Sample management for core needle biopsy devices.

Abstract

The core needle biopsy device includes a needle assembly, a drive assembly, and a tissue sample holder. The needle assembly includes a puncturator and a hollow cutter. The puncturator includes a sharp distal tip and a notch proximal to the distal tip. The puncturator is slidably disposed within the cutter to sever the tissue sample into the notch of the puncturator. The drive assembly is configured to selectively move the puncturator and the cutter. The tissue sample holder has a sample chamber, a drive member, and a wiper. The driver is configured to bend the wiper relative to a portion of the biopsy device to manipulate the severed tissue sample into the sample chamber.

Description

[Technical field]

[0001] Priority This application claims priority to U.S. Provisional Application No. 63 / 316,184, filed March 3, 2022, and entitled "Sample Management for Core Needle Biopsy Device," and U.S. Provisional Application No. 63 / 340,030, filed May 10, 2022, and entitled "Sample Cup for Core Needle Biopsy Device," the disclosures of which are incorporated herein by reference. [Background technology]

[0002] A biopsy is the removal of a tissue sample from a patient to allow the tissue to 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 assisted biopsy). After the tissue sample is collected, it is generally analyzed in a laboratory (e.g., a pathology laboratory, a biomedical laboratory, etc.) that is set up to perform the appropriate tests (such as histological analysis).

[0003] Biopsy samples have been obtained in a variety of ways in a variety of medical procedures, including open and percutaneous methods using a variety of devices. For example, some biopsy devices may be fully operable by a user using one hand and with a single insertion to obtain 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.

[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 piercer with a lateral tissue receiving notch located adjacent the distal end of the piercer. Once tissue is received within the notch, an elongated, hollow cutting sheath translates over the notch to sever the tissue sample. The severing tissue sample is then stored within the notch until both the piercer 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 piercer 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 includes a lateral opening adjacent a sharp distal tip. A hollow cutter is disposed within the hollow needle, and to sever the tissue sample, the hollow cutter is moved axially relative to the lateral opening of the needle. Once the tissue sample is severed by the hollow cutter, it is transported axially within the cutter and collected in a tissue collection feature.

[0006] Examples of vacuum assisted biopsy devices and biopsy system components are shown in U.S. Pat. No. 5,526,822, issued on June 18, 1996 and entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue," U.S. Pat. No. 6,086,544, issued on July 11, 2000 and entitled "Control Apparatus for an Automated Surgical Biopsy Device," U.S. Pat. No. 6,162,187, issued on December 19, 2000 and entitled "Fluid Collection Apparatus for a Surgical Device," U.S. Pat. No. 6,432,065, issued on August 13, 2002 and entitled "Method for Using a Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Pat. No. 6,432,065, issued on June 22, 2004 and entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," U.S. Pat. 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. 7,938,361, issued on May 10, 2011, entitled "Vacuum Timing Algorithm for Biopsy Device,"No. 786, issued on December 21, 2011 and entitled "Tissue Biopsy Device with Rotatably Linked Thumbwheel and Tissue Sample Holder," U.S. Patent No. 8,083,687, issued on February 1, 2012 and entitled "Biopsy Sample Storage," U.S. Patent No. 8,118,755, issued on February 1, 2012 and entitled "Tetherless Biopsy Device with Reusable Portion," U.S. Patent No. 8,206,316, issued on June 26, 2012 and entitled "Biopsy Device with Discrete Tissue Chambers," U.S. Patent No. 8,702,623, issued on April 22, 2014 and entitled "Biopsy Device with Motorized Needle Firing," U.S. Patent No. 8,858,465, issued on October 14, 2014 and entitled "Biopsy Device with Motorized Needle Firing," and U.S. Patent No. 8,858,465, issued on May 3, 2016 and entitled "Biopsy Device Tissue Sample Holder with Bulk Chamber and No. 9,326,755, entitled "Pathology Chamber," the disclosures of each of the above U.S. patents are incorporated herein by reference.

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

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

[0009] In some embodiments, it may be desirable to combine features of core needle biopsy devices and vacuum assisted biopsy devices to obtain the benefits of both devices and also to reduce overall drawbacks. For example, a core needle biopsy device may be advantageous in terms of its simplicity, lightness, and maneuverability. Additionally, a core needle biopsy device generally includes a smaller sized needle, which may be desirable to improve patient comfort and recovery time. On the other hand, a vacuum assisted biopsy device may be advantageous in that it can collect multiple samples with a single insertion. Thus, a simple, lightweight biopsy device that can collect multiple samples with a single insertion may be desirable.

[0010] One of the challenges in using a biopsy device may include managing the tissue sample after it is collected using the biopsy device. In some instances where a core needle biopsy device is used, problems may arise due to the unique configuration of the needle and cutter. For example, the cutter may be on the outside of the inner piercer, stylet, or needle. In that case, a notch in the inner piercer may be used to carry the detached tissue sample through the cutter. While the use of a notch may improve sample collection in some scenarios, collection of the detached tissue sample from the notch may be difficult due to the size and / or shape of the notch and the properties of the detached 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 a core needle biopsy device and a vacuum assisted biopsy device.

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

[0012] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the invention 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 some components or portions of components are shown in phantom, as depicted by dashed lines. [Brief description of the drawings]

[0013] [Figure 1] 1 shows a perspective view of a version of a core needle biopsy device. [Diagram 2] 2 shows an exploded view of the needle assembly of the core needle biopsy device of FIG. 1; [Diagram 3] FIG. 3 shows a perspective view of the needle assembly of FIG. 2. [Figure 4] 2 shows a perspective view of a drive assembly of the core needle biopsy device of FIG. 1; [Diagram 5] 2 shows a perspective view of a tissue sample holder of the core needle biopsy device of FIG. 1; [Figure 6] 6 shows an exploded perspective view of the tissue sample holder of FIG. 5. [Figure 7] 6 shows a perspective view of the outer housing of the tissue sample holder of FIG. 5. [Figure 8] FIG. 6 shows an exploded perspective view of the extraction mechanism of the tissue sample holder of FIG. 5; [Figure 9] FIG. 9 shows a perspective view of a wiper of the extraction mechanism of FIG. 8. [Figure 10] 6 shows another perspective view of the tissue sample holder of FIG. 5 with the extraction mechanism positioned to collect the tissue sample. [Figure 11A] 6 shows a cross-sectional end view of the tissue sample holder of FIG. 5 with an extraction mechanism positioned to collect a tissue sample. [Figure 11B] 10 shows another cross-sectional end view of the tissue sample holder of FIG. 5 with the extraction mechanism in the wiper bending position of FIG. 9. [Figure 11C] 9 shows yet another cross-sectional end view of the tissue sample holder of FIG. 5 with the wiper of FIG. 9 pushing the tissue sample out. [Figure 11D]6 shows yet another cross-sectional end view of the tissue sample holder of FIG. 5 with a tissue sample advanced into the sample chamber of the tissue sample holder. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[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 certain 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, which is, by way of example, 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. Thus, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0016] Biopsy devices may be utilized to collect tissue samples in a variety of ways. For example, in some cases, 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 tissue sample collected. Such multi-compartment tissue sample holders may further include a tray or strip that holds each tissue sample separately from the other tissue samples. Such a tray or strip may be removable or otherwise separable from the tissue sample holder upon the conclusion 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 a variety of imaging modalities, such as ultrasound image 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 type of imaging guidance used.

[0018] Both vacuum-assisted and core needle biopsy devices may have various advantages over the other depending on the situation. For example, one advantage of a vacuum-assisted biopsy device is that the vacuum assistance allows for the extraction of multiple tissue samples with a single insertion. However, a core needle biopsy device does not have this feature, but it may nevertheless be desirable to use a core needle biopsy device in some scenarios. For example, a core needle biopsy device may generally include a smaller needle than a vacuum-assisted biopsy device, which may reduce patient anxiety and increase the ability of the needle to penetrate a lesion. Thus, in some cases, it may be desirable to incorporate the multiple sample extraction feature of a vacuum-assisted biopsy device into a core needle biopsy device in order to obtain the benefits found in both styles of biopsy devices.

[0019] A desirable feature of the device described herein is that it is a core needle biopsy device, which allows for the acquisition of multiple samples with a single insertion while still using a core needle type device. To facilitate this functionality, the biopsy device further includes a tissue sample holder having one or more features that facilitate collection of a detached tissue sample from a notch, dugout, opening, and / or other sample collection feature.

[0020] I. Example of a Core Needle Biopsy Device with Multiple Sample Collection FIG. 1 illustrates a 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) encases the various components of the biopsy device (10), which are used to drive the needle assembly (20) through cutting and tissue sampling cycles. To this end, this version of the outer housing (14) is sized and shaped to be grasped by an operator in one hand. Although not illustrated, it should be understood that in some versions, the outer housing (14) may include multiple sections, with each section interconnecting to form the outer housing (14).

[0021] A. Needle Assembly Example 2 and 3 show the needle assembly (20) in more detail. As shown in FIG. 2, the needle assembly (20) includes an elongated piercer (22) and an elongated cutter (40). As described in more detail below, the piercer (22) is generally movable relative to the cutter (40) to pierce the tissue and collect a tissue sample, while the cutter is generally movable relative to the piercer (22) to sever the tissue sample. The piercer (22) includes a generally cylindrical rod (28) (also referred to as a shaft) having a sharpened distal tip (24) and a notch (26) disposed adjacent the distal tip (24). As described in more detail below, the distal tip (24) is generally configured to penetrate tissue of a patient. Also, as described in more detail below, the notch (26) is generally configured to receive tissue therein such that the tissue sample may be collected in the notch (26) after the tissue sample has been severed by the cutter (40).

[0022] The end (30) is disposed at the proximal end of the puncture device (22). This version of the end (30) is overmolded or otherwise fixedly attached to the proximal end of the puncture device (22) and is generally configured to enhance maneuverability of the puncture device (22). Specifically, the end (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 puncture device 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 of the puncture device (22). As will be described in more detail below, this feature enables the puncture device drive assembly (130) to drive the movement of the puncture device (22) through a predetermined movement sequence.

[0023] Cutter (40) includes a generally hollow cylindrical tube configured to receive puncture (22) therein. Cutter (40) includes 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 puncture (22) to protrude from cutter (40) when puncture (22) is moved relative to cutter (40). In some versions, such as the one shown, 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 a cutting cycle and a tissue sampling cycle by allowing notch (26) of puncture (22) to move relative to distal end (42) of cutter (40).

[0024] The open distal end (42) of this version includes a tapered edge (43). The tapered edge (43) is generally configured to bite into tissue and separate a tissue sample when the cutter (40) is moved relative to the notch (26) of the piercer (22). It should be understood, therefore, that the tapered edge (43) is generally configured to function as a blade. While the present 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 a plurality of serrated edges in addition to or in place of the taper illustrated. 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.

[0025] Cannula portion (44) of cutter (40) extends proximally from distal end (42) through end (50) so that piercer (22) can be received at the proximal end of cutter (40). Unlike end (30) of piercer (22), end (50) of cutter (40) is generally elongated to allow end (50) to accommodate additional features that will be described in more detail below. In this version, the distal extension of end (50) may be relative to outer housing (14) to allow a portion of end (50) to be easily accessible to an operator for tissue sample collection purposes. Various suitable tissue collection mechanisms associated with end (50) are described in more detail below.

[0026] End (50) of cutter (40) includes cutter collar (52), piercer collar (53), drive feature (54), and tissue collection feature (60) (also referred to as a ledge, primary ledge, wiper catch, or wiper engagement feature) disposed between cutter collar (52) and drive feature (54). Cutter collar (52) is generally configured to receive a proximal end of cutter (40) to securely secure cutter (40) to end (50). Additionally, cutter collar (52) is configured to facilitate access of piercer (22) to cutter (40). In this configuration, piercer (22) can be slidably disposed within end (50) and extend distally through 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).

[0027] Puncture collar (53) extends distally from a portion of drive feature (54) and is generally configured to slidably receive a portion of puncture (22). Specifically, puncture collar (53) is disposed along a common axis with cutter (40) and cutter collar (52) such that puncture (22) is aligned with cutter (40) along the same common axis. Thus, cutter (40), cutter collar (52), and puncture collar (53) may be configured to act cooperatively to maintain puncture (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 the notch is disposed within tissue collection feature (60).

[0028] Drive features (54) on end (50) are generally configured to engage features of cutter drive assembly (120) for manipulating cutter (40) via drive end (50) through a predetermined sequence of movement. Although 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 a corresponding component of cutter drive assembly (120) to enable manipulation of cutter (40) via end (50).

[0029] 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 be adjacent to 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 a hollow interior, or lumen, defined by the cannula portion (44). As described in more detail below, this relationship between the tissue collection feature (60) and the cannula portion (44) enables an operator to remove the tissue sample from the cutter (40) once the tissue sample has been collected by the lancet (22).

[0030] 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 upwardly relative to the cutter collar (52) and the piercer 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 piercer 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 (200) to facilitate transfer of a tissue sample from the notch (26) of the piercer (22) into the tissue sample holder (200).

[0031] 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).

[0032] FIG. 3 illustrates a puncture tool (22) disposed within a cutter (40). As shown, cutter (40) is generally configured to receive puncture tool (22) such that puncture tool (22) is coaxial with cutter (40). Additionally, puncture tool (22) is generally movable relative to open distal end (42) of cutter (40). It should be understood that in some situations, puncture tool (22) moves relative to cutter (40) while cutter (40) remains stationary. In other situations, cutter (40) moves relative to puncture tool (22) while puncture tool (22) remains stationary. In either case, it should be understood that puncture tool (22) and cutter (40) are generally configured such that notch (26) of puncture tool (22) can be moved in and out of cutter (40) such that notch (26) can be disposed distally or proximally relative to open distal end (42) of cutter (40). As described in more detail below, this configuration allows the lancet (22) and cutter (40) to operate in coordination to penetrate tissue, sever tissue samples, and draw tissue samples in for collection by an operator via the tissue collection feature (60).

[0033] B. Drive Assembly Example FIG. 4 illustrates the internal components of the body 12 of the biopsy device 10 with the outer housing 14 removed. As shown, within the outer housing 14, the body 12 includes a drive assembly 100. The drive assembly 100 is generally configured to engage the needle assembly 20 and drive the lancet 22 and cutter 40 through a predetermined sequence of movements to penetrate tissue and obtain multiple tissue samples with a single insertion of the needle assembly 20 into a patient. Although not illustrated, it should be understood that the outer housing 14 defines various internal geometries that support or otherwise engage the drive assembly 100. It should be understood that such internal geometries are used to provide relative movement of various components of the drive assembly 100 relative to other components of the drive assembly 100 and / or the outer housing 14.

[0034] The drive assembly (100) includes a cutter drive assembly (120), a lancet drive assembly (130), and a fire assembly (140). Generally, the needle fire assembly (140) is configured to cock and fire the cutter (40) and lancet (22) in a predetermined sequence to sever a tissue sample. To retrieve the severed tissue sample, the cutter drive assembly (120) is generally configured to retract the cutter (40). Similarly, the lancet drive assembly (130) is generally configured to retract the lancet (22). It should be appreciated that in some versions, both the cutter drive assembly (120) and the lancet drive assembly (130) may be configured to rotate the cutter (40) and / or the lancet (22), respectively.

[0035] The needle fire assembly (140) is generally shown diagrammatically in this version. It should be understood, therefore, that in some versions the needle fire assembly (140) may take a variety of forms, including gears, racks, lead screws, carriages, springs, and / or other combinations. Such needle fire assembly (140) components may be generally configured to rapidly fire the cutter (40) and piercer (22) in a predetermined sequence to penetrate tissue. For example, in some versions the needle fire assembly (140) is configured to rapidly fire the piercer (22) distally to penetrate tissue. The needle fire assembly (140) may also be configured to rapidly fire the cutter (40) distally. The firing of the cutter (40) may be delayed or slowed relative to the piercer (22) so that the notch (26) may be exposed to the cutter (40). This sequence may allow tissue to enter notch (26) so that the notch may be severed by subsequent movement of cutter (40). Additionally, it should be appreciated that needle fire assembly (140) may include other components and / or features to allow for cocking of cutter (40) and / or piercer (22) prior to firing.

[0036] Cutter drive assembly (120) is generally configured to translate and / or rotate cutter (40) either independently of or in coordination with piercer (22). For example, cutter drive assembly (120) may include various combinations of gears, racks, lead screws, carriages, springs, and / or the like to drive cutter (40) in a predetermined sequence. In one such sequence, cutter (40) is retracted proximally relative to outer housing (14) to prepare cutter (40) for a tissue collection sequence, which is described in more detail below. Additionally, cutter drive assembly (120) may also be configured to rotate cutter (40) in a predetermined sequence to assist in a tissue collection sequence, which is described in more detail below.

[0037] The piercer drive assembly (130) is generally configured to translate and / or rotate the piercer (22) either independently of the cutter (40) or in coordination with the cutter (40). For example, the piercer drive assembly (120) may include various combinations of gears, racks, lead screws, carriages, springs, and / or other mechanisms to drive the piercer (22) in a predetermined sequence. In one such sequence, the piercer (22) is retracted proximally relative to the cutter (40) after severing the tissue sample to draw the tissue sample proximally toward the outer housing (14). Once the piercer (22) is retracted, the tissue sample may be extracted for collection in a tissue collection sequence, which is described in more detail below.

[0038] In this version, the drive assembly (100) is powered by one or more motors (150, 152). Specifically, this version of the drive assembly (100) includes a drive motor (150) and a fire motor (152). This version of the drive motor (150) communicates with both the cutter drive assembly (120) and the lancet drive assembly (130) to provide rotational motion to both assemblies, thereby ultimately driving the translation and / or rotation of both the cutter (40) and the lancet (22). Similarly, the fire motor (152) communicates with the fire assembly (140) to drive the fire and / or cocking of the cutter (40) and the lancet (22). While this version of the drive assembly (100) includes two motors (150, 152), it should be understood that in other versions, any suitable number of motors may be used, such as a single motor or three or more motors. Additionally, the motors (150, 152) may be configured to drive the cutter drive assembly (120), the lancing assembly (130), and / or the fire assembly (140) in various combinations.

[0039] While the present version of the cutter drive assembly (120), puncture drive assembly (130), and fire assembly (140) are shown generally as three separate drive assemblies, it should be understood that in other versions, various elements of the cutter drive assembly (120), puncture drive assembly (130), and fire assembly (140) can be combined into a single drive assembly or multiple drive assemblies to drive the movement of the cutter (40) and puncture (22) according to the sequences described herein. In some versions, the cutter drive assembly (120), puncture drive assembly (130), and fire assembly (140) can be constructed according to at least some of the teachings of U.S. Ser. No. 16 / 381,573, filed April 11, 2019, and entitled "Core Needle Biopsy Device for Collecting Multiple Samples in a Single Insertion," the disclosure of which is incorporated herein by reference.

[0040] C. Example of a Tissue Sample Holder As noted above, in this version, the needle assembly (20) is configured as a core needle type tissue collection assembly capable of collecting multiple samples with a single insertion. In some versions, each time a tissue sample is collected, the tissue sample may be physically removed from the tissue collection feature (54) by the operator and stored in another location (e.g., a formalin jar). However, this physical removal may be undesirable in some versions, as it may add an additional step to the biopsy procedure, thereby increasing procedure time. Furthermore, this physical removal may introduce extra variability into the biopsy procedure by requiring the operator to keep track of the collected tissue samples throughout the biopsy procedure. This physical removal may also cause the operator to frequently re-grasp throughout the biopsy procedure, which may generally be undesirable. Therefore, in some versions, it may be desirable to include a tissue sample holder or other sample collection mechanism within the biopsy device (10) to collect and store tissue samples throughout the biopsy procedure.

[0041] 5 and 6 show a version of a tissue sample holder (200) that may be readily incorporated into the biopsy device (10) described above. This version of the tissue sample holder (200) includes an extraction mechanism (240) disposed within a generally cylindrical outer housing (210). The tissue sample holder (200) is generally configured to collect multiple tissue samples from the tissue collection feature (60) of the needle assembly (20) during a biopsy procedure using rotation of the extraction mechanism (240). As described in more detail below, the tissue sample holder (200) is generally configured to collect and store tissue samples in any suitable number of bulk collection configurations.

[0042] The outer housing (210) is generally configured to enclose the extraction mechanism (240) within a chamber defined by the outer housing (210). In this version, the outer housing (210) is formed from a combination of elements, although in other versions a single element may be used. Specifically, the outer housing (210) in this version includes a removable cover (212) (also referred to as a cup, sample cup, sample window, sample receiver, or sample accumulator) that is configured to be secured to a portion of the body (12) of the biopsy device (10) that is configured to receive the cover (212). Thus, the combination of the cover (212) and the body (12) of the biopsy device (10) together define the outer housing (210). In this version, the cover (212) and the body (12) together may seal the interior of the tissue sample holder (200) from the external environment. Thus, in some versions, the cover (212) and / or the body (12) may include certain sealing elements to facilitate a fluid and / or air-tight seal between the cover (212) and the body (12).

[0043] 7 shows the cover (212) in more detail. The cover (212) is generally configured to facilitate collection of one or more tissue samples by engaging an extraction mechanism (240), as described in more detail below. Although features of the cover (212) for facilitating collection of one or more tissue samples are described herein as being integral with the cover (212), it should be understood that in other versions, such features may be separate components secured to either the cover (212) or other portions of the biopsy device (10).

[0044] As best shown in FIG. 7, the cover (212) includes a generally D-shaped outer wall (214). The outer wall (214) is configured to cover at least a portion of the body (12) of the body device (10) and enclose at least a portion of the extraction mechanism (240) within an interior defined by the outer wall (214). The outer wall (214) includes various features that protrude from a portion of the outer wall (214) to facilitate the utility of the tissue sample holder (200). For example, the outer wall (214) defines a lancing device interface (216), a sample chamber (218), and an auxiliary sample catch (220) (also referred to as a sample knife, secondary catch, secondary ledge, or sample scraper). The lancing device interface (216), sample chamber (218), and sample catch (220) generally may operate in coordination with the extraction mechanism (240) to collect and store one or more tissue samples obtained via the needle assembly (20).

[0045] The piercer interface (216) projects inwardly (e.g., upwardly, laterally, or a combination of both) at an angle from a portion of the outer wall (214). The piercer interface (216) defines a slight ledge, shelf, or overhang. As described below, the ledge defined by the piercer interface (216) may be disposed proximate a portion of the end (50) to direct one or more tissue samples into the sample chamber (218). Additionally, the angled projection of the piercer interface (216) separates the sample chamber (218) from the remainder of the interior of the outer wall (214) to at least partially define a separate area for collecting one or more tissue samples.

[0046] The sample chamber (218) is generally configured to receive multiple tissue samples. As noted above, the sample chamber (218) is defined at least in part by the lancing device interface (216). Specifically, the lancing device interface (216) in this version defines one side of the sample chamber (218), while the opposing side and floor of the sample chamber (218) are defined by the outer wall (214). Specifically, a curved portion of the outer wall (214) defines the side of the sample chamber (218) opposite the lancing device interface (216), and the floor is defined by a lateral extension of the outer wall (214). These features together define a recess in the outer wall (214) that defines the sample chamber (218).

[0047] The sample catch (220) extends inwardly from a top of the outer wall (214) to define a protrusion into the interior of the outer wall (214). As described in more detail below, the sample catch (220) is generally configured to engage one or more portions of the extraction mechanism (240) to transfer a tissue sample onto a surface of the sample catch (220). To facilitate such functionality, the sample catch (220) may have a variety of configurations. For example, in the present version, the sample catch (220) is configured as a rectangular member that extends from a distal end of the outer wall (214) to a proximal end of the outer wall (214). Optionally, the innermost end of the sample catch (220) may be angled in some versions to provide an edge that may be used to scrape or otherwise remove a tissue sample from a portion of the extraction mechanism (240). While the present version of the sample catch (220) is generally rectangular, in other versions the sample catch (220) may assume a variety of alternative shapes, such as curved. Additionally, some versions of the sample catch (220) may include multiple tines or extension members rather than being a single continuous piece as shown.

[0048] The cover (212) further includes certain features configured to facilitate engagement of the cover (212) with the body (12) of the biopsy device (10). Specifically, the cover (212) includes a grip (222), a proximal wall (224), and one or more engagement members (228). The grip (222) is configured to facilitate gripping of the cover (212) by an operator during removal of the cover (212) from the body (12). Thus, the present version of the grip (222) includes a number of ridges or ribs that protrude from the outer surface of the outer wall (214). Of course, in other versions, the grip (222) may include indentations, knurling, and / or other grip-facilitating structures.

[0049] The proximal wall (224) extends laterally across the proximal end of the outer wall (214). The proximal wall (224) is generally configured to cooperate with the body (12) to enclose a chamber defined by the cover (212). In some versions, the proximal wall (224) may be a separate component that may be removable from the cover (212). To facilitate access to the interior of the cover (212), the proximal wall further includes an access opening (226). The access opening (226) is generally configured to accommodate the shapes of various structures that may extend into or through the cover (212). For example, in the present version, both the cutter (40) and the end (50) may extend into or through a portion of the cover (212). Thus, the access opening (224) has a size and shape to accommodate both the cutter (40) and at least a portion of the end (50).

[0050] Engagement member (228) extends from a bottom surface of outer wall (214). Engagement member (228) is generally configured to engage at least a portion of body (12) to releasably secure cover (212) to body (12). For example, in some versions, body (12) may include notches, recesses, indentations, depressions, and / or the like, which may be covered or encapsulated by cover (212). Such notches, recesses, indentations, depressions, or other features may expose a portion of needle assembly (20) therein such that a portion of needle assembly (20) may be visible through at least a portion of cover (212). Thus, engagement member (228) may facilitate coupling of cover (212) to body (12) and promote encapsulation of a portion of body (12) by cover (212). In this version, the engaging members (228) include snap-fit ​​fasteners that may be configured to matingly engage corresponding features on the body (12). Of course, a variety of alternative fastening mechanisms may be used.

[0051] As best shown in FIG. 8 , the extraction mechanism (240) includes a driver (242) (also referred to as a rotatable member, drive shaft, or actuation member) and a wiper (250) (also referred to as a sample blade or sample manipulator). The driver (242) in this version is configured as an elongated shaft that is rotatable within the outer housing (210). Specifically, the driver (242) may be configured to rotate a full 360° or more to facilitate collection of multiple tissue samples. In some versions, the driver (242) may extend proximally within the body (12) and communicate with the drive assembly (100) such that the driver (242) may be driven by the drive assembly (100). In such versions, the movement of the driver (242) may be in a predetermined sequence along with the movement of the lancet (22) and cutter (40). Additionally, the driver (242) in some versions may be configured to drive the movement of other components of the biopsy device (10). For example, in some versions, driver (242) may be used to release end (50) of cutter (40) to facilitate firing of cutter (40). Of course, other suitable uses for driver (242) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0052] Driver (242) includes one or more openings (244) extending laterally through driver (242). Openings (244) are generally configured to receive at least a portion of wiper (250) to enable coupling of wiper (250) to driver (242). As such, openings (244) are positioned proximate a distal end of driver (242) at a point that aligns with other components of tissue sample holder (200), such as lancing device interface (216), sample chamber (218), and / or sample catch (220).

[0053] As best seen in FIGS. 8 and 9, the wiper (250) is configured to couple to the opening (244) of the driver (242) such that the driver (242) can rotate the wiper (250) to extract a tissue sample from the notch (26) of the lancing device (22) and move the tissue sample into the sample chamber (218) of the tissue sample holder (200). As will be appreciated, the wiper (250) is generally configured to operate in concert with other portions of the tissue sample holder (200) to propel the tissue sample as a projectile into the sample chamber (218). This propulsion of the tissue sample may be characterized in a variety of ways, such as slapping, flicking, snapping, etc. It will be appreciated that while the present version includes a single wiper (250), other versions may use multiple wipers (250).

[0054] The wiper (250) includes a mounting portion (252) and an actuation portion (256). The mounting portion (252) includes one or more connectors (254) configured to engage corresponding openings (244) in the driver (242). In this version, the connectors (254) are each generally configured as a mushroom-shaped connector or other interference-fit type feature to secure the wiper (250) to the driver (242). Of course, in other versions, various alternative configurations of the connectors (254) may be used. In such alternative configurations, an interference fit may be used. Alternatively, in other configurations, a snap fit may be used. In still other configurations, a permanent fastener, such as an overmolded or adhesive bond, may be used.

[0055] The manipulation portion (256) includes a curved body (258) having an engagement surface (260) on one side of the curved body (258) and a number of ribs (262) (also referred to as fins) on another, opposing side of the curved body (258). The curvature of the curved body (258) is generally in the direction of rotation provided by the driver (242). In other words, the curved body (258) extends laterally away from the driver (242) and is curved away from the longitudinal axis of the driver (242). Although the term "curved" is used herein in reference to the curved body (258), it should be understood that in some versions, the curved body (258) may optionally extend straight away from the driver (242) and not be curved. As will be explained in more detail below, the curvature of curved body (258) promotes engagement with other portions of tissue sample holder (200) in a specific, predetermined sequence to facilitate manipulation of the tissue sample.

[0056] The engagement surface (260) is generally flat and smooth. The orientation of the engagement surface (260) is on the inside of the curved body (258) such that the engagement surface (260) defines a slight concave surface. The engagement surface (260) is configured to contact the tissue sample and move the tissue sample from the notch (26) of the lancing device (22) to the sample chamber (218). In some versions, the engagement surface (260) may further include specific features that prevent adhesion or sticking between the engagement surface (260) and the tissue sample. For example, in some versions, the engagement surface (260) (or the entire outer surface of the wiper (250)) may include a hydrophobic or non-stick coating to prevent the tissue sample from sticking to the engagement surface (260). Additionally or alternatively, some versions of the engagement surface (260) may include ridges or other non-smooth surface features that may reduce the tendency of tissue to stick to the engagement surface (260). In such an embodiment, the presence of the ridges may reduce the need for a coating.In yet another version, engagement surface (260) may include a hydrophilic coating.

[0057] The ribs (262) extend laterally from the mounting portion (252) on a surface of the curved body (258) opposite the engagement surface (260). The thickness of each rib (262) generally increases as each rib (262) extends from the mounting portion (252). This increase in thickness increases the amount of material of the wiper (250) in the area laterally offset from the mounting portion (252). Such an increase in the amount of material is generally desirable to shift the center of mass of the wiper (250), thereby facilitating enhanced weight distribution. As described above and in further detail below, the wiper (250) is generally configured to propel, slap, or flick the tissue sample. Thus, it may be desirable to concentrate mass toward the outer ends of the wiper (250) to facilitate the desired manipulation of the tissue sample. Additionally, in some versions, the structure of the ribs (262) may be used to promote at least some rigidity within the structure of the wiper (250).

[0058] All of the ribs (262) in this version are generally of uniform width (relative to the axis of the driver (242)) and spaced apart relative to one another. It should be understood that in some versions, the width and / or spacing of one or more individual ribs (262) may be modified to affect the balance characteristics of the wiper (250). For example, in some versions, one or more ribs (262) may be wider than other ribs (262) or some ribs (262) may be spaced closer together than other ribs (262) to concentrate the mass of the ribs (262) in a particular area of ​​the wiper (250). By way of example only, in some versions, the ribs (262) on the proximal end of the wiper (250) may be approximately 3.5 times wider or more than the other ribs (262) to concentrate the mass toward the proximal end of the wiper (250).

[0059] While the wiper (250) in this example is of a single piece of material, it should be understood that in other versions, the wiper (250) may be segmented in one or more ways. For example, in some versions, the wiper (250) may include one or more slots, which may be used to divide the engagement surface (260) into different sections, each section configured to bend independently of the other sections. Such slots may extend inward from the outer edge of the wiper (250) toward the mounting portion (252). In such versions, the specific length of each slot may be 25-75% of the width of the wiper (250). In still other versions, such slots may extend the entire width of the wiper (250) and completely segment the wiper (250). In other words, in some versions, the wiper (250) may be configured as multiple separate wipers (250) connected to the driver (254) at various locations along the length of the driver (254).

[0060] In this version, the wiper (250) includes a material having certain properties that provide a balance between flexibility and stiffness. Examples of materials having a suitable balance between flexibility and stiffness may include, for example, polymers or rubber. In some versions, regardless of the specific material used, this balance may be characterized as a durometer. A variety of suitable durometers may be used. For example, in this version, a durometer of 85 may be used. In other versions, a durometer of 76.5 to 93.5 may be used. Of course, in other versions, a variety of suitable durometers may be used, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0061] 10 illustrates the relationship between the extraction mechanism 240, the outer housing 210, the end 50 of the cutter 40, and the puncture mechanism 22 when the biopsy device 10 is configured to extract a tissue sample from the notch 26 of the puncture mechanism 22. In this configuration, the puncture mechanism 22 is retracted proximally to align the notch 26 with the tissue collection feature 60 of the end 50, while the end 50 is advanced distally such that the end 50 is disposed within the outer housing 210. Specifically, the tissue collection feature 60 of the end 50 is aligned with both the puncture interface 216 of the outer housing 210 and the wiper 250 of the extraction mechanism 240. In this alignment, the tissue collection feature (60) defines a path that extends toward the notch (26) of the lancing device (22) and into the sample chamber (218). Thus, the wiper (250) can sweep along the curved path defined by the tissue collection feature (60) to transport the tissue sample from the notch (26) and into the sample chamber (218).

[0062] 11A-11D show an embodiment using a wiper (250) to convey the tissue sample from the notch (26) into the sample chamber (218). As shown in FIG. 11A, the lancing device (22) and cutter (40) may initially start in the position described above where the biopsy device (10) is configured for tissue sample extraction. This corresponds to the notch (26) of the lancing device (22) being retracted so that it is aligned with the tissue collection feature (60) of the end (50) to expose the tissue sample inside the tissue sample holder (200). At this stage, the driver (242) of the extraction mechanism (240) rotates to position the wiper (250) in approximately the 9 o'clock position, such that the wiper is positioned slightly above the tissue collection feature (60).

[0063] Once the biopsy device (10) is configured to perform tissue sample extraction, as described above and shown in FIG. 11A, the extraction mechanism (240) may be used to extract the tissue sample. To extract the tissue sample, the driver (242) may rotate in a counterclockwise direction (looking from the distal end of the biopsy device (10) toward the proximal end of the biopsy device (10)) to move a portion of the wiper (250) into contact with the tissue collection feature (60) of the end (50). As shown in FIG. 11B, this rotation of the driver (242) may continue once engagement between the wiper (250) and the tissue collection feature (60) is achieved, causing tension to be applied to the wiper (250) due to interference between the wiper (250) and the tissue collection feature (60). This tensioning of the wiper (250) may result in some bending of the wiper (250), as shown in FIG. 11B. That is, the driver (242) may be configured to bend the wiper (250) relative to a portion of the biopsy device (10). In any event, the applied tension may store at least some potential energy in the wiper (250) as the driver (242) continues to rotate while a portion of the wiper (250) is held in a fixed position by engaging the tissue collection feature (60).

[0064] Further rotation of the driver (242) may cause the wiper (250) to continue to bend until the wiper (250) is pulled past a portion of the tissue collection feature (60). As the wiper (250) is pulled past a portion of the tissue collection feature (60), the wiper (250) may suddenly be released from engagement with the tissue collection feature (60), thereby releasing the potential energy stored within the wiper (250). During the release of this stored potential energy, the wiper (250) may rapidly advance around the curve defined by the tissue collection feature (60) and into the notch (26) of the lancing device (22) and engage the tissue sample (TS) within the notch (26). Thereafter, continued rapid movement of the wiper (250) with the tissue sample (TS) disposed on the engagement surface (260) of the wiper (250) may propel the tissue sample (TS) out of the notch (26) and towards the sample chamber (218), as shown in FIG. 11C.

[0065] As the wiper (250) consumes the stored potential energy, the movement of the wiper (250) may rapidly slow down (or even reverse in some circumstances) to approximately match the movement of the driver (242). As the movement of the wiper (250) slows down, the momentum of the tissue sample (TS) may continue in the initial direction of the wiper (250). Thus, the tissue sample (TS) may detach from the wiper (250) at this stage and be propelled from the wiper (250) toward the sample chamber (218) as shown in FIG. 11D. Additionally or alternatively, the sample catch (220) may contribute to the sudden deceleration of the wiper (250) to propel the tissue sample (TS). In either case, the release of potential energy from the wiper (250) may result in the tissue sample (TS) being generally thrown, tossed, or fired from the notch (26) of the lancing device (22) into the sample chamber (218).

[0066] In some scenarios, the wiper (250) and tissue sample (TS) may not separate for various reasons. For example, in some circumstances, the tissue sample (TS) may be atypically dry or atypically wet. As a result, the tissue sample (TS) may be more adhesive or sticky and therefore have a tendency to stick to the wiper (250). In other circumstances, the tissue sample (TS) may be less dense than more typical tissue samples (TS). As a result, the tissue sample (TS) may have less momentum and may separate from the wiper (250). Regardless of the circumstances, in scenarios where separation fails, the sample catch (220) may act as a secondary separation device that scrapes or otherwise extracts the tissue sample (TS) from the wiper (250) as it rotates past the sample catch (220).

[0067] Once the tissue sample (TS) has been successfully detached from the wiper (250) and deposited within the sample chamber (218), the driver (242) may continue to rotate to return the wiper (250) to the position shown in Figure 11A. The lancing device (22) and cutter (40) may then be used to sever and collect another tissue sample, and the process described above with respect to Figures 11A-11D may be repeated to collect one or more subsequent tissue samples within the sample chamber (218). This process may then be repeated until the desired number of tissue samples have been collected.

[0068] II. 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.

[0069] Example 1 1. The core needle biopsy device comprising: a needle assembly including a puncturator and a hollow cutter, the puncturator including a sharp distal tip and a notch proximal to the distal tip, the puncturator being slidably disposed within the cutter to sever a tissue sample into the notch of the puncturator; a drive assembly configured to selectively move the puncturator and the cutter; and a tissue sample holder having a sample chamber, a driver, and a wiper, the driver configured to bend the wiper relative to a portion of the biopsy device to manipulate a detached tissue sample into the sample chamber.

[0070] Example 2 2. The core needle biopsy device of example 1, wherein the driver includes a rotatable shaft, the wiper being secured to the shaft such that rotation of the shaft rotates the wiper relative to the lancing device, thereby manipulating a detached tissue sample into the sample chamber.

[0071] Example 3 The core needle biopsy device of example 1 or example 2, wherein the needle assembly further comprises a cutter end associated with a proximal end of the cutter, the cutter end including a ledge configured to engage the wiper.

[0072] Example 4 4. The core needle biopsy device of example 3, wherein the cutter end includes a curved surface extending toward a portion of the piercer.

[0073] Example 5 5. The core needle biopsy device of any one or more of Examples 1 to 4, 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.

[0074] Example 6 6. The core needle biopsy device of example 5, wherein the outer cover comprises one or more walls that define the sample chamber.

[0075] Example 7 The core needle biopsy device of example 5 or example 6, wherein the outer cover includes a piercer interface positioned adjacent to a portion of the piercer.

[0076] Example 8 The core needle biopsy device of any one or more of Examples 5-7, wherein the outer cover includes a sample catch, the sample catch configured to engage a portion of the wiper to scrape a tissue sample from the wiper.

[0077] Example 9 9. The core needle biopsy device of example 8, wherein the sample catch is positioned adjacent to the sample chamber.

[0078] Example 10 The core needle biopsy device of any one or more of Examples 5-9, wherein the outer cover includes one or more connectors configured to releasably secure the outer cover to the housing of the biopsy device.

[0079] Example 11 11. The core needle biopsy device of any one or more of Examples 1-10, wherein the tissue sample holder comprises a single wiper.

[0080] Example 12 12. The core needle biopsy device of any one or more of Examples 1-11, wherein the wiper comprises a material having a durometer of 76.5 to 93.5.

[0081] Example 13 The core needle biopsy device of any one or more of Examples 1-12, wherein the wiper comprises a material having a durometer of about 85.

[0082] Example 14 14. The core needle biopsy device of any one or more of Examples 1-13, wherein the wiper has a hydrophobic coating.

[0083] Example 15 15. The core needle biopsy device of any one or more of Examples 1-14, 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.

[0084] Example 16 1. A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device including a lancet having a sample notch and a cutter movable relative to the sample notch to sever a tissue sample, the tissue sample holder comprising: a body defining a sample chamber and a wiper catch; and a wiper movable relative to a portion of the tissue sample holder to manipulate a severed tissue sample from the sample notch of the lancet into the sample chamber of the body, the wiper catch configured to engage with the wiper to store potential energy within the structure of the wiper.

[0085] Example 17 The tissue sample holder of Example 16, further comprising a rotatable shaft, the wiper extending radially outward from the shaft, the body including an outer wall defining the sample chamber, and the wiper configured to rotate within the outer wall of the body to move the separated tissue sample within the sample chamber.

[0086] Example 18 18. The tissue sample holder of example 17, wherein the wiper defines a curved portion, the curved portion defining a curve oriented in a direction corresponding to a direction of rotation of the shaft.

[0087] Example 19 The tissue sample holder of any one or more of Examples 16-18, wherein the wiper defines an engagement surface configured to engage a detached tissue sample, and the wiper includes a plurality of ribs extending along a surface of the wiper opposite the engagement surface.

[0088] Example 20 1. A method for collecting a tissue sample using a biopsy device, comprising: retracting a sample notch defined by a lancing device proximally into a tissue sample holder; moving a wiper within the tissue sample holder to engage the wiper with a ledge; bending the wiper against the ledge to store potential energy in the wiper; and moving the wiper to disengage the wiper from the ledge to release the stored potential energy and propel a detached tissue sample into a sample chamber of the tissue sample holder.

[0089] Example 21 21. The method of example embodiment 20, wherein the act of moving the wiper includes rotating the wiper using a shaft coupled to the wiper.

[0090] Example 22 22. The method of claim 21, wherein the act of bending the wiper comprises rotating the shaft coupled to the wiper.

[0091] Example 23 The method of example 21 or example 22, further comprising rotating the shaft 360 degrees or more to collect multiple tissue samples.

[0092] Example 24 The method of any one or more of Examples 20-23, further comprising moving the wiper to sweep the wiper across a sample catch of the tissue sample holder.

[0093] 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 sever a tissue sample; a tissue sample holder having a body defining a sample chamber; a drive member and a wiper extending from a portion of the drive member, the drive member configured to move the wiper into engagement with a portion of the biopsy device to drive movement of the wiper at a variable speed, thereby propelling a tissue sample from the wiper into the sample chamber.

[0094] Example 26 26. The biopsy device of example 25, wherein the drive member includes a rotatable shaft, and the wiper is fixed to the shaft such that rotation of the shaft is configured to rotate the wiper relative to a portion of the needle assembly, thereby manipulating the tissue sample into the sample chamber.

[0095] Example 27 A biopsy device as described in Example 25 or Example 26, wherein the needle assembly includes a cutter and a puncture, the puncture being coaxially disposed within the cutter, and the puncture including a notch configured to accept the tissue sample.

[0096] Example 28 28. The biopsy device of example embodiment 27, wherein the wiper defines a length corresponding to a length of the notch in the piercer.

[0097] Example 29 The biopsy device of any one or more of Examples 25-28, wherein the wiper is configured to be received within the notch of the lancing device.

[0098] Example 30 30. The biopsy device of any one or more of Examples 25-29, wherein the wiper has a tissue engaging surface and a rear surface opposite the tissue engaging surface.

[0099] Example 31 The biopsy device of Example 30, wherein the wiper defines a curvature and the tissue engaging surface is associated with the curvature such that the tissue engaging surface defines a concave surface.

[0100] Example 32 The biopsy device of example 30 or example 31, wherein the tissue engaging surface has a hydrophobic coating.

[0101] Example 33 33. The biopsy device of any one or more of Examples 30-32, wherein the rear surface has a plurality of ribs, the plurality of ribs extending from an inner end of the wiper to an outer end of the wiper.

[0102] Example 34 34. The biopsy device of example embodiment 33, wherein each rib of the plurality of ribs defines a thickness that increases as each rib extends from the inner end to the outer end.

[0103] Example 35 The biopsy device of any one or more of Examples 25-34, wherein the wiper defines a thin, substantially rectangular shape.

[0104] Example 36 1. The core needle biopsy device comprising: a body; a needle assembly extending distally from a portion of the body, the needle assembly including a puncturator and a hollow cutter, the puncturator including a sharp distal tip and a notch proximal to the distal tip, the puncturator being slidably disposed within the cutter to sever a tissue sample into the notch of the puncturator; a drive assembly configured to selectively move the puncturator and the cutter; and a tissue sample holder having a cover, a driver, and a wiper, the cover removably secured to a portion of the body, the cover defining a tissue sample chamber, the driver configured to move the wiper relative to the cover to manipulate the severed tissue sample into the sample chamber defined by the cover.

[0105] Example 37 37. The core needle biopsy device of claim 36, wherein the cover of the tissue sample holder includes a piercer interface, the piercer interface defining a portion of the tissue sample chamber.

[0106] Example 38 A core needle biopsy device as described in Example 36, wherein the cover of the tissue sample holder includes an outer wall and a piercer interface, the piercer interface protruding inwardly at an angle from a portion of the outer wall to define a portion of the tissue sample chamber.

[0107] Example 39 The core needle biopsy device of Example 36, wherein the cover of the tissue sample holder includes a piercer interface, the piercer interface defining a portion of the sample chamber, and the piercer interface configured to direct the separated tissue sample into the tissue sample chamber.

[0108] Example 40 40. The core needle biopsy device of any one of Examples 37 to 39, wherein the puncture interface defines a ledge disposed adjacent to a portion of the puncture.

[0109] Example 41 41. The core needle biopsy device of any of Examples 36-40, wherein the cover includes a sample catch that protrudes inwardly from a portion of the cover toward the tissue sample chamber.

[0110] Example 42 A core needle biopsy device as described in any of Examples 36 to 40, wherein the cover includes a sample catch that protrudes inwardly from a portion of the cover toward the tissue sample chamber, the sample catch being configured to engage the wiper to scrape the tissue sample from the wiper.

[0111] Example 43 A core needle biopsy device as described in any of Examples 36 and 41-42, wherein the cover further includes an outer wall, a proximal wall, and a puncture interface extending from the proximal wall through an interior defined by the outer wall, and the outer wall, the proximal wall, and the puncture interface together define the tissue sample chamber.

[0112] Example 44 The core needle biopsy device of any of Examples 36 and 41-42, wherein the cover further includes an outer wall, a proximal wall, and a puncture interface extending from the proximal wall through the outer wall, the outer wall, the proximal wall, and the puncture interface together defining the tissue sample chamber, the outer wall defining a curved portion, the curved portion defining a portion of the tissue sample chamber, and the puncture interface is disposed on an opposite side of the curved portion.

[0113] Example 45 The core needle biopsy device of any one of Examples 36 and 41-42, wherein the cover further includes an outer wall, a proximal wall, and a puncture interface extending from the proximal wall through the outer wall, the outer wall, the proximal wall, and the puncture interface together defining the tissue sample chamber, the outer wall defining a curved portion, the curved portion defining a portion of the tissue sample chamber, the puncture interface being disposed opposite the curved portion, and a floor of the tissue sample chamber being defined by a lateral extension of the outer wall.

[0114] Example 46 A core needle biopsy device as described in any of Examples 36 and 41-42, wherein the cover further includes an outer wall and a puncture interface, the outer wall and the puncture interface together defining a recess corresponding to the tissue sample chamber.

[0115] Example 47 A core needle biopsy device described in any of Examples 36 to 46, wherein the needle portion further includes an end configured to drive movement of the cutter, and the cover is configured to slidably receive the end.

[0116] Example 48 48. The core needle biopsy device of any of Examples 36 to 47, wherein the body defines a notch, and the cover is configured to engage the body to surround the notch.

[0117] Example 49 48. The core needle biopsy device of any one of Examples 36 to 47, wherein the body defines a notch and the cover is configured to form a snap fit with the body to surround the notch.

[0118] Example 50 50. The core needle biopsy device of any one of Examples 36 to 49, wherein at least a portion of the cover is transparent.

[0119] Example 51 13. The core needle biopsy device comprising: a body defining a recess; a needle assembly extending distally from a portion of the body, the needle assembly including a puncturator and a hollow cutter, the puncturator including a sharp distal tip and a notch proximal to the distal tip, the puncturator being slidably disposed within the cutter to sever a tissue sample into the notch of the puncturator; a drive assembly configured to selectively move the puncturator and the cutter; a tissue extraction mechanism including a driver and a wiper, the driver configured to move relative to the needle assembly to manipulate the tissue sample from the notch of the puncturator; and a tissue collection assembly including a sample window, the sample window configured to cover the recess of the body, the sample window defining a sample chamber disposed adjacent to the needle assembly, the sample chamber configured to receive the tissue sample from the wiper.

[0120] Example 52 52. The core needle biopsy device of example 51, wherein the sample window is removably coupled to the recess in the body.

[0121] Example 53 A core needle biopsy device described in either Example 51 or Example 52, further comprising one or more sealing elements disposed between the body and the sample window, the one or more sealing elements configured to provide a seal between the sample window and the body.

[0122] Example 54 54. A core needle biopsy device as described in any of Examples 51 to 53, wherein a portion of the needle assembly is exposed within the recess such that the portion of the needle assembly is visible through the sample window.

[0123] Example 55 a core needle biopsy device comprising: a body defining a recess; a needle assembly extending distally from a portion of the body and extending proximally through the recess, the needle assembly including a puncturator and a hollow cutter, the puncturator including a sharp distal tip and a notch proximal to the distal tip, the puncturator being slidably disposed within the cutter to sever a tissue sample into the notch of the puncturator; a drive assembly configured to selectively move the puncturator and the cutter; and a tissue extraction mechanism including a driver and a wiper, the drive assembly configured to selectively move the puncturator and the cutter. 11. The core needle biopsy device comprising: the tissue extraction mechanism, a wiper protruding outwardly from a portion of the wiper; and a tissue collection assembly including a sample window, the sample window configured to cover the recess in the body, the sample window including a lateral protrusion, the lateral protrusion defining a sample chamber disposed adjacent to the needle assembly, the driver of the tissue extraction mechanism configured to rotate within the body to manipulate the tissue sample from the notch in the lancing tool and into the sample chamber.

[0124] Example 56 The core needle biopsy device of any one of Examples 36 to 50 and Example 55, wherein the driver is configured to rotate the wiper relative to the cover.

[0125] Example 57 A core needle biopsy device described in any of Examples 36 to 50 and Example 55, wherein the driver is configured to move the wiper laterally relative to a longitudinal axis defined by the needle assembly.

[0126] Example 58 The core needle biopsy device of any one of Examples 36-50 and 55-57, wherein the driver is configured to move the wiper across the notch of the lancet toward the tissue sample chamber of the cover.

[0127] Example 59 1. A method for collecting a tissue sample using a biopsy device, comprising: rotating a wiper against a sample notch defined by a lancing device toward a cover defining a tissue sample chamber; wiping a first tissue sample from the notch of the lancing device into the tissue sample chamber such that the first tissue sample is retained in the tissue sample chamber; and removing the cover from the biopsy device with the first tissue sample disposed in the tissue sample chamber.

[0128] Example 60 60. The method of example 59, further comprising swabbing a second tissue sample from the notch of the lancet into the tissue sample chamber to contain both the first tissue sample and the second tissue sample within the tissue sample chamber.

[0129] Example 61 60. The method of example 59, further comprising the step of collecting the first tissue sample and the second tissue sample from the tissue sample chamber after removing the cover.

[0130] Example 62 62. The method of any of Examples 59-61, wherein the step of rotating the wiper comprises moving the wiper laterally relative to a longitudinal axis defined by the lancing device.

[0131] Example 63 A method according to any of Examples 59 to 62, wherein the step of wiping the first tissue sample includes propelling the first tissue sample from the wiper into the tissue sample chamber of the cover.

[0132] Example 64 The method of any of Examples 59 to 62, wherein the step of wiping the first tissue sample includes rubbing a portion of the wiper across a sample catch defined by the cover.

[0133] 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.

[0134] It should be understood that any of the variations of the devices described herein may include various other features in addition to or instead 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 herein by reference. It should be understood that the teachings herein can be readily applied to any device described in any of the other references cited herein, and thus 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.

[0135] 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.

[0136] [Embodiment] (1) A core needle biopsy device comprising: a needle assembly including a puncturator and a hollow cutter, the puncturator including a sharp distal tip and a notch proximal to the distal tip, the puncturator being slidably disposed within the cutter to sever a tissue sample into the notch of the puncturator; a drive assembly configured to selectively move the puncturator and the cutter; and a tissue sample holder having a sample chamber, a driver, and a wiper, the driver configured to bend the wiper relative to a portion of the biopsy device to manipulate a severed tissue sample into the sample chamber. (2) The core needle biopsy device of claim 1, wherein the driver includes a rotatable shaft and the wiper is fixed to the shaft such that rotation of the shaft is configured to rotate the wiper relative to the lancing device, thereby manipulating the severed tissue sample into the sample chamber. (3) The core needle biopsy device of claim 1 or claim 2, wherein the needle assembly further comprises a cutter end associated with a proximal end of the cutter, the cutter end including a ledge configured to engage the wiper. (4) The core needle biopsy device of claim 3, wherein the cutter end includes a curved surface extending toward a portion of the puncture device. (5) The core needle biopsy device of any one or more of embodiments 1 to 4, 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.

[0137] (6) The core needle biopsy device of embodiment 5, wherein the outer cover includes one or more walls that define the sample chamber. (7) The core needle biopsy device of embodiment 5 or embodiment 6, wherein the outer cover includes a puncture interface positioned adjacent to a portion of the puncture. (8) The core needle biopsy device of any one or more of embodiments 5 to 7, wherein the outer cover includes a sample catch, the sample catch configured to engage a portion of the wiper to scrape a tissue sample from the wiper. (9) The core needle biopsy device of embodiment 8, wherein the sample catch is positioned adjacent to the sample chamber. (10) The core needle biopsy device of any one or more of embodiments 5 to 9, wherein the outer cover includes one or more connectors configured to releasably secure the outer cover to the housing of the biopsy device.

[0138] (11) The core needle biopsy device of any one or more of the preceding claims, wherein the tissue sample holder comprises a single wiper. (12) The core needle biopsy device of any one or more of the preceding claims, wherein the wiper comprises a material having a durometer of 76.5 to 93.5. (13) The core needle biopsy device of any one or more of the preceding claims, wherein the wiper comprises a material having a durometer of about 85. (14) The core needle biopsy device of any one or more of the preceding claims, wherein the wiper has a hydrophobic coating. (15) The core needle biopsy device of any one or more of the preceding claims, 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.

[0139] (16) A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device including a lancet having a sample notch and a cutter movable relative to the sample notch to sever a tissue sample, the tissue sample holder comprising: a body defining a sample chamber, and a wiper catch; and a wiper movable relative to a portion of the tissue sample holder to manipulate a severed tissue sample from the sample notch of the lancet into the sample chamber of the body, the wiper catch configured to engage the wiper to store potential energy within the structure of the wiper. (17) The tissue sample holder of embodiment 16, further comprising a rotatable shaft, the wiper extending radially outward from the shaft, the body including an outer wall defining the sample chamber, and the wiper configured to rotate within the outer wall of the body to move the severed tissue sample within the sample chamber. (18) The tissue sample holder of embodiment 17, wherein the wiper defines a curved portion, the curved portion defining a curve oriented in a direction corresponding to a direction of rotation of the shaft. (19) The tissue sample holder of any one or more of embodiments 16-18, wherein the wiper defines an engagement surface configured to engage a detached tissue sample, and the wiper includes a plurality of ribs extending along a surface of the wiper opposite the engagement surface. (20) A method for collecting a tissue sample using a biopsy device, comprising: retracting a sample notch defined by a lancing device proximally into a tissue sample holder; moving a wiper within the tissue sample holder to engage the wiper with a ledge; bending the wiper against the ledge to store potential energy in the wiper; and moving the wiper to disengage the wiper from the ledge to release the stored potential energy and propel a detached tissue sample into a sample chamber of the tissue sample holder.

[0140] 21. The method of claim 20, wherein the act of moving the wiper includes rotating the wiper using a shaft coupled to the wiper. (22) The method of claim 21, wherein the act of bending the wiper includes rotating the shaft coupled to the wiper. (23) The method of embodiment 21 or embodiment 22, further comprising rotating the shaft 360° or more to collect multiple tissue samples. (24) The method of any one or more of embodiments 20 to 23, further comprising moving the wiper to sweep the wiper across a sample catch of the tissue sample holder. (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 sever a tissue sample; a body defining a sample chamber; a tissue sample holder having a drive member and a wiper extending from a portion of the drive member, the drive member configured to move the wiper into engagement with a portion of the biopsy device to drive movement of the wiper at a variable speed, thereby propelling a tissue sample from the wiper into the sample chamber.

[0141] (26) The biopsy device of claim 25, wherein the drive member includes a rotatable shaft, and the wiper is fixed to the shaft such that rotation of the shaft is configured to rotate the wiper relative to a portion of the needle assembly, thereby manipulating the tissue sample into the sample chamber. (27) The biopsy device of embodiment 25 or embodiment 26, wherein the needle assembly includes a cutter and a puncture, the puncture being coaxially disposed within the cutter, and the puncture including a notch configured to receive the tissue sample. (28) The biopsy device of embodiment 27, wherein the wiper defines a length corresponding to a length of the notch in the piercer. (29) The biopsy device of any one or more of embodiments 25 to 28, wherein the wiper is configured to be received within the notch of the lancet. (30) The biopsy device of any one or more of embodiments 25 to 29, wherein the wiper has a tissue engaging surface and a rear surface opposite the tissue engaging surface.

[0142] (31) The biopsy device of embodiment 30, wherein the wiper defines a curvature and the tissue engaging surface is associated with the curvature such that the tissue engaging surface defines a concave surface. (32) The biopsy device of embodiment 30 or embodiment 31, wherein the tissue engaging surface has a hydrophobic coating. (33) The biopsy device according to any one or more of embodiments 30 to 32, wherein the rear surface has a plurality of ribs, the plurality of ribs extending from an inner end of the wiper to an outer end of the wiper. (34) The biopsy device of embodiment 33, wherein each rib of the plurality of ribs defines a thickness that increases as each rib extends from the inner end to the outer end. (35) The biopsy device of any one or more of embodiments 25 to 34, wherein the wiper defines a thin, substantially rectangular shape.

[0143] (36) A core needle biopsy device, comprising: (a) a main body; (b) a needle assembly extending distally from a portion of the body, the needle assembly including a piercer and a hollow cutter, the piercer including a sharp distal tip and a notch proximal to the distal tip, the piercer slidably disposed within the cutter to sever a tissue sample into the notch of the piercer; (b) a drive assembly configured to selectively move the lancet and the cutter; (c) a tissue sample holder having a cover, a driver, and a wiper, the cover removably secured to a portion of the body, the cover defining a tissue sample chamber, and the driver configured to move the wiper relative to the cover to manipulate a severed tissue sample into the sample chamber defined by the cover; The core needle biopsy device. (37) The core needle biopsy device of embodiment 36, wherein the cover of the tissue sample holder includes a piercer interface, the piercer interface defining a portion of the tissue sample chamber. (38) The core needle biopsy device of claim 36, wherein the cover of the tissue sample holder includes an outer wall and a piercer interface, the piercer interface protruding inwardly at an angle from a portion of the outer wall to define a portion of the tissue sample chamber. (39) The core needle biopsy device of embodiment 36, wherein the cover of the tissue sample holder includes a piercer interface, the piercer interface defining a portion of the sample chamber, and the piercer interface configured to direct the separated tissue sample into the tissue sample chamber. (40) The core needle biopsy device of any one of embodiments 37 to 39, wherein the puncture interface defines a ledge disposed adjacent to a portion of the puncture.

[0144] (41) The core needle biopsy device of any one of embodiments 36 to 40, wherein the cover includes a sample catch that projects inwardly from a portion of the cover toward the tissue sample chamber. (42) The core needle biopsy device of any one of claims 36 to 40, wherein the cover includes a sample catch that protrudes inwardly from a portion of the cover toward the tissue sample chamber, the sample catch being configured to engage the wiper to scrape the tissue sample from the wiper. (43) A core needle biopsy device as described in any one of embodiments 36 and 41 to 42, wherein the cover further includes an outer wall, a proximal wall, and a puncture interface extending from the proximal wall through an interior defined by the outer wall, and the outer wall, the proximal wall, and the puncture interface together define the tissue sample chamber. (44) A core needle biopsy device as described in any one of embodiments 36 and 41 to 42, wherein the cover further includes an outer wall, a proximal wall, and a puncture interface extending from the proximal wall through the outer wall, the outer wall, the proximal wall, and the puncture interface together defining the tissue sample chamber, the outer wall defining a curved portion, the curved portion defining a portion of the tissue sample chamber, and the puncture interface being disposed opposite the curved portion. (45) A core needle biopsy device as described in any of embodiments 36 and 41-42, wherein the cover further includes an outer wall, a proximal wall, and a puncture interface extending from the proximal wall through the outer wall, the outer wall, the proximal wall, and the puncture interface together defining the tissue sample chamber, the outer wall defining a curved portion, the curved portion defining a portion of the tissue sample chamber, the puncture interface being disposed opposite the curved portion, and a floor of the tissue sample chamber being defined by a lateral extension of the outer wall.

[0145] (46) A core needle biopsy device as described in any one of embodiment 36 and embodiment 41 to embodiment 42, wherein the cover further includes an outer wall and a puncture interface, the outer wall and the puncture interface together defining a recess corresponding to the tissue sample chamber. (47) A core needle biopsy device according to any one of embodiments 36 to 46, wherein the needle portion further includes an end portion configured to drive movement of the cutter, and the cover is configured to slidably receive the end portion. (48) The core needle biopsy device of any one of embodiments 36 to 47, wherein the body defines a notch, and the cover is configured to engage the body to surround the notch. (49) The core needle biopsy device of any one of embodiments 36 to 47, wherein the body defines a notch, and the cover is configured to form a snap fit with the body to surround the notch. (50) The core needle biopsy device of any one of embodiments 36 to 49, wherein at least a portion of the cover is transparent.

[0146] (51) A core needle biopsy device, comprising: (a) a body defining a recess; (b) a needle assembly extending distally from a portion of the body, the needle assembly including a piercer and a hollow cutter, the piercer including a sharp distal tip and a notch proximal to the distal tip, the piercer slidably disposed within the cutter to sever a tissue sample into the notch of the piercer; (b) a drive assembly configured to selectively move the lancet and the cutter; (c) a tissue extraction mechanism including a driver and a wiper, the driver configured to move relative to the needle assembly to manipulate the tissue sample from the notch of the lancing device; (d) a tissue collection assembly including a sample window configured to cover the recess in the body, the sample window defining a sample chamber disposed proximate to the needle assembly, the sample chamber configured to receive the tissue sample from the wiper; The core needle biopsy device. (52) The core needle biopsy device of embodiment 51, wherein the sample window is removably coupled to the recess in the body. (53) The core needle biopsy device of either embodiment 51 or embodiment 52, further comprising one or more sealing elements disposed between the body and the sample window, the one or more sealing elements configured to provide a seal between the sample window and the body. (54) The core needle biopsy device of any one of embodiments 51 to 53, wherein a portion of the needle assembly is exposed within the recess such that the portion of the needle assembly is visible through the sample window. (55) A core needle biopsy device, comprising: (a) a body defining a recess; (b) a needle assembly extending distally from a portion of the body and extending proximally through the recess, the needle assembly including a piercer and a hollow cutter, the piercer including a sharp distal tip and a notch proximal to the distal tip, the piercer being slidably disposed within the cutter to sever a tissue sample into the notch of the piercer; (b) a drive assembly configured to selectively move the lancet and the cutter; (c) a tissue extraction mechanism including a driver and a wiper, the wiper protruding outwardly from a portion of the wiper; and (d) a tissue collection assembly including a sample window configured to cover the recess of the body, the sample window including a lateral protrusion defining a sample chamber disposed adjacent to the needle assembly, the driver of the tissue extraction mechanism configured to rotate within the body to manipulate the tissue sample from the notch of the lancing device into the sample chamber; The core needle biopsy device.

[0147] (56) The core needle biopsy device of any one of embodiments 36 to 50 and embodiment 55, wherein the driver is configured to rotate the wiper relative to the cover. (57) The core needle biopsy device of any one of embodiments 36 to 50 and embodiment 55, wherein the driver is configured to move the wiper laterally relative to a longitudinal axis defined by the needle assembly. (58) The core needle biopsy device of any one of embodiments 36 to 50 and embodiments 56 to 57, wherein the driver is configured to move the wiper across the notch of the lancet toward the tissue sample chamber of the cover. (59) A method for collecting a tissue sample using a biopsy device, comprising: (a) rotating a wiper against a sample notch defined by a lancing device toward a cover defining a tissue sample chamber; (b) swiping a first tissue sample from the notch of the lancing device into the tissue sample chamber such that the first tissue sample is retained in the tissue sample chamber; (c) removing the cover from the biopsy device with the first tissue sample disposed in the tissue sample chamber; The method comprising: (60) The method of embodiment 59, further comprising swabbing a second tissue sample from the notch of the lancing device into the tissue sample chamber to contain both the first tissue sample and the second tissue sample in the tissue sample chamber.

[0148] (61) The method of embodiment 60, further comprising the step of collecting the first tissue sample and the second tissue sample from the tissue sample chamber after the step of removing the cover. (62) The method of any one of claims 59 to 61, wherein the step of rotating the wiper includes moving the wiper laterally relative to a longitudinal axis defined by the lancing device. (63) The method of any one of embodiments 59 to 62, wherein the step of wiping the first tissue sample includes propelling the first tissue sample from the wiper into the tissue sample chamber of the cover. (64) The method of any one of embodiments 59 to 62, wherein the step of wiping the first tissue sample includes rubbing a portion of the wiper across a sample catch defined by the cover.

Claims

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 sever 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 having a sample chamber, a driver, and a wiper, the driver configured to bend the wiper relative to a portion of the core needle biopsy device to manipulate a severed tissue sample into the sample chamber.

2. 10. The core needle biopsy device of claim 1, wherein the driver includes a rotatable shaft, the wiper being secured to the shaft such that rotation of the shaft rotates the wiper relative to the lancing device, thereby manipulating the severed tissue sample into the sample chamber.

3. The core needle biopsy device of claim 1 , wherein the needle assembly further comprises a cutter end associated with a proximal end of the cutter, the cutter end including a ledge configured to engage the wiper.

4. The core needle biopsy device of claim 3 , wherein the cutter end includes a curved surface that extends toward a portion of the lancing device.

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

6. 6. The core needle biopsy device of claim 5, wherein the outer cover has a D-shaped configuration defining a curved portion and one or more walls, at least one of the curved portion and the one or more walls defining the sample chamber, and a portion of the needle assembly is visible through the curved portion and at least one of the one or more walls.

7. The core needle biopsy device of claim 5 , wherein the outer cover includes a lancing device interface disposed adjacent a portion of the lancing device.

8. The core needle biopsy device of claim 5 , wherein the outer cover includes a sample catch configured to engage a portion of the wiper to scrape the tissue sample from the wiper.

9. The core needle biopsy device of claim 8 , wherein the sample catch is positioned adjacent to the sample chamber.

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

11. The core needle biopsy device of claim 1 , wherein the wiper comprises a material having a durometer of 76.5 to 93.

5.

12. The core needle biopsy device of claim 1 , wherein the wiper comprises a material having a durometer of about 85.

13. 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.

14. 1. 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 for severing a tissue sample, and a cutter movable relative to the sample notch, the tissue sample holder comprising: a body defining a sample chamber and a wiper catch; a cover configured to surround the sample chamber, the cover including a curved portion, the cover being transparent so that a portion of the cutter or the lancing device can be seen through the curved portion of the cover, the curved portion defining one or more sides of the sample chamber; and a wiper movable relative to a portion of the tissue sample holder to manipulate the severed tissue sample from the sample notch of the lancing device into the sample chamber of the body, the wiper catch configured to engage with the wiper to store potential energy within the structure of the wiper.

15. 15. The tissue sample holder of claim 14, further comprising a rotatable shaft, the wiper extending radially outward from the shaft, the body including an outer wall defining the sample chamber, the wiper configured to rotate within the outer wall of the body to move the severed tissue sample within the sample chamber.

16. 16. The tissue sample holder of claim 15, wherein the wiper defines a curved portion, the curved portion of the wiper defining a curve oriented in a direction corresponding to a direction of rotation of the shaft.

17. 15. The tissue sample holder of claim 14, wherein the wiper defines an engagement surface configured to engage a severed tissue sample, the wiper including a plurality of ribs extending along a surface of the wiper opposite the engagement surface.

18. 1. A method for collecting a tissue sample using a biopsy device, comprising: retracting a sample notch defined by a lancing instrument proximally into a tissue sample holder; moving a wiper within the tissue sample holder to engage the wiper with a ledge; bending the wiper against the ledge to store potential energy within the wiper; and moving the wiper to disengage the wiper from the ledge, releasing the stored potential energy and propelling a detached tissue sample into a sample chamber of the tissue sample holder.

19. A tissue sample holder as described in claim 14, wherein the cover further includes a pair of walls extending from each side of the curved portion, and the sample chamber is visible through the curved portion and at least one of the pair of walls.

20. A tissue sample holder as described in claim 14, wherein the cover further includes a pair of walls extending from each side of the curved portion, the curved portion and the pair of walls together defining a D-shaped configuration, and the wiper and the sample chamber are visible through the curved portion and the pair of walls.

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