Biopsy device with integrated dither feature - Patent Application 20070229633
By integrating rotatable and rotatable cutters and elastic members on the probes of the biosample sample equipment, the difficulty of obtaining samples for existing equipment under the needs of multi-directional motion is solved, and efficient and accurate biosample acquisition and processing is achieved.
Patent Information
- Application Number
- JP2024559062
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-04-28
- Filing Date
- 2023-04-13
- Publication Date
- 2025-05-02
AI Technical Summary
When obtaining biosample samples, it is difficult to achieve efficient and accurate sample acquisition and processing, especially in the case of multi-directional motion requirements.
A biosample test device is designed that includes a probe with a cutting drive device equipped with a rotatable and rotatable cutter that provides precise control of the cutter in multi-directional motion by integrating elastic members on the probe to provide the force required for directional change.
It realizes efficient and precise bio-test sample acquisition and processing under the requirements of multi-directional motion, and improves the stability and accuracy of sample acquisition.
Smart Images

Figure 2025514026000001_ABST
Abstract
Description
[Technical field]
[0001] Priority This application claims priority to U.S. Provisional Application No. 63 / 335,839, entitled "Biopsy Device with Integrated Dither Feature," filed April 28, 2022, the disclosure of which is incorporated herein by reference. [Background technology]
[0002] Biopsy samples have been obtained in a variety of ways in a variety of medical procedures using a variety of devices. Biopsy devices may be used with stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or otherwise. For example, some biopsy devices may be fully operable by a user using one hand and with a single insertion to take one or more biopsy samples from a patient. In addition, some biopsy devices may be tethered to a vacuum module and / or a control module for communication of fluids (e.g., pressurized air, saline, atmosphere, vacuum, etc.), for transmission of power, and / or for transmission of commands, etc. Other biopsy devices may be fully or at least partially operable without being tethered to or otherwise connected to another device.
[0003] Examples of some versions of biopsy devices and biopsy system components are U.S. Patent No. 5,928,164, issued on July 27, 1999 and entitled "Apparatus for Automated Biopsy and Collection of Soft Tissue," U.S. Patent No. 6,086,544, issued on July 11, 2000 and entitled "Control Apparatus for an Automated Surgical Biopsy Device," U.S. Patent No. 6,752,768, issued on June 22, 2004 and entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Patent No. 7,442,171, issued on October 8, 2008 and entitled "Remote Thumbwheel for a Surgical Biopsy Device," U.S. Patent No. 7,442,171, issued on November 23, 2010 and entitled "Biopsy Device Tissue Port No. 7,837,632 entitled "Clutch and Valving System for Tetherless Biopsy Device" issued on December 1, 2010, U.S. Patent No. 7,854,706 entitled "Clutch and Valving System for Tetherless Biopsy Device" issued on May 10, 2011, U.S. Patent No. 7,938,786 entitled "Vacuum Timing Algorithm for Biopsy Device" issued on February 21, 2012, U.S. Patent No. 8,118,755 entitled "Biopsy Sample Storage" issued on June 26, 2012, U.S. Patent No. 8,206,316 entitled "Tetherless Biopsy Device with Reusable Portion" issued on June 26, 2012, U.S. Patent No. 8,241,226 entitled "Biopsy Device with Rotatable Tissue Sample Holder" issued on August 14, 2012, and U.S. Patent No. 8,241,226 entitled "Presentation of Biopsy The present invention is disclosed in U.S. Patent No. 9,345,457, entitled "Sample by Biopsy Device."The disclosures of each of the above US patents are incorporated herein by reference.
[0004] Additional examples of versions of biopsy devices and biopsy system components are described in U.S. Publication No. 2010 / 0152610, published June 17, 2010 and entitled "Hand Actuated Tetherless Biopsy Device with Pistol Grip," U.S. Publication No. 2010 / 0160819, published June 24, 2010 and entitled "Biopsy Device with Central Thumbwheel," U.S. Publication No. 2012 / 0109007, published May 3, 2012 and entitled "Handheld Biopsy Device with Needle Firing," U.S. Publication No. 2012 / 0283563, published November 8, 2012 and entitled "Biopsy Device with Manifold Alignment Feature and Tissue Sensor," U.S. Publication No. 2012 / 0283563, published December 5, 2013 and entitled "Control for Biopsy Device with Central Thumbwheel," U.S. Publication No. 2012 / 0283564, published December 5, 2013 and entitled "Control for Biopsy Device with Central Thumbwheel," U.S. Publication No. 2012 / 0283565, published December 5, 2013 and entitled "Control for Biopsy Device with Central Thumbwheel," U.S. Publication No. 2012 / 0283566, published December 5, 2013 and entitled "Control for Biopsy Device with Central Thumbwheel," U.S. Publication No. 2012 / 0283567, published December 5, 2013 and entitled "Control for Biopsy Device with Central Thumbwheel," U.S. Publication No. 2012 / 0283568, published December 5, 2013 and entitled "Control for Biopsy Device with Central Thumbwheel," U.S. Publication No. 201 No. 2013 / 0324882, published on Feb. 6, 2014 and entitled "Biopsy System," and U.S. Publication No. 2014 / 0039343, published on June 7, 2018 and entitled "Apparatus to Allow Biopsy Sample Visualization During Tissue Removal." The disclosures of each of the above U.S. patent application publications are incorporated herein by reference.
[0005] Although a number of systems and methods have been made and used to obtain biopsy samples, it is believed that no one prior to the inventors made or used the invention as recited in the accompanying claims.
[0006] While the specification concludes with claims particularly pointing out and distinctly claiming the present technique, it is believed the same will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which like reference characters identify the same elements and in which: [Brief description of the drawings]
[0007] [Figure 1] 1 shows a schematic diagram of an example of a biopsy system including a biopsy device and a vacuum control module. [Diagram 2] 2 illustrates a perspective view of the probe of the biopsy device of FIG. 1 with a portion of the probe housing removed to show the cutter drive assembly. [Diagram 3] 3 shows an exploded perspective view of the cutter drive assembly of FIG. 2. [Figure 4] FIG. 3 shows a perspective view of a cutter overmold of the cutter drive assembly of FIG. 2. [Diagram 5] FIG. 3 shows a perspective view of a translation member of the cutter drive assembly of FIG. 2. [Figure 6] FIG. 3 shows a front view of the rotating member of the cutter drive assembly of FIG. 2. [Figure 7] 7 shows a perspective cross-sectional view of the cutter drive assembly of FIG. 2 taken along line 7-7 of FIG. 2. [Figure 8] 3 shows a detailed perspective view of a portion of the housing of FIG. 2. [Figure 9A] 3 shows another perspective cross-sectional view of the cutter drive assembly of FIG. 2 using the cutter drive assembly to translate the cutter distally. [Figure 9B] 3 shows yet another perspective cross-sectional view of the cutter drive assembly of FIG. 2 using the cutter drive assembly to rotate while the cutter is in the distal position. [Figure 9C] 3 shows yet another perspective cross-sectional view of the cutter drive assembly of FIG. 2, using the cutter drive assembly to translate the cutter proximally. [Figure 9D] 3 shows yet another perspective cross-sectional view of the cutter drive assembly of FIG. 2 using the cutter drive assembly to rotate while the cutter is in the proximal position. [Figure 10A]3 illustrates another top cross-sectional view of the cutter drive assembly of FIG. 2 using the cutter drive assembly to translate the cutter distally. [Figure 10B] 3 illustrates another top cross-sectional view of the cutter drive assembly of FIG. 2 using the cutter drive assembly to rotate while the cutter is in the distal position. [Figure 10C] 3 illustrates yet another top cross-sectional view of the cutter drive assembly of FIG. 2 using the cutter drive assembly to rotate while the cutter is in the proximal position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0008] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be implemented in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the technology and, together with the description, serve to explain the principles of the technology. It will be understood, however, that the technology is not limited to the precise configurations shown.
[0009] The following description of specific examples of the technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art from the following description, by way of example. One best mode is contemplated for carrying out the technology. As will be appreciated, the technology described herein allows for other different and obvious aspects, all without departing from the technology. Thus, the drawings and description should be regarded as illustrative in nature, and not limiting.
[0010] I. Overview of an Example Biopsy System FIG. 1 illustrates an embodiment of a biopsy system (2), which may include a biopsy device (10) and a vacuum control module (400). The biopsy device (10) in this example includes a probe (100) and a holster (200). A needle (110) extends distally from the probe (100) and may be insertable into the patient's tissue to obtain tissue samples by translating a hollow cutter (150) (see FIG. 2) relative to a lateral aperture (114). Tissue samples such as these may be transported through the needle (110) via the cutter 150 and placed in a tissue sample holder (300) at the proximal end of the probe (100), as will also be described in more detail below.
[0011] It should also be understood that use of the term "holster" herein should not be read as requiring any portion of the probe (100) to be inserted into any portion of the holster (200). For example, in some versions, the holster (200) may only abut the probe (100) using one or more prongs (not shown), coupling the probe (100) to the holster (200). In other versions, the holster (200) may receive a portion of the probe (100) to facilitate coupling between the probe (100) and the holster (200). In still other versions, the probe (100) and the holster (200) may be a unitary or integral structure such that the two components cannot be separated. By way of example only, in versions in which the probe (100) and the holster (200) are provided as separable components, the probe (100) may be provided as a disposable component while the holster (200) is provided as a reusable component. Yet, other suitable structural and functional relationships between probe (100) and holster (200) will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0012] It should be appreciated that the biopsy device (10) may be used in conjunction with a variety of imaging guidance modalities. Suitable imaging guidance modalities may include stereotactic guidance, ultrasound guidance, MRI guidance, and the like. In some versions, the biopsy device (10) may include features and / or configurations that are dedicated to a given imaging guidance modality. For example, with respect to stereotactic guidance, the biopsy device (10) may be configured to be attached to a table or fixture. With respect to stereotactic guidance or other imaging guidance modalities, the biopsy device (10) may be sized and configured such that the biopsy device (10) can be operated with one hand of an operator. In particular, the operator may be able to grasp the biopsy device (10), insert the needle (110) into the patient's breast, and collect one or more tissue samples from within the patient's breast, all using only one hand. Alternatively, the operator may grasp the biopsy device (10) with multiple hands and / or provide any desired assistance. In some configurations, the operator may obtain multiple tissue samples with only one insertion of the needle (110) into the patient's breast. Such tissue samples may be pneumatically deposited in tissue sample holder 300 and subsequently retrieved from tissue sample holder 300 for analysis. While the examples described herein often refer to obtaining a biopsy sample from a patient's breast, it should be understood that biopsy device 10 may be used in a variety of other procedures for a variety of other purposes and in a variety of other portions of a patient's anatomy (e.g., prostate, thyroid, etc.). Various exemplary components, features, configurations, and operability of biopsy device 10 are described in further detail below and will be apparent to those of ordinary skill in the art in view of the teachings herein.
[0013] This version of holster (200) is generally configured to drive and / or control one or more features of probe (100). For example, holster (200) may include one or more motors (not shown) that may be in communication with probe (100) to drive movement of cutter (150) to obtain one or more tissue samples. Additionally or alternatively, some versions of holster (200) may include one or more user input features to facilitate control of various functions of probe (100).
[0014] Holster (200) may include one or more drive gears (not shown), which may be in communication with probe (100) to rotate and translate cutter (150), as described in more detail below. In some versions, such gears may be driven by a motor housed within holster (200) or by a motor positioned outside of but in communication with holster (200). The motors referred to herein may receive power from vacuum control module (400) via cable (90). Additionally, data may be communicated between vacuum control module (400) and holster (200) via cable (90). In some versions, such data may be used by control module (400) to display certain graphical user interface screens on a touch screen (410) integrated into control module (400). In some other versions, the one or more motors are powered by one or more batteries located within the holster (200) and / or the probe (100). It should therefore be understood that the cable (90) is merely optional, as are the other components described herein. As yet another merely exemplary version, the motors may be pneumatically powered, and thus the cable (90) may be replaced with a conduit communicating a pressurized fluid medium to the holster (200). As yet another merely exemplary version, the cable (90) may include one or more rotational drive cables driven by a motor located outside the holster (200). It should also be understood that two or three of the motors may be combined into a single motor. Other suitable methods by which the various motors may be driven will be apparent to those of skill in the art in view of the teachings herein.
[0015] As mentioned above, the probe (100) of the present example includes a needle (110) extending distally therefrom such that it may be inserted into the tissue of a patient to obtain a tissue sample. As shown in FIG. 1, a vacuum control module (400) is coupled to the probe (100) via a valve assembly (500) and tubing (20, 30, 40, 60) and is operable to selectively provide vacuum, saline, atmosphere, and vent to the probe (100). The internal components of the valve assembly of the present example are constructed and arranged as described in U.S. Publication No. 2013 / 0218047, published August 22, 2013, and entitled "Biopsy Device Valve Assembly," the disclosure of which is incorporated herein by reference.
[0016] Also as mentioned above, in some versions of the holster (200), one or more drive gears may be used to transmit power to the probe (100). Thus, to facilitate the transmission of power to the probe (100), the probe (100) may include one or more gears or other drive elements. In some versions, such gears may be exposed to a portion of the holster (200) such that one or more gears of the probe (100) may mesh with one or more corresponding gears of the holster (200). Alternatively, in other versions, the probe (100) may include exposed spline elements or other rotational transmission features that may engage with corresponding features of the holster (200). Of course, in still other versions, a variety of suitable alternative power transmission features may be used to transmit power between the probe (100) and the holster (200), as would be apparent to one of ordinary skill in the art in view of the teachings herein.
[0017] This version of the needle (110) includes a lateral aperture (114) located proximate the distal end of the needle (110). In some versions, the distal end of the needle (110) may be of a blunt configuration. Blunt configurations such as these may be desirable for versions of the biopsy device (10) that primarily use associated accessories such as a targeting set used in MR-guided procedures to perform tissue penetration. Alternatively, the distal tip of the needle (110) may include a sharp tissue piercing tip that may be configured to puncture and penetrate tissue. Other suitable configurations that may be used for the distal end of the needle (110) will be apparent to those of skill in the art in view of the teachings herein.
[0018] The lateral aperture (114) is sized to receive prolapsed tissue during operation of the biopsy device (10). A hollow tubular cutter (150) (see FIGS. 2 and 3) having a sharp distal edge may be disposed within the needle (110). The cutter (150) is operable to rotate and translate relative to the needle (110) to pass through the lateral aperture (114) and cut a tissue sample from the tissue protruding through the lateral aperture (114). For example, the cutter (150) may move from an extended position to a retracted position to "open" the lateral aperture (114) so that tissue may protrude therethrough, and then move back from the retracted position to the extended position to cut the protruding tissue.
[0019] Although not shown, it should be understood that in some versions, the needle (110) may include a multi-lumen configuration. In such versions, the upper lumen (alternatively referred to as the axial lumen) may be used to receive the cutter (150) and the lower lumen may be used to communicate atmosphere or other fluids to the distal end of the needle (110). Multi-lumen configurations such as these may be facilitated in some versions with one longitudinal wall, multiple walls, tubes, and / or other structural features. As will be appreciated, the presence of additional lumens may be desirable to facilitate the transport of one or more tissue samples through the cutter (150) by facilitating optimal fluid pressure balance on each side of the tissue sample being transported. A suitable multi-lumen configuration for the needle (110) is disclosed in U.S. Patent No. 7,918,803, issued April 5, 2011, entitled "Methods and Devices for Automated Biopsy and Collection of Soft Tissue," the disclosure of which is incorporated herein by reference.
[0020] II. EXAMPLES OF CUTTER DRIVE ASSEMBLY WITH INTEGRAL RETURN FEATURE As discussed above, the cutter (150) is operable to simultaneously rotate and translate relative to the needle (110) to sever a tissue sample from tissue protruding through the lateral aperture (114). As best seen in FIGS. 2-7, the probe (100) includes an outer housing (670) that houses and retains at least a portion of the cutter drive assembly (610). The cutter drive assembly (610) is configured to drive translational and rotational motion of the cutter (150) relative to the needle (110). As described in more detail below, the cutter drive assembly (610) is generally configured to receive rotational input from the holster (200) or other suitable component and convert such rotational input into translational and rotational motion of the cutter (150). It should be understood that while in this version a single rotational input is used to drive the cutter drive assembly (610), in other versions the cutter drive assembly (610) may be configured to receive multiple inputs in either rotational or linear modes of input.
[0021] As best shown in FIG. 3, the cutter drive assembly (610) includes a manifold (612), a cutter overmold (620) (also referred to as a sleeve), a translation member (640), a rotation member (650), and a cutter drive gear (660). Although not shown, it should be understood that the manifold (612) may be in fluid communication with a portion of the needle (110) to facilitate flow of fluid from one or more tubes (20, 30, 40, 60) into at least a portion of the needle (110). To facilitate such fluid flow while allowing movement of the cutter (150), the manifold (612) may receive at least a portion of the cutter (150) and / or cutter overmold (620) while allowing translational and rotational movement of the cutter (150) and / or cutter overmold (620) relative to the manifold (612).
[0022] The cutter overmold (620) is generally configured to convert rotational input from the cutter drive gear (660) into rotational and translational motion of the cutter (150) in cooperation with the translation member (640) and the rotation member (650). As such, the cutter overmold (620) is generally overmolded or otherwise secured to an outer surface of the cutter (150) such that rotational and / or translational motion of the cutter overmold (620) results in corresponding rotational and / or translational motion of the cutter (150). While this version uses an overmold to secure the cutter overmold (620) to the cutter (150), it should be understood that other versions may use any suitable fastening mechanism, such as adhesives, mechanical fasteners, etc.
[0023] As best shown in Figure 4, the cutter overmold (620) includes a generally smooth, cylindrical distal portion (622), and a drive portion (630). The distal portion (622) is generally configured to be received within the manifold (612) such that the distal portion (622) can seal against an inner diameter of the manifold (612). Thus, at least a portion of the distal portion (622) can be configured to seal against the manifold (612) to facilitate flow of fluid within the manifold (612) to the needle (110).
[0024] Distal portion (622) further defines a flange (624) disposed approximately centrally thereon. As described in more detail below, flange (624) may be used in some versions to locate cutter overmold (620) and / or cutter (150) proximally relative to other components of cutter drive assembly (610). Optionally, in some versions, flange (624) may also be used in conjunction with manifold (612) to drive valve components within manifold (612) or otherwise manipulate a seal between cutter overmold (620) and manifold (612).
[0025] The drive portion (630) is generally configured to engage the translation member (640) and the rotation member (650) to drive the translational and rotational motion of the cutter (150) in response to a rotational input from the rotation member (650). The drive portion (630) includes a threaded portion (632) and one or more channels (638) (also referred to as a keyed portion). The threaded portion (632) is generally configured to engage complementary features of the translation member (640) and drive the translational motion of the cutter overmold (620) and the cutter (150) using the rotational motion of the cutter overmold (620). The threaded portion (632) is disposed between a distal zero pitch portion (634) and a proximal zero pitch portion (636). As described in more detail below, the combination of the threaded portion (632) and the zero pitch portions (634, 636) are configured to provide translational movement of the cutter (150) through a predetermined range of motion, yet allow the cutter (150) to rotate outside of the predetermined range of motion.
[0026] The one or more channels (638) are generally configured to engage the rotating member (650) and transmit the rotational motion of the rotating member (650) to the cutter overmold (620) and the cutter (150). Each channel (638) extends within the outer diameter of the drive portion (630) to define a rectangular cross-sectional area for receiving a corresponding feature of the rotating member (650). In other words, each channel (638) is defined by a slot that extends from one end of the drive portion (630) to another end. Although only one channel (638) is visible in FIG. 4, it should be understood that the present version may include another substantially similar channel (638) on the opposite side of the drive portion (630). Alternatively, some versions may use other suitable numbers of channels (638), such as three, four, etc. In still other versions, one or more of the channels (638) may be omitted entirely or replaced with other structural features, such as protrusions, or unique geometric shapes, such as hexagonal shaped rods.
[0027] Each channel (638) of this version overlaps with the threaded portion (632) such that the individual threads of the threaded portion (632) are interrupted by a portion of each channel (638). Additionally, each channel (638) extends into at least a portion of each zero pitch portion (634, 636) to allow the cutter overmold (620) to rotate continuously regardless of the particular relative translational position of the cutter overmold (620). This particular overlap configuration may be desirable in some situations where the size of the probe (100) is constrained. For example, by using this version of the overlap configuration, the overall length of the cutter drive assembly (610) may be reduced. In other versions, the threads (632) and the channel (638) (or other keyed features) may be separate from one another, such that one separate section of the cutter overmold (620) may engage the translation member (640) and another separate section may engage the rotation member (650). Such alternative versions may be desirable to facilitate ease of manufacturability in situations where the size of the probe (100) is not constrained.
[0028] The translation member (640) is generally configured to receive a portion of the cutter overmold (620) to engage the threads (632) and convert rotational motion of the cutter overmold (620) into translational motion of the cutter overmold (620). As best shown in FIG. 5, the translation member (640) includes a receiver (642) and a base (648), with portions of the receiver (642) extending proximally and distally from the base (648). The receiver (642) is generally configured to coaxially receive at least a portion of the drive portion (630) of the cutter overmold (620). Thus, the receiver (642) defines a generally cylindrical shape that corresponds to the shape of the drive portion (630).
[0029] The exterior of the receiver (642) includes one or more wings (644) extending from the outer surface of the receiver (642). The wings (644) are positioned distal to the base (648) and distal to the receiver (642). Each wing (644) is generally configured to engage a portion of the probe (100) to anchor the rotational position of the translation member (640). In other words, each wing (644) is generally configured to prevent or resist rotational movement of the translation member (640) relative to the cutter overmold (620). While the present version includes two wings (644), it should be understood that in other versions, any suitable number of wings (644) may be used. In still other versions, the wings (644) may be omitted entirely and instead replaced with other mechanical grounding features, such as posts, legs, or the outer diameter of the irregularly shaped receiver (642).
[0030] The inner diameter of the receiver (642) defines one or more threads (646) that extend around the inner diameter of the receiver (642). The threads (646) are generally configured to engage the threads (632) of the drive portion (630). As described in more detail below, the translation member (640) may be rotationally fixed relative to the cutter overmold (620). The threads (646) may thus be used to drive translational motion of the cutter overmold (620) by engagement with the threads (632) in response to rotational motion of the cutter overmold (620) relative to the translation member (640). In this version, the threads (646) are isolated to a proximal end of the receiver (642). However, it should be understood that in other versions, the threads (646) may be located at any suitable location along the inner diameter of the receiver (642) or may instead extend through the entire length of the receiver (642).
[0031] Base (648) extends outwardly from the outer diameter of receiver (642) and defines a square or rectangular shaped outline. As described in more detail below, base (648) may be configured to engage a portion of probe (100) to ground an axial location of translation member (640) within probe (100). Additionally, base (648) may be used to prevent rotational movement of at least a portion of translation member (640) within probe (100), as similarly described above with respect to wings (644).
[0032] The rotating member (650) is generally configured to engage a portion of the drive portion (630) to rotate the cutter overmold (620). As best shown in FIG. 6, the rotating member (650) includes a receiver (652) and a rotation gear (656). The receiver (652) is configured to receive at least a portion of the drive portion (630) to drive the rotational movement of the cutter overmold (620). Thus, the receiver (652) defines a generally hollow cylindrical shape that corresponds to the shape of the drive portion (630) of the cutter overmold (620).
[0033] The inner diameter of the receiver (652) includes one or more engagement protrusions (654) that protrude into the hollow interior of the receiver (652). The protrusions (654) are configured to engage the channels (638) of the drive portion (630). Thus, the protrusions (654) can be used to mechanically ground the rotational motion of the cutter overmold (620) and the rotational motion of the rotating member (650). In this version, two protrusions (654) are used that correspond to the respective square or rectangular shapes of the corresponding channels (638). However, it should be understood that in other versions in which different channel (638) configurations are used, different corresponding protrusion (654) configurations can be used as well. In other words, the protrusions (654) and the channels (638) together define a keyed arrangement having a key-keyway configuration. Thus, it should be understood that in other versions, a variety of alternative keyed configurations may be used that may be configured to transfer rotational motion from the rotating member (650) to the cutter overmold (620).
[0034] Rotation gear (656) extends from the outer diameter of receiver (652) at the proximal end of receiver (652). Rotation gear (656) is configured to mesh with drive gear (660) and receive rotational motion from drive gear (656) to rotate receiver (652). In this version, rotation gear (656) is configured as a bevel gear such that drive gear (660) may be positioned at an angle relative to rotation gear (656). In other versions, rotation gear (656) may be configured as a spur gear, or any other suitable gear, to urge drive gear (660) in a different direction. Additionally, while in this version only drive gear (660) and rotation gear (656) are shown, it should be understood that in other versions additional gears may be used.
[0035] As best shown in FIG. 7, the cutter overmold (620) may be received within both the translation member (640) and the rotation member (650). In particular, the translation member (640) and the rotation member (650) may both be disposed along a common axis corresponding to the longitudinal axis of the cutter (150) and the cutter overmold (620). The translation member (640) and the rotation member (650) are generally proximate or adjacent to one another in this version, but may be spaced apart in other versions. The particular location of the translation member (640) relative to the rotation member (650) is such that the translation member (640) may engage the threaded portion (632) of the cutter overmold (620) and the rotation member (650) may engage the channel (638). Thus, the translation member (640) is located distal to the rotation member (650) in this version due to the particular configuration of the cutter overmold (150), although it should be understood that in some versions the locations of the translation member (640) and rotation member (650) may be reversed.
[0036] 8 illustrates the outer housing (670) of the probe (100) with the components of the cutter drive assembly (610) removed to show the internal geometry of the outer housing (670) in greater detail. As can be seen, the outer housing (670) includes variously shaped portions to hold the components of the cutter drive assembly (610) in place. Additionally, the outer housing (670) includes one or more resilience members (672) configured to act as integral return features by positively engaging at least a portion of the cutter drive assembly (610), as described in more detail below.
[0037] The resilience member (672) protrudes inwardly from an outer surface defined by the outer housing (670). The shape of the protrusion of the resilience member (672) is generally rectangular with a concave curvature on the outer end of the resilience member (672). As will be explained in more detail below, the concave curvature at the outer end of the resilience member (672) is generally configured to engage certain components of the cutter overmold (620). In the present version, a generally rectangular shape is used, but it should be understood that various other shapes may be used, such as a square shape, a triangular shape, an oval shape, etc.
[0038] The resilience member (672) is configured as a thin strip that is integral with the outer housing (670). The particular thickness of the resilience member (672) may be a function of both the particular material of the outer housing (670) and the thickness of the resilience member (672). For example, the resilience member (672) is generally configured to be relatively stationary or rigid to resist movement of a portion of the cutter drive assembly (610). Additionally, the resilience member (672) is also generally configured to provide some flexion in response to a portion of the cutter drive assembly (610) and to store potential energy from the cutter drive assembly (610) within the resilience member (672). In other words, the resilience member (672) may be generally configured to have resilience or spring-like properties. Thus, the resilience member (672) may have a variety of thicknesses depending on the mechanical properties of the material used for the outer housing (670).
[0039] 8 shows only a single resilience member (672), it should be understood that the present version includes two resilience members (672). For example, in the present version, the outer housing (670) is of a crimped shell configuration, so the version shown is one half of two roughly mirror image halves. Thus, the outer housing (670) may include another half that also includes a resilience member (672) substantially similar to the one shown (672).
[0040] 9A-10C illustrate an exemplary use of the cutter drive assembly (610) in communication with the resilience member (672) of the outer housing (670). As can be seen in FIGS. 9A and 10A, the cutter drive assembly (610) may be used initially to translate and simultaneously rotate the cutter (150). In this configuration, the drive gear (660) rotates in a first direction, driving the rotational motion of the rotating member (650) in a first direction (e.g., counterclockwise as shown in FIG. 9A) via the rotating gear (656).
[0041] Rotational movement of the rotational member (650) may result in corresponding rotational movement of the cutter overmold (610) and the cutter (150) due to engagement between the engagement protrusions (654) and the channels (638). Rotational movement of the cutter overmold (610) may in turn result in distal translational movement of the cutter overmold (610) and the cutter (150) due to engagement between the threads (646) of the translation member (640) and the threaded portion (632) of the cutter overmold (620).
[0042] When the cutter (150) is rotated and translated by the cutter overmold (610) as shown in Figures 9A and 10A, the resilience member (672) may remain adjacent to the cutter overmold (620) but may be disengaged from the cutter overmold (610) due to the configuration of the distal portion (622). In other words, the cutter overmold (610) may rotate and translate through a range of motion without engaging the resilience member (672).
[0043] The simultaneous translational and rotational movement of the cutter (150) through the cutter overmold (620) may continue until the threads (632) of the cutter overmold (620) disengage from the threads (646) of the translation member (640). In other words, the translational movement of the cutter overmold (620) may continue until the translation member (640) reaches the proximal zero pitch portion (636) of the cutter overmold (620). At this point, the cutter overmold (620) and cutter (150) may continue to be rotated by the rotation member (650) without further translation because there are no threads in the proximal zero pitch portion (636). In some circumstances, this condition may be referred to as "freewheeling."
[0044] As the threads (646) of the translation member (640) approach the proximal zero pitch portion (636), the resilience member (672) may engage the distal zero pitch portion (634) of the cutter overmold (620), as shown in Figures 9B and 10B. Further translational motion of the cutter overmold (620) may cause at least some bending or flexing of the resilience member (672) as the resilience member (672) absorbs translational kinetic energy from the cutter overmold (620). As a result, the resilience member (672) may exert a force on the cutter overmold (620) in a proximal direction.
[0045] With the resilience member (672) engaged with the cutter overmold (620), as shown in Figures 9B and 10B, at least some engagement between the threads (646) of the translation member (640) and the threads (632) of the cutter overmold (620) may be maintained by the proximal force applied by the resilience member (672). Even during this partially engaged state, the cutter overmold (620) may be free to rotate. Additionally, some slight vibration or back and forth translation of the cutter overmold (620) and cutter (150) may occur as the ends of the threads (646) and threads (632) interact with one another.
[0046] After distal translation of the cutter (150) is completed, it may be desirable to reverse the translation of the cutter (150) from the distal to the proximal direction. For example, distal translation of the cutter (150) may be used to close the lateral aperture (114) to cut a tissue sample, and proximal translation of the cutter (150) may be used to open the lateral aperture (114) to receive tissue. As shown in FIG. 9C, the translation direction of the cutter (150) may be reversed by reversing the direction of rotational motion of the drive gear (660) from the first direction described above to an opposite second direction. As a result, the rotating member (650) may be reversed in the opposite second direction (e.g., clockwise as shown in FIG. 9C).
[0047] Upon reversal of the rotational motion of the rotating member (650), the force generated by the resilience member (672) may be beneficial in facilitating full engagement between the threads (632) of the cutter overmold (620) and the threads (646) of the translation member (640). In particular, as described above, the resilience member (672) may impart a proximal force to the cutter overmold (620) when engaging the distal zero pitch portion (634) of the cutter overmold (620). With this proximal force applied, the threads (632) and threads (646) may easily re-engage when the rotational motion of the cutter overmold (620) is reversed by the rotating member (650).
[0048] Upon re-engagement of the threads (632) and the threads (646), the cutter overmold (620) and the cutter (150) may rotate and simultaneously translate through a range of proximal translation. As best shown in Figures 9D and 10C, the proximal translation of the cutter overmold (620) and the cutter (150) may continue until the threads (646) of the translation member (640) reach the distal end of the threads (632) of the cutter overmold (620). In other words, the proximal translation of the cutter overmold (620) may continue until the threads (646) of the translation member (640) reach the distal zero pitch portion (634) of the cutter overmold (620). At this point, the threads (632) and the threads (646) may at least partially disengage from one another such that continued rotational movement of the rotating member (650) causes rotational movement of the cutter overmold (620).
[0049] As the threads (646) of the translation member (640) approach the distal zero pitch portion (634), the resilience member (672) may engage the flange (624) of the cutter overmold (620), as shown in FIGS. 9D and 10C. Thus, it should be understood that there may be a predetermined relationship between the location of the flange (624), the distal zero pitch portion (634), and the length of the threaded portion (632). In this version, the flange (624) is separated from the distal zero pitch portion (634) by a length that approximately corresponds to the length of the threaded portion (632). Further translational motion of the cutter overmold (620) may cause at least some bending or flexing of the resilience member (672) as the resilience member absorbs translational kinetic energy from the cutter overmold (620). As a result, the resilience member (672) may exert a force on the cutter overmold (620) in a distal direction.
[0050] With the resilience member (672) engaged with the flange (624) of the cutter overmold (620), as shown in Figures 9D and 10C, at least some engagement between the threads (646) of the translation member (640) and the threads (632) of the cutter overmold (620) may be maintained by the distal force applied by the resilience member (672). Even during this partially engaged state, the cutter overmold (620) may be free to rotate. Additionally, some slight vibration or back and forth translation of the cutter overmold (620) and cutter (150) may occur as the ends of the threads (646) and threads (632) interact with one another.
[0051] After the proximal translation of the cutter (150) is completed, it may be desirable to reverse the translation of the cutter (150) from the proximal direction back to the distal direction. The direction of translation of the cutter (150) may be reversed in a similar manner by reversing the direction of rotational motion of the drive gear (660) from the second direction to the first direction, such that the rotational member (650) may also be reversed in the first direction.
[0052] Upon reversal of the rotational motion of the rotating member (650), the force generated by the resilience member (672) may be beneficial in facilitating full engagement between the threads (632) of the cutter overmold (620) and the threads (646) of the translating member (640). In particular, as described above, the resilience member (672) may exert a distal force on the cutter overmold (620) when engaging the flange (624) of the cutter overmold (620). With this distal force applied, the threads (632) and threads (646) may readily re-engage upon reversal of the rotational motion of the cutter overmold (620) by the rotating member (650).
[0053] III. Exemplary Combinations The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any "claims" that may be presented at any time in this application or in any subsequent application following this application. No disclaimers are intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features that are referred to in the examples below. Thus, unless expressly indicated otherwise later by the inventor or by the intended inventor's successors, etc., none of the aspects or features referred to below should be considered critical. If any "claims" are presented in this application or in any subsequent application related to this application that include additional features beyond those referred to below, those additional features should not be presumed to have been added for any reason related to patentability.
[0054] Example 1 1. A biopsy device comprising: a body including an outer housing; a needle extending distally from the body; a cutter configured to rotate and translate relative to the needle; and a cutter drive assembly including a cutter overmold secured to a portion of the cutter, the cutter overmold including a threaded portion and one or more channels, the threaded portion configured to drive translational motion of the cutter and the one or more channels configured to drive rotational motion of the cutter; wherein the outer housing defines a resilience member extending inwardly from an inner surface of the outer housing, the resilience member configured to engage the cutter overmold and apply either a proximal force or a distal force to the cutter overmold.
[0055] Example 2 The biopsy device of example 1, wherein the resilience member is configured to apply both the proximal force and the distal force to the cutter overmold.
[0056] Example 3 The biopsy device of example 2, wherein the resilience member is configured to apply the proximal force or the distal force to the cutter overmold depending on the orientation of the cutter overmold relative to the resilience member.
[0057] Example 4 The biopsy device of any one of Examples 1 to 3, wherein the cutter overmold defines a distal zero pitch portion and a proximal zero pitch portion, and the threaded portion is disposed between the distal zero pitch portion and the proximal zero pitch portion.
[0058] Example 5 The biopsy device of example 4, wherein the resilience member is configured to engage the distal zero pitch portion.
[0059] Example 6 A biopsy device as described in any of Examples 1 to 5, wherein the resilience member is a first resilience member and the outer housing further defines a second resilience member, and the first resilience member and the second resilience member extend inwardly in opposite directions from the inner surface of the outer housing.
[0060] Example 7 A biopsy device described in any of Examples 1 to 6, wherein the cutter drive assembly further includes a translation member and a rotation member, the translation member configured to engage the threaded portion of the cutter overmold, and the rotation member configured to engage the one or more channels of the cutter overmold.
[0061] Example 8 The biopsy device of example 7, wherein the rotating member is further configured to receive a single rotational input that simultaneously drives rotational and translational motion of the cutter.
[0062] Example 9 The biopsy device of any one of Examples 7 to 8, wherein the translation member includes one or more threads configured to engage the threaded portion of the cutter overmold.
[0063] Example 10 The biopsy device of Example 9, wherein the resilience member is configured to maintain at least partial engagement between the one or more threads of the translation member and the threaded portion of the cutter overmold during a reversal of the translational motion direction of the cutter.
[0064] Example 11 The biopsy device of Example 9, wherein the resilience member is configured to maintain at least partial engagement between the one or more threads of the translation member and the threaded portion of the cutter overmold during reversal of translational motion of the cutter from the distal direction to the proximal direction, and during return of translational motion of the cutter from the proximal direction to the distal direction.
[0065] Example 12 The biopsy device according to any one of Examples 1 to 11, wherein the resilience member is configured to engage and disengage from the cutter overmold within a predetermined range of cutter translational motion.
[0066] Example 13 13. The biopsy device according to any one of Examples 1 to 12, wherein the cutter overmold is configured to rotate freely relative to the resilience member.
[0067] Example 14 The biopsy device of any one of Examples 1 to 13, wherein the cutter overmold further comprises a flange, and the resilience member is configured to engage the flange.
[0068] Example 15 15. The biopsy device of example embodiment 14, wherein the flange is disposed distal to the threaded portion.
[0069] Example 16 1. A probe for use with a biopsy device comprising: a housing; a needle extending distally from the housing; a cutter configured to rotate and translate relative to the needle; and a cutter drive assembly including a sleeve coaxial with the cutter and configured to drive the rotational and translational motion of the cutter, the sleeve including a threaded portion and a keyed portion, the threaded portion configured to drive the translational motion of the cutter and the keyed portion configured to drive the rotational motion of the cutter, a portion of the housing extending into a hollow interior of the outer housing to engage at least a portion of the sleeve when the sleeve is in a distal and proximal position.
[0070] Example 17 The probe of Example 16, wherein the portion of the housing extending into the hollow interior of the outer housing includes an elongated strip, the elongated strip configured to bend in response to movement of the sleeve within the housing.
[0071] Example 18 The probe of Example 17, wherein the sleeve includes a flange and a distal zero pitch portion, and the elongated strip is configured to alternately engage the flange and the distal zero pitch portion to maintain engagement between the threaded portion and a portion of the cutter drive assembly.
[0072] Example 19 The probe of example 18, wherein the flange and the distal zero pitch portion are separated by a first length, the threaded portion defines a second length, and the first length corresponds to the second length.
[0073] Example 20 1. A probe for use with a biopsy device comprising: a housing; a needle extending distally from the housing; a cutter configured to rotate and translate relative to the needle; a cutter drive assembly including a sleeve coaxial with a longitudinal axis defined by the cutter and configured to drive the rotational and translational motion of the cutter, the sleeve including a threaded portion and a keyed portion, the threaded portion configured to drive the translational motion of the cutter and the keyed portion configured to drive the rotational motion of the cutter; and a flipping mechanism mechanically grounded to a portion of the housing, the flipping mechanism configured to bias the sleeve in a predetermined direction parallel to the longitudinal axis of the cutter.
[0074] IV. Conclusion It should be recognized that any patent, publication, or other disclosure material referred to as being incorporated herein in whole or in part by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. Thus, and to the extent necessary, the disclosure expressly set forth herein takes precedence over any conflicting material incorporated herein by reference. Any material, or portion thereof, referred to as being incorporated herein by reference but which conflicts with existing definitions, statements, or other disclosure material set forth herein, is incorporated only to the extent that no conflict arises between the incorporated material and the existing disclosure material.
[0075] Embodiments of the present invention have application in conventional endoscopic and open surgical instrumentation, as well as in robotic-assisted surgery.
[0076] By way of example only, the embodiments described herein may be processed prior to a surgical procedure. First, new or used instruments may be obtained and cleaned as necessary. The instruments may then be sterilized. In one sterilization technique, the instruments are placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instruments may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high energy electrons. The radiation may kill bacteria within the instruments and container. The sterilized instruments may then be stored in the sterile container. The sealed container may keep the instruments sterile until opened in the medical facility. The device may also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.
[0077] Embodiments of the devices disclosed herein can be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. Specifically, embodiments of the devices disclosed herein may be disassembled and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, embodiments of the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. One of ordinary skill in the art will recognize that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
[0078] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Although some of such potential modifications have been mentioned, others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. described above are illustrative and not required. Thus, it is understood that the scope of the present invention should be considered in conjunction with the following "claims" and is not limited to the details of structure and operation shown and described in the specification and drawings.
[0079] [Embodiment] (1) A biopsy device comprising: (a) a body including an outer housing; (b) a needle extending distally from the body; and (c) a cutter configured to rotate and translate relative to the needle; (d) a cutter drive assembly, the cutter drive assembly including a cutter overmold secured to a portion of the cutter, the cutter overmold including a threaded portion and one or more channels, the threaded portion configured to drive translational movement of the cutter and the one or more channels configured to drive rotational movement of the cutter; and Equipped with The biopsy device, wherein the outer housing defines a resilience member extending inwardly from an inner surface of the outer housing, the resilience member configured to engage the cutter overmold and apply either a proximal force or a distal force to the cutter overmold. (2) A biopsy device as described in embodiment 1, wherein the resilience member is configured to apply both the proximal force and the distal force to the cutter overmold. (3) The biopsy device of embodiment 2, wherein the resilience member is configured to apply the proximal force or the distal force to the cutter overmold depending on the orientation of the cutter overmold relative to the resilience member. (4) A biopsy device described in any one of embodiments 1 to 3, wherein the cutter overmold defines a distal zero pitch portion and a proximal zero pitch portion, and the threaded portion is disposed between the distal zero pitch portion and the proximal zero pitch portion. (5) The biopsy device of claim 4, wherein the resilience member is configured to engage the distal zero pitch portion.
[0080] (6) A biopsy device described in any one of embodiments 1 to 5, wherein the resilience member is a first resilience member and the outer housing further defines a second resilience member, and the first resilience member and the second resilience member extend inwardly in opposite directions from the inner surface of the outer housing. (7) A biopsy device described in any one of embodiments 1 to 6, wherein the cutter drive assembly further includes a translation member and a rotation member, the translation member configured to engage the threaded portion of the cutter overmold, and the rotation member configured to engage the one or more channels of the cutter overmold. (8) The biopsy device of embodiment 7, wherein the rotating member is further configured to receive a single rotational input that simultaneously drives rotational and translational motion of the cutter. (9) The biopsy device of any one of claims 7 to 8, wherein the translation member includes one or more threads configured to engage the threaded portion of the cutter overmold. (10) The biopsy device of embodiment 9, wherein the resilience member is configured to maintain at least partial engagement between the one or more threads of the translation member and the threaded portion of the cutter overmold during reversal of the translational direction of the cutter.
[0081] (11) The biopsy device of embodiment 9, wherein the resilience member is configured to maintain at least partial engagement between the one or more threads of the translation member and the threaded portion of the cutter overmold during reversal of translational motion of the cutter from the distal direction to the proximal direction, and during return of translational motion of the cutter from the proximal direction to the distal direction. (12) The biopsy device according to any one of embodiments 1 to 11, wherein the resilience member is configured to engage and disengage from the cutter overmold within a predetermined range of cutter translational motion. (13) The biopsy device according to any one of embodiments 1 to 12, wherein the cutter overmold is configured to rotate freely relative to the resilience member. (14) The biopsy device of any one of embodiments 1 to 13, wherein the cutter overmold further includes a flange, and the resilience member is configured to engage the flange. (15) The biopsy device of embodiment 14, wherein the flange is disposed distal to the threaded portion.
[0082] (16) A probe for use with a biopsy device, comprising: (a) a housing; (b) a needle extending distally from the housing; and (c) a cutter configured to rotate and translate relative to the needle; (d) a cutter drive assembly including a sleeve coaxial with the cutter and configured to drive rotational and translational motion of the cutter, the sleeve including a threaded portion and a keyed portion, the threaded portion configured to drive translational motion of the cutter and the keyed portion configured to drive rotational motion of the cutter; and Including, The probe, wherein a portion of the housing extends into a hollow interior of the outer housing to engage at least a portion of the sleeve when the sleeve is in a distal position and a proximal position. (17) The probe of claim 16, wherein the portion of the housing extending into the hollow interior of the outer housing includes an elongated strip, the elongated strip configured to bend in response to movement of the sleeve within the housing. (18) The probe of claim 17, wherein the sleeve includes a flange and a distal zero pitch portion, and the elongated strip is configured to alternately engage the flange and the distal zero pitch portion to maintain engagement between the threaded portion and a portion of the cutter drive assembly. (19) The probe of claim 18, wherein the flange and the distal zero pitch portion are separated by a first length, the threaded portion defines a second length, and the first length corresponds to the second length. (20) A probe for use with a biopsy device, comprising: (a) a housing; (b) a needle extending distally from the housing; and (c) a cutter configured to rotate and translate relative to the needle; (d) a cutter drive assembly including a sleeve coaxial with a longitudinal axis defined by the cutter and configured to drive rotational and translational motion of the cutter, the sleeve including a threaded portion and a keyed portion, the threaded portion configured to drive translational motion of the cutter and the keyed portion configured to drive rotational motion of the cutter; and (e) a flipping mechanism mechanically grounded to a portion of the housing, the flipping mechanism configured to bias the sleeve in a predetermined direction parallel to the longitudinal axis of the cutter; and The probe comprising:
Claims
1. 1. A biopsy device comprising: (a) a body including an outer housing; (b) a needle extending distally from the body; and (c) a cutter configured to rotate and translate relative to the needle; (d) a cutter drive assembly, the cutter drive assembly including a cutter overmold secured to a portion of the cutter, the cutter overmold including a threaded portion and one or more channels, the threaded portion configured to drive translational movement of the cutter and the one or more channels configured to drive rotational movement of the cutter; and Equipped with The biopsy device, wherein the outer housing defines a resilience member extending inwardly from an inner surface of the outer housing, the resilience member configured to engage the cutter overmold and apply either a proximal force or a distal force to the cutter overmold.
2. The biopsy device of claim 1 , wherein the resilience member is configured to apply both the proximal force and the distal force to the cutter overmold.
3. The biopsy device of claim 2 , wherein the resilience member is configured to apply the proximal force or the distal force to the cutter overmold depending on the orientation of the cutter overmold relative to the resilience member.
4. The biopsy device of any one of claims 1 to 3, wherein the cutter overmold defines a distal zero pitch portion and a proximal zero pitch portion, and the threaded portion is disposed between the distal zero pitch portion and the proximal zero pitch portion.
5. The biopsy device of claim 4 , wherein the resilience member is configured to engage the distal zero pitch portion.
6. 2. The biopsy device of claim 1, wherein the resilience member is a first resilience member and the outer housing further defines a second resilience member, the first resilience member and the second resilience member extending inwardly in opposite directions from the inner surface of the outer housing.
7. 2. The biopsy device of claim 1, wherein the cutter drive assembly further comprises a translation member and a rotation member, the translation member configured to engage the threaded portion of the cutter overmold and the rotation member configured to engage the one or more channels of the cutter overmold.
8. The biopsy device of claim 7 , wherein the rotating member is further configured to receive a single rotational input that simultaneously drives rotational and translational motion of the cutter.
9. The biopsy device of claim 7 or 8, wherein the translation member includes one or more threads configured to engage the threaded portion of the cutter overmold.
10. 10. The biopsy device of claim 9, wherein the resilience member is configured to maintain at least partial engagement between the one or more threads of the translation member and the threaded portion of the cutter overmold during a reversal of a translational direction of the cutter.
11. 10. The biopsy device of claim 9, wherein the resilience member is configured to maintain at least partial engagement between the one or more threads of the translation member and the threaded portion of the cutter overmold during reversal of translational motion of the cutter from a distal direction to a proximal direction and during return of translational motion of the cutter from the proximal direction to the distal direction.
12. The biopsy device of claim 1 , wherein the resilience member is configured to engage and disengage from the cutter overmold at a predetermined range of cutter translational motion.
13. The biopsy device of claim 1 , wherein the cutter overmold is configured to freely rotate relative to the resilience member.
14. The biopsy device of claim 1 , wherein the cutter overmold further comprises a flange, and the resilience member is configured to engage the flange.
15. The biopsy device of claim 14 , wherein the flange is disposed distally of the threaded portion.
16. 1. A probe for use with a biopsy device, comprising: (a) a housing; (b) a needle extending distally from the housing; and (c) a cutter configured to rotate and translate relative to the needle; (d) a cutter drive assembly including a sleeve coaxial with the cutter and configured to drive rotational and translational motion of the cutter, the sleeve including a threaded portion and a keyed portion, the threaded portion configured to drive translational motion of the cutter and the keyed portion configured to drive rotational motion of the cutter; and Including, The probe, wherein a portion of the housing extends into a hollow interior of the outer housing to engage at least a portion of the sleeve when the sleeve is in a distal position and a proximal position.
17. The probe of claim 16 , wherein the portion of the housing that extends into the hollow interior of the outer housing includes an elongated strip, the elongated strip configured to bend in response to movement of the sleeve within the housing.
18. 18. The probe of claim 17, wherein the sleeve includes a flange and a distal zero pitch portion, and the elongated strip is configured to alternately engage the flange and the distal zero pitch portion to maintain engagement between the threaded portion and a portion of the cutter drive assembly.
19. 20. The probe of claim 18, wherein the flange and the distal zero pitch portion are separated by a first length, and the threaded portion defines a second length, the first length corresponding to the second length.
20. 1. A probe for use with a biopsy device, comprising: (a) a housing; (b) a needle extending distally from the housing; and (c) a cutter configured to rotate and translate relative to the needle; (d) a cutter drive assembly including a sleeve coaxial with a longitudinal axis defined by the cutter and configured to drive rotational and translational motion of the cutter, the sleeve including a threaded portion and a keyed portion, the threaded portion configured to drive translational motion of the cutter and the keyed portion configured to drive rotational motion of the cutter; and (e) a flipping mechanism mechanically grounded to a portion of the housing, the flipping mechanism configured to bias the sleeve in a predetermined direction parallel to the longitudinal axis of the cutter; and The probe comprising: