User interface of the biopsy device

Abstract

A core needle biopsy device includes a needle assembly, a drive assembly, and a user interface. The needle assembly includes a puncture rod and a hollow cutter. The puncture rod includes a sharp distal tip and a notch proximate the distal tip. The puncture rod is slidably disposed within the cutter to sever a tissue sample into the notch of the puncture rod. The drive assembly is configured to selectively move the puncture rod and the cutter. The user interface includes a plurality of indicators. Each of the plurality of indicators is configured to independently transition between a plurality of predetermined states to collectively define a plurality of predetermined state sequences indicating movement of the puncture rod and the cutter via a drive mechanism.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 926,805, filed on October 28, 2019, entitled “User Interface for Biopsy Device,” the disclosure of which is incorporated herein by reference. Background Art

[0003] A variety of devices have been used in a variety of ways to obtain biopsy samples in various medical procedures, including open and percutaneous approaches. For example, some biopsy devices may be fully operable by a user using a single hand and capture one or more biopsy samples from a patient with a single insertion. In addition, some biopsy devices may be tethered to a vacuum module and / or a control module, such as for communication of fluids (e.g., compressed air, saline, atmospheric air, vacuum, etc.), for transmission of power, and / or for transmission of commands. Other biopsy devices may be fully or at least partially operable without being tethered or otherwise connected to another device.

[0004] One technique for collecting breast biopsies is to use a core needle biopsy device. A core needle biopsy device utilizes a sharp, solid puncture needle equipped with a lateral tissue-receiving notch located near the distal end of the puncture needle. Once tissue is received within the notch, an elongated, hollow cutting sheath translates over the notch to sever the tissue sample. The severed tissue sample is then stored within the notch until the puncture needle and cutting sheath are removed from the patient. Therefore, with a core needle biopsy device, only one tissue sample can be collected per insertion of the puncture needle and cutting sheath.

[0005] Another technique for performing a breast biopsy is using a vacuum-assisted breast biopsy device. Unlike core needle breast biopsy procedures, a vacuum-assisted breast biopsy device allows the probe to remove multiple samples without having to remove the probe from the breast after each sample. For example, in a vacuum-assisted breast biopsy device, a hollow needle is used to penetrate the tissue. The hollow needle includes a lateral aperture adjacent to a sharp distal tip. A hollow cutter is positioned within the hollow needle and moves axially relative to the lateral aperture of the needle to sever the tissue sample. Once the hollow cutter severs the tissue sample, the tissue sample is conveyed axially through the cutter and collected in a tissue collection feature.

[0006] Examples of vacuum-assisted biopsy devices and biopsy system components are disclosed in the following documents: U.S. Patent No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue,” filed on June 18, 1996; U.S. Patent No. 6,086,544, entitled “Control Apparatus for an Automated Surgical Biopsy Device,” filed on July 11, 2000; U.S. Patent No. 7,442,171, entitled “Remote Thumbwheel for a Surgical Biopsy Device,” filed on October 8, 2008; and U.S. Patent No. 7,442,171, entitled “Clutch and Valving System for Tetherless Biopsy Device,” filed on December 1, 2010. No. 7,854,706, entitled “Vacuum Timing Algorithm for Biopsy Device,” filed on May 10, 2011; No. 7,938,786, entitled “Vacuum Timing Algorithm for Biopsy Device,” filed on February 1, 2012; and No. 8,206,316, entitled “Tetherless Biopsy Device with Reusable Portion,” filed on June 26, 2012. The disclosures of each of the above-cited U.S. patents are incorporated herein by reference.

[0007] Examples of core needle biopsy devices are disclosed in the following documents: U.S. Patent No. 5,560,373, entitled “Needle Core Biopsy Instrument with Durable or Disposable Cannula Assembly,” filed on October 1, 1996; U.S. Patent No. 5,817,033, entitled “Needle Core Biopsy Device,” filed on October 6, 1998; and U.S. Patent No. 5,511,556, entitled “Needle Core Biopsy Instrument,” filed on April 30, 1996. The disclosures of each of the above-cited U.S. patents are incorporated herein by reference.

[0008] One challenge in both of the biopsy device configurations described above is operating the biopsy device with real-time feedback and limited user interaction points. Such challenges may arise due to the unique puncture and cutter configurations encountered in the context of core needle biopsy devices. For example, due to the relatively simple nature of the core needle biopsy device, the puncture and / or cutting sheath may be driven by a spring-actuated mechanism. However, such a mechanism may require multiple buttons or user input features to perform different movements during the tissue collection sequence. In some instances, the diversity of user input features may be undesirable due to operator confusion. Furthermore, such a mechanism may provide limited means for operator feedback, thereby exacerbating operator confusion. Therefore, certain user interface features may need to be integrated into the biopsy device to simplify the operator experience while also providing real-time feedback.

[0009] While several systems and methods have been made and used for obtaining and processing biopsy samples, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] While the specification concludes with claims which particularly point out and distinctly claim 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 like reference numerals identify like elements. In the drawings, some components or portions of components are shown in phantom as depicted by broken lines.

[0011] Figure 1 depicts a perspective view of an exemplary core needle biopsy device;

[0012] Figure 2 depiction Figure 1 An exploded view of a needle assembly of a core needle biopsy device;

[0013] Figure 3 depiction Figure 2 a perspective view of a distal portion of a needle assembly;

[0014] Figure 4 depiction Figure 1 A perspective view of a drive assembly of a core needle biopsy device;

[0015] Figure 5 depiction Figure 1 A perspective view of a tissue sample holder of a core needle biopsy device;

[0016] Figure 6 depiction Figure 1 A detailed perspective view of an exemplary user interface of a core needle biopsy device;

[0017] Figure 7 Depicted in Figure 6 Used in various states of the user interface Figure 1 A schematic flow chart of a core needle biopsy device;

[0018] Figure 8 Depicted in the first state Figure 6 A detailed top view of the user interface;

[0019] Figure 9 Depicted in the second state Figure 6 Another detailed top view of the user interface of ;

[0020] Figure 10 Depicted in the third state Figure 6 Yet another detailed top view of the user interface of ;

[0021] Figure 11 Depicted in the fourth state Figure 6 Yet another detailed top view of the user interface of ;

[0022] FIG12 depicts the fifth state Figure 6 Yet another detailed top view of the user interface of ;

[0023] FIG. 13 depicts the sixth state Figure 6 Yet another detailed top view of the user interface of ;

[0024] Figure 14 Depicted in the seventh state Figure 6 Yet another detailed top view of the user interface of ;

[0025] Figure 15 Depicted in the eighth state Figure 6 Yet another detailed top view of the user interface of ;

[0026] Figure 16 Depicted in the Ninth State Figure 6Yet another detailed top view of the user interface of ; and

[0027] Figure 17 Depicted in the tenth state Figure 6 Yet another detailed top view of the user interface of .

[0028] The accompanying drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways (including those not necessarily depicted in the drawings). The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it should be understood that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0029] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. Through the following description, other examples, features, aspects, embodiments and advantages of the present invention will become apparent to those skilled in the art. As an example, the following description is intended to be one of the best modes for implementing the present invention. As will be appreciated, the present invention can have other different and obvious aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be regarded as illustrative and non-restrictive in nature.

[0030] 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 so that all tissue samples collected during a given biopsy procedure are placed in a single tissue sample basket. In some other cases, tissue samples are collected into a tissue sample holder having 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 conclusion of the biopsy procedure, such a tray or strip can be removed from the tissue sample holder or otherwise separated.

[0031] Regardless of the structure in which the tissue sample is stored, the tissue sample can be collected using a biopsy device under the guidance of various imaging modalities, such as ultrasound image guidance, stereotactic (X-ray) guidance, MRI guidance, positron emission mammography ("PEM") guidance, breast-specific gamma imaging ("BSGI") guidance, or other guidance. Each procedure has its own approach based on the form of imaging guidance used.

[0032] Depending on the context, both vacuum-assisted and core needle biopsy devices may have various advantages over the other. For example, one advantage of a vacuum-assisted biopsy device is that the vacuum assistance allows for the removal of multiple tissue samples using a single insertion. However, while a core needle biopsy device lacks this feature, there is still a need for the use of a core needle biopsy device. For example, a core needle biopsy device is typically able to have a smaller needle relative to a core needle biopsy device, thereby reducing patient anxiety and improving the ability of the needle to penetrate the lesion. Therefore, in some cases, it may be desirable to incorporate the multiple sample removal feature of a vacuum-assisted biopsy device into a core needle biopsy device to achieve the benefits present in both types of biopsy devices.

[0033] A desirable feature of the devices described herein is a core needle biopsy device that allows for a single insertion of multiple samples using a core needle-type device. To facilitate this functionality, the biopsy device also includes a tissue sample holder having one or more features to facilitate collection of a severed tissue sample from notches, recesses, holes, and / or other sample collection features.

[0034] I. Exemplary Core Needle Biopsy Device with Multiple Sample Collection

[0035] Figure 1 An exemplary core needle biopsy device (10) for use in 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 an outer shell (14) and a user interface (300) disposed on the outer shell (14). As will be described in more detail below, the outer shell (14) encloses various components of the biopsy device (10). As will be described in more detail below, such components can be activated or otherwise controlled by the user interface (300) to drive the needle assembly (20) in a cutting cycle and a tissue collection cycle. To this end, the outer shell (14) of this example is sized and shaped to be grasped by an operator using a single hand. Similarly, the user interface (300) is positioned to be suitable for actuation by a single hand. Although not shown, it should be understood that in some examples, the outer shell (14) can include multiple parts, such that each part is interconnected to form the outer shell (14). For example, in some instances, outer housing (14) may be formed from a combination of a disposable probe and a reusable holster.

[0036] A. Exemplary Needle Assemblies

[0037] Figure 2 and Figure 3 The needle assembly (20) is shown in greater detail. Figure 2As seen in FIG, the needle assembly (20) includes an elongated piercer (22) and an elongated cutter (40). As will be described in more detail below, the piercer (22) is generally movable relative to the cutter (40) to pierce tissue and collect a tissue sample, while the cutter (40) is generally movable relative to the piercer (22) to sever the tissue sample. The piercer (22) includes a generally cylindrical rod having a sharp distal tip (24) and a notch (26) disposed adjacent the distal tip (24). As will be described in more detail below, the distal tip (24) is generally configured to penetrate the patient's tissue. As will be described in more detail below, the notch (26) is generally configured to receive tissue therein so that the tissue sample can be collected within the notch (26) after it is severed by the cutter (40).

[0038] The end portion (30) is disposed on the proximal end of the piercer (22). The end portion (30) of the present embodiment is overmolded onto the proximal end of the piercer (22) and is generally configured to enhance the maneuverability of the piercer (22). Specifically, the end portion (30) includes a receiving feature (32) in the form of a cylindrical recess or notch. The receiving feature (32) is configured to receive a portion of the piercer drive assembly (300). As will be described in more detail below, this allows the piercer drive assembly (300) to drive the movement of the piercer (22) through a predetermined movement sequence.

[0039] The cutter (40) comprises a generally hollow cylindrical tube configured to receive the piercer (22) therein. The cutter (40) comprises an open distal end (42), a cannula portion (44), and a tip portion (50). The open distal end (42) is configured to allow at least a portion of the piercer (22) to protrude from the cutter (40) when the piercer (22) moves relative to the cutter (40). As will be described in greater detail below, this configuration allows the needle assembly (20) to move during a cutting cycle and a tissue collection cycle by allowing the notch (26) of the piercer (22) to move relative to the distal end (42) of the cutter (40).

[0040] The open distal end (42) of the present example includes a tapered edge (43). The tapered edge (43) is generally configured to cut through tissue to separate a tissue sample when the cutter (40) moves relative to the notch (26) of the piercer (22). Therefore, it should be understood that the tapered edge (43) is generally configured to act as a blade. Although the present example is described and shown as using a tapered configuration, it should be understood that various alternative configurations can be used in other examples. For example, in some examples, the tapered edge (43) includes a plurality of serrations as a supplement or alternative to the tapered shape shown. In yet other examples, as will be understood by those of ordinary skill in the art in view of the teachings herein, the tapered edge (43) can include any other additional or alternative cutting surface.

[0041] The cannula portion (44) of the cutter (40) extends proximally from the distal end (42) through the end portion (50) so that the puncture device (22) can be received together with the proximal side of the cutter (40). Unlike the end portion (30) of the puncture device (22), the end portion (50) of the cutter (40) is generally elongated so that the end portion (50) can accommodate additional features that will be described in more detail below. In this example, the end portion (50) can extend distally relative to the outer shell (14) to allow a portion of the end portion (50) to be accessed by the operator for tissue sample collection purposes. A merely illustrative example of a tissue collection mechanism associated with the end portion (50) will be described in more detail below.

[0042] The distal end portion (50) of the cutter (40) includes a receiving feature (52) and a tissue collection feature (54). Like the receiving feature (32) of the piercer (22), the receiving feature (52) of the distal end portion (50) includes a cylindrical recess, slot, or other receiving feature configured to receive at least a portion of the cutter drive assembly (200). As will be described in greater 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) through a predetermined movement sequence.

[0043] The tissue collection feature (54) is disposed distally relative to the receiving feature (52). The tissue collection feature (54) generally defines an elongated slot open to the cannula portion (44) of the cutter (40). Thus, the cannula portion (44) includes a notch portion (46) adjacent to or otherwise defining the tissue collection feature (54). Thus, it should be understood that the tissue collection feature (54) is in communication with the hollow interior or lumen defined by the cannula portion (44). As will be described in greater detail below, this relationship between the tissue collection feature (54) and the cannula portion (44) allows an operator to remove a tissue sample from the cutter (40) as the tissue sample is collected by the puncture device (22).

[0044] The end portion (50) further includes a driver (53) extending outwardly from an outer surface of the end portion (50). The driver (53) generally comprises a square or rectangular shape. As will be described in more detail below, the driver (53) is generally configured to manipulate certain features associated with the various tissue collection features described herein. Although the driver (53) of this example is shown in conjunction with the end portion (50), it should be understood that in other examples, the driver (53) can be associated with other components or omitted entirely.

[0045] Figure 3The piercer (22) is shown disposed within the cutter (40). As can be seen, the cutter (40) is generally configured to receive the piercer (22) such that the piercer (22) is coaxial with the cutter (40). In addition, the piercer (22) is generally movable relative to the open distal end (42) of the cutter (40). It should be understood that in some cases, the piercer (22) moves relative to the cutter (40) while the cutter (40) remains stationary. In other cases, the cutter (40) moves relative to the piercer (22) while the piercer (22) remains stationary. In either case, it should be understood that the piercer (22) and the cutter (40) are generally configured such that the notch (26) of the piercer (22) moves into and out of the cutter (40), such that the notch (26) can be disposed distally or proximally relative to the open distal end (42) of the cutter (40). As will be described in greater detail below, this configuration allows piercer (22) and cutter (40) to cooperate to pierce tissue, cut a tissue sample, and retrieve the tissue sample for collection by an operator via tissue collection feature (54).

[0046] B. Exemplary Drive Assemblies

[0047] Figure 4 The internal components of the body (12) of the biopsy device (10) are shown with the outer housing (14) removed. As can be seen, inside the outer housing (14), the body (12) includes a drive assembly (100). The drive assembly (100) is generally configured to engage the needle assembly (20) to drive the puncture device (22) and the cutter (40) through a predetermined movement sequence, thereby piercing tissue and collecting multiple tissue samples by a single insertion of the needle assembly (20) into the patient's body. Although not shown, it should be understood that the outer housing (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 housing (14).

[0048] The drive assembly (100) includes a cutter drive assembly (120), a piercer drive assembly (130), and a firing assembly (140). Typically, the firing assembly (140) is configured to strike (or fire) and fire the cutter (40) and the piercer (22) in a predetermined sequence to cut off a tissue sample. To collect the cut tissue sample, the cutter drive assembly (120) is typically configured to retract the cutter (40). Similarly, the piercer drive assembly (130) is typically configured to retract the piercer (22). It should be understood that in some instances, the cutter drive assembly (120) and the piercer drive assembly (130) can both be configured to rotate the cutter (40) and / or the piercer (22), respectively.

[0049] In this example, the firing assembly (140) is generally schematically shown. Therefore, it should be understood that in some instances, the firing assembly (140) can take various forms with a combination of a gear, a rack, a lead screw, a bracket, a spring, etc. Such components of the firing assembly (140) can generally be configured to quickly fire the cutter (40) and the puncture device (22) in a predetermined sequence to pierce the tissue. For example, in some instances, the firing assembly (140) is configured to quickly fire the puncture device (22) distally to pierce the tissue. The firing assembly (140) is also configured to quickly fire the cutter (40) distally. The firing of the cutter (40) can be delayed relative to the puncture device (22) or slower relative to the puncture device (22) so that the notch (26) can be exposed relative to the cutter (40). This sequence can allow tissue to enter the notch (26), thereby allowing the tissue to be cut off by subsequent movement of the cutter (40). Additionally, it should be understood that firing assembly (140) may include other components and / or features to allow for cocking of cutter (40) and / or piercer (22) prior to firing.

[0050] The cutter drive assembly (120) is generally configured to translate and / or rotate the cutter (40) independently of the puncture device (22) or in unison with the puncture device. For example, the cutter drive assembly (120) may include various combinations of gears, racks, screws, brackets, springs, etc. to drive the cutter (40) through a predetermined sequence. In one such sequence, the cutter (40) is retracted proximally relative to the outer shell (14) to prepare the cutter (40) for a tissue collection sequence described in more detail below. Additionally, 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.

[0051] The piercer drive assembly (130) is generally configured to translate and / or rotate the piercer (22) independently of the cutter (40) or in unison with the cutter (40). For example, the piercer drive assembly (120) may include various combinations of gears, racks, screws, brackets, springs, etc. to drive the piercer (22) through a predetermined sequence. In one such sequence, after severing the tissue sample to retract the tissue sample proximally toward the outer housing (14), the piercer (22) is retracted proximally relative to the cutter (40). Once the piercer (22) is retracted, the tissue sample can be extracted for collection in a tissue collection sequence described in more detail below.

[0052] In the present example, the drive assembly (100) is powered by one or more motors (150, 152). Specifically, the drive assembly (100) of the present example includes a drive motor (150) and a firing motor (152). The drive motor (150) of the present example is connected to both the cutter drive assembly (120) and the piercer drive assembly (130) to provide rotational motion to the two assemblies, which ultimately drives the translation and / or rotation of both the cutter (40) and the piercer (22). Similarly, the firing motor (152) is connected to the firing assembly (140) to drive the firing and / or striking of the cutter (40) and the piercer (22). Although the drive assembly (100) of the present 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, motors (150, 152) may be configured to drive cutter drive assembly (120), piercer drive assembly (130), and / or firing assembly (140) in various combinations.

[0053] Although the cutter drive assembly (120), piercer drive assembly (130), and firing assembly (140) of the present 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), piercer drive assembly (130), and firing assembly (140) can be combined into a single drive assembly or multiple drive assemblies to drive the movement of the cutter (40) and piercer (22) according to the sequence described herein. In some examples, the cutter drive assembly (120), piercer drive assembly (130), and firing assembly (140) can be constructed according to at least some of the teachings of U.S. Serial No. 16 / 381,573, filed on 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.

[0054] C. Exemplary Tissue Sample Holders

[0055] like Figure 5As shown in FIG, the biopsy device (10) of the present example includes a tissue sample holder (200) for collecting multiple samples during a single insertion of a needle assembly (20). The tissue sample holder (200) of the present example includes an extraction mechanism (240) disposed within a cylindrical outer shell (210). The tissue sample holder (200) is generally configured to collect multiple tissue samples from the tissue collection feature (54) of the needle assembly (20) using rotation of the extraction mechanism (240) during a biopsy procedure. As will be described in more detail below, the tissue sample holder (200) is generally configured to collect and store six tissue samples, but in other examples, any suitable number may be collected and stored.

[0056] The outer housing (210) includes a cylindrical body (212) defining a sample chamber (213), an open distal end (214), a closed proximal end (not shown), and a needle receiving portion (216) extending between the open distal end (214) and the closed proximal end. In the present example, the outer housing (210) is generally transparent to enhance visibility of the tissue sample during sample collection. Although the outer housing (210) of the present example is shown as having an open distal end (214), it should be understood that in other examples, the open distal end (214) can be closed or capped to seal the sample chamber (213) of the outer housing (210) from the environment.

[0057] The needle receiving portion (216) is generally configured as a semi-cylindrical recess or protrusion in the otherwise cylindrical shape of the outer shell (210). The size of the needle receiving portion (216) generally corresponds to the size and shape of the needle assembly (20). Thus, the needle receiving portion (216) generally defines a recess or recessed area in which the needle assembly (20) can be placed.

[0058] The extraction mechanism (240) includes a shaft (242) and a plurality of scrapers (250) arranged about the shaft (242). The shaft (242) is generally rotatable to rotate the scrapers (250) within the outer housing (210) to collect and store tissue samples as each tissue sample is collected by the needle assembly (20). The proximal end of the shaft (242) includes a keying portion (244) configured to communicate with a manual or motorized driver to rotate the shaft (242).

[0059] The distal end of the shaft (242) includes a plurality of couplers (246) extending outwardly from the outer surface of the shaft (242). Each coupler (246) is generally configured to receive a corresponding scraper blade (250), thereby providing a secure and secure base for each scraper blade (250). Each coupler (246) of the present example 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 coupler (246) may extend axially along the length of the shaft (242) to a length approximately equal to the length of each scraper blade (250).

[0060] Each scraper (250) defines a generally curved or wavy surface at the outer end. In the current curved shape, there is a concavity oriented in the direction of rotation of the shaft (242). The specific shape of each scraper (250) is generally configured to engage a tissue sample atraumatically to remove the tissue sample from the tissue collection feature (54) and place it in the sample chamber (213) of the outer shell (210). Although each scraper (250) of this example has a curved shape, it should be understood that various other shapes can be used in other examples, such as circular, square, triangular, etc. In addition, although each scraper (250) is shown as having a generally consistent longitudinal shape, it should be understood that in some examples, the shape can change as the scraper (250) extends axially.

[0061] The scraper (250) is typically formed of a flexible but partially elastic material (e.g., rubber or an elastomer). For example, the scraper (250) is typically flexible enough to bend around the interface between the outer shell (210) and the needle assembly (20). When each scraper (250) engages with the tissue, this flexibility can typically reduce trauma while also promoting complete 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 according to a durometer. Although a variety of suitable durometers can be used, a suitable durometer range is 30 to 80.

[0062] Each coupler (246) and scraper (250) is typically arranged in an angularly spaced manner around the shaft (242) such that the scrapers (250) are spaced apart from each other by equal angular distances. This typically causes the coupler (246) and scraper (250) to collectively form a starburst pattern. This configuration may require dividing the sample chamber (213) into six equal segments for storage of tissue samples. However, it will be appreciated that in other examples, other suitable spacings, including unequal spacings, may be used.

[0063] Although not shown, it should be understood that tissue sample holder (200) can have a variety of different configurations for collecting one or more tissue samples. By way of example only, in some instances, tissue sample holster (200) can be configured in accordance with any one or more of the teachings of U.S. Serial No. 62 / 916,277, filed October 17, 2019, entitled “Sample Management for Core Needle Biopsy Device,” the disclosure of which is incorporated herein by reference.

[0064] In use, after the cutter (40) and piercer (22) have been driven by the drive assembly (100) to sever and collect a tissue sample, collection of the tissue sample can begin using the tissue sample holder (200). Specifically, once the tissue sample has been severed, the notch (26) of the piercer (22) is used to transfer the tissue sample to the tissue collection feature (54).

[0065] 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). Thus, to collect a tissue sample, the shaft (242) can be rotated to rotate each scraper (250) within the sample chamber (213) to sweep a 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 selected scraper (250) engages the tissue sample to push the tissue sample out of the tissue collection feature (54).

[0066] Once selected scraper (250) sweeps notch (26), the rotation of shaft can continue. Continuing to rotate causes tissue sample to move around the inside of outer shell (210), to allow storage of tissue sample and to prepare needle assembly (20) to collect more tissue sample. At this stage, the rotation of shaft (242) can continue in coordination with the sequence motion of cutter (40) and puncture device (22), to cut off and collect another tissue sample. Or, the rotation of shaft (242) can temporarily stop to allow cutter (40) and puncture device (22) to reposition and collect another tissue sample. In any case, once another tissue sample is collected, the rotation of shaft (242) can be used to sweep another scraper (250) across 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 has collected the desired number of tissue samples.

[0067] II. Exemplary User Interfaces

[0068] In some instances, it may be desirable to incorporate certain user interface features into the biopsy device (10) that provide real-time feedback and simplified interaction for the operator. For example, as described above, the drive assembly (100) and the firing assembly (140) are configured to drive the needle assembly (20) in a predetermined motion sequence to collect one or more tissue samples. In some instances, the sequence can be controlled at various points during this motion sequence. However, such control may result in the addition of multiple buttons or other operator input features. In some instances, such a configuration may be undesirable because multiple operator input features may cause operator confusion. Therefore, it may be desirable to limit the specific number of operator input features while still providing some control. In addition, due to limited operator feedback during the motion sequence, the predetermined sequence described above may also cause operator confusion. Therefore, in some instances, it may be desirable to include various indicators to provide real-time feedback regarding the status of the biopsy device (10). Although an exemplary user interface (300) is described below, it should be understood that various alternative user interfaces may be used without departing from the teachings contained herein.

[0069] Figure 6 An exemplary user interface (300) that can be readily incorporated into the biopsy device (10) described above is shown. The user interface (300) of this example is generally configured to control the operation of the drive assembly (100) and the firing assembly (140) to collect one or more tissue samples using the needle assembly (20). Additionally, the user interface (300) is generally configured to provide real-time feedback to the operator regarding the status of the biopsy device (10) as the drive assembly (100) and the firing assembly (140) move the needle assembly (20) through various operational states.

[0070] The user interface (300) includes a button or actuator (310), a power indicator (314), and a series of indicators (320, 322, 324) related to the operating state of the biopsy device (10). The actuator (310) of the present example is in communication with the drive assembly (100) and / or the firing assembly (140) through direct electrical communication, direct mechanical communication, or some combination thereof. Alternatively, in some examples, the actuator (310) is in communication with a controller or other electronic circuit configured to communicate with the drive assembly (100) and / or the firing assembly (140). Regardless, it should be understood that the actuator (310) is generally configured to control the operation of the drive assembly (100) and / or the firing assembly (140). As will be described in greater detail below, this may generally involve an operator depressing or otherwise manipulating actuator (310) to cause drive assembly (100) and / or firing assembly (140) to move needle assembly (20) through various predetermined sequences of operations.

[0071] The power indicator (314) is located distally of the actuator (310) and is generally configured to provide an indication of the power status of the biopsy device (10). Specifically, the power indicator (314) of this example includes a row of multiple light emitting diodes (LEDs) configured to illuminate in a predetermined sequence. The biopsy device (10) of this example is battery (160) operated. Therefore, the sequential illumination of the LEDs of the power indicator (314) is configured to provide an indication of the remaining power in the battery (160). Although the power indicator (314) of this example includes four LEDs, it should be understood that any suitable number of LEDs may be used in other examples.

[0072] The series of indicators (320, 322, 324) includes a proximal indicator (320), an intermediate indicator (322), and a distal indicator (324). Typically, each indicator (320, 322, 324) is configured to independently transition through multiple states to convey certain status information related to the biopsy device (10). For example, in the present example, each indicator (320, 322, 324) is an LED configured to transition between an off state (not emitting light), a continuously on state (emitting light), and a flashing on state (periodically emitting light). However, it should be understood that in other examples, the specific state used can vary. For example, in some examples, the indicators (320, 322, 324) are configured to emit a variety of different colors, and these colors can be used to convey certain status information related to the biopsy device (10). In other examples, the illumination of indicators (320, 322, 324) may be controlled such that each indicator (320, 322, 324) flashes at a variable rate to convey certain status information related to biopsy device (10). Of course, various alternative statuses may be used as will be apparent to one of ordinary skill in the art in view of the teachings herein.

[0073] As described above, the indicators (320, 322, 324) are configured as three separate LEDs. However, it should be understood that in other examples, alternative configurations may be used. For example, in some examples, the indicators (320, 322, 324) may be formed from a single LED screen that is graphically divided into multiple segments. These segments may then be illuminated similarly to the lighting described above. Alternatively, the lighting described above may be replaced with symbols, graphics, numbers, emoticons, etc. to provide the same status information in an alternative manner.

[0074] Figures 7 to 15An exemplary operational sequence is shown that can be used to communicate the operational status of the biopsy device (10) to the operator via indicators (320, 322, 324). In the initial state, the outer housing (14) is separated so that the probe is separated from the holster. To begin the sequence, as shown in box (400), the probe is attached to the holster to fully form the outer housing (14). Once the probe is connected to the holster as shown in box (400), the initialization sequence automatically begins as shown in box (410). When the biopsy device (10) performs the initialization sequence, the proximal indicator (320), the intermediate indicator (322), and the distal indicator (324) all flash or blink synchronously as shown in box (412) to communicate that the biopsy device (10) is performing the initialization sequence. The status of each indicator (320, 322, 324) as shown in box (412) is displayed in the Figure 8 It is shown graphically in .

[0075] After initialization is complete, the biopsy device (10) automatically stops. Simultaneously, the proximal indicator (320), the intermediate indicator (322), and the distal indicator (324) all switch from flashing or blinking to continuously illuminating or otherwise continuously brightening. This state of the indicators (320, 322, 324) is Figure 7 Schematically shown in the box (422) and in Figure 9 It is shown graphically in .

[0076] When all indicators light up continuously (320, 322, 324), as Figure 7 Schematically shown in the box (422) and in Figure 9 , the operator can understand that initialization has been completed. At this stage, the operator can press or otherwise actuate the actuator (310) to begin firing the needle assembly (20). After pressing the actuator (310), the drive assembly (100) and / or the firing assembly (140) can be activated to automatically fire or trigger both the piercer (22) and the cutter (40). During this sequence, the distal indicator (320) and the intermediate indicator (322) can be switched to an off state, as shown in FIG. Figure 7 At the same time, the proximal indicator (324) can be switched to a flashing or blinking state, also as shown in the box (434). Figure 7 As shown in the box (434). Figure 7 Schematically shown in the box (434) and in Figure 10 The combination of indicators ( 320 , 322 , 324 ) shown graphically in , may convey that firing of biopsy device ( 10 ) is in progress.

[0077] exist Figure 7 Schematically shown in the box (434) and in Figure 10The status of the indicators (320, 322, 324) shown graphically in FIG can continue for the duration of the entire firing sequence. Once the needle assembly (20) is Figure 7 The indicator (320, 322, 324) can be switched to the Figure 7 Schematically shown in the box (438) and in Figure 11 . In this state, both the proximal indicator (320) and the intermediate indicator (322) are switched to an off state. Simultaneously, the distal indicator (324) is switched to a continuously on or continuously illuminated state. In this state, the indicators (320, 322, 324) communicate to the operator that the firing sequence is complete and the biopsy device (10) is ready for sample collection.

[0078] Once Figure 7 Schematically shown in the box (438) and in Figure 11 Once indicators (320, 322, 324) are activated, the operator can then proceed to position the biopsy device (10) to collect a tissue sample. In one application, this process can include marking tissue, injecting a therapeutic agent into a patient, securing tissue, or otherwise preparing for insertion of the needle assembly (20). Once all required preparations are complete, the operator can position the distal end of the needle assembly (20) adjacent to the patient's target tissue. Optionally, this can also include inserting a portion of the needle assembly (20) into the patient.

[0079] Once the needle assembly (20) is positioned as desired, it can be positioned as follows: Figure 7 The actuator (310) is pressed as shown in the box (440) to initiate the firing. At this stage, the drive assembly (100) and / or the firing assembly (140) can be activated to fire the puncture device (22) distally through the patient's tissue. Figure 7 As schematically shown in the box (444) of FIG. 12 and graphically shown in FIG. 12 , once the actuator (310) is depressed, the indicators (320, 322, 324) are activated for the duration of the piercer (22) firing. Specifically, the proximal indicator (320) can be turned off, the intermediate indicator (322) can be switched to a flashing or blinking state, and the distal indicator (324) can be switched to an illuminated or continuously on state. Thus, it should be understood that, as Figure 7 The states of indicators (320, 322, 324) schematically shown in box (444) and graphically shown in Figure 12 correspond to the process of firing the piercer (22).

[0080] Once the piercer (22) has been fired as shown in box (446), the indicators (320, 322, 324) automatically switch to the Figure 713. As can be seen, in this state, the proximal indicator (320) can be turned off, while the intermediate indicator (322) and the distal indicator (324) can be switched to an illuminated or continuously on state. Therefore, it should be understood that, as Figure 7 The status of indicators (320, 322, 324), schematically shown in box (448) and graphically shown in FIG. 13, communicates to the operator that the firing of the piercer (22) is complete.

[0081] Once the piercer (22) has been fired, the operator can then begin collecting tissue samples. To begin collecting tissue samples, the operator can press the actuator (310), such as Figure 7 As shown in the box (450) of . Once the actuator (310) is pressed, the drive assembly (100) and / or the firing assembly (140) can be activated to fire the cutter (40) distally. This movement causes the distal end (42) of the cutter (40) to sever the tissue sample into the notch (26) of the puncture device. In some applications, severing of the tissue sample can be further facilitated by the natural prolapse of the tissue into the notch (26) before or during the advancement of the cutter (40). Similarly, the indicators (320, 322, 324) automatically switch to the positions shown in FIG. Figure 7 Schematically shown in the box (454) and in Figure 14 As can be seen, in this state, the proximal indicator (320) can be switched to a flashing or blinking state, while the intermediate indicator (322) and distal indicator (324) can be switched to an illuminated or continuously on state. Figure 7 Schematically shown in the box (454) and in Figure 14 The status of the indicators (320, 322, 324) shown in the figure conveys to the operator that the cutter (40) is firing and the sample collection process is in progress. This state can continue until the sample collection is completed.

[0082] After the cutter (40) has been fired, sample collection is continued by activating the drive assembly (100) and / or the firing assembly (140) to retract the puncture device (22) proximally while the cutter (40) remains in place. This proximal retraction of the puncture device (22) pulls the severed tissue sample proximally to the tissue sample holder (200), where the severed tissue sample can be collected by the tissue sample holder (200) or any other tissue sample collection device using the above-described process. For example, the shaft (242) can be rotated using the keying portion (244) to rotate the scraper (250) to extract the tissue sample from the notch (26). Once the tissue sample is extracted from the notch (26), the puncture device (22) can be advanced distally to return to its original position prior to firing as shown in block (430) or after initialization as shown in block (420).

[0083] In such Figure 7 After the sample collection is completed as shown in the box (456), the indicators (320, 322, 324) automatically switch to Figure 7 Schematically shown in the box (458) and in Figure 15 As can be seen, in this state, the proximal indicator (320), the intermediate indicator (322) and the distal indicator (324) can all be turned off. Therefore, it should be understood that if Figure 7 Schematically shown in the box (458) and in Figure 15 The status of indicators (320, 322, 324) graphically shown in Figure 3 communicates to the operator that the cutter (40) firing and sample collection process is complete.

[0084] Once the sample collection has been completed, the biopsy device (10) is ready to collect additional samples, as shown in box (460). At this stage, the biopsy device (10) can be opened by pressing the actuator (310) again and returning to the Figure 7 The biopsy procedure may be performed by moving the needle assembly (20) to the next frame (430) to optionally collect more additional samples. In some instances, this may include the intermediate step of manipulating the shaft (242) of the tissue sample holder (200) to reposition any previously collected tissue samples as needed. The above process is then repeated again, starting at frame (430). Alternatively, if the desired number of samples has been collected, the needle assembly (20) may be removed from the patient and the biopsy procedure completed.

[0085] Figure 16 and Figure 17 Some alternative states of indicators (320, 322, 324) that may be used in addition to the states described above are shown. For example, Figure 16The state of indicators (320, 322, 324) is shown, which may correspond to a state in which the probe is detached from the holster of the biopsy device (10). In this state, all indicators (320, 322, 324) are set to an off state. In addition, the power indicator (314) is also set to an off state. In some applications, this state may be desired to conserve power when the biopsy device (10) is not in use.

[0086] Figure 17 Show Figure 16 In this state, the probe can still be removed from the holster. However, it may still be desirable for the operator to obtain input from the power indicator (314). To this end, the operator can use the power indicator (314) when the holster is detached from the probe and the user interface is in Figure 16 The actuator (310) is pressed in the state shown. Once the actuator (310) is pressed, the power indicator (314) can be activated to communicate to the operator the power level remaining in the holster of the biopsy device (10). At the same time, the indicators (320, 322, 324) remain in the off state. After the actuator (310) is pressed, the power indicator (314) can remain on for a predetermined period of time. Alternatively, the power indicator (314) can remain on indefinitely until the actuator (310) is pressed again or the probe is attached to the holster.

[0087] III. Exemplary Combinations

[0088] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be filed at any time in this application or a subsequent application hereof. No disclaimer. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, no aspect or feature mentioned below should be considered critical unless expressly indicated as such by the inventor or successor in interest at a later date. If any claim is filed in this application or a subsequent submission related to this application that includes additional features in addition to the features mentioned below, it should not be assumed that those additional features have been added for any reason related to patentability.

[0089] Example 1

[0090] A core needle biopsy device comprises: a needle assembly, wherein the needle assembly includes a piercer and a hollow cutter, wherein the piercer includes a sharp distal tip and a notch proximate the distal tip, wherein the piercer is slidably disposed within the cutter to sever a tissue sample into the notch of the piercer; a drive assembly configured to selectively move the piercer and the cutter; and a user interface having a plurality of indicators, wherein each of the plurality of indicators is configured to independently transition between a plurality of predetermined states to collectively define a plurality of predetermined state sequences indicating movement of the piercer and the cutter via a drive mechanism.

[0091] Example 2

[0092] The core needle biopsy device of Example 1, wherein the user interface includes three indicators.

[0093] Example 3

[0094] The core needle biopsy device of examples 1 or 2, wherein each of the plurality of indicators is configured to switch between a continuously on state, a flashing state, and an off state.

[0095] Example 4

[0096] The core needle biopsy device of any one or more of Examples 2-3, wherein the plurality of indicators are arranged along axes that are parallel relative to the puncture.

[0097] Example 5

[0098] A core needle biopsy device as described in any one or more of Examples 1 to 4, wherein the drive assembly is configured to move the puncture and the cutter through a predetermined initialization sequence, wherein each of the plurality of indicators is configured to transition to a first predetermined state during the initialization sequence.

[0099] Example 6

[0100] The core needle biopsy device of example 5, wherein each indicator of the plurality of indicators is configured to transition to a second predetermined state after completion of the initialization sequence.

[0101] Example 7

[0102] A core needle biopsy device as described in any one or more of Examples 1 to 4, wherein the drive assembly is configured to move the piercer and the cutter through a predetermined firing sequence, wherein each of the plurality of indicators is configured to transition to a first predetermined state during the firing sequence.

[0103] Example 8

[0104] The core needle biopsy device of example 7, wherein each indicator of the plurality of indicators is configured to transition to a second predetermined state after completion of the firing sequence.

[0105] Example 9

[0106] A core needle biopsy device as described in any one or more of Examples 1 to 4, wherein the drive assembly is configured to move the puncture and the cutter through a predetermined sample collection sequence, and wherein each of the plurality of indicators is configured to transition to a first predetermined state during the firing sequence.

[0107] Example 10

[0108] The core needle biopsy device of Example 9, wherein each indicator of the plurality of indicators is configured to transition to a second predetermined state after the sample collection sequence is completed.

[0109] Example 11

[0110] A core needle biopsy device as described in Example 9, wherein the sample collection sequence includes firing the puncture tool, the cutter, or firing the puncture tool and the cutter together.

[0111] Example 12

[0112] A user interface incorporated into a core needle biopsy device, wherein the user interface includes: an actuator that is connected to one or more features of the biopsy device; and an indicator array, wherein the indicator array includes a first indicator, a second indicator, and a third indicator, wherein each of the first indicator, the second indicator, and the third indicator is configured to transition between a first state, a second state, and a third state to define a plurality of predetermined state sequences corresponding to operating states of the core needle biopsy device.

[0113] Example 13

[0114] The user interface of example 12, wherein the plurality of state sequences comprises an initialization state sequence, a firing state sequence, a first firing sequence, and a second firing sequence, wherein each state sequence is unique relative to each other state sequence.

[0115] Example 14

[0116] A user interface as described in Example 12 or 13, wherein each of the first indicator, the second indicator and the third indicator is configured to automatically transition between the first state, the second state and the third state in response to operator interaction with the actuator.

[0117] Example 15

[0118] A user interface as described in any one or more of Examples 12 to 14, wherein each of the first indicator, the second indicator, and the third indicator is configured to automatically transition between the first state, the second state, and the third state in response to operation of the biopsy device.

[0119] Example 16

[0120] A user interface as described in any one or more of Examples 12 to 15, wherein the first state corresponds to a given indicator being off, wherein the second state corresponds to a given indicator being continuously on, and wherein the third state corresponds to a given indicator being intermittently on.

[0121] Example 17

[0122] The user interface of any one or more of Examples 12 to 16 further comprises a power indicator, wherein the power indicator is configured to communicate the power status of the biopsy device to an operator.

[0123] Example 18

[0124] A user interface as described in any one or more of Examples 12 to 17, wherein the indicator array includes a single LED screen, wherein each of the first indicator, the second indicator, and the third indicator is formed by a segment of the LED screen.

[0125] Example 19

[0126] The user interface of any one or more of Examples 12 to 17, wherein each of the first indicator, the second indicator, and the third indicator is an LED.

[0127] Example 20

[0128] A method for collecting a tissue sample using a biopsy device, the method comprising: firing the biopsy device by proximally retracting a puncture and a cutter relative to a probe and a holster of the biopsy device; indicating the firing step using an indicator array by adjusting a plurality of indicators of the indicator array to a predetermined first state sequence; firing one or more of the puncture or the cutter; indicating the firing step by adjusting the plurality of indicators of the indicator array to a predetermined second state sequence different from the first state sequence; collecting a tissue sample using the puncture and the cutter; and indicating the collecting step by adjusting the plurality of indicators of the indicator array to a predetermined third state sequence different from the first and second state sequences.

[0129] Example 21

[0130] A method as described in Example 20, wherein the firing step includes firing the piercer, and wherein the step of collecting the tissue sample includes firing the cutter.

[0131] Example 22

[0132] The method of Example 20 or 21 further includes the steps of: removing the probe from the holster; and indicating that the probe is removed from the holster by adjusting the multiple indicators of the indicator array to a predetermined third state sequence different from the first, second and third state sequences.

[0133] Example 23

[0134] The method of example 22 further comprising the step of indicating a power level associated with the holster using a power indicator by pressing a button associated with the indicator array.

[0135] While various embodiments of the present invention have been shown and described, other adaptations of the methods and systems described herein may be accomplished by appropriate modifications by those skilled in the art without departing from the scope of the present 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 required. Accordingly, the scope of the present invention should be considered in light of the appended claims and should not be construed as being limited to the details of the structures and operations shown and described in the specification and drawings.

[0136] It should be understood that any version of the apparatus described herein may include various other features in addition to or in place of those described above. By way of example only, any apparatus 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 herein can be readily applied to any apparatus described in any other reference cited herein, such that the teachings herein can be readily combined with the teachings of any reference cited herein in a variety of ways. Other types of apparatus into which the teachings herein may be incorporated will be readily apparent to those of ordinary skill in the art.

[0137] It is understood that any patent, publication, or other public material that is incorporated herein by reference, in whole or in part, is hereby incorporated only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public material set forth in the present disclosure. Accordingly, and to the extent necessary, the disclosure as expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is incorporated herein by reference but conflicts with existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public material.

Claims

1. A core needle biopsy device comprising: (a) a needle assembly comprising a piercer and a hollow cutter, the piercer comprising a sharp distal tip and a notch proximate the distal tip, the piercer being slidably disposed within the cutter to sever a tissue sample into the notch of the piercer; wherein the distal portion of the cutter includes a receiving feature and a tissue collection feature, the tissue collection feature being disposed distally relative to the receiving feature, the tissue collection feature being in communication with the hollow interior of the cutter and the tissue sample being transferred to the tissue collection feature using the notch of the piercer; (b) a drive assembly configured to selectively move the piercer and the cutter; (c) a user interface having a plurality of indicators, each of the plurality of indicators being configured to independently transition between a plurality of predetermined states to collectively define a plurality of predetermined state sequences indicative of movement of the piercer and the cutter via a drive mechanism; as well as (d) a tissue sample holder for collecting a plurality of tissue samples, wherein the tissue sample holder comprises an extraction mechanism disposed within a cylindrical outer shell; the extraction mechanism comprises a shaft and a scraper, the shaft being rotatable to rotate the scraper within the outer shell to collect the tissue samples; And as the scraper blade sweeps across the notch, the scraper blade engages the tissue sample to push the tissue sample out of the tissue collection feature.

2. The core needle biopsy device of claim 1 , wherein the user interface comprises three indicators. 3 . The core needle biopsy device of claim 1 , wherein each of the plurality of indicators is configured to switch between a continuously on state, a flashing state, and an off state.

4. The core needle biopsy device of claim 1, wherein the plurality of indicators are arranged along an axis parallel to the puncture member.

5. The core needle biopsy device of claim 1 , the drive assembly being configured to move the piercer and the cutter through a predetermined initialization sequence, each of the plurality of indicators being configured to transition to a first predetermined state during the initialization sequence.

6. The core needle biopsy device of claim 5, each indicator of the plurality of indicators being configured to transition to a second predetermined state after completion of the initialization sequence.

7. The core needle biopsy device of claim 1 , the drive assembly being configured to move the piercer and the cutter through a predetermined firing sequence, each of the plurality of indicators being configured to transition to a first predetermined state during the firing sequence.

8. The core needle biopsy device of claim 7, each indicator of the plurality of indicators being configured to transition to a second predetermined state after completion of the firing sequence.

9. The core needle biopsy device of claim 1 , the drive assembly being configured to move the piercer and the cutter through a predetermined sample collection sequence, each of the plurality of indicators being configured to transition to a first predetermined state during the sample collection sequence.

10. The core needle biopsy device of claim 9, each indicator of the plurality of indicators being configured to transition to a second predetermined state after the sample collection sequence is complete.

11. The core needle biopsy device of claim 9, wherein the sample collection sequence comprises firing the puncture tool, the cutter, or both the puncture tool and the cutter.

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