Online organizational analysis and delivery method

Abstract

A biopsy system includes a biopsy device, a tissue processor, and a tissue delivery tube. A biopsy device includes a probe, a needle, and a cutter. The cutter is movable relative to the needle to cut one or more tissue samples. A tissue processor includes a tissue sample holder and an analysis assembly. A tissue sample holder includes a sample tray including a plurality of sample chambers. The sample tray also includes an outer surface defining one or more sample stop features and a plurality of receiving openings. Each receiving opening corresponds to a sample chamber. The tissue delivery tube is adapted to be connected between a tissue sample holder and a cutter of a biopsy device. The sample tray is configured to move relative to the tissue delivery tube to selectively align one or more sample stop features or each receiving opening with the tissue delivery tube.

Description

priority

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 540,967, filed September 28, 2023, entitled “Method for Online Tissue Analysis and Delivery,” 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 illustration 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 illustrative 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 example 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 example tissue processing component that can be easily incorporated into the system of Figure 1 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 Figure 3 A detailed perspective view of the sample tray of the tissue sample holder;

[0012] Figure 5A It shows Figure 4 Another detailed perspective view of the sample tray, in which the sample tray is positioned relative to the tissue delivery tube to stop the tissue sample;

[0013] Figure 5B It shows Figure 4 Another detailed elevation view of the sample tray, in which the sample tray is relative to... Figure 5A The tissue delivery tube is positioned to allow tissue sample movement;

[0014] Figure 6 It shows Figure 2 A side elevation view of the tissue processing component used to image tissue samples during use;

[0015] Figure 7 It shows that it can be easily combined with Figure 2 A three-dimensional view of another example of an alternative tissue sample holder in a tissue processing component;

[0016] Figure 8 It shows that it can be easily combined with Figure 2 A perspective view of another example of an alternative tissue sample holder in a tissue processing component; and

[0017] Figure 9 It shows Figure 8 Top plan view of the sample stop mechanism of the tissue sample holder.

[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 Explanatory Biopsy Systems

[0021] Figure 1A An illustrative 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) that are 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 illustrative 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 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).

[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. Explanatory Organization Processing Components

[0036] Tissue processing component (300) in Figure 1A and Figure 2 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).

[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, 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 exterior of the tissue sample holder (340) is defined by a cylindrical or circular tray container (344) having a cup (346) with a lid (348). The tray container (344) typically contains a sample tray (350). Therefore, the tray container (344) is configured to removably receive the sample tray (350). The tray container (344) is typically desired to control the vacuum applied to the sample tray (350) or to manage fluid transfer into one or more portions of the sample tray (350). While this version includes a tray container (344), it should be understood that in other versions, the tray container (344) is entirely optional and may be omitted. In this version, the cup body (346), lid (348), or both can be omitted.

[0041] As described above, the tissue sample holder (340) of this example includes a sample tray (350) (see Figure 3 The sample tray (350) is configured to receive and contain tissue samples in a predetermined arrangement. As will be described in more detail below, the samples thus collected can then be imaged or otherwise analyzed by an analysis component (380), which is also integrated into the tissue processor (310). As will also be described in more detail below, the sample tray (350) typically has a rotating configuration, allowing the sample tray (350) or other components associated with the sample tray (350) to move within a collection drawer (320) to sequentially collect tissue samples within discrete portions of the sample tray (350).

[0042] like Figure 3 As best shown, the sample tray (350) of this example includes a cylindrical body (352) having a plurality of partition walls (354) extending outward from a central portion of the body (352). The partition walls (354) define a plurality of triangular or fan-shaped sample chambers (356) arranged in a circular pattern around the central portion of the body (352). Thus, as will be described in more detail below, the sample tray (350) is generally rotatable about the central portion of the body (352) to sequentially receive one or more tissue samples in each sample chamber (356).

[0043] As will be described in more detail below, the tissue sample holder (340) also includes a actuator (370) in communication with the sample tray (350). The actuator (370) is typically configured to rotate the sample tray (350) to move the sample chamber (356) about an axis. Although the actuator (370) is shown in this example as including a shaft and one or more gears, it should be understood that the actuator (370) may include other structural features such as a motor, cam, additional shaft, additional gear, cable, wheel and / or others.

[0044] The upper portion of the cylindrical body (352) is typically open or otherwise exposed to the outside of the sample tray (350). Therefore, each sample chamber (356) is typically accessible from the upper portion of the cylindrical body (352). In other examples, the upper portion of the rectangular body (352) is closed or otherwise covered relative to the outside of the sample tray (350). In further examples, one or more portions of the cylindrical body (352) may be configured to be selectively covered, for example, through a door, lid, 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. Therefore, 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 can be covered. In other examples, such covering may be omitted, and the vacuum may be controlled by other components (e.g., the aforementioned tray container (344)).

[0045] The lower portion of the cylindrical body (352) includes a base plate (not shown). In this example, the base plate is formed of a material that is generally solid. While the base plate in this example is generally impermeable, in some examples, the base plate may have at least some permeability. For example, in some examples, the base plate includes a semi-permeable membrane or mesh configured to allow fluid to pass through the base plate. This permeability may be desirable for controlling the fluid entering the sample tray (350). Therefore, in other examples, the base plate is generally impermeable but may include other fluid management features such as ports, valves, and / or others. In further examples, fluid may be controlled via vacuum tubes and / or other structures.

[0046] like Figure 3 As best shown, the sides of the cylindrical body (352) define a plurality of receiving openings (358) communicating with each corresponding sample chamber (356). Alternatively, a portion of the cylindrical body (352) (e.g., the lower part or interior of the central portion of the cylindrical body (352)) defines one or more vacuum openings (not shown). Such vacuum openings may also communicate with each corresponding sample chamber (356) to facilitate vacuum flow through a given sample chamber (356). Alternatively, in some examples, the entire sample tray (350) may be placed under vacuum by applying a vacuum to the tray container (344).

[0047] Each receiving opening (358) is configured to communicate independently with the tissue delivery tube (302) so that one or more tissue samples can be delivered to the corresponding sample chamber (356). Accordingly, in the example including a vacuum opening, each vacuum opening is configured to communicate with a vacuum tube (not shown) or other vacuum source so that a vacuum can be delivered to the corresponding sample chamber (356) to draw one or more tissue samples into the corresponding sample chamber (356) under vacuum.

[0048] like Figure 4 As shown, the sides of the cylindrical body (352) also include a plurality of sample stop features (360) adjacent to each receiving opening (358). Each sample stop feature (360) is generally configured to block or otherwise prevent tissue samples from entering the corresponding sample chamber (356) through the cylindrical body (352), while allowing at least some fluid to flow through the cylindrical body (352) into the corresponding sample chamber (356). As will be described in more detail below, each sample stop feature (360) is configured to stop the tissue sample in the tissue delivery tube (302) for imaging or other analysis before the tissue sample to be stopped is delivered into the sample chamber (356) through the corresponding receiving opening (358).

[0049] In this version, each sample chamber (356) is associated with a corresponding sample stop feature (360). Therefore, each sample chamber (356) is in communication with both the corresponding sample stop feature (360) and the receiving opening (358). In this configuration, a given receiving opening (358) is positioned near one side of the corresponding sample chamber (356), while a given sample stop feature (360) is positioned near the opposite side of the corresponding sample chamber (356). Thus, the receiving opening (356) and the sample stop feature (360) are typically positioned along a line and are generally adjacent to each other. This configuration may be desirable to allow rotation of the sample tray (350) to transpose the tissue delivery tube (302) between the receiving opening (356) and the sample stop feature (360). Although this example shows each sample stop feature (360) defining a corresponding receiving opening (358), in other examples, the sample stop feature (360) and each corresponding receiving opening (358) may be separate from each other.

[0050] Each sample stop feature (360) in this example is configured as a porous structure integrated into a portion of the cylindrical body (352). Suitable porous structures can include a variety of configurations. For example, in this example, a mesh or sieve configuration is used. In other examples, multiple discrete holes, perforations, or openings are used. In yet another example, some semi-permeable membrane is used. In other examples, this porous structure is omitted entirely and replaced with a movable gate structure. Although the sample stop feature (360) in this example is integral with the cylindrical body (352), it should be understood that in other examples, the sample stop feature (360) may be separable from the cylindrical body (352) and fixedly or removably attached to the cylindrical body.

[0051] like Figure 5A and Figure 5B As best shown, the sample tray (350) is positioned proximal to the tissue delivery tube (302). As will be described in more detail below, the sample tray (350) is generally rotatable relative to the tissue delivery tube (302) via a actuator (370) to allow the tissue delivery tube (302) to move between a sample stop configuration for each sample chamber (356) and a sample acquisition configuration. The tissue delivery tube (302) is generally aligned along a sampling axis that extends substantially perpendicular to the axis of rotation of the sample tray (350). In some examples, a vacuum tube (not shown) may also be aligned with the sampling axis, or alternatively with the axis of rotation. In examples including a vacuum tube, both the tissue delivery tube (302) and the vacuum tube are configured to communicate with a selected sample chamber (356) among a plurality of sample chambers (356) depending on the rotational position of the sample tray (350) relative to the tissue delivery tube (302).

[0052] like Figure 6As best shown, the tissue sample holder (340) is adjacent to the analysis component (380) to facilitate imaging and / or analysis of the tissue sample before it is transferred to the sample tray (350). Specifically, the analysis component (380) includes one or more imaging elements configured to image or otherwise analyze the tissue sample contained within the tissue delivery tube (302). In this example, the analysis component (380) is configured for X-ray imaging. Thus, the analysis component (380) includes a source (382) and a detector (384) oriented on opposite sides of the tissue delivery tube (302) to define an imaging axis (IA). In this example, the detector (384) may be integrated into a portion of the tissue processor (310), such as a collection drawer (320) or another component such as a housing. Meanwhile, the source (382) is oriented above the detector (384) and may be integrated into another portion of the tissue processor (310), such as an upper housing. The detector (384) and source (382) are typically centered around the tissue delivery tube (302) so that the tissue sample can be imaged before being transferred to the sample chamber (356) of the sample tray (350).

[0053] like Figures 5A to 6 As best shown, in use, the sample tray (350) is configured to receive tissue samples in each sample chamber (356), and the analysis component (380) is configured to image or otherwise analyze each tissue sample within the tissue delivery tube (302) before the tissue sample is transferred to a given sample chamber (356). Figure 5A As shown, the sample tray (350) is initially rotated to the sample stop position by the actuator (370). In this position, the sample tray (350) is positioned such that the sample stop feature (360) is aligned with the sampling axis defined by the tissue delivery tube (302). When the given sample stop feature (360) is aligned with the tissue delivery tube (302), a vacuum can be communicated through the sample stop feature (360) to facilitate the delivery of tissue through the tissue delivery tube (302). Furthermore, the sample stop feature (360) can prevent tissue samples within the tissue delivery tube (302) from entering the associated sample chamber (356).

[0054] When a tissue sample is blocked by a sample blocking feature (360), the blocked tissue sample can be imaged or otherwise analyzed by the analysis component (380). For example... Figure 6 As shown in the best embodiment, the source (382) and detector (384) can work together to image or otherwise analyze the blocked tissue sample along the imaging axis (IA) while the blocked tissue sample is held within the tissue delivery tube (302).

[0055] After imaging and / or analysis of the blocked tissue sample, the sample tray (350) can be removed from... Figure 5A The sample stop position shown is rotated to Figure 5B The sample collection position is shown. In this position, the sample tray (350) is moved so that the receiving opening (358) of the given sample chamber (356) is aligned with the sampling axis defined by the tissue delivery tube (302). The blocked tissue sample then passes freely through the receiving opening (358), exits the tissue delivery tube (302), and enters the given sample chamber (356).

[0056] Once the subsequently blocked tissue sample is received in a given sample chamber (356), the same rotation process described above can be repeated to image and / or analyze and capture one or more additional tissue samples. This process can be repeated until each sample chamber (356) is filled or the desired number of tissue samples has been collected. In this example, the capture of tissue samples is performed sequentially, such that each consecutive sample chamber (356) is filled. However, in other examples, a different order may be used. For example, in some examples, every other sample chamber (356) may be filled. Furthermore, or alternatively, in some examples, the rotation may be reversed to capture multiple samples in a single sample chamber (356).

[0057] Figure 7 An illustrative alternative tissue sample holder (440) is shown, which can be readily incorporated into the tissue processor (310) described above to replace or supplement the tissue sample holder (340). Like the tissue sample holder (340) described above, the tissue sample holder (440) of this example includes a sample tray (450) and a actuator (470). The actuator (470) of this example is substantially the same as the actuator (370) described above. For example, the actuator (470) is typically configured to rotate the sample tray (450) and may include various structural features such as shafts, gears, motors, cams, cables, wheels, and / or others.

[0058] Similar to the sample tray (350) described above, the sample tray (450) of this example includes a cylindrical body (452) having a plurality of partition walls (454) extending outward from a central portion of the body (452). The partition walls (454) define a plurality of triangular or fan-shaped sample chambers (456) arranged in a circular pattern around the central portion of the body (452). Thus, as will be described in more detail below, the sample tray (450) is generally rotatable around the central portion of the body (452) to sequentially receive one or more tissue samples in each sample chamber (456).

[0059] Similar to the sample tray (350) described above, the sides of the cylindrical body (452) define a plurality of receiving openings (458) communicating with each corresponding sample chamber (456). Alternatively, a portion of the cylindrical body (452) (e.g., the lower part or interior of the central portion of the cylindrical body (452)) defines one or more vacuum openings (not shown). Such vacuum openings may also communicate with each corresponding sample chamber (456) to facilitate vacuum flow through a given sample chamber (456). Alternatively, in some examples, the entire sample tray (450) can be placed under vacuum by applying a vacuum to the tray container (344).

[0060] Each receiving opening (458) is configured to communicate independently with the tissue delivery tube (302) so that one or more tissue samples can be delivered to the corresponding sample chamber (456). Correspondingly, in an example including a vacuum opening, each vacuum opening is configured to communicate with a vacuum tube (not shown) or other vacuum source so that a vacuum can be delivered to the corresponding sample chamber (456) to draw one or more tissue samples into the corresponding sample chamber (456) under vacuum.

[0061] Similar to the sample tray (350) described above, the cylindrical body (452) also includes a sample stop feature (460) on its side. However, unlike the sample tray (350) described above, the sample tray (450) of this example includes only a single sample stop feature (460). As will be described in more detail below, the configuration of the single sample stop feature (460) in this example is likely desirable to allow the sample tray (450) to have one or more additional sample chambers (456) relative to the sample chamber (356) described above within the same occupied space. In other words, the single sample stop feature (460) is configured to serve as the sample stop feature (460) for all sample chambers (456), rather than having a dedicated sample stop feature for each sample chamber (456). Therefore, the total area occupied by the sample stop feature (460) is smaller.

[0062] Similar to the sample stop feature (360) described above, the sample stop feature (460) of this example is typically configured to block or otherwise prevent tissue samples from entering the interior of the cylindrical body (352) through the cylindrical body (352), while allowing at least some fluid to pass through the cylindrical body (352). As will be described in more detail below, the sample stop feature (460) is configured to stop the tissue sample within the tissue delivery tube (302) for imaging or other analysis before the tissue sample to be stopped is delivered into the sample chamber (456) through a given receiving opening (458).

[0063] In this version, only a single sample chamber (456) is associated with the sample stop feature (460). Therefore, the sample chamber (456) corresponding to the sample stop feature (460) can be characterized as an unoccupiable sample chamber (456). In other words, the sample chamber (456) associated with the sample stop feature (460) cannot receive tissue samples because the sample stop feature (460) does not define an opening or port for conveying tissue samples. In some examples, this configuration can be characterized as the sample stop feature (460) being associated with a gap or dead space defined by the sample tray (450). Although a particular sample chamber (456) associated with the sample stop feature (460) is shown to have a similar shape and / or size to other sample chambers (456), in some examples, the sample chamber (456) may have a different shape, size, and / or other characteristics. In other examples, the sample stop feature (460) may be defined or associated with a receiving opening similar to the receiving opening (458) to allow the sample stop feature (460) to both block and receive tissue samples, similar to the combination of the sample stop feature (360) and the receiving opening (358) described above.

[0064] The sample stop feature (460) in this example is configured as a porous structure integrated into a portion of the cylindrical body (452). Suitable porous structures can include a variety of configurations. For example, in this example, a mesh or sieve configuration is used. In other examples, multiple discrete holes, perforations, or openings are used. In yet another example, some semi-permeable membrane is used. In other examples, this porous structure is omitted entirely, and a movable gate structure is used instead. Although the sample stop feature (460) in this example is integral with the cylindrical body (452), it should be understood that in other examples, the sample stop feature (460) may be detachable from the cylindrical body (452) and fixedly or removably attached to the cylindrical body.

[0065] In use, the tissue sample holder (440) is used in a similar manner to the tissue sample holder (340) described above. For example, similar to the description above, the sample tray (440) is rotated using a driver (470) to align the various parts of the sample tray (440) with the sampling axis defined by the tissue delivery tube (302) to block tissue samples for imaging and / or analytical purposes, and then the subsequently blocked tissue samples are received to collect samples in each sample chamber (456).

[0066] However, unlike the use of the sample tray (350) described above, the use of the sample tray (450) in this example involves a different rotation sequence to accommodate the configuration of the individual sample stop feature (460) in this example. For example, the sample tray (450) is first rotated to align the sample stop feature (460) with the sampling axis defined by the tissue delivery tube (302) to block the tissue sample and retain the blocked tissue sample within the tissue delivery tube (302) for imaging and / or analytical purposes. After imaging and / or analysis, the sample tray (450) is rotated to align the selected receiving opening (458) with the sampling axis defined by the tissue delivery tube (302), and the subsequently blocked tissue sample can then be delivered to a given sample chamber (456) to capture the tissue sample. After capturing the tissue sample, the sample tray (450) is then rotated to align the sample stop feature (460) with the sampling axis again. The same process can then be used to image and / or analyze and capture subsequent tissue samples. The process can be repeated for each receiving opening (458) and sample chamber (456) combination until each sample chamber (456) is filled or the desired number of tissue samples have been collected.

[0067] Figure 8 An illustrative alternative tissue sample holder (540) is shown, which can be readily incorporated into the tissue processor (310) described above, either as a replacement for or supplement to the tissue sample holders (340, 440). The tissue sample holder (540) of this example is substantially the same as the tissue sample holder (440) described above. For example, like the tissue sample holder (440) described above, the tissue sample holder (540) of this example includes a sample tray (550) and a drive (not shown). The drive of this example is substantially the same as the drive (470) described above, such that the drive is typically configured to rotate the sample tray (550) and may include various structural features such as shafts, gears, motors, cams, cables, wheels, and / or others.

[0068] Similar to the sample tray (450) described above, the sample tray (550) of this example includes a cylindrical body (552) having a plurality of partition walls (554) extending outward from a central portion of the body (552). The partition walls (554) define a plurality of triangular or fan-shaped sample chambers (556) arranged in a circular pattern around the central portion of the body (552). Thus, as will be described in more detail below, the sample tray (550) is generally rotatable around the central portion of the body (552) to sequentially receive one or more tissue samples in each sample chamber (556).

[0069] Similar to the sample tray (450) described above, the sides of the cylindrical body (552) define a plurality of receiving openings (558) communicating with each corresponding sample chamber (556). Optionally, a portion of the cylindrical body (552) (e.g., the lower part or interior of the central portion of the cylindrical body (552)) defines one or more vacuum openings (not shown). Such vacuum openings may also communicate with each corresponding sample chamber (556) to facilitate vacuum flow through a given sample chamber (556). Alternatively, in some examples, the entire sample tray (550) can be placed under vacuum by applying a vacuum to the tray container (344).

[0070] Similar to the aforementioned receiving opening (458), each receiving opening (558) is configured to communicate independently with the tissue delivery tube (302), allowing one or more tissue samples to be delivered into the corresponding sample chamber (556). Correspondingly, each receiving opening (558) is configured to communicate with a vacuum tube (620) or other vacuum source, allowing a vacuum to be delivered into the corresponding sample chamber (556) to draw one or more tissue samples into the corresponding sample chamber (556) under vacuum.

[0071] Unlike the sample tray (450) described above, the cylindrical body (552) omits a structure similar to the sample stop feature (460) on its sides. Although it should be understood that such a structure may be optionally included in some examples. In addition to or in place of structures such as the sample stop feature (460), the tissue sample holder (540) of this example is equipped with or associated with a sample stop assembly (600). Typically, the sample stop assembly (600) is configured to manipulate a vacuum applied to the tissue sample to stop the tissue sample within the sample stop assembly (600) for imaging outside the sample tray (450). In some cases, the sample stop assembly (600) may preferably have a structure similar to the sample stop feature (460). For example, in some cases, examples including the sample stop feature (460) may provide a limited separation between the stopped tissue sample and other structures of the tissue sample holder (440, 540), which may interfere with imaging of the tissue sample depending on the specific imaging element used. In contrast, aspects of the sample stop assembly (600) can provide at least some predetermined spacing between the stopped tissue sample and other elements of the tissue sample holder (540), thereby providing unobstructed imaging in certain situations.

[0072] The sample stop assembly (600) includes a sample tube (610), a delivery vacuum tube (620), a vacuum splitter tube (630), and a fluid controller (640). The sample tube (610) is typically connected to the fluid controller (640) to selectively control the passage of the tissue sample through the sample tube (610), as will be described in more detail below.

[0073] The sample tube (610) includes a sample receiving tube (612) and two stop ports (614) extending perpendicularly to the sample receiving tube (612). The sample receiving tube (612) is sized and configured to receive tissue samples. Furthermore, the sample receiving tube (612) is configured to image the tissue samples. Therefore, depending on the specific imaging mode used, the sample receiving tube (612) can be optically transparent, X-ray transparent, and / or other types. The sample receiving tube (612) extends distally from the sample tray (550) toward the tissue delivery tube (302) such that the distal end of the sample receiving tube (612) can communicate with the tissue delivery tube (302). Therefore, the sample receiving tube (612) is hollow and configured to receive tissue samples from the tissue delivery tube (302).

[0074] Stop ports (614) extend perpendicularly from the sample tube (610) relative to the longitudinal axis defined by the sample tube (610). The stop ports (614) also extend one another. The stop ports (614) may optionally be positioned along a common axis. It can be understood that in some examples, this positioning along a common axis may be desirable to balance the fluid pressure relative to the tissue sample. Each stop port (614) typically communicates with the hollow interior of the sample tube (610) to facilitate fluid communication between the stop port (614) and the sample tube (610).

[0075] like Figure 9 As best shown, each stop port (614) includes a plurality of perforations (616) (also collectively referred to as porous portions in some examples) extending through the surface of each stop port (614). As will be described in more detail below, the perforations (616) are generally configured collectively as a porous structure to allow fluid flow through the wall defining each stop port (614) while preventing the flow of solid materials such as tissue. In this example, the perforations (616) are oriented perpendicularly to the longitudinal axis defined by the sample tube (610). In some examples, the perforations (616) may be configured as a plurality of slots oriented perpendicularly to the longitudinal axis defined by the sample tube (610). In other examples, the perforations (616) may be configured as a plurality of openings or boreholes arranged in a plurality of linear arrangements. Of course, other suitable configurations of the perforations (616) will be apparent to those skilled in the art in light of the teachings herein.

[0076] The sample tube (610) is in communication with the fluid controller (640) via a delivery vacuum tube (620) and a vacuum shunt tube (630). Specifically, the delivery vacuum tube (620) is in communication with the sample tray (550), which is in fluid communication with the proximal end of the sample tube (610) via a given receiving opening (558) associated with the transposition sample chamber (556). Although not shown, it should be understood that the tissue sample holder (540) may include other features associated with the delivery vacuum tube (620) to direct fluid communication into the sample tray (550), such as caps, manifolds, seals, and / or others. In any case, it should be understood that the proximal end of the sample tube (610) is generally in communication with the delivery vacuum tube (620) to communicate with the fluid controller (640).

[0077] Simultaneously, the stop port (614) is connected to the vacuum shunt (630), which in turn connects the stop port (614) to the fluid controller (640). In this configuration, the fluid controller (640) is configured to control the flow of vacuum or other fluid to the proximal end of the sample tube (610) or the stop port (614) to influence the movement of the tissue sample through the sample tube (610). Specifically, the fluid controller (640) may apply a vacuum to the proximal end of the sample tube (610) to cause axial movement of the tissue sample through the tissue delivery tube (302) and / or the sample tube (610). Similarly, the fluid controller (640) may apply a vacuum to the stop port (614) to prevent axial movement of the tissue sample through the sample tube (610).

[0078] The fluid controller (640) can take various forms and is configured to selectively control fluid flow to the delivery vacuum tube (620) and / or the vacuum splitter tube (630). In some examples, the fluid controller (640) may include a vacuum manifold configured to guide fluid through its communication. In other examples, the fluid controller (640) may include a stopcock valve or other valve. In any case, in such examples, the fluid controller (640) can be manually or electrically actuated using a control system.

[0079] In use, the fluid controller (640) can initially be configured to connect a vacuum to the proximal end of the sample tube (610) via a delivery vacuum tube (620). While the sample tube (610) is under vacuum, a tissue sample can be delivered into the sample tube (610) via a tissue delivery tube (302). Once the tissue sample is received within the sample tube (610), the fluid controller (640) can then connect the vacuum to a stop port (614) via a vacuum splitter tube (630). This will change the vacuum flow from axial alignment with the sample tube (610) to perpendicular alignment, thereby stopping the tissue sample within the sample tube (610). However, the vacuum can continue to flow through the perforation (616), allowing fluid to drain from the sample tube (610) while other solid materials, such as the tissue sample, remain in place.

[0080] Imaging can be performed when the tissue sample is contained within the sample tube (610). Figure 9 An imaging region (AR) for imaging tissue samples is shown. It can be seen that the imaging region (AR) is offset relative to the sample tray (550), thereby providing imaging that is not obstructed by the elements of the sample tray (550).

[0081] After imaging, the tissue sample can be transferred through the sample tube (610) to the sample tray (550). Specifically, the fluid controller (640) can then switch to reconnect the vacuum to the proximal end of the sample tube (610) via the delivery vacuum tube (620). With the vacuum applied to the proximal end of the sample tube (610), the tissue sample can be pulled proximally through the sample tube (610) and into the sample chamber (556) of the sample tray (550). This process can then be repeated to collect and image any number of subsequent tissue samples.

[0082] In some examples, actuation of the fluid controller (640) may be associated with rotation of the sample tray (550). For example, the fluid controller (640) may switch vacuum communication to the proximal end of the sample tube (610) after the sample tray (550) has rotated to transpose the sample tube (610) from one sample chamber (556) to another sample chamber (556). This can be advantageous because such transposition can indicate that the sample tray (550) has been positioned to receive a new tissue sample, thus associating it with the axial delivery of the tissue sample through the sample tube (610). In other examples, other suitable features may be associated with actuation of the fluid controller (640), such as operation of the imaging element, operation of the biopsy device (10), and / or others. Furthermore, or alternatively, actuation of the fluid controller (640) may be controlled at least in part by a timer, a sensor, and / or user input.

[0083] III. Exemplary Combinations

[0084] 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.

[0085] Example 1

[0086] A biopsy system includes: a biopsy device including 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 processor in communication with the biopsy device, the tissue processor including a tissue sample holder and an analysis component, the tissue sample holder including a sample tray including a plurality of sample chambers configured to receive one or more tissue samples cut by the cutter, the sample tray also including an outer surface defining one or more sample stop features and a plurality of receiving openings, each receiving opening corresponding to a sample chamber; and a tissue delivery tube adapted to be connected between the tissue sample holder and the cutter of the biopsy device, the sample tray being configured to move relative to the tissue delivery tube to selectively align one or more sample stop features or each receiving opening with the tissue delivery tube.

[0087] Example 2

[0088] According to the biopsy system described in Example 1, each of the one or more sample stop features is porous.

[0089] Example 3

[0090] According to the biopsy system described in Example 1 or 2, each of the one or more sample stop features defines a mesh configuration.

[0091] Example 4

[0092] According to any one of Examples 1 to 3, in the biopsy system, one or more sample stop features include a single sample stop feature.

[0093] Example 5

[0094] According to any one of Examples 1 to 3, in the biopsy system, one or more sample stop features include a single sample stop feature adjacent to a gap defined by a sample tray.

[0095] Example 6

[0096] According to any one of Examples 1 to 3, the biopsy system includes one or more sample stop features comprising a plurality of sample stop features, each sample stop feature corresponding to one of a plurality of sample chambers.

[0097] Example 7

[0098] According to any one of Examples 1 to 3, the biopsy system includes one or more sample stop features comprising a plurality of sample stop features, each sample stop feature corresponding to one of a plurality of sample chambers, each sample stop feature being disposed adjacent to a corresponding receiving opening.

[0099] Example 8

[0100] According to any one of Examples 1 to 3, the biopsy system includes one or more sample stop features comprising a plurality of sample stop features, each sample stop feature corresponding to one of a plurality of sample chambers, and each sample stop feature defining a corresponding receiving opening.

[0101] Example 9

[0102] According to any one of Examples 1 to 8, the biopsy system is configured to rotate relative to the tissue delivery tube.

[0103] Example 10

[0104] According to any one of Examples 1 to 8, in the biopsy system, the sample tray is configured to rotate about a rotation axis relative to the tissue delivery tube, with each receiving opening and sample stop feature aligned along a plane oriented perpendicular to the rotation axis.

[0105] Example 11

[0106] According to any one of Examples 1 to 10, the tissue sample holder further includes a driver configured to rotate the sample tray about an axis.

[0107] Example 12

[0108] According to any one of Examples 1 to 10, the tissue sample holder further includes a driver configured to rotate a sample tray about a rotation drive axis, with a plurality of sample chambers aligned along a plane oriented perpendicular to the rotation drive axis.

[0109] Example 13

[0110] According to any one of Examples 1 to 12, the biopsy system 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.

[0111] Example 14

[0112] According to any one of Examples 1 to 12, the biopsy system 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 aligned with a portion of the tissue delivery tube.

[0113] Example 15

[0114] According to any one of Examples 1 to 14, the biopsy system includes a sample tray comprising a cylindrical body defining a plurality of sample chambers arranged in a circular pattern around a central portion of the cylindrical body.

[0115] Example 16

[0116] 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 having a plurality of openings and one or more porous portions associated with one or more of the plurality of openings, the tissue tray being movable relative to the tissue delivery tube to selectively communicate each opening or each porous portion with the tissue delivery tube; and an analysis component defining an imaging axis extending from a detector, a portion of the tissue delivery tube being aligned with the imaging axis.

[0117] Example 17

[0118] According to the device described in Example 16, one or more porous portions are configured to block tissue samples relative to a portion of the tissue tray, and one or more porous portions are also configured to allow vacuum flow through a portion of the tissue tray.

[0119] Example 18

[0120] According to the device of Example 16, the tissue tray further includes a plurality of sample chambers, each opening communicating with a corresponding sample chamber among the plurality of sample chambers, such that each opening is configured to convey a tissue sample from the tissue delivery tube to the corresponding sample chamber, and one or more perforations are configured to block a tissue sample relative to one of the plurality of sample chambers.

[0121] Example 19

[0122] According to any one of Examples 16 to 18, one or more porous portions include a mesh integral with the side portion of the tissue tray.

[0123] Example 20

[0124] A method for analyzing tissue samples, the method comprising: transporting a tissue sample collected by a biopsy device through a tissue delivery tube; stopping the transport of the tissue sample through the tissue delivery tube near a sample tray; analyzing the stopped tissue sample while it is located within the tissue delivery tube; and transferring the tissue sample from the tissue delivery tube to a sample chamber in the tissue tray.

[0125] Example 21

[0126] The method according to Example 20 further includes, after the step of analyzing the blocked tissue sample, rotating the tissue tray to align the receiving opening of the tissue tray with the tissue delivery tube.

[0127] Example 22

[0128] The method according to Example 20 or 21 further includes rotating the tissue tray so that the sample stop feature of the tissue tray is aligned with the tissue delivery tube prior to the step of stopping the delivery of the tissue sample.

[0129] Example 23

[0130] According to any one of Examples 20 to 22, the step of stopping the transport of the tissue sample includes using a portion of the tissue tray to stop the transport of the tissue sample through the tissue transport tube.

[0131] Example 24

[0132] According to any one of Examples 20 to 23, the step of transferring the tissue sample from the tissue delivery tube to the sample chamber is performed after the step of analyzing the tissue sample.

[0133] Example 25

[0134] 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 rotatable tissue tray defining a plurality of sample chambers and a plurality of receiving openings corresponding to each sample chamber; and a sample stop assembly positioned adjacent to the tissue tray, the sample stop assembly including a sample tube in communication with the tissue delivery tube such that the sample tube is configured to deliver one or more tissue samples from the tissue delivery tube into the sample chambers of the tissue tray, the sample tube including one or more stop ports extending outward relative to a longitudinal axis defined by the sample tube, the one or more stop ports being configured to receive a vacuum to selectively stop one or more tissue samples within the sample tube for imaging.

[0135] Example 26

[0136] According to the device described in Example 25, one or more stop ports include a porous structure configured to allow fluid to flow through the porous structure while preventing tissue from flowing through the porous structure.

[0137] Example 27

[0138] According to the device described in Example 26, the porous structure includes a plurality of perforations.

[0139] Example 28

[0140] According to the device described in Example 27, a plurality of perforations are oriented perpendicularly to the longitudinal axis defined by the sample tube.

[0141] Example 29

[0142] According to any one of Examples 25 to 28, the device includes one or more stop ports comprising a pair of stop ports positioned along a common axis.

[0143] Example 30

[0144] According to the device described in Example 29, the paired stop ports extend perpendicularly relative to the longitudinal axis defined by the sample tube.

[0145] Example 31

[0146] According to any one of Examples 25 to 30, the sample stop assembly further includes a fluid controller in communication with one or more stop ports and the proximal end of the sample tube, the fluid controller being configured to selectively divert fluid flow from the proximal end of the sample tube to one or more stop ports.

[0147] 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.

[0148] Embodiments of the present invention have applications in conventional endoscopic and open surgical instruments as well as robot-assisted surgery.

[0149] 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.

[0150] 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.

[0151] 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 device, comprising: (i) Probe, (ii) A needle, extending from the probe, and (iii) A cutter that is movable relative to a needle to cut one or more tissue samples; (b) A tissue processor in communication with a biopsy device, the tissue processor including a tissue sample holder and an analysis component, the tissue sample holder including a sample tray including a plurality of sample chambers configured to receive one or more tissue samples cut by a cutter, the sample tray also including an outer surface defining one or more sample stop features and a plurality of receiving openings, each receiving opening corresponding to a sample chamber; and (c) A tissue delivery tube adapted to be connected between a tissue sample holder and a cutter of a biopsy device, wherein a sample tray is configured to move relative to the tissue delivery tube to selectively align one or more sample stop features or each receiving opening with the tissue delivery tube.

2. The biopsy system of claim 1, wherein each of the one or more sample stop features is porous.

3. The biopsy system according to claim 1 or 2, wherein each of the one or more sample stop features defines a mesh configuration.

4. The biopsy system according to any one of claims 1 to 3, wherein one or more sample stopping features include a single sample stopping feature.

5. The biopsy system according to any one of claims 1 to 3, wherein one or more sample stop features include a single sample stop feature adjacent to a gap defined by a sample tray.

6. The biopsy system according to any one of claims 1 to 3, wherein one or more sample stop features comprise a plurality of sample stop features, each sample stop feature corresponding to one of a plurality of sample chambers.

7. The biopsy system according to any one of claims 1 to 3, wherein one or more sample stop features comprise a plurality of sample stop features, each sample stop feature corresponding to one of a plurality of sample chambers, and each sample stop feature is disposed adjacent to a corresponding receiving opening.

8. The biopsy system according to any one of claims 1 to 3, wherein one or more sample stop features comprise a plurality of sample stop features, each sample stop feature corresponding to one of a plurality of sample chambers, and each sample stop feature defining a corresponding receiving opening.

9. The biopsy system according to any one of claims 1 to 8, wherein the sample tray is configured to rotate relative to the tissue delivery tube.

10. The biopsy system according to any one of claims 1 to 8, wherein the sample tray is configured to rotate about a rotation axis relative to the tissue delivery tube, and each receiving opening and sample stop feature is aligned along a plane oriented perpendicular to the rotation axis.

11. The biopsy system according to any one of claims 1 to 10, wherein the tissue sample holder further comprises an actuator configured to rotate the sample tray about an axis.

12. The biopsy system according to any one of claims 1 to 10, wherein the tissue sample holder further comprises a driver configured to rotate the sample tray about a rotation drive axis, and the plurality of sample chambers are aligned along a plane oriented perpendicular to the rotation drive axis.

13. The biopsy system according to any one of claims 1 to 12, wherein the analysis component includes 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.

14. The biopsy system according to any one of claims 1 to 12, wherein the analysis component includes 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 aligned with a portion of the tissue delivery tube.

15. The biopsy system according to any one of claims 1 to 14, wherein the sample tray comprises a cylindrical body defining a plurality of sample chambers arranged in a circular pattern around a central portion of the cylindrical body.

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, the tissue tray including a plurality of openings and one or more porous portions associated with one or more of the plurality of openings, the tissue tray being movable relative to a tissue delivery tube to selectively communicate each opening or each porous portion with the tissue delivery tube. and (c) Analysis component, defining an imaging axis extending from the detector, with a portion of the tissue delivery tube aligned with the imaging axis.

17. The device of claim 16, wherein one or more porous portions are configured to block tissue samples relative to a portion of the tissue tray, and the one or more porous portions are further configured to allow vacuum flow through a portion of the tissue tray.

18. The device of claim 16, wherein the tissue tray further comprises a plurality of sample chambers, each opening communicating with a corresponding sample chamber among the plurality of sample chambers, such that each opening is configured to convey a tissue sample from the tissue delivery tube to the corresponding sample chamber, and one or more perforations are configured to block a tissue sample relative to one of the plurality of sample chambers.

19. The device according to any one of claims 16 to 18, wherein one or more porous portions include a mesh integral with the side portion of the tissue tray.

20. A method for analyzing tissue samples, the method comprising: (a) Transporting tissue samples collected by the biopsy device through a tissue delivery tube; (b) Stop the transport of tissue samples through the tissue delivery tube near the sample tray; (c) Analyze the stopped tissue sample when it is located inside the tissue delivery tube; as well as (d) Transfer tissue samples from the tissue delivery tube to the sample chamber of the tissue tray.

21. The method of claim 20, further comprising, after the step of analyzing the blocked tissue sample, rotating the tissue tray to move the receiving opening of the tissue tray to align with the tissue delivery tube.

22. The method of claim 20 or 21, further comprising, prior to the step of stopping the transport of the tissue sample, rotating the tissue tray to align the sample stop feature of the tissue tray with the tissue transport tube.

23. The method according to any one of claims 20 to 22, wherein the step of stopping the transport of the tissue sample includes using a portion of the tissue tray to stop the transport of the tissue sample through the tissue transport tube.

24. The method according to any one of claims 20 to 23, wherein the step of transferring the tissue sample from the tissue delivery tube to the sample chamber is performed after the step of analyzing the tissue sample.

25. 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 rotatable tissue tray defining multiple sample chambers and multiple receiving openings corresponding to each sample chamber; and (c) A sample stop assembly positioned adjacent to a tissue tray, the sample stop assembly including a sample tube in communication with a tissue delivery tube such that the sample tube is configured to deliver one or more tissue samples from the tissue delivery tube into a sample chamber of the tissue tray, the sample tube including one or more stop ports extending outward relative to a longitudinal axis defined by the sample tube, the one or more stop ports being configured to receive a vacuum to selectively stop one or more tissue samples within the sample tube for imaging.

26. The device of claim 25, wherein one or more stop ports include a porous structure configured to allow fluid to flow through the porous structure while preventing tissue from flowing through the porous structure.

27. The device according to claim 26, wherein the porous structure comprises a plurality of perforations.

28. The device of claim 27, wherein the plurality of perforations are oriented perpendicularly to the longitudinal axis defined by the sample tube.

29. The device according to any one of claims 25 to 28, wherein one or more stop ports comprise a pair of stop ports positioned along a common axis.

30. The device of claim 29, wherein the paired stop ports extend perpendicularly to the longitudinal axis defined by the sample tube.

31. The device according to any one of claims 25 to 30, wherein the sample stop assembly further comprises a fluid controller in communication with one or more stop ports and the proximal end of the sample tube, the fluid controller being configured to selectively divert fluid flow from the proximal end of the sample tube to one or more stop ports.

Images