Biopsy device with in-line sample imaging outside aspiration path

Abstract

A biopsy system includes a biopsy device, a control module, and a tissue delivery tube. A biopsy device includes a probe, a needle, and a cutter. A needle extends distally from the probe. The cutter is movable relative to the needle to cut one or more tissue samples. A control module is in communication with the biopsy device and includes a sample tray configured to receive one or more tissue samples cut by the cutter. The tissue delivery tube is adapted to be connected between a tissue sample holder and a cutter of a biopsy device. The sample tray has a sampling configuration and an imaging configuration. The sample tray is configured to move between a sampling axis corresponding to the sampling configuration and an imaging axis corresponding to the imaging configuration to receive one or more tissue samples and subsequently image the one or more tissue samples received within the sample tray.

Description

priority

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 540,965, filed September 28, 2023, entitled “Biopsy Apparatus with Online Sample Imaging Outside the Aspiration Path,” the disclosure of which is incorporated herein by reference. Background Technology

[0002] Various devices and methods are used to obtain biopsy samples in a variety of medical procedures. For example, some biopsy devices are fully operable by the user with one hand and can collect one or more biopsy samples from a patient with a single puncture. Furthermore, some biopsy devices can be tethered to vacuum and / or control modules, for example, for the flow of fluids (such as compressed air, saline, atmospheric air, vacuum, etc.), for the transmission of electricity, and / or for the transmission of commands. Other biopsy devices can be fully or at least partially operable without being tethered to or otherwise connected to another device. Biopsy devices can be used under stereotactic guidance, ultrasound guidance, magnetic resonance imaging (MRI) guidance, positron emission tomography (PEM) guidance, breast-specific gamma imaging (BSGI) guidance, or other guidance methods.

[0003] Biopsy apparatus and biopsy system components are disclosed, by way of example only, in the following U.S. patents: U.S. Patent No. 5,526,822, entitled "Method and Apparatus for Automated Biopsy and Soft Tissue Collection," issued June 18, 1996; U.S. Patent No. 6,017,316, entitled "Vacuum Control System and Method for Automated Biopsy Apparatus," issued January 25, 2000; U.S. Patent No. 6,086,544, entitled "Control Apparatus for Automated Surgical Biopsy Apparatus," issued July 11, 2000; and U.S. Patent No. 6,432,065, entitled "Method for Using a Surgical Biopsy System with Remote Control for Selecting Operating Modes," issued 200... Granted August 13, 2002; U.S. Patent No. 7,442,171, entitled "Remote Finger Wheel for Surgical Biopsy Apparatus," granted October 8, 2008; U.S. Patent No. 7,854,706, entitled "Clutch and Valve System for Wireless Biopsy Apparatus," granted December 1, 2010; U.S. Patent No. 7,914,464, entitled "Surgical Biopsy System with Remote Control for Selecting Operating Modes," granted March 29, 2011; U.S. Patent No. 7,938,786, entitled "Vacuum Timing Algorithm for Biopsy Apparatus," granted May 10, 2011; U.S. Patent No. 8,083,687, entitled "With Rotary..." "Tissue biopsy device with connected finger wheel and tissue sample holder", granted December 21, 2011; U.S. Patent No. 8,118,755, entitled "Biopsy Sample Storage", granted February 21, 2012; U.S. Patent No. 8,206,316, entitled "Wireless Biopsy Device with Reusable Parts", granted June 26, 2012; U.S. Patent No. 8,491,496, entitled "Biopsy Device with Sample Storage Function", granted July 23, 2013; U.S. Patent No. 8,702,623, entitled "Biopsy Device with Independent Tissue Chamber", granted April 22, 2014; U.S. Patent No. 8,764,68 Patent No. 0, entitled "Handheld Biopsy Device with Needle-Firing Function," granted July 1, 2014; U.S. Patent No. 9,095,326, entitled "Biopsy System with Vacuum Control Module," granted August 4, 2015; U.S. Patent No. 9,326,755, entitled "Tissue Sample Holder for Biopsy Device with Large-Capacity Chamber and Pathology Chamber," granted May 3, 2016; U.S. Patent No. 9,345,457, entitled "Presenting Biopsy Samples via Biopsy Device," granted May 24, 2016; U.S. Patent No. 10,905,404, entitled "Tissue Sample Holder with Enhancement Features," granted February 2, 2021.And U.S. Patent No. 11,504,101, entitled "Biopsy Apparatus with Remote Multi-Compartment Tissue Sample Holder," granted November 22, 2022. The disclosure of each of the above-cited U.S. patents is incorporated herein by reference.

[0004] Other exemplary biopsy devices and biopsy system components are disclosed in the following U.S. patent publications: U.S. Patent Publication No. 2006 / 0074345, entitled "Biopsy Apparatus and Method," published April 6, 2006, now abandoned; U.S. Patent Publication No. 2010 / 0152610, entitled "Manually Actuated Wireless Biopsy Device with Pistol Grip," published June 17, 2010; and U.S. Patent Publication No. 2010 / 0160819, entitled "Biopsy Device with Central Grip," published June 17, 2010. The following U.S. patent applications were published on June 24, 2012, and are now abandoned: U.S. Patent Publication No. 2012 / 0283563, entitled "Biopsy Apparatus with Manifold Alignment Features and Tissue Sensors," published on November 8, 2012, and now abandoned; U.S. Patent Application No. 2013 / 0150751, entitled "Biopsy Apparatus with Insertable Probes," published on June 13, 2013; and U.S. Patent Application No. 2013 / 0324882, entitled "Control for a Biopsy Apparatus," published on December 5, 2013. The publications of each of the aforementioned U.S. patent applications, non-provisional patent applications, and provisional patent applications are incorporated herein by reference.

[0005] Although various systems and methods have been manufactured and used for obtaining biopsy samples, it is believed that no one had manufactured or used the invention described in the appended claims prior to the inventors. Attached Figure Description

[0006] Although the specification concludes with claims that specifically point out and explicitly claim protection for the present technology, it is believed that the technology will be better understood through the following description, taken in conjunction with certain examples in the accompanying drawings, in which the same reference numerals identify the same elements, wherein:

[0007] Figure 1A A three-dimensional view of an exemplary biopsy system is shown;

[0008] Figure 1B It shows Figure 1A A detailed three-dimensional view of the needle of the biopsy device in the biopsy system;

[0009] Figure 2 A perspective view of an exemplary tissue processing component that can be easily incorporated into the system of FIG1 is shown;

[0010] Figure 3A It shows Figure 2Top view of the tissue sample holder of the tissue processing component;

[0011] Figure 3B It shows Figure 3A Another top view of the tissue sample holder, which advances the tissue sample for imaging;

[0012] Figure 4 It shows Figure 3A A partial three-dimensional view of the tissue sample holder;

[0013] Figure 5A It shows that it can be easily combined with Figure 2 A perspective view of an exemplary alternative tissue sample holder in a tissue processing component, the tissue sample holder being in a delivery configuration;

[0014] Figure 5B It shows Figure 5A Another stereoscopic view of the tissue sample holder, in the imaging configuration;

[0015] Figure 5C It shows Figure 5A A front elevation view of a tissue sample holder, showing the tissue sample holder in a position... Figure 5B Imaging configuration;

[0016] Figure 6 It shows that it can be easily combined with Figure 2 A three-dimensional diagram of another exemplary alternative tissue sample holder in the tissue processing component; and

[0017] Figure 7 It shows Figure 7 A frontal elevation view of a tissue sample holder, wherein a portion of the tissue sample holder is rotated for imaging of the tissue sample.

[0018] The accompanying drawings are not intended to be limiting in any way, and it is conceivable that various embodiments of the present technology may be implemented in a variety of other ways, including those not necessarily shown in the drawings. The drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the present technology and, together with the description, serve to explain the principles of the present technology; however, it should be understood that the present technology is not limited to the precise arrangement shown. Detailed Implementation

[0019] The following description of certain examples of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is presented by way of illustration and is one of the best modes contemplated for implementing the present technology. As will be appreciated, the present technology is capable of having other different and obvious aspects, all of which do not depart from the present technology. Therefore, the drawings and descriptions should be considered illustrative in nature and not restrictive.

[0020] I. Overview of Exemplary Biopsy Systems

[0021] Figure 1A An exemplary biopsy system (2) is shown, comprising a biopsy device (10) and a vacuum control module (400). The biopsy device (10) of this example includes a probe (100) and a kit (200). A needle (110) extends distally from the probe (100) and is inserted into patient tissue to obtain a tissue sample. These tissue samples are delivered via the needle to a tissue processing assembly (300), which has a tissue delivery tube (302) connected to the proximal end of the probe (100), which will be described in more detail below. It should also be understood that the term “kit” as used herein should not be construed as requiring any part of the probe (100) to be inserted into any part of the kit (200). For example, in this example, the kit (200) includes a set of forks (not shown) received by at least a portion of the probe (100) to releasably secure the probe (100) to the kit (200). The probe (100) may optionally include one or more resilient tabs (104) that can be pressed inward to disengage from the fork arm, allowing the user to simultaneously press down two tabs (104) and then pull the probe (100) back and away from the kit (200) to separate the probe (100) from the kit (200). Of course, a variety of other types of structures, components, features, etc. (e.g., bayonet mounts, latches, clamps, clamps, snap-fits, etc.) can be used to provide a removable connection between the probe (100) and the kit (200). Furthermore, in some biopsy devices (10), the probe (100) and the kit (200) may be an integral or one-piece structure, making the two components non-separable. By way of example only, in versions where the probe (100) and the kit (200) are provided as separable components, the probe (100) may be provided as a disposable component, while the kit (200) may be provided as a reusable component. Given the teachings of this paper, other suitable structural and functional relationships between the probe (100) and the kit (200) will be apparent to those skilled in the art.

[0022] The biopsy device (10) of this example is configured to be mounted to a workbench or fixture and used under stereotactic guidance. Of course, the biopsy device (10) can alternatively be used under ultrasound guidance, magnetic resonance imaging (MRI) guidance, positron emission tomography (PEM) guidance, breast-specific gamma imaging (BSGI) guidance, or other guidance. It should also be understood that the biopsy device (10) may be sized and configured such that the biopsy device (10) can be operated by a user with one hand. Specifically, the user may grasp the biopsy device (10) with one hand, insert the needle (110) into the patient's breast, and collect one or more tissue samples from the patient's breast. Alternatively, the user may grasp the biopsy device (10) with more than one hand and / or with any desired assistance. In some cases, the user may collect multiple tissue samples by inserting the needle (110) into the patient's breast only once. Such tissue samples may be pneumatically deposited within at least a portion of the tissue processing assembly (300) and subsequently removed from the tissue processing assembly (300) for further analysis. Although the examples described herein generally involve obtaining biopsy samples from a patient's breast, it should be understood that the biopsy device (10) can be used in a variety of other procedures, for a variety of other purposes, and for a variety of other sites of a patient's anatomy (e.g., prostate, thyroid, etc.). Various exemplary components, features, configurations, and operability of the biopsy device (10) will be described in more detail below; and other suitable components, features, configurations, and operability will be apparent to those skilled in the art in light of the teachings herein.

[0023] The kit (200) of this example includes a housing (202) that encloses various components for driving the various components of the probe (100) to collect tissue samples. Although not shown, it should be understood that the kit (200) of this example includes one or more gears (not shown) that mesh with corresponding gears of the probe (100). Specifically, these gears are exposed through the upper part of the housing (202) to mesh with corresponding gears of the probe (100) when the probe (100) is coupled to the kit (200). This configuration allows the kit (200) to transmit rotational motion to the probe (100), thereby driving the various components of the probe (100) to collect tissue samples. For example, the gears may drive a hollow tubular cutter (150) within the needle (110) (see... Figure 1B The associated actuation component cuts off the tissue sample received within the lateral aperture (114) defined by the needle (110). Similarly, other gears may be used to rotate the needle (110).

[0024] As described above, in some examples, the gears associated with the kit (200) can provide rotation of the needle (110) relative to the probe (100). In this example, this rotation is manually actuated by rotating a knob (210). Specifically, the knob (210) is connected to the gears associated with the rotation of the needle (110) via a series of gears (not shown) and shafts (not shown), such that rotation of the knob (210) causes the needle (110) to rotate. By way of example only, such a needle rotation mechanism may be constructed according to the teachings of U.S. Publication No. 2008 / 0214955, the disclosure of which is incorporated herein by reference. As another example, which is merely illustrative, the needle rotation mechanism may be constructed according to the teachings of U.S. Publication No. 2010 / 0160819, the disclosure of which is incorporated herein by reference. In some other versions, the needle (110) is rotated by a motor. In yet another version, the needle (110) is simply rotated by rotating a finger wheel (116). Given the teachings herein, various other suitable ways of providing the rotation of the needle (110) will be apparent to those skilled in the art. It should also be understood that some versions may not provide the rotation of the needle (110).

[0025] The kit (200) also includes a firing lever (226) and a fork (222) that engage with the needle (110) and fire it distally. By way of example only, such firing may be useful when the biopsy device (10) is mounted to a stereotactic stage fixture or other fixation device and the tip (112) is adjacent to the patient's breast, allowing the needle firing mechanism to be actuated to drive the needle (110) into the patient's breast. The needle firing mechanism can be configured to drive the needle (110) along any suitable range of motion to drive the tip (112) to any suitable distance relative to the fixation of the probe (100).

[0026] In this example, the needle firing mechanism is connected to the needle (110) via a firing lever (226) and a firing fork (222). The firing lever (226) and the firing fork (222) are integrally fixed together. The firing fork (222) includes a pair of fork arms that receive the hub (120) of the needle (110) between the pair of fork arms. The fork arms of the firing fork (222) are positioned between the annular flange of the hub (120) and the finger wheel, such that the needle (110) will translate integrally with the firing lever (226) and the fork (222). However, the fork arm removably receives the hub member (120), such that the fork member (222) can be easily secured to the hub member (120) when the probe (100) is engaged with the kit (200); and such that the hub member (120) can be easily removed from the fork member (222) when the probe (100) is disengaged from the kit (200). The fork arm is also configured to allow the hub member (120) to rotate between the fork arms. Other suitable components, configurations, and relationships will be apparent to those skilled in the art in light of the teachings herein. The internal components of the needle firing mechanism of this example are configured and arranged as described in U.S. Non-Provisional Patent No. 8,858,465 (titled “Biopsy Device with Electric Needle Firing,” granted October 14, 2014), the disclosure of which is incorporated herein by reference.

[0027] The kit (200) in this example is powered by one or more motors (not shown) housed within a housing (202). These motors are typically configured to drive one or more gears, thereby rotating and translating a tubular cutter (150) disposed within a needle (110). The kit (200) also includes a motor (not shown) operable to drive a firing lever (226), thereby tensioning and firing the needle (110). In this example, all motors mentioned herein are housed within the kit (200) and receive power from a vacuum control module (400) via a cable (90). Furthermore, data can be transmitted between the vacuum control module (400) and the kit (200) via the cable (90). In some other versions, one or more motors are powered by one or more batteries located within the kit (200) and / or the probe (100). Therefore, it should be understood that, like the other components described herein, the cable (90) is merely optional. As another illustrative variation, the motor may be pneumatically driven, such that the cable (90) may be replaced by a conduit for conveying pressurized fluid medium to the kit (200). As yet another illustrative variation, the cable (90) may comprise one or more rotary drive cables driven by a motor located outside the kit (200). It should also be understood that two or three motors may be combined into a single motor. Other suitable ways in which various motors are driven will be apparent to those skilled in the art in light of the teachings herein.

[0028] The probe (100) in this example includes a needle (110) extending distally from the probe (100) and inserted into the patient's tissue to obtain a tissue sample. Such a tissue sample is delivered proximally through the needle (110) into a delivery tube (302), where the tissue sample can be deposited within at least a portion of a tissue processing assembly (300), which will be described in more detail below. A vacuum control module (400) is coupled to the probe (100) via a valve assembly (500) and tubes (20, 30), operable to selectively supply the probe (100) with vacuum, saline, atmospheric air, and exhaust. Although this example shows paired tubes (20, 30), it should be understood that in some examples, one tube may be omitted and replaced by the tissue delivery tube (302) discussed below. The internal components of the valve assembly in this example are configured and arranged as described in U.S. Publication No. 2013 / 0218047 entitled “Biopsy Device Valve Assembly”, published on August 22, 2013, the disclosure of which is incorporated herein by reference.

[0029] As described above, the probe (100) may include one or more gears to engage with corresponding gears of the kit (200). These gears are operable to drive the cutter actuation mechanism in the probe (100). The probe (100) may also include another gear configured to engage with corresponding gears of the kit (200) to rotate the needle (110).

[0030] The needle (110) of this example includes a cannula (113) having a tissue puncture tip (112), a lateral aperture (114) proximal to the tip (112), and a hub member (120). The tissue puncture tip (112) is configured to puncture and penetrate tissue without requiring significant force or pre-forming an opening in the tissue prior to insertion of the tip (112). Alternatively, the tip (112) may be blunt (e.g., rounded, flat, etc.) if desired. By way of example only, the tip (112) may be configured in accordance with any teachings in U.S. Patent No. 8,801,742, entitled “Needle Assembly and Blade Assembly for Biopsy Device,” issued August 12, 2014, the disclosure of which is incorporated herein by reference. As another illustrative example only, the tip (112) may be configured in accordance with at least some of the teachings of U.S. Patent No. 9,486,186, entitled “Biopsy Device with Insertion Probe,” issued November 8, 2016, the disclosure of which is incorporated herein by reference. Other suitable configurations that may be used for the tip (112) in light of the teachings herein will be apparent to those skilled in the art.

[0031] The lateral aperture (114) is sized to receive prolapsed tissue during operation of the device (10). Although not shown, it should be understood that a hollow tubular cutter (150) with a sharp distal edge is located within the needle (110). The cutter (150) is operable to rotate and translate relative to the needle (110) and through the lateral aperture (114) to cut a tissue sample from tissue protruding through the lateral aperture (114). For example, the cutter (150) can move from an extended position to a retracted position, thereby “opening” the lateral aperture (114) to allow tissue protrusion through; and then move back from the retracted position to the extended position to cut off the protruding tissue. As will be described in more detail below, the needle (110) can be rotated to orient the lateral aperture (114) at any desired angular position about the longitudinal axis of the needle (110). In this example, such rotation of the needle (110) is facilitated by a hub member (120), which will be described in more detail below.

[0032] In some examples, the needle (110) also includes a longitudinal wall (not shown) extending proximally from a proximal portion of the tip (112). In such examples, the wall may extend only a length less than the full length of the cannula (113). However, in other examples, the wall may extend the full length of the cannula (113) if desired. When the needle (110) includes this wall, the wall may define a double-lumen structure within the needle (110). In examples where the wall extends only a portion of the needle (110), it should be understood that at least a portion of the cutter (150) may also define a double-lumen structure of the needle (110). Furthermore, to facilitate fluid flow between the lumens, the wall may include multiple openings (not shown). Examples of such configurations are disclosed in U.S. Patent No. 7,918,803 (titled “Methods and Apparatus for Automated Biopsy and Soft Tissue Collection,” issued April 5, 2011), the disclosure of which is incorporated herein by reference. Of course, any other suitable configuration may be used, as with any other component described herein.

[0033] In this example, the hub member (120) is overmolded around the needle (110) such that the hub member (120) and the needle (110) rotate and translate integrally with each other. By way of example only, the needle (110) may be formed of metal, and the hub member (120) may be formed of a plastic material overmolded around the needle (110) to integrally secure and form the hub member (120) to the needle (110). The hub member (120) and the needle (110) may also be formed of any other suitable material or one or more, and may be secured together in any other suitable manner. In this example, the hub member (120) defines a finger wheel feature to provide manual rotation of the needle. Given the teachings herein, various other suitable ways of providing manual rotation of the needle (110) will be apparent to those skilled in the art. It should also be understood that rotation of the needle (110) can be automated in various ways, including, but not limited to, the various forms of automated needle rotation described in the various references cited herein.

[0034] As described above, the needle (110) houses a hollow tubular cutter operable to simultaneously translate and rotate relative to the needle (110) to cut a tissue sample from tissue protruding through a lateral aperture (114). Although not shown, it should be understood that in some examples, such a cutter (150) may be operatively coupled to a cutter drive mechanism disposed within the probe. Such a cutter drive mechanism may communicate with one or more gears that may mesh with one or more corresponding gears of the kit (200). Thus, the cutter drive mechanism may be driven by the gears of the kit (200) to simultaneously rotate and translate the cutter (150) disposed within the needle (110). In some examples, the cutter (150) drive mechanism may include various threaded and keyed features to facilitate simultaneous rotation and translation of the cutter (150). In such examples, a single rotary input may be converted by the cutter drive mechanism into both rotation and translation of the cutter (150). Alternatively, in other examples, rotation and translation of the cutter (150) may be provided by a separate rotary input. In another example, rotation and translation of the cutter (150) can be provided by the combined action of two rotational inputs, for example by two gears moving at different rotational speeds. In some versions, the aforementioned cutter actuation components are further configured according to at least some of the teachings in U.S. Patent No. 9,345,457, entitled “Presenting a Biopsy Sample via a Biopsy Apparatus,” issued May 24, 2016, the disclosure of which is incorporated herein by reference. As another example, merely illustrative, the cutter (150) disposed within the needle (110) can be rotated and / or translated using a pneumatic motor or the like. Other suitable ways in which the cutter (150) disposed within the needle (110) can be actuated in light of the teachings herein will be apparent to those skilled in the art.

[0035] II. Exemplary tissue processing components

[0036] The tissue processing component (300) is shown in Figure 1- Figure 4 As best shown in Figure 1, at least a portion of the tissue processing assembly (300) is incorporated into the vacuum control module (400). However, it should be understood that in other examples, the tissue processing assembly (300) may be completely independent of the vacuum control module (400). The tissue processing assembly (300) of this example includes a tissue delivery tube (302) and a tissue processor (310). The tissue delivery tube (302) extends from the tissue processor (310) to the biopsy device (10). As will be described in more detail below, the tissue delivery tube (302) is generally configured to receive tissue samples from a cutter (150) disposed within a needle (110) and to transfer such tissue samples from the biopsy device (10) to the tissue processor (310).

[0037] The tissue processor (310) typically includes a housing (312) and a collection drawer (320). As will be described in more detail below, the tissue processor (310) is typically configured to receive multiple tissue samples from a tissue delivery tube (302). The tissue samples are then typically arranged in a predetermined configuration. As will also be described in more detail below, the tissue processor (310) may include various sample analysis features to provide operating room analysis of the tissue samples collected within the tissue processor (310). Suitable analytical features may include, among others, X-ray emitters and receivers, CCD cameras for visual examination, bioimpedance sensors, and / or others.

[0038] A collection drawer (320) is received within a portion of the housing (312). The collection drawer (320) is typically translatable into and out of the housing (312) to provide access to the interior of the collection drawer (320), thereby allowing the removal of tissue samples and / or various components from the tissue processor (310), as will be described in more detail below. In some examples, the collection drawer (320) is manually operable to translate relative to the housing (312). In other examples, the translation of the collection drawer (310) is powered by a motor-driven or pneumatically driven assembly to provide automatic or semi-automatic translation of the collection drawer (310).

[0039] like Figure 2As best shown, the interior of the collection drawer (320) includes a base plate (324) defining an interior space (326) and multiple side walls (322). A tissue delivery tube (302) is configured to communicate with the interior space (326) of the collection drawer (320) via a tube port (328) disposed in at least one side wall (322) of the collection drawer (320). Although not shown, it should be understood that in some examples, the side walls (322) and / or the base plate (324) may include one or more ports to provide drainage of fluid from the collection drawer (320). For example, in some cases, the biopsy device (10) is used with saline or other fluid media. During the tissue sample collection process, at least some waste fluid from the biopsy operation can flow into the interior space (326) of the collection drawer (320). Therefore, in such examples, it may be desirable to include drainage ports through the side walls (322) and / or the base plate (324).

[0040] In this example, the collection drawer (320) houses a tissue sample holder (340) within an internal space (326) defined by sidewalls (322) and a base plate (324). The tissue sample holder (340) of this example is typically in communication with a tissue delivery tube (302) to receive multiple tissue samples in a predetermined arrangement or configuration. The tissue sample holder (340) of this example includes a sample tray (350) having an elongated rectangular structure and configured to translate relative to the tissue delivery tube (302) within the collection drawer (320). As will be described in more detail below, the sample tray (350) is typically in a cassette configuration such that the sample tray (350) is translatable within the collection drawer (320) to continuously collect tissue samples within discrete portions of the sample tray (350). In some examples, the tissue sample holder (340) may further include one or more tray containers, lids, or housings that can be configured to removably receive the sample tray (350). In such examples, such a tray container may be desirable for controlling the vacuum applied to the sample tray (350) or managing the fluid transferred to one or more portions of the sample tray (350). Of course, in other versions, such a tray container is entirely optional and may be omitted.

[0041] The sample tray (350) of this example includes a rectangular body (352) having a plurality of partition walls (354) defining a plurality of sample chambers (356). The front portion of the rectangular body (352) defines a plurality of receiving openings (358) communicating with each corresponding sample chamber (356). Simultaneously, the rear portion of the rectangular body (352) defines a plurality of vacuum openings (360), also communicating with each corresponding sample chamber (356). Each receiving opening (358) is configured to independently communicate with a tissue delivery tube (302) such that one or more tissue samples can be transferred into the corresponding sample chamber (356). Correspondingly, each vacuum opening (360) is configured to communicate with a vacuum tube (304) disposed opposite to the tissue delivery tube (302) such that a vacuum can be transmitted into the corresponding sample chamber (356) to draw one or more tissue samples into the corresponding sample chamber (356) under a vacuum transmitted via the vacuum tube (304).

[0042] The upper portion of the rectangular body (352) is typically open or otherwise exposed to the exterior of the sample tray (350), allowing access to each sample chamber (356) from the upper portion of the rectangular body (352). In other examples, one or more portions of the rectangular body (352) may be configured to be selectively covered, for example, through a door, cover, housing, and / or others. In some examples, such selective covering may be desirable to control the vacuum flow through the sample chambers (356), particularly during the transport of one or more tissue samples. Thus, in some examples, each sample chamber (356) may be independently coverable, such that only the specific sample chamber (356) receiving one or more tissue samples may be covered. In other examples, all sample chambers (356) may be covered simultaneously. In yet another example, such covering may be omitted, and the vacuum may be controlled by other components such as fixtures or housings associated with the collection drawer (320).

[0043] The lower part of the rectangular body (352) includes a base plate (362) (see...). Figure 3A and Figure 3B In this example, the base plate (362) is formed of a material that is generally solid. While the base plate (362) in this example is generally impermeable, in some examples, the base plate (362) may have at least some permeability. For example, in some examples, the base plate (362) includes a semi-permeable membrane or mesh configured to allow fluid to pass through the base plate (362). Such permeability may be desirable for controlling the fluid entering the sample tray (350). Therefore, in other examples, the base plate (362) is generally impermeable but may include other fluid management features such as ports, valves, and / or others. In another example, fluid may be controlled via a vacuum tube (304).

[0044] like Figure 3A As shown, a sample tray (350) is positioned between the proximal end of a tissue delivery tube (302) and the distal end of a vacuum tube (304), wherein the delivery tube (302) and the vacuum tube (304) are aligned along a common axis that extends substantially perpendicular to the longitudinal axis of the sample tray (350). Thus, both the tissue delivery tube (302) and the vacuum tube (304) are configured to communicate with selected sample chambers (356) of a plurality of sample chambers (356) depending on the axial position of the sample tray (350) relative to the tissue delivery tube (302) and the vacuum tube (304). To facilitate this communication, one or more portions of the sample tray (305) may include slidable seals, guides, or other structures configured to allow the tissue delivery tube (302) and the vacuum tube (304) to seal with each opening (358, 360) while allowing the sample tray (350) to slide relative to the tissue delivery tube (302) and the vacuum tube (304).

[0045] As described above, the sample tray (350) is typically configured to translate relative to the tissue delivery tube (302) and the vacuum tube (304). In some examples, the tissue sample holder (340) includes one or more translation mechanisms configured to facilitate the translation of the sample tray (350). It should be understood that such translation mechanisms can take many forms, such as linear actuators, rack-and-pinion translators, wheel-based translators, and / or others. Such mechanisms can also be motor-driven or mechanically driven (e.g., by a spring-loaded mechanism). In other examples, the translation of the sample tray (350) can be manually controlled by an operator. In other examples, the sample tray (350) is secured within a collection drawer (320), while the delivery tube (302) and the vacuum tube (304) are configured to translate via one or more translation mechanisms similar to those described above.

[0046] like Figure 3A , Figure 3B and Figure 4 As best shown, in use, the sample tray (350) is configured to receive tissue samples in each sample chamber (356) and to image each received tissue sample upon receipt. Figure 3A As shown, the sample tray (350) can be initially aligned relative to the tissue delivery tube (302) and the vacuum tube (304), such that a predetermined initial sample chamber (356) is aligned with the tissue delivery tube (302) and the vacuum tube (304). In this example, the predetermined initial sample chamber (356) corresponds to the rightmost sample chamber (356), although any other sample chamber (356) may be used in other examples.

[0047] Regardless of the specific predetermined initial sample chamber (356), tissue samples can be transferred into the predetermined initial sample chamber (356) via a tissue delivery tube (302) and a vacuum tube (304). The tissue delivery tube (302) and the vacuum tube (304) work together to use the vacuum provided by the vacuum tube (304) to transport the tissue sample from the biopsy device (10) into the predetermined initial sample chamber (356). Although not shown, it should be understood that the sample tray (350) and / or the vacuum tube (304) may include one or more tissue stop structures configured to prevent the tissue sample from advancing from a given sample chamber (356) into the vacuum tube (304).

[0048] Once tissue samples are available Figure 3A As shown, the sample is received in a predetermined initial sample chamber (356), and the sample tray (350) can be advanced to position the predetermined initial sample chamber (356) aligned with the imaging axis (IA), as... Figure 3B As shown. In this example, the advancement is shown as pushing the sample tray (350) to the right towards a single sample chamber (356). However, it should be understood that different advancement methods or modes may be used in other examples. In this example, the advancement of the single sample chamber (356) may be desired to simultaneously align the next adjacent open sample chamber (356) with the tissue delivery tube (302) and the vacuum tube (304) for delivering another tissue sample while imaging.

[0049] Once the sample tray (350) is Figure 3B The illustrated propulsion method allows imaging of tissue samples positioned within a predetermined initial sample chamber (356). Specifically, as shown... Figure 4 As best shown, the tissue processing component (300) also includes an analysis component (380) aligned with the imaging axis (IA). The analysis component (380) is typically configured to analyze one or more properties of the tissue. For example, in this example, the analysis component (380) includes an X-ray source (382) and an X-ray detector (384). Both the X-ray source (382) and the X-ray detector (384) are operable to collaboratively image the tissue sample when it is aligned with the imaging axis (IA). In some examples, this X-ray-based imaging may be desirable to detect the presence of one or more calcifications within the tissue sample in real time, thereby providing the operator with feedback that can be used to collect subsequent tissue samples.

[0050] After analysis using the analysis component (380), another tissue sample can be collected in another sample chamber (356). As mentioned above, in some examples, the subsequent collection of another tissue sample may also occur simultaneously with the analysis or imaging. In any case, the process of tissue sample collection and analysis or imaging can then be repeated to continuously fill each sample chamber (356) of the sample tray (350), or until the desired number of tissue samples has been collected.

[0051] III. Exemplary Alternative Sample Trays

[0052] As described above, the tissue sample holder (340) includes a sample tray (350) with a generally box-like configuration. However, in some examples, it may be desirable to incorporate different sample trays with different configurations into the tissue sample holder (340). Such alternative sample tray configurations may be desired to provide the aforementioned real-time sample analysis capabilities, combined with certain alternative functions to achieve different operational objectives. For example, in some cases, different sizes or operational footprints may be desired. Additionally or alternatively, different functionalities may be desired, such as separating aspects of sample analysis from sample storage. Although certain specific alternative sample trays (450, 550) are described below, it should be understood that such alternative sample trays (450, 550) may include one or more features of the sample tray (350) described above. Furthermore, in some examples, one or more sample trays (350, 450, 550) described herein may be used in combination with other sample trays (350, 450, 550).

[0053] Figure 5A and Figure 5B An exemplary alternative sample tray (450) is shown that can be easily incorporated into the tissue sample holder (340) described above. The sample tray (450) is typically configured to receive one or more tissue samples within a portion therein and to manipulate such received tissue samples for further analysis or imaging. As will be understood, the sample tray (450) of this example can be used in combination with or in place of the sample tray (350).

[0054] like Figure 5AAs best shown, the sample tray (450) of this example includes a body (452) defining a sample chamber (456) and a pivot (470). The body (452) typically defines a prismatic or pie-shaped exterior, with the sample chamber (456) oriented adjacent to the wider portion of the body (452) and the pivot (470) oriented adjacent to the narrower portion of the body (452). As will be described in more detail below, the body (452) is typically configured to move relative to the tissue delivery tube (302) and / or the vacuum tube (304) to move the sample chamber (456) between the tissue delivery axis defined by the tissue delivery tube (302) and the imaging axis (IA).

[0055] The sample chamber (456) typically extends longitudinally through the body (452) from the distal end to the proximal end. Thus, the sample chamber (456) defines an open distal end (458) and an open proximal end (not shown). The open distal end (458) is configured to selectively communicate with a tissue delivery tube (302), while the open proximal end is configured to selectively communicate with a vacuum tube (304). As will be described in more detail below, the sample chamber (456) is configured to receive one or more tissue samples from the tissue delivery tube (302) via the open distal end (458). Optionally, one or more received tissue samples may be transported out of the sample chamber (456) via the open proximal end and the vacuum tube (304). Thus, in some examples, the sample tray (450) is configured as a temporary tissue sample storage container, in which one or more tissue samples may be held for imaging or analytical purposes before being transported to another container for final tissue sample storage.

[0056] The sample chamber (456) is typically defined by a rectangular or trapezoidal cross-sectional shape, although other shapes may be used. In this example, the shape of the sample chamber (456) is generally a function of the shape of the body (452). Therefore, the shape of the sample chamber (456) generally corresponds to the shape of the wider portion of the body (452). In other examples, the sample chamber (456) has a shape independent of the shape of the body (452). For example, in some examples, the sample chamber (456) is cylindrical or elliptical. Of course, given the teachings herein, it will be apparent to those skilled in the art that various alternative shapes may be used for the sample chamber (456).

[0057] In this example, the ontology (452) defines a single sample chamber (456), which is typically sized to receive a single tissue sample. In other examples, the specific configuration of the sample chamber (456) may be varied. For example, in some examples, the ontology (452) defines multiple sample chambers (456). Alternatively or concurrently, the ontology (452) defines sample chambers (456) of different sizes, which are configured to receive multiple tissue samples.

[0058] As described above, the sample chamber (456) is configured to communicate with the tissue delivery tube (302) and / or the vacuum tube (304). Therefore, it should be understood that the body (452) and / or the sample chamber (456) may be equipped with certain sealing features configured to engage the tissue delivery tube (302) and / or the vacuum tube (304). As an example only, suitable sealing features may include O-rings and / or gaskets, which, in combination with other structural features such as housings, retaining devices, springs, and / or others, are possible. Such sealing features are typically configured to facilitate a seal between the sample chamber (456) and the tubes (302, 304) while allowing selective movement of the body (452) relative to the tubes (302, 304).

[0059] The pivot (470) is positioned adjacent to a narrower portion of the body (452) or opposite to the position of the sample chamber (456). The pivot (470) typically defines an axis about which the body (452) can pivot. Although not shown, it should be understood that the pivot (470) may include other structural features such as rods, bearings, blocks, pivot points, levers, arms, and / or others. For example, in some examples, the pivot (470) is connected to a rod that is in communication with a motor to drive the rotation of the pivot (470) via the rod.

[0060] like Figures 5A to 5C As shown, the sample tray (450) is used to collect tissue samples from the tissue delivery tube (302) along the sampling axis, and then move away along the sampling axis to align with the imaging axis for imaging or other analysis of the collected tissue samples. Figure 5A Ideally, the sample tray (450) is initially positioned such that the sample chamber (456) is aligned with the sampling axis defined by the tissue delivery tube (302) and / or the vacuum tube (304). During this alignment, a vacuum is provided to the open proximal end of the sample tray (450) to aspirate tissue samples through the tissue delivery tube (302) and through the open distal end (458) into the sample chamber (456). Alternatively, in some examples, in addition to or in lieu of a vacuum from the vacuum tube (304), positive pressure saline is used to push the tissue sample into the sample chamber (456).

[0061] Once a tissue sample is received within the sample chamber (456), the sample tray (450) includes one or more features to prevent the tissue sample from advancing, thereby retaining the tissue sample within the sample chamber (456). Suitable structures for preventing the advancement of the tissue sample may include, for example, a movable or fixed screen or mesh, a movable gate, a flexible seal, one or more tapering features within the sample chamber (456), and / or others. In other examples, the prevention of the tissue sample's advancement may be functionally facilitated. For example, a vacuum and / or saline source may be shut off to eliminate the force applied to the tissue sample to move along the sampling axis. In such examples, the shut-off of the vacuum and / or saline source may be based on a count or a timer. In other examples, the shut-off of the vacuum and / or saline source may be based on a sensor associated with the sample tray (450), which may be used to detect the presence of a tissue sample within the sample chamber (456).

[0062] Once the tissue sample has stopped advancing within the sample chamber (456), it may be desirable to image or otherwise analyze the tissue sample received within the sample chamber (456). Such imaging or other analysis may be desired to provide real-time feedback to the operator instructing them to collect additional tissue samples. For example, if one or more calcifications are detected in the tissue sample, the operator may collect additional samples from a similar area. Alternatively, if no calcifications are detected in the tissue sample, the operator may reposition the biopsy device (10) to collect additional tissue samples from another area.

[0063] like Figure 5B and Figure 5C As best shown, tissue samples received in the sample chamber (456) are analyzed by rotating or moving the sample tray (450) about a pivot (470) and relative to the tubes (302, 304). This moves the sample chamber (456) away from the sampling axis and aligns it with the imaging axis (IA) defined by the X-ray source (382) and X-ray detector (384) of the analysis assembly (380). Once the sample chamber (456) is moved and aligned with the imaging axis (IA), the X-ray source (382) and X-ray detector (384) are activated to image the tissue sample.

[0064] After imaging and / or analyzing the tissue sample, it may be desirable to remove the tissue sample from the sample chamber (456) to empty the sample chamber (456) for the collection of one or more additional tissue samples. For example, in this example, the sample tray (450) is moved back to alignment with the sampling axis (see Figure 5AOnce the sample tray (450) is moved back to alignment with the sampling axis, a vacuum tube (304) can be used to transport tissue samples from the sample chamber (456) to one or more additional sample trays of a tissue sample holder (340) configured to hold the tissue samples. It should be understood that such additional sample trays can take various configurations, such as cassette configurations, rotary configurations, or high-capacity configurations (e.g., single-chamber sample baskets). Although this example uses a vacuum tube (304) for transporting tissue samples after imaging or analysis, it should be understood that in other examples, dedicated transport tubes may be used. For example, in some examples, another transport tube may be aligned with the imaging axis (IA). After imaging and / or analysis, another transport tube may be used to transport tissue samples without requiring the sample tray (450) to be moved. In other examples, subsequent removal of the tissue samples may be performed manually, with the tissue samples being manually removed from the sample chamber (456) by an operator.

[0065] Figure 6 An exemplary alternative sample tray (550) is shown, which is similar to the sample tray (450) described above. For example, like the sample tray (450), the sample tray (550) of this example is generally configured to receive one or more tissue samples within a portion thereof and to manipulate such received tissue samples for further analysis or imaging. As will be understood, the sample tray (550) of this example can be used in combination with or in place of the sample trays (350, 450) described above.

[0066] As can be seen, the sample tray (550) of this example includes a body (552) that defines a first portion (551), a second portion (561), and a pivot (570). The first portion (551) and the second portion (561) each define a corresponding sample chamber (556, 566), wherein the pivot (570) is disposed between the sample chambers (556, 566). Thus, unlike the body (452) described above, the body (552) of this example typically defines a biprismatic or bidisc-shaped exterior, wherein the sample chambers (556, 566) are oriented adjacent to each wider portion of the body (552), and the pivot (570) is oriented adjacent to the narrower portion of the body (552). In other words, the body (552) defines a generally hourglass-shaped cross-section with two wider portions opposite the narrower portions. As will be described in more detail below, the body (552) is generally configured to move relative to the tissue delivery tube (302) and / or the vacuum tube (304) so ​​that the sample chamber (556, 566) moves between the tissue delivery axis defined by the tissue delivery tube (302) and the imaging axis (IA).

[0067] Each sample chamber (556, 566) typically extends longitudinally through the body (552) from its distal end to its proximal end. Thus, each sample chamber (556, 566) defines a corresponding open distal end (558, 568) and an open proximal end (not shown). Each open distal end (558, 568) is configured to selectively communicate with the tissue delivery tube (302), while each corresponding open proximal end is configured to selectively communicate with the vacuum tube (304). As will be described in more detail below, each sample chamber (556, 566) is configured to receive one or more tissue samples from the tissue delivery tube (302) via its corresponding open distal end (558, 568). Optionally, one or more received tissue samples may be delivered from each sample chamber (556, 566) via the open proximal end and the vacuum tube (304). Therefore, in some examples, the sample tray (550) is configured as a temporary tissue sample storage container, in which one or more tissue samples can be held for imaging or analytical purposes before being transferred to another container for final tissue sample storage.

[0068] Each sample chamber (556, 566) typically defines a rectangular or trapezoidal cross-sectional shape, although other shapes may be used. In this example, the shape of each sample chamber (556, 566) is typically a function of the shape of the body (552). Therefore, the shape of each sample chamber (556, 566) typically corresponds to the shape of the wider portion of the body (552). In other examples, each sample chamber (556, 566) has a shape independent of the shape of the body (552). For example, in some examples, each sample chamber (556, 566) is cylindrical or elliptical. Alternatively or alternatively, each sample chamber (556, 566) defines a different shape relative to the other sample chambers (566, 556). Of course, given the teachings herein, it will be apparent to those skilled in the art that various alternative shapes may be used for each sample chamber (556, 566).

[0069] In this example, the ontology (552) defines a single sample chamber (556, 566) for each section (551, 561). Furthermore, each chamber (556, 566) is typically sized to receive a single tissue sample. In other examples, the specific construction of each sample chamber (556, 566) can easily vary, either independently or identically. For example, in some examples, the ontology (552) defines multiple sample chambers (556, 566) within each section (551, 561). Alternatively or concurrently, the ontology (552) defines sample chambers (556, 566) of different sizes, configured to receive multiple tissue samples.

[0070] As described above, each sample chamber (556, 566) is configured to communicate with the tissue delivery tube (302) and / or the vacuum tube (304). Therefore, it should be understood that the body (552) and / or each sample chamber (556, 566) may be equipped with certain sealing features configured to engage the tissue delivery tube (302) and / or the vacuum tube (304). As an example only, suitable sealing features may include O-rings and / or gaskets, which, in combination with other structural features such as housings, retaining devices, springs, and / or others, are possible. Such sealing features are generally configured to facilitate a seal between each sample chamber (556, 566) and the tube (302, 304) while allowing selective movement of the body (552) relative to the tube (302, 304).

[0071] In addition to the sealing features described above, in some examples, the body (552) and / or each sample chamber (556, 566) are configured with certain vacuum management features. For example, such as Figure 6 As shown, in some examples, the vacuum tube (304) is laterally offset relative to the tissue delivery tube (302). This configuration may be desirable to facilitate the collection of tissue samples within one sample chamber (556, 566), while another tissue sample is delivered from another sample chamber (566, 556). In such examples, it may still be desirable to provide a vacuum to the tissue delivery tube (302) via a given sample chamber (556, 566). Therefore, such vacuum management features can be configured to selectively or continuously deliver a vacuum from the vacuum tube (304) to one or both of the sample chambers (556, 566). Suitable vacuum management features include manifolds, one or more channels extending through the body (552), additional tubes, and / or others, etc. In other examples, a vacuum is delivered to each sample chamber (556, 566) separately via a dedicated vacuum tube for each sample chamber (556, 566).

[0072] A pivot (570) is positioned adjacent to a narrower portion of the body (552) or between each sample chamber (556, 566). The pivot (570) typically defines an axis about which the body (552) can pivot. Although not shown, it should be understood that the pivot (570) may include other structural features such as rods, bearings, blocks, pivot points, levers, arms, and / or others. For example, in some examples, the pivot (570) is connected to a rod that is in communication with a motor to drive rotation of the pivot (570) via the rod.

[0073] like Figure 6 and Figure 7As best shown, the sample tray (550) is used to collect tissue samples from the tissue delivery tube (302) along the sampling axis, and then move away along the sampling axis to align with the imaging axis for imaging or other analysis of the collected tissue samples. However, unlike the sample tray (450) described above, the sample tray (550) of this example is configured to simultaneously collect and image or otherwise analyze tissue samples using two sample chambers (556, 566). Figure 6 Ideally, the sample tray (550) is initially positioned such that the first sample chamber (556) is aligned with the sampling axis defined by the tissue delivery tube (302). Simultaneously, the second sample chamber (566) is aligned with the imaging axis (IA), allowing imaging or other analysis of the second sample chamber (566) while tissue samples are collected within the first sample chamber (556). During this alignment, a vacuum may optionally be provided to the open proximal end of the sample tray (550) and may be delivered to the first sample chamber (556) via a manifold or other vacuum management feature to aspirate tissue samples through the tissue delivery tube (302) and into the first sample chamber (556) through the open distal end (558). Alternatively, in some examples, positive pressure saline may be used to push the tissue sample into the first sample chamber (556) in addition to or instead of a vacuum from the vacuum tube (304).

[0074] Once a tissue sample is received within the first sample chamber (556), the sample tray (550) includes one or more features to prevent the tissue sample from advancing, thereby retaining the tissue sample within the first sample chamber (556). Suitable structures for preventing the advancement of the tissue sample may include, for example, a movable or fixed screen or mesh, a movable gate, a flexible seal, one or more tapering features within the first sample chamber (556), and / or others. In other examples, the prevention of the tissue sample's advancement may be functionally facilitated. For example, a vacuum and / or saline source may be shut off to eliminate the force applied to the tissue sample to move along the sampling axis. In such examples, the shut-off of the vacuum and / or saline source may be based on a count or a timer. In other examples, the shut-off of the vacuum and / or saline source may be based on a sensor associated with the sample tray (550), which may be used to detect the presence of a tissue sample within the first sample chamber (556).

[0075] Once the tissue sample stops advancing within the first sample chamber (556), it may be desirable to image or otherwise analyze the tissue sample received within the first sample chamber (556). Figure 6 and Figure 7As best shown, the tissue sample received in the first sample chamber (556) is analyzed by rotating or moving the sample tray (550) about a pivot (570) and relative to the tubes (302, 304). This moves the first sample chamber (556) away from the sampling axis and aligns it with the imaging axis (IA) defined by the X-ray source (382) and X-ray detector (384) of the analysis assembly (380). Simultaneously, this movement moves the second sample chamber (566) away from the imaging axis (IA) and aligns it with the sampling axis. Once the first sample chamber (556) is aligned with the imaging axis (IA), the X-ray source (382) and X-ray detector (384) are activated to image the tissue sample. Furthermore, once the second sample chamber (566) is aligned with the sampling axis, the second sample chamber (566) is configured to receive another tissue sample, as similarly described above with respect to the first sample chamber (556). In some examples, the reception of this other tissue sample may optionally occur simultaneously with imaging or other analysis via the analysis component (380).

[0076] After imaging and / or analysis of a tissue sample, it may be desirable to remove the tissue sample from the first sample chamber (556) to empty the first sample chamber (556) for collecting one or more additional tissue samples. For example, in this example, a vacuum tube (304) is positioned aligned with the imaging axis (IA). Thus, in this example, the vacuum tube (304) is used to remove the tissue sample from the first sample chamber (556) after imaging or other analysis without additional movement of the body (552). Meanwhile, a second sample chamber (566) may receive another tissue sample therein simultaneously, before, or after this. The vacuum tube (304) can be used to transport the tissue sample from the first sample chamber (556) to one or more additional sample trays of a tissue sample holder (340) configured to hold the tissue sample. It should be understood that such additional sample trays may take various configurations, such as a cassette configuration, a rotary configuration, or a high-capacity configuration (e.g., a single-chamber sample basket). Although this example uses a vacuum tube (304) for transporting tissue samples after imaging or analysis, it should be understood that dedicated transport tubes may be used in other examples. For example, in some examples, a dedicated transport tube may be aligned with the imaging axis (IA), while the vacuum tube (304) may be aligned with the sampling axis. After imaging and / or analysis, another transport tube may be used to transport the tissue sample, again without requiring the sample tray (450) to be moved. In other examples, subsequent removal of the tissue sample may be performed manually by an operator removing the tissue sample from the first sample chamber (556). After removing the tissue sample from the first sample chamber (556), the same procedure described above may be repeated for the second sample chamber (566).

[0077] IV. Exemplary Combinations

[0078] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be filed at any time in this application or in any subsequent filing. No waiver is intended. The following examples are provided for illustrative purposes only. It is conceivable that the various teachings herein may be arranged and applied in many other ways. It is also conceivable that some variations may omit certain features mentioned in the following examples. Therefore, no aspect or feature mentioned below should be considered critical unless explicitly stated by the inventor or an interested party at a later date. If any claim is filed in this application or in any subsequent filing related to this application that includes additional features beyond those mentioned below, such additional technical features should not be considered added for any patentability-related reason.

[0079] Example 1

[0080] A biopsy system includes: a biopsy device comprising: a probe, a needle extending from the probe, and a cutter movable relative to the needle to cut one or more tissue samples; a control module in communication with the biopsy device, the control module including a tissue sample holder, the tissue sample holder including a sample tray configured to receive one or more tissue samples cut by the cutter; and a tissue delivery tube adapted to connect between the tissue sample holder and the cutter of the biopsy device, the sample tray having a sampling configuration and an imaging configuration, the sample tray being configured to move between a sampling axis corresponding to the sampling configuration and an imaging axis corresponding to the imaging configuration to receive one or more tissue samples and subsequently image the one or more tissue samples received within the sample tray.

[0081] Example 2

[0082] According to the biopsy system described in Example 1, the sample tray includes a rectangular body that defines a plurality of sample chambers arranged along the longitudinal axis of the rectangular body.

[0083] Example 3

[0084] According to the biopsy system described in Example 2, the sample tray is configured to translate in a direction parallel to the longitudinal axis of the body to move one of the multiple sample chambers from the sampling axis to the imaging axis.

[0085] Example 4

[0086] According to the biopsy system described in Example 2 or 3, the sample tray defines a plurality of receiving openings, each receiving opening corresponding to one of a plurality of sample chambers, and each receiving opening is configured to selectively communicate with a tissue delivery tube.

[0087] Example 5

[0088] According to the biopsy system described in Example 4, the sample tray further defines a plurality of vacuum openings, each vacuum opening corresponding to one of a plurality of sample chambers, each vacuum opening being configured to selectively communicate with a vacuum tube to generate a vacuum in a given sample chamber among the plurality of sample chambers.

[0089] Example 6

[0090] According to the biopsy system described in Example 5, the tissue delivery tube and the vacuum tube define the sampling axis.

[0091] Example 7

[0092] According to any one of Examples 1 to 5, the biopsy system has a sample tray configured to translate proximally relative to the delivery tube.

[0093] Example 8

[0094] According to the biopsy system of Example 1, the sample tray includes a body defining a pivot and a first sample chamber, the first sample chamber being offset relative to the pivot and configured to receive one or more tissue samples therein.

[0095] Example 9

[0096] According to the biopsy system described in Example 8, the body is configured to rotate relative to a pivot to move the first sample chamber between the sampling axis and the imaging axis.

[0097] Example 10

[0098] According to the biopsy system described in Example 8 or 9, the body defines a first part and a second part, the first part being opposite to the second part, a first sample chamber being defined by the first part, and the second part defining a second sample chamber.

[0099] Example 11

[0100] According to the biopsy system described in Example 10, a pivot is positioned between a first portion and a second portion, and the body is configured to rotate relative to the pivot to alternately move the first sample chamber and the second sample chamber between the sampling axis and the imaging axis.

[0101] Example 12

[0102] According to the biopsy system described in Example 8 or 9, the body defines a triangular cross-sectional shape.

[0103] Example 13

[0104] According to the biopsy system described in Example 8 or 9, the body defines an hourglass-shaped cross-section.

[0105] Example 14

[0106] According to any one of Examples 1 to 13, the tissue delivery tube is configured to use vacuum, saline, or a combination thereof to deliver one or more tissue samples through the tissue delivery tube.

[0107] Example 15

[0108] The biopsy system according to any one of Examples 1 to 14 further includes an analysis component comprising an X-ray source and an X-ray detector, the X-ray source and the X-ray detector being positioned relative to each other to define an imaging axis.

[0109] Example 16

[0110] An apparatus for use with a biopsy device, the apparatus comprising: a tissue delivery tube configured to receive and deliver one or more tissue samples acquired by the biopsy device; a tissue sample holder including a tissue tray selectively communicated with the tissue delivery tube to receive one or more tissue samples acquired by the biopsy device from the tissue delivery tube; and an analysis component defining an imaging axis extending from a detector, the tissue tray being configured to move relative to the analysis component to align with the imaging axis to analyze the one or more tissue samples acquired by the biopsy device.

[0111] Example 17

[0112] According to the device described in Example 16, the tissue delivery tube defines a sampling axis that is offset relative to the imaging axis.

[0113] Example 18

[0114] The device according to Example 16 also includes a vacuum tube having a distal opening positioned relative to the proximal opening of the tissue delivery tube, the vacuum tube being configured to receive one or more tissue samples from a tissue tray.

[0115] Example 19

[0116] According to any one of Examples 16 to 18, the analysis components include a source and a detector, wherein the source is an X-ray source and the detector is an X-ray detector.

[0117] Example 20

[0118] A method for analyzing tissue samples, the method comprising: transporting a tissue sample collected by a biopsy device through a tissue delivery tube into a sample chamber of a tissue tray aligned with a sampling axis defined by the tissue delivery tube; moving the sample chamber of the tissue tray relative to the sampling axis to align the sample chamber with an imaging axis; and imaging the tissue sample while the sample chamber of the tissue tray is aligned with the sampling axis.

[0119] Example 21

[0120] According to the method described in Example 20, the step of moving the sample chamber of the tissue tray relative to the sampling axis further includes translating the tissue tray so that another sample chamber is aligned with the sampling axis.

[0121] Example 22

[0122] According to the method of Example 20, the step of moving the sample chamber of the tissue tray relative to the sampling axis further includes rotating the tissue tray relative to a pivot to move the sample chamber relative to the sampling axis.

[0123] Example 23

[0124] According to the method described in Example 22, the step of moving the sample chamber of the tissue tray relative to the sampling axis further includes moving another sample chamber of the tissue tray to be aligned with the sampling axis while moving the sample chamber to be aligned with the imaging axis.

[0125] Example 24

[0126] The method according to Example 20 further includes, after imaging the tissue sample, moving the tissue tray relative to the sampling axis to receive another tissue sample within the tissue tray.

[0127] It should be understood that any patent, publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with the existing definitions, statements, or other public materials set forth in this disclosure. Therefore, and to the extent necessary, the public disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference but conflicting with the existing definitions, statements, or other public materials set forth herein, will be incorporated only to the extent that such incorporated material does not conflict with the existing public disclosure.

[0128] Embodiments of the present invention have applications in conventional endoscopic and open surgical instruments as well as robot-assisted surgery.

[0129] By way of example only, the embodiments described herein can be processed before surgery. First, new or used instruments can be obtained and cleaned if necessary. The instruments can then be sterilized. In one sterilization technique, the instruments are placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instruments are then placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation can kill bacteria on the instruments and in the container. The sterilized instruments can then be stored in a sterile container. Sealing the container keeps the instruments sterile until they are opened in a medical facility. Any other techniques known in the art can also be used to sterilize the devices, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

[0130] Embodiments of the devices disclosed herein can be repaired for reuse after at least one use. Repair may include any combination of the following steps: disassembling the device, subsequently cleaning or replacing specific parts, and subsequently reassembling. Specifically, embodiments of the devices disclosed herein can be disassembled, and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific parts, embodiments of the device can be reassembled in a repair facility or immediately by a surgical team prior to a surgical procedure for subsequent use. Those skilled in the art will understand that the repair of the device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repair devices are within the scope of this application.

[0131] Various embodiments of the invention have been shown and described, and those skilled in the art can further adapt the methods and systems described herein by appropriate modifications without departing from the scope of the invention. Several such potential modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should not be construed as limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A biopsy system, comprising: (a) A biopsy apparatus, comprising: (i) Probe, (ii) The needle extending from the probe, and (iii) A cutter, movable relative to the needle, to cut one or more tissue samples; (b) A control module in communication with a biopsy device, the control module including a tissue sample holder, the tissue sample holder including a sample tray configured to receive one or more tissue samples cut by a cutter; and (c) A tissue delivery tube adapted to be connected between a tissue sample holder and a cutter of a biopsy apparatus, the sample tray having a sampling configuration and an imaging configuration, the sample tray being configured to move between a sampling axis corresponding to the sampling configuration and an imaging axis corresponding to the imaging configuration to receive one or more tissue samples and subsequently image one or more tissue samples received in the sample tray.

2. The biopsy system of claim 1, wherein the sample tray comprises a rectangular body defining a plurality of sample chambers arranged along the longitudinal axis of the rectangular body.

3. The biopsy system of claim 2, wherein the sample tray is configured to translate in a direction parallel to the longitudinal axis of the body to move one of the plurality of sample chambers from the sampling axis to the imaging axis.

4. The biopsy system according to claim 2 or 3, wherein the sample tray defines a plurality of receiving openings, each receiving opening corresponding to one of a plurality of sample chambers, and each receiving opening is configured to selectively communicate with a tissue delivery tube.

5. The biopsy system of claim 4, wherein the sample tray further defines a plurality of vacuum openings, each vacuum opening corresponding to one of a plurality of sample chambers, each vacuum opening being configured to selectively communicate with a vacuum tube to generate a vacuum in a given sample chamber among the plurality of sample chambers.

6. In the biopsy system of claim 5, the tissue delivery tube and the vacuum tube define the sampling axis.

7. The biopsy system according to any one of claims 1 to 5, wherein the sample tray is configured to translate proximally relative to the delivery tube.

8. The biopsy system of claim 1, wherein the sample tray includes a body defining a pivot and a first sample chamber offset relative to the pivot and configured to receive one or more tissue samples therein.

9. The biopsy system of claim 8, wherein the body is configured to rotate relative to a pivot to move the first sample chamber between the sampling axis and the imaging axis.

10. The biopsy system according to claim 8 or 9, wherein the body defines a first portion and a second portion, the first portion being opposite to the second portion, a first sample chamber being defined by the first portion, and the second portion defining a second sample chamber.

11. The biopsy system of claim 10, wherein the pivot is positioned between the first portion and the second portion, and the body is configured to rotate relative to the pivot to alternately move the first sample chamber and the second sample chamber between the sampling axis and the imaging axis.

12. The biopsy system according to claim 8 or 9, wherein the body defines a triangular cross-sectional shape.

13. The biopsy system according to claim 8 or 9, wherein the body defines an hourglass cross-sectional shape.

14. The biopsy system according to any one of claims 1 to 13, wherein the tissue delivery tube is configured to use a vacuum, saline, or a combination thereof to deliver one or more tissue samples through the tissue delivery tube.

15. The biopsy system according to any one of claims 1 to 14, further comprising an analysis component including an X-ray source and an X-ray detector, the X-ray source and the X-ray detector being positioned relative to each other to define an imaging axis.

16. An apparatus for use with a biopsy device, the apparatus comprising: (a) A tissue delivery tube configured to receive and deliver one or more tissue samples collected by a biopsy device; (b) A tissue sample holder, comprising a tissue tray selectively connected to a tissue delivery tube to receive one or more tissue samples collected by a biopsy device from the tissue delivery tube; and (c) An analysis component defining an imaging axis extending from the detector, wherein a tissue tray is configured to move relative to the analysis component to align with the imaging axis for analyzing one or more tissue samples acquired by the biopsy device.

17. The device of claim 16, wherein the tissue delivery tube defines a sampling axis that is offset relative to the imaging axis.

18. The device of claim 16, further comprising a vacuum tube including a distal opening positioned relative to the proximal opening of the tissue delivery tube, the vacuum tube being configured to receive one or more tissue samples from a tissue tray.

19. The apparatus according to any one of claims 16 to 18, wherein the analysis component comprises a source and a detector, the source being an X-ray source and the detector being an X-ray detector.

20. A method for analyzing tissue samples, the method comprising: (a) Tissue samples collected by the biopsy device are transported through a tissue delivery tube into a sample chamber of a tissue tray aligned with the sampling axis defined by the tissue delivery tube; (b) Move the sample chamber of the tissue tray relative to the sampling axis to align the sample chamber with the imaging axis; and (c) Imaging the tissue sample while aligning the sample chamber of the tissue tray with the sampling axis.

21. The method of claim 20, wherein the step of moving the sample chamber of the tissue tray relative to the sampling axis further comprises translating the tissue tray to align another sample chamber with the sampling axis.

22. The method of claim 20, wherein the step of moving the sample chamber of the tissue tray relative to the sampling axis further comprises rotating the tissue tray relative to a pivot to move the sample chamber relative to the sampling axis.

23. The method of claim 22, wherein the step of moving the sample chamber of the tissue tray relative to the sampling axis further comprises moving another sample chamber of the tissue tray to be aligned with the sampling axis while moving the sample chamber to be aligned with the imaging axis.

24. The method of claim 20, further comprising, after imaging the tissue sample, moving the tissue tray relative to the sampling axis to receive another tissue sample within the tissue tray.

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