Sample management for core needle biopsy devices.

Abstract

1. A core needle biopsy device comprising: a needle assembly including a lancet and a hollow cutter, the lancet including a sharp distal tip and a notch proximal to the distal tip, the lancet being slidably disposed within the cutter to cut a tissue sample into the notch in the lancet; a drive assembly configured to selectively move the lancet and the cutter; and a tissue sample holder including a sample chamber, a fluid source, and a nozzle, the fluid source configured to eject liquid or gas from the nozzle onto a portion of the biopsy device to manipulate the cut tissue sample into the sample chamber.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 435,649, entitled "Sample Management for Core Needle Biopsy Device," filed December 28, 2022, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] A biopsy is the removal of a tissue sample from a patient so that the tissue can be examined for signs of cancer or other disorders. Tissue samples can be obtained in a variety of ways using a variety of medical procedures involving a variety of sample collection devices. For example, a biopsy can be an open procedure (surgical removal of tissue after making an incision) or a percutaneous procedure (e.g., by fine needle aspiration, core needle biopsy, or vacuum biopsy). After the tissue sample is collected, it is typically analyzed in a laboratory (e.g., a pathology laboratory, a biomedical laboratory, etc.) set up to perform the appropriate tests (e.g., histological analysis).

[0003] Biopsy samples have been obtained in a variety of ways in various medical procedures, including open and percutaneous methods, using a variety of devices. For example, some biopsy devices may be fully operable by a user with one hand and a single insertion to obtain one or more biopsy samples from a patient. Additionally, some biopsy devices may be tethered to a vacuum module and / or a control module for fluid communication (e.g., pressurized air, saline, atmosphere, vacuum, etc.), for power transmission, and / or for command transmission, etc. Other biopsy devices may be fully or at least partially operable without being tethered or otherwise connected to another device.

[0004] One technique for collecting breast biopsies involves the use of a core needle biopsy device. One such device is the MAX-CORE disposable core biopsy instrument manufactured by Bard Biopsy Systems. Core needle biopsy devices often use a sharp, solid lancing tool with a lateral tissue-receiving notch located adjacent the distal end of the lancing tool. Once tissue is received within the notch, an elongated, hollow cutting sheath translates over the notch to sever the tissue sample. The severed tissue sample is then stored within the notch until both the lancing tool and the cutting sheath are removed from the patient. Thus, core needle biopsy devices are capable of collecting only one tissue sample per insertion of the lancing tool and cutting sheath.

[0005] In contrast to core needle breast biopsy procedures, vacuum-assisted breast biopsy devices allow the probe to extract multiple samples without the need to remove the probe from the breast after each sample collection. For example, vacuum-assisted breast biopsy devices use a hollow needle to penetrate tissue. The hollow needle has a lateral opening adjacent to a sharp distal tip. A hollow cutter is disposed within the hollow needle, and the hollow cutter is moved axially relative to the lateral opening of the needle to sever the tissue sample. Once the tissue sample is severed by the hollow cutter, it is transported axially through the cutter and collected in a tissue collection feature.

[0006] Examples of suction biopsy devices and biopsy system components are disclosed in U.S. Patent No. 5,526,822, issued June 18, 1996, entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue," U.S. Patent No. 6,086,544, issued July 11, 2000, entitled "Control Apparatus for an Automated Surgical Biopsy Device," U.S. Patent No. 6,162,187, issued December 19, 2000, entitled "Fluid Collection Apparatus for a Surgical Device," U.S. Patent No. 6,432,065, issued August 13, 2002, entitled "Method for Using a Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Patent No. 6,432,065, issued June 22, 2004, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," and U.S. Patent No. 6,432,065, issued June 22, 2004, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode." U.S. Patent No. 6,752,768, issued on October 8, 2008, entitled "Remote Thumbwheel for a Surgical Biopsy Device," U.S. Patent No. 7,442,171, issued on December 1, 2010, entitled "Clutch and Valving System for Tetherless Biopsy Device," U.S. Patent No. 7,854,706, issued on December 1, 2010, entitled "Clutch and Valving System for Tetherless Biopsy Device," U.S. Patent No. 7,914,464, issued on March 29, 2011, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Patent No. 7,938, issued on May 10, 2011, entitled "Vacuum Timing Algorithm for Biopsy Device,"No. 786, issued on December 21, 2011, entitled "Tissue Biopsy Device with Rotatably Linked Thumbwheel and Tissue Sample Holder," U.S. Patent No. 8,083,687, issued on February 1, 2012, entitled "Biopsy Sample Storage," U.S. Patent No. 8,118,755, issued on February 1, 2012, entitled "Tetherless Biopsy Device with Reusable Portion," U.S. Patent No. 8,206,316, issued on June 26, 2012, entitled "Biopsy Device with Discrete Tissue Chambers," U.S. Patent No. 8,702,623, issued on April 22, 2014, entitled "Biopsy Device with Motorized Needle Firing," U.S. Patent No. 8,858,465, issued on October 14, 2014, entitled "Biopsy Device with Motorized Needle Firing," and U.S. Patent No. 8,858,465, issued on May 3, 2016, entitled "Biopsy Device Tissue Sample Holder with Bulk Chamber and Pathology No. 9,326,755 entitled "Suitable for a Parallel Compression Chamber," the disclosures of each of these cited U.S. patents are incorporated herein by reference.

[0007] Additional examples of suction biopsy devices and biopsy system components are described in U.S. Publication No. 2006 / 0074345, published April 6, 2006, now abandoned, entitled "Biopsy Apparatus and Method," U.S. Publication No. 2009 / 0131821, published May 21, 2009, now abandoned, entitled "Graphical User Interface for Biopsy System Control Module," U.S. Publication No. 2010 / 0152610, published June 17, 2010, now abandoned, entitled "Hand Actuated Tetherless Biopsy Device with Pistol Grip," U.S. Publication No. 2010 / 0160819, published June 24, 2010, now abandoned, entitled "Biopsy Device with Central Thumbwheel," and U.S. Publication No. 2010 / 0160819, published December 5, 2013, now abandoned, entitled "Control for Biopsy System Control Module." and U.S. Publication No. 2013 / 0324882, entitled "Method and Apparatus for Promoting a Novel Electrode-Based Imaging Device." The disclosure of each of the above U.S. patent application publications is incorporated herein by reference.

[0008] Examples of core needle biopsy devices are disclosed in U.S. Patent No. 5,560,373, entitled "Needle Core Biopsy Instrument with Durable or Disposable Cannula Assembly," issued October 1, 1996; U.S. Patent No. 5,817,033, entitled "Needle Core Biopsy Device," issued October 6, 1998; U.S. Patent No. 5,971,939, entitled "Needle Core Biopsy Device," issued October 26, 1999; and U.S. Patent No. 5,511,556, entitled "Needle Core Biopsy Instrument," issued April 30, 1996. The disclosures of each of the above U.S. patents are incorporated herein by reference.

[0009] In some instances, it may be desirable to combine the features of core needle biopsy devices and suction biopsy devices to obtain the benefits of both devices and also to reduce their overall disadvantages. For example, core needle biopsy devices may be advantageous due to their simplicity, lightness, and ease of use. Furthermore, core needle biopsy devices generally include smaller needle sizes, which may be desirable for improving patient comfort and recovery time. On the other hand, suction biopsy devices may be advantageous due to their ability to collect multiple samples with a single insertion. Therefore, a simple, lightweight biopsy device capable of collecting multiple samples with a single insertion may be desirable.

[0010] One challenge in using a biopsy device can be managing the tissue sample after it is collected using the biopsy device. In some instances where a core needle biopsy device is used, problems can arise due to the unique configuration of the needle and cutter. For example, the cutter may be on the inner piercer, stylet, or exterior of the needle. In that case, a notch in the inner piercer may be used to convey the severed tissue sample through the cutter. While using a notch can improve sample collection in some scenarios, collection of the severed tissue sample from the notch can be difficult due to the size and / or shape of the notch and the properties of the severed tissue sample (e.g., "adhesive" or "sticky"). Therefore, it may be desirable to integrate certain tissue sample collection features into a biopsy device that combines features of core needle biopsy devices and suction-assisted biopsy devices.

[0011] Although several systems and methods have been made and used for obtaining biopsy samples, it is believed that no one prior to the present inventors has made or used the invention as set forth in the appended claims.

[0012] While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed the present invention will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which some components or portions of components are shown in perspective, as indicated by dashed lines. [Brief explanation of the drawings]

[0013] [Figure 1] 1 shows a perspective view of a version of a core needle biopsy device. [Figure 2] 2 shows an exploded view of the needle assembly of the core needle biopsy device of FIG. 1; [Figure 3] 3 shows a schematic diagram of the needle assembly of FIG. 2 along with a drive assembly and tissue handler. [Figure 4] 4 shows a schematic diagram of the tissue handler of FIG. 3, the tissue handler including an extraction mechanism. [Figure 5] 4 shows a perspective view of another extraction mechanism, which is incorporated into the drive assembly of FIG. 3; [Figure 6] 6 shows an exploded perspective view of the extraction mechanism of FIG. 5. [Figure 7] FIG. 6 shows a detailed perspective view of a retraction mechanism for use with the actuator of the extraction mechanism of FIG. 5; [Figure 8A] 6 illustrates a cross-sectional view of the extraction mechanism of FIG. 5, with the actuator of the extraction mechanism in a cocking configuration. [Figure 8B] 6 illustrates another cross-sectional view of the extraction mechanism of FIG. 5, with the actuator of the extraction mechanism in a starting configuration. [Figure 9] 1. FIG. 4 shows a perspective view of yet another extraction mechanism for incorporation into the biopsy device of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0014] The drawings are not intended to be limiting in any way, and it is envisioned that various embodiments of the invention may be practiced in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention. It will be understood, however, that the invention is not limited to the precise configurations shown.

[0015] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description. The following description illustrates one of the best modes contemplated for carrying out the present invention. As will be understood, the present invention is capable of other different and obvious aspects, all without departing from the present invention. Accordingly, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0016] Biopsy devices can be utilized to collect tissue samples in a variety of ways. For example, in some instances, tissue samples are collected in a single tissue basket, such that all tissue samples collected during a given biopsy procedure are accumulated in the single tissue sample basket. In some other instances, tissue samples are collected in a tissue sample holder having a separate compartment for each collected tissue sample. Such multi-compartment tissue sample holders may further include trays or strips that hold each tissue sample separately from the other tissue samples. Such trays or strips may be removable or otherwise separable from the tissue sample holder upon completion of the biopsy procedure.

[0017] Regardless of the structure in which the tissue sample is stored, the tissue sample may be collected using a biopsy device under the guidance of various imaging modalities, such as ultrasound imaging guidance, stereotactic (X-ray) guidance, MRI guidance, positron emission mammography ("PEM") guidance, breast-specific gamma imaging ("BSGI") guidance, etc. Each procedure has its own methodology based on the form of imaging guidance used.

[0018] Both suction biopsy devices and core needle biopsy devices may have various advantages over the other, depending on the situation. For example, one advantage of suction biopsy devices is that they allow for the extraction of multiple tissue samples with a single insertion, due to vacuum assistance. However, core needle biopsy devices lack this feature, although their use may be desirable in some scenarios. For example, core needle biopsy devices may generally include a smaller needle than suction biopsy devices, thereby reducing patient anxiety and increasing the needle's ability to penetrate the lesion. Therefore, in some cases, it may be desirable to incorporate the multiple sample extraction feature of a suction biopsy device into a core needle biopsy device to obtain the benefits present in both styles of biopsy devices.

[0019] A desirable feature of the devices described herein that are core needle biopsy devices is that they allow for the acquisition of multiple samples with a single insertion while still using a core needle type device. To facilitate this function, the biopsy device further comprises a tissue sample holder having one or more features that facilitate the collection of cut tissue samples from notches, dugouts, openings, and / or other sample collection features.

[0020] 1. Example of a core needle biopsy device with multiple sample collection

[0021] FIG. 1 illustrates one version of a core needle biopsy device 10 for use in a breast biopsy procedure. This version of the core needle biopsy device 10 includes a body 12 and a needle assembly 20 extending distally from the body 12. The body 12 includes an outer housing 14 and an actuation member 16 disposed on the outer housing 14. As described in further detail below, the outer housing 14 encloses various components of the biopsy device 10, which are used to drive the needle assembly 20 through cutting and tissue-grabbing cycles. To this end, this version of the outer housing 14 is sized and shaped to be grasped by an operator in one hand. While not shown, it should be understood that in some versions, the outer housing 14 may include multiple sections interconnected to form the outer housing 14.

[0022] A. Example of a needle assembly

[0023] Figures 2 and 3 show needle assembly 20 in more detail. As shown in Figure 2, needle assembly 20 includes an elongated lancer 22 and an elongated cutter 40. As described in more detail below, lancer 22 is generally movable relative to cutter 40 to pierce tissue and collect a tissue sample, and the cutter is generally movable relative to lancer 22 to sever the tissue sample. lancer 22 includes a generally cylindrical rod 28 (also referred to as a shaft) having a sharpened distal tip 24 and a notch 26 disposed proximate distal tip 24. As described in more detail below, distal tip 24 is generally configured to penetrate tissue of a patient. Also, notch 26 is generally configured to receive tissue therein so that the tissue sample may be collected therein after it has been severed by cutter 40, as described in more detail below.

[0024] The end portion (30) is disposed at the proximal end of the lancet (22). This version of the end portion (30) is overmolded or otherwise fixedly attached to the proximal end of the lancet (22) and is generally configured to enhance maneuverability of the lancet (22). Specifically, the end portion (30) includes a receiving feature (32) in the form of a cylindrical recess. The receiving feature (32) is configured to receive a portion of the lancet drive assembly (130). Thus, the receiving feature (32) in this version may be configured as a carriage or other engagement feature configured to facilitate driving the lancet (22). As described in more detail below, this feature enables the lancet drive assembly (130) to drive the movement of the lancet (22) through a predetermined movement sequence.

[0025] Cutter (40) comprises a generally hollow cylindrical tube configured to receive lancer (22) therein. Cutter (40) comprises an open distal end (42), a cannula portion (44), and an end portion (50). Open distal end (42) is configured to allow at least a portion of lancer (22) to protrude from cutter (40) when lancer (22) is moved relative to cutter (40). In some versions, such as the illustrated version, open distal end (42) may also be oriented obliquely relative to the longitudinal axis of cutter (40). In other versions, open distal end (42) may alternatively be perpendicular to the longitudinal axis of cutter (40). As described in more detail below, this configuration allows needle assembly (20) to move through cutting and tissue-grabbing cycles by allowing notch (26) of lancer (22) to move relative to distal end (42) of cutter (40).

[0026] The open distal end (42) of this version includes a tapered edge (43). The tapered edge (43) is generally configured to cut through tissue and separate the tissue sample when the cutter (40) is moved relative to the notch (26) of the lancing device (22). It should be understood, therefore, that the tapered edge (43) is generally configured to function as a blade. While this version is described and illustrated as using a tapered configuration, it should be understood that in other versions, various alternative configurations may be used. For example, in some versions, the tapered edge (43) includes multiple serrated edges in addition to or instead of the illustrated taper. In still other versions, the tapered edge (43) may include any other additional or alternative cutting surface, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0027] Cannula portion (44) of cutter (40) extends proximally from distal end (42) through end portion (50) so that lancer (22) can be received at the proximal end of cutter (40). Unlike end portion (30) of lancer (22), end portion (50) of cutter (40) is generally elongated to allow end portion (50) to accommodate additional features, which will be described in more detail below. In this version, the distal extension of end portion (50) may be relative to outer housing (14) to allow a portion of end portion (50) to be more accessible to an operator for tissue sample collection purposes. Various suitable tissue collection features associated with end portion (50) are described in more detail below.

[0028] The end (50) of the cutter (40) includes a cutter collar (52), a piercer collar (53), a drive feature (54), and a tissue collection feature (60) (also referred to as a ledge, primary ledge, wiper catch, or wiper engagement feature) disposed between the cutter collar (52) and the drive feature (54). The cutter collar (52) is generally configured to receive the proximal end of the cutter (40) and securely secure the cutter (40) to the end (50). Additionally, the cutter collar (52) is configured to facilitate access of the piercer (22) to the cutter (40). In this configuration, the piercer (22) is slidably disposed within the end (50) and can extend distally through the cutter (40). As described in more detail below, this configuration may allow the puncture tool (22) to slide proximally within the cutter (40) and end (50) to retract the notch (26) from the proximal end of the cutter (40), thereby exposing the notch (26) within the tissue collection feature (60).

[0029] Lance collar (53) extends distally from a portion of drive feature (54) and is generally configured to slidably receive a portion of lance (22). Specifically, lance collar (53) is disposed along a common axis with cutter (40) and cutter collar (52) such that lance (22) is aligned with cutter (40) along the same common axis. Thus, cutter (40), cutter collar (52), and lance collar (53) may be configured to work cooperatively to maintain lance (22) along the common axis. As described in more detail below, this feature may be desirable during use to remove a tissue sample from notch (26) when notch (26) is disposed within tissue collection feature (60).

[0030] Drive features (54) on end (50) are generally configured to engage features on cutter drive assembly (120) for manipulating cutter (40) through a predetermined movement sequence via drive end (50). While a variety of suitable configurations may be used, in this version, drive features (54) include drive openings (56) and release openings (58). Each opening (56, 58) may be configured to engage with a corresponding component of cutter drive assembly (120) to enable manipulation of cutter (40) via end (50).

[0031] The tissue collection feature (60) is disposed distally relative to the drive feature (54). The tissue collection feature (60) generally defines an elongated notch that is open or otherwise exposed to the cannula portion (44) of the cutter (40). In this version, the proximal end of the cutter (40) is disposed distally of the tissue collection feature (60) to expose the interior of the cutter (40) to the tissue collection feature (60). However, it should be understood that in other versions, the cannula portion (44) may include a notch, opening, side opening, or other feature that may abut or otherwise define the tissue collection feature (60). In any event, it should be understood that the tissue collection feature (60) is in communication with the hollow interior, or lumen, defined by the cannula portion (44). As will be explained in more detail below, this relationship between the tissue collection feature (60) and the cannula portion (44) allows the operator to remove the tissue sample from the cutter (40) once it has been collected by the lancing device (22).

[0032] The tissue collection feature (60) includes an engagement ledge (62) (also referred to as a protrusion, primary ledge, stop member, or tensioner) and a recess (64). The engagement ledge (62) extends upward relative to the cutter collar (52) and the lancer collar (53) to define a curved or wavy profile. The engagement ledge (62) further extends longitudinally along the length of the tissue collection feature (60), or from the cutter collar (52) to the lancer collar (53). As described in more detail below, the engagement ledge (62) is generally configured to engage one or more portions of the tissue sample holder (17) to facilitate transfer of a tissue sample from the notch (26) of the lancer (22) into the tissue sample holder (17).

[0033] Recess (64) is disposed adjacent or proximate to engagement ledge (62) and extends from cutter collar (52) to piercer collar (53). Recess (64) is generally configured to receive piercer (22) therein and provide access to notch (26) of piercer (22). As such, recess (64) defines a curved shape that may be complementary to the shape of piercer (22).

[0034] FIG. 3 illustrates the lancet 22 disposed within the cutter 40 and in communication with the drive assembly 70 and a schematic diagram of the tissue handler 100. The drive assembly 70 may include a cutter drive 72 configured to translate the cutter 40 and a lancet drive 74 configured to translate the lancet 22. As shown, the cutter 40 is generally configured to receive the lancet 22 such that the lancet 22 is coaxial with the cutter 40. Furthermore, the lancet 22 is generally movable relative to the open distal end 42 of the cutter 40. It should be understood that in some circumstances, the lancet 22 moves relative to the cutter 40 through the action of the lancet drive 74, while the cutter 40 remains stationary. In other situations, the cutter 40 moves relative to the lancing device 22 through the operation of the cutter drive 72, while the lancing device 22 remains stationary. In either case, it should be understood that the lancing device 22 and cutter 40 are generally configured such that the notch 26 of the lancing device 22 can be positioned distally or proximally relative to the open distal end 42 of the cutter 40 by moving the notch 26 into and out of the cutter 40. As explained in more detail below, this configuration allows the lancing device 22 and cutter 40 to operate in concert to puncture tissue, sever a tissue sample, and retract the tissue sample for collection by an operator via the tissue collection feature 60. In some versions, the drive assembly (70) may be configured according to one or more of the teachings of U.S. Publication No. 2002 / 0249075, published August 11, 2022, the disclosure of which is incorporated herein by reference.

[0035] B. Example of a fluid-based tissue handler

[0036] 4 illustrates a tissue handler 100 for extracting tissue from a needle assembly 20. The tissue handler 100 may include an extraction mechanism 110 and a sample chamber 164. The extraction mechanism 110 may be configured to dislodge or otherwise remove tissue disposed within the notch 26 of the lancing device 22. As described in more detail below, the extraction mechanism 110 may generally be configured to eject a fluid toward the notch 26 of the lancing device 22, which may move the tissue sample from the notch into a portion of the sample chamber 164.

[0037] The extraction mechanism (110) may include a fluid source (150), a fluid conduit (158), and a lancing device receiving portion (140). The fluid source (150) may be configured to contain or hold a fluid used to remove or transfer a tissue sample. The fluid source (150) may be capable of storing either a liquid or a gas and may be configured to be disposable or reusable and refillable. The fluid source may be located wholly or partially inside or outside the biopsy device (10). In some versions, the fluid source (150) may be removable from the biopsy device (10) such that the fluid source (150) may be omitted from the biopsy device (10) when not in use.

[0038] Optionally, actuator (152) may be located within or proximate to fluid source (150). Actuator (152) may generally be configured to facilitate transport of fluid from fluid source (150) to a nearby region. In some versions, actuator (152) may include a plunger or piston similar to the structure in a syringe. In other versions, actuator (152) may include an electric pump or the like. Alternatively, fluid source (150) may omit actuator (152) and instead rely on fluid pressure within fluid source (150) for fluid communication.

[0039] The fluid source (150) may include any fluid that can be stored within the fluid source (150). The fluid may be a liquid, a gas, or any combination such that the fluid can be expelled from the fluid source (150). Some examples of fluids may be ambient air, oxygen, nitrogen, water, or saline. When in liquid form, the fluid may have a viscosity that prevents the fluid from seeping out of the fluid source (150). Seepage may be prevented simply by a high fluid viscosity that requires the fluid to be forced out of the fluid source (150). Seepage may also be prevented by a high fluid surface tension that prevents the fluid from exiting the orifice of the fluid source (150) while simultaneously allowing an alternative medium to enter the fluid source (150). In some versions, the fluid source (150) may include a one-way check valve. Such a one-way check valve may allow fluid to enter the fluid source (150) in the flow path, yet remain held in place under a partial vacuum until the fluid source (150) is pressurized.

[0040] The fluid source (150) may be in fluid communication with the fluid conduit (158), either directly or through an intermediate conduit or tube (not shown). The fluid conduit (158) is generally configured to allow fluid flow from the fluid source (150) to the fluid conduit (158) to drain the fluid from the fluid source (150). Fluid may also be able to flow from the fluid conduit (158) into the fluid source (150) to fill the fluid source (150) with fluid. The fluid conduit (158) may be positioned adjacent to an orifice of the fluid source (150). The fluid conduit (158) may be configured to reduce head loss, such as by forming a straight tube, or to accommodate slight misalignment or movement across the fluid conduit (158), such as by including flexible sidewalls. The fluid conduit (158) may have rigid sidewalls and / or a consistent diameter to enable the fluid conduit (158) to maintain a consistent pressure and flow of fluid throughout the fluid conduit (158). The fluid conduit (158) may have sidewalls that can maintain a vacuum without collapsing, such as when the fluid source (150) is refilled by applying a vacuum at the fluid source (150). The fluid conduit (158) may be incorporated into other portions of the tissue handler (100) or drive assembly (70), such as within the cutter drive (72), the lancing drive (74), the fluid source (150), or the sample chamber (164) (described below).

[0041] The fluid conduit (158) may be in fluid communication with the fluid nozzle feature (130). The fluid nozzle feature (130) may be removably coupled to the fluid conduit (158) or may be integral with the fluid conduit (158). The fluid nozzle feature (130) may be capable of directing fluid toward the tissue sample in a targeted manner by spraying or propelling the fluid through a spout, opening, orifice, or jet. The fluid nozzle feature (130) may be capable of spraying the fluid in a more directed solid stream or fan-like manner in the general direction of the lancing portion (140).

[0042] The piercer receiving portion (140) may be configured to position and / or expose a portion of the piercer (22) relative to the fluid conduit (158) and / or fluid nozzle feature (130) to facilitate fluid communication from the fluid conduit (158) and / or fluid nozzle feature (130) to the portion of the piercer (22). The piercer receiving portion (140) may include one or more features configured to facilitate or enable tissue removal from the portion of the piercer (22). Such features may include shelves, ledges, curved surfaces, openings, orifices, or channels that may direct fluid flow from the fluid nozzle feature (130) toward the piercer (22). In some versions, the piercer receiving portion (140) may be incorporated into the biopsy device (10) as one or more portions of the tissue collection feature (60) described above. In yet other versions, the piercer receiving portion (140) may be omitted and the nozzle feature (130) may be positioned proximate a structure such as the tissue collection feature (60).

[0043] The sample chamber (164) may be positioned proximate to the lancing device receiving portion (140) and may be configured to capture and contain one or more tissue samples removed from a portion of the lancing device (22) by fluid ejected from the fluid nozzle feature (130). In some versions, the sample chamber (164) may be a fluidly sealed container such that a portion of the tissue sample may remain captured within the sample chamber (164). The sample chamber (164) may also include a vent or valve configured to relieve any pressure buildup in the sample chamber (164) when the fluid nozzle feature (130) ejects fluid. The interior of the sample chamber (164) may be accessible for removing or otherwise collecting a tissue sample. Access to the interior of the sample chamber (164) may be achieved by removing a portion of the sample chamber (164), such as a cap or canister, from the tissue handler (100), or by rotating or sliding a portion of the sample chamber (164) to provide access to the interior. The sample chamber (164) may be configured to collect each tissue sample separately and keep each tissue sample separate from any other tissue samples collected.

[0044] The tissue handler (100) may be partially operable with any portion of the biopsy device (10), such that the operation of one component or system may drive a portion of the tissue handler (100). As one example, the actuator (152) may be released (also referred to as actuated) or cocked by the cutter drive (72) and / or the lancet drive (74). Such integration with the cutter drive (72) and / or the lancet drive (74) may be desirable to coordinate movement of the needle assembly (20) with the operation of the actuator (152). As a specific example, the actuator (152) may be driven away from the fluid source (150) by the lancet drive (74). Once the actuator 152 reaches the appropriate position, the actuator 152 is released (also called actuated) by the lancing device drive 74, driving the actuator 152 toward the fluid source 150, thereby removing tissue from the notch 26 of the lancing device 22. In other versions, the actuator 152 may be controlled by a separate actuation mechanism, such as a motor-driven mechanism, a linear drive, a lead screw, a manually driven lever, a gear, a wheel, and / or a plunger.

[0045] C. Example of a tissue handler with integrated drive assembly

[0046] 5-7 illustrate an alternative extraction mechanism (210) that may be used in the tissue handler (100) described above in place of the extraction mechanism (110). As shown in FIG. 5 and described in detail below, this version of the extraction mechanism (210) is integrated into a portion of the drive assembly (70) to enable the extraction of tissue from the needle assembly (20) using air pressure or another fluid medium in coordination with the drive of the needle assembly (20) provided by the drive assembly (70). Like the extraction mechanism (110) described above, this version of the extraction mechanism (210) may include a fluid source (250), a fluid conduit (258), and a nozzle (230). In some versions, the fluid source (250), the fluid conduit (258), and the nozzle (230) may be configured substantially similarly to the fluid source (150), the fluid conduit (158), and / or the fluid nozzle feature (130) described above, unless otherwise noted herein.

[0047] The fluid source (250) may be in the form of a cylinder or tube capable of containing a fluid. The fluid source (250) may have an opening at its distal end for a fluid source connector (251) for fluidly connecting the fluid source (250) to a fluid conduit (258). The fluid source (250) may be capable of capturing a volume of fluid capable of dislodging tissue from the lancet (22). The fluid source (250) may have a rigid sidewall configured to withstand fluid pressure without substantial deformation or expansion. The fluid source (250) may include or be attached to the fluid source connector (251). The fluid source connector (251) may be attached to the distal end of the fluid source (250). The fluid source connector (251) may be fluidly sealed at the connector-fluid source junction and the connector-conduit junction, thereby reducing leakage of fluid within the fluid source (250).

[0048] The actuator (252) is configured to be received within the fluid source (250). Specifically, the actuator (252) may be in the form of a piston that translates within the fluid source (250). As shown in FIG. 6, the actuator (252) may optionally include one or more longitudinally extending ribs. Such ribs may be configured to promote stiffness without adding substantial weight and to maintain alignment within the fluid source (250) during translation of the actuator (252). As described in more detail below, the actuator (252) is configured to translate within the fluid source (250) to move fluid from the fluid source (250) through the fluid conduit (258) toward the nozzle (230). To facilitate such movement of fluid, the actuator (252) may include a seal (253), such as a gasket or O-ring, at its distal end to sealingly engage the interior of the fluid source (250).

[0049] The fluid conduit (258) may extend axially through the fluid source (250) and the actuator (252). Specifically, the fluid conduit (258) may define a generally elongated cylindrical structure. In some versions, this elongated cylindrical structure may serve as a guide for the actuator (252), actuator spring (254), or the like. For example, the actuator (252) in this version is configured to slidably engage the fluid conduit (258) to allow translation of the actuator (252) relative to the fluid conduit (258) and the fluid source (250). Thus, the fluid conduit (258) extends the length of the extraction mechanism (210) in this version, but may be shorter than the length of the extraction mechanism (210) in other versions. As described in more detail below, the fluid conduit (258) may define a lumen (253) extending through a portion thereof. Thus, the fluid conduit (258) may be of a material rigid enough to support the lumen (253) when under pressure.

[0050] In this version, fluid conduit (258) is optionally incorporated into certain aspects of drive assembly (70). For example, in this version, fluid conduit (258) is incorporated into a rod-like structure that may be configured to control one or more functions of drive assembly (70), such as actuation of cutter (40) and / or lancing device (22), via rotation of the rod-like structure. In some versions, the rod-like structure of fluid conduit (258) may be configured according to one or more teachings of U.S. Publication No. 2002 / 0249075, published August 11, 2022, the disclosure of which is incorporated herein by reference. In still other versions, fluid conduit (258) may be configured entirely separately from drive assembly (70), as will be understood by one of ordinary skill in the art in view of the teachings herein.

[0051] The lumen (253) may be defined by the fluid conduit (258) to extend from an opening in the sidewall of the fluid conduit (258) to a distal opening of the fluid conduit (258). The lumen (253) may extend further along the longitudinal axis defined by the fluid conduit (258). In this version, the lumen (253) extends only a portion of the entire length of the fluid conduit (258). Specifically, the lumen (253) extends only to the distal portion of the fluid conduit (258). Accordingly, the proximal portion of the fluid conduit (258) may optionally be solid, and structures such as the lumen (253) may be omitted. Such a solid proximal configuration may be desirable to provide increased support or stiffness for the actuator (252) and / or actuator spring (254). The fluid conduit (258) may include a distal end having a larger diameter than the proximal end. The larger diameter may be able to prevent the fluid source (250) from advancing distally as the actuator (252) advances into the fluid source (250).

[0052] The fluid conduit (258) may be fluidly coupled to the nozzle (230) at the distal end of the fluid conduit (258). Such a fluid coupling may be configured to allow fluid traveling through the lumen (253) to reach and be discharged from the nozzle (230). As noted above, in some versions, the fluid conduit (258) may be rotatable to facilitate certain functions of the drive assembly (70). Additionally, as described in more detail below, it may be desirable for the nozzle (230) to be in a fixed position. Accordingly, in this version, the fluid conduit (258) may be coupled to the nozzle (230) with a coupling configured to allow relative rotation between the fluid conduit (258) and the nozzle (230), while simultaneously maintaining the fluid conduit (258) and the nozzle (230) in a fixed axial position. Such a coupling between the fluid conduit (258) and the nozzle (230) may also include one or more seals that fluidly seal the coupling between the fluid conduit (258) and the nozzle (230).

[0053] In some versions, a release gear (256) (also referred to as a drive gear) is disposed at the proximal end of the fluid conduit (258). In such versions, the release gear (256) is configured to rotate the fluid conduit (258) using input from one or more drive mechanisms, such as a motor. In some versions, the rotation of the fluid conduit (258) via the release gear (256) may be used to facilitate one or more functions of the drive assembly (70), as described above. Additionally or alternatively, the rotation of the fluid conduit (258) via the release gear (256) may be used to facilitate one or more aspects of the actuation of the actuator (252), as described in more detail below.

[0054] The nozzle 230 may be secured to a portion of the biopsy device 10 such that the nozzle 230 is rotatably and / or longitudinally fixed relative to the sample chamber, the lancing device 22, and / or the cutter 40. Rotatably securing the nozzle 230 allows the nozzle 230 opening to be aimed at the tissue, allowing the operator to eject tissue into the sample chamber without having to adjust its orientation. Rotatably securing the nozzle 230 may be accomplished using adhesives, hardware, or by integrally incorporating the nozzle into the sample chamber. The nozzle 230 may be fluidly sealed to the fluid conduit 258 using an O-ring seal, a gasket, or a tapered connection so that the fluid conduit 258 can rotate relative to the nozzle 230. The sample chamber and nozzle 230 may be removably coupled to the remainder of the tissue handler so that any part that contacts the tissue can be replaced from the other parts of the tissue handler.

[0055] The extraction mechanism 210 further includes an actuator spring 254 coaxially disposed with the fluid source 250, the actuator 252, and the fluid conduit 258. The actuator spring 254 may be configured to exert a force on the proximal end of the actuator 252. As described in more detail below, the actuator spring 254 is configured to urge the actuator 252 into the fluid source 250, thereby expelling fluid from the fluid source 250. Accordingly, although not shown, it should be understood that the proximal end of the actuator spring 254 may be axially fixed relative to the actuator 252. In some versions, such axial fixation may be facilitated by a release gear 256. In yet other versions, such axial fixation may be facilitated by a portion of a housing, such as the housing 14 of the biopsy device 10. Although the actuator spring (254) in this version is shown as a coil spring, in other versions, the actuator spring (254) may be any other type of spring or linear device capable of exerting a directional force on the actuator (252).

[0056] As noted above, this version of the extraction mechanism 210 is configured to be incorporated into part of the drive assembly 70 of the biopsy device 10. Specifically, the extraction mechanism 210 is incorporated into part of the lancing device drive 74. In other versions, the extraction mechanism 210 may be incorporated into the cutter drive 72, or into both the cutter drive 72 and the lancing device drive 74. In yet other versions, the extraction mechanism 210 may be entirely separate from the drive assembly 70.

[0057] 5 and 7, the actuator 252 is configured to engage a portion of the lancing drive 74 such that the lancing drive 74 can control one or more aspects of the actuation of the actuator 252. Specifically, the lancing drive 74 includes a lead screw 234 and a lancing carriage 232. The lead screw 234 and the lancing carriage 232 are configured together to drive the translation of the lancing device 22 by rotation of the lead screw 234 and translation of the lancing carriage 232 along the length of the lead screw 234. Such translation of the lancing carriage 232 may in turn be used to control one or more aspects of the actuation of the actuator 252, as will be described in more detail below. In some versions, the lead screw (234) and puncture carriage (232) may be configured in accordance with one or more of the teachings of U.S. Publication No. 2002 / 0249075, published August 11, 2022, the disclosure of which is incorporated herein by reference.

[0058] As best seen in Figure 7, the actuator (252) may be configured to releasably couple to the lancing device carriage (232). Specifically, the lancing device carriage (232) may include a laterally extending latch (260) configured to releasably couple with a corresponding latch lip (262) on the actuator (252). This allows movement of the actuator (252) to be selectively linked to movement of the cutter carriage (232) and, therefore, the lancing device (22). In some versions, the actuator (252) may include multiple latch lips (262) around the circumference of the actuator (252).

[0059] 8A and 8B show a series of actuators (252) transitioning from a proximal cocked position to a distal released (also called actuated) position. FIG. 8A illustrates that with the actuator (252) in the cocked position and the actuator spring (254) in a compressed orientation, the fluid source (250) may be substantially or completely filled with fluid or gas. As the actuator (252) begins to transition from the cocked position shown in FIG. 8A to the released (also called actuated) position shown in FIG. 8B, the fluid or gas in the fluid source (250) may begin to move through the lumen (253) of the fluid conduit (258). A portion of the lumen (253) may be positioned proximal to the fluid source connector (251) such that the lumen (253) is in fluid communication with the fluid source (250). The fluid conduit (258) may include an opening to the fluid source (250) immediately proximal to the fluid source connector (251). In this configuration, actuator 252 may be movable distally completely into fluid source 250, leaving fluid source 250 with no or minimal liquid, i.e., no or minimal dead space in fluid source 250, and any fluid or gas that was in fluid source 250 is forced out of nozzle 230 and into lumen 253. If the fluid source holds a compressible gas rather than a fluid, minimizing dead space may be advantageous to ensure maximum gas pressure throughout the stroke of actuator 252.

[0060] To transition the actuator (252) to the cocked position shown in Figure 8A, the catch (260) of the lancing device carriage (232) may releasably engage with the latch lip (262) while the lancing device carriage (232) is retracted to retract the lancing device (220). Once the lancing device carriage (232) is coupled to the actuator (252), the lead screw (234) can rotate about its axis to continue translating the lancing device carriage (232), which in turn retracts the actuator (252). The actuator (252) may remain releasably coupled to the puncture carriage (232) during this transition, such that the actuator (252) may also transition from a distal position to a proximal position, thereby compressing the actuator spring (254) between the actuator (252) and a fixed point, such as the housing (14) of the biopsy device (10) or a release gear (256), and applying a distal force to the actuator (252).

[0061] While actuator (252) transitions from the distal position to the proximal position, actuator (252) may be capable of generating a vacuum within fluid source (250) such that gas or liquid is drawn into fluid source (250) and subsequently expelled through nozzle (230) upon release of actuator (252). In this version, actuator (252) is configured to draw atmospheric air into the interior of fluid source (250) through nozzle (230). In other versions, a separate fluid reservoir may be coupled to fluid source (250) to allow any suitable substitute fluid to be drawn into fluid source (250) by actuator (252). Suitable substitute fluids may include, for example, saline, water, various oils, inert gases, etc.

[0062] Once the actuator (252) is fully retracted to the proximal position, it may be desirable to disengage the actuator (252) from the piercer carriage (232), thereby releasing the actuator (252). Such disengagement may be accomplished in a variety of ways. For example, in some versions, disengagement may be automatically driven by the difference between the travel distance of the actuator (252) and the travel distance of the piercer carriage (232). In such versions, the piercer carriage (232) may continue to translate distally after the actuator (252) reaches a hard stop. One or more portions of the latch (260) or latch lip (262) may be constructed with a resilient yet flexible portion to allow the actuator (252) to disengage from the piercer carriage (232) when a predetermined force is exceeded. In yet other versions, disengagement may be controlled by an external mechanism, such as rotation of the fluid conduit (258). For example, in such a version, fluid conduit (258) may include one or more protrusions configured to rotate actuator (252). Similarly, one or more portions of latch (260) or latch lip (262) may include a cam mechanism configured to respond to rotation of actuator (252). Fluid conduit (258) may then be rotated by release gear (256) to rotate actuator (252) and release latch (260) and latch lip (262). Still other suitable mechanisms may be used to facilitate disconnection, as will be understood by those skilled in the art in view of the teachings herein.

[0063] When the actuator (252) is disengaged from the receiving portion (232) in the cocked position, the actuator spring (254) may begin to extend, driving the actuator (252) distally into the fluid source (250). As the actuator (252) advances into the fluid source (250), any gas or fluid within the fluid source (250) may be forced into the lumen (253) of the fluid conduit (258). The gas or fluid may travel through the lumen (253) and into the nozzle (230). The nozzle (230) may be a separate component from the fluid conduit (258), and the joint therebetween may be sealed. The gas or fluid is then expelled from the nozzle (230) in a direction toward the notch (26) of the piercer (22). Discharging gas or fluid from nozzle 230 toward notch 26 may be sufficient to remove tissue from notch 26 into the sample chamber. Nozzle 230 may be configured to direct fluid or gas directly into notch 26, directly onto the tissue within notch 26, or may include a broad profile to remove notch 26 and portions surrounding notch 26 of any tissue.

[0064] Once the actuator 252 transitions to the release (also called actuation) position and tissue is removed from the notch 26, the lancing device 22 and lancing device carriage 232 may be advanced distally in preparation for collecting another tissue sample. As the lancing device carriage 232 advances distally, it may again releasably couple with the actuator 252 to begin a new cycle. As the actuator 252 begins to retract to the proximal position, the fluid source 250 may begin to refill based on the vacuum applied by the removal of the actuator 252. If the fluid source 250 is filled with gas, this gas may be drawn from the surrounding environment and may take a reverse path from the previous evacuation. In other words, as the actuator 252 retracts proximally, ambient air may travel through the nozzle 230, through the lumen 253, and back to the fluid source 250. When the fluid source (250) is filled with fluid, a separate fluid container (not shown) may be available to refill the fluid source (250) when the actuator (252) is retracted from the fluid source (250).

[0065] D. Example of a tissue handler with fluid ports

[0066] FIG. 9 illustrates an alternative extraction mechanism (310) in place of the extraction mechanisms (110, 210). The extraction mechanism (310) includes a fluid port (370) that can be directed to the outside of the upper portion of the outer housing (314). In other words, the extraction mechanism (310) is configured for use with saline or other suitable fluids to manipulate a tissue sample. The fluid port (370) may be in fluid communication with an external gas or fluid supply (not shown) that can supply either gas or fluid to the fluid port (370). The fluid port (370) may be in fluid communication with a nozzle (330). The nozzle (330) may include an opening facing the notch (326) of the lancing device so that the nozzle (330) can eject fluid or gas toward the notch (326) to remove tissue from the notch (326) and into the tissue collection feature (360). This example may allow for multiple pulses of gas or fluid to be sent through the fluid port (370) and nozzle (330) to remove a single piece of tissue. The ejection of fluid or gas through the nozzle (326) may be automatically controlled by the biopsy device (310) without operator input. Alternatively, the ejection may be manually controlled using a valve (not shown) within the tissue handler (310) or by controlling the pressure within the gas or fluid supply. The tissue collection feature (360) may include a valve or vent (372) to prevent accumulation of fluid ejected from the nozzle (330) or to prevent pressure buildup within the tissue collection feature (360). The valve or vent (372) may be removably coupled to an external collection device to collect excess fluid passing through the valve or vent (372). In some versions, the fluid ports (370) and nozzles (230) may be configured substantially similarly to the fluid sources (150, 250), fluid conduits (158, 258), and / or fluid nozzle features (130, 230) described above, unless otherwise specified herein.

[0067] As tissue is removed from notch 326, notch 326 can be advanced distally to capture additional tissue samples. Retracting notch 326 proximally may allow nozzle 330 to remove additional tissue samples in the same manner as the first. Tissue handler 310 may be able to collect an unlimited number of samples in this manner.

[0068] II. Exemplary Combinations

[0069] 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 patent that may be filed at any time in this application or in any subsequent application thereto. 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 referred to in the examples below. Accordingly, none of the aspects or features referred to below should be considered critical unless later expressly indicated otherwise by the inventor or by a successor in interest to the inventor. If any claims are presented in this application or in any subsequent application related to this application that include additional features other than those referred to below, those additional features shall not be considered added for any reasons related to patentability.

[0070] Example 1 1. A core needle biopsy device comprising: a needle assembly including a lancet and a hollow cutter, the lancet including a sharp distal tip and a notch proximal to the distal tip, the lancet being slidably disposed within the cutter to cut a tissue sample into the notch of the lancet; a drive assembly configured to selectively move the lancet and the cutter; and a tissue sample holder including a sample chamber, a fluid source, and a nozzle, the fluid source configured to eject liquid or gas from the nozzle into a portion of the biopsy device to manipulate the tissue sample cut into the sample chamber.

[0071] Example 2 The core biopsy device of Example 1, wherein the fluid source includes a piston and a cylinder, and the nozzle is fixed to the fluid source, such that the advancement of the piston into the cylinder causes the liquid or the gas to be ejected from the nozzle and manipulate the cut tissue sample into the sample chamber.

[0072] Example 3 3. The core needle biopsy device of example 2, wherein the fluid source further comprises a spring configured to advance the piston into the cylinder.

[0073] Example 4 4. The core needle biopsy device of any one of Examples 2 to 3, wherein the fluid source further includes a latch mechanism disposed on the piston or the cylinder, the latch mechanism configured to translate with the puncture device when the puncture device is in a distal position and to move relative to the puncture device when the puncture device is in a proximal position.

[0074] Example 5 5. The core needle biopsy device of example 4, wherein the latching mechanism includes a protrusion extending laterally from the cylinder.

[0075] Example 6 6. The core needle biopsy device of any one or more of Examples 2-5, wherein the nozzle is in fluid communication with the interior of the cylinder.

[0076] Example 7 7. The core needle biopsy device of any one of Examples 1 to 6, wherein the fluid source is configured to eject gas from the nozzle onto a portion of the biopsy device to manipulate the cut tissue sample into the sample chamber.

[0077] Example 8 8. The core needle biopsy device of any one of Examples 1 to 7, wherein the tissue sample holder further comprises a shaft extending distally from the nozzle through the fluid source, the distal portion of the shaft having a lumen configured to position the nozzle in fluid communication with the fluid source.

[0078] Example 9 9. The core needle biopsy device of example 8, wherein the tissue sample holder further includes a seal disposed between the nozzle and the shaft and configured to prevent leakage outside the nozzle and the shaft.

[0079] Example 10 10. The core needle biopsy device of any one of Examples 1 to 9, wherein the tissue sample holder further includes an outer cover configured to removably couple to a housing of the biopsy device, the outer cover defining at least a portion of the sample chamber.

[0080] Example 11 11. The core needle biopsy device of example 10, wherein the outer cover includes one or more walls that define the sample chamber.

[0081] Example 12 12. The core needle biopsy device of claim 10 or 11, wherein the outer cover includes a lancet interface positioned adjacent to a portion of the lancet.

[0082] Example 13 A core needle biopsy device as described in any of Examples 10 to 12, wherein the outer cover includes one or more connectors configured to releasably secure the outer cover to the housing of the biopsy device.

[0083] Example 14 14. The core needle biopsy device of any one of Examples 1 to 13, wherein the tissue sample holder includes a single nozzle.

[0084] Example 15 15. The core needle biopsy device of any one of Examples 1 to 14, further comprising a body having a distal end, the needle assembly extending distally from the distal end of the body, and the tissue sample holder disposed at the distal end of the body.

[0085] Example 16 1. A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device comprising a lancing device having a sample notch and a cutter movable relative to the sample notch for severing a tissue sample, the tissue sample holder comprising a body defining a sample chamber and a nozzle configured to manipulate the cut tissue sample from the sample notch of the lancing device into the sample chamber of the body.

[0086] Example 17 17. The tissue sample holder of claim 16, wherein the body has an outer wall defining the sample chamber, and the nozzle is configured to direct liquid or gas within the outer wall of the body toward a cut tissue sample within the sample chamber.

[0087] Example 18 A tissue sample holder as described in Example 16 or 17, wherein the nozzle is in fluid communication with a gas line or liquid line extending outside the core needle biopsy device, and the gas line or liquid line is configured to manipulate a tissue sample cut from the sample notch of the lancet into the sample chamber of the main body by passing gas or liquid through the nozzle.

[0088] Example 19 19. The tissue sample holder of any of Examples 16-18, wherein the nozzle is configured to perform multiple operations on the tissue sample cut from the sample notch of the lancing device.

[0089] Example 20 1. A method for collecting a tissue sample using a biopsy device, comprising: proximally retracting a sample notch defined by a lancet into a tissue sample holder; and ejecting a jet of gas or liquid from a nozzle toward the sample notch.

[0090] Example 21 21. The method of claim 20, wherein ejecting the gas or liquid from the nozzle toward the sample notch manipulates the cut tissue sample from the sample notch of the lancing device into a sample chamber of the main body.

[0091] Example 22 22. The method of example 20 or 21, further comprising advancing a piston into a cylinder, thereby ejecting the gas or the liquid from the nozzle.

[0092] Example 23 23. The method of example 22, further comprising retracting the piston from the cylinder, thereby filling the cylinder with the gas or the liquid.

[0093] Example 24 24. The method of claim 23, wherein the cylinder is filled with the gas or liquid by passing the gas or liquid through the nozzle.

[0094] Example 25 1. A biopsy device comprising: a body defined by a probe and a holster; a needle assembly extending distally from the probe, the needle assembly configured to cut a tissue sample; and a tissue sample holder having a body defining a sample chamber, a drive member, and a nozzle extending from a portion of the drive member, the drive member configured to compress a liquid or gas, and the nozzle configured to eject the liquid or gas to force the tissue sample from the needle assembly into the sample chamber.

[0095] Example 26 The biopsy device of Example 25, wherein the drive member includes a cylinder and a piston, the piston being removably coupled to the needle assembly, and the piston being configured to retract from the cylinder depending on the needle assembly and to advance into the cylinder independently of the needle assembly.

[0096] Example 27 A biopsy device as described in Example 25 or Example 26, wherein the needle assembly includes a cutter and a puncture device, the puncture device being coaxially arranged within the cutter, and the puncture device including a notch configured to accept the tissue sample.

[0097] Example 28 28. The biopsy device of example embodiment 27, wherein the nozzle is configured to be aligned with the notch of the lancet.

[0098] Example 29 1. A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device comprising a lancing device having a sample notch and a cutter movable relative to the sample notch for severing a tissue sample, the tissue sample holder comprising a body defining a sample chamber and a nozzle configured to manipulate the cut tissue sample from the sample notch of the lancing device into the sample chamber of the body.

[0099] While 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. While some of these potential modifications have been mentioned, others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. described above are illustrative and not required. Accordingly, it is understood that the scope of the present invention should be considered in relation to the following claims, and is not limited to the details of structure and operation shown and described in the specification and drawings.

[0100] It should be understood that any of the versions of the devices described herein may include various other features in addition to or in place of those described above. Also, by way of example only, any of the devices described herein may include one or more of the various features disclosed in any of the various references incorporated by reference herein. It should be understood that the teachings herein are readily applicable to any of the devices described in any of the other references cited herein, and as a result, the teachings herein can be readily combined in numerous ways with the teachings of any of the references cited herein. Other types of devices that can incorporate the teachings herein will be apparent to those skilled in the art.

[0101] It should be recognized that any patent, publication, or other disclosure material referred to herein as being incorporated by reference, in whole or in part, is incorporated herein only to the extent that the incorporated material does not contradict existing definitions, descriptions, or other disclosure material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein will take precedence over any conflicting material incorporated herein by reference. Any material, or portion thereof, referred to herein as being incorporated by reference, but which contradicts existing definitions, descriptions, or other disclosure material set forth herein, is incorporated only to the extent that no contradiction arises between the incorporated material and the existing disclosure material.

[0102] [Embodiment] (1) A core needle biopsy device, comprising: (a) a needle assembly including a lancet and a hollow cutter, the lancet including a sharp distal tip and a notch proximal to the distal tip, the lancet being slidably disposed within the cutter to sever a tissue sample within the notch of the lancet; (b) a drive assembly configured to selectively move the lancing device and the cutter; and (c) a tissue sample holder including a sample chamber, a fluid source, and a nozzle, the fluid source configured to eject a liquid or gas from the nozzle toward a portion of the biopsy device to manipulate a severed tissue sample into the sample chamber. 10. The core needle biopsy device according to claim 9, further comprising: (2) A core biopsy device as described in embodiment 1, wherein the fluid source includes a piston and a cylinder, and the nozzle is fixed to the fluid source, such that the advancement of the piston into the cylinder causes the liquid or the gas to be ejected from the nozzle to manipulate the cut tissue sample into the sample chamber. (3) The core needle biopsy device of embodiment 2, wherein the fluid source further comprises a spring, the spring configured to advance the piston into the cylinder. (4) A core needle biopsy device according to any one of claims 2 to 3, wherein the fluid source further comprises a latch mechanism disposed on the piston or the cylinder, the latch mechanism being configured to translate with the puncture device when the puncture device is in a distal position and to move relative to the puncture device when the puncture device is in a proximal position. (5) The core needle biopsy device of claim 4, wherein the latch mechanism includes a protrusion extending laterally from the cylinder.

[0103] (6) The core needle biopsy device of any one or more of embodiments 2 to 5, wherein the nozzle is in fluid communication with the interior of the cylinder. (7) A core needle biopsy device as described in any one of claims 1 to 6, wherein the fluid source is configured to eject gas from the nozzle onto a portion of the biopsy device to manipulate the cut tissue sample into the sample chamber. (8) A core needle biopsy device as described in any one of embodiments 1 to 7, wherein the tissue sample holder further comprises a shaft extending distally from the nozzle through the fluid source, the distal portion of the shaft having an inner lumen, the inner lumen configured to position the nozzle in fluid communication with the fluid source. (9) The core needle biopsy device of embodiment 8, wherein the tissue sample holder further comprises a seal disposed between the nozzle and the shaft and configured to prevent leakage outside the nozzle and the shaft. (10) A core needle biopsy device as described in any one of embodiments 1 to 9, wherein the tissue sample holder further comprises an outer cover configured to removably couple to a housing of the biopsy device, the outer cover defining at least a portion of the sample chamber.

[0104] (11) The core needle biopsy device of embodiment 10, wherein the outer cover includes one or more walls that define the sample chamber. (12) The core needle biopsy device of embodiment 10 or embodiment 11, wherein the outer cover includes a puncture device interface positioned adjacent to a portion of the puncture device. (13) The core needle biopsy device of any one of embodiments 10 to 12, wherein the outer cover includes one or more connectors configured to releasably secure the outer cover to the housing of the biopsy device. (14) The core needle biopsy device according to any one of the preceding embodiments, wherein the tissue sample holder includes a single nozzle. (15) The core needle biopsy device of any one of claims 1 to 14, further comprising a body having a distal end, the needle assembly extending distally from the distal end of the body, and the tissue sample holder disposed at the distal end of the body.

[0105] (16) A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device including a lancing device having a sample notch and a cutter movable relative to the sample notch for severing a tissue sample, the tissue sample holder including a body defining a sample chamber and a nozzle configured to manipulate the cut tissue sample from the sample notch of the lancing device into the sample chamber of the body. (17) The tissue sample holder of embodiment 16, wherein the body includes an outer wall defining the sample chamber, and the nozzle is configured to direct a liquid or gas into the outer wall of the body to move the cut tissue sample into the sample chamber. (18) A tissue sample holder as described in embodiment 16 or 17, wherein the nozzle is in fluid communication with a gas or liquid line extending outside the core needle biopsy device, and the gas or liquid line is configured to manipulate a cut tissue sample from the sample notch of the lancing device into the sample chamber of the main body by passing gas or liquid through the nozzle. (19) A tissue sample holder according to any one of embodiments 16 to 18, wherein the nozzle is configured to perform multiple operations on the tissue sample cut from the sample notch of the lancing device. (20) A method for collecting a tissue sample using a biopsy device, the method comprising: proximally retracting a sample notch defined by a lancing tool into a tissue sample holder; and ejecting a jet of gas or liquid from a nozzle toward the sample notch.

[0106] (21) The method of embodiment 20, wherein ejecting the gas or liquid from the nozzle toward the sample notch manipulates the cut tissue sample from the sample notch of the lancing device into a sample chamber of the main body. (22) The method of claim 20 or 21, further comprising advancing a piston into a cylinder, thereby ejecting the gas or the liquid from the nozzle. 23. The method of claim 22, further comprising retracting the piston from the cylinder, thereby filling the cylinder with the gas or the liquid. 24. The method of claim 23, wherein the cylinder is filled with the gas or liquid by passing the gas or liquid through the nozzle. (25) A biopsy device comprising: a body defined by a probe and a holster; a needle assembly extending distally from the probe, the needle assembly configured to cut a tissue sample; and a tissue sample holder having a body defining a sample chamber, a drive member, and a nozzle extending from a portion of the drive member, the drive member configured to compress a liquid or gas, and the nozzle configured to eject the liquid or gas to force the tissue sample from the needle assembly into the sample chamber.

[0107] (26) The biopsy device of embodiment 25, wherein the drive member includes a cylinder and a piston, the piston being removably coupled to the needle assembly, and the piston being configured to retract from the cylinder dependent on the needle assembly and to advance into the cylinder independently of the needle assembly. (27) The biopsy device of embodiment 25 or embodiment 26, wherein the needle assembly includes a cutter and a puncture device, the puncture device being coaxially disposed within the cutter, and the puncture device including a notch configured to receive the tissue sample. (28) The biopsy device of embodiment 27, wherein the nozzle is configured to be aligned with the notch of the puncture device. (29) A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device including a lancing device having a sample notch and a cutter movable relative to the sample notch for severing a tissue sample, the tissue sample holder including a body defining a sample chamber and a nozzle configured to manipulate the cut tissue sample from the sample notch of the lancing device into the sample chamber of the body.

Claims

1. 1. A core needle biopsy device comprising: (a) a needle assembly including a lancet and a hollow cutter, the lancet including a sharp distal tip and a notch proximal to the distal tip, the lancet being slidably disposed within the cutter to sever a tissue sample within the notch of the lancet; (b) a drive assembly configured to selectively move the lancing device and the cutter; and (c) a tissue sample holder including a sample chamber, a fluid source, and a nozzle, the fluid source configured to eject a liquid or gas from the nozzle toward a portion of the biopsy device to manipulate a severed tissue sample into the sample chamber; 10. The core needle biopsy device of claim 1,

2. 2. The core biopsy device of claim 1, wherein the fluid source includes a piston and cylinder, and the nozzle is fixed to the fluid source, such that the advancement of the piston into the cylinder causes the liquid or gas to be ejected from the nozzle to manipulate the cut tissue sample into the sample chamber.

3. The core needle biopsy device of claim 2 , wherein the fluid source further comprises a spring, the spring configured to advance the piston into the cylinder.

4. 4. The core needle biopsy device of claim 2, wherein the fluid source further comprises a latch mechanism disposed on the piston or cylinder, the latch mechanism configured to translate with the puncture device when the puncture device is in a distal position and to move relative to the puncture device when the puncture device is in a proximal position.

5. The core needle biopsy device of claim 4 , wherein the latching mechanism includes a protrusion extending laterally from the cylinder.

6. The core needle biopsy device of claim 2 , wherein the nozzle is in fluid communication with the interior of the cylinder.

7. The core needle biopsy device of claim 1 , wherein the fluid source is configured to direct a jet of gas from the nozzle onto a portion of the biopsy device to manipulate the severed tissue sample into the sample chamber.

8. 2. The core needle biopsy device of claim 1, wherein the tissue sample holder further comprises a shaft extending distally from the nozzle through the fluid source, a distal portion of the shaft having a lumen configured to position the nozzle in fluid communication with the fluid source.

9. 9. The core needle biopsy device of claim 8, wherein the tissue sample holder further comprises a seal disposed between the nozzle and the shaft and configured to prevent leakage outside the nozzle and the shaft.

10. The core needle biopsy device of claim 1 , wherein the tissue sample holder further comprises an outer cover configured to removably couple to a housing of the biopsy device, the outer cover defining at least a portion of the sample chamber.

11. The core needle biopsy device of claim 10 , wherein the outer cover includes one or more walls that define the sample chamber.

12. The core needle biopsy device of claim 10 or claim 11, wherein the outer cover includes a lancing device interface positioned adjacent a portion of the lancing device.

13. The core needle biopsy device of claim 10 , wherein the outer cover includes one or more connectors configured to releasably secure the outer cover to the housing of the biopsy device.

14. The core needle biopsy device of claim 1 , wherein the tissue sample holder includes a single nozzle.

15. 10. The core needle biopsy device of claim 1, further comprising a body having a distal end, the needle assembly extending distally from the distal end of the body, and the tissue sample holder disposed at the distal end of the body.

16. 1. A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device comprising a lancing device having a sample notch and a cutter movable relative to the sample notch for severing a tissue sample, the tissue sample holder comprising a body defining a sample chamber and a nozzle configured to manipulate the cut tissue sample from the sample notch of the lancing device into the sample chamber of the body.

17. 17. The tissue sample holder of claim 16, wherein the body includes an outer wall defining the sample chamber, and the nozzle is configured to direct a liquid or gas into the outer wall of the body to move a severed tissue sample into the sample chamber.

18. 18. The tissue sample holder of claim 16 or 17, wherein the nozzle is in fluid communication with a gas or liquid line extending outside the core needle biopsy device, the gas or liquid line being configured to manipulate a cut tissue sample from the sample notch of the lancing tool into the sample chamber of the body by passing gas or liquid through the nozzle.

19. 17. The tissue sample holder of claim 16, wherein the nozzle is configured to perform multiple operations on the tissue sample severed from the sample notch of the lancing device.

20. A method for collecting a tissue sample using a biopsy device, the method comprising: proximally retracting a sample notch defined by a lancet into a tissue sample holder; and ejecting a jet of gas or liquid from a nozzle toward the sample notch.

21. 21. The method of claim 20, wherein ejecting the gas or liquid from the nozzle toward the sample notch manipulates a severed tissue sample from the sample notch of the lancing device into a sample chamber of the main body.

22. 22. The method of claim 20 or 21, further comprising advancing a piston into a cylinder, thereby ejecting the gas or the liquid from the nozzle.

23. 23. The method of claim 22, further comprising retracting the piston from the cylinder, thereby filling the cylinder with the gas or the liquid.

24. 24. The method of claim 23, wherein the cylinder is filled with the gas or liquid by passing the gas or liquid through the nozzle.

25. 1. A biopsy device comprising: a body defined by a probe and a holster; a needle assembly extending distally from the probe, the needle assembly configured to cut a tissue sample; and a tissue sample holder having a body defining a sample chamber, a drive member, and a nozzle extending from a portion of the drive member, the drive member configured to compress a liquid or gas, and the nozzle configured to eject the liquid or gas to force the tissue sample from the needle assembly into the sample chamber.

26. 26. The biopsy device of claim 25, wherein the drive member includes a cylinder and a piston, the piston removably coupled to the needle assembly, the piston configured to retract from the cylinder dependent on the needle assembly and to advance into the cylinder independent of the needle assembly.

27. 27. The biopsy device of claim 25 or claim 26, wherein the needle assembly includes a cutter and a puncturer, the puncturer being coaxially disposed within the cutter, the puncturer including a notch configured to receive the tissue sample.

28. 28. The biopsy device of claim 27, wherein the nozzle is configured to align with the notch of the lancing device.

29. 1. A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device comprising a lancing device having a sample notch and a cutter movable relative to the sample notch for severing a tissue sample, the tissue sample holder comprising a body defining a sample chamber and a nozzle configured to manipulate the cut tissue sample from the sample notch of the lancing device into the sample chamber of the body.

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