Articulated imaging and sample collection unit

Abstract

A biopsy system includes a biopsy device, a tissue delivery tube, and a tissue sample holder. 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. The tissue delivery tube is configured to be coupled to a portion of the biopsy device to convey one or more cut tissue samples out of the biopsy device. The tissue sample holder is separate from the biopsy device and is configured to be coupled to a tissue delivery tube to receive one or more cut tissue samples. A tissue sample holder includes a sample tray and an analysis assembly. The sample tray is configured to receive one or more cut tissue samples. The sample tray has a fixed spatial relationship with respect to the analysis assembly.

Description

priority

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 540,966, filed September 28, 2023, entitled “Articulated Imaging and Sample Collection Unit,” 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 3 It shows Figure 2 A three-dimensional view of the tissue sample holder of the tissue processing component;

[0011] Figure 4 It shows along Figure 3 The 4-4 line is cut off Figure 3 A cross-sectional view of the sample tray of the tissue sample holder;

[0012] Figure 5 It shows Figure 2 Front elevation view of the tissue sample holder;

[0013] Figure 6 It shows Figure 2 Detailed perspective view of the tube hinge of the tissue sample holder;

[0014] Figure 7 It shows Figure 2 A three-dimensional view of a tissue sample holder, in which Figure 6 The tube hinge moves for tissue collection;

[0015] Figure 8 It shows Figure 2 Another three-dimensional view of the tissue sample holder, in which Figure 6 The tube hinge remains stationary, while the other components of the tissue processing assembly move for tissue collection.

[0016] 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

[0017] 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.

[0018] I. Overview of an exemplary biopsy system

[0019] Figure 1AAn 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.

[0020] 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.

[0021] 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).

[0022] 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).

[0023] 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).

[0024] 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.

[0025] 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.

[0026] 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.

[0027] As described above, the probe (100) may include one or more gears to engage with corresponding gears in 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 in the kit (200) to rotate the needle (110).

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] II. Exemplary organization processing components

[0034] Tissue processing component (300) in Figures 1A-4 As shown in the best example. Figure 1A As shown, 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).

[0035] 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.

[0036] 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).

[0037] 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).

[0038] In this example, a collection drawer (320) houses a tissue sample holder (340) within an internal space (326) defined by side walls (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) and an analytical component (380) integrated into at least a portion of the sample tray (350). The sample tray (350) and the analytical component (380) together define an elongated rectangular structure configured to receive tissue samples in a linear arrangement relative to a longitudinal axis defined by the sample tray (350). As will be described in more detail below, such collected samples can then be imaged or otherwise analyzed by the analytical component (380). As will be described in more detail below, the sample tray (350) is typically configured in a box-like manner, allowing the sample tray (350) or other components associated with it to move within a 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 tray containers may be desirable for controlling the vacuum applied to the sample tray (350) or managing fluids transferred into one or more portions of the sample tray (350). Of course, in other versions, such tray containers are entirely optional and may be omitted.

[0039] like Figure 3 and Figure 4As best shown, 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). Optionally, the rear portion of the rectangular body (352) defines a plurality of vacuum openings (not shown), also communicating with each corresponding sample chamber (356). Each receiving opening (358) is configured to communicate independently with a tissue delivery tube (302) such that one or more tissue samples can be delivered into the corresponding sample chamber (356). Correspondingly, in the example including the vacuum openings, each vacuum opening is configured to communicate with a vacuum tube (not shown) or other vacuum source disposed opposite to the tissue delivery tube (302) such that a vacuum can be delivered into the corresponding sample chamber (356) to draw one or more tissue samples into the corresponding sample chamber (356) under vacuum.

[0040] The upper portion of the rectangular body (352) is typically closed by a top surface (361) or otherwise covered. In other examples, the upper portion of the rectangular body (352) is open or otherwise exposed to the outside of the sample tray (350), allowing access to each sample chamber (356) from the upper portion of the rectangular body (352). In further examples, one or more portions of the rectangular body (352) may be configured to be selectively covered, for example, by a door, cover, housing, and / or others. In some examples, such selective covering may be desirable for controlling 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, 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).

[0041] The lower part of the rectangular body (352) includes a base plate (362) (see...). Figure 4 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).

[0042] like Figure 3 As best shown, the sample tray (350) is positioned proximal to the tissue delivery tube (302). The delivery tube (302) is typically aligned with the sampling axis, which extends substantially perpendicular to the longitudinal axis of the sample tray (350). In some examples, a vacuum tube (not shown) may also be aligned with the sampling axis. Thus, in such examples, the tissue delivery tube (302) and the vacuum tube are each configured to communicate with a selected sample chamber (356) among a plurality of sample chambers (356) depending on the axial position of the sample tray (350) relative to the tissue delivery tube (302).

[0043] like Figure 5 As best shown, the tissue sample holder (340) includes an analysis component (380) integrated into a portion of a sample tray (350). Specifically, the analysis component (380) includes one or more imaging elements configured to image or otherwise analyze tissue samples contained within the sample tray (350). In this example, the analysis component (380) is configured for X-ray imaging. Therefore, the analysis component (380) includes a source (382) and a detector (384) oriented on opposite sides of the sample tray (350). In this example, the detector (384) is integrated into a portion of a base plate (362). Meanwhile, the source (382) is oriented above a top surface (361) using a source arm (386). The source arm (386) extends upward and laterally relative to the top surface (361). The upwardly extending portion of the source arm (386) is configured to position the source (382) at a fixed distance from the sample tray (350). The lateral extension of the source arm (386) is configured to position the source (382) near the center point of the sample tray (350). Although the source arm (386) is generally an integral part relative to the sample tray (350), it should be understood that in other examples, the source arm (386) may be a separate part fixedly fastened to the sample tray (350) or any other part having a substantially fixed spatial relationship with respect to the sample tray (350).

[0044] The source (382) and detector (384) are configured together to image each sample chamber (356) of the sample tray (350) using a single image or analytical acquisition. Specifically, the detector (384) spans beneath each sample chamber (356) to overlap with each sample chamber (356). Simultaneously, the source (382) is positioned at a distance from the sample tray (350) to project a triangular beam with a width corresponding to the width of the detector (384). The source (382) and detector (384) are centered together along an imaging axis (IA) corresponding to the center of the sample tray (350).

[0045] In this example, both the source (382) and the detector (384) are configured for X-ray imaging. Such X-ray imaging may include real-time or digital X-ray imaging, as will be described in more detail below. Such imaging modes may be desirable to simultaneously image all sample chambers (356) while using software or image processing to visualize each sample chamber (356) individually. Of course, in other examples, various alternative imaging or other analysis modes may be used. It should be understood that different source (382) or detector (384) configurations may be used in examples using different analysis modes. In such examples, either the source (382) or detector (384) may be omitted. In other examples, the source (382) and detector (384) may be combined into a single component oriented on either side of the sample tray (350).

[0046] As described above, each sample chamber (356) is configured to selectively communicate with the tissue delivery tube (302) such that one or more tissue samples can be received within each sample chamber (356). To facilitate such selective communication, the tissue sample holder (340) of this example includes a tube hinge (370) (also referred to as a tube slide) near the receiving opening (358). The tube hinge (370) is generally configured to connect the tissue delivery tube (302) to the sample tray (350) while allowing the delivery tube (302) to move relative to the sample tray (350).

[0047] like Figure 6 As shown, the tube connector (370) includes a track (372), a sliding seal (374), and a tube actuator (378). The track (372) extends above and below a receiving opening (358) along the length of the sample tray (350), the receiving opening (358) being located between each of the upper and lower portions of the track (372). The track (372) is configured to slidably receive a portion of the seal (374) such that the seal (374) can slide along the length of the track (372) and / or the longitudinal axis of the sample tray (350).

[0048] The seal (374) is typically configured to sealably engage with the distal surface of the sample tray (350) while also being movable relative to the sample tray (350). The seal (374) defines a generally rectangular shape corresponding to the shape and / or configuration of the track (372). The seal (374) also includes a hollow tubular protrusion (376) extending from the distal surface of the seal (374), which is configured to be received within the tissue delivery tube (302), thereby coupling the tissue delivery tube (302) to the seal (374).

[0049] The tube actuator (378) defines a generally forked configuration configured to receive the tissue delivery tube (302) between each tooth of the forked structure of the tube actuator (378). The tube actuator (378) is configured to apply force to the tissue delivery tube (302) and the seal (374) (via the tubular protrusion (376)) to drive the tissue delivery tube (302) and the seal (374) along the track (372). Although not shown, it should be understood that the tube actuator (378) is configured to be coupled to other driving features, such as linear actuators, rack-and-pinion actuators, cables and / or others, to facilitate movement of the tissue delivery tube (302) relative to the sample tray (350). Such a mechanism may also be electrically driven or mechanically driven (e.g., by a spring-loaded mechanism). In another example, the translation of the tube actuator (370) may be fixed relative to other components such as a collection drawer (320), while the sample tray (350) itself may be moved by such a mechanism. In another example, any movement can be manually controlled by the operator.

[0050] like Figure 7 and Figure 8 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. In some examples, the tissue delivery tube (302) can be moved relative to the sample tray (350) via a tube hinge (370), such as Figure 7 As shown. Meanwhile, in other examples, the tissue delivery tube (302) can remain fixed, while the sample tray (350) moves relative to the tissue delivery tube (302), such as... Figure 8 As shown.

[0051] In use, the sample tray (350) can be initially aligned relative to the tissue delivery tube (302) such that a predetermined initial sample chamber (356) is aligned with the tissue delivery tube (302). In this example, the predetermined initial sample chamber (356) corresponds to the leftmost sample chamber (356), although any other sample chamber (356) may be used in other examples.

[0052] Regardless of the specific predetermined initial sample chamber (356), tissue samples can be transferred to the predetermined initial sample chamber (356) via a tissue delivery tube (302) to transport the tissue sample from the biopsy device (10) to the predetermined initial sample chamber (356) using vacuum and / or saline. Although not shown, it should be understood that the sample tray (350) may include one or more tissue stop structures configured to prevent the tissue sample from being removed from the given sample chamber (356), thereby retaining the tissue sample within the given sample chamber (356).

[0053] Once a tissue sample is received in the predetermined initial sample chamber (356), the sample tray (350) or tissue delivery tube (302) can be advanced to position another sample chamber (356) aligned with the tissue delivery tube (302). In this example, such advancement is shown as moving the tissue delivery tube (302) or sample tray (350) to the right or left, respectively. In some examples, such advancement can be sequential, such that the next adjacent sample chamber (356) is aligned with the tissue delivery tube (302). In other examples, advancement can be any other suitable sequence (e.g., moving from one end to the other).

[0054] Once the sample tray (350) is advanced, another tissue sample can be received in the next aligned sample chamber (356). This process can be repeated until all sample chambers (356) are filled. Alternatively, the process can continue until the desired number of tissue samples have been collected.

[0055] Imaging or other analyses can be performed at any stage of the tissue sample collection process described above. As mentioned above, the movement of the sample tray (350) and the movement of the analysis component (380) are fixed or coordinated. Therefore, the analysis component (380) is positioned to image or otherwise analyze the sample tray (350) at any point in time during sample collection. Also as mentioned above, such imaging or other analyses typically correspond to the entire sample tray (350). Therefore, any collected tissue sample is simultaneously imaged or otherwise analyzed. Thus, in some examples, it may be desirable to perform imaging or other analyses after all desired samples have been collected into the sample tray (350). In other examples, imaging or analysis can be performed after each sample collection or after the collection of a predetermined group of samples. In yet another example, imaging or analysis can be performed continuously regardless of whether samples are collected.

[0056] Regardless of when imaging or other analysis occurs, such imaging or analysis can include at least some image processing steps. For example, in this example, the analysis component (380) is configured for digital or real-time X-ray imaging. Therefore, such X-ray imaging includes acquiring an image of the entire sample tray. The image of the entire sample tray can then be processed to produce individual sample images of each collected tissue sample. The operator can then analyze such individual sample images in real time or at the end of the biopsy procedure. When real-time imaging is used, such real-time imaging analysis can be used to notify the operator to collect subsequent tissue samples.

[0057] III. Exemplary Combinations

[0058] 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.

[0059] Example 1

[0060] 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 tissue delivery tube configured to be coupled to a portion of the biopsy device to deliver one or more cut tissue samples from the biopsy device; and a tissue sample holder detached from the biopsy device and configured to be coupled to the tissue delivery tube to receive one or more cut tissue samples, the tissue sample holder including a sample tray and an analysis component, the sample tray being configured to receive one or more cut tissue samples, the sample tray having a fixed spatial relationship relative to the analysis component.

[0061] Example 2

[0062] 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.

[0063] Example 3

[0064] According to the biopsy system described in Example 2, the analysis component is positioned relative to the sample tray to simultaneously analyze each of the multiple sample chambers.

[0065] Example 4

[0066] 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.

[0067] Example 5

[0068] According to the biopsy system described in Example 4, the tissue sample holder further includes a tube actuator configured to drive relative movement between the tissue delivery tube and the sample tray.

[0069] Example 6

[0070] According to the biopsy system described in Example 5, the tube actuator includes a seal configured to slide relative to the sample tray between each receiving opening of a plurality of sample openings.

[0071] Example 7

[0072] According to the biopsy system described in Example 5, the tube actuator includes a seal configured to slide along a track defined by a portion of the sample tray to translate relative to the sample tray between each receiving opening of a plurality of sample openings.

[0073] Example 8

[0074] According to any one of Examples 1 to 7, the biopsy system includes an X-ray source and an X-ray detector.

[0075] Example 9

[0076] According to the biopsy system described in Example 8, the X-ray source and the X-ray detector have a fixed spatial relationship relative to the sample tray.

[0077] Example 10

[0078] According to the biopsy system described in Example 8 or 9, both the X-ray source and the X-ray detector are integrated with a portion of the sample tray.

[0079] Example 11

[0080] According to the biopsy system of Example 1, the sample tray includes a rectangular body defining a plurality of sample chambers arranged along the longitudinal axis of the rectangular body, and the analysis components include an X-ray source and an X-ray detector, the X-ray detector defining a length corresponding to the length defined by the plurality of sample chambers.

[0081] Example 12

[0082] According to the biopsy system of Example 1, the sample tray includes a rectangular body defining a plurality of sample chambers arranged along the longitudinal axis of the rectangular body, and the analysis components include an X-ray source and an X-ray detector, with at least a portion of the X-ray detector positioned below each of the plurality of sample chambers.

[0083] Example 13

[0084] The biopsy system according to Examples 1 to 12 also includes a control module, and a tissue sample holder is disposed within a portion of the control module.

[0085] Example 14

[0086] According to any one of Examples 1 to 13, the biopsy system has a sample tray configured to move relative to the tissue delivery tube.

[0087] Example 15

[0088] According to any one of Examples 1 to 13, the tissue delivery tube is configured to move relative to the sample tray.

[0089] Example 16

[0090] 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 sample tray comprising a plurality of linearly arranged sample chambers, each sample chamber selectively connected to 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 including one or more imaging elements positioned relative to the sample tray to simultaneously image each of the plurality of sample chambers.

[0091] Example 17

[0092] According to the device described in Example 16, the analysis component further includes an arm that is securely attached to a sample tray and configured to position one of one or more imaging elements at a fixed position relative to the sample tray.

[0093] Example 18

[0094] According to the device described in Example 16 or 17, the sample tray and analysis components are configured together to move relative to the tissue delivery tube.

[0095] Example 19

[0096] According to any one of Examples 16 to 18, one or more imaging elements include an X-ray source and an X-ray detector.

[0097] Example 20

[0098] A method for analyzing tissue samples, the method comprising: transporting a first tissue sample collected by a biopsy device through a tissue delivery tube into a first sample chamber of a sample tray; moving the sample tray relative to the tissue delivery tube to align a second sample chamber with the tissue delivery tube; transporting a second tissue sample collected by the biopsy device through the tissue delivery tube into a second sample chamber of the sample tray; simultaneously imaging the first and second tissue samples to form an image of the entire sample tray; and acquiring a separate image of each of the first and second tissue samples from the image of the entire sample tray.

[0099] Example 21

[0100] According to the method of Example 20, the step of moving the sample tray relative to the tissue delivery tube further includes translating the tissue tray along a longitudinal axis defined by the tissue tray.

[0101] Example 22

[0102] According to the method described in Example 20 or 21, the step of imaging the first tissue sample and the second tissue sample includes imaging by X-ray imaging.

[0103] Example 23

[0104] According to the method described in Example 20 or 21, the step of imaging the first tissue sample and the second tissue sample includes imaging by digital X-ray imaging.

[0105] 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.

[0106] Embodiments of the present invention have applications in conventional endoscopic and open surgical instruments as well as robot-assisted surgery.

[0107] 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.

[0108] 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.

[0109] 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, the biopsy system comprising: (a) A biopsy device, the biopsy device comprising: (i) Probe, (ii) The needle extending from the probe, and (iii) A cutter, which is movable relative to a needle to cut one or more tissue samples; (b) A tissue delivery tube, configured to be coupled to a part of a biopsy apparatus to deliver one or more cut tissue samples from the biopsy apparatus; and (c) A tissue sample holder, separate from the biopsy device and configured to be coupled to a tissue delivery tube to receive one or more cut tissue samples, the tissue sample holder including a sample tray and an analysis component, the sample tray being configured to receive one or more cut tissue samples, the sample tray having a fixed spatial relationship with respect to the analysis component.

2. The biopsy system according to claim 1, wherein the sample tray includes 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 analysis component is positioned relative to the sample tray to simultaneously analyze each of the multiple sample chambers.

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 tissue sample holder further comprises a tube actuator configured to drive relative movement between the tissue delivery tube and the sample tray.

6. The biopsy system of claim 5, wherein the tube actuator includes a seal configured to slide relative to the sample tray between each receiving opening of the plurality of sample openings.

7. The biopsy system of claim 5, wherein the tube actuator includes a seal configured to slide along a track defined by a portion of the sample tray to translate relative to the sample tray between each receiving opening of the plurality of sample openings.

8. The biopsy system according to any one of claims 1 to 7, wherein the analysis components include an X-ray source and an X-ray detector.

9. The biopsy system according to claim 8, wherein the X-ray source and the X-ray detector have a fixed spatial relationship relative to the sample tray.

10. In the biopsy system of claim 8 or 9, both the X-ray source and the X-ray detector are integrated with a portion of the sample tray.

11. The biopsy system of claim 1, wherein the sample tray comprises a rectangular body defining a plurality of sample chambers arranged along a longitudinal axis of the rectangular body, and the analysis components include an X-ray source and an X-ray detector defining a length corresponding to the length defined by the plurality of sample chambers.

12. The biopsy system of claim 1, wherein the sample tray includes a rectangular body defining a plurality of sample chambers arranged along a longitudinal axis of the rectangular body, and the analysis components include an X-ray source and an X-ray detector, at least a portion of the X-ray detector being positioned below each of the plurality of sample chambers.

13. The biopsy system according to any one of claims 1 to 12, further comprising a control module, wherein a tissue sample holder is disposed within a portion of the control module.

14. The biopsy system according to any one of claims 1 to 13, wherein the sample tray is configured to move relative to the tissue delivery tube.

15. The biopsy system according to any one of claims 1 to 13, wherein the tissue delivery tube is configured to move relative to the sample tray.

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, the tissue sample holder comprising a sample tray including a plurality of sample chambers arranged linearly, each sample chamber being 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, including one or more imaging elements positioned relative to a sample tray to simultaneously image each of a plurality of sample chambers.

17. The apparatus of claim 16, wherein the analysis component further comprises an arm securely attached to a sample tray and configured to position one of one or more imaging elements at a fixed position relative to the sample tray.

18. The device of claim 16 or 17, wherein the sample tray and the analysis components are configured together to move relative to the tissue delivery tube.

19. The apparatus according to any one of claims 16 to 18, wherein one or more imaging elements comprise an X-ray source and an X-ray detector.

20. A method for analyzing tissue samples, the method comprising: (a) The first tissue sample collected by the biopsy device is transported through the tissue delivery tube to the first sample chamber of the sample tray; (b) Move the sample tray relative to the tissue delivery tube to align the second sample chamber with the tissue delivery tube; (c) The second tissue sample collected by the biopsy device is transported through the tissue delivery tube to the second sample chamber of the sample tray; (d) Simultaneously image the first tissue sample and the second tissue sample to form an image of the entire sample tray; and (e) Obtain individual images of each of the first and second tissue samples from the entire sample tray image.

21. The method of claim 20, wherein the step of moving the sample tray relative to the tissue delivery tube further comprises translating the tissue tray along a longitudinal axis defined by the tissue tray.

22. The method of claim 20 or 21, wherein the step of imaging the first tissue sample and the second tissue sample includes imaging by X-ray imaging.

23. The method of claim 20 or 21, wherein the step of imaging the first tissue sample and the second tissue sample includes imaging by digital X-ray imaging.

Images