Reusable biopsy system and method

Abstract

A biopsy system comprising a syringe system with a needle supported by a needle hub and a syringe barrel having a vent, along with a plunger slidably engaged with the syringe barrel. The plunger can be moved between a distal position, a first proximal position, and a second proximal position. The plunger being distal of the vent in one or both of the distal position or first proximal position. Additionally, a handle is included with a rotation mechanism that can rotate the needle about its longitudinal axis. This system allows for precise and controlled biopsy procedures, offering improved maneuverability and accuracy during tissue sampling.

Description

REUSABLE BIOPSY SYSTEM AND METHODPRIORITY

[0001] This application claims the benefit of priority to International Patent Application No. PCT / CN2024 / 089771, filed April 25, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Conventional biopsy systems typically consist of a syringe system for extracting tissue samples and a handle for controlling the syringe system during the biopsy procedure. The syringe system typically includes a needle supported by a needle hub, a syringe barrel for housing the needle, and a plunger for controlling the movement of fluids within the syringe barrel. The plunger is manually operated to create a vacuum within the syringe barrel for extracting tissue samples through the needle. However, existing syringe systems may lack efficient mechanisms for controlling the movement of the plunger and the orientation of the needle during the biopsy procedure, leading to potential inaccuracies and inefficiencies in tissue sample collection.

[0003] In some systems, the plunger movement is controlled solely by manual manipulation, which can result in inconsistent vacuum generation and sample extraction. Additionally, the orientation of the needle during tissue penetration and sample collection is often fixed, limiting the flexibility and precision of the biopsy procedure. While some systems may incorporate limited rotational capabilities for the needle, these mechanisms are often cumbersome to operate and may not provide the desired range of motion for optimal tissue sampling.

[0004] Furthermore, existing biopsy systems may lack integrated features that allow for simultaneous control of both the plunger movement and the needle orientation, leading to challenges in coordinating these essential functions during a biopsy procedure. The need for improved biopsy systems with enhanced control mechanisms for precise tissue sample extraction and needle manipulation has become increasingly apparent in the medical field.

[0005] Disclosed herein are biopsy systems and associated methods thereof directed to address the foregoing.SUMMARY

[0006] In some aspects, the techniques described herein relate to a biopsy system including, a syringe system including, a needle extending along a longitudinal axis and defining a needle lumen and supported by a needle hub, a syringe barrel having a vent disposed in a side wall thereof, and a plunger slidably engaged with the syringe barrel between a distal position, a first proximal position and a second proximal position, wherein the plunger in the distal position or the first proximal position is distal of the vent, and a handle including, a vacuum loading button coupled with the plunger and configured to move the plunger between the distal position, the first proximal position and the second proximal position, and a rotation assembly configured to rotate the needle about the longitudinal axis.

[0007] In some aspects, the techniques described herein relate to a biopsy system, wherein the handle further includes a handle shaft coupled to the vacuum loading button, a distal end of the handle shaft coupled to a proximal end of the plunger.

[0008] In some aspects, the techniques described herein relate to a biopsy system, wherein the rotation assembly further includes a motor coupled to the handle shaft that is slidable engaged with a barrel socket, the barrel socket coupled with a proximal end of the syringe barrel.

[0009] In some aspects, the techniques described herein relate to a biopsy system, wherein the handle shaft includes a groove extending longitudinally and slidably engages a tab of the barrel socket and configured to prevent rotation of the handle shaft relative to the barrel socket.

[0010] In some aspects, the techniques described herein relate to a biopsy system, wherein the proximal end of the syringe barrel includes a plug configured to slidably engage a socket recess of the barrel socket and prevent rotation of the syringe barrel relative to the barrel socket when engaged therewith.

[0011] In some aspects, the techniques described herein relate to a biopsy system, wherein one or more of the handle shaft, the barrel socket, and the syringe barrel are rotatable about the longitudinal axis relative to the handle.

[0012] In some aspects, the techniques described herein relate to a biopsy system, wherein the distal end of the handle shaft includes a flange extending annularly, and theproximal end of the plunger includes a cradle configured to engage the flange along an axis extending perpendicular to the longitudinal axis.

[0013] In some aspects, the techniques described herein relate to a biopsy system, further including a cover slidably engaged with the syringe barrel, a proximal end of the cover configured to engage the handle and secure the cover thereto, a distal end of the cover configured to abut against a portion of the syringe barrel to prevent longitudinal movement of the syringe barrel relative to the handle when the cover is engaged with the handle.

[0014] In some aspects, the techniques described herein relate to a biopsy system, further including a biasing member configured to bias the vacuum loading button from the distal position to one or both of the first proximal position and the second proximal position.

[0015] In some aspects, the techniques described herein relate to a biopsy system, wherein the vacuum loading button further includes a pawl slidably engaged therewith between an extended position and a retracted position, and configured to abut against a first abutment surface of a body of the handle to retain the vacuum loading button and the plunger, coupled thereto, in the distal position.

[0016] In some aspects, the techniques described herein relate to a biopsy system, further including a second abutment surface disposed on the body of the handle, the pawl configured to engage the second abutment surface to retain the vacuum loading button and the plunger in the first proximal position.

[0017] In some aspects, the techniques described herein relate to a biopsy system, further including a first button slidably engaged with the body and aligned with the first abutment surface, and wherein actuating the first button slides the pawl from the extended position to the retracted position to disengage the first abutment surface.

[0018] In some aspects, the techniques described herein relate to a biopsy system, further including a second button slidably engaged with the body and aligned with the second abutment surface, and wherein actuating the second button slides the pawl from the extended position to the retracted position to disengage the second abutment surface.

[0019] In some aspects, the techniques described herein relate to a biopsy system, further including a rotation button configured, when actuated, to close a circuit between the motor and a power source to actuate the motor.

[0020] In some aspects, the techniques described herein relate to a biopsy system, wherein the motor is an electric motor and the power source is a rechargeable battery.

[0021] In some aspects, the techniques described herein relate to a method of use for a biopsy device having a handle that is reusable and a syringe system that is disposable including, actuating a vacuum loading button on the handle to urge a plunger of the syringe system to a distal position, actuating a first retraction button to urge the plunger to a first proximal position and creating a vacuum within a syringe barrel of the syringe system, actuating a rotation button to rotate a needle of the syringe system about a longitudinal axis, and actuating a second retraction button to urge the plunger to a second proximal position such that a plunger head is proximal of a vent aperture disposed in a side wall of the syringe barrel and releasing the vacuum from the syringe barrel.

[0022] In some aspects, the techniques described herein relate to a method, wherein actuating the vacuum loading button to urge the plunger to the distal position further includes deflecting a biasing member that biases the vacuum loading button to the second proximal position and engaging a pawl of the vacuum loading button with a first abutment surface of a body of the handle to retain the vacuum loading button, and the plunger coupled thereto, in the distal position.

[0023] In some aspects, the techniques described herein relate to a method, wherein actuating the first retraction button disengages the pawl from the first abutment surface of the body to allow the biasing member to retract the vacuum loading button and the plunger to the first proximal position.

[0024] In some aspects, the techniques described herein relate to a method, wherein actuating the rotation button causes a motor to rotate a handle shaft to rotate a barrel socket, to rotate the syringe barrel of the syringe system, to rotate the needle.

[0025] In some aspects, the techniques described herein relate to a method, wherein actuating the second retraction button disengages the pawl from a second abutment surface ofthe body to allow the biasing member to retract the vacuum loading button and the plunger to the second proximal position.

[0026] In some aspects, the techniques described herein relate to a method, wherein actuating the first retraction button further includes changing a status indicator from a distal position to a first proximal position, and wherein actuating the second retraction button further includes changing the status indicator from the first proximal position to the second proximal position.

[0027] In some aspects, the techniques described herein relate to a method of coupling a syringe system to a handle, the syringe system including a needle extending along a longitudinal axis, the method including, actuating a vacuum loading button to a distal position to extend a distal end a handle shaft distally of a distal end of a body of the handle, engaging a proximal end of a plunger of the syringe system with the distal end of the handle shaft, sliding a syringe barrel of the syringe system proximally relative to the plunger to engage a proximal end of the syringe barrel with a barrel socket of the handle, and sliding a cover over the syringe barrel to engage a proximal end of the cover with the body, a distal end of the cover abutting against a portion of the syringe barrel to retain the syringe barrel in the barrel socket.

[0028] In some aspects, the techniques described herein relate to a method, wherein engaging the plunger with the handle shaft further includes engaging a flange of the handle shaft with a cradle along an axis extending perpendicular to the longitudinal axis.BRIEF DESCRIPTION OF DRAWINGS

[0029] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0030] FIG. 1A shows a perspective view of a biopsy system having a disposable syringe system and a reusable handle, in accordance with embodiments disclosed herein.

[0031] FIG. IB shows a plan view of the biopsy system of FIG. 1 A, in accordance with embodiments disclosed herein.

[0032] FIG. 1C shows an exploded, side view of the biopsy system of FIG. 1A, in accordance with embodiments disclosed herein.

[0033] FIG. 2A shows an exploded perspective view of the syringe system of the biopsy system, in accordance with embodiments disclosed herein.

[0034] FIG. 2B shows a side view of a syringe barrel of the syringe system of FIG. 2A, in accordance with embodiments disclosed herein.

[0035] FIG. 2C shows a proximal end view of a syringe barrel of the syringe system, in accordance with embodiments disclosed herein.

[0036] FIG. 2D shows a side view of a plunger of the syringe system of FIG. 2A, in accordance with embodiments disclosed herein.

[0037] FIG. 2E shows a proximal end view of a plunger of the syringe system, in accordance with embodiments disclosed herein.

[0038] FIG. 3 A shows a perspective view of a handle of a biopsy system, in accordance with embodiments disclosed herein.

[0039] FIG. 3B shows a longitudinal cross-section view of a biopsy system, in accordance with embodiments disclosed herein.

[0040] FIGS. 4A-4D show a method of coupling a syringe system to a handle, in accordance with embodiments disclosed herein.

[0041] FIG. 4E shows a perspective view of close-up detail of a distal end of the handle, in accordance with embodiments disclosed herein.

[0042] FIG. 4F shows a distal end view of the handle, in accordance with embodiments disclosed herein.

[0043] FIG. 5 A shows a longitudinal cross-section view of the biopsy system in a distal position, in accordance with embodiments disclosed herein.

[0044] FIG. 5B shows close up detail of a vacuum “on” button with the biopsy system in a distal position, in accordance with embodiments disclosed herein.

[0045] FIG. 5C shows a longitudinal cross-section view of the biopsy system in a first proximal position, in accordance with embodiments disclosed herein.

[0046] FIG. 5D shows close up detail of a vacuum “off’ button with the biopsy system in a first proximal position, in accordance with embodiments disclosed herein.

[0047] FIG. 5E shows close up detail of a vacuum “off’ button with the biopsy system in a second proximal position, in accordance with embodiments disclosed herein.

[0048] FIG. 5F shows close-up detail of the syringe system with the plunger in the first proximal position, in accordance with embodiments disclosed herein.

[0049] FIG. 5G shows close-up detail of the syringe system with the plunger in the second proximal position, in accordance with embodiments disclosed herein.

[0050] FIG. 6A shows an exploded view of a syringe system rotation assembly of a biopsy system, in accordance with embodiments disclosed herein.

[0051] FIG. 6B shows a perspective view of a syringe system rotation assembly of a biopsy system, in accordance with embodiments disclosed herein.

[0052] FIGS. 7A-7I show an exemplary method of use for a biopsy system, in accordance with embodiments disclosed herein.DESCRIPTION

[0053] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0054] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally usedto distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “right,” “left,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”

[0055] In the following description, the terms “or” and “and / or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and / or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

[0056] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a needle or system disclosed herein includes a portion of the needle or system intended to be near or relatively nearer to a clinician when the needle or system is used on a patient. Likewise, a “proximal length” of, for example, the needle or system includes a length of the needle or system intended to be near or relatively nearer to the clinician when the needle or system is used on the patient. A “proximal end” of, for example, the needle or system includes an end of the needle or system intended to be near or relatively nearer to the clinician when the needle or system is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the needle or system can include the proximal end of the needle or system; however, the proximal portion, the proximal end portion, or the proximal length of the needle or system need not include the proximal end of the needle or system. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the needle or system is not necessarily a terminal portion or terminal length of the needle or system.

[0057] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a needle or system disclosed herein includes a portion of the needle or system intended to be near or relatively nearer to a patient when the needle or system is used on apatient. Likewise, a “distal length” of, for example, the needle or system includes a length of the needle or system intended to be near or relatively nearer to the patient when the needle or system is used on the patient. A “distal end” of, for example, the needle or system includes an end of the needle or system intended to be near or relatively nearer to the patient when the needle or system is used on the patient. The distal portion, the distal end portion, or the distal length of the needle or system can include the distal end of the needle or system; however, the distal portion, the distal end portion, or the distal length of the needle or system need not include the distal end of the needle or system. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the needle or system is not necessarily a terminal portion or terminal length of the needle or system.

[0058] To assist in the description of embodiments described herein, as shown in FIG. 1A, a longitudinal axis extends parallel to an axial length of the needle, a lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal axis and lateral axis.

[0059] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0060] FIGS. 1A-1C show details of a biopsy system 100, generally including a disposable syringe system (“syringe system”) 110 and a reusable handle (“handle”) 200. FIG. 1A shows a perspective view of the biopsy system 100. FIG. IB shows a plan view of the biopsy system 100. FIG. 1C shows an exploded view of the biopsy system 100. Advantageously, the syringe system 110 can be easily detached from the handle 200 after use and discarded. The handle 200 can be cleaned, sterilized and recharged ready for reuse. The system 100 minimizes disposable components reducing the amount of medical waste and minimizing associated costs. Further, the system 100 provides a standardized vacuum application and an easy, one-handed operation for simultaneous vacuum application and needle rotation, leaving the technicians alternate hand free for insertion site stabilization and / or imaging the target location.

[0061] FIG. 2 A shows an exploded view of the syringe system 110 of the biopsy system 100 of FIG. 1 A. In an embodiment, the syringe system 110 generally includes a biopsy needle 112, a syringe barrel 120, a plunger 130, and a cover 140. The biopsy needle 112 defines a needle lumen 114 communicating with an opening at a sharpened distal tip 116. A proximalend of the biopsy needle 112 is supported by a needle hub 118. The needle hub 118 is configured to engage a distal end of the syringe barrel 120 and provide fluid communication between the syringe barrel 120 and the needle lumen 114. The needle hub 118 can engage the syringe barrel 120 using a luer lock, twist lock, bayonet attachment, threaded attachment, interference fit engagement, press fit engagement, snap fit engagement, combinations thereof, or the like.

[0062] The syringe barrel 120 defines a cavity 122 having a cylindrical shape and defining a circular cross-sectional shape. It will be appreciated, however, that other cross- sectional shapes are also contemplated. In an embodiment, the syringe barrel 120 further includes a syringe coupling 124 disposed at a distal end and configured to engage the needle hub 118 and provide fluid communication between the cavity 122 and the needle hub 118 and needle lumen 114. The coupling can be configured to engage the hub 118 using a luer lock, twist lock, bayonet attachment, threaded attachment, interference fit engagement, press fit engagement, snap fit engagement, combinations thereof, or the like.

[0063] A proximal end of the syringe barrel includes a plug 126 defining a hexagonal cross-sectional shape and defining an outer diameter greater than an outer diameter of the syringe barrel 120. As will be appreciated, the plug 126 can define different faceted cross- sectional shapes including triangular, square, rectangular, pentagonal, octagonal, or the like without departing from the spirit of the invention. In an embodiment, the syringe barrel 120 further includes a vent 128, such as a vacuum release aperture, disposed in a side wall of the syringe barrel 120 and provides fluid communication between the cavity 122 and the surrounding environment.

[0064] In an embodiment, the plunger 130 is configured to slidably engage the cavity 122 of the syringe barrel 120. The plunger 130 includes a stem 132 extending longitudinally and includes a plunger head 134 at a distal end. The plunger head 134, or at least a portion thereof, can be formed of a flexible material and configured to form an airtight and / or fluid tight seal with the inner wall of the cavity 122. Exemplary materials included in the plunger head 134 include rubber, silicone rubber, polymer, elastomer, combinations thereof, or the like. As such, as the plunger head 134 is retracted proximally, the plunger head 134 can form a vacuum within a distal portion of the cavity 122.

[0065] A proximal end of the plunger 130 includes a plunger coupling 136 configured to engage the handle 200. In an embodiment, the plunger coupling 136 includes a cam lock engagement, however, it will be appreciated that this is not intended to be limiting and other engagements are contemplated such as press-fit, snap-fit, interference fit, threaded engagements, combinations thereof, or the like.

[0066] In an embodiment, a cover 140 is provided to receive a portion of one or more of the needle 112, needle hub 118, syringe barrel 120, and plunger 130. The cover 140 defines a cover lumen 142 extending longitudinally that defines an inner diameter that is equal to or greater than an outer diameter of the syringe barrel 120. In an embodiment, the inner diameter of the cover lumen 142 is greater than an outer diameter of the plug 126. As such, as shown in FIGS. 1 A-1B a portion of one or more of the needle 112, needle hub 118, syringe barrel 120, and plunger 130 can extend through the cover lumen 142 and extend distally of a distal end of the cover 140. In an embodiment, a proximal end of the cover 140 engages the handle 200 to secure the cover 140 thereto. The cover 140 can engage the handle 200 using one of a press- fit engagement, snap-fit engagement, interference fit engagement, threaded engagement, bayonet fit engagement, latches, clips, combinations thereof, or the like.

[0067] FIG. 2B shows a side view of the syringe barrel 120 showing the syringe coupling 124 disposed distally, the vent 128 disposed in a side wall, and the plug 126 disposed proximally. FIG. 2C shows a proximal end view of the syringe barrel 120 showing a hexagonal cross-sectional shape to the plug 126. As shown, the outer diameter of the plug 126 is greater than the outer diameter of the syringe barrel 120.

[0068] FIG. 2D shows a side view of the plunger 130 including the plunger stem 132, the plunger head 134 and the plunger coupling 136. FIG. 2E shows a proximal end view of the plunger 130. As shown, the plunger head 134 defines a conical distal end configured to match a funnel shaped distal end of the cavity 122 of the syringe barrel 120. As such, when the plunger 130 is disposed distally within the cavity 122, the distal surface of the plunger head 134 engages the distal surface of the cavity 122. As shown, the plunger coupling 136 includes a cam lock engagement having a semi-circular cradle 138 configured to receive and engage a circular flange 246 of the handle 200 along an axis extending perpendicular to the longitudinal axis. The cradle 138 can engage the flange 246 in an interference fit, snap-fit or press-fit engagement to secure the flange 246 therein. As such, the plunger coupling 136 can secure the plunger 130 to the flange 246 and prevent any longitudinal movement therebetween. Further,the plunger 130 can disengage the flange 246 by moving the plunger along an axis perpendicular to the longitudinal axis, e.g., lateral, transverse, or along an axis at an angle therebetween. Further, the cover 140, when engaged with the handle 200 can mitigate lateral or transverse movement of the plunger 130 to prevent accidental disengagement of the plunger 130 from the handle 200, as described in more detail herein.

[0069] FIG. 3A shows a perspective view of the handle 200. FIG. 3B shows a longitudinal cross-section view of the biopsy system 100. The handle 200 has a body 202 extending longitudinally between a proximal end and a distal end. The handle 200 generally includes one or more control buttons 220 disposed on a side of the body 202, a vacuum loading button 230 disposed at a proximal end, a status indicator 204 disposed on a side of the body 202 and a barrel socket 210 disposed at a distal end of the body 202. In an embodiment, the one or more control buttons 220 includes a rotation button 222, a vacuum “on” button 224, and a vacuum “off’ button 226. In an embodiment, actuating the rotation button 222 actuates an electric motor 240 disposed within the body 202 to rotate the barrel socket 210 and rotate the syringe system 110 coupled thereto.

[0070] In an embodiment, actuating the vacuum “on” button 224 releases a biasing member 242, e.g., a compression spring or the like, to retract the plunger 130 from a distal position, where the plunger head 134 is in contact with a distal end of the cavity 122, to a first proximal position to generate a vacuum within the syringe barrel 120. The plunger head 134 in the first proximal position is disposed distally of the vent 128. In an embodiment, actuating the vacuum “off” button 226 releases the biasing member 242 to retract the plunger 130 from the first proximal position, where the plunger head 134 is distal of the vent 128, to a second proximal position, proximal of the vent 128 to release the vacuum from within the syringe barrel 120. The plunger head 134 in the second proximal position is proximal of the first proximal position.

[0071] In an embodiment, the vacuum loading button 230 is slidably engaged with the body 202 along a longitudinal axis. Actuating the vacuum loading button 230 from a proximal position to a distal position urges the plunger 130 distally from a proximal position (i.e., one of the first proximal position or the second proximal position) to the distal position. In an embodiment, the status indicator 204 provides a visual indication of the relative position of the plunger 130, i.e., positioned in one of the distal position, first proximal position, or the second proximal position.

[0072] FIG. 3B shows a longitudinal cross-section view of the system 100 including the syringe system 110 coupled with the handle 200. The vacuum loading button 230 is slidably engaged with the body 202 and is biased towards the second proximal position, as shown in FIG. 3B, by the biasing member 242 such as a compression spring or the like. An electric motor 240 is housed in a distal portion of the vacuum loading button 230 and is functionally coupled with a barrel socket 210. The handle 200 further includes a power source, such as a rechargeable or replaceable battery, mains adaptor or similar suitable power source. Actuating the rotation button 222 closes a circuit which activates the electric motor 240 and rotates the barrel socket 210. This in turn rotates the syringe system 110 which is coupled to the barrel socket 210, as described in more detail herein.

[0073] The handle 200 includes a handle shaft 244 extending longitudinally and is slidably engaged with the body 202 along a longitudinal axis. A proximal end of the handle shaft 244 is coupled to one or both of the vacuum loading button 230 and the motor 240. A distal portion of the handle shaft 244 extends through the barrel socket 210. A distal end of the handle shaft 244 defines a flange 246 extending annularly and configured to engage the plunger coupling 136 as described herein. The handle shaft 244 is rotatably engaged with the body 202 such that it can rotate about a longitudinal axis.

[0074] FIGS. 4A-4F show further details of the engagement between the plunger 130 and the handle 200. FIG. 4A shows the syringe system 110 and the handle 200 in a disengaged position with the plunger 130 in a proximal position, e.g., a second proximal position, and the handle shaft 244 in a distal position, e.g., with the vacuum loading button 230 in a distal most position. As such, the flange 246 at the distal end of the handle shaft 244 extends distally of the barrel socket 210 to facilitate coupling the plunger 130 therewith. Note that the body 202 is shown in wire frame for ease of illustration.

[0075] As shown in FIG. 4B, the flange 246 can slidably engage the cradle 138 along an axis extending perpendicular to the longitudinal axis, e.g., a lateral or transverse axis. Optionally, the cradle 138 can engage the flange 246 in one of a press-fit, interference-fit, or snap-fit engagement, to secure the flange 246 therewith. As such, the plunger 130 is releasably coupled with the handle shaft 244. The plunger 130 and handle shaft 244 assembly are fixed relative to each other along a longitudinal axis. However, the plunger 130 and handle shaft 244 assembly are still slidable along the longitudinal axis relative to one or both of the syringebarrel 120 and the body 202. As such, the syringe system 110 and the handle 200 are releasably engaged with each other by way of the plunger coupling 136 and handle shaft 244.

[0076] As shown in FIG. 4C, once the plunger coupling 136 is engaged with the flange 246 of the handle shaft 244, the syringe barrel 120 can be urged proximally along the longitudinal axis such that the plug 126 engages the barrel socket 210. As the syringe barrel 120 is urged proximally, the plunger head 134 slides relative to the syringe barrel 120, within the cavity 122. As described herein, the plug 126 defines a hexagonal cross-sectional shape. Further, the barrel socket 210 defines a socket recess 212 having a corresponding hexagonal shape that is equal to, or slightly larger than the hexagonal outer perimeter of the plug 126. The plug 126 slidably engages the socket recess 212 along the longitudinal axis and prevents any rotational movement of the plug 126 relative to the barrel socket 210. As such, any rotation of the barrel socket 210 about the longitudinal axis causes rotation of the syringe barrel 120 about the longitudinal axis.

[0077] As shown in FIG. 4D, once the syringe barrel 120 is engaged with the barrel socket 210, the cover 140 can be slidably engaged over the syringe barrel 120 along a longitudinal axis to engage the handle 200. A proximal end of the cover 140 engages the body 202 of the handle 200 in one of a press-fit, interference-fit, snap-fit, threaded engagement, or combinations thereof, or similar suitable engagement. To note, the cover 140 is shown in wire frame for ease of illustration. The cover 140 defines a cover lumen 142 configured to receive the syringe barrel 120 therein. A distal end of the cover lumen 142 includes a lip extending radially inwards and configured to abut against a distally facing surface of the syringe barrel 120 when the cover 140 is engaged with the body 202. As such, the cover 140 prevents the syringe barrel 120 and plug 126 from sliding distally relative to the barrel socket 210 and accidentally disengaging the barrel socket 210. Further, the cover 140 prevents the plunger from sliding perpendicular to the longitudinal axis, thereby preventing accidental disengagement of the plunger coupling 136 from the handle shaft 244.

[0078] FIG. 4E shows a perspective view of the distal end of the handle 200 showing the handle shaft 244, the flange 246, the barrel socket 210 and the socket recess 212 defining a hexagonal cross-sectional shape. FIG. 4F shows a distal end view of the handle showing the handle shaft 244, the flange 246, the barrel socket 210 and the socket recess 212 defining a hexagonal cross-sectional shape.

[0079] FIGS. 5A-5G show details of the vacuum “on” button 224 and vacuum “off’ button 226 actuation. FIG. 5 A shows a longitudinal cross-sectional view of the system 100 including the syringe system 110 coupled with the handle 200 with the vacuum loading button 230 in the distal position. To note, the biopsy needle 112 is not shown of ease of illustration. FIG. 5B shows close up detail of a pawl 232 of the vacuum loading button 230 engaged with a first abutment surface 254 of the body 202 to retain the vacuum loading button 230 in the distal position. FIG. 5C shows a longitudinal cross-sectional view of the system 100 with the vacuum loading button 230 in a first proximal position. FIG. 5D shows close up detail of the pawl 232 of the vacuum loading button 230 engaged with a second abutment surface 256 of the body 202 to retain the vacuum loading button 230 in the first proximal position. FIG. 5E shows close up detail of the pawl 232 of the vacuum loading button 230 disengaged from the second abutment surface 256 of the body 202 allowing the vacuum loading button 230 to extend to the second proximal position. FIG. 5F shows the plunger head 134 in the first proximal position, disposed distally of the vent 128. FIG. 5F shows the plunger head 134 in the second proximal position, disposed proximally of the vent 128.

[0080] As shown in FIG. 5A, the vacuum loading button 230 is urged distally to the distal position compressing the biasing member 242 and urging the handle shaft 244 and the plunger 130 coupled thereto, to the distal position. The vacuum loading button 230 further includes the pawl 232 slidably engaged therewith along an axis extending perpendicular to the longitudinal axis, e.g., the transverse axis. The pawl 232 further includes a pawl biasing member 234, e.g., a compression spring or the like, configured to bias the pawl 232 towards the extended position as shown in FIG. 5 A. The pawl 232 in the extended position being further away from a central longitudinal axis 70 of the vacuum loading button 230 relative to the retracted position where the pawl 232 is relatively closer to central longitudinal axis 70.

[0081] The pawl 232 has an angled distal surface 236 and a proximally facing abutment surface 238. As the vacuum loading button 230 is urged distally, the angled distal face of the pawl 232 allows the pawl 232 to slide from the extended position to the retracted position and slide over one or more abutment surfaces disposed on the body 202, by urging the pawl 232 downwards as the pawl 232 passes over the abutment surface. Once the pawl 232 has passed over the abutment surface, the pawl biasing member 234 urges the pawl 232 back to the extended position. Once the vacuum loading button 230 is released, the central biasing member 242 urges the vacuum loading button 230 proximally until the proximally facing abutmentsurface 238 of the pawl 232 engages an abutment surface of the body 202 to prevent further proximal movement.

[0082] As shown in FIG. 5A, the body 202 includes a first abutment surface 254 aligned with the vacuum “on” button 224 and a second abutment surface 256 aligned with the vacuum “off’ button 226. The vacuum loading button 230 can be urged distally to the distal position where the plunger 130 is in the distal position, i.e., the plunger head 134 engaging a distal end of the cavity 122, and the central biasing member 242 is compressed. The angled distal surface 236 allows the pawl 232 to pass over both the second abutment surface 256 and the first abutment surface 254 to allow the vacuum loading button 230 to reach the distal position. Once at the distal position, the pawl biasing member 234 urges the pawl 232 to the extended position, allowing the proximally facing abutment surface 238 to engage the first abutment surface 254 of the body 202 and retain the vacuum loading button 230 in the distal position.

[0083] As shown in FIG. 5B, actuating the vacuum “on” button 224 includes urging the vacuum “on” button 224 transversely downwards and urges pawl 232 from the extended position to the retracted position. In the retracted position, the pawl 232 disengages the first abutment surface 254 and allows the central biasing member 242 to urge the vacuum loading button 230 and the pawl 232 proximally past the first abutment surface 254. Once the pawl 232 has traveled past the first abutment surface 254, the pawl 232 disengages the vacuum “on” button 224 allowing the pawl biasing member 234 to urge the pawl 232 to the extended position and engage the second abutment surface 256. As shown in FIG. 5C, the pawl 232, engaged with the second abutment surface 256 retains the vacuum loading button 230, and plunger 130 coupled thereto, at the first proximal position.

[0084] As shown in FIG. 5D, actuating the vacuum “off’ button 226 includes urging the vacuum “off’ button 226 transversely downwards and urges pawl 232 from the extended position to the retracted position. The pawl 232 disengages the second abutment surface 256 and allows the central biasing member 242 to urge the vacuum loading button 230 and the pawl 232 proximally past the second abutment surface 256 and allows the central biasing member 242 to urge the vacuum loading button 230, and plunger 130 coupled thereto, to the second proximal position (FIG. 5E). FIG. 5F shows the plunger head 134 in the first proximal position, distal to the vent 128, and applying a vacuum to the proximal portion of the cavity 122.FIG. 5G shows the plunger head 134 in the second proximal position, proximal to the vent 128, with the vacuum released.

[0085] FIGS. 6A-6B show further details of the syringe system rotation assembly including one or more of the vacuum loading button 230, the motor 240, the handle shaft 244, the barrel socket 210, the syringe barrel 120 and the plunger 130. FIG. 6A shows and exploded view of the syringe system rotation assembly. FIG. 6B shows the syringe system rotation assembly in an assembled state. In an embodiment, actuating the rotation button 222 closes an electrical circuit that causes the motor 240 to rotate. The motor 240 is coupled with a proximal end of the handle shaft 244, optionally by way of one or more motor shafts, axels, gears, or the like. The handle shaft 244 is slidably engaged with the barrel socket 210 to allow the handle shaft 244 to slide along a longitudinal axis relative to the barrel socket 210.

[0086] The handle shaft 244 further includes one or more grooves 248 extending longitudinally along a side of the handle shaft 244 and configured to engage a tab 214 of the barrel socket 210. The tab 214 extends radially inward from a perimeter of a proximal opening of the barrel socket 210, through which the handle shaft 244 extends. The tab 214 engages the groove 248 to allow the handle shaft 244 to slide relative to the barrel socket 210 but to also prevent the handle shaft 244 from rotating about the longitudinal axis relative to the barrel socket 210. As such, as the handle shaft 244 is rotated by the motor 240, the handle shaft 244 in turn, rotates the barrel socket 210 about the longitudinal axis. Further, the hexagonally shaped plug 126 of the syringe barrel 120 is engaged with the socket recess 212 of the barrel socket 210. As such, as the barrel socket 210 is rotated by the handle shaft 244, the barrel socket 210 in turn rotates the syringe barrel 120 and biopsy needle 112 coupled thereto.

[0087] FIGS. 7A-7I show an exemplary method of use for the system 100. As shown in FIGS. 7A-7B, the handle 200 of the system 100 is provided and a technician can actuate the vacuum loading button 230, urging the vacuum loading button 230 from the second proximal position (FIG. 7A) to the distal position (FIG. 7B). The pawl 232 of the vacuum loading button 230 engages the first abutment surface 254 adjacent the vacuum “on” button 224 to retain the vacuum loading button 230 in the distal position. In the distal position, the handle shaft 244 which is coupled to the vacuum loading button 230 is urged distally such that the distal end thereof, including the flange 246 extends from the barrel socket 210 and distally of the distal end of the handle 200.

[0088] In an embodiment, the status indicator 204 is functionally coupled to the vacuum loading button 230 and provides a visual indicator of the position that the system 100 is set to, i.e., one of the distal position, first proximal position, or second proximal position. In an embodiment, the status indicator 204 includes an aperture or window disposed in the body 202 and an indicator line coupled with the vacuum loading button 230 that moves along a longitudinal axis as the vacuum loading button 230 moves along the longitudinal axis. It will be appreciated however, that the status indicator may take other forms such as one or more lights, dials, alphanumeric indicators, LCD screens, mechanical indicators, combinations thereof, or the like to provide one or more of a visual, auditory, or tactile indicators of the position the system 100 is set to.

[0089] As shown in FIG. 7C, the distal end of the handle shaft 244 extends from the distal end of the handle 200 to facilitate coupling the disposable syringe system 110 to the handle 200. A syringe system 110 is provided with the plunger 130 positioned proximally relative to the syringe barrel 120. As such, the plunger coupling 136 extends proximally of a proximal end of the syringe barrel 120 to facilitate coupling the plunger coupling 136 with the flange 246 of the handle shaft 244. A technician can slide the flange 246 into the cradle 138 along an axis perpendicular to the longitudinal axis. The cradle 138 can retain the flange 246 therein with an interference fit, snap fit or press-fit engagement. Once the flange 246 is engaged with the cradle 138, the syringe barrel 120 aligns with the barrel socket 210 of the handle 200. As shown in FIG. 7D, the technician can slide the syringe barrel 120 proximally, relative to the plunger 130, such that the plug 126 engages the socket recess 212 of the barrel socket 210.

[0090] As shown in FIG. 7E, with the syringe barrel 120 engaged with the barrel socket 210 the cover 140 is slid axially over the syringe barrel 120 in a proximal direction until a proximal end of the cover 140 engages the distal end of the handle 200. A distal end of the cover lumen 142 abuts against a distally facing surface of the syringe barrel 120 to prevent distal movement of the syringe barrel 120 relative to the handle 200 and prevent accidental disengagement thereof.

[0091] As shown in FIG. 7F, with the cover 140 engaged with the handle 200, the syringe coupling 124 extends through the cover lumen 142 distally of the cover 140. A biopsy needle 112 can be coupled with the syringe barrel 120 by coupling a needle hub 118 with the syringe coupling 124. The system 100 is now prepared for use.

[0092] As shown in FIG. 7G a technician can advance the system 100 until a distal tip 116 of the needle penetrates a target location within the body of the patient. Optionally the distal tip 116 can be guided to the target location under medical imaging, e.g., ultrasound imaging or the like. The vacuum “on” button 224 can be actuated to depress the pawl 232 and allow the central biasing member 242 to urge the vacuum loading button 230 from the distal position to the first proximal position. The proximal movement of the vacuum loading button 230 in turn urges the handle shaft 244 and plunger 130 proximally to the first proximal position to apply a vacuum to the distal portion of cavity 122. The vacuum in turn draws fluid and tissue through the needle lumen 114 and into the cavity 122.

[0093] The rotation button 222 can also be actuated to activate the motor 240 and rotate the syringe system 110. The rotation button 222 can be actuated before, concurrently with, or after actuation of the vacuum “on” button 224. Actuating the rotation button 222 closes an electrical circuit that activates the motor 240. The motor 240 rotates the handle shaft 244 which rotates the barrel socket 210, which rotates the syringe barrel 120 and biopsy needle 112 coupled thereto. Advantageously, the rotation of the biopsy needle 112 facilitates cutting a portion of tissue at the target location while the vacuum facilitates withdrawing the tissue sample, fluids, and the like to the cavity 122.

[0094] As shown in FIG. 7H, once the sample has been retrieved, the rotation button 222 can be released to break the circuit and deactivate the motor 240, stopping further rotation of the biopsy needle 112. Optionally, the rotation button 222 is configured to actuate a first time to activate the motor 240 and actuate a second time to deactivate motor 240. These and other forms of electric switches including rocker switches, lever switches, push button, touch sensitive pads, etc. are contemplated to fall within the scope of the present invention. The technician can then actuate the vacuum “off’ button 226 to depress the pawl 232 and disengage the second abutment surface 256 allowing the central biasing member 242 to withdraw the vacuum loading button 230 from the first proximal position to the second proximal position. In turn, the handle shaft 244 and plunger 130 are withdrawn proximally until the plunger head 134 is proximal of the vent 128 releasing the vacuum from the cavity 122.

[0095] As shown in FIG. 71, once the sample is collected, the system 100 can be withdrawn from the target location. In an embodiment, the sample can be deposited to a suitable container for further analysis by actuating the vacuum loading button 230 from the second proximal position to the distal position, urging the sample through the needle lumen114 and into the container. In an embodiment, the biopsy needle 112 can be detached from the syringe coupling 124 prior actuating the vacuum loading button 230 and depositing the sample to the container. In an embodiment, the syringe system 110 can be detached from the handle 200 prior to depositing the sample in a container.

[0096] To detach the syringe system from the handle 200, the cover 140 can be detached from the handle 200 and slid distally to disengage the syringe barrel 120. The syringe barrel 120 can be slid distally to disengage the plug 126 from the barrel socket 210. The plunger coupling 136 can then be slid perpendicular to the longitudinal axis to disengage the flange 246 from the cradle 138. After use, the syringe system 110 can be disposed of in a suitable manner and the handle 200 can be cleaned, sterilized, and / or recharged ready for reuse.

[0097] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A biopsy system, comprising: a syringe system, comprising: a needle extending along a longitudinal axis and defining a needle lumen and supported by a needle hub; a syringe barrel having a vent disposed in a side wall thereof; and a plunger slidably engaged with the syringe barrel between a distal position, a first proximal position and a second proximal position, wherein the plunger in the distal position or the first proximal position is distal of the vent; and a handle, comprising: a vacuum loading button coupled with the plunger and configured to move the plunger between the distal position, the first proximal position and the second proximal position; and a rotation assembly configured to rotate the needle about the longitudinal axis.

2. The biopsy system according to claim 1, wherein the handle further includes a handle shaft coupled to the vacuum loading button, a distal end of the handle shaft coupled to a proximal end of the plunger.

3. The biopsy system according to claim 2, wherein the rotation assembly further includes a motor coupled to the handle shaft that is slidable engaged with a barrel socket, the barrel socket coupled with a proximal end of the syringe barrel.

4. The biopsy system according to claim 3, wherein the handle shaft includes a groove extending longitudinally and slidably engages a tab of the barrel socket and configured to prevent rotation of the handle shaft relative to the barrel socket.

5. The biopsy system according to claim 3, wherein the proximal end of the syringe barrel includes a plug configured to slidably engage a socket recess of the barrel socket and prevent rotation of the syringe barrel relative to the barrel socket when engaged therewith.

6. The biopsy system according to claim 3, wherein one or more of the handle shaft, the barrel socket, and the syringe barrel are rotatable about the longitudinal axis relative to the handle.

7. The biopsy system according to claim 2, wherein the distal end of the handle shaft includes a flange extending annularly, and the proximal end of the plunger includes a cradle configured to engage the flange along an axis extending perpendicular to the longitudinal axis.

8. The biopsy system according to any of the preceding claims, further including a cover slidably engaged with the syringe barrel, a proximal end of the cover configured to engage the handle and secure the cover thereto, a distal end of the cover configured to abut against a portion of the syringe barrel to prevent longitudinal movement of the syringe barrel relative to the handle when the cover is engaged with the handle.

9. The biopsy system according to any of the preceding claims, further including a biasing member configured to bias the vacuum loading button from the distal position to one or both of the first proximal position and the second proximal position.

10. The biopsy system according to any of the preceding claims, wherein the vacuum loading button further includes a pawl slidably engaged therewith between an extended position and a retracted position, and wherein the pawl is configured to abut against a first abutment surface of a body of the handle to retain the vacuum loading button and the plunger, coupled thereto, in the distal position.

11. The biopsy system according to claim 10, further including a second abutment surface disposed on the body of the handle, the pawl configured to engage the second abutment surface to retain the vacuum loading button and the plunger in the first proximal position.

12. The biopsy system according to claim 10, further including a first button slidably engaged with the body and aligned with the first abutment surface, and wherein actuating the first button slides the pawl from the extended position to the retracted position to disengage the first abutment surface.

13. The biopsy system according to claim 11, further including a second button slidably engaged with the body and aligned with the second abutment surface, and whereinactuating the second button slides the pawl from the extended position to the retracted position to disengage the second abutment surface.

14. The biopsy system according to claim 3, further including a rotation button configured, when actuated, to close a circuit between the motor and a power source to actuate the motor.

15. The biopsy system according to claim 14, wherein the motor is an electric motor and the power source is a rechargeable battery.

16. A method of use for a biopsy device having a handle that is reusable and a syringe system that is disposable, comprising: actuating a vacuum loading button on the handle to urge a plunger of the syringe system to a distal position; actuating a first retraction button to urge the plunger to a first proximal position and creating a vacuum within a syringe barrel of the syringe system; actuating a rotation button to rotate a needle of the syringe system about a longitudinal axis; and actuating a second retraction button to urge the plunger to a second proximal position such that a plunger head is proximal of a vent aperture disposed in a side wall of the syringe barrel and releasing the vacuum from the syringe barrel.

17. The method according to claim 16, wherein actuating the vacuum loading button to urge the plunger to the distal position further includes deflecting a biasing member that biases the vacuum loading button to the second proximal position and engaging a pawl of the vacuum loading button with a first abutment surface of a body of the handle to retain the vacuum loading button, and the plunger coupled thereto, in the distal position.

18. The method according to claim 17, wherein actuating the first retraction button disengages the pawl from the first abutment surface of the body to allow the biasing member to retract the vacuum loading button and the plunger to the first proximal position.

19. The method according to claim 17, wherein actuating the second retraction button disengages the pawl from a second abutment surface of the body to allow the biasing member to retract the vacuum loading button and the plunger to the second proximal position.

20. The method according to any of claims 16-19, wherein actuating the rotation button causes a motor to rotate a handle shaft to rotate a barrel socket, to rotate the syringe barrel of the syringe system, to rotate the needle.

21. The method according to any of claims 16-20, wherein actuating the first retraction button further includes changing a status indicator from a distal position to a first proximal position, and wherein actuating the second retraction button further includes changing the status indicator from the first proximal position to the second proximal position.

22. A method of coupling a syringe system to a handle, the syringe system including a needle extending along a longitudinal axis, the method comprising: actuating a vacuum loading button to a distal position to extend a distal end a handle shaft distally of a distal end of a body of the handle; engaging a proximal end of a plunger of the syringe system with the distal end of the handle shaft; sliding a syringe barrel of the syringe system proximally relative to the plunger to engage a proximal end of the syringe barrel with a barrel socket of the handle; and sliding a cover over the syringe barrel to engage a proximal end of the cover with the body, a distal end of the cover abutting against a portion of the syringe barrel to retain the syringe barrel in the barrel socket.

23. The method according to claim 22, wherein engaging the plunger with the handle shaft further includes engaging a flange of the handle shaft with a cradle along an axis extending perpendicular to the longitudinal axis.

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