Sample management for core needle biopsy devices

Abstract

A core needle biopsy device includes a needle assembly, a drive assembly, and a tissue sample holder. The needle assembly includes a piercer and a hollow cutter. The piercer includes a sharp distal tip and a notch proximate the distal tip. The piercer is slidably disposed within the cutter to sever a tissue sample into the notch of the piercer. The drive assembly is configured to selectively move the piercer and the cutter. The tissue sample holder has a sample chamber and a spatula. The spatula is movable relative to the piercer and cutter to manipulate the severed tissue sample into the sample chamber.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application Serial No. 62 / 916,277, filed October 17, 2020, entitled “Sample Management for Core Needle Biopsy Device,” the disclosure of which is incorporated herein by reference. Background Technology

[0003] A biopsy is the removal of a tissue sample from a patient to examine the tissue for signs of cancer or other diseases. Tissue samples can be obtained in various ways using a variety of medical procedures involving various sample collection devices. For example, a biopsy can be an open procedure (where tissue is surgically removed after an incision is made) or a percutaneous procedure (e.g., via fine-needle aspiration, core-needle biopsy, or vacuum-assisted biopsy). After the tissue sample is collected, it is typically analyzed in a laboratory established to perform appropriate tests (e.g., a pathology laboratory, a biomedical laboratory, etc.).

[0004] Various devices have been used to obtain biopsy samples in a variety of medical procedures, including open and percutaneous methods. For example, some biopsy devices are fully operable by a single hand and can capture one or more biopsy samples from a patient with a single insertion. Additionally, some biopsy devices can be tethered to vacuum and / or control modules, for example, for fluid communication (e.g., compressed air, saline, atmosphere, vacuum, etc.), for power transmission, and / or for command transmission. Other biopsy devices can be fully or at least partially operable without being tethered to or otherwise connected to another device.

[0005] One technique for collecting breast biopsies is using a core needle biopsy device. One such device is the MAX-CORE disposable core biopsy instrument manufactured by Bard BiopsySystems. Core needle biopsy devices often use a sharp, solid trocar equipped with a lateral tissue receiving slot located near the distal end of the trocar. As the tissue is received within the slot, a thin, hollow cutting sheath slides across the slot to cut the tissue sample. The cut tissue sample is then stored within the slot until the trocar and cutting sheath are removed from the patient. Therefore, in a core needle biopsy device, only one tissue sample can be collected per insertion of the trocar and cutting sheath.

[0006] Unlike core needle breast biopsy procedures, vacuum-assisted breast biopsy devices allow the probe to retrieve multiple samples without removing it from the breast after each sample is collected. For example, in a vacuum-assisted breast biopsy device, a hollow needle is used to pierce the tissue. The hollow needle includes a lateral aperture adjacent to its sharp distal tip. A hollow cutter is positioned within the hollow needle and moves axially relative to the needle's lateral aperture to cut the tissue sample. Once the hollow cutter has cut the tissue sample, the tissue sample is axially transported through the cutter and collected in a tissue collection feature.

[0007] Examples of vacuum-assisted biopsy devices and biopsy system components are disclosed in the following documents: U.S. Patent No. 5,526,822, filed June 18, 1996, entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue"; U.S. Patent No. 6,086,544, filed July 11, 2000, entitled "Control Apparatus for an Automated Surgical Biopsy Device"; U.S. Patent No. 6,162,187, filed December 19, 2000, entitled "Fluid Collection Apparatus for a Surgical Device"; and U.S. Patent No. 6,162,187, filed August 13, 2002, entitled "Method for Using a Surgical Biopsy System with Remote Control for Selecting an Operational Mode". U.S. Patent No. 6,432,065, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode" (filed June 22, 2004); U.S. Patent No. 6,752,768, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode" (filed June 22, 2004); U.S. Patent No. 7,442,171, entitled "Remote Thumbwheel for a Surgical Biopsy Device" (filed October 8, 2008); U.S. Patent No. 7,854,706, entitled "Clutch and Valving System for Tetherless Biopsy Device" (filed December 1, 2010); and U.S. Patent No. 7,854,706, entitled "Surgical Biopsy System with Remote Control for Selecting an Operational Mode" (filed March 29, 2011); U.S. Patent No. 7,914,464 to “Mode”;U.S. Patent No. 7,938,786, filed May 10, 2011, entitled "Vacuum Timing Algorithm for Biopsy Device"; U.S. Patent No. 8,083,687, filed December 21, 2011, entitled "Tissue Biopsy Device with Rotatably Linked Thumbwheel and Tissue Sample Holder"; U.S. Patent No. 8,118,755, filed February 1, 2012, entitled "Biopsy Sample Storage"; and U.S. Patent No. 26, 2012, entitled "Tetherless Biopsy Device with Reusable Parts". U.S. Patent No. 8,206,316 entitled "Biopsy Device with Discrete Tissue Chambers" (filed April 22, 2014); U.S. Patent No. 8,702,623 entitled "Biopsy Device with Discrete Tissue Chambers" (filed October 14, 2014); U.S. Patent No. 8,858,465 entitled "Biopsy Device with Motorized Needle Firing" (filed October 14, 2014); and U.S. Patent No. 9,326,755 entitled "Biopsy Device Tissue Sample Holder with Bulk Chamber and Pathology Chamber" (filed May 3, 2016). The disclosures of the U.S. patents cited above are incorporated herein by reference.

[0008] Other examples of vacuum-assisted biopsy devices and biopsy system components are disclosed in the following documents: U.S. Publication No. 2006 / 0074345, entitled "Biopsy Apparatus and Method," published April 6, 2006, and now obsolete; U.S. Publication No. 2009 / 0131821, entitled "Graphical User Interface for Biopsy System Control Module," published May 21, 2009, and now obsolete; U.S. Publication No. 2010 / 0152610, entitled "Hand Actuated Tetherless Biopsy Device with Pistol Grip," published June 17, 2010, and now obsolete; and U.S. Publication No. 24, 2010, entitled "Biopsy Device with Central..." U.S. Patent Application Publication No. 2010 / 0160819 entitled “Thumbwheel”; and U.S. Patent Application Publication No. 2013 / 0324882 entitled “Control for Biopsy Device”, filed December 5, 2013. The disclosure of each of the foregoing U.S. Patent Application Publications is incorporated herein by reference.

[0009] Exemplary core biopsy devices are disclosed in the following documents: U.S. Patent No. 5,560,373, filed October 1, 1996, entitled "Needle Core Biopsy Instrument with Durable or Disposable Cannula Assembly"; U.S. Patent No. 5,817,033, filed October 6, 1998, entitled "Needle Core Biopsy Device"; U.S. Patent No. 5,971,939, filed October 26, 1999, entitled "Needle Core Biopsy Device"; and U.S. Patent No. 5,511,556, filed April 30, 1996, entitled "Needle Core Biopsy Instrument". The disclosures of the above-mentioned U.S. patents are incorporated herein by reference.

[0010] In some cases, it may be necessary to combine features from both core-needle biopsy devices and vacuum-assisted biopsy devices to gain the advantages of both while reducing overall disadvantages. For example, core-needle biopsy devices may be advantageous due to their simplicity, light weight, and ease of operation. Furthermore, core-needle biopsy devices typically include smaller needle gauges, which may be desirable for increasing patient comfort and reducing recovery time. Meanwhile, vacuum-assisted biopsy devices may be advantageous because they can collect multiple samples in a single insertion. Therefore, a simple and lightweight biopsy device capable of collecting multiple samples in a single insertion may be needed.

[0011] One challenge in the aforementioned biopsy device configuration is managing the tissue sample after it has been collected using the biopsy device. This can present challenges due to the unique needle and cutter configuration encountered in the context of a core needle biopsy device. For example, the cutter may be located outside the internal trocar, core needle, or needle. The severed tissue sample can then be transported through the cutter using a notch in the internal trocar. While using a notch can improve sample collection, collecting the severed tissue sample from the notch can be challenging due to the size and / or shape of the notch and the characteristics of the severed tissue sample (e.g., “sticky” or “adhesive”). Therefore, it may be necessary to integrate certain tissue sample collection features into a biopsy device that combines the features of a core needle biopsy device and a vacuum-assisted biopsy device.

[0012] Although several systems and methods have been developed and used to obtain biopsy samples, it is believed that no one has made or used the invention described in the appended claims before the inventors. Attached Figure Description

[0013] Although this specification concludes with claims that specifically point out and clearly claim protection for the invention, it is believed that the invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which similar reference numerals identify the same elements. In the drawings, some parts or portions of parts are shown as imaginary diagrams as depicted by dashed lines.

[0014] Figure 1 A perspective view depicting an exemplary core needle biopsy device;

[0015] Figure 2 Depicting Figure 1 An exploded view of the needle assembly of a core needle biopsy device;

[0016] Figure 3 Depicting Figure 2 A perspective view of the needle component;

[0017] Figure 4 Depicting Figure 1 A perspective view of the drive assembly of a core needle biopsy device;

[0018] Figure 5 Depicting Figure 1 A perspective view of the tissue sample holder in a core needle biopsy device;

[0019] Figure 6 Depicting Figure 5 A perspective view of the outer shell of the tissue sample holder;

[0020] Figure 7 Depicting Figure 6 A side cross-sectional view of the outer shell, which is along... Figure 6 The cross-section of line 7-7;

[0021] Figure 8 Depicting Figure 5 A perspective view of the extraction mechanism of the tissue sample holder;

[0022] Figure 9 Depicting Figure 5 A front view of the tissue sample holder;

[0023] Figure 10A Depicting Figure 5 Another perspective view of the tissue sample holder, in which the extraction mechanism is positioned to collect tissue samples;

[0024] Figure 10B Depicting Figure 5 Another perspective view of the tissue sample holder, in which the extraction mechanism rotates to move the tissue sample;

[0025] Figure 11 The description can be easily combined with Figure 1 A perspective view of another exemplary tissue sample holder in a biopsy device;

[0026] Figure 12 depicts Figure 11 Another perspective view of the tissue sample holder, wherein the tissue sample holder is positioned to collect tissue samples;

[0027] Figure 12B Depicting Figure 11 Another perspective view of the tissue sample holder, in which the tissue sample holder is translated to collect tissue samples;

[0028] Figure 12C Depicting Figure 11 Another perspective view of a tissue sample holder, wherein the tissue sample holder is positioned to collect another tissue sample;

[0029] Figure 13 The description can be easily combined with Figure 1 A perspective view of yet another exemplary tissue sample holder in a biopsy device;

[0030] Figure 14 Depicting Figure 13A perspective view of the base of the tissue sample holder;

[0031] Figure 15 Depicting Figure 14 Another perspective view of the base;

[0032] Figure 16 Depicting Figure 13 An exploded perspective view of the gear assembly of the tissue sample holder;

[0033] Figure 17A Depicting Figure 13 Another perspective view of the tissue sample holder, wherein the tissue sample holder is positioned to collect tissue samples;

[0034] Figure 17B Depicting Figure 13 Another perspective view of the tissue sample holder, in which the tissue sample holder is translated to collect tissue samples;

[0035] Figure 18A Depicting Figure 13 A partial perspective cross-sectional view of a tissue sample holder, wherein the scraper of the tissue sample holder is positioned to collect tissue samples;

[0036] Figure 18B Depicting Figure 13 Another perspective cross-sectional view of the tissue sample holder, in which Figure 18A The scraper blade swept across Figure 2 The slot of the puncture device in the needle assembly;

[0037] Figure 18C Depicting Figure 13 Another perspective cross-sectional view of a tissue sample holder, in which another scraper of the tissue sample holder is positioned to collect another tissue sample;

[0038] Figure 19 The description can be easily combined with Figure 1 A perspective view of yet another exemplary tissue sample holder in a biopsy device;

[0039] Figure 20 Depicting Figure 19 Perspective exploded view of the tissue sample holder;

[0040] Figure 21A Depicting Figure 19 Another perspective view of the tissue sample holder, wherein the scraper of the tissue sample holder is positioned to collect tissue samples;

[0041] Figure 21B Depicting Figure 19 Another perspective view of the tissue sample holder, in which Figure 21A The scraper is rotated to move the tissue sample; and

[0042] Figure 21C Depicting Figure 19 Another perspective view of the tissue sample holder, in which Figure 21A The scraper is rotated to place the tissue sample into the tissue tray.

[0043] The accompanying drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be practiced in a variety of other ways (including those not necessarily depicted in the drawings). The drawings, which are incorporated in and constitute a part of this specification, illustrate some aspects of the invention and, together with the description, explain the principles of the invention; however, it should be understood that the invention is not limited to the precise arrangements shown. Detailed Implementation

[0044] The following description of certain examples of the invention should not be construed as limiting the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which, by way of example, represents one of the best modes contemplated for carrying out the invention. It will be appreciated that the invention can have other different and obvious aspects, all of which do not depart from the invention. Therefore, the drawings and description should be considered illustrative rather than restrictive in nature.

[0045] Biopsy devices can be used to collect tissue samples in a variety of ways. For example, in some cases, tissue samples are collected into a single tissue basket, such that all tissue samples collected during a given biopsy procedure are placed in a single tissue sample basket. In other cases, tissue samples are collected into a tissue sample holder, which has a separate compartment for each collected tissue sample. Such a multi-compartment tissue sample holder may additionally include a tray or strip that individually holds each tissue sample separately from the other tissue samples. At the end of the biopsy procedure, this tray or strip can be removed from the tissue sample holder or otherwise detached.

[0046] Regardless of the structure of the stored tissue sample, tissue samples can be collected using a biopsy device under the guidance of various imaging modalities, such as ultrasound imaging guidance, stereotactic (X-ray) guidance, MRI guidance, positron emission tomography (“PEM” guidance), breast-specific gamma imaging (“BSGI”) guidance, or other guidance. Each procedure has its own methodology depending on the type of imaging guidance used.

[0047] Depending on the context, both vacuum-assisted biopsy devices and core-needle biopsy devices may have various advantages over the other. For example, one advantage of vacuum-assisted biopsy devices is that vacuum assistance allows for the retrieval of multiple tissue samples with a single insertion. However, while core-needle biopsy devices lack this feature, they are still necessary. For instance, core-needle biopsy devices are generally able to have smaller needles than core-needle biopsy devices, thereby reducing patient anxiety and increasing the needle's ability to penetrate lesions. Therefore, in some cases, it may be necessary to combine the multiple sample retrieval feature of vacuum-assisted biopsy devices with that of core-needle biopsy devices to achieve the benefits present in both types of biopsy devices.

[0048] The ideal feature of the device described herein is a core needle biopsy device that allows for the simultaneous insertion of multiple samples in a single procedure using a core needle-type device. To facilitate this function, the biopsy device also includes a tissue sample holder having one or more features to facilitate the collection of severed tissue samples from notches, pits, pores, and / or other sample collection features. Currently, only vacuum-assisted biopsy devices are considered to possess this capability.

[0049] I. An exemplary core needle biopsy device with multiple sample collection

[0050] Figure 1 An exemplary core needle biopsy device (10) for a breast biopsy procedure is shown. 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 a housing (14) and an actuating member (16) disposed on the housing (14). As will be described in more detail below, the housing (14) surrounds various components of the biopsy device (10) for driving the needle assembly (20) in cutting and tissue collection cycles. For this purpose, the size and shape of the housing (14) of this example are adapted for single-handed gripping by an operator. Although not shown, it should be understood that in some examples, the housing (14) may include multiple portions such that each portion interconnects to form the housing (14).

[0051] A. Exemplary pin component

[0052] Figure 2 and Figure 3 The needle assembly (20) is shown in more detail. (See also...) Figure 2As seen below, the needle assembly (20) includes a slender puncture device (22) and a slender cutter (40). As will be described in more detail below, the puncture device (22) is generally movable relative to the cutter (40) to puncture tissue and collect a tissue sample, while the cutter is generally movable relative to the puncture device (22) to cut the tissue sample. The puncture device (22) includes a generally cylindrical rod having a sharp distal tip (24) and a notch (26) disposed adjacent to the distal tip (24). As will be described in more detail below, the distal tip (24) is generally configured to puncture the patient's tissue. As will also be described in more detail below, the notch (26) is generally configured to receive tissue therein, such that the tissue sample can be collected within the notch (26) after being cut by the cutter (40).

[0053] A distal portion (30) is disposed on the proximal end of the trocar (22). In this example, the distal portion (30) is overmolded onto the proximal end of the trocar (22) and is generally configured to enhance the operability of the trocar (22). Specifically, the distal portion (30) includes a receiving feature (32) in the form of a cylindrical notch or slot. The receiving feature (32) is configured to receive a portion of the trocar drive assembly (300). As will be described in more detail below, this allows the trocar drive assembly (300) to drive the movement of the trocar (22) through a predetermined movement sequence.

[0054] The cutter (40) comprises a generally hollow cylindrical tube configured to receive a trocar (22) therein. The cutter (40) includes an open distal end (42), a cannula portion (44), and a distal end portion (50). The open distal end (42) is configured to allow at least a portion of the trocar (22) to protrude from the cutter (40) as the trocar (22) moves relative to the cutter (40). As will be described in more detail below, this configuration allows the needle assembly (20) to move in cutting and tissue collection cycles by allowing the notch (26) of the trocar (22) to move relative to the distal end (42) of the cutter (40).

[0055] The distal end (42) of the opening in this example includes a tapered edge (43). The tapered edge (43) is typically configured to cut through tissue to separate tissue samples as the cutter (40) moves relative to the notch (26) of the trocar (22). Therefore, it should be understood that the tapered edge (43) is typically configured to function as a blade. Although this example is described and shown using a tapered configuration, it should be understood that various alternative configurations may be used in other examples. For example, in some examples, the tapered edge (43) includes multiple serrations as a complement to or alternative to the tapered shape shown. In still other examples, given the teachings herein, as will be understood by one of ordinary skill in the art, the tapered edge (43) may include any other additional or alternative cutting surfaces.

[0056] The cannula portion (44) of the cutter (40) extends proximally from the distal end (42) through the distal portion (50), allowing the trocar (22) to be received together with the proximal end of the cutter (40). Unlike the distal portion (30) of the trocar (22), the distal end (50) of the cutter (40) is typically elongated, allowing the distal portion (50) to accommodate additional features, which will be described in more detail below. In this example, the distal portion (50) may extend distally relative to the housing (14) to allow a portion of the distal portion (50) to be accessible by the operator for tissue sample collection purposes. Various suitable tissue collection mechanisms associated with the distal portion (50) will be described in more detail below.

[0057] The distal portion (50) of the cutter (40) includes a receiving feature (52) and a tissue collection feature (54). Similar to the receiving feature (32) of the puncture device (22), the receiving feature (52) of the distal portion (50) includes a cylindrical notch, slot, or other receiving feature configured to receive at least a portion of the cutter drive assembly (200). As will be described in more detail below, the receiving feature (52) is configured to receive at least a portion of the cutter drive assembly (200) to allow the cutter drive assembly (200) to move the cutter (40) via a predetermined movement sequence.

[0058] The tissue collection feature (54) is positioned distally relative to the receiving feature (52). The tissue collection feature (54) typically defines an elongated notch opening to the cannula portion (44) of the cutter (40). Thus, the cannula portion (44) includes a cut portion (46) adjacent to or otherwise defining the tissue collection feature (54). Therefore, it should be understood that the tissue collection feature (54) communicates with the hollow interior or lumen defined by the cannula portion (44). As will be described in more detail below, this relationship between the tissue collection feature (54) and the cannula portion (44) allows the operator to remove the tissue sample from the cutter (40) while the tissue sample is being collected by the trocar (22).

[0059] The end portion (50) also includes actuators (53) extending outward from the outer surface of the end portion (50). The actuators (53) typically have a square or rectangular shape. As will be described in more detail below, the actuators (53) are typically configured to manipulate certain features associated with the various tissue collection features described herein. Although the actuators (53) in this example are shown in conjunction with the end portion (50), it should be understood that in other examples, the actuators (53) may be associated with other components or omitted entirely.

[0060] Figure 3A puncture device (22) disposed within a cutter (40) is shown. As can be seen, the cutter (40) is generally configured to receive the puncture device (22) such that the puncture device (22) is coaxial with the cutter (40). Additionally, the puncture device (22) is generally movable relative to the distal end (42) of the opening of the cutter (40). It should be understood that in some cases, the puncture device (22) moves relative to the cutter (40) while the cutter (40) remains stationary. In other cases, the cutter (40) moves relative to the puncture device (22) while the puncture device (22) remains stationary. In either case, it should be understood that the puncture device (22) and the cutter (40) are generally configured such that the notch (26) of the puncture device (22) moves into and out of the cutter (40), such that the notch (26) can be disposed distally or proximally relative to the distal end (42) of the opening of the cutter (40). As will be described in more detail below, this configuration allows the puncture device (22) and the cutter (40) to work together to puncture tissue, cut tissue samples and retrieve tissue samples for collection by the operator via the tissue collection feature (54).

[0061] B. Exemplary Driver Components

[0062] Figure 4 The internal components of the body (12) of the biopsy device (10) with the outer shell (14) removed are shown. As can be seen, within the outer shell (14), the body (12) includes a drive assembly (100). The drive assembly (100) is generally configured to engage the needle assembly (20) to drive the trocar (22) and the cutter (40) via a predetermined movement sequence, thereby puncturing tissue and collecting multiple tissue samples by a single insertion of the needle assembly (20) into the patient. Although not shown, it should be understood that the outer shell (14) defines various internal geometries that support or otherwise engage the drive assembly (100). As will be understood, such internal geometries are used to provide relative movement of the various components of the drive assembly (100) relative to other components of the drive assembly (100) and / or the outer shell (14).

[0063] The drive assembly (100) includes a cutter drive assembly (120), a puncture device drive assembly (130), and a firing assembly (140). Typically, the needle firing assembly (140) is configured to strike and fire the cutter (40) and the puncture device (22) in a predetermined sequence to cut a tissue sample. To collect the cut tissue sample, the cutter drive assembly (120) is typically configured to retract the cutter (40). Similarly, the puncture device drive assembly (130) is typically configured to retract the puncture device (22). It should be understood that in some instances, both the cutter drive assembly (120) and the puncture device drive assembly (130) can be configured to rotate the cutter (40) and / or the puncture device (22), respectively.

[0064] In this example, the needle firing assembly (140) is generally shown schematically. Therefore, it should be understood that in some instances, the needle firing assembly (140) may take various forms with combinations of gears, racks, lead screws, brackets, springs, etc. Such components of the needle firing assembly (140) can typically be configured to rapidly fire the cutter (40) and the puncturist (22) in a predetermined sequence to puncture tissue. For example, in some instances, the needle firing assembly (140) is configured to rapidly fire the puncturist (22) distally to puncture 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 or slower relative to the puncturist (22), such that the notch (26) may be exposed relative to the cutter (40). This sequence may allow tissue to enter the notch (26), allowing the tissue to be severed by subsequent movement of the cutter (40). Additionally, it should be understood that the needle firing assembly (140) may include other components and / or features to allow the cutter (40) and / or puncturist (22) to be snapped prior to firing.

[0065] The cutter drive assembly (120) is typically configured to translate and / or rotate the cutter (40) independently of or in conjunction with the puncture device (22). For example, the cutter drive assembly (120) may include various combinations of gears, racks, lead screws, brackets, springs, etc., to drive the cutter (40) in a predetermined sequence. In one such sequence, the cutter (40) is retracted proximally relative to the housing (14) to prepare the cutter (40) for a tissue collection sequence described in more detail below. Alternatively, the cutter drive assembly (120) may also be configured to rotate the cutter (40) in a predetermined sequence to assist in the tissue collection sequence described in more detail below.

[0066] The trocar drive assembly (130) is typically configured to translate and / or rotate the trocar (22) independently of or in conjunction with the cutter (40). For example, the trocar drive assembly (120) may include various combinations of gears, racks, lead screws, brackets, springs, etc., to drive the trocar (22) via a predetermined sequence. In one such sequence, the trocar (22) retracts proximally relative to the cutter (40) after the tissue sample has been cut to retract the tissue sample proximally toward the housing (14). Once the trocar (22) is retracted, the tissue sample can be extracted for collection in the tissue collection sequence described in more detail below.

[0067] In this example, the drive assembly (100) is powered by one or more motors (150, 152). Specifically, the drive assembly (100) of this example includes a drive motor (150) and a firing motor (152). The drive motor (150) of this example is in communication with both the cutter drive assembly (120) and the puncture 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 puncturer (22). Similarly, the firing motor (152) is in communication with the firing assembly (140) to drive the firing and / or striking of the cutter (40) and the puncturer (22). Although the drive assembly (100) of this example includes two motors (150, 152), it should be understood that any suitable number of motors, such as a single motor, or three or more motors, can be used in other examples. Additionally, the motors (150, 152) can be configured to drive the cutter drive assembly (120), the puncture drive assembly (130), and / or the firing assembly (140) in various combinations.

[0068] Although the cutter drive assembly (120), puncture drive assembly (130), and firing assembly (140) of this example are schematically shown as three separate drive assemblies, it should be understood that in other examples, various elements of the cutter drive assembly (120), puncture 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 puncturer (22) according to the sequence described herein. In some examples, the cutter drive assembly (120), puncture drive assembly (130), and firing assembly (140) may be constructed based on at least some of the teachings of U.S. Serial No. 16 / 381,573, filed April 11, 2019, entitled “Core Needle Biopsy Device for Collecting Multiple Samples in a Single Insertion,” the disclosure of which is incorporated herein by reference.

[0069] C. Exemplary tissue sample holder

[0070] As described above, in this example, the needle assembly (20) is configured as a core needle tissue collection assembly capable of collecting multiple samples with a single insertion. In some instances, each time a tissue sample is collected, the tissue sample can be physically removed by the operator from the tissue collection feature (54) and placed in a separate location (e.g., a formalin container). However, in some instances, such physical removal may be undesirable as it may add an extra step to the biopsy procedure, thereby increasing procedure time. Furthermore, such physical removal may introduce additional variables into the biopsy procedure by requiring the operator to track the collected tissue sample throughout the biopsy. Such physical removal may also lead to the operator frequently changing the grip throughout the biopsy, which is generally undesirable. Physical removal may also be undesirable because the physical movement of the tissue sample can damage the tissue structure. Therefore, in some instances, it may be necessary to include a tissue sample holder or other sample collection mechanism within the biopsy device (10) to collect and store tissue samples throughout the biopsy.

[0071] Figure 5 A tissue sample holder (200) is shown that can be easily used with the biopsy device (10) described above. The tissue sample holder (200) of this example includes an extraction mechanism (240) disposed within a cylindrical housing (210). The tissue sample holder (200) is typically configured to collect multiple tissue samples during a biopsy procedure using the rotation of the extraction mechanism (240) from the tissue collection feature (54) of the needle assembly (20). As will be described in more detail below, the tissue sample holder (200) is typically configured to collect and store six tissue samples, but in other examples any suitable number may be collected and stored.

[0072] Figure 6 and Figure 7 The housing (210) is shown in more detail. As can be seen, the housing (210) includes a cylindrical body (212) defining a sample chamber (213), 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 example, the housing (210) is generally transparent to improve the visibility of tissue samples during sample collection. Although the housing (210) in this example is shown with an open distal end (214), it should be understood that in other examples, the open distal end (214) may be closed or capped to seal the sample chamber (213) of the housing (210) relative to the environment.

[0073] The needle receiving portion (216) is typically configured as a semi-cylindrical recess or protrusion in the shape of another cylindrical part of the outer shell (210). The size of the needle receiving portion (216) is typically designed to correspond to the size and shape of the needle assembly (20). Thus, the needle receiving portion (216) typically defines a recess or recessed area in which the needle assembly (20) can be placed. As will be described in more detail below, the specific depth of the needle receiving portion (216) may be related to the specific geometric configuration of the tissue collection feature (54) of the needle assembly (20) to aid in the extraction of tissue samples from the tissue collection feature (54).

[0074] The closed proximal end (218) of the housing (210) includes a shaft hole (220) and a pinhole (222). As will be described in more detail below, the shaft hole (220) is configured to receive a rotatable part of the extraction mechanism (240) to allow the extraction mechanism (240) to rotate from the outside of the housing (210). The pinhole (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 the shaft hole (220) and / or the pinhole (222) may include seals, O-rings, gaskets, etc., to seal the sample chamber (213) of the housing (210) relative to the environment.

[0075] Figure 8 The extraction mechanism (240) is shown in more detail. As can be seen, the extraction mechanism (240) includes a shaft (242) and a plurality of scrapers (250) arranged around the shaft (242). The shaft (242) is generally rotatable, thereby rotating the scrapers (250) within the 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 keying portion (244) configured to communicate with a manual or motorized actuator to rotate the shaft (242). Although the keying portion (244) in this example has a generally square shape, it should be understood that the keying portion (244) can have various configurations suitable for transmitting rotational motion, such as keys, one or more keyways or channels, hexagonal shapes, D-shapes, etc.

[0076] Although not shown, it should be understood that the shaft (242) can be driven by a keying portion (244) via various mechanisms. For example, in some instances, the keying portion (244) is rotatably coupled to any suitable part of the drive assembly (100), such as the cutter drive assembly (120), the puncture drive assembly (130), the firing assembly (140), or some combination thereof. This configuration is desirable for coordinating the rotation of the shaft (242) with the movement of the cutter (40) and / or the puncture device (22). Alternatively, the biopsy device (10) can be configured to include a completely independent drive mechanism for the shaft (242). For example, in some instances, a separate motor can be used to directly power the rotation of the shaft (242) via a transmission or other drive mechanism. In other instances, the rotation of the shaft (242) can be driven by a manual rotation mechanism, such as a wheel, button, or other similar mechanism.

[0077] The distal end of the shaft (242) includes a plurality of connectors (246) extending outward from the outer surface of the shaft (242). Each connector (246) is typically configured to receive a corresponding scraper (250), thereby providing a secure base for each scraper. In this example, each connector (246) defines a generally rectangular cross-section. In other examples, various alternative cross-sectional shapes may be used, such as triangular, circular, square, etc. Although not shown, it should be understood that the connectors (246) may extend axially along the length of the shaft (242) for approximately the same length as each scraper (250).

[0078] Each scraper (250) includes a receiving portion (252) and a tissue manipulation portion (254). The receiving portion (252) has a shape complementary to that of the connector (246), such that the receiving portion (252) is configured to receive the connector (246). Thus, each receiving portion (252) in this example defines an approximately rectangular shape corresponding to the rectangular shape of each connector (246). However, it should be understood that in instances where the connector (246) has a different shape, the shape of the receiving portion (252) can also be changed.

[0079] Each actuating portion (254) defines a generally curved or wavy surface at the outer end of each scraper (250). In the present curved shape, there is a concavity oriented in the rotational direction of the axis (242). The particular shape of each actuating portion (254) is generally configured to non-invasively engage tissue samples to remove tissue samples from the tissue collection feature (54) and place them into the sample chamber (213) of the housing (210). Although each actuating portion (254) in this example has a curved shape, it should be understood that various other shapes, such as circles, squares, triangles, etc., may be used in other examples. In addition, although each actuating portion (254) is shown to have a generally uniform longitudinal shape, it should be understood that in some examples the shape may vary as the actuating portion (254) extends axially. For example, in some examples, each actuating portion (254) may include one or more grooves to enhance fluid management.

[0080] The scraper (250) is typically formed of a flexible but partially elastic material, such as rubber or an elastomer. For example, the scraper (250) is typically flexible enough to bend around the interface between the housing (210) and the needle assembly (20). This flexibility typically reduces trauma when each scraper (250) engages with tissue, while also facilitating full engagement between each scraper (250) and the tissue. At the same time, at least some elasticity is provided so that each scraper (250) can push or otherwise move the tissue sample. In some instances, the flexibility of each scraper (250) can be characterized using a hardness tester. While a variety of suitable hardness testers can be used, a suitable range is 30 to 80.

[0081] As in Figure 9 Ideally, each connector (246) and scraper (250) is typically arranged around the axis (242) at angular intervals, such that the scrapers (250) are spaced apart by equal angular distances. This typically results in the connectors (246) and scrapers (250) together forming a starburst pattern. This configuration may require dividing the sample chamber (213) into six equal segments for organizing sample storage. However, it should be understood that other suitable spacings, including unequal spacings, may be used in other instances.

[0082] If still Figure 9 As seen in the image, each scraper (250) extends outward relative to the connector (246) away from the axis (242). When the extraction mechanism (240) is disposed within the housing (210), the axial extension of each scraper (250) causes the actuating portion (254) to contact the inner surface of the housing (210). Therefore, it should be understood that each scraper (250) is generally configured to slide along the inner surface of the housing (210) to sweep one or more tissue samples around the inner surface of the housing (210).

[0083] Figure 10A and Figure 10B This illustrates an exemplary use of the tissue sample holder (200) to collect tissue samples from the needle assembly (20). (See also...) Figure 10A As can be seen optimally, after the cutter (40) and puncturist (22) have been driven by the drive assembly (100) to cut and collect the tissue sample (TS), the tissue sample holder (200) can begin collecting the tissue sample. Specifically, once the tissue sample (TS) has been cut, the slot (26) of the puncturist (22) is used to transfer the tissue sample (TS) to the tissue collection feature (54).

[0084] In this example, the tissue sample holder (200) is positioned along the axis of the needle assembly (20) such that each scraper (250) is aligned with the tissue collection feature (54). Therefore, to collect the tissue sample (TS), the shaft (242) can be rotated to rotate each scraper (250) within the sample chamber (213) to sweep the selected scraper (250) adjacent to the tissue collection feature (54) across the notch (26). As the selected scraper (250) sweeps across the notch (26), the actuating portion (254) engages the tissue sample (TS) to push the tissue sample (TS) out of the tissue collection feature (54).

[0085] Once the selected scraper (250) has swept across the groove (26), the rotation of the shaft can continue, as... Figure 10B As shown in the diagram. Continued rotation causes the tissue sample (TS) to move inside the housing (210) to allow storage of the tissue sample (TS) and to prepare the needle assembly (20) for collecting more tissue samples. At this stage, rotation of the shaft (242) can continue in coordination with the sequential movement of the cutter (40) and puncturist (22) to cut and collect another tissue sample. Alternatively, rotation of the shaft (242) can be temporarily stopped to allow the cutter (40) and puncturist (22) to reposition and collect another tissue sample. In any case, once another tissue sample has been collected, rotation of the shaft (242) can be used to sweep another scraper (250) across the notch (26) to collect another tissue sample. The same process can 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.

[0086] II. An exemplary alternative tissue sample holder with a translatable lower scraper

[0087] Figure 11Another exemplary tissue sample holder (300) that can be easily incorporated into the biopsy apparatus (10) described above is shown. The tissue sample holder (300) of the presented example includes a base (310) with a plurality of scrapers (350). Like the tissue sample holder (200) described above, the tissue sample holder (300) of this example 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 example is configured to be movable by the needle assembly (20) to collect tissue samples from the tissue collection feature (54).

[0088] Figure 11 The base (310) is best viewed from the center. As can be seen, the base (310) generally defines an arcuate shape, which defines at least a certain degree of concavity. Although the base (310) of this example defines an arcuate shape, it should be understood that in other examples, the base (310) may define a flat configuration. The base (310) includes a distal sidewall (312), a proximal sidewall (318), and a base plate (316) extending between the distal sidewall (312) and the proximal endwall (318). Both the proximal sidewall (318) and the distal sidewall (312) extend upward from the base plate (316). The proximal sidewall (318) and the distal sidewall (312) further extend longitudinally along the entire length of the base plate (316). Thus, it should be understood that the proximal sidewall (318) and the distal sidewall (312) surround the proximal and distal ends of the base plate (316), respectively. As will be described in more detail below, this housing is used in conjunction with a scraper (350) to define a plurality of sample chambers (330) within the body (310).

[0089] The distal wall (312), base plate (316), and proximal wall (318) are all shown as having a solid structure in this example. However, it should be understood that in other examples, any of the distal wall (312), base plate (316), and / or proximal wall (318) may include one or more vents to provide ventilation. For example, in some examples, the base plate (316) may include multiple vents or ventilation slots to drain fluid during tissue sample collection. The appropriate size of the vents can generally be designed to allow liquid flow while preventing the flow of solid substances such as tissue samples. One or more vents may also be provided in the distal wall (312) or proximal wall (318) to further facilitate liquid drainage.

[0090] The base (310) also includes a plurality of manipulators (320) extending from the proximal side of the proximal sidewall (318). As will be described in more detail below, each manipulator (320) is typically configured to engage part of the needle assembly (20) to drive movement of the base (310) during tissue collection, thereby transposing a given sample chamber (330) via the tissue collection feature (54). The base (310) of this example includes five manipulators (320), but any suitable number may be used. For example, in this example, each manipulator (320) corresponds to a specific sample chamber (330). Thus, additional manipulators (320) may also be used in examples with additional sample chambers (330).

[0091] Each manipulator (320) includes an inclined surface (322) and a drive surface (324). The inclined surface (322) and drive surface (324) of each manipulator (320) are arranged such that each manipulator (320) forms a wedge-like shape. It should be understood that various alternative shapes can be used for each manipulator (320). For example, in this example, the specific geometry 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 examples where different drive mechanisms can be used, different manipulator (320) geometries can be used. By way of example only, in some examples, the manipulator (320) may be configured as teeth in a rack to engage gears, pawls, cams, etc.

[0092] Scraper blades (350) are arranged on the base (310) to further define each sample chamber (330). Specifically, each scraper blade (350) extends upward from the base plate (316) and is spaced equidistant from each adjacent scraper blade (350). Each scraper blade (350) also extends across the base plate (316) from the distal sidewall (312) to the proximal sidewall (318). In this example, six scraper blades (350) are included to divide the area of ​​the base plate (316) into five sample chambers (330). However, it should be understood that in other examples, various alternative numbers of scraper blades (350) may be used to form more or fewer sample chambers (330).

[0093] The scraper (350) extends further upward beyond the upward extensions of the distal wall (312) and proximal wall (318). Therefore, the scraper (350) in this example is configured to protrude outward from the bottom (310). As will be described in more detail below, this configuration allows the distal wall (312) and proximal wall (318) to travel along portions of the needle assembly (20), while the scraper (350) can enter the tissue collection feature (54) to extract tissue samples.

[0094] Unlike the scraper (250) described above, the scraper (350) of this example has a generally continuous rectangular cross-sectional configuration with rounded corners. However, it should be understood that the scraper (350) is generally still configured to engage with the tissue collection feature (54) to remove tissue samples from it. Therefore, it should be understood that the scraper (350) is generally formed of a flexible but partially elastic material (e.g., rubber or elastomer). As described similarly above, the scraper (350) is generally flexible enough to bend around a feature of the needle assembly (20). This flexibility generally reduces trauma when each scraper (350) engages with tissue, while also facilitating full engagement between each scraper (350) and the tissue. At the same time, at least some elasticity is provided so that each scraper (350) can push or otherwise move the tissue sample. In some instances, the flexibility of each scraper (350) can be characterized by a hardness tester. While a variety of suitable hardness testers can be used, a suitable hardness tester range is 30 to 80.

[0095] Figure 12A A tissue sample holder (300) incorporated into the biopsy apparatus (10) is shown. As can be seen, the tissue sample holder (300) can be received within a channel or other receiving feature or component defined by the outer housing (14) of the biopsy apparatus (10). A suitable channel within the housing (14) can be shaped to generally correspond to the shape of the base (310), such that the base (310) can be located within the channel. Alternatively, a suitable channel can 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) allows the base (310) to move freely laterally below the needle assembly (20), while the scraper (350) can still fully engage the tissue collection feature (54). As will be described in more detail below, this configuration allows the base (310) to be movable to rotate the sample chamber (330) via the needle assembly (20), while also allowing the scraper (350) to engage the tissue collection feature (54) to facilitate the removal of the tissue sample therefrom.

[0096] Figures 12A to 12C This illustrates an exemplary use of the tissue sample holder (300) for collecting severed tissue samples. The collection of severed tissue samples is... Figure 12A It begins in the middle. Figure 12A As shown in the stage, it should be understood that the cutter (40) and puncturist (22) have been actuated by the drive assembly (100) to cut the tissue sample and transport the cut tissue sample proximally to the tissue collection feature (54). Once the cut tissue sample has been transported proximally, the cutter (40) and puncturist (22) can be... Figure 12A The rotation shown in the figure. This rotation causes the tissue collection feature (54) to rotate clockwise from an upward orientation to a downward orientation.

[0097] The rotation of the cutter (40) and the puncturist (22) also causes the actuator (53) of the distal portion (50) to rotate. Specifically, the actuator (53) is generally aligned with the tissue collection feature (54) such that the actuator (53) moves from an upward orientation to a downward orientation. When the actuator (53) reaches the downward orientation, the actuator (53) sweeps between the two manipulators (320) of the tissue sample holder (300), which is allowed by the inclined surface (322) of the manipulator (320) positioned laterally relative to the actuator (53).

[0098] As the actuator (53) rotates further downward, at least a portion of the actuator (53) engages the drive surface (324) of the given manipulator (320). Due to the orientation of the drive surface (324), the continued rotation of the actuator (53) causes the given manipulator (320) to be pushed laterally by the actuator (53). When the given manipulator (320) is pushed laterally, the base (310) is also pushed laterally.

[0099] The continuous rotation of the cutter (40) and puncturist (22) causes the base (310) to face towards Figure 12B The positional translation is shown. As can be seen, this causes the given scraper (350) to be translated laterally into the tissue collection feature (54) and across the slot (26). As the scraper (350) sweeps across the slot (26), the cut tissue sample is displaced from the tissue collection feature (54) and enters the given sample chamber (330) of the tissue sample holder (300). Thus, tissue collection in this example is provided by the translation of the scraper (350) in coordination with the rotation of the cutter (40) and the puncturist (22).

[0100] Further rotation of the cutter (40) and puncturist (22) can cause the base (310) to translate further until the actuator (53) disengages from the manipulator (320). Figure 12C As seen in the image, this rotation can continue until the drive (53) rotates from... Figure 12A The original position shown is rotated approximately 360 degrees to set up the collection of another tissue sample using another manipulator (320). This rotation and tissue collection pattern can be repeated sequentially until all sample chambers (320) are filled. Alternatively, at any stage, the base (310) can be manually actuated to disrupt the collection sequence and begin collecting samples at the previously rotated sample chambers (320) to place multiple tissue samples in each sample chamber.

[0101] III. An exemplary alternative tissue sample holder with a translatable upper scraper

[0102] Figure 13Another exemplary tissue sample holder (400) that can be easily incorporated into the biopsy apparatus (10) described above is shown. The tissue sample holder (400) of the presented example includes a base (410) having a plurality of scrapers (450). Like the tissue sample holder (200) described above, the tissue sample holder (400) of this example 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 example is configured to be movable by a gear assembly (460) optionally in communication with the needle assembly (20) to collect one or more tissue samples from the tissue collection feature (54).

[0103] exist Figure 14 and Figure 15 The base (410) is best viewed from the center. As can be seen, the base (410) generally defines an arcuate shape, which defines at least a certain degree of concavity. Although the base (410) of this example defines an arcuate shape, it should be understood that in other examples, the base (410) may define a flat configuration. The base (410) includes a distal sidewall (412), a proximal sidewall (418), and a base plate (416) extending between a portion of the distal sidewall (412) and a portion of the proximal sidewall (418). Both the proximal sidewall (418) and the distal sidewall (412) extend upward from the base plate (416). The proximal sidewall (418) and the distal sidewall (412) further extend longitudinally along the entire length of the base plate (416). Thus, it should be understood that the proximal sidewall (418) and the distal sidewall (412) surround the proximal and distal ends of the base plate (416), respectively. Furthermore, the shell defines a single sample chamber (430) within the main body (410).

[0104] The distal wall (412), base plate (416), and proximal wall (418) are all shown as having a solid structure in this example. However, it should be understood that in other examples, any of the distal wall (412), base plate (416), and / or proximal wall (418) may include one or more vents to provide ventilation. For example, in some examples, the base plate (416) may include multiple vents or ventilation slots to drain fluid during tissue sample collection. The appropriate size of the vents can generally be designed to allow liquid flow while preventing the flow of solid substances such as tissue samples. One or more vents may also be provided in the distal wall (412) or proximal wall (418) to further facilitate liquid drainage.

[0105] The base (410) also includes a distal upper wall (402) and a proximal upper wall (404) generally oriented above the distal wall (412) and the proximal wall (418). Specifically, the distal upper wall (402) and the proximal upper wall (404) extend from one side of the distal wall (412) and the proximal wall (418), respectively, before bending approximately 180 degrees, such that the distal upper wall (402) and the proximal upper wall (404) extend rearward over the top of the distal wall (412) and the proximal wall (418). The distal upper wall (402) and the proximal upper wall (404) are further spaced apart from the distal wall (412) and the proximal wall (418) by a distance that approximately corresponds to the size of the needle assembly (20). Therefore, the base (410) is typically configured to receive the needle assembly (20) between the distal upper wall (402) and distal wall (412) at the distal end and the proximal upper wall (404) and proximal wall (418) at the proximal end.

[0106] The distal upper wall (402) and the proximal upper wall (404) are interconnected by a plurality of slats (406). The slats (406) are typically configured to provide additional structural stiffness to the base (410). The size of each slat (406) is typically designed to roughly correspond to the thickness of each scraper (450). As will be described in more detail below, each slat (406) typically provides structural support for the corresponding scraper (450) to aid in the collection of tissue samples.

[0107] The base (410) also includes a plurality of manipulators (420) extending from the proximal side of the proximal sidewall (418). As will be described in more detail below, each manipulator (420) is generally configured to engage part of the gear assembly (460) to drive movement of the base (410) during tissue collection, thereby displacing a given scraper (450) via the tissue collection feature (54). The base (410) of this example includes six manipulators (420), but any suitable number may be used. For example, in this example, each manipulator (420) corresponds to a specific scraper (450). Thus, additional manipulators (420) may also be used in examples with additional scrapers (450).

[0108] Each manipulator (420) includes a plurality of gear teeth (422) grouped together to form a single manipulator (420). As will be described in more detail below, the teeth (422) are generally configured to engage a gear assembly (460) to allow manipulation of the base (410). It should be understood that various alternative shapes may be used for each manipulator (420). For example, in this example, the specific geometry of each manipulator (420) is generally configured to interact with a specific structure of the gear assembly (460). Thus, in other examples where different drive mechanisms may be used, different manipulator (420) geometries may be used. By way of example only, in some examples, the manipulator (420) may be configured as teeth in a rack to engage gears, pawls, cams, etc.

[0109] Scraper blades (450) are arranged on the base (410) and spaced evenly. Each scraper blade (450) extends downward from the corresponding slat (406) toward the base plate (416). Each scraper blade (450) also extends across the length of each corresponding slat (406) from the distal upper wall (402) to the proximal upper wall (404). In this example, six scraper blades (450) are included. However, it should be understood that various alternative numbers of scraper blades (450) are used in other examples.

[0110] The scraper (450) extends further downward into the spaces defined between the distal wall (412) and distal superior wall (402) and the proximal wall (418) and proximal superior wall (404), respectively. Thus, the scraper (450) of this example is configured to protrude into the interior of the bottom (410). As will be described in more detail below, this configuration allows the walls (402, 404, 412, 418) to travel along portions of the needle assembly (20), while the scraper (450) can enter the tissue collection feature (54) to extract tissue samples.

[0111] Unlike the scraper (250) described above, the scraper (450) of this example has a generally continuous rectangular cross-sectional configuration with rounded corners. However, it should be understood that the scraper (450) is generally still configured to engage with the tissue collection feature (54) to remove tissue samples from it. Therefore, it should be understood that the scraper (450) is generally formed of a flexible but partially elastic material (e.g., rubber or elastomer). As described similarly above, the scraper (450) is generally flexible enough to bend around a feature of the needle assembly (20). This flexibility generally reduces trauma when each scraper (450) engages with tissue, while also facilitating full engagement between each scraper (450) and the tissue. At the same time, at least some elasticity is provided so that each scraper (450) can push or otherwise move the tissue sample. In some instances, the flexibility of each scraper (450) can be characterized by a hardness tester. While a variety of suitable hardness testers can be used, a suitable hardness tester range is 30 to 80.

[0112] Figure 16 The gear assembly (460) is shown in more detail. As can be seen, the gear assembly (460) includes a drive shaft (462) having an elongated spur gear (464) and a partially intermittent gear (470). The shaft (462) is configured to be rotatably driven by a power source such as a motor or a manual drive mechanism. In some instances, the shaft (462) may be interconnected with the drive assembly (100) such that the rotation of the shaft (462) is associated with the operating characteristics of the drive assembly (100).

[0113] An elongated spur gear (464) is typically configured to drive the rotation of a partially intermittent gear (470). The elongated spur gear (464) has an elongated configuration to allow continuous drive of the partially intermittent gear (470) during a predetermined translation range. In some instances, this can allow the needle assembly (20) to translate via another mechanism (e.g., a drive assembly (100)) while still allowing the elongated spur gear (464) to rotate the needle assembly (20).

[0114] The intermittent gear (470) comprises a continuous portion (472) and an intermittent portion (474). The continuous portion (472) comprises gear teeth oriented around the entire periphery of the intermittent gear (470). Meanwhile, the intermittent portion (474) comprises only four gear teeth isolated from a single segment. In this configuration, the continuous portion (472) is configured to mesh with an elongated spur gear (464) such that the intermittent gear (470) can be continuously driven 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 intermittent gear (470) rotates continuously. As will be described in more detail below, this function can generally be used to influence the translation timing of the movement of the base (410) relative to other parts of the biopsy device (10).

[0115] Figures 17A to 18C This illustrates an exemplary use of the tissue sample holder (400) for collecting severed tissue samples. The collection of severed tissue samples is... Figure 17A and Figure 18A It begins in the middle. Figure 17A and Figure 18A As shown in the stage, it should be understood that the cutter (40) and puncturist (22) have been actuated by the drive assembly (100) to cut the tissue sample and transport the cut tissue sample proximally to the tissue collection feature (54). Once the cut tissue sample has been transported proximally, the cutter (40) and puncturist (22) can be... Figure 17AThe rotation shown in the figure. This rotation causes the tissue collection feature (54) to rotate clockwise from approximately 10 o'clock to approximately 12 o'clock.

[0116] The rotation of the cutter (40) and the puncture device (22) is coordinated with the rotation of the drive shaft (462) of the gear assembly (460). Alternatively, in some instances, the rotation of the cutter (40) and the puncture device (22) is provided by a separate drive mechanism similar to the drive assembly (100) described above. In this example, the cutter (40) is rotated by a continuous portion (472) of a partially intermittent gear (470), which is rotated by an elongated spur gear (474) of the drive shaft (462). Figure 17A As can be seen, this rotation of the intermittent gear (470) also causes translation of the base (410) through the engagement between the intermittent portion (474) and the gear teeth (422) of the given manipulator (420).

[0117] As the cutter (40) and puncturist (22) rotate while translating on the base (410), the given scraper (450) is laterally translated into the tissue collection feature (54). Figure 18B As shown, this lateral translation causes a given scraper (450) to sweep across the groove (26). As the scraper (450) sweeps across the groove (26), the cut tissue sample is displaced from the tissue collection feature (54).

[0118] After the severed tissue sample is displaced from the tissue collection feature (54), gravity can pull the severed tissue sample downward into the sample chamber (430). Alternatively, in some applications, the surface tension in the moisture may cause the severed tissue sample to remain temporarily on a given scraper (450) until gravity is sufficient, or until it is removed by the operator. Thus, tissue collection in this example is provided by the translation of the scraper (450) in coordination with the rotation of the cutter (40) and the puncturist (22).

[0119] Further rotation of the cutter (40) and puncturist (22) may cause the base (410) to translate further until the given scraper (450) detaches from the tissue collection feature (54), as Figure 17B and Figure 18C As shown in the diagram. At this stage, the intermittent portion (474) of the partial intermittent gear (470) can disengage from the given manipulator (420) associated with the given scraper (450). Once disengaged, the partial intermittent gear (470) can continue to rotate the cutter (40) and / or the piercer (22) while the base (410) remains stationary.

[0120] The cutter (40) and / or puncturist (22) can therefore continue until approximately 360 degrees of rotation is completed, thereby returning the cutter (40) and / or puncturist (22) to Figure 17A The position is shown in the diagram. Another tissue sample can then be cut, and the above process can be repeated by engaging another manipulator (420) with the intermittent portion (474) of the partially intermittent gear (470). This rotation and tissue collection pattern can be repeated sequentially until all scrapers (450) have been used. Alternatively, at any stage, the base (410) can be manually actuated to disrupt the collection sequence and begin collecting samples at the previously rotated scraper (450) to collect multiple tissue samples with each scraper.

[0121] As described above, in some instances, the rotation of the cutter (40) and puncturer (22) is provided by a separate drive mechanism similar to the drive assembly (100) described above. It should be understood that in such instances, the rotation of the cutter (40) and / or puncturer (22) can be independent of the translation of the base (410). For example, in such instances, the cutter (40) and puncturer (22) can be positioned to align with a given scraper (450) prior to any rotation of the drive shaft (462) and thus the translation of the base (410) via the partial intermittent gear (470). Once the cutter (40) and / or puncturer (22) are positioned as needed, the drive shaft (462) can begin to rotate to translate the base (410) using the partial intermittent gear (470) as described similarly above. Therefore, in some instances, the cutter (40) and puncturist (22) define discrete series of movements relative to the base (410), rather than such movements coordinated with the base (410). This configuration may be desirable to reduce the additional complexity that might be required for coordinated movements.

[0122] IV. Exemplary Alternative Tissue Sample Holder with Rotatable Scraper

[0123] Figure 19 and Figure 20 Another exemplary tissue sample holder (500) that can be readily incorporated into the biopsy apparatus (10) described above is shown. The tissue sample holder (500) of this example includes an extraction mechanism (540) disposed within a generally cylindrical housing (510). The tissue sample holder (500) is typically configured to collect multiple tissue samples during a biopsy procedure using the tissue collection feature (54) of the rotating needle assembly (20) of the extraction mechanism (540). As will be described in more detail below, the tissue sample holder (500) is typically configured to collect and store tissue samples in any suitable bulk collection configuration.

[0124] The outer casing (510) includes a cylindrical body (512) defining a sample chamber (513), 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 casing (510) is generally transparent to improve the visibility of tissue samples during sample collection. Although the outer casing (510) of this example is shown with 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 casing (510) relative to the environment.

[0125] The needle receiving portion (516) is typically configured as a semi-cylindrical recess or protrusion in the shape of another cylindrical part of the outer shell (510). The size of the needle receiving portion (516) is typically designed to correspond to the size and shape of the needle assembly (20). Thus, the needle receiving portion (516) typically defines a recess or recessed area in which the needle assembly (20) can be placed. As will be described in more detail below, the specific depth of the needle receiving portion (516) may be related to the specific geometric configuration of the tissue collection feature (54) of the needle assembly (20) to aid in the extraction of tissue samples from the tissue collection feature (54).

[0126] Although not shown, it should be understood that the closed proximal end (518) of the housing (510) may include a shaft hole (not shown) and a pin hole (not shown). As will be described in more detail below, a suitable shaft hole may be configured to receive a rotatable part of the extraction mechanism (540) to allow the extraction mechanism (540) to rotate externally relative to the housing (510). A suitable pin hole is sized to allow the needle assembly (20) to pass proximally through the closed proximal end (518). Although not shown, it should be understood that the shaft hole and / or pin hole may include seals, O-rings, gaskets, etc., to seal the sample chamber (513) of the housing (510) relative to the environment.

[0127] The outer casing (510) further defines a tray receiver (520) adjacent to the sample chamber (513). As will be described in more detail below, the tray receiver (520) is configured to receive a tissue tray (560) for collecting tissue samples. In this example, the tray receiver (520) is formed as a generally rectangular channel. Since one side of the tray receiver (520) opens to the sample chamber (513), the tray receiver (520) can also be characterized as having a C-shaped cross-section. Therefore, the tray receiver (520) is generally in communication with the sample chamber (513) to allow tissue samples to be placed within the tissue tray (560).

[0128] The tray receiver (520) includes a locator (522) to facilitate holding the tissue tray (560) in a predetermined position. In this example, the locator (522) is formed as a slightly protruding, L-shaped, or J-shaped portion. As will be understood, this particular shape, together with the rectangular shape of the tray receiver (520), can help maintain the position of the tissue tray (560) within the tray receiver (520).

[0129] Although the tray receiver (520) in this example is shown to have a specific shape, it should be understood that various shapes can be used. For example, as will be described in more detail below, the shape of the tray receiver (520) is generally complementary to that of the tissue tray (560). Thus, in instances where the shape of the tissue tray (560) is varied, the shape of the tray receiver (520) can also be varied to complement the tissue tray (560).

[0130] Figure 20 The extraction mechanism (540) is shown in more detail. As can be seen, the extraction mechanism (540) includes a shaft (542) and a single scraper (550) projecting outward from the shaft (542). The shaft (542) is generally rotatable, thereby rotating the scraper (550) within the housing (510) to collect and store tissue samples as each tissue sample is collected by the needle assembly (20). The proximal end of the shaft (542) includes a keying portion (544) configured to communicate with a manual or motorized actuator to rotate the shaft (542). Although the keying portion (544) in this example is formed by a generally rectangular channel or keyway, it should be understood that the keying portion (544) can have various configurations suitable for transmitting rotational motion, such as keys, multiple keyways or channels, hexagonal shapes, D-shapes, etc.

[0131] Although not shown, it should be understood that the shaft (542) can be driven by a keying portion (544) via various mechanisms. For example, in some instances, the keying portion (544) is rotatably coupled to any suitable part of the drive assembly (100), such as the cutter drive assembly (120), the puncture drive assembly (130), the firing assembly (140), or some combination thereof. This configuration is desirable for coordinating the rotation of the shaft (542) with the movement of the cutter (40) and / or the puncture device (22). Alternatively, the biopsy device (10) can be configured to include a completely independent drive mechanism for the shaft (542). For example, in some instances, a separate motor can be used to directly power the rotation of the shaft (542) via a transmission or other drive mechanism. In other instances, the rotation of the shaft (542) can be driven by a manual rotation mechanism, such as a wheel, button, or other similar mechanism.

[0132] The distal end of the shaft (542) includes a connector channel (546) extending inward from the outer surface of the shaft (542). The connector channel (546) is typically configured to receive the scraper (550), thereby providing a secure base for the scraper (550). In this example, the connector channel (546) is formed by a generally rectangular channel. In other examples, various alternative shapes, such as triangles, circles, squares, etc., may be used. Additionally, or in alternatives, in some examples, the connector channel (546) may be configured to protrude to engage a corresponding channel within the scraper (550). Although not shown, it should be understood that the connector channel (546) may extend axially along the length of the shaft (542) by a length approximately equal to the length of the scraper (550).

[0133] The scraper (550) in this example is typically configured as a thin rectangular strip with rounded outer corners. As described above, the scraper (550) is configured to be received within a connector channel (546) of the shaft (542). A suitable connection between the scraper (550) and the shaft (542) can be achieved in various ways, such as bonding, welding, mechanical fastening, etc. Although this example is shown as including only a single scraper (550), it should be understood that in other examples, multiple scrapers (550) may be included, which are oriented around the shaft (542) in a manner similar to that of the scraper (250) described above.

[0134] The scraper (550) extends outward relative to the connector (546) away from the axis (542). When the extraction mechanism (540) is disposed within the housing (510), the axial extension of the scraper (550) causes the outer edge of the scraper (550) to contact the inner surface of the housing (510). Therefore, it should be understood that the scraper (550) is generally configured to slide along the inner surface of the housing (510) to sweep one or more tissue samples around the inner surface of the housing (510).

[0135] The scraper (550) is typically formed of a flexible but partially elastic material, such as rubber or an elastomer. For example, the scraper (550) is typically flexible enough to bend around the interface between the housing (510) and the needle assembly (20). This flexibility typically reduces trauma when the scraper (550) engages with tissue, while also facilitating full engagement between the scraper (550) and the tissue. At the same time, at least some elasticity is provided so that the scraper (550) can push or otherwise move the tissue sample. In some instances, the flexibility of the scraper (550) can be characterized using a hardness tester. While a variety of suitable hardness testers can be used, a suitable range is 30 to 80.

[0136] As described above, the tissue sample holder (500) also includes a tissue tray (560) configured to be received within a tray receiver (520) of the 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, the extension of which corresponds approximately to the axial length of the scraper (550). The upper portion of the tissue receiver (562) includes collection teeth (564) projecting outward and downward relative to the upper surface of the tissue receiver (562). As will be described in more detail below, the collection teeth (564) are generally configured to remove tissue samples from the surface scraper (550).

[0137] The tissue receiver (562) in this example typically 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 vents, slots, perforations, etc., to help drain various fluids encountered during the biopsy procedure. Therefore, it should be understood that various vents may be configured to facilitate fluid flow while also preventing the flow of larger solid materials, such as tissue samples.

[0138] A handle (566) extends proximally from the tissue receiver (562). In this example, the handle (566) comprises a thin rectangular strip. The handle (566) is typically configured for gripping by an operator to remove or insert tissue tray (560) relative to the housing (510). The handle (566) is typically curved to facilitate gripping. Alternatively, the handle (566) may also be equipped with various gripping features, such as protrusions, bumps, perforations, etc., to facilitate gripping.

[0139] Figure 21A and Figure 21C This illustrates an exemplary use of the tissue sample holder (500) to collect tissue samples from the needle assembly (20). (See also...) Figure 21A As can be seen optimally, after the cutter (40) and puncturist (22) have been driven by the drive assembly (100) to cut and collect the tissue sample, the tissue sample can be collected using the tissue sample holder (500). Specifically, once the tissue sample has been cut, the tissue sample is transferred to the tissue collection feature (54) using the notch (26) of the puncturist (22).

[0140] In this example, the tissue sample holder (500) is positioned along the axis of the needle assembly (20) such that the scraper (550) is aligned with the tissue collection feature (54). Therefore, to collect the tissue sample, the axis (542) can be rotated to rotate the scraper (550) within the sample chamber (513) to sweep across the scraper (550) adjacent to the tissue collection feature (54), as... Figure 21A As shown in the diagram. Further rotation of the shaft (542) allows the scraper (550) to sweep across the slot (26). As the scraper (550) sweeps across the slot (26), it engages the tissue sample to push the tissue sample out of the tissue collection feature (54) and reach... Figure 21B The location shown.

[0141] Once the scraper (550) has swept across the groove (26), the rotation of the shaft (542) can continue, as... Figure 21B As shown in the diagram. Continued rotation causes the tissue sample to move inside the outer shell (210) to allow the tissue sample to move toward the tissue tray (560). Figure 21C As shown, a tissue sample can be placed in the tissue tray (560) by sweeping a scraper (550) across the collection teeth (564). This movement causes the cut tissue sample to be rubbed off the scraper (550) and onto the collection teeth (564). Gravity can then cause the cut tissue sample to fall into the tissue receiver (562) for storage.

[0142] Once the severed tissue sample has been collected in the tissue tray (560), the rotation of the shaft (542) can continue in coordination with the sequential movement of the cutter (40) and trocar (22) to cut and collect another tissue sample. Alternatively, the rotation of the shaft (542) can be temporarily stopped to allow the cutter (40) and trocar (22) to be repositioned and another tissue sample collected. In any case, once another tissue sample has been collected, the rotation of the shaft (542) can be used again to sweep the scraper (550) across the slot (26) to collect another tissue sample. The same process can then be repeated as many times as appropriate until the tissue tray (560) is full or the required number of tissue samples has been collected.

[0143] V. Exemplary Combinations

[0144] The following examples illustrate various non-exhaustive ways in which the teachings herein can 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 filed at any time in this application or subsequent applications. No disclaimer. The following examples are provided for illustrative purposes only. Many other ways in which the various teachings herein can be arranged and applied are contemplated. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered critical unless the inventor or a successor with the inventor's interest expressly indicates so at a later date. If any claim in this application or a subsequent filing relating to this application includes features other than those mentioned below, those additional features should not be presumed to have been added for any reason related to patentability.

[0145] Example 1

[0146] A core needle biopsy device includes: a needle assembly comprising a puncture device and a hollow cutter, wherein the puncture device includes a sharp distal tip and a notch adjacent to the distal tip, wherein the puncture device is slidably disposed within the cutter to cut a tissue sample into the notch of the puncture device; a drive assembly configured to selectively move the puncture device and the cutter; and a tissue sample holder having a sample chamber and a scraper, wherein the scraper is movable relative to the puncture device and the cutter to manipulate the cut tissue sample into the sample chamber.

[0147] Example 2

[0148] As described in Example 1, in a core biopsy apparatus, the tissue sample holder includes a rotatable shaft, wherein the scraper is fixed to the shaft such that rotation of the shaft is configured to rotate the scraper relative to the puncture device, thereby manipulating the cut tissue sample into the sample chamber.

[0149] Example 3

[0150] As described in Example 2, the core needle biopsy device, wherein the tissue sample holder includes a plurality of scrapers, each scraper being fixed to the shaft such that each scraper extends radially outward from the shaft.

[0151] Example 4

[0152] As described in Example 2, the core needle biopsy device includes a single scraper extending radially outward from the axis.

[0153] Example 5

[0154] As described in Example 1, the core needle biopsy device, wherein the tissue sample holder further includes a base, wherein the base includes a plurality of sidewalls and a base plate defining the sample chamber, wherein the scraper is fixed to the base, wherein the base is configured to translate relative to the trocar to translate the scraper relative to the trocar, thereby manipulating the cut tissue sample into the tissue sample chamber.

[0155] Example 6

[0156] As described in Example 5, the core needle biopsy device further includes a manipulator in communication with a drive mechanism, such that the drive mechanism is configured to drive the base to translate relative to the puncture device.

[0157] Example 7

[0158] The core needle biopsy device as described in Example 6, wherein the manipulator includes a plurality of wedge manipulators.

[0159] Example 8

[0160] As described in Example 6, the core needle biopsy device includes a plurality of gear teeth arranged in a plurality of discrete groups.

[0161] Example 9

[0162] As described in Example 6, the core biopsy device includes a manipulator comprising a plurality of gear teeth arranged in a plurality of discrete groups, wherein the drive assembly includes a gear having an intermittent gear portion configured to mesh with the plurality of gear teeth to intermittently translate the base in response to continuous rotation of the gear.

[0163] Example 10

[0164] The core needle biopsy apparatus as described in any one or more of Examples 1 to 9 further includes a sample tray configured to receive within a portion of the tissue sample holder, wherein the sample tray is configured to engage the scraper to manipulate a cut tissue sample from the scraper into an interior space defined by the sample tray.

[0165] Example 11

[0166] As described in Example 10, the core needle biopsy device includes a sample tray with collection teeth configured to engage the scraper to manipulate a cut tissue sample from the scraper into the internal space defined by the sample tray.

[0167] Example 12

[0168] The core needle biopsy apparatus as described in any one or more of Examples 1 to 11, wherein the scraper comprises a material having a hardness of 30 to 80.

[0169] Example 13

[0170] The core needle biopsy apparatus as described in any one or more of Examples 1 to 11, wherein the scraper defines a thin, substantially rectangular shape.

[0171] Example 14

[0172] The core needle biopsy apparatus as described in any one of Examples 1 to 11, wherein the scraper defines a curved edge configured to engage tissue without damage.

[0173] Example 15

[0174] The core needle biopsy apparatus as described in any one or more of Examples 1 to 14 further includes a body having a distal end, wherein the needle assembly extends distally from the distal end of the body, and wherein the tissue sample holder is disposed on the distal end of the body.

[0175] Example 16

[0176] A tissue sample holder for use with a core needle biopsy device, wherein the core needle biopsy device includes a puncture device having a sample slot and a cutter movable relative to the sample slot to cut a tissue sample, wherein the tissue sample holder includes: a body defining a sample chamber; and at least one scraper movable relative to a portion of the tissue sample holder to manipulate the cut tissue sample from the sample slot of the puncture device into the sample chamber of the body.

[0177] Example 17

[0178] The tissue sample holder as described in Example 16 further includes a rotatable shaft, wherein the scraper extends radially outward from the shaft, wherein the body includes a cylindrical inner wall defining the sample chamber, and wherein the scraper is configured to slide along the inner wall of the body to move a cut tissue sample within the sample chamber.

[0179] Example 18

[0180] As in Example 17, the tissue sample holder, wherein the scraper defines a curved portion, wherein the curved portion defines a curvature oriented in a direction corresponding to the rotational direction of the axis.

[0181] Example 19

[0182] As described in Example 17, in a tissue sample holder, the scraper is fixed to the body such that the body is configured to move the scraper relative to the puncture device.

[0183] Example 20

[0184] A method for collecting tissue samples using a biopsy device, the method comprising: retracting a sample inlet defined by a puncture device proximally into a tissue sample holder; moving a scraper within the tissue sample holder to sweep the scraper across the sample inlet; and moving the scraper further away from the sample inlet and toward a sample chamber.

[0185] Example 21

[0186] The method described in Example 20, wherein the action of moving the scraper blade includes rotating the scraper blade using a shaft coupled to the scraper blade.

[0187] Example 22

[0188] The method described in Example 21, wherein the scraper is a first scraper, further includes rotating the shaft to move a second scraper within the tissue sample holder to sweep the second scraper across the sample slot.

[0189] Example 23

[0190] The method described in Example 20, wherein the action of moving the scraper blade includes translating the scraper blade by translating the base attached to the scraper blade.

[0191] Example 24

[0192] The method described in any one or more of Examples 20 to 23 further includes moving the scraper to sweep the scraper across the collection teeth of the tissue tray.

[0193] Example 25

[0194] The method described in any one or more of Examples 20 to 24, wherein the action of moving the scraper includes using the scraper to manipulate the tissue sample.

[0195] Example 26

[0196] A biopsy device includes: a body defined by a probe and a sheath; a needle assembly extending distally from the probe, wherein the needle assembly is configured to cut a tissue sample; and a tissue sample holder having a sample chamber and a scraper, wherein the scraper is movable relative to a portion of the needle assembly to manipulate the cut tissue sample into the sample chamber.

[0197] Example 27

[0198] As described in Example 26, the biopsy apparatus wherein the tissue sample holder includes a rotatable shaft, wherein the scraper is fixed to the shaft such that rotation of the shaft is configured to rotate the scraper relative to a portion of the needle assembly, thereby manipulating the cut tissue sample into the sample chamber.

[0199] Example 28

[0200] The biopsy apparatus as described in Example 27, wherein the tissue sample holder includes a plurality of scrapers, wherein each scraper is fixed to the shaft such that each scraper extends radially outward from the shaft.

[0201] Example 29

[0202] As described in Example 27, the biopsy apparatus wherein the tissue sample holder includes a single scraper that extends radially outward from the axis.

[0203] Example 30

[0204] The biopsy apparatus of Example 26, wherein the tissue sample holder further includes a base, wherein the base includes a plurality of sidewalls and a base plate defining the sample chamber, wherein the scraper is fixed to the base, wherein the base is configured to translate relative to the needle assembly to translate the scraper relative to the needle assembly, thereby manipulating the cut tissue sample into the tissue sample chamber.

[0205] Example 31

[0206] The biopsy apparatus as described in Example 30 further includes a drive mechanism, wherein the base further includes a manipulator, wherein the manipulator is in communication with the drive mechanism such that the drive mechanism is configured to drive translation of the base relative to the needle assembly.

[0207] Example 32

[0208] The biopsy apparatus as described in Example 31, wherein the manipulator includes a plurality of wedge manipulators.

[0209] Example 33

[0210] The biopsy apparatus as described in Example 31, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of discrete groups.

[0211] Example 34

[0212] The biopsy apparatus as described in Example 31, wherein the manipulator includes a plurality of gear teeth arranged in a plurality of discrete groups, wherein the drive assembly includes a gear having an intermittent gear portion, wherein the intermittent gear portion is configured to mesh with the plurality of gear teeth to intermittently translate the base in response to continuous rotation of the gear.

[0213] Example 35

[0214] The biopsy apparatus as described in any one or more of Examples 26 to 34 further includes a sample tray configured to receive within a portion of the tissue sample holder, wherein the sample tray is configured to engage the scraper to manipulate a cut tissue sample from the scraper into an interior space defined by the sample tray.

[0215] Example 36

[0216] As described in Example 35, the biopsy apparatus includes a sample tray comprising collection teeth configured to engage the scraper to manipulate a cut tissue sample from the scraper into the internal space defined by the sample tray.

[0217] Example 37

[0218] Biopsy apparatus as described in any one or more of Examples 26 to 36, wherein the scraper comprises a material having a hardness of 30 to 80.

[0219] Example 38

[0220] Biopsy apparatus as described in any one or more of Examples 26 to 36, wherein the scraper defines a thin, substantially rectangular shape.

[0221] Example 39

[0222] Biopsy apparatus as described in any one of Examples 26 to 36, wherein the scraper defines curved edges configured to engage tissue without damage.

[0223] Example 40

[0224] Biopsy apparatus as described in any one or more of Examples 26 to 39, wherein the probe has a distal end, wherein the needle assembly extends distally from the distal end of the probe, and wherein the tissue sample holder is disposed on the distal end of the probe.

[0225] Various embodiments of the invention have been shown and described. Other adaptations of the methods and systems described herein can be achieved by those skilled in the art through appropriate modifications without departing from the scope of the invention. Several such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the appended claims and should not be construed as limited to the details of the structures and operations shown and described in the specification and drawings.

[0226] It should be understood that, in addition to or in lieu of the features described above, any version of the instrument described herein may include a variety of other features. By way of example only, any instrument described herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference. It should also be understood that the teachings of this document can be readily applied to any instrument described in any other reference cited herein, such that the teachings of this document can be readily combined with the teachings of any reference cited herein in a variety of ways. Other types of instruments to which the teachings of this document can be incorporated will be apparent to those skilled in the art.

[0227] It should be understood that any patent, publication, or other disclosure material incorporated herein by reference, in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other disclosure material set forth in this disclosure. Therefore, and where necessary, any conflicting material incorporated herein by reference will be replaced by the disclosure expressly set forth herein. Any material or portion thereof incorporated herein by reference that conflicts with any existing definitions, statements, or other disclosure material set forth herein will be incorporated only to the extent that it will not create a conflict between the incorporated material and any existing disclosure material.

Claims

1. A core needle biopsy device, comprising: (a) A needle assembly comprising a puncturist and a hollow cutter, the puncturist comprising a sharp distal tip and a notch adjacent to the distal tip, the puncturist being slidably disposed within the cutter to cut a tissue sample into the notch of the puncturist. (b) A drive assembly configured to selectively move the puncture device and the cutter; as well as (c) A tissue sample holder having a sample chamber, a rotatable shaft, and a scraper, wherein the scraper extends from and is fixed to the rotatable shaft, the rotatable shaft and the scraper being located within the sample chamber, such that rotation of the rotatable shaft is configured to rotate the scraper relative to the puncturist and cutter within the sample chamber to manipulate a cut tissue sample into the sample chamber; The scraper is flexible and defines a tissue manipulation portion. The scraper is configured to sweep across the notch such that the manipulation portion engages the severed tissue sample to push the severed tissue sample out of the notch and into the sample chamber.

2. The core needle biopsy device of claim 1, wherein the tissue sample holder comprises a plurality of scrapers, each scraper being fixed to the shaft such that each scraper extends radially outward from the shaft.

3. The core needle biopsy device of claim 1, wherein the tissue sample holder comprises a single scraper extending radially outward from the axis.

4. The core needle biopsy apparatus of any one of claims 1 to 3, further comprising a sample tray configured to receive within a portion of the tissue sample holder, the sample tray being configured to engage the scraper to manipulate a severed tissue sample from the scraper into an interior space defined by the sample tray.

5. The core needle biopsy apparatus of claim 4, wherein the sample tray includes collection teeth configured to engage the scraper to manipulate a severed tissue sample from the scraper into the internal space defined by the sample tray.

6. The core needle biopsy device according to any one of claims 1 to 3, wherein the scraper comprises a material having a hardness of 30 to 80.

7. The core needle biopsy device as claimed in any one of claims 1 to 3, wherein the scraper defines a thin, substantially rectangular shape.

8. The core needle biopsy device according to any one of claims 1 to 3, wherein the scraper defines a curved edge configured to engage tissue without damage.

9. The core needle biopsy device according to any one of claims 1 to 3, 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 on the distal end of the body.

10. A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device comprising a puncturist having a sample orifice and a cutter movable relative to the sample orifice to cut a tissue sample, the tissue sample holder comprising: (a) A body defining a sample chamber and a rotatable axis; as well as (b) At least one scraper blade, The scraper extends from and is fixed to the rotatable shaft, the rotatable shaft and the scraper being located in the sample chamber, such that rotation of the rotatable shaft is configured to rotate the scraper relative to the puncturist and cutter within the sample chamber to manipulate the cut tissue sample into the sample chamber; The scraper is flexible and defines a tissue manipulation portion, which is configured to sweep across the sample slot such that the manipulation portion engages the severed tissue sample to push the severed tissue sample out of the sample slot and into the sample chamber.

11. The tissue sample holder of claim 10, wherein the scraper extends radially outward from the axis, the body includes a cylindrical inner wall defining the sample chamber, and the scraper is configured to slide along the inner wall of the body to move a cut tissue sample within the sample chamber.

12. The tissue sample holder of claim 11, wherein the scraper defines a curved portion, the curved portion being defined by a curvature oriented in a direction corresponding to the rotational direction of the axis.

13. A biopsy device comprising: (a) The main body, defined by the probe and the sheath; A needle assembly extending distally from the probe, wherein the needle assembly is configured to cut a tissue sample and includes a puncture device and a hollow cutter, the puncture device including a notch, the puncture device being slidably disposed within the cutter to cut a tissue sample into the notch of the puncture device; as well as (b) A tissue sample holder having a sample chamber, a rotatable shaft, and a scraper extending from and fixed to the rotatable shaft, the rotatable shaft and the scraper being located within the sample chamber such that rotation of the rotatable shaft is configured to rotate the scraper relative to the puncture device and cutter within the sample chamber to manipulate a cut tissue sample into the sample chamber; The scraper is flexible and defines a tissue manipulation portion. The scraper is configured to sweep across the notch such that the manipulation portion engages the severed tissue sample to push the severed tissue sample out of the notch and into the sample chamber.

14. The biopsy apparatus of claim 13, wherein the tissue sample holder comprises a plurality of scrapers, wherein each scraper is fixed to the shaft such that each scraper extends radially outward from the shaft.

15. The biopsy apparatus of claim 13, wherein the tissue sample holder comprises a single scraper extending radially outward from the axis.

16. The biopsy apparatus of any one of claims 13 to 15, further comprising a sample tray configured to receive within a portion of the tissue sample holder, wherein the sample tray is configured to engage the scraper to manipulate a severed tissue sample from the scraper into an interior space defined by the sample tray.

17. The biopsy apparatus of claim 16, wherein the sample tray includes collection teeth, wherein the collection teeth are configured to engage the scraper to manipulate a severed tissue sample from the scraper into the internal space defined by the sample tray.

18. The biopsy apparatus of any one of claims 13 to 15, wherein the scraper comprises a material having a hardness of 30 to 80.

19. The biopsy device of any one of claims 13 to 15, wherein the scraper defines a thin, substantially rectangular shape.

20. The biopsy apparatus of any one of claims 13 to 15, wherein the scraper defines a curved edge configured to engage tissue without damage.

21. The biopsy apparatus of any one of claims 13 to 15, wherein the probe has a distal end, wherein the needle assembly extends distally from the distal end of the probe, and wherein the tissue sample holder is disposed on the distal end of the probe.

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