodiments, in the covered condition, the sample notch 282 of the inner coaxial needle segment 280 is covered by the first intermediate coaxial needle segment 210 and at least a portion of the distal penetrating tip 288 distally extends beyond a first distal cutting edge 310 of the first intermediate coaxial needle segment 210.

[0048] Collectively, FIGS. 1 and 4 illustrate that the biopsy device 12 may include a first ball joint 214 coupling the inner coaxial needle segment 280 to the first intermediate coaxial needle segment 210, a second ball joint 216 coupling the first intermediate coaxial needle segment 210 to the second intermediate coaxial needle segment 230, and a third ball joint 218 coupling the second intermediate coaxial needle segment 230 to the outer coaxial needle segment 260. Each of the ball joints of the variable length needle 220 has a ball joint bore 227.

[0049] As shown in FIG. 4, the inner coaxial needle segment 280 extends longitudinally in the distal direction 36 from the first ball joint 214. An innermost lumen 248, best seen in FIG. 8, extends throughout the inner coaxial needle segment 280 including the first ball joint 214. The first intermediate coaxial needle segment 210 extends longitudinally in the distal direction 36 from the second ball joint 216. A first intermediate coaxial needle lumen 270, best seen in FIG. 8, extends throughout the first intermediate coaxial needle segment 210, including the second ball joint 216. The second intermediate coaxial needle segment 230 extends longitudinally in the distal direction 36 from the third ball joint 218. A second intermediate coaxial needle lumen 272, best seen in FIG. 8, extends throughout the second intermediate coaxial needle segment 230, including the third ball joint 218. The outer coaxial needle segment 260 extends longitudinally in the distal direction 36 from the outer housing 18 and, in particular, from the distal face 182, as demonstrated in FIG. 1. An outermost coaxial needle lumen 292, best seen in FIG. 8, extends throughout the outer coaxial needle segment 260, including the fourth ball joint 225.

[0050] Each of the first ball joint 214, the second ball joint 216, the third ball joint 218, and the fourth ball joint 225, respectively, provides a telescopic and pivotal coupling of the plurality of coaxially arranged telescoping needle segments 240. In addition, the first ball joint 214 provides for articulation, e.g., transverse directional steering relative to the longitudinal axis 46, of the inner coaxial needle segment 280. The second ball joint 216 provides for articulation of the first intermediate coaxial needle segment 210. The third ball joint 218 provides for articulation of the second intermediate coaxial needle segment 230. The enlarged portion 312, shown in FIG. 1, which in some embodiments is the fourth ball joint 225, shown schematically in FIG. 3, provides for articulation of the outer coaxial needle segment 260.

[0051] The first ball joint 214 is larger than the outer diameter of the first intermediate coaxial needle segment 210 measured at the first distal cutting edge 310 so that as the inner coaxial needle segment 280 is linearly translated by the drive 20 in the distal direction 36, the inner coaxial needle segment 280 does not come uncoupled from the first intermediate coaxial needle segment 210. Likewise, the second ball joint 216 is larger than the outer diameter of the second intermediate coaxial needle segment 230 measured at the second distal end 231 so that as the first intermediate coaxial needle segment 210 is distally advanced by the drive 20, the first intermediate coaxial needle segment 210 does not come uncoupled from the second intermediate coaxial needle segment 230. Also, the third ball joint 218 is larger than the outer diameter of the outer coaxial needle segment 260 measured at the outer coaxial needle segment distal end 262 so that as the second intermediate coaxial needle segment 230 is distally advanced by the drive 20, the second intermediate coaxial needle segment 230 does not come uncoupled from the outer coaxial needle segment 260. The distal bore 314 is sized to retain the enlarged portion 312 within the interior 22 of the outer housing 18. In embodiments, the enlarged portion 312 defines the fourth ball joint 225 sized to fit within the socket 104 and for the proximal portion 265 of the outer coaxial needle segment 260 to remain coupled with the socket 104 and the interior 22.

[0052] In FIGS. 1 and 4, the variable length needle 220 is shown in a fully extended configuration. FIG. 5 shows the inner coaxial needle segment 280 fully retracted into the first intermediate coaxial needle segment 210. FIG. 6 shows the inner coaxial needle segment 280 partially retracted into the first intermediate coaxial needle segment 210. FIG. 6 shows the variable length needle 220 in a more extended configuration than the partially retracted configuration of the variable length needle 220 shown in FIG. 5.

[0053] As shown in FIG. 4, the drive shaft 21 is directly coupled to the proximal end 250 or at least the first ball joint 214 of the inner coaxial needle segment 280, such that as the drive shaft 21 is extended in a distal direction 36 by way of engagement with the spindle nut 24, the gear assembly 117, and the motor 116, the inner coaxial needle segment 280 also is extended in the distal direction 36. Since the inner coaxial needle segment 280 is coupled to the first intermediate coaxial needle segment 210 via the first ball joint 214 and the first distal end 311 having a smaller diameter than the largest diameter of the first ball joint 214, as the inner coaxial needle segment 280 is distally advanced in the distal direction 36, the first intermediate coaxial needle segment 210 is pulled along by way of the first ball joint 214 in the distal direction. The pattern continues. As the first intermediate coaxial needle segment 210 is pulled along as a result of the drive shaft 21 distally advancing the inner coaxial needle segment 280, the first intermediate coaxial needle segment proximal end 252 may engage with the second distal end 231 of the second intermediate coaxial needle segment 230, resulting in the second intermediate coaxial needle segment 230 being pulled in the distal direction 36. As the second intermediate coaxial needle segment 230 distally advances, the second intermediate coaxial needle segment proximal end 254 may engage the outer coaxial needle segment distal end 262 of the outer coaxial needle segment 260, resulting in the outer coaxial needle segment 260 being pulled in the distal direction 36. Stated another way, the outer coaxial needle segment 260 is pulled along by the at least one intermediate coaxial needle segment 30 to translate the outer coaxial needle segment 260 in the distal direction 36 relative to the outer housing 18. Once the enlarged portion 312 is distally advanced to engage with the coupling interface 102, the variable length needle 220 has reached the fully extended configuration shown in FIGS. 1 and 4. As just demonstrated, the drive 20 may linearly translate the inner coaxial needle segment 280 having the sample notch 282 and the at least one intermediate coaxial needle segment 30 relative to the outer housing 18, and, in embodiments, the drive 20 may linearly translate the inner coaxial needle segment 280, the at least one intermediate coaxial needle segment 30, and the outer coaxial needle segment 260 relative to the outer housing 18.

[0054] As demonstrated in FIGS. 4-6, the variable length needle 220 may be controlled so that the sample notch 282 is partially covered such that an exposed sample notch length L, as shown in FIG. 6, is shorter than the maximum exposed sample notch length 283, shown in FIGS. 1 and 4. With the controller interface 70, a user may select the exposed sample notch length L in order to control the size of a tissue specimen 294 to be collected from the target site 14 in the subject 16.

[0055] Because the first intermediate coaxial needle segment 210 has a first distal cutting edge 310 at the first distal end 311, any tissue that extends into the sample notch 282 will be cut when the inner coaxial needle segment 280 is linearly translated in the proximal direction 34 from the fully extended condition shown in FIGS. 1 and 4 to a partially retracted condition, for example, the partially retracted condition shown in FIG. 6, and to the fully retracted condition, best seen in FIG. 5, such that the sample notch 282 of the inner coaxial needle segment 280 slides past the first distal cutting edge 310 as the inner coaxial needle segment 280 retracts into the first intermediate coaxial needle segment 210 to cover the sample notch 282. That is, the inner coaxial needle segment 280 is fully retracted into the first intermediate coaxial needle segment 210 in FIG. 5, whereas the variable length needle 220 itself is in a partially retracted configuration in FIG. 5, because each of the first intermediate coaxial needle segment 210, the second intermediate coaxial needle segment 230, and the outer coaxial needle segment 260 are in their respective fully extended conditions while only the inner coaxial needle segment 280 is in a fully retracted condition. Because the inner coaxial needle segment 280 is retracted relative to the first intermediate coaxial needle segment 210 in FIG. 5, the working length W2 of the variable length needle 220 is shorter relative to the working length W of the variable length needle 220, when the variable length needle 220 is in the fully extended configuration shown in FIGS. 1 and 4.

[0056] In some embodiments, the vacuum 45 may apply negative pressure to the inner lumen 166 of the variable length needle 220 and, in embodiments, via the drive shaft lumen 23 which is fluidly coupled with the inner lumen 166 and, more particularly, with the innermost lumen 248 of the inner coaxial needle segment 280 to draw tissue from the target site 14 into the sample notch 282. In embodiments, the drive 20 retracts the inner coaxial needle segment 280 to sever the tissue, extending into the sample notch 282, along the first distal cutting edge 310, producing the tissue specimen 294. In still other embodiments, the at least one intermediate coaxial needle segment 30 that is adjacent to the inner coaxial needle segment 280 is driven distally by the drive 20 to sever the aspirated tissue from the supporting tissue at the target site 14 with the first distal cutting edge 310 while closing the sample notch 282 and producing the tissue specimen 294.

[0057] In embodiments, the vacuum pressure within the inner lumen 166 of the variable length needle 220 causes the tissue specimen to be drawn through the inner lumen 166 of the variable length needle 220 and into the sample collection canister 44 shown in FIGS. 1 and 2. In embodiments, the vacuum applied within the drive shaft lumen 23 of the drive shaft 21, which may be directly coupled to the inner coaxial needle segment 280, may cause the tissue specimen 294 to be drawn through the drive shaft 21 in the proximal direction 34 toward the vacuum 45 and the sample collection canister 44 shown in FIGS. 1 and 2. The tissue specimen 294 may travel proximally through distal vacuum coupler 51 a vacuum tube lumen 49 of a vacuum tube 47 and through a proximal vacuum coupler 53 and into the sample collection canister 44. Positive pressure or even ambient conditions distal to the tissue specimen can facilitate tissue passing through the inner lumen 166 of the variable length needle 220. If another tissue specimen 294 is desired, the variable length needle 220 may be rotated by the drive 20, in particular, the gear assembly 117 engaging the threads 26 on the drive shaft 21 via the spindle nut 24 in one or more steps to repeat obtaining another tissue specimen in the same manner without otherwise removing the variable length needle 220 from the subject 16. In embodiments, the tissue specimen 294 may be obtained with the sample notch 282 of the variable length needle in the exemplary initial position shown in FIG. 1, which is considered zero degrees. The variable length needle 220 may be rotated to any of the these exemplary positions: the exemplary initial position shown in FIG. 1; a second position, which is 90 degrees clockwise from the initial position; at a third position, which is 180 degrees from the initial position; and at a fourth position, which is 270 degrees from the initial position. A person of ordinary skill in the art will recognize that there are infinite rotary positions existing in 360 degrees of the rotational movement 48 of the variable length needle 220 provided by the drive 20. Of course, the locations of the second, third, and fourth positions may be reversed. The position of the sample notch 282 may be indicated by a marker arrow on the window 122 so that the physician or other operating personnel can readily determine what the orientation of the sample notch 282 within the subject 16.

[0058] Referring now to FIGS. 7 and 8, the variable length needle 220 is shown in an exemplary fully retracted configuration. In still other embodiments, a fully retracted configuration of the variable length needle 220 is demonstrated when the distal penetrating tip 288, the first distal end with the first distal cutting edge 310, and the second distal end 231 are aligned with or are proximal to the outer coaxial needle segment distal end 262 of the outer coaxial needle segment 260. As demonstrated in FIGS. 7 and 8, the plurality of coaxially arranged telescoping needle segments 240 may nest within each other in the fully retracted configuration. In embodiments, all of the plurality of coaxially arranged telescoping needle segments 240 may fit within the interior 22 of the outer housing 18 in the fully retracted configuration, such that as the inner coaxial needle segment 280 is distally advanced via the drive 20, the at least one intermediate coaxial needle segment 30 linearly advances relative to the outer coaxial needle segment 260 and the outer housing 18.

[0059] FIG. 8 is a cross-section view of the biopsy device 12 of FIG. 7 taken across line 8. The inner coaxial needle segment 280 has an inner telescoping needle segment wall 242, an inner telescoping needle segment interior surface 244, and an inner telescoping needle segment exterior surface 246. The inner telescoping needle segment interior surface 244 defines an innermost lumen 248. The first intermediate coaxial needle segment 210 has a first wall 222 with a first interior surface 224 and a first exterior surface 226. The first interior surface 224 defines a first intermediate coaxial needle lumen 270. The second intermediate coaxial needle segment 230 has a second wall 234 with a second interior surface 236 and a second exterior surface 238. The second interior surface 236 defines a second intermediate coaxial needle lumen 272. The outer coaxial needle segment 260 has a third wall 274 with a third interior surface 276 and a third exterior surface 278. The third interior surface 276 defines an outermost coaxial needle lumen 292. Together the innermost lumen 248, the first intermediate coaxial needle lumen 270, the second intermediate coaxial needle lumen 272, and the outermost coaxial needle lumen 292 maintain the inner lumen 166 of the variable length needle 220 whether the variable length needle 220 is in the fully extended configuration of FIG. 4, the partially retracted configuration of FIG. 5, or the fully retracted configuration, for example, the configuration shown in FIG. 7.

[0060] In addition, FIG. 8 demonstrates a coaxial arrangement of segments. More specifically, the inner coaxial needle segment 280 may be coaxially arranged within the first intermediate coaxial needle lumen 270 of the first intermediate coaxial needle segment 210. The first intermediate coaxial needle segment 210 may be coaxially arranged within the second intermediate coaxial needle lumen 272 of the second intermediate coaxial needle segment 230. The second intermediate coaxial needle segment 230 may be coaxially arranged with the outermost coaxial needle lumen 292 of the outer coaxial needle segment 260. In embodiments, each of the plurality of coaxially arranged telescoping needle segments 240 may be centered on the longitudinal axis 46 of the variable length needle 220. [0061] FIG. 9 depicts the second ball joint 216 pivotally coupling the first intermediate coaxial needle segment 210 to the second intermediate coaxial segment 230. The structure of the second ball joint 216 is representative of the structure of each of the first ball joint 214, the third ball joint 218, and the fourth ball joint 225 previously addressed. The second ball joint 216 fluidly couples the first intermediate coaxial needle lumen 270 with the second intermediate coaxial needle lumen 272 via a ball joint bore 227.

[0062] As depicted in FIG. 10, the biopsy device 12 may include the first ball joint 214 pivotally and directly coupling the inner coaxial needle segment 280 with the first intermediate coaxial needle segment 210, the second ball joint 216 pivotally and directly coupling the first intermediate coaxial needle segment 210 with the second intermediate coaxial needle segment 230, and the third ball joint 218 pivotally and directly coupling the second intermediate coaxial needle segment 230 with the outer coaxial needle segment 260.

[0063] In embodiments, the steering system 68 may include an articulation system 134 (e.g., a pulley system) that may articulate each of the each of the plurality of coaxially arranged telescoping needle segments 240 of the variable length needle 220 by pivoting each of the first ball joint 214, the second ball joint 216, and the third ball joint 218. Pivoting of each of the plurality of coaxially arranged telescoping needle segments 240 may occur along a first pivot axis 38 relative to the longitudinal axis 46, along a second pivot axis 40 relative to the longitudinal axis 46, or a combination of extending along the first pivot axis 38 and along the second pivot axis 40 relative to the longitudinal axis 46, resulting in the collective pivot angle 33, demonstrated schematically in FIG. 2. Positioned near the first ball joint 214 of the inner coaxial needle segment 280 is located a first pulley 136. A second pulley 138 is located near the second ball joint 216 on the first intermediate coaxial needle segment 210. Near the third ball joint 218 of the second intermediate coaxial needle segment 230 is positioned a third pulley 140. In embodiments, the first pulley 136, the second pulley 138, and the third pulley 140, respectively, may be arranged on the exterior surface 246, 226, 238, respectively, of each of the plurality of coaxially arranged telescoping needle segments 240. In still other embodiments, each of the first pulley 136, the second pulley 138, and the third pulley 140 may be arranged on the interior surface of each of the plurality of coaxially arranged telescoping needle segments 240, respectively. Along the first pulley 136, the second pulley 138, and the third pulley 140 is a cable 142. The articulation system 134 may include any number of pulleys and cables. The pulleys and cables may be arranged inside the inner lumen 166 or on the exterior of the variable length needle 220. [0064] In some embodiments, the articulation system 134 may include a lever 144 directly coupled to the cable 142. Alternatively, instead of a lever 144, the articulation system 134 uses a spindle nut 24 or other linear drive mechanism through which the cable 142 extends to pull up the slack of the cable 142. In embodiments, the drive 20 may operate the mechanical drive train 50 to operate the steering system 68, which in this embodiment includes the articulation system 134, to apply a force to at least one linear drive mechanism, e.g. the lever 144, to pull the cable 142 in the proximal direction 34 or to push the cable 142 in the distal direction 36. In these embodiments, the lever 144 may be coupled to the motor 116 or be available for manual operation by the user of the biopsy device 12. In embodiments, the lever 144 is coupled to the inner coaxial needle segment 280, such that the lever 144 causes articulation of at least the inner coaxial needle segment 280 along the second pivot axis 40.

[0065] In use, pulling the cable 142 in the proximal direction 34, results in the plurality of coaxially arranged telescoping needle segments 240, collectively, being pulled into an exemplary contracted configuration, for example, the configuration of the variable length needle 220 shown in FIG. 10, in which the plurality of coaxially arranged telescoping needle segments 240 are pivoted along the second pivot axis 40. Pushing the lever 144 in a distal direction 36 uncurls the plurality of coaxially arranged telescoping needle segments 240 from the contracted configuration to a straight configuration, such as, the configuration shown in FIG. 15. As will be appreciated by those skilled in the art, there are an infinite number of contracted configurations and one straight configuration in which each of the plurality of coaxially arranged telescoping needle segments 240 are coaxial with the longitudinal axis 46 of the variable length needle 220. Moreover, when the drive 20 applies force to pull the cable 142 in the proximal direction 34, at least one of the plurality of coaxially arranged telescoping needle segments 240 is moved along the second pivot axis 40. The articulation system 134 causes articulation of each of the plurality of coaxially arranged telescoping needle segments 240 along at least the second pivot axis 40.

[0066] In an embodiment, the articulation system 134 may include a second cable 146 arranged to couple with each of a fourth pulley 150, a fifth pulley 152, a sixth pulley 154 in order for each of the inner coaxial needle segment 280, the first intermediate coaxial needle segment 210, and the second intermediate coaxial needle segment 230 to articulate or pivot along the first pivot axis 38. The drive 20 may include a second lever 156 coupled to the second cable 146. The drive 20 may operate the articulation system 134 to apply a force to the second lever 156, to pull the second cable 146 in the proximal direction 34 to achieve at least one contracted configuration or to push the second cable 146 in the distal direction 36 to achieve the straight configuration, such as, the configuration shown in FIG. 1. The second lever 156 is coupled to the inner coaxial needle segment 280, such that the second lever 156 causes articulation of at least the inner coaxial needle segment 280 along the first pivot axis 38.

[0067] As depicted in FIG. 10, in an embodiment, the steering system 68 includes the articulation system 134 having the first cable 142 and the second cable 146, as previously described, such that the steering system 68 may apply a force to each of the first cable 142 and the second cable 146 in the proximal direction 34, such that the plurality of coaxially arranged telescoping needle segments 240 pivots along the second pivot axis 40 and the first pivot axis 38, respectively, resulting in a collective pivot angle 33 relative to the longitudinal axis 46.

[0068] In embodiments, the steering system 68 includes at least one lever, such as lever 144, coupled to each of the plurality of coaxially arranged telescoping needle segments 240, and the at least one lever independently articulates each of the plurality of coaxially arranged telescoping needle segments 240. In embodiments, the steering system 68 comprises a lever for each of the plurality of coaxially arranged telescoping needle segments 240, such that each of the plurality of coaxially arranged telescoping needle segments 240 is able to be articulated by operation of its respective lever.

[0069] In still other embodiments, as demonstrated in FIGS. 11 and 12, an illustrative biopsy device 612 having an illustrative variable length needle 620, which may be the same structurally as the variable length needle 220 described above, may include an activation spring 132 for a spring-powered, high velocity advancement into tissues with higher densities, such as, for example, bone. In these embodiments, the activation spring 132 replaces the motor 116, gear assembly 117 and spindle nut 24 of the drive 20 of the biopsy device 12, described above. The illustrative variable length needle 620 is slidably engaged with the activation spring 132 and is slidable within an interior of an illustrative outer housing 618 of the illustrative biopsy device 612. The activation spring 132 may bias the illustrative variable length needle 620 toward the distal direction 36. In an embodiment, a tensioning nut 118 is coupled to the activation spring 132. In an embodiment, rotating the tensioning nut 118 can adjust the tension on the activation spring 132 and can modify the amount of force required to compress the activation spring 132 and activate the illustrative biopsy device 612.

[0070] FIGS. 11 and 12 further demonstrate the illustrative biopsy device 612 in use penetrating a skin 402, a fat 404, a muscle 406, and a bone 408 via a single entry point 405. From a completely retraction position 470 through the single entry point 405, the illustrative variable length needle 620, which is equally representative of the variable length needle 220 of the biopsy device 12 previously discussed, may be positioned into a first position 410, a second position 420, a third position 430, a fourth position 440, a fifth position 450, and a sixth position 460. As shown in FIG. 11, the illustrative variable length needle 620 may pivot along a collective pivot axis 622, along the first pivot axis 38 to achieve the first position 410 and the second position 420 and any position in between. Furthermore, the illustrative variable length needle 620 may extend or retract to any position existing between the completely retraction position 470 and the fourth position 440, such as, for example, the third position 430. Furthermore, the illustrative variable length needle 620 may pivot to any position within a range along the collective pivot axis 622 in between the first position 410 and the second position 420. Likewise, the illustrative variable length needle 620 may pivot to any position between the fifth position 450 and the sixth position 460.

[0071] The structure of the illustrative biopsy device 612, such as, but not limited to, the combination of the steering system 68, the distal bore 314, and the enlarged portion 312, permits the illustrative variable length needle 620 to pivot from at least a first position 410 to at least a second position 420 along the first pivot axis 38 relative to the longitudinal axis 46, as shown in FIG. 11. The third position 430 is shown as a partially retracted configuration of the variable length needle 220 relative to the longitudinal axis 46 and the outer housing 18. In some embodiments, as demonstrated in the completely retraction position 470, the entirety of the illustrative variable length needle 620 may be retracted entirely into an interior of the illustrative outer housing 618. In FIG. 11, the fourth position 440 is shown as a fully extended configuration of the illustrative variable length needle 620 relative to the longitudinal axis 46 and the illustrative outer housing 618 to achieve a depth to reach the target site in the subject. As demonstrated in FIG. 12, the illustrative variable length needle 620 may pivot along the second pivot axis 40 relative to the longitudinal axis 46 to the fifth position 450 and the sixth position 460 and to any position therebetween.

[0072] FIG. 13 shows a flowchart 500 depicting an example method for advancing and steering a distal penetrating tip 188 of a biopsy device 12 to a target site 14 in a subject 16. At block 502, the biopsy device 12 is provided. The biopsy device 12 with an outer housing 18 defining an interior 22, a drive 20, and a variable length needle 220 coupled to the outer housing 18. The variable length needle 220 has a plurality of coaxially arranged telescoping needle segments 240 including an outer coaxial needle segment 260, an inner coaxial needle segment 280, and at least one intermediate coaxial needle segment 30 radially interposed between the outer coaxial needle segment 260 and the inner coaxial needle segment 280. The inner coaxial needle segment 280 has the distal penetrating tip 288. The drive 20 is operatively coupled to the inner coaxial needle segment 280. Each of the plurality of coaxially arranged telescoping needle segments 240 is pivotally and slidably coupled to at least one coaxial needle segment of the plurality of coaxially arranged telescoping needle segments 240.

[0073] In embodiments, at block 504, the method may include providing the biopsy device 12 with a steering system 68 including a articulation system 134, as described herein.

[0074] Additionally or alternatively, as demonstrated at block 506, the inner coaxial needle segment with a sample notch 282 and a first distal cutting edge 310 on the first distal end 311 of a first intermediate coaxial needle segment 210 arranged immediately proximal and adjacent to the inner coaxial needle segment 280 are provided.

[0075] At block 508, a controller circuit 54 is communicatively coupled to the drive 20. At block 510, an imaging system 60 is communicatively coupled to the controller circuit 54.

[0076] In selected additional or alternative embodiments, at block 512, an image, containing a visualization of the variable length needle 220 with respect to a target site 14 in a subject 16, is generated by the imaging system 60. In embodiments, at block 514, the controller circuit 54 determines a depth to reach the target site 14 in the subject 16.

[0077] At block 516, the controller circuit 54 controls the drive 20 to advance the distal penetrating tip 188 to the target site 14.

[0078] In embodiments, at block 518, the biopsy device 12 includes the outer coaxial needle segment 260 pivotally and slidably coupled to the outer housing 18. In selected embodiments, at block 520, a collective pivot angle 33 to position the outer coaxial needle segment 260 is selected. In embodiments, block 520 is performed by the controller circuit 54, and the drive 20 provides that the outer coaxial needle segment 260 achieves the collective pivot angle 33, which was selected by the controller circuit 54, by controlling the steering system 68.

[0079] In embodiments, at block 522, the distal penetrating tip 188 is steered to the target site 14 with the articulation system 134 to pivot at least one intermediate coaxial needle segment 30. In selected additional or alternative embodiments, as demonstrated at block 524, the inner coaxial needle segment 280 is retracted to cut a tissue protruding into the sample notch 282. The product of block 524 is the tissue specimen 294. In embodiments, at block 526, the tissue specimen 294 is deposited in a sample collection canister 44 located in the interior 22 of the outer housing 18 of the biopsy device 12.

[0080] It should now be understood that the disclosed apparatuses and systems include a biopsy device 12 that has a variable length needle 220 with a distal penetrating tip 188 that is Advanceable and steerable to a target site 14 within a subject 16. With the variable length needle 220, the operator of the apparatus may steer or the disclosed biopsy system 10 via controller circuit 54 may control the advancing and steering of the distal tip of the variable length needle 220 to avoid the chest wall or blood vessels by selectively linearly translating the variable length needle 220 along a longitudinal axis 46, selectively steering any or all of the plurality of coaxially arranged telescoping needle segments 240 along a first pivot axis 38, a second pivot axis 40, or both the first pivot axis 38 and the second pivot axis 40 relative to the longitudinal axis 46 of the biopsy device 12, and selectively rotating the variable length needle 220, including the sample notch 282, to produce a tissue specimen 294 from the target site 14.

[0081] ASPECTS LISTING.

[0082] Aspect 1. A biopsy device includes an outer housing defining an interior, a drive disposed within the interior, and a variable length needle coupled and/or couplable to the drive. The variable length needle extends distally from the outer housing. The variable length needle has a plurality of coaxially arranged telescoping needle segments including an outer coaxial needle segment, an inner coaxial needle segment, and at least one intermediate coaxial needle segment at least partially and or at least in one position radially interposed between the outer coaxial needle segment and the inner coaxial needle segment. The variable length needle extends distally from the outer housing with the outer coaxial needle segment extending distally from a distal face of the outer housing, at least one intermediate coaxial needle segment coupled to and extending distally from the outer coaxial needle segment, and the inner coaxial needle segment coupled to and extending distally from the at least one intermediate coaxial needle segment. The drive causes (is configured to cause) linear translation of the variable length needle such that each or at least one of the at least one intermediate coaxial needle segment and the inner coaxial needle segment is telescopically movable relative to the outer coaxial needle segment. Optionally, the at least one intermediate coaxial needle segment has a first intermediate coaxial needle segment radially adjacent to the inner coaxial needle segment having a distal cutting edge.

[0083] Aspect 2. The biopsy device according to Aspect 1, further includes a sample notch in the inner coaxial needle segment.

[0084] Aspect 3. The biopsy device according to Aspect 2, further includes a distal cutting edge on the at least one intermediate coaxial needle segment.

[0085] Aspect 4. The biopsy device according to any of Aspects 2 or 3, wherein the at least one intermediate coaxial needle segment includes a first intermediate coaxial needle segment and a second intermediate coaxial needle segment, and the device is configured such that sample notch of the inner coaxial needle segment is selectively covered or uncovered by the first intermediate coaxial needle segment.

[0086] Aspect 5. The biopsy device according to any of Aspects 1 to 4, further includes a joystick coupled with the drive to control the linear translation of the variable length needle.

[0087] Aspect 6. The biopsy device according to any of Aspects 1 to 5, wherein the outer coaxial needle segment has an enlarged portion pivotally coupled within a distal bore of the outer housing, the distal bore sized to retain the enlarged portion within the outer housing, the enlarged portion arranged within the outer housing to selectively pivot the variable length needle.

[0088] Aspect 7. The biopsy device according to any of Aspects 1 to 6, wherein the variable length needle is extendable to a working needle length of about 10 cm to about 20 cm from a distal face of the outer housing.

[0089] Aspect 8. The biopsy device according to any of Aspects 1 to 7, wherein the drive linearly translates the variable length needle from a single entry point into a subject to a target site in the subject.

[0090] Aspect 9. The biopsy device according to any of Aspects 1 to 5, wherein the outer housing comprises a ball joint coupled to the outer coaxial needle segment.

[0091] Aspect 10. The biopsy device according to any of Aspects 4 to 8, further includes a first ball joint coupling the inner coaxial needle segment to the first intermediate coaxial needle segment, a second ball joint coupling the first intermediate coaxial needle segment to the second intermediate coaxial needle segment, and a third ball joint coupling the second intermediate coaxial needle segment to the outer coaxial needle segment. Each of the first, second, and third ball joints provides a telescopic and pivotal coupling of the plurality of coaxially arranged telescoping needle segments, wherein the first ball joint provides for articulation of the inner coaxial needle segment, the second ball joint provides for articulation of the first intermediate coaxial needle segment, and the third ball joint provides for articulation of the second intermediate coaxial needle segment.

[0092] Aspect 11. The biopsy device according to Aspect 10, wherein the outer coaxial needle segment comprises a fourth ball joint configured to be coupled to the outer housing, the fourth ball joint provides for articulation of the outer coaxial needle segment relative to the outer housing. [0093] Aspect 12. The biopsy device according to any of claims 10 to 11, further includes a first lever coupled to the inner coaxial needle segment, and the first lever causes articulation of at least the inner coaxial needle segment along a first pivot axis. [0094] Aspect 13. The biopsy device according to Aspect 12, further includes a second lever coupled to the inner coaxial needle segment, wherein the second lever causes articulation of at least the inner coaxial needle segment along a second pivot axis.

[0095] Aspect 14. The biopsy device according to any of Aspects 10 to 11, further includes a pulley system having a cable coupled with each of the plurality of coaxially arranged telescoping needle segments. The pulley system causes articulation of each of the plurality of coaxially arranged telescoping needle segments.

[0096] Aspect 15. The biopsy device according to Aspect 14, further includes a lever coupled to the cable of the pulley system, the lever is coupled with the drive, wherein the device is configured such that the drive applies force to the lever to operate the pulley system to cause articulation of the variable length needle.

[0097] Aspect 16. The biopsy device according to any of Aspects 4 to 15, wherein the device is configured such that the drive retracts the inner coaxial needle segment relative to the first intermediate coaxial needle segment to achieve a selected sample notch length.

[0098] Aspect 17. The biopsy device according to any of Aspects 1 to 16, wherein the device is configured such that the drive linearly translates the variable length needle to a selected working length.

[0099] Aspect 18. A biopsy system includes a biopsy device, optionally the device of any of the preceding Aspects. The biopsy device includes an outer housing defining an interior, a drive located within the interior, and a variable length needle coupled to the drive. The variable length needle extends distally from the outer housing. The variable length needle has a plurality of coaxially arranged telescoping needle segments. The plurality of coaxially arranged telescoping needle segments includes an outer coaxial needle segment, an inner coaxial needle segment having a distal penetrating tip, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment. The variable length needle extends distally from the outer housing with the outer coaxial needle segment extending distally from a distal face of the outer housing, at least one intermediate coaxial needle segment coupled to and extending distally from the outer coaxial needle segment, and the inner coaxial needle segment coupled to and extending distally from the at least one intermediate coaxial needle segment. The drive may be drivably coupled to the inner coaxial needle segment. The biopsy system further includes an imaging system configured to generate an image containing a visualization of the variable length needle with respect to a target site in a subject, and a controller circuit communicatively coupled and/or couplable with the drive and the imaging system. The drive effectuates linear translation of the variable length needle such that each of the at least one intermediate coaxial needle segment and the inner coaxial needle segment is telescopically movable relative to the outer coaxial needle segment. The controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site in the subject.

[0100] Aspect 19. The biopsy system according to Aspect 18, the at least one intermediate coaxial needle segment includes a first intermediate coaxial needle segment and a second intermediate coaxial needle segment. The first intermediate coaxial needle segment is arranged to be radially adjacent to the inner coaxial needle segment. The second intermediate coaxial needle segment is arranged to be radially adjacent to the first intermediate coaxial needle segment and the outer coaxial needle segment. The inner coaxial needle segment has a sample notch, and the sample notch of the inner coaxial needle segment is selectively covered or uncovered by a first intermediate coaxial needle segment.

[0101] Aspect 20. The biopsy system according to Aspect 19, wherein the first intermediate coaxial needle segment has a distal cutting edge.

[0102] Aspect 21. The biopsy system according to any of Aspects 18 to 20, wherein the controller circuit is configured to identify the target site within the image, the controller circuit is configured to control the drive to automatically advance the variable length needle to the target site.

[0103] Aspect 22. The biopsy system according to any of Aspects 18 to 21, wherein the controller circuit is configured to estimate a working length of the variable length needle to reach the target site, and the controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site.

[0104] Aspect 23. The biopsy system according to any of Aspects 18 to 22, wherein the device is configured such that the drive linearly translates each of the at least one intermediate coaxial needle segment and the inner coaxial needle segment with respect to the outer coaxial needle segment.

[0105] Aspect 24. The biopsy system according to any of Aspects 18 to 23, wherein the imaging system is configured to provide real time image data to the controller circuit, the controller circuit is configured to process the real time image data to control the drive to linearly translate the inner coaxial needle segment to the target site.

[0106] Aspect 25. The biopsy system according to Aspect 19, wherein the imaging system is configured to provide real time image data to the controller circuit, the controller circuit is configured to process the real time image data to control the drive to linearly translate the inner coaxial needle segment to the target site, the controller circuit is configured to process the real time image data to control the drive to linearly translate the first intermediate coaxial needle segment with respect to the sample notch of the inner coaxial needle segment to control a sample notch length.

[0107] Aspect 26. The biopsy system according to any of Aspects 18 to 23, wherein the imaging system is configured to provide on demand image data to the controller circuit, the controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site via the on demand image data.

[0108] Aspect 27. The biopsy system according to Aspect 19, wherein the imaging system is configured to provide on demand image data to the controller circuit, the controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site via the on demand image data, the controller circuit is configured to process the on demand image data to control the drive to linearly translate the first intermediate coaxial needle segment with respect to the sample notch of the inner coaxial needle segment to control a sample notch length.

[0109] Aspect 28. A method is provided for advancing and steering a distal penetrating tip of a biopsy device to a target site (in a subject), optionally the biopsy device of any of the preceding Aspects. The method includes providing a biopsy device. The biopsy device includes an outer housing, a drive located within the outer housing, and a variable length needle configured to be coupled to the outer housing. The variable length needle configured to extend distally from the outer housing. The variable length needle has a plurality of coaxially arranged telescoping needle segments including an outer coaxial needle segment, an inner coaxial needle segment, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment. The inner coaxial needle segment includes the distal penetrating tip. The drive may be operatively coupled to the inner coaxial needle segment. Each of the plurality of coaxially arranged telescoping needle segments is pivotally and slidably coupled to at least one coaxial needle segment of the plurality of coaxially arranged telescoping needle segments. A controller circuit communicatively coupling with the drive. An imaging system may be communicatively coupled to the controller circuit. The method further includes generating an image containing a visualization of the variable length needle with respect to a target site in a subject, determining a depth to reach the target site in the subject, and controlling the drive to advance the distal penetrating tip to the target site. [0110] Aspect 29. The method according to Aspect 28, further including providing the biopsy device with a steering system including an articulation system. The method includes providing the biopsy device includes the outer coaxial needle segment pivotally and slidably coupled to the outer housing. The method includes selecting a pivot angle to position the outer coaxial needle segment and steering the distal penetrating tip to the target site with the pulley system to pivot at least one intermediate coaxial needle segment.

[0111] Aspect 30. The method according to any of Aspects 28 to 30, further including providing the inner coaxial needle segment with a sample notch and a distal cutting edge on the distal end of a first intermediate coaxial needle segment arranged immediately proximal and adjacent to the inner coaxial needle segment, and retracting the inner coaxial needle segment to cut a tissue protruding into a sample notch.

[0112] While embodiments of the present disclosure have been described with respect to at least one embodiment, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which the present disclosure pertains and which fall within the limits of the appended claims.

Claims

1. A biopsy device, comprising: an outer housing defining an interior; a drive disposed within the interior; and a variable length needle configured to be coupled to the drive, the variable length needle extending distally from the outer housing, the variable length needle having a plurality of coaxially arranged telescoping needle segments including an outer coaxial needle segment, an inner coaxial needle segment, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment, wherein the drive causes linear translation of the variable length needle such that each of the at least one intermediate coaxial needle segment and the inner coaxial needle segment is telescopically movable relative to the outer coaxial needle segment.

2. The biopsy device according to claim 1, further comprising a sample notch in the inner coaxial needle segment.

3. The biopsy device according to claim 2, further comprising a distal cutting edge on the at least one intermediate coaxial needle segment.

4. The biopsy device according to any of claims 2 to 3, wherein the at least one intermediate coaxial needle segment comprises a first intermediate coaxial needle segment and a second intermediate coaxial needle segment, the sample notch of the inner coaxial needle segment is selectively covered or uncovered by the first intermediate coaxial needle segment.

5. The biopsy device according to any of claims 1 to 4, further comprising a joystick coupled with the drive to control the linear translation of the variable length needle.

6. The biopsy device according to any of claims 1 to 5, wherein the outer coaxial needle segment has an enlarged portion pivotally coupled within a distal bore of the outer housing, the distal bore sized to retain the enlarged portion within the outer housing, the enlarged portion arranged within the outer housing to selectively pivot the variable length needle.

7. The biopsy device according to any of claims 1 to 6, wherein the variable length needle is extendable from 10 cm to 20 cm from a distal face of the outer housing.

8. The biopsy device according to any of claims 1 to 7, wherein the drive linearly translates the variable length needle from a single entry point into a subject to a target site in the subject.

9. The biopsy device according to any of claims 1 to 5, wherein the outer housing comprises a ball joint coupled to the outer coaxial needle segment.

10. The biopsy device according to any of claims 4 to 8, further comprising: a first ball joint coupling the inner coaxial needle segment to the first intermediate coaxial needle segment; a second ball joint coupling the first intermediate coaxial needle segment to the second intermediate coaxial needle segment; and a third ball joint coupling the second intermediate coaxial needle segment to the outer coaxial needle segment, wherein each of the first, second, and third ball joints provides a telescopic and pivotal coupling of the plurality of coaxially arranged telescoping needle segments, wherein the first ball joint provides for articulation of the inner coaxial needle segment, the second ball joint provides for articulation of the first intermediate coaxial needle segment, and the third ball joint provides for articulation of the second intermediate coaxial needle segment.

11. The biopsy device according to claim 10, wherein the outer coaxial needle segment comprises a fourth ball joint configured to be coupled to the outer housing, the fourth ball joint provides for articulation of the outer coaxial needle segment relative to the outer housing.

12. The biopsy device according to any of claims 10 to 11, further comprising a first lever coupled to the inner coaxial needle segment, wherein the first lever causes articulation of at least the inner coaxial needle segment along a first pivot axis.

13. The biopsy device according to claim 12, further comprising a second lever coupled to the inner coaxial needle segment, wherein the second lever causes articulation of at least the inner coaxial needle segment along a second pivot axis.

14. The biopsy device according to any of claims 10 to 11, further comprising an articulation system having a cable coupled with each of the plurality of coaxially arranged telescoping needle segments, wherein the articulation system causes articulation of each of the plurality of coaxially arranged telescoping needle segments.

15. The biopsy device according to claim 14, further comprising a lever coupled to the cable of the articulation system, the lever is coupled with the drive, wherein the drive applies force to the lever to operate the articulation system to cause articulation of the variable length needle.

16. The biopsy device according to any of claims 4 to 15, wherein the drive retracts the inner coaxial needle segment relative to the first intermediate coaxial needle segment to achieve a selected sample notch length.

17. The biopsy device according to any of claims 1 to 16, wherein the drive linearly translates the variable length needle to a selected working length.

18. A biopsy system comprising: a biopsy device, comprising: an outer housing defining an interior, a drive located within the interior, and a variable length needle couplable to the drive, the variable length needle extending distally from the outer housing, the variable length needle having a plurality of coaxially arranged telescoping needle segments including an outer coaxial needle segment, an inner coaxial needle segment having a distal penetrating tip, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment, the drive drivably coupable to the inner coaxial needle segment; an imaging system configured to generate an image containing a visualization of the variable length needle with respect to a target site in a subject; and a controller circuit communicatively coupled with the drive and the imaging system, wherein the drive effectuates linear translation of the variable length needle such that each of the at least one intermediate coaxial needle segment and the inner coaxial needle segment is telescopically movable relative to the outer coaxial needle segment, the controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site in the subject.

19. The biopsy system of claim 18, wherein the at least one intermediate coaxial needle segment comprises a first intermediate coaxial needle segment and a second intermediate coaxial needle segment, the first intermediate coaxial needle segment arranged to be radially adjacent to the inner coaxial needle segment, the second intermediate coaxial needle segment arranged to be radially adjacent to the first intermediate coaxial needle segment and the outer coaxial needle segment, the inner coaxial needle segment has a sample notch, the sample notch of the inner coaxial needle segment is selectively covered or uncovered by the first intermediate coaxial needle segment.

20. The biopsy system of claim 19, wherein the first intermediate coaxial needle segment has a distal cutting edge.

21. The biopsy system of any of claims 18 to 20, wherein the controller circuit is configured to identify the target site within the image, the controller circuit is configured to control the drive to automatically advance the variable length needle to the target site.

22. The biopsy system of any of claims 18 to 21, wherein the controller circuit is configured to estimate a working length of the variable length needle to reach the target site, the controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site.

23. The biopsy system of any of claims 18 to 22, wherein the drive linearly translates each of the at least one intermediate coaxial needle segment and the inner coaxial needle segment with respect to the outer coaxial needle segment.

24. The biopsy system of any of claims 18 to 23, wherein the imaging system is configured to provide real time image data to the controller circuit, the controller circuit is configured to process the real time image data to control the drive to linearly translate the inner coaxial needle segment to the target site.

25. The biopsy system of claim 19, wherein the imaging system is configured to provide real time image data to the controller circuit, the controller circuit is configured to process the real time image data to control the drive to linearly translate the inner coaxial needle segment to the target site, the controller circuit is configured to process the real time image data to control the drive to linearly translate the first intermediate coaxial needle segment with respect to the sample notch of the inner coaxial needle segment to control a sample notch length.

26. The biopsy system of any of claims 18 to 23, wherein the imaging system is configured to provide on demand image data to the controller circuit, the controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site via the on demand image data.

27. The biopsy system of claim 19, wherein the imaging system is configured to provide on demand image data to the controller circuit, the controller circuit is configured to control the drive to linearly translate the inner coaxial needle segment to the target site via the on demand image data, the controller circuit is configured to process the on demand image data to control the drive to linearly translate the first intermediate coaxial needle segment with respect to the sample notch of the inner coaxial needle segment to control a sample notch length.

28. A method for advancing and steering a distal penetrating tip of a biopsy device to a target site in a subject, the method comprising: providing a biopsy device, comprising: an outer housing, a drive located within the outer housing, and a variable length needle configured to be coupled to the outer housing, the variable length needle configured to extend distally from the outer housing, the variable length needle having a plurality of coaxially arranged telescoping needle segments including an outer coaxial needle segment, an inner coaxial needle segment, and at least one intermediate coaxial needle segment radially interposed between the outer coaxial needle segment and the inner coaxial needle segment, the inner coaxial needle segment having the distal penetrating tip, the drive configured to be operatively coupled to the inner coaxial needle segment, each of the plurality of coaxially arranged telescoping needle segments is pivotally and slidably coupled to at least one coaxial needle segment of the plurality of coaxially arranged telescoping needle segments; communicatively coupling a controller circuit with the drive; communicatively coupling an imaging system to the controller circuit; generating an image containing a visualization of the variable length needle with respect to a target site in a subject; determining a depth to reach the target site in the subject; and controlling the drive to advance the distal penetrating tip to the target site.

29. The method of claim 28, further comprising: providing the biopsy device with a steering system including an articulation system; providing the biopsy device includes the outer coaxial needle segment pivotally and slidably coupled to the outer housing; selecting a pivot angle to position the outer coaxial needle segment; and steering the distal penetrating tip to the target site with the articulation system to pivot at least one intermediate coaxial needle segment.

30. The method of any of claims 28 to 29, further comprising: providing the inner coaxial needle segment with a sample notch and a distal cutting edge on the distal end of a first intermediate coaxial needle segment arranged immediately proximal and adjacent to the inner coaxial needle segment; and retracting the inner coaxial needle segment to cut a tissue protruding into a sample notch.