WO2024091430A1 - Detection of calcification in a targeted breast biopsy tissue - Google Patents

Abstract

A biopsy device includes a tissue collection assembly and a sensor assembly. The tissue collection assembly includes a needle, a cutter movable relative to the needle, and a tissue sample holder. The cutter being in communication with the tissue sample holder to deposit one or more tissue samples into the tissue sample holder. The cutter being configured to transport the one or more tissue samples along a sampling axis. The sensor assembly including an emitter and a detector. The emitter and detector being positioned on opposing sides of the sampling axis. The emitter being configured to emit electromagnetic energy through a tissue sample of the one or more tissue samples and to the detector while the tissue sample is moving along the sampling axis.

Description

DETECTION OF CALCIFICATION IN A TARGETED BREAST BIOPSY TISSUE

PRIORITY

[0001] This application claims priority to U.S. Provisional Application Ser. No. 63/419,774, entitled “Detection of Calcification in a Targeted Breast Biopsy Tissue,” filed October 27, 2022, the disclosure of which is incorporated by reference herein.

BACKGROUND

[0002] Biopsy samples have been obtained in a variety of ways in various medical procedures using a variety of devices. Biopsy devices may be used under stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or otherwise. For instance, some biopsy devices may be fully operable by a user using a single hand, and with a single insertion, to capture one or more biopsy samples from a patient. In addition, some biopsy devices may be tethered to a vacuum module and/or control module, such as for communication of fluids (e.g., pressurized air, saline, atmospheric air, vacuum, etc.), for communication of power, and/or for communication of commands and the like. Other biopsy devices may be fully or at least partially operable without being tethered or otherwise connected with another device.

[0003] Examples of such biopsy devices and biopsy system components are disclosed in U.S. Pat. No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue,” issued June 18, 1996; U.S. Pat. No. 6,086,544, entitled “Control Apparatus for an Automated Surgical Biopsy Device,” issued July 11, 2000; U.S. Pat. No. 7,442,171, entitled “Remote Thumbwheel for a Surgical Biopsy Device,” issued October 8, 2008; U.S. Pat. No. 7,854,706, entitled “Clutch and Valving System for Tetherless Biopsy Device,” issued December 1, 2010; U.S. Pat. No. 7,938,786, entitled “Vacuum Timing Algorithm for Biopsy Device,” issued May 10, 2011; and U.S. Pat. No. 8,118,755, entitled “Biopsy Sample Storage,” issued February 21, 2012. The disclosure of each of the above-cited U.S. Patents is incorporated by reference herein. [0004] During collection of biopsy samples, the detection of the presence of calcifications in a given biopsy sample can be a useful indicator for a clinician. For instance, the presence of calcifications may indicate potentially cancerous tissue or otherwise indicate the need for additional investigation via pathology investigation. Thus, biopsy samples having calcifications may indicate that biopsy samples are being collected from a desired region of interest, while the absence of calcifications may indicate that biopsy samples are being collected from area of tissue outside the desired region of interest.

[0005] In some instances, calcifications may be detected within one or more biopsy samples using a procedure room x-ray system. Such procedure room x-ray systems may be separate from the biopsy system itself. Thus, in such configurations, biopsy samples may be first removed from one or more components of a biopsy device, transported to the procedure room x-ray system, and then be subjected to x-ray to identify the presence of calcifications.

[0006] Such a procedure room x-ray system may be undesirable in some circumstances because transport of biopsy samples between the biopsy device and the procedure room x-ray system may result in inefficiencies. Such inefficiencies may flow from manipulation of the biopsy device to remove the biopsy samples, the physical movement of biopsy samples, and/or other disruptions associated movement of the biopsy samples. Furthermore, the physical movement may distract from the procedure itself, reducing overall accuracy of the procedure. Accordingly, it may be desirable to incorporate one or more forms of biopsy sample calcification detection into one or more components of a biopsy device to simplify procedure room workflow and improve efficiency and accuracy of a biopsy procedure.

[0007] While several systems and methods have been made and used for obtaining a biopsy sample, it is believed that no one prior to the inventor has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] While the specification concludes with claims which particularly point out and distinctly claim this technology, it is believed this technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0009] FIG. 1 depicts a schematic view of an example biopsy system including a biopsy device and a vacuum control module;

[0010] FIG. 2 depicts a perspective view of a tissue collection assembly of the biopsy device of FIG. 1;

[0011] FIG. 3 depicts an exploded perspective view of a portion of the tissue collection assembly of FIG 2;

[0012] FIG. 4 depicts a perspective cross-sectional view of the tissue collection assembly of FIG. 2, the cross-section taken along line 4-4 of FIG. 2;

[0013] FIG. 5 depicts a front cross-sectional view of the tissue collection assembly of FIG. 2, the cross-section taken along line 4-4 of FIG. 2;

[0014] FIG. 6 depicts a schematic diagram of an example system of various hardware components that may be readily incorporated into the biopsy system of FIG. 1;

[0015] FIG. 7 depicts a schematic flow diagram of an example process for processing signals generated by one or more portions of the tissue collection assembly of FIG. 2;

[0016] FIG. 8 depicts a plot of a first data set generated by the process of FIG. 7 prior to application of a step of Fast Fourier Transform (FFT), the first data set corresponding to a tissue sample without calcium;

[0017] FIG. 9 depicts another plot of the first data set of FIG. 8 after application of the step of FFT; [0018] FIG. 10 depicts a plot of a second data set generated by the process of FIG. 7 prior to application of the step of FFT, the second data set corresponding to a tissue sample with calcium; and

[0019] FIG. 11 depicts another plot of the second data set of FIG. 10 after application of the step of FFT.

[0020] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present technology, and together with the description serve to explain the principles of the technology; it being understood, however, that this technology is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

[0021] The following description of certain examples of the technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the technology. As will be realized, the technology described herein is capable of other different and obvious aspects, all without departing from the technology. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0022] I. Overview of Exemplary Biopsy System

[0023] FIG. 1 depicts an exemplary biopsy system (2) comprising a biopsy device (10) and a vacuum control module (400). Biopsy device (10) of the present example may include a handpiece or body defined by a probe (100) and a holster (200). Probe (100) and holster (200) are together configured to collect one or more biopsy samples. Specifically, and ss will be described in greater detail below, a needle (110) extending distally from probe (100) may generally configured for insertion into a patient’s tissue to obtain tissue samples. Such tissue samples may be deposited in a tissue sample holder (300) at the proximal end of probe (100), as will also be described in greater detail below.

[0024] In the present example, probe (100) and holster (200) may include certain coupling features (not shown) to facilitate coupling of probe (100) to holster (200). By way of example only, such coupling features may include various combinations of prongs, rigid flexible, or resilient tabs, and/or etc. Of course, a variety of other types of structures, components, features, etc. (e.g., bayonet mounts, latches, clamps, clips, snap fittings, etc.) may be used to provide removable coupling of probe (100) and holster (200). Furthermore, in some biopsy devices (10), probe (100) and holster (200) may be of unitary or integral construction, such that the two components cannot be separated. By way of example only, in versions where probe (100) and holster (200) are provided as separable components, probe (100) may be provided as a disposable component, while holster (200) may be provided as a reusable component. It should be understood that the use of the term “holster” herein should not be read as requiring any portion of probe (100) to be inserted into any portion of holster (200). Still other suitable structural and functional relationships between probe (100) and holster (200) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0025] In examples where probe (100) is separable from holster (200), probe (100) may be configured as a disposable component, while holster (200) may be configured as a reusable component. Thus, in such configurations, simpler and/or less expensive components may be incorporated into probe (200), while complex and/or more expensive components may be incorporated into holster (200). For instance, holster (200) may include robust multi-use components such as motors, electronics, wires, pumps, drive components, and/or etc. Meanwhile, probe (100) may include single use components such as tubing, manifolds, conduits, and/or etc. Additionally, some types of components may be shared between holster (200) and probe (100), but the particular component may be particularized for reuse in holster (200) or disposability in probe (100). By way of example only, both holster (200) and probe (100) may include one or more gears for transmitting mechanical power within biopsy device (10). However, such gears may be of a material suitable for reuse with holster (200) or disposability with probe (100).

[0026] Biopsy device (10) of the present example may be configured for use under a variety of imaging guidance modalities. For instance, in some examples, biopsy device (10) may be configured to mount to a table or fixture, and be used under stereotactic guidance. In other examples, biopsy device (10) may instead be configured for use under ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or otherwise. It should also be understood that biopsy device (10) may be sized and configured such that biopsy device (10) may be operated by a single hand of an operator. In particular, an operator may grasp biopsy device (10), insert needle (110) into a patient’s breast, and collect one or a plurality of tissue samples from within the patient’s breast, all with just using a single hand. Alternatively, an operator may grasp biopsy device (10) with more than one hand and/or with any desired assistance. In some settings, the operator may capture a plurality of tissue samples with just a single insertion of needle (110) into the patient’s breast. Such tissue samples may be pneumatically deposited in tissue sample holder (300), and later retrieved from tissue sample holder (300) for analysis. While examples described herein may refer to the acquisition of biopsy samples from a patient’s breast, it should be understood that biopsy device (10) may be used in a variety of other procedures for a variety of other purposes and in a variety of other parts of a patient’s anatomy (e.g., prostate, thyroid, etc.). Various exemplary components, features, configurations, and operabilities of biopsy device (10) will be described in greater detail below; while other suitable components, features, configurations, and operabilities will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0027] As shown in FIG. 1, vacuum control module (400) is coupled with probe (100) via a valve assembly (500) and tubes (20, 30, 40, 60), which is operable to selectively provide vacuum, saline, atmospheric air, and/or venting to probe (100). Although valve assembly (500) is shown separately from vacuum control module (400) in the present example, it should be understood that in other examples, valve assembly (500) may be received within vaccum control module (400) via a valve receptacle. Suitable valve receptacles may be configured to receive valve assembly (500) to maintain sterility between valve assembly (500) and vacuum control module (400) to permit reuse of vaccum control module (400). The internal components of the valve assembly of the present example are configured and arranged as described in U.S. Pub. No. 2013/0218047, entitled “Biopsy Device Valve Assembly,” published August 22, 2013, the disclosure of which is incorporated by reference herein.

[0028] Vaccum control module (400) of the present example includes a vacuum canister (70) and a display (410). Although not shown, it should be understood that vacuum control module (400) may additionally include certain internal components such as one or more motors, processors, relays, circuitry, and/or etc. As will be understood, vaccum control module (400) is generally configured to provide electro-mechanical control of biopsy device (10) via a cable (90) coupling biopsy device (10) to vaccum control module (400). Vaccum control module (400) further configured to control the pneumatic state of biopsy device (10) via vaccum canister (70) and/or valve assembly (500).

[0029] Display (410) of vacuum control module (400) is generally configured to control the various functions of vaccum control module (400) by way of a user interface. In particular, such a user interface may be configured to initiate algorithms associated with the electro-mechanical controls and pneumatic controls of vaccum control module (400) referenced above. In some examples, display (410) display may be configured as a touch screen such that display may operate as both a user input and an output. In addition, or in the alternative, vacuum control module (400) may include, or be in communication with, dedicated user input features such as buttons, foot pedals, and/or etc.

[0030] II. Exemplary Tissue Collection Assembly

[0031] FIG. 2 shows an example of a tissue collection assembly (600) that may be readily incorporated into one or more portions of probe (100) and/or holster (200) of biopsy device (10) described above. Tissue collection assembly (600) is generally configured to permit collection of one or more tissue samples. Although not shown, it should be understood that tissue collection assembly (600) may be in communication with one or more of tubes (20, 30, 40, 60) described above to receive vacuum, atmospheric air, saline, and/or combinations thereof to transport one or more collected tissue sample though tissue collection assembly (600). Tissue collection assembly (600) may further be in communication with one or more components associated with cable (90) to facilitate movement of various components of tissue collection assembly (600) as will be described in greater detail below.

[0032] Tissue collection assembly (600) includes a needle (610), a hollow tubular cutter (620), a cutter drive assembly (650), and a tissue sample holder (700). Needle (610) is generally configured for insertion into tissue of a patient to collect one or more tissue samples from the patient. In some examples, needle (610) may extend distally from probe (100) or other portions of biopsy device (10). Thus, needle (610) may be manipulated by probe (100) and/or holster (200) for insertion into the patient.

[0033] To facilitate insertion and collection of one or more tissue samples, needle (610) includes a sharp distal tip (612) and a lateral aperture (614) proximate to distal tip (612). By way of example only, distal tip (612) may be configured in accordance with any of the teachings in U.S. Pat. No. 8,801,742, entitled “Needle Assembly and Blade Assembly for Biopsy Device,” issued August 12, 2014, the disclosure of which is incorporated by reference herein. As another merely illustrative example, distal tip (612) may be configured in accordance with at least some of the teachings in U.S. Pub. No. 2013/0150751 , the disclosure of which is incorporated by reference herein. Other suitable configurations that may be used for distal tip (612) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0034] Lateral aperture (614) is sized to receive prolapsed tissue during operation of biopsy device (10). In particular, cutter (620) may be disposed within a hollow interior of needle (610) and may be operable to rotate and translate relative to needle (610). In this configuration, cutter (620) may be configured to move relative to lateral aperture (614) to sever a tissue sample from tissue protruding through lateral aperture (614). For instance, cutter (620) may be moved from an extended position to a retracted position, thereby “opening” lateral aperture (614) to allow tissue to protrude therethrough; then from the retracted position back to the extended position to sever the protruding tissue. In some examples, needle (610) and/or cutter (620) may be configured in accordance with one or more teachings of U.S. Patent No. 7,918,803, entitled “Methods and Devices for Automated Biopsy and Collection of Soft Tissue,” issued April 5, 2011, the disclosure of which is incorporated by reference herein.

[0035] Cutter drive assembly (650) is generally configured to simultaneously translate and rotate cutter (620) relative to needle (610) to sever a tissue sample from tissue protruding through lateral aperture (614). In the present example, cutter drive assembly (650) includes a nut (652), a gear (654), and a cutter sleeve (660) (also referred to as a cutter overmold or overmold). Nut (652) is generally configured to remain stationary relative to ration of cutter (620) to drive translation of cutter (620) via internal threading (not shown) and external threading (662) of cutter sleeve (660). Meanwhile, gear (654) is positioned coaxially with cutter (620) to drive rotation of cutter (620) via a keyed portion (664) of cutter sleeve (660). Thus, gear (654) is configured to rotate cutter (620), while nut (652) is configured to convert such rotation of cutter (620) into simultaneous translation of cutter (620).

[0036] Although cutter drive assembly (650) of the present example is shown in a particular configuration using a single gear (654) in combination with nut (652), it should be understood that various alternative configurations may be used in some examples. For instance, in some examples, cutter drive assembly (650) may include multiple gears (654), while incorporating one or more elements of nut (652) into such multiple gears (654). In such examples, differential rotation between the multiple gears (654) may be configured to produce simultaneous rotation and translation of cutter (620). In some examples, the foregoing cutter actuation components are further configured in accordance with at least some of the teachings of U.S. Pat. No. 8,206,316 entitled “Tetherless Biopsy Device with Reusable Portion,” issued Jun. 26, 2012; and/or U.S. Pat. No. 8,764,680, entitled “Handheld Biopsy Device with Needle Firing,” issued Jul. 1, 2014, the disclosures of which are incorporated by reference herein. As yet another merely illustrative example, cutter drive assembly (650) may be omitted in some examples and instead cutter (620) may be rotated and/or translated using pneumatic motors, etc. Still other suitable ways in which cutter (620) may be actuated will be apparent to those of ordinary skill in the art in view of the teachings herein. [0037] As best seen in FIGS. 5-7 cutter (150) includes an overmold (160) that is unitarily secured to cutter (150). Overmold (160) includes a generally smooth and cylindraceous distal portion (166), threading (162) in a mid-region of overmold (160), and a set of hexagonal flats (164) extending along a proximal portion of overmold (160). Distal portion (166) extends into manifold (122). Manifold (122) seals against distal portion (166) such that manifold (122) such that manifold (122) maintains the fluid tight coupling between second lumen (192) and tube (46) even when cutter (150) is translated and rotated relative to manifold (122).

[0038] A gear (140) is positioned on flats (164) and includes a set of internal flats (not shown) that complement flats (164). Thus, gear (140) rotates overmold (160) and cutter (150) when gear (140) is rotated. However, overmold (160) is slidable relative to gear (140), such that cutter (150) may translate relative to chassis (160) despite gear (140) being longitudinally fixed relative to chassis (160). Gear (140) is rotated by gear (230). As best seen in FIGS. 7-8, a nut (142) is associated with threading (162) of overmold (160). In particular, nut (142) includes internal threading (144) that meshes with threading (162) of overmold (160). Nut (142) is fixedly secured relative to chassis (160). Thus, when gear (140) rotates cutter (150) and overmold (160), cutter (150) will simultaneously translate due to the meshing of threading (144, 162). In some examples, the foregoing cutter actuation components are further configured in accordance with at least some of the teachings of U.S. Pub. No. 2008/0214955, the disclosure of which is incorporated by reference herein. As yet another merely illustrative example, cutter (150) may be rotated and/or translated using pneumatic motors, etc. Still other suitable ways in which cutter (150) may be actuated will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0039] Tissue sample holder (700) is generally configured to receive one or more tissue samples severed by cutter (620). In particular, cutter (620) is generally configured to transport severed tissue samples axially through the hollow interior thereof from lateral aperture (614) of needle (610) and into a portion of tissue sample holder (700). Thus, tissue sample holder (700) may include one or more chambers, compartments, or cavities configured to receive one or more tissue samples. [0040] It should be understood that tissue sample holder (700) may be in a variety of configurations. For instance, in some examples, tissue sample holder (700) may have a multi-chamber configuration. Such a multi-chamber configuration may have a plurality of chambers for receipt of one or more tissue samples within each chamber. In such examples, each chamber may include a tray, basket, or other feature to promote removability of one or more tissue samples from tissue sample holder (700). Additionally, one or more components of tissue sample holder (700) may be rotatable or otherwise movable to facilitate communication of one or more tissue samples into each chamber. In other examples, tissue sample holder (700) may have a bulk chamber configuration. Such a bulk chamber configuration may have a single chamber configured to receive a plurality of tissue samples therein. By way of example only, tissue sample holder (700) may be configured in accordance with at least some of the teachings of U.S. Pat. No. 9,345,457, the disclosure of which is incorporated by reference herein. As another merely illustrative example, tissue sample holder may be configured in accordance with at least some of the teachings of U.S. Pat. No. 9,999,406, the disclosure of which is incorporated by reference herein.

[0041] III. Example Calcification Detection System

[0042] In some instances, it may be beneficial to immediately examine a recently biopsied tissue sample through certain imaging modalities to identify calcifications within the tissue sample. For instance, such an examination may provide operational feedback to the clinician to identify whether the biopsy tissue sample is from within a target region or outside the target region. However, conventional imaging devices or systems may place limitations on how quickly the biopsied tissue sample can be analyzed due to the time elapsed extracting the tissue sample from the biopsy device, positioning the tissue sample into an examination container, and subsequently inserting the examination container into an imaging system to produce images of the specimen for analysis. A biopsy device adapted to directly identify calcifications in real-time without removal of the tissue sample from the biopsy device may accordingly be beneficial to reduce the amount of time and effort required to analyze the tissue sample during a biopsy procedure. Furthermore, being able to immediately analyze the tissue specimen during a biopsy procedure may permit an operator to confirm whether the targeted tissue was successfully acquired at each instance of tissue extraction, thereby reducing the number of tissue samples extracted from the patient.

[0043] As best seen in FIG. 2, tissue collection assembly (600) may include or be associated with, a sensor assembly (800). Sensor assembly (800) is generally configured to analyze a tissue sample disposed within tissue collection assembly (600) to identify the presence of calcifications within the tissue sample. In the present example, sensor assembly (800) is disposed proximate tissue sample holder (700) to analyze a tissue sample as the tissue sample passes through cutter (620) towards tissue sample holder (700). Although sensor assembly (800) is disposed proximate tissue sample holder (700) in the present example, it should be understood that sensor assembly (800) may be disposed in multiple positions relative to the components of tissue collection assembly (600) in other examples. For instance, in some examples, sensor assembly (800) may be disposed within one or more portions of tissue sample holder (700). In other examples, sensor assembly (800) may be disposed proximate needle (610) between needle (610) and cutter drive assembly (650). In still other examples, sensor assembly (800) may be integrated within one or more portions of cutter drive assembly (650). Still other positions of sensor assembly (800) relative to tissue collection assembly (600) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0044] As best seen in FIG. 3, sensor assembly (800) includes a body (810), a first sensor element (820), and a second sensor element (824). Body (810) is generally configured to locate the position of first sensor element (820) and second sensor element (824) relative to each other and relative to cutter (620). Body (810) is further generally configured to receive cutter (620) such that cutter (620) may pass though body (810) and into tissue sample holder (700). Thus, body (810) of the present example defines a generally cylindrical configuration with a distal opening (812) and a proximal opening (814) that define a hollow bore extending through body (810).

[0045] Body (810) may comprise a variety of materials. For instance, in some examples, body (810) may comprise a rigid material such as a rigid polymer, a metal, and/or a composite. Such a rigid material may be desirable to promote more consistant positioning of first sensor element (820) and second sensor element (824) relative to each other and relative to cutter (620). In other examples, body (810) may comprise a flexible material or partially flexible material such as a rubber, a flexible polymer, and/or a flexible composite material. Such a flexible or partially flexible material may be desirable to support some movement of cutter (620), while maintaining the position of first sensor element (820) and second sensor element (824) relative to each other and relative to cutter (620). Of course, in some examples, body (810) may comprise multiple materials (or one anisotropic material) to achieve various combinations of flexiblity and rigidity in different portions of body (810). Alternatively, in some examples, body (810) may be omitted entirely and first sensor element (820) and second sensor element (824) may be located by other elements such as a housing of probe (100) and/or holster (200).

[0046] As also seen in FIG. 3, cutter (620) may include a transparent section (622) corresponding to body (810). As will be described in greater detail below, first sensor element (820) and/or second sensor element (824) may be used to communicate various forms of electromagnetic radiation to and from a tissue sample disposed within cutter (620). Thus, transparent section (622) may be configured with at least some transparency relative to the electromagnetic radiation used to permit such communication to and from a tissue sample disposed within cutter (620). In some examples, this transparency may be characterized as “clear.” In other examples, this transparency may be characterized in other ways depending on the particular form of electromagnetic radiation used.

[0047] Although cutter (620) of the present example is shown as having only a transparent section (622) proximate a proximal end thereof, in other examples, the cutter (620) may be entirely transparent. In other words, transparent section (622) may extend the entire length of cutter (620) in some examples. As described above, sensor assembly (800) may be disposed on other positions relative to tissue collection assembly (600). Thus, transparent section (622) may likewise be disposed at various positions along the length of cutter (620) corresponding to the particular position of sensor assembly (800). Alternatively, in examples where sensor assembly (800) is associated with other elements of tissue collection assembly (600), transparent section (622) may be omitted entirely from cutter (620), while other portions of tissue collection assembly (800) may be transparent (e.g., one or more portions of tissue sample holder (300), one or more portions of needle (610), one or more portions of cutter drive assembly (650), and/or etc.).

[0048] First sensor element (820) and second sensor element (824) are generally configured to detect the presence of calcifications within tissue. In particular, either first sensor element (820) or second sensor element (824) may be configured as an emitter, while the other of first sensor element (820) or second sensor element (824) may be configured as a detector. In this configuration, the emitter may emit electromagnetic radiation that may pass though a tissue sample disposed between first sensor element (820) and second sensor element (824). The detector may then receive any electromagnetic radiation communicated through the tissue sample.

[0049] In the present example, first sensor element (820) and second sensor element (824) are positioned in a generally opposing relationship relative to each other. In other words, first sensor element (820) and second sensor element (824) may be positioned on opposite sides of cutter (620) along a common axis. Such a common axis may be perpendicular to the longitudinal axis of cutter (620) in some examples, or oblique to the longitudinal axis of cutter (620) in other examples. In this configuration, first sensor element (820) and second sensor element (824) are configured to communicate electromagnetic radiation relative to each other and through a tissue sample disposed within cutter (620).

[0050] Although a generally opposing relationship is used in the present example between first sensor element (820) and second sensor element (824), it should be understood that various alternative relationships may be used in other examples. For instance, in some examples, first sensor element (820) and second sensor element (824) may be positioned on generally the same side of cutter (620). In such a configuration, both first sensor element (820) and second sensor element (824) may be positioned along a common axis or substantially common axis. Alternatively, first sensor element (820) and second sensor element (824) may be positioned in an offset relationship and angled such that their respective emission/detection axes intersect at a common point (e.g., the position of a tissue sample). Regardless, in such configurations, first sensor element (820) and second sensor element (824) may be configured for detection of calcifications via reflection of electromagnetic radiation from a tissue sample rather than communication of electromagnetic radiation through a tissue sample. Thus, it should be understood that in such configurations, first sensor element (820) and second sensor element (824) may be combined into a single sensor element that both emits and receives electromagnetic radiation.

[0051] As described above, first sensor element (820) and second sensor element (824) may be configured to transmit and/or receive electromagnetic radiation. Thus, a variety of wavelengths or combinations of wavelengths of electromagnetic radiation may be used in transmission and reception. For instance, in some examples, wavelengths of electromagnetic radiation within the visible light spectrum may be used (e.g., about 380 to 740 nm). Although any suitable wavelength within the visible light spectrum may be used, some wavelengths within the visible light spectrum may be more desirable than others. For instance, wavelengths corresponding to the color red (e.g., about 625 to 740 nm) may be more desirable due to increased depth of penetration within tissue.

[0052] In other examples, first sensor element (820) and second sensor element (824) may be configured to transmit and/or receive other wavelength of electromagnetic radiation. For instance, in some examples, wavelengths of electromagnetic radiation within the infrared spectrum may be used (e.g., about 700 to 1,400 nm). As will be described in greater detail below, wavelengths in the infrared spectrum may be desirable to due to availability of available equipment. Additionally, wavelengths in the infrared spectrum may be desirable due to increased depth of penetration within tissue relative to other forms of electromagnetic radiation.

[0053] Regardless of the particular wavelength of electromagnetic radiation used, the source of electromagnetic radiation may be in the form of a laser source. The use of a laser source may be desirable due to the emission of coherent light, which may be desirable to maintain the wavelength emitted within relatively small range and to reduce interference. Use of a laser source may further be desirable for the relatively high intensity of transmission. Of course, other suitable light sources may be used. For instance, in some versions, a fixed light source may be used. In such configurations, the fixed light source may remain stationary relative to a movable sensor element (820, 824). Although the particular intensity used may be varied, intensity during use may generally remain consistent over time.

[0054] Detection of electromagnetic radiation emitted from either first sensor element (820) or second sensor element (824) may be performed with a variety of commercially available detectors. Generally, a given detector may be matched to the particular spectrum of electromagnetic radiation used. Additionally, a detector having relatively high sample rate (e g., 100 samples per second) may be desirable to minimize the amount of time to analyze a given tissue sample. Although some signal processing may be integrated into a given detector, excessive integrated signal processing may be undesirable in some circumstances because this may lead to reduced sampling rates.

[0055] Although first sensor element (820) and second sensor element (824) are described herein as having either one emitter or one detector, it should be understood first sensor element (820) and/or second sensor element (824) may include multiple emitters or detectors or combinations of emitters and detectors. Thus, each of first sensor element (820) or second sensor element (824) may include an array of emitters, detectors, or combinations thereof. Additionally, although not shown, it should be understood such emitters and/or detectors may be associated with certain ancillary components such as lenses, filters, reflectors, and/or etc. Such components may be integrated into such emitters and/or detectors or separate therefrom.

[0056] FIGS. 4 and 5 show an example of sensor assembly (800) in use with tissue collection assembly (600). As can be seen in FIG. 4, a tissue sample (TS) may be severed using cutter (620) and then transported axially though cutter (620) towards sensor assembly (800). Once tissue sample (TS) reaches sensor assembly (800), one of first sensor element (820) or second sensor element (824) may analyze tissue sample (TS) by emitting electromagnetic energy as shown in FIG. 5. Such electromagnetic energy may then at least partially pass though transparent section (622) of cutter (620) and tissue sample (TS). The other of first sensor element (820) or second sensor element (824) may then detect any electromagnetic energy that passed through tissue sample (TS).

[0057] During analysis of tissue sample (TS), tissue sample (TS) may move continuously relative to sensor assembly (800). Alternatively, one or more portions of sensor assembly (800) may move relative to a stationary tissue sample (TS). Such relative movement between tissue sample (TS) and sensor assembly (800) may permit full analysis of tissue sample (TS) from one end to another. In other words, relative movement may be desirable to scan a length of tissue sample (TS) rather than concentrating analysis at a single point or portion of tissue sample (TS).

[0058] In some examples, tissue sample (TS) may move freely through cutter (620) at a rate based on the particular level of vacuum supplied by tubes (20, 30, 40, 60). In other examples, it may be desirable to control the rate of travel through cutter (620) to maintain the rate of travel of tissue sample (TS) within a predetermined range. Thus, in some examples, cutter (620) may include certain velocity control features that may impact the rate of travel of tissue sample (TS) through cutter (620). Such velocity control features may include, for example, protrusions, vaccum channels, ribs, ridges, and/or etc. In addition, or in the alternative, separate velocity control features may be used in connection with cutter (620). For instance, separate velocity control features may include movable gates, stoppers, valves, and/or etc. Although such features may be used to control the velocity of tissue sample (TS), such features may also be used to entirely arrest movement of tissue sample (TS). In such examples where tissue sample (TS) is arrested entirely, first sensor element (820) and second sensor element (824) may move relative to tissue sample (TS) instead of tissue sample (TS) moving relative to first sensor element (820) and second sensor element (824).

[0059] IV. Example of Signal Processing System for Detection of Calcifications

[0060] FIG. 6 shows a schematic diagram of an example of a signal processing system

(900) that may be readily incorporated into biopsy system (2) described above. Signal processing system (900) may further be used in combination with tissue collection assembly (600) and sensor assembly (800) to analyze one or more tissue samples. In particular, signal processing system (900) is generally configured to control functions of biopsy device (10), vacuum control module (400), and tissue collection assembly (600). Additionally, signal processing system (900) is further configured to control sensor assembly (800) and analyze output from sensor assembly (800) by applying various algorithms described in greater detail below. Although signal processing system (900) is shown as a single system used in connection with biopsy device (10), vacuum control module (400), tissue collection assembly (600) and sensor assembly (800), it should be understood signal processing system (900) may be divided into one or more separate systems dedicated to particular functions of biopsy device (10), vacuum control module (400), tissue collection assembly (600), and/or sensor assembly (800).

[0061] Signal processing system (900) includes a data processor (910) in communication with a plurality of controllers and/or interfaces (920, 930, 940, 950) used to implement various functions of biopsy device (10), vacuum control module (400), tissue collection assembly (600), and/or sensor assembly (800). Data processor (910) is further in communication with memory (912) and data storage (914), which may be used in combination with data processor (910) to facilitate various functions of data processor (910) described in greater detail below. Although data processor (910) of the present example is shown as a single element, it should be understood that data processor (910) may include multiple processors in some examples, with one or more of such multiple processors being dedicated to particular functions.

[0062] Memory (912) may include random access memory (RAM), which may be configured for short-term storage of data. Meanwhile, data storage (914) may include a solid-state drive or a hard disk drive, which may be configured for long-term storage of data. Memory (912) and data storage (914) may also be in communication with each other to facilitate transfer of data between short-term storage and long-term storage. Together, data processor (910), memory (912), and data storage (914) may be configured to execute computer programs, in the form of software, to implement various functions of biopsy device (10), vacuum control module (400), tissue collection assembly (600), and/or sensor assembly (800) described in greater detail below. Although data processor (910), memory (912), and data storage (914) are shown as being in relatively close physical proximity, it should be understood that any one or more of data processor (910), memory (912), and data storage (914) may be physically separated from each other and one or more functions described herein may be performed remotely (e.g., cloud-based computation and signal processing).

[0063] In some examples, data processor (910), memory (912), and/or data storage (914) may be disposed within vaccum control module (400) and may communicate with other elements of biopsy system (2) via cable (90). In other examples, data processor (910), memory (912), and/or data storage (914) may be disposed within other components such as one or more portions of biopsy device (10). Such a configuration may be particularly desirable where data processor (910) is divided into multiple separate data processors (910) or sub-processors. In such examples, one or more data processors (910) may be disposed within one or more portions of biopsy device (10), while one or more data processors (910) may be disposed within vacuum control module (400). In such configurations, specific data processors (910) may be localized in connection with particular functions.

[0064] Signal processing system (900) further includes a vacuum controller (920) in communication with data processor (910). Vaccum controller (920) in combination with data processor (910) is generally configured to control various vacuum functions associated with biopsy device (10). Thus, vacuum controller (920) is in communication with vacuum module (922), which may be in communication with one or more of vacuum canister (70), valve assembly (500), and/or other components associated with vacuum control module (400) to facilitate delivery of vacuum, atmospheric air, and/or saline to biopsy device (10).

[0065] Signal processing system (900) further includes a cutter controller (930) in communication with data processor (910). Cutter controller (930) in combination with data processor (910) is generally configured to control various functions associated with movement of cutter (620) or other associated components. For instance, cutter controller (910) may be in communication with one or more motors (932) to communicate or receive signals to one or more motors (932) to drive one or more motors (932). One or more motors (932) may then drive cutter (620) via cutter drive assembly (650).

[0066] Signal processing system (900) further includes an emitter controller (940) and a detector interface (950) in communication with data processor (910). Emitter controller (940) in combination with data processor (910) is generally configured to drive emission of electromagnetic radiation via either first sensor element (820) or second sensor element (824). Thus, emitter controller (940) may be in communication with either first sensor element (820) or second sensor element (824) depending on which of first sensor element (820) or second sensor element (824) is configured as an emitter. Similarly, detector interface (950) in combination with data processor (910) is generally configured to receive and process signals generated by either first sensor element (820) or second sensor element (824). Thus, detector interface (950) may be in communication with either first sensor element (820) or second sensor element (824) depending on which of first sensor element (820) or second sensor element (824) is configured as a detector.

[0067] Data processor (910) is also in communication with display (410) of vacuum control module (400). Optionally, a graphical processing module or graphical processing feature may be used in combination with display (410) and data processor (910) to drive display (410). Generally, data processor (910) may be configured to drive display (410) to communicate certain information to an operator. For instance, data processor (910) may drive display (410) to show graphical features associated with biopsy device (10) to illustrate operational conditions such as the position of cutter (620) relative to lateral aperture (614), the level of vacuum within needle (610) and/or cutter (620), the status of tissue sample holder (700) with respect to tissue sample occupancy, the particular mode of operation of biopsy device (10), and/or etc. Additionally, data processor (910) may be configured to drive display (410) to show results of tissue sample analysis via first sensor element (820) and second sensor element (824). As will be described in greater detail below, such results may be illustrated simply with symbolic or color coded indicators, or complexly with numerical readouts and/or plots.

[0068] Although data processor (910) is shown as being in communication with display (410), it should be understood that data processor (910) may also be in communication with any other suitable indicator to communicate results of tissue sample analysis to an operator. For instance, in some examples, holster (200) may include an indicator, display, LED array and/or etc. to communicate results of tissue sample analysis performed via data processor (910). As with display (410) described above, the communication of such results may be in a variety of forms from simple to complex. Suitable forms of communications of the results are described in greater detail below.

[0069] Signal processing system (900) further includes a communications port (960) in communication with data processor (910). As can be seen, communication port (960) may be used to couple signal processing system (900) with a network (970) such as a hospital picture archiving and communication system (PACS). Thus, communication port (960) may link signal processing system (900) to a plurality of remote computers (972) and displays (974) for remote viewing of data associated with biopsy system (2). Although the present example includes communications port (960), it should be understood that communications port (960) is optional in other examples and may be omitted.

[0070] FIG. 7 shows an example tissue analysis algorithm (1000) that may be used with data processor (910), emitter controller (940), detector interface (950), and other associated components to process data associated with a tissue sample to identify calcifications in the tissue sample or otherwise analyze the tissue sample. Although tissue analysis algorithm (1000) may be executed primarilly by data processor (910) in the present example, it should be understood that execution may be performed by one or more modules associated with data processor (910) in some examples. Such modules may be dedicated to a particular operation of tissue analysis algorithm (1000) to promote efficiency in execution.

[0071] As can be seen, raw data may first be captured at block (1010). At this stage, data processor (910) may communicate with emitter controller (940) to emit electromagnetic radiation via first sensor element (820) or second sensor element (824). Any electromagnetic radiation detected by the other of first sensor element (820) or second sensor element (824) may then be communicated to data processor (910) via detector interface (910).

[0072] After collection and communication of raw data in block (1010), the raw data may be subjected to one or more pre-processing operations as shown in block (1020). Such pre-processing operations may be generally configured to improve signal communication efficiency, signal communication quality, emphasize certain elements of the detected signal, and/or etc. Such pre-processing operations may include analog components, digital components, or various combinations of analog and digital components. As described above, some pre-processing may optionally be performed onboard either first sensor element (820) or second sensor element (824) when acting as a detector. As also described above, such onboard signal processing may be undesirable in some circumstances due to limitations on sampling rate. Thus, in other examples, some or all of pre-processing operations may be performed in connection with detector interface (950), data processor (910), and/or other circuitry in communication with detector interface (950) and/or data processor (910). In still other examples, pre-processing operations may be omitted entirely.

[0073] After one or more pre-processing operations are optionally performed, the data are subjected to a Fast Fourier Transformation (FFT). FFT may be performed using data processor (910) (or one or more modules associated with data processor (910)), memory (912), and/or data storage (914). As will be described in greater detail below, performance of FFT may be desirable to make certain patterns in the raw data more readily identifiable. Such patterns may be directly observed in some circumstances or identified by other subsequently applied algorithms.

[0074] After application of FFT to the raw or pre-processed data, the resulting data may be subjected to further algorithms using machine learning and/or artificial intelligence features. Such algorithms may be generally configured to identify patterns associated with the presence of calcifications and then provide an operator with a simplified output (e.g., no calculations, calcifications detected, etc ). In such algorithms, attributes such as frequency, amplitude, and/or frequency components of FFT may be measured and compared with one or more existing datasets. Such one or more existing datasets may include data collected with known tissue with calcification and no calcification. Through comparison with the one or more existing datasets a determination may be made if the calcification is present or not to the operator.

[0075] In one example of a machine learning and/or artificial intelligence data processing operation, a feature extraction operation is first performed as indicated at block (1040). At this stage, attributes such as frequency, amplitude, and frequency components of FFT may be measured using data processor (910). After the feature extraction operation, a pattern recognition operation may be used via data processor (910) to compare the extracted features to features in known datasets as indicated at block (1050). As described in greater detail below, such known datasets may include a plurality of tests where the presence of calcifications in the tested tissue samples is known.

[0076] The machine learning and/or artificial intelligence features described herein are generally configured to recongize relevant patterns in existing data sets to process FFT data into a simple output. One such simple output may be a “stop light” output indicating calcifications detected (e.g., green), no calcifications detected (e.g., red), or partial calcifications detected (e.g., yellow). In operation, data processor (910) may be configured to implement one or more machine learning algorithms in order to identify calcifications within tissue using FFT data provided as an input to the machine leaning algorithm. The machine learning algorithm may operate by identifying structures or features present in the FFT data that are consistent with training data used to train the machine learning algorithm. Further, the machine learning and/or artificial intelligence features may correspond to one or more of a machine learning model, a convolutional neural network, and/or etc.

[0077] FIGS. 8 through 11 show example plots of data associated with the tissue sample analysis processes described above. In particular, FIGS. 8 and 10 show data collected from a detector after at least some pre-processing such as the pre-processing described above with respect block (1020) of FIG. 7. Similarly, FIGS. 9 and 11 show the same data after the data was subjected to FFT processing such as the FFT processing described above with respect to block (1030) of FIG. 7.

[0078] The data shown in FIGS. 8 through 11 was obtained through testing. In particular, a test apparatus was prepared with a visible light emitter in the form of a continuous red laser light on one side of a sample area and a corresponding visible light detector on another side of the sample area. Tissue samples were then moved though the sample area past the visible light emitter and the visible light detector and the resulting signal generated by the visible light detector was recorded. The tissue samples used were chicken breast and pig breast tissue. In one test (FIGS. 8 and 9), the tissue sample included no intentionally added calcium. In another test (FIGS. 10 and 11), the tissue sample included intentional additions of calcium of varying sizes to approximate the presence of calcifications.

[0079] As described above, FIGS. 8 and 10 show the resulting data after some preprocessing and before FFT with and without calcium present, respectively. As can be seen, no discernable trends, patterns, or particular artifacts are observable from the raw or pre-processed data. However, upon application of FFT (FIGS. 9 and 11), particular patterns emerge. In particular, comparing the results of the tissue sample without calcium (FIG. 9) and the tissue sample with calcium (FIG. 11), variations in amplitude and frequency are observable. With respect to amplitude, greater amplitude is observable with respect to the tissue sample without calcium (FIG. 9) relative to the tissue sample with calcium (FIG. 11). With respect to frequency, less frequency peak spacing is observable with respect to the tissue sample without calcium (FIG. 9) relative to the tissue sample with calcium (FIG. 11). Additionally, greater frequency peaks are observable with respect to the tissue sample without calcium (FIG. 9) relative to the tissue sample with calcium (FIG. 11). Such differences in frequency peaks suggest light getting absorbed or reflected due to the presence of calcium.

[0080] Although FIGS. 8 through 11 show data associated with the tissue sample analysis processes described above in plotted form, it should be understood that reduction of the data to plotted form is merely optional. For instance, in some examples, the data after the application of FFT may be used as an input for training of a machine learning algorithm similar to the algorithms described above. In such examples, the particular data input used for training may be either in plotted form (such as the data shown in FIGS. 9 and 11) or may be in numerical form. Additionally, presentation of any data described herein in plotted from to an operator during a medical procedure is merely optional. For instance, in some examples, plotted data may be used only for the purpose of training. In such examples, the output of machine learning algorithms described above may be in a simplified form such as a stoplight configuration (e.g., red, yellow, green) to indicate the presence of calcifications, no calcifications, or an intermediate condition (e.g., some calcifications). In other examples, any data may be available in plotted or numerical form and may be optionally accessible to an operator either during or after a medical procedure.

[0081] V. Exemplary Combinations

[0082] 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 restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.

[0083] Example 1

[0084] A biopsy device, the biopsy device comprising: a tissue collection assembly, including: a needle, a cutter movable relative to the needle, and a tissue sample holder, the cutter being in communication with the tissue sample holder to deposit one or more tissue samples into the tissue sample holder, the cutter being configured to transport the one or more tissue samples along a sampling axis; and a sensor assembly, the sensor assembly including an emitter and a detector, the emitter and detector being positioned on opposing sides of the sampling axis, the emitter being configured to emit electromagnetic energy through a tissue sample of the one or more tissue samples and to the detector while the tissue sample is moving along the sampling axis.

[0085] Example 2

[0086] The biopsy device of Example 1, the sensor assembly being proximate the tissue sample holder.

[0087] Example 3

[0088] The biopsy device of Examples 1 or 2, the sensor assembly including a body, the body being configured to support the emitter and the detector.

[0089] Example 4

[0090] The biopsy device of Example 3, the body defining a bore, the bore being configured to receive a portion of the cutter.

[0091] Example 5

[0092] The biopsy device of any of Examples 1 through 4, the emitter and the detector being disposed along a sample analysis axis, the sample analysis axis being oriented at an angle relative to the sapling axis.

[0093] Example 6

[0094] The biopsy device of Example 5, the sample analysis axis being perpendicular relative to the sampling axis.

[0095] Example 7 [0096] The biopsy device of any of Examples 1 through 6, the emitter being configured to emit electromagnetic energy as laser light.

[0097] Example 8

[0098] The biopsy device of any of Examples 1 through 7, the emitter being configured to emit electromagnetic energy as one or more of the visible light spectrum, or the infrared light spectrum.

[0099] Example 9

[00100] The biopsy device of any of Examples 1 through 8, the detector being configured to detect electromagnetic energy at a predetermined sample rate, the sample rate being 100 samples per second or more.

[00101] Example 10

[00102] The biopsy device of any of Examples 1 through 8, the detector being configured to detect electromagnetic energy at a predetermined sample rate, the sample rate being 120 samples per second or more.

[00103] Example 11

[00104] The biopsy device of any of Examples 1 through 10, the cutter including a transparent portion, the transparent portion being configured to permit electromagnetic energy emitted from the emitter to pass through the cutter to the detector.

[00105] Example 12

[00106] The biopsy device of Example 11, the transparent portion of the cutter extending from a proximal end of the cutter and terminating proximally of a distal end of the cutter.

[00107] Example 13

[00108] The biopsy device of any of Examples 1 through 12, the cutter including one or more movement control features, each movement control feature of the one or more

- 21 - movement control features being configured to manipulate movement of the one or more tissue samples through the cutter.

[00109] Example 14

[00110] The biopsy device of any of Examples 1 through 13, further comprising a data processor, the data processor being in communication with the detector to receive a sample data set from the detector, the data processor being configured to execute a Fast Fourier Transform (FFT) with respect to the sample data set to output a FFT data set.

[00111] Example 15

[00112] The biopsy device of Example 14, the data processor being further configured to execute a feature extraction algorithm and a pattern recognition algorithm with respect to the FFT data set to identify one or more calcifications within a tissue sample of the one or more tissue samples.

[00113] Example 16

[00114] A system for analyzing a tissue sample, the system comprising: at least one hardware processor; and one or more modules configured to, when executed by the at least one hardware processor: initiate emission of electromagnetic radiation from an emitter, receive signal data from a detector corresponding to the electromagnetic radiation emitted from the emitter after passing through a tissue sample, and identify the presence of one or more calcifications present in the tissue sample based on the signal data received from the detector.

[00115] Example 17

[00116] The system of Example 16, the one or more modules being further configured to apply a Fast Fourier Transform (FFT) with respect to the signal data to generate a FFT data set.

[00117] Example 18 [00118] The system of Example 17, the one or more modules being further configured to apply a feature extraction algorithm and a pattern recognition algorithm to the FFT data set.

[00119] Example 19

[00120] The system of Example 18, the feature extraction algorithms including extracting one or more attributes including frequency, amplitude, or mean distance between frequency peaks from the FFT data set to generate an extracted feature data set.

[00121] Example 20

[00122] The system of Example 19, the pattern recognition algorithm including comparing the extracted feature data set to one or more existing data sets.

[00123] Example 21

[00124] A method of determining the presence of one or more calcifications in a tissue sample, comprising: performing a scan of the tissue sample to generate scan data; applying a Fast Fourier Transform (FFT) to the scan data to generate FFT data; providing the FFT data as an input to a machine learning algorithm; and determining, based on an output of the machine learning algorithm, whether the scan data is indicative of the one or more calcifications present in the tissue sample.

[00125] Example 22

[00126] The method of Example 21, the step of performing the scan of the tissue sample includes moving the tissue sample relative to a sensor assembly including an emitter and a detector.

[00127] Example 23

[00128] The method of Example 21 or 22, the step of performing the scan of the tissue sample includes generating the scan data at a predetermined sample rate, the sample rate being 100 samples per second or more. [00129] Example 24

[00130] The method of any of Examples 21 through 23, the step of performing the scan of the tissue sample being performed while the tissue sample is being transported through a portion of a tissue collection assembly of a biopsy device.

[00131] Example 25

[00132] The method of any of Examples 21 through 24, further comprising indicating the determination of the presence of the one or more calcifications in the tissue sample on an indicator, the indicator providing an indication of no calcifications detected or calcifications detected.

[00133] Example 26

[00134] The method of any of Examples 21 through 24, further comprising indicating the determination of the presence of the one or more calcifications in the tissue sample on an indicator, the indicator providing a stop light indicator configuration.

[00135] Example 27

[00136] A biopsy system, the biopsy system comprising: a tissue collection assembly, including: a needle, a cutter movable relative to the needle, and a tissue sample holder, the cutter being in communication with the tissue sample holder to deposit one or more tissue samples into the tissue sample holder, the cutter being configured to transport the one or more tissue samples along through at least a portion of a sampling lumen extending from a distal end of the cutter and into a portion of the tissue sample holder; and a sensor assembly, the sensor assembly including an emitter and a detector, the emitter and detector being positioned on opposing sides of a portion of the sampling lumen, the emitter being configured to emit electromagnetic energy through a tissue sample of the one or more tissue samples and to the detector, the detector being configured to generate sample data corresponding to the tissue sample is response to relative movement between the sensor assembly and the tissue sample. [00137] Example 28

[00138] The biopsy system of Example 27, the cutter defining a portion of the sampling lumen.

[00139] Example 29

[00140] The biopsy system of Example 27, the cutter defining the entirety of the sampling lumen.

[00141] Example 30

[00142] The biopsy system of any of Examples 27 through 29, the detector being configured to generate the sample data corresponding to the tissue sample in response to movement of the tissue sample relative to the sensor assembly.

[00143] Example 31

[00144] The biopsy system of any of Examples 27 through 30, further comprising a probe and a holster, the holster being in communication with the probe, the probe being configured to house at least a portion of the tissue collection assembly and the sensor assembly.

[00145] Example 32

[00146] The biopsy system of any of Examples 27 through 30, further comprising a probe and a holster, the holster being in communication with the probe, the probe being configured to house at least a portion of the tissue collection assembly, the holster being configured to house at least a portion of the sensor assembly.

[00147] VI. Conclusion

[00148] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

[00149] Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

I/we claim:

1. A biopsy device, the biopsy device comprising:

(a) a tissue collection assembly, including:

(i) a needle,

(ii) a cutter movable relative to the needle, and

(iii) a tissue sample holder, the cutter being in communication with the tissue sample holder to deposit one or more tissue samples into the tissue sample holder, the cutter being configured to transport the one or more tissue samples along a sampling axis; and

(b) a sensor assembly, the sensor assembly including an emitter and a detector, the emitter and detector being positioned on opposing sides of the sampling axis, the emitter being configured to emit electromagnetic energy through a tissue sample of the one or more tissue samples and to the detector while the tissue sample is moving along the sampling axis.

2. The biopsy device of claim 1, the sensor assembly being proximate the tissue sample holder.

3. The biopsy device of claims 1 or 2, the sensor assembly including a body, the body being configured to support the emitter and the detector.

4. The biopsy device of claim 3, the body defining a bore, the bore being configured to receive a portion of the cutter.

5. The biopsy device of any of claims 1 through 4, the emitter and the detector being disposed along a sample analysis axis, the sample analysis axis being oriented at an angle relative to the sapling axis.

6. The biopsy device of claim 5, the sample analysis axis being perpendicular relative to the sampling axis.

7. The biopsy device of any of claims 1 through 6, the emitter being configured to emit electromagnetic energy as laser light.

8. The biopsy device of any of claims 1 through 7, the emitter being configured to emit electromagnetic energy as one or more of the visible light spectrum, or the infrared light spectrum.

9. The biopsy device of any of claims 1 through 8, the detector being configured to detect electromagnetic energy at a predetermined sample rate, the sample rate being 100 samples per second or more.

10. The biopsy device of any of claims 1 through 8, the detector being configured to detect electromagnetic energy at a predetermined sample rate, the sample rate being 120 samples per second or more.

11. The biopsy device of any of claims 1 through 10, the cutter including a transparent portion, the transparent portion being configured to permit electromagnetic energy emitted from the emitter to pass through the cutter to the detector.

12. The biopsy device of claim 11, the transparent portion of the cutter extending from a proximal end of the cutter and terminating proximally of a distal end of the cutter.

13. The biopsy device of any of claims 1 through 12, the cutter including one or more movement control features, each movement control feature of the one or more movement control features being configured to manipulate movement of the one or more tissue samples through the cutter.

14. The biopsy device of any of claims 1 through 13, further comprising a data processor, the data processor being in communication with the detector to receive a sample data set from the detector, the data processor being configured to execute a Fast Fourier Transform (FFT) with respect to the sample data set to output a FFT data set.

15. The biopsy device of claim 14, the data processor being further configured to execute a feature extraction algorithm and a pattern recognition algorithm with respect to the FFT data set to identify one or more calcifications within a tissue sample of the one or more tissue samples.

16. A system for analyzing a tissue sample, the system comprising:

(a) at least one hardware processor; and

(b) one or more modules configured to, when executed by the at least one hardware processor:

(i) initiate emission of electromagnetic radiation from an emitter,

(ii) receive signal data from a detector corresponding to the electromagnetic radiation emitted from the emitter after passing through a tissue sample, and

(iii) identify the presence of one or more calcifications present in the tissue sample based on the signal data received from the detector.

17. The system of claim 16, the one or more modules being further configured to apply a Fast Fourier Transform (FFT) with respect to the signal data to generate a FFT data set.

18. The system of claim 17, the one or more modules being further configured to apply a feature extraction algorithm and a pattern recognition algorithm to the FFT data set.

19. The system of claim 18, the feature extraction algorithms including extracting one or more attributes including frequency, amplitude, or mean distance between frequency peaks from the FFT data set to generate an extracted feature data set.

20. The system of claim 19, the pattern recognition algorithm including comparing the extracted feature data set to one or more existing data sets.

21. A method of determining the presence of one or more calcifications in a tissue sample, comprising:

(a) performing a scan of the tissue sample to generate scan data;

(b) applying a Fast Fourier Transform (FFT) to the scan data to generate FFT data;

(c) providing the FFT data as an input to a machine learning algorithm; and

(d) determining, based on an output of the machine learning algorithm, whether the scan data is indicative of the one or more calcifications present in the tissue sample.

22. The method of claim 21, the step of performing the scan of the tissue sample includes moving the tissue sample relative to a sensor assembly including an emitter and a detector.

23. The method of claim 21 or 22, the step of performing the scan of the tissue sample includes generating the scan data at a predetermined sample rate, the sample rate being 100 samples per second or more.

24. The method of any of claims 21 through 23, the step of performing the scan of the tissue sample being performed while the tissue sample is being transported through a portion of a tissue collection assembly of a biopsy device.

25. The method of any of claims 21 through 24, further comprising indicating the determination of the presence of the one or more calcifications in the tissue sample on an indicator, the indicator providing an indication of no calcifications detected or calcifications detected.

26. The method of any of claims 21 through 24, further comprising indicating the determination of the presence of the one or more calcifications in the tissue sample on an indicator, the indicator providing a stop light indicator configuration.

27. A biopsy system, the biopsy system comprising:

(a) a tissue collection assembly, including:

(i) a needle,

(ii) a cutter movable relative to the needle, and

(iii) a tissue sample holder, the cutter being in communication with the tissue sample holder to deposit one or more tissue samples into the tissue sample holder, the cutter being configured to transport the one or more tissue samples along through at least a portion of a sampling lumen extending from a distal end of the cutter and into a portion of the tissue sample holder; and

(b) a sensor assembly, the sensor assembly including an emitter and a detector, the emitter and detector being positioned on opposing sides of a portion of the sampling lumen, the emitter being configured to emit electromagnetic energy through a tissue sample of the one or more tissue samples and to the detector, the detector being configured to generate sample data corresponding to the tissue sample is response to relative movement between the sensor assembly and the tissue sample.

28. The biopsy system of claim 27, the cutter defining a portion of the sampling lumen.

29. The biopsy system of claim 27, the cutter defining the entirety of the sampling lumen.

30. The biopsy system of any of claims 27 through 29, the detector being configured to generate the sample data corresponding to the tissue sample in response to movement of the tissue sample relative to the sensor assembly.

31 . The biopsy system of any of claims 27 through 30, further comprising a probe and a holster, the holster being in communication with the probe, the probe being configured to house at least a portion of the tissue collection assembly and the sensor assembly.

32. The biopsy system of any of claims 27 through 30, further comprising a probe and a holster, the holster being in communication with the probe, the probe being configured to house at least a portion of the tissue collection assembly, the holster being configured to house at least a portion of the sensor assembly.