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 perforator and a hollow cutter. The perforator has a sharp distal tip and a notch proximal to the distal tip. The perforator is slidably disposed within the cutter to sever the tissue sample into the notch in the perforator. The drive assembly is configured to selectively move the perforator and the cutter. The tissue sample holder has a sample chamber and a wiper. The wiper is movable relative to the perforator and the cutter to manipulate the severed tissue sample into the sample chamber.

Description

[Technical field]

[0001] Priority This application claims priority to U.S. Provisional Patent Application No. 62 / 916,277, entitled “Sample Management for Core Needle Biopsy Device,” filed October 17, 2020, the disclosure of which is incorporated by reference herein. [Background technology]

[0002] A biopsy is the removal of a tissue sample from a patient so that the tissue can be examined for signs of cancer or other disorders. Tissue samples can be obtained in a variety of ways using a variety of medical procedures involving a variety of sample collection devices. For example, a biopsy can be an open procedure (surgical removal of tissue after making an incision) or a percutaneous procedure (e.g., fine needle aspiration, core needle biopsy, or vacuum-assisted biopsy). After the tissue sample is collected, it is typically 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 are taken 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. Additionally, some biopsy devices may be connected to a vacuum module and / or a control module for the transmission of fluids (e.g., pressurized air, saline, atmospheric air, vacuum, etc.), the transmission of power, and / or the transmission of commands, etc. Other biopsy devices may be fully or at least partially operable without being connected or otherwise coupled to another device.

[0004] One technique for collecting breast biopsy material 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, rigid perforator with a lateral tissue receiving notch located adjacent the distal end of the perforator. Once tissue is received within the notch, an elongated hollow cutting sheath translates over the notch to sever the tissue sample. The severed tissue sample is then stored within the notch until both the perforator 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 perforator and cutting sheath.

[0005] In contrast to core needle breast biopsy procedures, vacuum assisted breast biopsy devices allow the probe to remove multiple samples without the need to withdraw the probe from the breast after every sample is collected. For example, vacuum assisted breast biopsy devices use a hollow needle to penetrate tissue. The hollow needle includes a side opening adjacent to a sharp distal tip. A hollow cutter is disposed inside the hollow needle and moved axially relative to the needle's side opening to cut the tissue sample. Once the tissue sample is cut by the hollow cutter, the tissue sample is transported axially through the cutter and collected in a tissue collection feature.

[0006] Examples of vacuum assisted biopsy devices and components of biopsy systems are described in U.S. Pat. No. 5,526,822, entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue," issued June 18, 1996; U.S. Pat. No. 6,086,544, entitled "Control Apparatus for an Automated Surgical Biopsy Device," issued July 11, 2000; U.S. Pat. No. 6,162,187, entitled "Fluid Collection Apparatus for a Surgical Device," issued December 19, 2000; U.S. Pat. No. 6,432,065, entitled "Method for Using a Surgical Biopsy System with Remote Control for Selecting an Operational Mode," issued August 13, 2002; U.S. Pat. No. 6,432,065, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode," issued June 22, 2004; No. 6,752,768 entitled "Remote Thumbwheel for a Surgical Biopsy Device" issued on October 8, 2008; U.S. Patent No. 7,442,171 entitled "Remote Thumbwheel for a Surgical Biopsy Device" issued on December 1, 2010; U.S. Patent No. 7,854,706 entitled "Clutch and Valving System for Tetherless Biopsy Device" issued on December 1, 2010; U.S. Patent No. 7,914,464 entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode" issued on March 29, 2011; U.S. Patent No. 7,938,No. 786, entitled "Tissue Biopsy Device with Rotatably Linked Thumbwheel and Tissue Sample Holder," issued on December 21, 2011; U.S. Patent No. 8,118,755, entitled "Biopsy Sample Storage," issued on February 1, 2012; U.S. Patent No. 8,206,316, entitled "Tetherless Biopsy Device with Reusable Portion," issued on June 26, 2012; U.S. Patent No. 8,702,623, entitled "Biopsy Device with Discrete Tissue Chambers," issued on April 22, 2014; U.S. Patent No. 8,858,465, entitled "Biopsy Device with Motorized Needle Firing," issued on October 14, 2014; and U.S. Patent No. 8,858,465, entitled "Biopsy Device with Motorized Needle Firing," issued on May 3, 2016. No. 9,326,755, entitled "U.S. Patent No. 6,226,326, entitled 'U.S. Patent No. 6,226,326,'" the disclosures of each of the above U.S. patents are incorporated herein by reference.

[0007] Further examples of vacuum assisted biopsy devices and biopsy system components can be found in U.S. Publication No. 2006 / 0074345, published April 6, 2006, now abandoned, entitled "Biopsy Apparatus and Method," U.S. Publication No. 2009 / 0131821, published May 21, 2009, now abandoned, entitled "Graphical User Interface For Biopsy System Control Module," U.S. Publication No. 2010 / 0152610, published June 17, 2010, now abandoned, entitled "Hand Actuated Tetherless Biopsy Device with Pistol Grip," U.S. Publication No. 2010 / 0160819, published June 24, 2010, now abandoned, entitled "Biopsy Device with Central Thumbwheel," and U.S. Publication No. 2013 / 0203636, published December 5, 2013, now abandoned, entitled "Control for Biopsy System Control Module." and U.S. Publication No. 2013 / 0324882, entitled "Method and Apparatus for Promoting a Novel Fluorescent Light-Emitting Diode Device." The disclosures of each of the above U.S. patent application publications are incorporated herein by reference.

[0008] Exemplary core needle biopsy devices are disclosed in U.S. Patent No. 5,560,373, entitled "Needle Core Biopsy Instrument with Durable or Disposable Cannula Assembly," issued on October 1, 1996, U.S. Patent No. 5,817,033, entitled "Needle Core Biopsy Device," issued on October 6, 1998, U.S. Patent No. 5,971,939, entitled "Needle Core Biopsy Device," issued on October 26, 1999, and U.S. Patent No. 5,511,556, entitled "Needle Core Biopsy Instrument," issued on April 30, 1996. The disclosures of each of the above-cited 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 advantages of both devices and reduce the overall disadvantages. For example, core needle biopsy devices may be advantageous due to their simplicity, light weight, and maneuverability. Additionally, core needle biopsy devices generally include smaller gauge needles, which may be desirable to improve patient comfort and recovery time. On the other hand, vacuum assisted biopsy devices may be advantageous for their ability to collect multiple samples with one insertion. Thus, a simple, lightweight biopsy device that can collect multiple samples with a single insertion may be desirable.

[0010] One challenge in the above biopsy device configurations is the management of tissue samples once collected using the biopsy device. Challenges may arise due to the unique needle and cutter configurations encountered in the context of core needle biopsy devices. For example, the cutter may be an internal perforator, a stylet, or external to the needle. A notch in the internal perforator may then be used to transport the severed tissue sample through the cutter. While the use of a notch may improve sample acquisition, collecting the severed tissue sample from the notch may be difficult due to the size and / or shape of the notch and the characteristics of the severed tissue sample (e.g., "sticky" or "clingy"). Therefore, certain tissue sample collection features may be desirable for incorporation into a biopsy device that combines the functionality of core needle and vacuum assisted biopsy devices.

[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 has made or used the invention described in the appended claims.

[0012] While the specification concludes with claims which particularly point out and distinctly claim the invention, the invention will be better understood from the following description of specific embodiments considered in conjunction with the accompanying drawings, in which like reference characters refer to the same elements, and in which some components or portions of components are shown in perspective, as represented by dashed lines. [Brief description of the drawings]

[0013] [Figure 1] 1 shows a perspective view of an exemplary core needle biopsy device. [Diagram 2] 2 shows an exploded view of a 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] FIG. 6 shows a perspective view of the outer housing of the tissue sample holder of FIG. 5. [Figure 7] 7 is a side cross-sectional view of the outer housing of FIG. 6, showing the cross-section taken along line 7-7 of FIG. 6. [Figure 8] FIG. 6 shows a perspective view of the extraction mechanism of the tissue sample holder of FIG. 5; [Figure 9] FIG. 6 shows a front view of the tissue sample holder of FIG. 5. [Figure 10A] 6 shows another perspective view of the tissue sample holder of FIG. 5 with a withdrawal mechanism positioned to collect a tissue sample. [Figure 10B] 6 shows yet another perspective view of the tissue sample holder of FIG. 5 with the extraction mechanism rotated to move the tissue sample. [Figure 11] 2 shows a perspective view of another exemplary tissue sample holder that can be readily incorporated into the biopsy device of FIG. 1. [Figure 12A] 12 illustrates another perspective view of the tissue sample holder of FIG. 11 with the tissue sample holder positioned to collect a tissue sample. [Figure 12B] 12 shows yet another perspective view of the tissue sample holder of FIG. 11 with the tissue sample holder translating to collect the tissue sample. [Figure 12C] 12 shows yet another perspective view of the tissue sample holder of FIG. 11 with the tissue sample holder positioned to collect another tissue sample. [Figure 13] 2 shows a perspective view of yet another exemplary tissue sample holder that can be readily incorporated into the biopsy device of FIG. 1; [Figure 14] FIG. 14 shows a perspective view of the base of the tissue sample holder of FIG. 13. [Figure 15] 15 shows another perspective view of the base of FIG. 14. [Figure 16] FIG. 14 shows a perspective exploded view of a gear assembly of the tissue sample holder of FIG. 13 . [Figure 17A] 14 illustrates another perspective view of the tissue sample holder of FIG. 13 with the tissue sample holder positioned to collect a tissue sample. [Figure 17B] 14 shows yet another perspective view of the tissue sample holder of FIG. 13 with the tissue sample holder translated to collect a tissue sample. [Figure 18A] 14 shows a partial perspective cross-sectional view of the tissue sample holder of FIG. 13 with the tissue sample holder wiper positioned to collect a tissue sample. [Figure 18B] 18B illustrates another partial perspective cross-sectional view of the tissue sample holder of FIG. 13 with the wiper of FIG. 18A sweeping across the notch of the perforator of the needle assembly of FIG. 2. [Figure 18C] 14 illustrates yet another partial perspective cross-sectional view of the tissue sample holder of FIG. 13 with another wiper of the tissue sample holder positioned to collect another tissue sample. [Figure 19] 2 shows a perspective view of yet another exemplary tissue sample holder that can be readily incorporated into the biopsy device of FIG. 1; [Figure 20] 20 shows a perspective exploded view of the tissue sample holder of FIG. 19. [Figure 21A]20 shows another perspective view of the tissue sample holder of FIG. 19 with the tissue sample holder wiper positioned to collect a tissue sample. [Figure 21B] 21B shows yet another perspective view of the tissue sample holder of FIG. 19 with the wiper of FIG. 21A rotated to move the tissue sample. [Figure 21C] 21B shows yet another perspective view of the tissue sample holder of FIG. 19 with the wiper of FIG. 21A rotated to deposit a tissue sample in a tissue tray. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0015] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments and advantages of the present invention will become apparent to those skilled in the art from the following description, which is illustrative and is one of the best modes contemplated for carrying out the present invention. As will be recognized, the present invention is capable of other various 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 deposited in a single tissue sample basket. In some other instances, tissue samples are collected in a tissue sample holder having a separate compartment for each collected tissue sample. Such multi-compartment tissue sample holders may further include a tray or strip that holds each tissue sample separately from the other tissue samples. Such trays or strips may be removable or otherwise separable from the tissue sample holder at the end 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 techniques, such as ultrasound image guidance, stereotactic (X-ray) guidance, MRI guidance, positron emission mammography ("PEM") guidance, breast dedicated 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 device depending on the context. For example, one advantage of vacuum-assisted biopsy devices is that vacuum assistance allows for the removal of multiple tissue samples with a single insertion. However, core needle biopsy devices lack this feature, but the use of core needle biopsy devices may still be desirable. For example, core needle biopsy devices may generally have a smaller needle compared to core needle biopsy devices, thereby reducing patient anxiety and increasing the ability of the needle to penetrate the lesion. Therefore, in some cases, it may be desirable to incorporate the multiple sample removal feature of vacuum-assisted biopsy devices into core needle biopsy devices to obtain the benefits present in both styles of biopsy devices.

[0019] A desirable feature of the devices described herein that are core needle biopsy devices is that they allow for a single insertion where multiple samples are taken while still using a core needle type device. To facilitate this function, the biopsy device further includes a tissue sample holder having one or more features to facilitate collection of the cut tissue sample from a notch, dugout, opening, and / or other sample collection feature. Currently, it is believed that the only devices that have this capability are vacuum assisted biopsy devices.

[0020] I. Exemplary Core Needle Biopsy Device with Multi-Sample Collection

[0021] FIG. 1 illustrates an exemplary core needle biopsy device (10) for use in a breast biopsy procedure. The core needle biopsy device (10) of this example 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) houses the various components of the biopsy device (10), which are used to drive the needle assembly (20) through cutting and tissue acquisition cycles. To this end, the outer housing (14) of this example is sized and shaped to be grasped by an operator in one hand. Although not illustrated, it should be understood that in some examples, the outer housing (14) may include multiple sections, with each section interconnecting to form the outer housing (14).

[0022] A. Exemplary Needle Assembly

[0023] 2 and 3 show the needle assembly (20) in more detail. As can be seen in FIG. 2, the needle assembly (20) comprises an elongated perforator (22) and an elongated cutter (40). As will be explained in more detail below, the perforator (22) is generally movable relative to the cutter (40) to perforate tissue and collect a tissue sample, while the cutter is generally movable relative to the perforator (22) to sever the tissue sample. The perforator (22) comprises a generally cylindrical rod having a sharpened distal tip (24) and a notch (26) disposed adjacent the distal tip (24). As will be explained in more detail below, the distal tip (24) is generally configured to pierce tissue of a patient. Similarly, as described in more detail below, notch (26) is generally configured to receive tissue therein such that a tissue sample may be collected in notch (26) after the tissue sample is cut by cutter (40).

[0024] The end portion (30) is disposed at the proximal end of the perforator (22). The end portion (30) in this example is overmolded onto the proximal end of the perforator (22) and is generally configured to enhance maneuverability of the perforator (22). In particular, the end portion (30) includes a receiving feature (32) in the form of a cylindrical recess or notch. The receiving feature (32) is configured to receive a portion of the perforator drive assembly (300). As will be explained in more detail below, this allows the perforator drive assembly (300) to drive the movement of the perforator (22) through a predetermined sequence of motion.

[0025] Cutter (40) comprises a generally hollow cylindrical tube configured to receive perforator (22) therein. Cutter (40) comprises an open distal end (42), a cannula portion (44), and an end portion (50). The open distal end (42) is configured to allow at least a portion of perforator (22) to protrude from cutter (40) when perforator (22) is moved relative to cutter (40). As described in more detail below, this configuration allows needle assembly (20) to move through cutting cycles and tissue acquisition cycles by allowing notch (26) of perforator (22) to move relative to distal end (42) of cutter (40).

[0026] The open distal end (42) of this embodiment includes a tapered edge (43). The tapered edge (43) is generally configured to slice tissue to separate a tissue sample when the cutter (40) is moved relative to the notch (26) of the perforator (22). It should be understood, therefore, that the tapered edge (43) is generally configured to function as a blade. Although this embodiment is described and shown using a tapered configuration, it should be understood that in other embodiments, various alternative shapes can be used. For example, in some embodiments, the tapered edge (43) includes a plurality of saw blades in addition to or in place of the taper shown. In still other embodiments, the tapered edge (43) can include any other additional or alternative cutting surface as would be apparent to one of ordinary skill in the art in view of the teachings herein.

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

[0028] End portion (50) of cutter (40) includes a receiving feature (52) and a tissue collecting feature (54). Similar to receiving feature (32) of perforator (22), receiving feature (52) of end portion (50) includes a cylindrical recess, slot, or other receiving feature configured to receive at least a portion of cutter drive assembly (200). As described in more detail below, receiving feature (52) is configured to receive at least a portion of cutter drive assembly (200) to enable cutter drive assembly (200) to move cutter (40) through a predetermined series of movements.

[0029] The tissue collecting feature (54) is disposed distally relative to the receiving feature (52). The tissue collecting feature (54) generally defines an elongated notch that opens into the cannula portion (44) of the cutter (40). As such, the cannula portion (44) includes a cutout portion (46) that is adjacent to or otherwise defines the tissue collecting feature (54). It should be understood that the tissue collecting feature (54) is therefore in communication with a hollow interior or lumen defined by the cannula portion (44). As will be explained in more detail below, this relationship between the tissue collecting feature (54) and the cannula portion (44) allows an operator to remove the tissue sample from the cutter (40) as the tissue sample is collected by the perforator (22).

[0030] End portion (50) further includes a driver (53) extending outwardly from an outer surface of end portion (50). Driver (53) generally comprises a square or rectangular shape. As described in more detail below, driver (53) is generally configured to operate a specific function associated with the various tissue collection functions described herein. Although driver (53) in this example is shown in connection with end portion (50), it should be understood that in other examples driver (53) may be associated with other components or may be omitted entirely.

[0031] 3 shows the perforator (22) disposed within the cutter (40). As shown, the cutter (40) is generally configured to receive the perforator (22) such that the perforator (22) is coaxial with the cutter (40). Additionally, the perforator (22) is generally movable relative to the open distal end (42) of the cutter (40). It should be understood that in some circumstances, the perforator (22) moves relative to the cutter (40), while the cutter (40) remains stationary. In other circumstances, the cutter (40) moves relative to the perforator (22), while the perforator (22) remains stationary. In either case, it should be understood that perforator (22) and cutter (40) are generally configured such that notch (26) of perforator (22) enters and exits cutter (40), such that notch (26) may be disposed distal or proximal to open distal end (42) of cutter (40). As described in more detail below, this configuration allows perforator (22) and cutter (40) to operate in coordination to pierce tissue, sever a tissue sample, and withdraw the tissue sample for collection by an operator via tissue collection feature (54).

[0032] B. Exemplary Drive Assembly

[0033] FIG. 4 illustrates the internal components of the body (12) of the biopsy device (10) with the outer housing (14) removed. As shown, inside 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 perforator (22) and cutter (40) through a predetermined series of movements, thereby penetrating tissue and obtaining multiple tissue samples with a single insertion of the needle assembly (20) into a patient. Although not shown, it should be understood that the outer housing (14) defines various internal features that support or otherwise engage the drive assembly (100). As should be understood, such internal features 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 perforator drive assembly (130), and a firing assembly (140). Generally, the needle firing assembly (140) is configured to cock and fire the cutter (40) and the perforator (22) in a predetermined sequence to sever a tissue sample. To collect the severed tissue sample, the cutter drive assembly (120) is generally configured to retract the cutter (40). Similarly, the perforator drive assembly (130) is generally configured to retract the perforator (22). It should be appreciated that in some embodiments, both the cutter drive assembly (120) and the perforator drive assembly (130) may be configured to rotate the cutter (40) and / or the perforator (22), respectively.

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

[0036] Cutter drive assembly (120) is generally configured to translate and / or rotate cutter (40) independently of or in coordination with perforator (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 be configured to rotate cutter (40) in a predetermined sequence to assist in tissue collection sequences, which are described in more detail below.

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

[0038] In this embodiment, the drive assembly (100) is powered by one or more motors (150, 152). Specifically, the drive assembly (100) in this embodiment includes a drive motor (150) and a firing motor (152). The drive motor (150) in this embodiment is in communication with both the cutter drive assembly (120) and the perforator drive assembly (130) to provide rotational motion to both assemblies, which ultimately drives the translation and / or rotation of both the cutter (40) and the perforator (22). Similarly, the firing motor (152) is in communication with the firing assembly (140) to drive the firing and / or cocking of the cutter (40) and the perforator (22). While the drive assembly (100) in this embodiment includes two motors (150, 152), it should be understood that in other embodiments, any suitable number of motors may be used, such as a single motor, or three or more motors. Further, the motors (150, 152) may be configured to drive the cutter drive assembly (120), the perforator drive assembly (130), and / or the firing assembly (140) in various combinations.

[0039] While the cutter drive assembly (120), perforator drive assembly (130), and firing assembly (140) in this example are shown generally as three separate drive assemblies, it should be understood that in other examples, various elements of the cutter drive assembly (120), perforator drive assembly (130), and firing assembly (140) may be combined into a single drive assembly or multiple drive assemblies to drive the movement of the cutter (40) and perforator (22) according to the sequences described herein. In some examples, the cutter drive assembly (120), perforator drive assembly (130), and firing assembly (140) may be constructed in accordance with 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. Exemplary Tissue Sample Holder

[0041] As noted above, in this embodiment, the needle assembly (20) is configured as a core needle style tissue acquisition assembly that may collect multiple samples using a single insertion. In some embodiments, each time a tissue sample is collected, the tissue sample may be physically removed from the tissue collection feature (54) by the operator and deposited in another location (e.g., a formalin jar). However, this physical removal may be undesirable in some embodiments, as it adds an additional step to the biopsy procedure, thereby increasing procedure time. Furthermore, this physical removal may introduce extra variance into the biopsy procedure by requiring the operator to keep track of the collected tissue sample throughout the biopsy procedure. This physical removal may also lead to frequent operator grip changes throughout the biopsy procedure, which is generally undesirable. Physical removal may also be undesirable, as physical movement of the tissue sample may degrade the structure of the tissue. Thus, in some embodiments, it may be desirable to include a tissue sample holder or other sample collection mechanism within the biopsy device (10) to collect and store the tissue sample throughout the biopsy procedure.

[0042] 5 illustrates a tissue sample holder (200) that may be readily used with the biopsy device (10) described above. The tissue sample holder (200) of this example includes a withdrawal mechanism (240) disposed within a cylindrical outer housing (210). The tissue sample holder (200) is generally configured to collect multiple tissue samples from the tissue collection feature (54) of the needle assembly (20) during a biopsy procedure using rotation of the withdrawal mechanism (240). As described in more detail below, the tissue sample holder (200) is generally configured to collect and store six tissue samples, although in other examples any suitable number may be collected and stored.

[0043] 6 and 7 show the outer housing (210) in more detail. As shown, the outer housing (210) includes a cylindrical body (212) defining a sample chamber (213) and an open distal end (214), a closed proximal end (218), and a needle receiving portion (216) extending between the open distal end (214) and the closed proximal end (218). In this embodiment, the outer housing (210) is generally transparent to facilitate visibility of the tissue sample during sample collection. Although the outer housing (210) in this embodiment is shown as having an open distal end (214), it should be understood that in other embodiments, the open distal end (214) may be closed or capped to seal the sample chamber (213) of the outer housing (210) from the environment.

[0044] The needle receiving portion (216) is generally configured as a semi-cylindrical recess or otherwise bulge in the cylindrical outer housing (210). The needle receiving portion (216) is generally sized to correspond to the size and shape of the needle assembly (20). Thus, the needle receiving portion (216) generally defines a pocket or recessed area in which the needle assembly (20) may be placed. As will be described in more detail below, the particular depth of the needle receiving portion (216) may bear some relationship to the particular geometric configuration of the tissue collecting feature (54) of the needle assembly (20) to aid in the extraction of a tissue sample from the tissue collecting feature (54).

[0045] The closed proximal end 218 of the outer housing 210 includes a shaft bore 220 and a needle bore 222. As described in more detail below, the shaft bore 220 is configured to receive a rotatable component of the extraction mechanism 240 to allow rotation of the extraction mechanism 240 from outside the outer housing 210. The needle bore 222 is sized to allow the needle assembly 20 to pass proximally through the closed proximal end 218. Although not shown, it should be understood that either the shaft bore 220 and / or the needle bore 222 may include seals, o-rings, gaskets, and / or the like to seal the sample chamber 213 of the outer housing 210 from the environment.

[0046] FIG. 8 shows the extraction mechanism (240) in greater detail. As shown, the extraction mechanism (240) includes a shaft (242) and a number of wipers (250) disposed about the shaft (242). The shaft (242) is generally rotatable, thereby rotating the wipers (250) within the outer housing (210) to collect and store tissue samples as each tissue sample is collected by the needle assembly (20). The proximal end of the shaft (242) includes a key portion (244) configured to communicate with either a manual or powered driver to rotate the shaft (242). The key portion (244) in this example has a generally square shape, however, it should be understood that the key portion (244) may have a variety of configurations suitable for transmitting rotational motion, such as a key, one or more keyways or channels, hexagonal, D-shaped, and / or the like.

[0047] Although not shown, it should be understood that the shaft (242) may be driven using the key portion (244) by a variety of mechanisms. For example, in some embodiments, the key portion (244) is rotatably coupled to any suitable portion of the drive assembly (100), such as the cutter drive assembly (120), the perforator drive assembly (130), the firing assembly (140), or some combination thereof. Such a configuration may be desirable to coordinate the rotation of the shaft (242) with the movement of the cutter (40) and / or the perforator (22). Alternatively, the biopsy device (10) may be configured to include an entirely separate drive mechanism for the shaft (242). For example, in some embodiments, a separate motor may be used to directly power the rotation of the shaft (242) via a transmission or other drive mechanism. In still other embodiments, the rotation of the shaft (242) may be driven by a manual rotation mechanism, such as a thumb wheel, push button, or other similar mechanism.

[0048] The distal end of shaft (242) includes a number of couplers (246) extending outwardly from an outer surface of shaft (242). Each coupler (246) is generally configured to receive a corresponding wiper (250) and provide a stable base for securing each wiper. Each coupler (246) in this embodiment defines a generally rectangular cross-section. In other embodiments, various alternative cross-sectional shapes, such as triangular, circular, square, etc., may be used. Although not shown, it should be understood that couplers (246) may extend axially along the length of shaft (242) a length approximately equal to the length of each wiper (250).

[0049] Each wiper (250) includes a receiving portion (252) and a tissue manipulation portion (254). The receiving portion (252) has a shape complementary to the coupler (246) such that the receiving portion (252) is configured to receive the coupler (246). Thus, in this embodiment, each receiving portion (252) defines a generally rectangular shape that corresponds to the rectangular shape of each coupler (246). However, it should be understood that in embodiments in which the coupler (246) has a different shape, the shape of the receiving portion (252) may be similarly modified.

[0050] Each of the manipulation portions (254) defines a generally curved or wavy surface at the outer end of each of the wipers (250). In the curved shapes of the present invention, there is a concave surface oriented in the direction of rotation of the shaft (242). The particular shape of each of the manipulation portions (254) is generally configured to non-traumatically engage and manipulate the tissue sample out of the tissue collection feature (54) and into the sample chamber (213) of the outer housing (210). While each of the manipulation portions (254) in this embodiment has a curved shape, it is understood that in other embodiments, various other shapes may be used, such as rounded, square, triangular, and / or the like. Additionally, while each of the manipulation portions (254) is shown as having a generally constant shape in the longitudinal direction, it is understood that in some embodiments, this shape may change as the manipulation portion (254) extends axially. For example, in some embodiments, each of the manipulation portions (254) may include one or more slots to enhance fluid management.

[0051] The wipers (250) are generally formed of a flexible and even partially resilient material, such as rubber or an elastomer. For example, the wipers (250) are generally flexible enough to bend around the interface between the outer housing (210) and the needle assembly (20). This flexibility may generally be desirable to facilitate full engagement between each wiper (250) and tissue while reducing trauma as each wiper (250) engages tissue. Meanwhile, at least some resilience is provided so that each wiper (250) can push or otherwise move the tissue sample. In some embodiments, the flexibility of each wiper (250) may be characterized in terms of a durometer. Although several suitable durometers may be used, one suitable durometer range is 30-80.

[0052] As best seen in FIG. 9. Each coupler (246) and wiper (250) is generally angularly spaced about shaft (242) such that wipers (250) are disposed at equal angular distances from one another. This generally results in couplers (246) and wipers (250) collectively forming a star pattern. This configuration may be desirable to divide sample chamber (213) into six equal segments for storing tissue samples. However, it should be understood that other suitable spacings, including non-equal spacings, may be used in other embodiments.

[0053] 9, each wiper (250) extends outwardly relative to coupler (246), away from shaft (242). When extraction mechanism (240) is disposed within outer housing (210), the axial extension of each wiper (250) is such that operating portion (254) contacts an inner surface of outer housing (210). It should be understood, therefore, that each wiper (250) is generally configured to slide along the inner surface of outer housing (210) to sweep one or more tissue samples around the inner surface of outer housing (210).

[0054] Figures 10A and 10B illustrate an exemplary use of the tissue sample holder (200) to collect a tissue sample from a needle assembly (20). As best seen in Figure 10A, collection of a tissue sample using the tissue sample holder (200) may begin after the cutter (40) and perforator (22) are driven by the drive assembly (100) to sever and collect a tissue sample (TS). Specifically, once the tissue sample (TS) is severed, it is transported to the tissue collection feature (54) using the notch (26) of the perforator (22).

[0055] In this embodiment, the tissue sample holder (200) is positioned along the axis of the needle assembly (20) such that each wiper (250) is aligned with a tissue collection feature (54). Thus, to collect a tissue sample (TS), the shaft (242) may be rotated to rotate each wiper (250) within the sample chamber (213) to sweep a selected wiper (250) adjacent the tissue collection feature (54) across the notch (26). As the selected wiper (250) sweeps across the notch (26), the manipulating portion (254) engages the tissue sample (TS) and pushes the tissue sample (TS) out of the tissue collection feature (54).

[0056] Once the selected wiper (250) has swept across the notch (26), the rotation of the shaft may continue as shown in FIG. 10B. Continuing rotation moves the tissue sample (TS) around the interior of the outer housing (210) to store the tissue sample (TS) and to store and prepare the needle assembly (20) for collecting an additional tissue sample. At this stage, the rotation of the shaft (242) may continue in coordination with the continued movement of the cutter (40) and perforator (22) for cutting and collecting another tissue sample. Alternatively, the rotation of the shaft (242) may be temporarily stopped to allow the cutter (40) and perforator (22) to reposition and collect another tissue sample. Nevertheless, once another tissue sample has been collected, the rotation of the shaft (242) may be used to sweep another wiper (250) across the notch (26) to collect another tissue sample. The same process may then be repeated any suitable number of times until the tissue sample holder (200) is full or the desired number of tissue samples has been collected.

[0057] II. Exemplary Alternative Tissue Sample Holder with Translatable Bottom Wiper

[0058] 11 illustrates another exemplary tissue sample holder (300) that may be readily incorporated into the biopsy device (10) described above. The tissue sample holder (300) of the illustrated embodiment includes a base (310) having a plurality of wipers (350). Similar to the tissue sample holder (200) described above, the tissue sample holder (300) of this embodiment is generally configured to collect a plurality of tissue samples from the tissue collection feature (54) of the needle assembly (20) during a biopsy procedure. However, unlike the tissue sample holder (200) described above, the tissue sample holder (300) of this embodiment is configured to be movable by the needle assembly (20) for collecting tissue samples from the tissue collection feature (54).

[0059] The base (310) is best seen in FIG. 11. As shown, the base (310) generally defines an arcuate shape that defines at least some concavity. While the base (310) in this embodiment defines an arcuate shape, it is understood that in other embodiments, the base (310) may define a flat configuration. The base (310) includes a distal wall (312), a proximal wall (318), and a floor (316) that extends between the distal wall (312) and the proximal wall (318). Both the proximal wall (318) and the distal wall (312) extend upwardly from the floor (316). The proximal wall (318) and the distal wall (312) further extend longitudinally along the entire length of the floor (316). It should thus be understood that the proximal wall (318) and the distal wall (312) respectively surround the proximal and distal ends of the floor (316). As will be explained in more detail below, this surround is used in conjunction with the wiper (350) to define a number of sample chambers (330) within the body (310).

[0060] The distal wall (312), floor (316), and proximal wall (318) are all shown in this embodiment as having a solid structure. However, it should be understood that in other embodiments, any of the distal wall (312), floor (316), and / or proximal wall (318) may include one or more vents to provide ventilation. For example, in some embodiments, the floor (316) may include multiple vent openings or vent slots to provide for the evacuation of fluids during collection of a tissue sample. A suitable vent opening may generally be sized to allow the flow of liquids while preventing the flow of solid matter, such as a tissue sample. One or more vents may likewise be disposed in the distal wall (312) or proximal wall (318) to further facilitate the evacuation of liquids.

[0061] The base (310) further includes a number of manipulators (320) extending from a proximal surface of the proximal wall (318). As described in more detail below, each manipulator (320) is generally configured to engage a portion of the needle assembly (20) to drive movement of the base (310) during tissue collection, thereby indexing a given sample chamber (330) in the tissue collection feature (54). The base (310) in this embodiment includes five manipulators (320), although any suitable number may be used. For example, in this embodiment, each manipulator (320) corresponds to a particular sample chamber (330). Thus, in embodiments with additional sample chambers (330), additional manipulators (320) may be used as well.

[0062] Each manipulator 320 includes an inclined surface 322 and a drive surface 324. The inclined surface 322 and the drive surface 324 of each manipulator 320 are arranged such that each manipulator 320 forms a shape similar to a wedge. It should be understood that various alternative shapes can be used for each manipulator 320. For example, in this embodiment, the particular geometric shape of each manipulator 320 is generally configured to interact with the needle assembly 20 to drive the movement of the base 310. Thus, in other embodiments in which different drive mechanisms may be used, different manipulator 320 shapes may be used. By way of example only, in some embodiments, the manipulator 320 may be configured as teeth in a rack for engaging gears, pawls, cams, and / or the like.

[0063] Wipers (350) are disposed on the base (310) to further define each sample chamber (330). Specifically, each wiper (350) extends upwardly from the floor (316) and is disposed equidistant from each adjacent wiper (350). Each wiper (350) also extends across the floor (316) from the distal wall (312) to the proximal wall (318). In this embodiment, six wipers (350) are included to divide the area of ​​the floor (316) into five sample chambers (330). However, it should be understood that in other embodiments, various alternative numbers of wipers (350) may be used to form more or fewer sample chambers (330).

[0064] The wiper (350) extends upwardly beyond the upward extension of the distal wall (312) and the proximal wall (318). Thus, the wiper (350) in this embodiment is configured to protrude outwardly from the base (310). As will be explained in more detail below, this configuration allows the distal wall (312) and the proximal wall (318) to ride along a portion of the needle assembly (20) while the wiper (350) enters the tissue collection feature (54) and can extract a tissue sample therefrom.

[0065] Unlike the wipers (250) described above, the wipers (350) of the present embodiment have a generally continuous rectangular cross-sectional configuration with rounded corners. However, it should be understood that the wipers (350) are still generally configured to engage with the tissue collecting features (54) to remove tissue samples therefrom. Accordingly, it should be understood that the wipers (350) are generally formed of a flexible and even partially resilient material, such as rubber or an elastomer. As above, the wipers (350) are generally flexible enough to bend around features of the needle assembly (20). This flexibility may generally be desirable to reduce trauma as each wiper (350) engages tissue, while at the same time facilitating full engagement between each wiper (350) and tissue. Meanwhile, at least some resiliency is provided so that each wiper (350) can push or otherwise move the tissue sample. In some embodiments, the flexibility of each wiper (350) may be characterized in terms of a durometer. Although several suitable durometers may be used, one suitable durometer range is 30-80.

[0066] FIG. 12A shows a tissue sample holder (300) incorporated into a biopsy device (10). As shown, the tissue sample holder (300) may be received within a channel or other receiving feature or component defined by the outer housing (14) of the biopsy device (10). A suitable channel within the outer housing (14) may be shaped to generally correspond to the shape of the base (310) such that the base (310) may ride within the channel. Additionally, the suitable channel may be configured to receive the base (310) directly below the needle assembly (20). In this example, the relationship between the base (310) and the needle assembly (20) is such that the base (310) is free to move laterally below the needle assembly (20) while the wiper (350) may still fully engage the tissue collection feature (54). As described in more detail below, this configuration allows the base (310) to be movable to index the needle assembly (20) into the sample chamber (330), while also allowing the wiper (350) to engage the tissue collection feature (54) to facilitate removal of the tissue sample therefrom.

[0067] 12A-12C illustrate an exemplary use of the tissue sample holder (300) to collect a cut tissue sample. Collection of the cut tissue sample begins in FIG. 12A. It should be understood that at the stage shown in FIG. 12A, the cutter (40) and perforator (22) have already been actuated by the drive assembly (100) to cut the tissue sample and transport the cut tissue sample proximal to the tissue collection feature (54). Once the cut tissue sample has been transported proximally, the cutter (40) and perforator (22) may be rotated as shown in FIG. 12A. This rotation rotates the tissue collection feature (54) clockwise from upwards to downwards.

[0068] Rotation of the cutter (40) and perforator (22) also results in rotation of the driver (53) of the end portion (50). In particular, the driver (53) is generally aligned with the tissue collection feature (54) such that the driver (53) moves from an upward to a downward direction as well. When the driver (53) reaches the downward direction, the driver (53) sweeps between the two manipulators (320) of the tissue sample holder (300), which is made possible by the angled surface (322) of the manipulator (320) that is disposed laterally relative to the driver (53).

[0069] As the driver (53) continues to rotate downward, at least a portion of the driver (53) engages the drive surface (324) of the given manipulator (320). Due to the orientation of the drive surface (324), continued rotation of the driver (53) results in the given manipulator (320) being pushed laterally by the driver (53). As the given manipulator (320) is pushed laterally, the base (310) is pushed laterally as well.

[0070] Continued rotation of the cutter (40) and perforator (22) results in translation of the base (310) towards the position shown in FIG. 12B. As shown, this causes a given wiper (350) to translate laterally into the tissue collection feature (54) and sweep across the notch (26). As the wiper (350) sweeps across the notch (26), the severed tissue sample is transferred from the tissue collection feature (54) to a given sample chamber (330) of the tissue sample holder (300). Thus, tissue collection in this embodiment is provided by the translation of the wiper (350) which is coordinated with the rotation of the cutter (40) and perforator (22).

[0071] Further rotation of the cutter (40) and perforator (22) may result in further translation of the base (310) until the driver (53) disengages from the manipulator (320). As seen in FIG. 12C, this rotation may continue until the driver (53) has rotated approximately 360 degrees from the original position shown in FIG. 12A to set up collection of another tissue sample using another manipulator (320). This pattern of rotation and tissue collection may be repeated successively until all sample chambers (320) are filled. Alternatively, at any stage, the base (310) may be manually actuated to interrupt the collection sequence and begin sample collection in the previously indexed sample chambers (320) to place multiple tissue samples in each sample chamber.

[0072] III. Exemplary Alternative Tissue Sample Holder with Translatable Top Wiper

[0073] 13 illustrates another exemplary tissue sample holder (400) that can be readily incorporated into the biopsy device (10) described above. The tissue sample holder (400) of the illustrated embodiment includes a base (410) having a plurality of wipers (450). Similar to the tissue sample holder (200) described above, the tissue sample holder (400) of this embodiment is generally configured to collect a plurality of tissue samples from the tissue collection feature (54) of the needle assembly (20) during a biopsy procedure. However, unlike the tissue sample holder (200) described above, the tissue sample holder (400) of this embodiment is configured to be movable by a gear assembly (460) that is optionally in communication with the needle assembly (20) for collecting one or more tissue samples from the tissue collection feature (54).

[0074] The base (410) is best seen in Figures 14 and 15. As shown, the base (410) generally defines an arcuate shape that defines at least some concavity. While the base (410) in this embodiment defines an arcuate shape, it is understood that in other embodiments, the base (410) may define a flat configuration. The base (410) includes a distal wall (412), a proximal wall (418), and a floor (416) that extends between a portion of the distal wall (412) and a portion of the proximal wall (418). Both the proximal wall (418) and the distal wall (412) extend upwardly from the floor (416). The proximal wall (418) and the distal wall (412) further extend longitudinally along the entire length of the floor (416). It should thus be understood that proximal wall (418) and distal wall (412) surround, respectively, the proximal and distal ends of floor (416). This surround defines a single sample chamber (430) within body (410).

[0075] The distal wall (412), floor (416), and proximal wall (418) are all shown in this embodiment as having a solid structure. However, it should be understood that in other embodiments, any of the distal wall (412), floor (416), and / or proximal wall (418) may include one or more vents to provide ventilation. For example, in some embodiments, the floor (416) may include multiple vent openings or vent slots to provide for the evacuation of fluids during collection of a tissue sample. A suitable vent opening may generally be sized to allow the flow of liquids while preventing the flow of solid matter, such as a tissue sample. One or more vents may likewise be disposed in the distal wall (412) or proximal wall (418) to further facilitate the evacuation of liquids.

[0076] The base portion (410) further includes a distal top wall (402) and a proximal top wall (404) that are generally oriented above the distal wall (412) and the proximal wall (418). Specifically, both the distal top wall (402) and the proximal top wall (404) extend from one side of the distal wall (412) and the proximal wall (418), respectively, before the distal top wall (402) and the proximal top wall (404) curve approximately 180 degrees to extend back above the distal wall (412) and the proximal wall (418). The distal top wall (402) and the proximal top wall (404) are further spaced from the distal wall (412) and the proximal wall (418), respectively, by a distance that generally corresponds to the size of the needle assembly (20). Thus, the base (410) is generally configured to receive the needle assembly (20) between the distal top wall (402) and the distal wall (412) at the distal end and the proximal top wall (404) and the proximal wall (418) at the proximal end.

[0077] The distal upper wall (402) and the proximal upper wall (404) are interconnected by a plurality of slats (406). The slats (406) are generally configured to provide additional structural rigidity to the base (410). Each slat (406) is generally sized to approximately correspond to a thickness of each wiper (450). As described in more detail below, each slat (406) generally provides structural support for a corresponding wiper (450) to aid in the collection of a tissue sample.

[0078] The base (410) further includes a number of manipulators (420) extending from a proximal surface of the proximal wall (418). As described in more detail below, each manipulator (420) is generally configured to engage a portion of a gear assembly (460) to drive movement of the base (410) during tissue collection, thereby indexing a given wiper (450) in the tissue collection feature (54). The base (410) in this embodiment includes six manipulators (420), although any suitable number may be used. For example, in this embodiment, each manipulator (420) corresponds to a particular wiper (450). Thus, in embodiments with additional wipers (450), the additional manipulators (420) may be used as well.

[0079] Each manipulator (420) includes multiple gear teeth (422) grouped together to form a single manipulator (420). As described in more detail below, the teeth (422) are generally configured to engage with a gear assembly (460) to allow manipulation of the base (410). It should be understood that a variety of alternative shapes may be used for each manipulator (420). For example, in this embodiment, the particular geometric shape of each manipulator (420) is generally configured to interact with the specific structure of the gear assembly (460). Thus, in other embodiments in which different drive mechanisms may be used, different manipulator (420) shapes may be used. By way of example only, in some embodiments, the manipulator (420) may be configured as teeth in a rack for engaging gears, pawls, cams, and / or the like.

[0080] The wipers (450) are disposed on the base (410) and are equally spaced apart. Each wiper (450) extends downwardly from a corresponding slat (406) toward the floor (416). Each wiper (450) also extends the entire length of each corresponding slat (406) from the distal top wall (402) to the proximal top wall (404). In this embodiment, six wipers (450) are included; however, it should be understood that in other embodiments, there are various alternative numbers of wipers (450).

[0081] The wiper (450) further extends downwardly into the space defined between the distal and upper distal walls (412) and the proximal and upper proximal walls (418) and (404), respectively. Thus, the wiper (450) of this embodiment is configured to protrude inwardly of the base (410). As described in more detail below, this configuration allows the walls (402, 404, 412, 418) to ride along a portion of the needle assembly (20) while the wiper (450) can enter the tissue collection feature (54) and extract a tissue sample therefrom.

[0082] Unlike the wipers (250) described above, the wipers (450) of the present embodiment have a generally continuous rectangular cross-sectional configuration with rounded corners. However, it should be appreciated that the wipers (450) are still generally configured to engage and remove tissue samples from the tissue collection features (54). It should be appreciated that the wipers (450) are generally formed of a flexible and even partially resilient material, such as rubber or an elastomer. As above, the wipers (450) are generally flexible enough to bend around the features of the needle assembly (20). This flexibility may generally be desirable to reduce trauma as each wiper (450) engages tissue, while also facilitating full engagement between each wiper (450) and tissue. Meanwhile, at least some resiliency is provided so that each wiper (450) can push or otherwise move the tissue sample. In some embodiments, the flexibility of each wiper (450) may be characterized in terms of a durometer. Although several suitable durometers may be used, one suitable durometer range is 30-80.

[0083] FIG. 16 shows gear assembly (460) in greater detail. As shown, gear assembly (460) includes a drive shaft (462) having an elongated spur gear (464) and a partially intermittent gear (470). Shaft (462) is configured to be rotatably driven by a power source, such as a motor or a manually driven mechanism. In some embodiments, shaft (462) may be interconnected with drive assembly (100) such that rotation of shaft (462) is coupled to an operating function of drive assembly (100).

[0084] Elongated spur gear (464) is generally configured to drive the rotation of partial intermittent gear (470). Elongated spur gear (464) has an elongated configuration that allows for continuous driving of partial intermittent gear (470) during translation of partial intermittent gear (470) through a predetermined range. In some embodiments, this allows for translation of needle assembly (20) by another mechanism (e.g., drive assembly (100)), while still allowing elongated spur gear (464) to rotate needle assembly (20).

[0085] The partial intermittent gear (470) includes a continuous portion (472) and an intermittent portion (474). The continuous portion (472) includes gear teeth oriented around the entire circumference of the partial intermittent gear (470), while the intermittent portion (474) includes only four gear teeth separated into a single section. In this configuration, the continuous portion (472) is configured to mesh with the elongated spur gear (464) so ​​as to continuously drive the partial intermittent gear (470) in response to rotation of the shaft (462). In contrast, the intermittent portion (474) is configured to mesh with the gear teeth (422) of each manipulator (420) to provide intermittent translation of the base (410) even when the partial intermittent gear (470) is continuously rotated. As will be explained in more detail below, this feature may be used generally to affect the timing of the translation of the base (410) relative to the movement of other parts of the biopsy device (10).

[0086] 17A-18C illustrate an exemplary use of the tissue sample holder (400) to collect a cut tissue sample. Collection of the cut tissue sample begins with FIGS. 17A and 18A. It should be understood that at the stage shown in FIGS. 17A and 18A, the cutter (40) and perforator (22) have already been actuated by the drive assembly (100) to cut the tissue sample and transport the cut tissue sample proximal to the tissue collection feature (54). Once the cut tissue sample has been transported proximally, the cutter (40) and perforator (22) may be rotated as shown in FIG. 17A. This rotation rotates the tissue collection feature (54) clockwise from approximately the 10 o'clock position to approximately the 12 o'clock position.

[0087] Rotation of the cutter (40) and perforator (22) is coordinated with rotation of the drive shaft (462) of the gear assembly (460). Alternatively, in some embodiments, rotation of the cutter (40) and perforator (22) is provided by a separate drive mechanism similar to drive assembly (100) described above. In this embodiment, the cutter (40) is rotated by a continuous portion (472) of a partial intermittent gear (470), which is rotated by an elongated spur gear (474) of the drive shaft (462). As seen in FIG. 17A, this rotation of the partial intermittent gear (470) also causes translation of the base (410) via engagement between the intermittent portion (474) of a given manipulator (420) and the gear teeth (422).

[0088] As the cutter (40) and perforator (22) rotate while the base (410) translates, a given wiper (450) translates laterally into the tissue collection feature (54). As shown in FIG. 18B, this lateral translation causes the given wiper (450) to sweep across the notch (26). As the wiper (450) sweeps across the notch (26), the severed tissue sample is moved away from the tissue collection feature (54).

[0089] After the severed tissue sample is transferred from the tissue collection feature 54, gravity may pull the severed tissue sample downward into the sample chamber 430. Alternatively, in some applications, surface tension of moisture may cause the severed tissue sample to remain on a given wiper 450, either temporarily until gravity is sufficient, or until it is removed by an operator. Thus, tissue collection in this embodiment is provided by translation of the wiper 450, coordinated with rotation of the cutter 40 and perforator 22.

[0090] Further rotation of the cutter (40) and perforator (22) may result in further translation of the base (410) until a given wiper (450) disengages from the tissue collection feature (54), as shown in Figures 17B and 18C. At this stage, the intermittent portion (474) of the partial intermittent gear (470) may disengage from a given manipulator (420) associated with the given wiper (450). Once disengaged, the partial intermittent gear (470) may continue to rotate the cutter (40) and / or perforator (22) while the base (410) remains stationary.

[0091] Thus, rotation of the cutter (40) and / or perforator (22) may continue until approximately 360 degrees of rotation is completed, returning the cutter (40) and / or perforator (22) to the position shown in FIG. 17A. Another tissue sample may then be cut and the above process repeated with another manipulator (420) engaged by the intermittent portion (474) of the partial intermittent gear (470). This pattern of rotation and tissue collection may be repeated successively until all wipers (450) have been used. Alternatively, at any stage, the base (410) may be manually actuated to interrupt the collection sequence and begin sample collection with the previously indexed wiper (450), collecting multiple tissue samples with each wiper.

[0092] As described above, in some embodiments, rotation of the cutter (40) and perforator (22) is provided by a separate drive mechanism similar to drive assembly (100) described above. It should be understood that in such embodiments, rotation of the cutter (40) and / or perforator (22) may be independent of translation of the base (410). For example, in such embodiments, the cutter (40) and perforator (22) may be positioned to align with a given wiper (450) prior to any rotation of the drive shaft (462) and thus translation of the base (410) via the partial intermittent gear (470). Once the cutter (40) and / or perforator (22) are positioned as desired, the drive shaft (462) may then begin to rotate to translate the base (410) using the partial intermittent gear (470) in a manner similar to that described above. Thus, in some embodiments, the cutter 40 and perforator 22 define a discrete series of motions relative to the base 410, rather than such motion being coordinated with the base 410. Such a configuration may be desirable to reduce the additional complexity that may be required for coordinated motions.

[0093] IV. Exemplary Alternative Tissue Sample Holder with Rotatable Wiper

[0094] 19 and 20 illustrate another exemplary tissue sample holder (500) that may be readily incorporated into the biopsy device (10) described above. The tissue sample holder (500) of this example includes a withdrawal mechanism (540) disposed within a generally cylindrical outer housing (510). The tissue sample holder (500) is generally configured to collect multiple tissue samples from the tissue collection feature (54) of the needle assembly (20) during a biopsy procedure using rotation of the withdrawal mechanism (540). As described in more detail below, the tissue sample holder (500) is generally configured to collect and store tissue samples in any suitable number of bulk collection configurations.

[0095] The outer housing (510) includes a cylindrical body (512) defining a sample chamber (513) and an open distal end (514), a closed proximal end (518), and a needle receiving portion (516) extending between the open distal end (514) and the closed proximal end (518). In this example, the outer housing (510) is generally transparent to facilitate visibility of the tissue sample during sample collection. While the outer housing (510) in this example is shown as having an open distal end (514), it should be understood that in other examples, the open distal end (514) may be closed or capped to seal the sample chamber (513) of the outer housing (510) from the environment.

[0096] The needle receiving portion (516) is generally configured as a semi-cylindrical recess or otherwise bulge in the cylindrical outer housing (510). The needle receiving portion (516) is generally sized to correspond to the size and shape of the needle assembly (20). Thus, the needle receiving portion (516) generally defines a pocket or recessed area in which the needle assembly (20) may be placed. As will be described in more detail below, the particular depth of the needle receiving portion (516) may bear some relationship to the particular geometric configuration of the tissue collecting feature (54) of the needle assembly (20) to aid in the extraction of a tissue sample from the tissue collecting feature (54).

[0097] Although not shown, it will be understood that the closed proximal end 518 of the outer housing 510 may include a shaft bore (not shown) and a needle bore (not shown). As described in more detail below, a suitable shaft bore may be configured to receive a rotatable component of the extraction mechanism 540 to allow rotation of the extraction mechanism 540 relative to the outside of the outer housing 510. A suitable needle bore may be sized to allow the needle assembly 20 to pass proximally through the closed proximal end 518. Although not shown, it will be understood that any shaft bore and / or needle bore may include seals, o-rings, gaskets, and / or the like to seal the sample chamber 513 of the outer housing 510 from the environment.

[0098] The outer housing (510) further defines a tray receiver (520) adjacent the sample chamber (513). As described in more detail below, the tray receiver (520) is configured to receive a tissue tray (560) for the purpose of collecting a tissue sample. In this embodiment, the tray receiver (520) is formed as a generally rectangular channel. The tray receiver (520) may also be characterized as having a C-shaped cross-section due to one side of the tray receiver (520) being open to the sample chamber (513). Thus, the tray receiver (520) is generally in communication with the sample chamber (513) and allows a tissue sample to be deposited in the tissue tray (560).

[0099] The tray receiver (520) includes a locator (522) to help hold the tissue tray (560) in place. In this embodiment, the locator (522) is formed as a slight overhang, an L-shaped portion, or a J-shaped portion. As will be appreciated, this particular shape, along with the rectangular shape of the tray receiver (520), may aid in maintaining the position of the tissue tray (560) within the tray receiver (520).

[0100] Although the tray receiver (520) in this example is shown as having a particular shape, it should be understood that a variety of shapes can be used. For example, as described in more detail below, the tray receiver (520) generally complements the shape of the tissue tray (560). Thus, in examples in which the shape of the tissue tray (560) varies, the shape of the tray receiver (520) can likewise be varied to complement the tissue tray (560).

[0101] FIG. 20 shows the extraction mechanism (540) in more detail. As shown, the extraction mechanism (540) includes a shaft (542) and a single wiper (550) projecting outwardly from the shaft (542). The shaft (242) is generally rotatable, thereby rotating the wiper (550) within the outer housing (510) to collect and store the tissue sample as each tissue sample is collected by the needle assembly (20). The proximal end of the shaft (542) includes a key portion (544) configured to communicate with either a manual or powered driver to rotate the shaft (542). The key portion (544) in this example forms a generally rectangular channel or keyway, although it should be understood that the key portion (544) may have a variety of configurations suitable for transmitting rotational motion, such as a key, multiple keyways or channels, square, hexagonal, D-shaped, and / or the like.

[0102] Although not shown, it should be understood that the shaft (542) may be driven using the key portion (544) by a variety of mechanisms. For example, in some embodiments, the key portion (544) is rotatably coupled to any suitable portion of the drive assembly (100), such as the cutter drive assembly (120), the perforator drive assembly (130), the firing assembly (140), or some combination thereof. Such a configuration may be desirable to coordinate the rotation of the shaft (542) with the movement of the cutter (40) and / or the perforator (22). Alternatively, the biopsy device (10) may be configured to include an entirely separate drive mechanism for the shaft (542). For example, in some embodiments, a separate motor may be used to directly power the rotation of the shaft (542) via a transmission or other drive mechanism. In still other embodiments, the rotation of the shaft (542) may be driven by a manual rotation mechanism, such as a thumb wheel, push button, or other similar mechanism.

[0103] The distal end of shaft (542) includes a coupler channel (546) extending inwardly from the outer surface of shaft (542). Coupler channel (546) is generally configured to receive wiper (550) and provide a stable base for securing wiper (550). In this embodiment, coupler channel (546) is formed as a generally rectangular channel. In other embodiments, various alternative shapes may be used, such as triangular, circular, square, etc. Additionally or alternatively, in some embodiments, coupler channel (546) may be configured as a protrusion for engaging a corresponding channel in wiper (550). Although not shown, it should be understood that coupler channel (546) may extend axially along the length of shaft (542) for a length approximately equal to the length of wiper (550).

[0104] The wiper (550) in this embodiment is generally configured as a thin rectangular strip with rounded outer corners. As described above, the wiper (550) is configured to be received within the coupler channel (546) of the shaft (542). A suitable coupling between the wiper (550) and the shaft (542) may be through adhesive bonding, welding, mechanical fastening, and / or a variety of other means. While this embodiment is shown as including only a single wiper (550), it should be understood that other embodiments may include multiple wipers (550) oriented around the shaft (542) similar to the orientation of wiper (250) described above.

[0105] The wiper (550) extends outwardly relative to the coupler (546), away from the shaft (542). When the extraction mechanism (540) is disposed within the outer housing (210), the axial extension of the wiper (550) is such that an outer end of the wiper (550) contacts an inner surface of the outer housing (510). It should thus be understood that the wiper (550) is generally configured to slide along the inner surface of the outer housing (510) to sweep one or more tissue samples around the inner surface of the outer housing (510).

[0106] The wiper (550) is generally formed of a flexible and even partially resilient material, such as rubber or an elastomer. For example, the wiper (550) is generally flexible enough to bend around the interface between the outer housing (510) and the needle assembly (20). This flexibility may generally be desirable to reduce trauma as the wiper (550) engages tissue, while also facilitating full engagement between the wiper (550) and tissue. Meanwhile, at least some resilience is provided to allow the wiper (550) to push or otherwise move the tissue sample. In some embodiments, the flexibility of the wiper (550) may be characterized in terms of a durometer. Although several suitable durometers may be used, one suitable durometer range is 30-80.

[0107] As described above, the tissue sample holder (500) further includes a tissue tray (560) configured to be received within the tray receiver (520) of the outer housing (510). The tissue tray (560) includes a tissue receiver (562) configured to receive a plurality of tissue samples and a handle (566) extending proximally from the tissue receiver (562). The tissue receiver (562) has a generally C-shaped cross-section that extends an axial length that generally corresponds to the length of the wiper (550). An upper portion of the tissue receiver (562) includes collection teeth (564) that project outwardly and downwardly relative to an upper surface of the tissue receiver (562). As described in more detail below, the collection teeth (564) are generally configured to remove a tissue sample from the surface wiper (550).

[0108] The tissue receiver (562) in this example generally comprises a solid structure. However, it should be understood that in other examples, the tissue receiver (562) may include one or more vents to aid in fluid management. For example, in some examples, the bottom surface of the tissue receiver (562) may include one or more vent openings, slots, perforations, etc. to aid in the drainage of various fluids encountered during a biopsy procedure. Thus, it should be understood that the various vents may be configured to facilitate the flow of liquids while also preventing the flow of larger solid objects, such as tissue samples.

[0109] A handle (566) extends proximally from the tissue receiver (562). The handle (566) in this example comprises a thin rectangular strip. The handle (566) is generally configured to be grasped by an operator to remove or insert the tissue tray (560) relative to the outer housing (510). The shape of the handle (566) is generally curved to facilitate grasping. Additionally or alternatively, the handle (566) may also be equipped with various gripping features to facilitate grasping, such as bulges, protrusions, perforations, and / or the like.

[0110] Figures 21A and 21C show an exemplary use of the tissue sample holder (200) to collect a tissue sample from a needle assembly (20). As best seen in Figure 21A, collection of a tissue sample using the tissue sample holder (500) may begin after the cutter (40) and perforator (22) are driven by the drive assembly (100) to sever and collect a tissue sample (TS). Specifically, once the tissue sample is severed, it is transported to the tissue collection feature (54) using the notch (26) of the perforator (22).

[0111] In this example, the tissue sample holder (500) is positioned along the axis of the needle assembly (20) such that the wipers (550) are aligned with the tissue collection features (54). Thus, to collect a tissue sample, the shaft (542) may be rotated to rotate each wiper (550) within the sample chamber (513) to sweep the wiper (550) adjacent the tissue collection feature (54) as shown in FIG. 21A. Further rotation of the shaft (542) may cause the wiper (550) to sweep across the notch (26). As the wiper (550) sweeps across the notch (26), the wiper (550) engages the tissue sample and pushes it away from the tissue collection feature (54) to the position shown in FIG. 21B.

[0112] Once the wiper (550) has swept across the notch (26), rotation of the shaft (542) may continue as shown in FIG. 21B. Continuing rotation moves the tissue sample around the interior of the outer housing (210) allowing the tissue sample to move towards the tissue tray (560). As shown in FIG. 21C, the tissue sample may be deposited onto the tissue tray (560) by the wiper (550) sweeping across the collection teeth (564) of the tissue tray (560). This motion may wipe the severed tissue sample off the wiper (550) and onto the collection teeth (564). Gravity may then cause the severed tissue sample to drop into the tissue receiver (562) for storage.

[0113] Once the cut tissue sample has been collected in the tissue tray (560), the rotation of the shaft (542) may continue in coordination with the continued movement of the cutter (40) and perforator (22) for the cutting and collection of another tissue sample. Alternatively, the rotation of the shaft (542) may be temporarily stopped to allow the cutter (40) and perforator (22) to reposition and collect another tissue sample. Nevertheless, once another tissue sample has been collected, the rotation of the shaft (542) may be used to again sweep the wiper (550) across the notch (26) to collect another tissue sample. The same process may then be repeated any suitable number of times until the tissue tray (560) is full or the desired number of tissue samples have been collected.

[0114] V. Exemplary Combinations

[0115] The following examples relate to various non-exhaustive methods 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 any subsequent application of this application. No disclaimer is intended. The following examples are presented 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 mentioned in the following examples. Thus, none of the aspects or features mentioned below should be considered critical unless specifically and expressly indicated otherwise by the inventor or by the intended successor of the inventor. If any claim is presented in this application or any subsequent application related to this application that includes additional features other than those mentioned below, these additional features should not be presumed to have been added for any reason related to patentability.

[0116] Example 1

[0117] 1. A core needle biopsy device comprising: a needle assembly, the needle assembly including a perforator and a hollow cutter, the perforator including a sharp distal tip and a notch proximal to the distal tip, the perforator slidably disposed within the cutter to cut a tissue sample into the notch of the perforator; a drive assembly configured to selectively move the perforator and the cutter; and a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to the perforator and cutter to manipulate the cut tissue sample into the sample chamber.

[0118] Example 2

[0119] The core needle biopsy device of Example 1, wherein the tissue sample holder includes a rotatable shaft, the wiper being fixed relative to the shaft such that rotation of the shaft rotates the wiper relative to the perforator, thereby configured to manipulate the cut tissue sample into the sample chamber.

[0120] Example 3

[0121] The core needle biopsy device of Example 2, wherein the tissue sample holder includes a plurality of wipers, each wiper secured to the shaft such that each wiper extends radially outward from the shaft.

[0122] Example 4

[0123] The core needle biopsy device of example 2, wherein the tissue sample holder includes a single wiper extending radially outward from the shaft.

[0124] Example 5

[0125] The core needle biopsy device of Example 1, wherein the tissue sample holder further comprises a base, the base comprising a plurality of side walls and a floor defining the sample chamber, the wiper is fixed to the base, and the base is configured to translate relative to the perforator to translate the wiper relative to the perforator, thereby manipulating a cut tissue sample into the tissue sample chamber.

[0126] Example 6

[0127] The core needle biopsy device of Example 5, wherein the base further includes a manipulator, the manipulator being in communication with the drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the perforator.

[0128] Example 7

[0129] The core needle biopsy device of Example 6, wherein the manipulator comprises a plurality of wedge-shaped manipulators.

[0130] Example 8

[0131] The core needle biopsy device of example 6, wherein the manipulator comprises a plurality of gear teeth arranged in a plurality of separate groups.

[0132] Example 9

[0133] The core needle biopsy device of Example 6, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of separate groups, and the drive assembly includes a gear having an intermittent gear portion configured to engage with the plurality of gear teeth to intermittently translate the base in response to continuous rotation of the gear.

[0134] Example 10

[0135] A core needle biopsy device described in any one or more of Examples 1 to 9, further comprising a sample tray configured to be received within a portion of the tissue sample holder, the sample tray configured to engage with the wiper to manipulate a cut tissue sample from the wiper and into an interior space defined by the sample tray.

[0136] Example 11

[0137] The core needle biopsy device of Example 10, wherein the sample tray includes collection teeth configured to engage with the wiper to manipulate the severed tissue sample from the wiper and into the interior space defined by the sample tray.

[0138] Example 12

[0139] The core needle biopsy device of any one or more of Examples 1-11, wherein the wiper comprises a material having a durometer of 30-80.

[0140] Example 13

[0141] The core needle biopsy device of any one or more of Examples 1-11, wherein the wiper defines a thin, generally rectangular shape.

[0142] Example 14

[0143] The core needle biopsy device of any one or more of Examples 1-11, wherein the wiper defines a curved end configured to atraumatically engage tissue.

[0144] Example 15

[0145] The core needle biopsy device of any one or more of Examples 1 to 14, further comprising a body having a distal end, the needle assembly extending distally from the distal end of the body, and the tissue sample holder disposed at the distal end of the body.

[0146] Example 16

[0147] A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device including a perforator having a sample notch and a cutter movable relative to the sample notch to cut a tissue sample, the tissue sample holder comprising a body defining a sample chamber, and at least one wiper movable relative to a portion of the tissue sample holder to manipulate the cut tissue sample from the sample notch of the perforator and into the sample chamber of the body.

[0148] Example 17

[0149] 17. The tissue sample holder of Example 16, further comprising a rotatable shaft, the wiper extending radially outward from the shaft, the body including a cylindrical inner wall defining the sample chamber, and the wiper configured to slide along the inner wall of the body to move the cut tissue sample within the sample chamber.

[0150] Example 18

[0151] 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.

[0152] Example 19

[0153] 18. The tissue sample holder of example 17, wherein the wiper is secured to the body such that the body is configured to move the wiper relative to the perforator.

[0154] Example 20

[0155] 1. A method for collecting a tissue sample using a biopsy device, comprising: retracting a sample notch defined by a perforator proximally into a tissue sample holder; moving a wiper within the tissue sample holder to sweep the wiper across the sample notch; and moving the wiper further from the sample notch toward a sample chamber.

[0156] Example 21

[0157] 21. The method of example embodiment 20, wherein the act of moving the wiper comprises rotating the wiper using a shaft coupled to the wiper.

[0158] Example 22

[0159] 22. The method of example 21, wherein the wiper is a first wiper, the method further comprising rotating the shaft to move a second wiper within the tissue sample holder to sweep the second wiper across the sample notch.

[0160] Example 23

[0161] 21. The method of example embodiment 20, wherein the act of moving the wiper comprises translating the wiper by translating a base coupled to the wiper.

[0162] Example 24

[0163] The method of any one or more of Examples 20-23, further comprising moving the wiper to sweep the wiper across the collection teeth of a tissue tray.

[0164] Example 25

[0165] The method of any one or more of Examples 20-24, wherein the act of moving the wiper both includes manipulating a tissue sample using the wiper.

[0166] Example 26

[0167] 1. A biopsy device comprising: a body defined by a probe and a holster; a needle assembly extending distally from the probe, the needle assembly configured to cut a tissue sample; and a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to a portion of the needle assembly to manipulate the cut tissue sample into the sample chamber.

[0168] Example 27

[0169] The biopsy device of Example 26, wherein the tissue sample holder includes a rotatable shaft, the wiper being fixed relative to the shaft such that rotation of the shaft rotates the wiper relative to a portion of the needle assembly, thereby configured to manipulate the severed tissue sample into the sample chamber.

[0170] Example 28

[0171] 28. The biopsy device of Example 27, wherein the tissue sample holder comprises a plurality of wipers, each wiper secured to the shaft such that each wiper extends radially outward from the shaft.

[0172] Example 29

[0173] 28. The biopsy device of Example 27, wherein the tissue sample holder includes a single wiper extending radially outward from the shaft.

[0174] Example 30

[0175] The biopsy device of Example 26, wherein the tissue sample holder further comprises a base, the base comprising a plurality of side walls and a floor defining the sample chamber, the wiper is fixed to the base, and the base is configured to translate relative to the needle assembly to translate the wiper relative to the needle assembly, thereby manipulating a cut tissue sample into the tissue sample chamber.

[0176] Example 31

[0177] The biopsy device of Example 30, further comprising a drive mechanism, the base further comprising a manipulator, the manipulator being in communication with the drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the needle assembly.

[0178] Example 32

[0179] 32. The biopsy device of embodiment 31, wherein the manipulator comprises a plurality of wedge-shaped manipulators.

[0180] Example 33

[0181] 32. The biopsy device of example embodiment 31, wherein the manipulator comprises a plurality of gear teeth arranged in a plurality of separate groups.

[0182] Example 34

[0183] The biopsy device of Example 31, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of separate groups, and the drive assembly includes a gear having an intermittent gear portion configured to engage with the plurality of gear teeth to intermittently translate the base in response to continuous rotation of the gear.

[0184] Example 35

[0185] The biopsy device of any one or more of Examples 26 to 34, further comprising a sample tray configured to be received within a portion of the tissue sample holder, the sample tray configured to engage the wiper to manipulate a severed tissue sample from the wiper and into an interior space defined by the sample tray.

[0186] Example 36

[0187] The biopsy device of Example 35, wherein the sample tray includes collection teeth configured to engage with the wiper to manipulate a cut tissue sample away from the wiper and into the interior space defined by the sample tray.

[0188] Example 37

[0189] The biopsy device of any one or more of Examples 26-36, wherein the wiper comprises a material having a durometer of 30-80.

[0190] Example 38

[0191] The biopsy device of any one or more of Examples 26-36, wherein the wiper defines a thin, generally rectangular shape.

[0192] Example 39

[0193] The biopsy device of any one or more of Examples 26-36, wherein the wiper defines a curved end configured to atraumatically engage tissue.

[0194] Example 40

[0195] The biopsy device of any one or more of Examples 26 to 39, wherein the probe has a distal end, the needle assembly extends distally from the distal end of the probe, and the tissue sample holder is disposed at the distal end of the probe.

[0196] 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. Some of such possible modifications have been mentioned, but others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. discussed above are illustrative and not required. Thus, it is understood that the scope of the present invention should be considered in relation to the following claims, and is not limited to the details of construction and operation shown and described in the specification and drawings.

[0197] 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.

[0198] Any patent, publication, or other disclosure material that is said to be incorporated herein by reference in whole or in part should be understood to be incorporated herein only to the extent that the incorporated material does not contradict existing definitions, descriptions or other disclosure material set forth in this disclosure. Thus, and to the extent necessary, the disclosure explicitly set forth herein takes precedence over any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated herein by reference but that contradicts existing definitions, descriptions or other disclosure material set forth herein, is incorporated only to the extent that there is no contradiction between the incorporated material and the existing disclosure material.

[0199] [Embodiment] (1) A core needle biopsy device, comprising: (a) a needle assembly including a perforator and a hollow cutter, the perforator including a sharp distal tip and a notch proximal to the distal tip, the perforator being slidably disposed within the cutter to sever a tissue sample into the notch of the perforator; (b) a drive assembly configured to selectively move the perforator and the cutter; (c) a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to the perforator and cutter to manipulate a severed tissue sample into the sample chamber; The core needle biopsy device. (2) The core needle biopsy device of embodiment 1, wherein the tissue sample holder includes a rotatable shaft, the wiper being fixed relative to the shaft such that rotation of the shaft rotates the wiper relative to the perforator, thereby configured to manipulate the cut tissue sample into the sample chamber. (3) The core needle biopsy device of embodiment 2, wherein the tissue sample holder includes a plurality of wipers, each wiper being fixed to the shaft such that each wiper extends radially outward from the shaft. (4) The core needle biopsy device of embodiment 2, wherein the tissue sample holder includes a single wiper extending radially outward from the shaft. (5) The core needle biopsy device of embodiment 1, wherein the tissue sample holder further comprises a base, the base including a plurality of side walls and a floor defining the sample chamber, the wiper is fixed to the base, and the base is configured to translate relative to the perforator to translate the wiper relative to the perforator, thereby manipulating a cut tissue sample into the tissue sample chamber.

[0200] (6) The core needle biopsy device of embodiment 5, wherein the base further includes a manipulator, the manipulator being in communication with the drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the perforator. (7) The core needle biopsy device of embodiment 6, wherein the manipulator comprises a plurality of wedge-shaped manipulators. (8) The core needle biopsy device of embodiment 6, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of separate groups. (9) The core needle biopsy device of embodiment 6, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of separate groups, and the drive assembly includes a gear having an intermittent gear portion configured to engage with the plurality of gear teeth to intermittently translate the base in response to continuous rotation of the gear. (10) A core needle biopsy device as described in any of embodiments 1 to 9, further comprising a sample tray configured to be received within a portion of the tissue sample holder, the sample tray configured to engage with the wiper to manipulate a cut tissue sample away from the wiper and into an interior space defined by the sample tray.

[0201] (11) The core needle biopsy device of embodiment 10, wherein the sample tray includes collection teeth configured to engage with the wiper to manipulate the severed tissue sample away from the wiper and into the interior space defined by the sample tray. (12) The core needle biopsy device of any one of the preceding claims, wherein the wiper comprises a material having a durometer of 30 to 80. (13) The core needle biopsy device of any one of claims 1 to 11, wherein the wiper defines a thin, generally rectangular shape. (14) The core needle biopsy device of any one of claims 1 to 11, wherein the wiper defines a curved end configured to atraumatically engage tissue. (15) A core needle biopsy device as described in any one of embodiments 1 to 14, further comprising a body having a distal end, the needle assembly extending distally from the distal end of the body, and the tissue sample holder being disposed at the distal end of the body.

[0202] (16) A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device including a perforator having a sample notch and a cutter movable relative to the sample notch to sever a tissue sample; the tissue sample holder comprising: (a) a body defining a sample chamber; (b) at least one wiper movable relative to a portion of the tissue sample holder, the at least one wiper manipulating a severed tissue sample from the sample notch of the perforator and into the sample chamber of the body; and Equipped with The tissue sample holder. (17) The tissue sample holder of embodiment 16, further comprising a rotatable shaft, the wiper extending radially outward from the shaft, the body including a cylindrical inner wall defining the sample chamber, and the wiper configured to slide along the inner wall of the body to move the cut 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 embodiment 17, wherein the wiper is secured to the body such that the body is configured to move the wiper relative to the perforator. (20) A method for collecting a tissue sample using a biopsy device, comprising: (a) proximally retracting a specimen notch defined by a perforator into a tissue specimen holder; (b) moving a wiper within the tissue sample holder to sweep the wiper across the sample notch; (c) moving the wiper further from the sample notch towards the sample chamber; The method comprising:

[0203] 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 embodiment 21, wherein the wiper is a first wiper, the method further comprising rotating the shaft to move a second wiper within the tissue sample holder to sweep the second wiper across the sample notch. 23. The method of claim 20, wherein the act of moving the wiper includes translating the wiper by translating a base coupled to the wiper. (24) The method of any one or more of embodiments 20-23, further comprising moving the wiper to sweep the wiper across the collection teeth of a tissue tray. (25) The method of any one or more of embodiments 20 to 24, wherein the acts of moving the wiper both include manipulating a tissue sample using the wiper.

[0204] (26) A biopsy device comprising: (a) a body defined by a probe and a holster, and a needle assembly extending distally from the probe, the needle assembly configured to sever a tissue sample; (b) a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to a portion of the needle assembly to manipulate a severed tissue sample into the sample chamber; and The biopsy device. (27) The biopsy device of embodiment 26, wherein the tissue sample holder includes a rotatable shaft, the wiper being fixed relative to the shaft such that rotation of the shaft rotates the wiper relative to a portion of the needle assembly, thereby configured to manipulate the severed tissue sample into the sample chamber. (28) The biopsy device of embodiment 27, wherein the tissue sample holder includes a plurality of wipers, each wiper being secured to the shaft such that each wiper extends radially outward from the shaft. (29) The biopsy device of embodiment 27, wherein the tissue sample holder includes a single wiper extending radially outward from the shaft. (30) The biopsy device of embodiment 26, wherein the tissue sample holder further comprises a base, the base including a plurality of side walls and a floor defining the sample chamber, the wiper is fixed to the base, and the base is configured to translate relative to the needle assembly to translate the wiper relative to the needle assembly, thereby manipulating the severed tissue sample into the tissue sample chamber.

[0205] (31) The biopsy device of embodiment 30, further comprising a drive mechanism, the base further comprising a manipulator, the manipulator being in communication with the drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the needle assembly. (32) The biopsy device of embodiment 31, wherein the manipulator includes a plurality of wedge-shaped manipulators. (33) The biopsy device of embodiment 31, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of separate groups. (34) The biopsy device of embodiment 31, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of separate groups, and the drive assembly includes a gear having an intermittent gear portion configured to engage with the plurality of gear teeth to intermittently translate the base in response to continuous rotation of the gear. (35) The biopsy device of any one or more of embodiments 26 to 34, further comprising a sample tray configured to be received within a portion of the tissue sample holder, the sample tray configured to engage with the wiper to manipulate a severed tissue sample from the wiper and into an interior space defined by the sample tray.

[0206] (36) The biopsy device of embodiment 35, wherein the sample tray includes collection teeth configured to engage with the wiper to manipulate a severed tissue sample from the wiper and into the interior space defined by the sample tray. (37) The biopsy device of any one or more of embodiments 26 to 36, wherein the wiper comprises a material having a durometer of 30 to 80. (38) The biopsy device of any one or more of embodiments 26 to 36, wherein the wiper defines a thin, generally rectangular shape. (39) The biopsy device of any one or more of embodiments 26 to 36, wherein the wiper defines a curved end configured to atraumatically engage tissue. (40) The biopsy device of any one or more of embodiments 26 to 39, wherein the probe has a distal end, the needle assembly extends distally from the distal end of the probe, and the tissue sample holder is disposed at the distal end of the probe.

Claims

1. 1. A core needle biopsy device comprising: (a) a needle assembly including a perforator and a hollow cutter, the perforator including a sharp distal tip and a notch proximal to the distal tip, the perforator being slidably disposed within the hollow cutter to sever a tissue sample into the notch of the perforator; (b) a drive assembly configured to selectively move the perforator and the hollow cutter; (c) a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to the perforator and the hollow cutter to manipulate a severed tissue sample into the sample chamber; Equipped with A core needle biopsy device, wherein the wiper comprises a material having a durometer of 30-80.

2. A core needle biopsy device, comprising: (a) a needle assembly including a perforator and a hollow cutter, the perforator including a sharp distal tip and a notch proximal to the distal tip, the perforator being slidably disposed within the hollow cutter to sever a tissue sample into the notch of the perforator; (b) a drive assembly configured to selectively move the perforator and the hollow cutter; (c) a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to the perforator and the hollow cutter to manipulate a severed tissue sample into the sample chamber; Equipped with A core needle biopsy device, wherein the wiper defines a thin, generally rectangular shape.

3. A core needle biopsy device, comprising: (a) a needle assembly including a perforator and a hollow cutter, the perforator including a sharp distal tip and a notch proximal to the distal tip, the perforator being slidably disposed within the hollow cutter to sever a tissue sample into the notch of the perforator; (b) a drive assembly configured to selectively move the perforator and the hollow cutter; (c) a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to the perforator and the hollow cutter to manipulate a severed tissue sample into the sample chamber; Equipped with A core needle biopsy device, wherein the wiper defines a curved end configured to atraumatically engage tissue.

4. A core needle biopsy device according to any of claims 1 to 3, wherein the tissue sample holder includes a rotatable shaft, the wiper being fixed relative to the shaft such that rotation of the shaft rotates the wiper relative to the perforator, thereby configured to manipulate the severed tissue sample into the sample chamber.

5. The core needle biopsy device of claim 4 , wherein the tissue sample holder includes a plurality of wipers, each wiper secured to the shaft such that each wiper extends radially outward from the shaft.

6. The core needle biopsy device of claim 4 , wherein the tissue sample holder includes a single wiper extending radially outward from the shaft.

7. A core needle biopsy device according to any of claims 1 to 3, wherein the tissue sample holder further comprises a base, the base including a plurality of side walls and a floor defining the sample chamber, the wiper is fixed to the base, and the base is configured to translate relative to the perforator to translate the wiper relative to the perforator, thereby manipulating a cut tissue sample into the sample chamber.

8. The core needle biopsy device of claim 7 , wherein the base further comprises a manipulator, the manipulator being in communication with the drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the perforator.

9. A core needle biopsy device comprising: (a) a needle assembly including a perforator and a hollow cutter, the perforator including a sharp distal tip and a notch proximal to the distal tip, the perforator being slidably disposed within the hollow cutter to sever a tissue sample into the notch of the perforator; (b) a drive assembly configured to selectively move the perforator and the hollow cutter; (c) a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to the perforator and the hollow cutter to manipulate a severed tissue sample into the sample chamber; Equipped with the tissue sample holder further comprises a base, the base including a plurality of side walls and a floor defining the sample chamber, the wiper secured to the base, the base configured to translate relative to the perforator to translate the wiper relative to the perforator and thereby manipulate the severed tissue sample into the sample chamber; the base further includes a manipulator, the manipulator in communication with a drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the perforator; A core needle biopsy device, wherein the manipulators include a plurality of wedge manipulators.

10. A core needle biopsy device comprising: (a) a needle assembly including a perforator and a hollow cutter, the perforator including a sharp distal tip and a notch proximal to the distal tip, the perforator being slidably disposed within the hollow cutter to sever a tissue sample into the notch of the perforator; (b) a drive assembly configured to selectively move the perforator and the hollow cutter; (c) a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to the perforator and the hollow cutter to manipulate a severed tissue sample into the sample chamber; Equipped with the tissue sample holder further comprises a base, the base including a plurality of side walls and a floor defining the sample chamber, the wiper secured to the base, the base configured to translate relative to the perforator to translate the wiper relative to the perforator and thereby manipulate the severed tissue sample into the sample chamber; the base further includes a manipulator, the manipulator in communication with a drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the perforator; A core needle biopsy device, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of separate groups.

11. A core needle biopsy device comprising: (a) a needle assembly including a perforator and a hollow cutter, the perforator including a sharp distal tip and a notch proximal to the distal tip, the perforator being slidably disposed within the hollow cutter to sever a tissue sample into the notch of the perforator; (b) a drive assembly configured to selectively move the perforator and the hollow cutter; (c) a tissue sample holder having a sample chamber and a wiper, the wiper being movable relative to the perforator and the hollow cutter to manipulate a severed tissue sample into the sample chamber; Equipped with the tissue sample holder further comprises a base, the base including a plurality of side walls and a floor defining the sample chamber, the wiper secured to the base, the base configured to translate relative to the perforator to translate the wiper relative to the perforator and thereby manipulate the severed tissue sample into the sample chamber; the base further includes a manipulator, the manipulator in communication with a drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the perforator; A core needle biopsy device, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of separate groups, and the drive assembly includes a gear having an intermittent gear portion configured to engage with the plurality of gear teeth to intermittently translate the base in response to continuous rotation of the gear.

12. A core needle biopsy device according to any preceding claim, further comprising a sample tray configured to be received within a portion of the tissue sample holder, the sample tray configured to engage the wiper to manipulate a severed tissue sample from the wiper and into an interior space defined by the sample tray.

13. The core needle biopsy device of claim 12 , wherein the sample tray includes collection tines configured to engage with the wiper to manipulate a severed tissue sample from the wiper and into the interior space defined by the sample tray.

14. A core needle biopsy device according to any preceding claim, 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 being disposed at the distal end of the body.

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