阅读说明：本技术 具有应用成像的活检装置 (Biopsy device with applied imaging ) 是由 布莱恩·R.·凯勒 帕特里克·A.·梅舍尔 于 2018-12-04 设计创作，主要内容包括：一种活检装置,包括主体、针、组织样本保持器和传感器。所述针从所述主体延伸。所述组织样本保持器与所述针连通以在由所述组织样本保持器限定的样本腔室内接收一个或多个组织样本。所述组织样本保持器包括接收腔。所述传感器被配置来检测x射线。所述接收腔的大小和形状被设定以接收所述传感器,使得所述传感器可移除地定位在所述组织样本保持器内。(A biopsy device includes a body, a needle, a tissue sample holder, and a sensor. The needle extends from the body. The tissue sample holder communicates with the needle to receive one or more tissue samples within a sample chamber defined by the tissue sample holder. The tissue sample holder includes a receiving cavity. The sensor is configured to detect x-rays. The receiving cavity is sized and shaped to receive the sensor such that the sensor is removably positioned within the tissue sample holder.)

1. A biopsy device with real-time imaging, comprising:

(a) a main body;

(b) a needle extending from the body;

(c) a tissue sample holder mounted to the body and in communication with the needle to receive one or more tissue samples; and

(d) an x-ray sensor configured to be positioned proximate to the tissue sample holder and adapted to receive x-rays that have passed through the one or more received tissue samples.

2. The biopsy device of claim 1, wherein the tissue sample holder comprises a plurality of sample chambers configured to receive and hold tissue samples.

3. The biopsy device of claim 1, wherein the tissue sample holder is configured to rotate relative to the body.

4. The biopsy device of claim 1, wherein the tissue sample holder comprises a receiving cavity configured to receive the x-ray sensor and a plurality of sample chambers arranged around the receiving cavity, wherein the tissue sample holder is configured to rotate to orient the x-ray sensor relative to the plurality of sample chambers.

5. The biopsy device of claim 1, further comprising an imaging device, wherein the imaging device is configured to emit x-rays, wherein the imaging device and the x-ray sensor are configured to cooperate to generate an x-ray image.

6. The biopsy device of claim 1, further comprising a processor coupled to the x-ray sensor and adapted to process the received x-rays in real-time while taking a biopsy of the one or more tissue samples.

7. The biopsy device of claim 1, further comprising: a processor coupled to the x-ray sensor; and a control module that controls the biopsy of the one or more tissue samples, the processor controlling an x-ray source to emit the x-rays through the tissue sample and process an image according to the x-rays received from the x-ray sensor in response to a signal from the control module indicating that a biopsy has been taken.

8. The biopsy device of claim 1, further comprising an imaging device, wherein the tissue sample holder comprises a receiving cavity for receiving the x-ray sensor and a plurality of sample chambers oriented around the receiving cavity, wherein the imaging device and the x-ray sensor are configured to cooperate to separately generate an x-ray image of each of the plurality of sample chambers.

9. The biopsy device of claim 1, wherein the tissue sample holder comprises a plurality of sample chambers oriented around a cavity, wherein the cavity is configured to receive the x-ray sensor therein to receive x-rays emitted through the one or more of the plurality of sample chambers.

10. The biopsy device of claim 1, wherein the sensor comprises an electronic circuit, an imager, a fiber optic plate, and a scintillator.

11. A biopsy device, comprising:

(a) a main body;

(b) a needle extending distally from the body;

(c) a tissue sample holder comprising one or more tissue chambers configured to store a tissue sample therein; and

(d) at least one sensor positioned within the tissue sample holder adjacent to one of the one or more tissue chambers, wherein the at least one sensor is operable to receive radiation from an imaging device, wherein the at least one sensor is configured to digitally transmit data in response to the radiation from the imaging device.

12. The biopsy device of claim 11, wherein the at least one sensor is fixedly secured relative to the body such that the at least one sensor maintains a static orientation during rotation of the tissue sample holder relative to the body.

13. The biopsy device of claim 11, wherein the tissue sample holder comprises a plurality of tissue chambers.

14. The biopsy device of claim 11, wherein the tissue sample holder comprises a plurality of tissue chambers, wherein the at least one sensor comprises a plurality of sensors, wherein each sensor corresponds to each tissue chamber of the plurality of tissue chambers.

15. The biopsy device of claim 14, wherein the sensor is fixedly secured relative to the tissue sample holder such that the sensor is configured to rotate during rotation of the tissue sample holder relative to the body.

16. The biopsy device of claim 15, wherein each sensor of the plurality of sensors is sized and shaped to be substantially equal to a size of each corresponding sample chamber.

17. A method of taking an image of a biopsy tissue sample from a biopsy device, the method comprising the steps of:

(a) inserting a needle into a patient to sever and extract a tissue sample;

(b) storing the tissue sample in a tissue sample holder;

(c) inserting a digital sensor into the tissue sample holder such that the digital sensor is positioned adjacent to the tissue sample;

(d) positioning an imaging device adjacent to the tissue sample holder such that a beam emitter of the imaging device is aligned toward the tissue sample and the digital sensor; and

(e) activating the imaging device to emit energy toward the tissue sample and the digital sensor.

18. The method of claim 17, further comprising generating an image of the tissue sample.

19. The method of claim 17, further comprising generating an image of the tissue sample, further comprising displaying a graphical representation of the tissue sample.

20. The method of claim 17, further comprising generating an image of the tissue sample, further comprising displaying a graphical representation of the tissue sample, further comprising rotating the tissue sample holder to align a different tissue sample with the beam emitter.

Background

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

Merely exemplary biopsy devices and biopsy system components are disclosed in: U.S. Pat. No. 5,526,822 entitled "Method and Apparatus for Automated Biopsy and Collection of Soft tissue", published at 18.6.1996; U.S. patent No. 6,086,544 entitled "Control Apparatus for Automated scientific Biopsy Device" issued at 11.7.2000; U.S. patent No. 7,442,171 entitled "Remote thumb for a scientific Biopsy Device" issued on 8.10.2008; U.S. patent No. 7,854,706 entitled "Clutch and vacuum System for thermal BiopsyDevice" issued on 12/1/2010; U.S. patent No. 7,938,786 entitled "Vacuum timing algorithm for Biopsy Device," issued 5/10/2011; and U.S. patent No. 8,118,755 entitled "Biopsy Sample Storage" issued on 21/2/2012. The disclosures of each of the above-referenced U.S. patents are hereby incorporated by reference.

After extracting a biopsy specimen from a patient using one of the exemplary biopsy device or biopsy system components disclosed above, an operator may wish to examine the tissue specimen with certain imaging modalities. Due to the significant amount of time required to extract a tissue sample from a biopsy device, position the sample into a test receptacle, and then insert the test receptacle into an imaging system to generate an image of the specimen for analysis, the timeliness of the operator testing the sample under such conditions may be limited.

While several systems and methods have been made and used to obtain biopsy samples, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.

Drawings

While the specification concludes with claims particularly pointing out and distinctly claiming the present technology, it is believed that the present technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements, and wherein:

FIG. 1 depicts a schematic diagram of an exemplary biopsy system including a biopsy device and a vacuum control module;

FIG. 2 depicts a perspective view of an exemplary biopsy device of the biopsy system of FIG. 1 including an exemplary probe coupled with an exemplary holster;

FIG. 3 depicts a perspective view of the biopsy device of FIG. 2 with the probe decoupled from the holster;

FIG. 4 depicts a perspective view of a probe of the biopsy device of FIG. 2;

FIG. 5 depicts an exploded view of the probe of FIG. 4;

FIG. 6 depicts a cross-sectional view of the needle assembly of the probe of FIG. 4;

FIG. 7 depicts a partial top plan view of a component of the probe of FIG. 4 with the top housing piece removed;

FIG. 8 depicts a side cross-sectional view of the component of FIG. 7 taken along line 8-8 of FIG. 7;

FIG. 9 depicts a perspective view of the tissue sample holder assembly of the probe of FIG. 4;

FIG. 10 depicts an exploded view of the proximal end of the probe of FIG. 4;

FIG. 11 depicts a side cross-sectional view of the tissue sample holder assembly of FIG. 9 with the tissue sample chamber aligned with the cutter;

FIG. 12 depicts an exploded view of the tissue sample holder assembly of FIG. 9;

FIG. 13 depicts a perspective view of an exemplary digital sensor;

FIG. 14 depicts an exploded perspective view of the digital sensor of FIG. 13;

FIG. 15 depicts a perspective view of an exemplary imaging device;

FIG. 16A depicts a side elevational view of the biopsy device of FIG. 2 with the digital sensor of FIG. 13 advanced toward the tissue sample holder assembly of FIG. 9;

FIG. 16B depicts a side elevational view of the biopsy device similar to FIG. 16A, but with the digital sensor positioned within the tissue sample holder assembly;

FIG. 17A depicts a side cutaway view of the biopsy device of FIG. 16A;

FIG. 17B depicts a side cutaway view of the biopsy device of FIG. 16B;

FIG. 17C depicts a side cutaway view of a biopsy device similar to FIG. 17B, but with the imaging device of FIG. 15 positioned adjacent to the tissue sample holder assembly;

fig. 18 depicts a schematic view of the imaging device of fig. 15 emitting a beam toward the digital sensor of fig. 13, wherein the digital sensor outputs a processed image of the contents contained in the tissue sample holder assembly;

FIG. 19 depicts a perspective view of an exemplary alternative biopsy device including a distal tissue sample viewing window;

FIG. 20 depicts a side cutaway view of the biopsy device of FIG. 19 with the imaging device of FIG. 15 selectively positioned adjacent to a distal tissue sample viewing window;

FIG. 21 depicts a side elevational view of another exemplary alternative biopsy device including a proximal tissue sample viewing window;

FIG. 22 depicts a side cutaway view of the biopsy device of FIG. 21 with the imaging device of FIG. 15 selectively positioned adjacent to a proximal tissue sample viewing window;

FIG. 23 depicts a side elevational view of the biopsy device of FIG. 2 with an exemplary alternative imaging device selectively positioned adjacent to the tissue sample holder assembly;

FIG. 24 depicts a side cross-sectional view of the biopsy device of FIG. 23 including an exemplary digital sensor positioned within a tissue sample holder assembly;

FIG. 25 depicts a perspective view of another exemplary alternative imaging device including an exemplary clamp arm and an exemplary digital sensor, wherein the tissue sample holder assembly of FIG. 9 is received by the clamp arm;

FIG. 26 depicts a side elevational view of the imaging device of FIG. 25 with the tissue sample holder assembly positioned between the digital sensor and the imaging device;

FIG. 27 depicts a side elevation view of another exemplary alternative imaging device including an exemplary tissue holder receiving arm and an exemplary digital sensor, wherein the tissue sample holder assembly of FIG. 9 is received by the tissue holder receiving arm;

FIG. 28 depicts a partial side elevational view of the imaging device of FIG. 27 with the digital sensor received within the tissue holder receiving arm and received by the tissue sample holder assembly; and is

Fig. 29 depicts a partial top elevation view of the imaging device of fig. 28 with the tissue sample holder assembly slidably engaged to the tissue holder receiving arm.

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

Detailed Description

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 by way of illustration, one of the best modes contemplated for carrying out the present technology. As will be realized, the technology described herein is capable of other different and obvious aspects, all without departing from the technology. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

I. Overview of an exemplary biopsy System

Fig. 1 depicts an exemplary biopsy system (2) including a biopsy device (10) and a vacuum control module (400). The biopsy device (10) of this example includes a probe (100) and a holster (200), as shown in fig. 2-3. A needle (110) extends distally from the probe (100) and is inserted into tissue of a patient to obtain a tissue sample. These tissue samples are deposited in a tissue sample holder (300) located at the proximal end of the probe (100), as will also be described in more detail below. It should also be understood that the use of the term "case" herein should not be read as requiring any portion of the probe (100) to be inserted into any portion of the case (200). In this example, the case (200) includes a set of prongs (208), the set of prongs (208) being received by the chassis (106) of the probe (100) to releasably secure the probe (100) to the case (200). Specifically, the probe (100) is first positioned on top of the casing (200), just proximal to the final position of the probe (100) with respect to the casing (200); the probe (100) is then slid distally to fully engage the prongs (208). The probe (100) further includes a set of resilient tabs (104), the set of resilient tabs (104) being depressible inwardly to disengage the prongs (208) such that a user can depress both tabs (104) simultaneously and then pull the probe (100) rearwardly and away from the case (200) in order to decouple the probe (100) from the case (200). Of course, a variety of other types of structures, components, features, etc. (e.g., bayonet mounts, latches, clamps, clips, snap fittings, etc.) may be used to provide removable coupling of the probe (100) to the case (200). Furthermore, in some biopsy devices (10), the probe (100) and the holster (200) may have a unitary or monolithic structure such that the two components cannot be separated. By way of example only, in versions where the probe (100) and the case (200) are provided as separable components, the probe (100) may be provided as a disposable component and the case (200) may be provided as a reusable component. Still other suitable structural and functional relationships between the probe (100) and the case (200) will be apparent to those of ordinary skill in the art in view of the teachings herein.

Some variations of the biopsy device (10) may include one or more sensors (not shown) in the probe (100) and/or the holster (200) that are configured to detect when the probe (100) is coupled with the holster (200). Such sensors or other features may also be configured to allow only certain types of probes (100) and sleeves (200) to be coupled together. Additionally or in the alternative, such sensors may be configured to disable one or more functions of the probe (100) and/or the case (200) until the appropriate probe (100) and case (200) are coupled together. In one merely illustrative example, the probe (100) includes a magnet (not shown) that is detected by a hall effect sensor (not shown) or some other type of sensor in the case (200) when the probe (100) is coupled with the case (200). As still another merely illustrative example, coupling of the probe (100) to the casing (200) may be detected using physical contact between conductive surfaces or electrodes, using RFID technology, and/or in numerous other ways that will be apparent to those of ordinary skill in the art in view of the teachings herein. Of course, such sensors and features may be changed or omitted as desired.

The biopsy device (10) of the present example is configured to be mounted to a table or fixture and used under stereotactic guidance. Of course, biopsy device (10) may instead be used under ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or otherwise. It should also be understood that biopsy device (10) may be sized and configured such that biopsy device (10) may be operated by a single hand of a user. Specifically, a user may grasp biopsy device (10), insert needle (110) into a breast of a patient, and collect one or more tissue samples from within the breast of the patient, all with only a single hand. Alternatively, the user may grasp biopsy device (10) with more than one hand and/or with any desired assist. In some environments, a user may capture multiple tissue samples by inserting the needle (110) into the breast of a patient only once. Such tissue samples may be pneumatically deposited in the tissue sample holder (300) and later retrieved from the tissue sample holder (300) for analysis. While the examples described herein often relate to taking a biopsy sample from a patient's breast, it should be understood that the biopsy device (10) may be used in a variety of other procedures for a variety of other purposes, and in a variety of other portions of the patient's anatomy (e.g., prostate, thyroid, etc.). Various exemplary components, features, configurations, and operability of biopsy device (10) are described in more detail below; and other suitable components, features, configurations, and operability will be apparent to one of ordinary skill in the art in view of the teachings herein.

Exemplary case

As shown in fig. 3, the case (200) of the present example includes a top housing cover (202), side panels (204), and a housing base (206) fixedly secured together. A gear (212, 230) is exposed through the top housing cover (202) and meshes with a gear (130, 140) of the probe (100) when the probe (100) and the case (200) are coupled together. In particular, the gears (230, 140) drive an actuation assembly of a cutter (150) within the needle (110); and the gears (212, 130) are used to rotate the needle (110). A gear (240) is located at the proximal end of the housing (200) and is engaged with the gear (182) of the probe (100) to rotate the rotatable member (310) of the tissue sample holder (300).

As noted above, rotation of the gear (212) provides rotation of the needle (110) relative to the probe (100). In this example, the gear (212) is rotated by rotating the knob (210). Specifically, the knob (210) is coupled to the gear (212) through a series of gears (not shown) and shafts (not shown) such that rotation of the knob (210) rotates the gear (212). A second knob (210) extends from the other side of the case (200). By way of example only, such a needle rotation mechanism may be constructed in accordance with the teachings of U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. As another merely illustrative example, the needle rotation mechanism may be constructed in accordance with 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 still other versions, the needle (110) is simply rotated by rotating the thumbwheel (116). Various other suitable ways in which rotation of the needle (110) may be provided will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that some versions may not provide for rotation of the needle (110).

The holster (200) also includes a firing bar (226) and a fork (222) coupled with the needle (110) and firing the needle (110) distally. By way of example only, such firing may be applicable to the following: the biopsy device (10) is mounted to a stereotactic table fixture or other fixture with the tip (112) adjacent to the breast of the patient such that a needle firing mechanism can be activated to drive the needle (110) into the breast of the patient. The needle firing mechanism may 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 stationary components of the probe (100).

In this example, the needle firing mechanism is coupled with the needle (110) via a firing bar (226) and a firing fork (222). The firing bar (226) and the firing fork (222) are integrally secured together. The firing fork (222) includes a pair of prongs (224), the pair of prongs (224) receiving the hub member (120) of the needle (110) therebetween. The fork (224) is positioned between the annular flange (118) and the thumbwheel (116) such that the needle (110) will translate integrally with the firing bar (226) and fork (222). Nevertheless, the fork (224) removably receives the hub member (120) so that the fork (222) can be easily fastened to the hub member (120) when the probe (100) is coupled with the case (200); and such that the hub member (120) is easily removable from the fork (222) when the probe (100) is decoupled from the case (200). The prongs (224) are also configured to allow the hub member (120) to rotate between the prongs (224). Other suitable components, configurations, and relationships will be apparent to those of ordinary skill in the art in view of the teachings herein. The internal components of the needle Firing mechanism of the present example are configured and arranged as described in U.S. patent No. 8,858,465 entitled "Biopsy Device with motorized needle filing," issued 10/14/2014, the disclosure of which is incorporated herein by reference.

The case (200) includes a motor (not shown) for driving the gears (230, 240), thereby rotating and translating the cutter (150) and rotating the rotatable member (310) of the tissue sample holder (300). The casing (200) also includes a motor (not shown) operable to drive the firing bar (226), and thus the arm and firing pin (110). All motors mentioned herein are housed within the casing (200) of the present example and receive power from the vacuum control module (400) via the cable (90). Furthermore, data may be communicated between the vacuum control module (400) and the casing (200) via a cable (90). As will be described in more detail below, such data may be used by the control module (400) to display certain graphical user interface screens on a touch screen (410) integrated into the control module (400). In some other versions, one or more motors may be powered by one or more batteries located within the case (200) and/or probe (100). It should therefore be understood that, as with the other components described herein, the cable (90) is only optional. As yet another merely illustrative variant, the electric motor may be pneumatically powered, so that the cable (90) may be replaced by a conduit conveying a pressurized fluid medium to the casing (200). As still other merely illustrative variations, cable (90) may include one or more rotary drive cables driven by a motor located outside of casing (200). It should also be understood that two or three of the motors may be combined into a single motor. Other suitable ways of driving the various motors will be apparent to those of ordinary skill in the art in view of the teachings herein.

Exemplary probes

The probe (100) of the present example includes a needle (110) extending distally from the probe (100), the needle (110) being inserted into tissue of a patient to obtain a tissue sample. These tissue samples are deposited in a tissue sample holder (300) located at the proximal end of the probe (100). As shown in fig. 1, a vacuum control module (400) is coupled with the probe (100) via a valve assembly (500) and tubing (20, 30, 40, 60), the vacuum control module (400) operable to selectively provide vacuum, saline, atmospheric air, and ventilation to the probe (100). The internal components of the Valve Assembly of this example are configured and arranged as described in U.S. publication No. 2013/0218047 entitled "BiopsyDevice Valve Assembly" published on 8/22/2013, the disclosure of which is incorporated herein by reference.

As shown in fig. 1-6, the probe (100) further includes a bottom plate (106) and a top housing (102) fixedly secured together. As best seen in fig. 3, the gear (140) is exposed through an opening (107) in the chassis (106) and is operable to drive a cutter actuation mechanism in the probe (100). As also seen in fig. 3, another gear (130) is exposed through the chassis (106) and is operable to rotate the needle (110), as will be described in more detail below. When the probe (100) and the case (200) are coupled together, the gear (140) of the probe (100) meshes with the exposed gear (230) of the case (200). Similarly, when the probe (100) and the case (200) are coupled together, the gear (130) of the probe (100) meshes with the exposed gear (212) of the case (200).

A. Exemplary needle Assembly

The needle (110) of the present example includes a cannula (113), the cannula (113) having a tissue piercing tip (112), a lateral aperture (114) proximal to the tip (112), and a hub member (120). The tissue piercing tip (112) is configured to pierce and penetrate tissue without requiring a substantial amount of force and without requiring a pre-formed 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 of the techniques in U.S. patent No. 8,801,742 entitled "Needle Assembly and Blade Assembly for biopsy Device," issued 8/12 2014, the disclosure of which is incorporated herein by reference. As another merely illustrative example, the nib (112) may be constructed in accordance with at least some of the teachings of U.S. publication No. 2013/0150751, the disclosure of which is incorporated herein by reference. Other suitable configurations for the tip (112) will be apparent to those of ordinary skill in the art in view of the teachings herein.

The lateral aperture (114) is sized to receive prolapsed tissue during operation of the device (10). A hollow tubular cutter (150) having a sharp distal edge (152) is located within the needle (110). The cutter (150) is operable to rotate and translate relative to the needle (110) and pass through the lateral aperture (114) to sever a tissue sample from tissue protruding through the lateral aperture (114). For example, the cutter (150) may be moved from an extended position to a retracted position, thereby "opening" the lateral aperture (114) to allow tissue to protrude therethrough; and then moved from the retracted position back to the extended position to sever the protruding tissue. As will be described in greater detail below, the needle (110) may be rotated to orient the lateral aperture (114) at any desired angular position about the longitudinal axis of the needle (110). In the present example, such rotation of the needle (110) is facilitated by the hub member (120), which is described in more detail below.

As best seen in fig. 6, the needle (110) further includes a longitudinal wall (190) extending proximally from a proximal portion of the tip (112). Although in this example the wall (190) does not extend along the full length of the cannula (113), it is understood that the wall (190) may extend along the full length of the cannula (113), if desired. The wall (190) defines a distal portion of a second lumen (192) outside the cutter (150) and parallel to the cutter (150). As shown in fig. 6, wall (190) proximally terminates at a longitudinal position just proximal to the position at which the distal cutting edge (152) of cutter (150) would be when cutter (150) is in the proximal-most position. The exterior of the cutter (150) and the interior of the cannula (113) together define a proximal portion of the second cavity (192) in the length of the needle (110) proximal to the proximal end of the wall (190).

The wall (190) comprises a plurality of openings (194), the plurality of openings (194) providing fluid communication between the second cavity (192) and a region within the cannula (113) above the wall (190) and below the lateral aperture (114). This further provides fluid communication between the second lumen (192) and a lumen (151) defined by the interior of the cutter (150), as will be described in more detail below. The openings (194) are arranged such that at least one opening (194) is located at a longitudinal position distal to a distal edge of the lateral aperture (114). Thus, the lumen (151) of the cutter (150) and the second lumen (192) may remain in fluid communication even when the cutter (150) is advanced to a position in which the distal cutting edge of the cutter (150) is located at a longitudinal position distal to the longitudinal position of the distal edge of the lateral aperture (114). An example of such a configuration is disclosed in U.S. patent No. 7,918,803 entitled "Methods and Devices for Automated Biopsy and Collection of Soft tissue", published 5.2011, the disclosure of which is incorporated herein by reference. Of course, as with any other components described herein, any other suitable configuration may be used.

The needle (110) may also have a plurality of external openings (not shown) formed therein, and the plurality of external openings may be in fluid communication with the second cavity (192). For example, such an external opening may be configured in accordance with the teachings of U.S. publication No. 2007/0032742 entitled "BiopsyDevice with Vacuum Assisted feeding Control" published on 8.2.2007, the disclosure of which is incorporated herein by reference. Of course, as with other components described herein, such external openings in the needle (110) are merely optional.

The hub member (120) of the present example is overmolded around the needle (110) such that the hub member (120) and the needle (110) rotate and translate integrally with one another. 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 that is overmolded around the needle (110) to integrally secure and form the hub member (120) to the needle (110). Alternatively, the hub member (120) and the needle (110) may be formed of any other suitable material and may be secured together in any other suitable manner. The hub member (120) includes an annular flange (118) and a thumbwheel (116). A gear (130) is slidably and coaxially disposed on the proximal portion (150) of the hub member (120) and is keyed to the hub member (120) such that rotation of the gear (130) will rotate the hub member (120) and the needle (110); the hub member (120) and the needle (110) are also translatable relative to the gear (130). The gear (130) is rotatably driven by the gear (212). Alternatively, the needle (110) may be rotated by rotating the thumbwheel (116). Various other suitable ways in which manual rotation of the needle (110) may be provided will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that rotation of the needle (110) may be automated in a variety of ways, including but not limited to various forms of automated needle rotation described in the various references cited herein.

As shown in fig. 4-7, the manifold (122) is attached, mounted, or otherwise secured to the proximal end of the needle (110). The manifold (122) defines a hollow interior (124) and includes a port (126) in fluid communication with the hollow interior (124). As best seen in fig. 6, the hollow interior (124) is also in fluid communication with the second lumen (192) of the needle (110). The port (126) is coupled with the tube (46) such that the manifold (122) provides fluid communication between the second cavity (192) and the tube (46). The manifold (122) also seals against the exterior of the needle (110) such that the manifold 122 provides a fluid-tight coupling between the second cavity (192) and the tube (46), even if the needle (110) translates and/or rotates relative to the manifold (122), such as during firing of the needle (110) or reorientation of the needle (110), respectively.

As shown in fig. 4, the needle (110) may be provided with a removable cap (115). The cap (115) of this example includes a resiliently biased latch (117), the resiliently biased latch (117) being configured to engage the thumbwheel (116) to removably secure the cap (115) to the needle (110). The cap (115) is configured to cover the tip (112) when the latch (117) is engaged with the thumbwheel (116) such that the cap (115) protects a user of the biopsy device (10) from inadvertent contact with the tip (112). The cap (115) may also include one or more pressure seals near the proximal and/or distal ends of the cap (115) to seal against the cannula (113). By way of example only, the cover (115) may be configured in accordance with at least some of the teachings of U.S. publication No. 2013/0150751, the disclosure of which is incorporated herein by reference. Various other suitable configurations for the cover (115) will be apparent to those of ordinary skill in the art in view of the teachings herein. Of course, the cover (115) may simply be omitted if desired. It should also be understood that, as with other components described herein, the needle (110) may be changed, modified, replaced, or supplemented in various ways; and the needle (110) may have a variety of alternative features, components, configurations, and functions. For example, the needle (110) may be constructed in accordance with the teachings of U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference, and/or in accordance with the teachings of any other reference cited herein.

B. Exemplary cutter Assembly

As noted above, the cutter (150) is operable to simultaneously translate and rotate relative to the needle (110) in order to sever a tissue sample from tissue protruding through the lateral aperture (114). As best seen in fig. 5-7, the cutter (150) includes an overmold (160) integrally secured to the cutter (150). The overmold (160) includes a generally smooth and cylindrical distal portion (166), threads (162) in a middle region of the overmold (160), and a set of hexagonal flats (164) extending along a proximal portion of the overmold (160). The distal portion (166) extends into the manifold (122). The manifold (122) seals against the distal portion (166) such that the manifold (122) maintains a fluid-tight coupling between the second lumen (192) and the tube (46), even when the cutter (150) translates and rotates relative to the manifold (122).

The gear (140) is positioned on the flat (164) and includes a set of internal flats (not shown) that are complementary to the flat (164). Thus, when the gear (140) rotates, the gear (140) rotates the overmold (160) and the cutter (150). However, the overmold (160) may slide relative to the gear (140) such that the cutter (150) may translate relative to the chassis (160) despite the gear (140) being longitudinally fixed relative to the chassis (160). The gear (140) is rotated by the gear (230). As best seen in fig. 7-8, the nut (142) is associated with the threads (162) of the overmold (160). Specifically, the nut (142) includes internal threads (144) that engage with threads (162) of the overmold (160). The nut (142) is fixedly secured relative to the chassis (160). Thus, when the gear (140) rotates the cutter (150) and overmold (160), the cutter (150) will simultaneously translate due to the engagement of the threads (144, 162). In some versions, the aforementioned cutter actuation components are further configured in accordance with at least some of the teachings of U.S. publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. As yet another merely illustrative example, a pneumatic motor or the like may be used to rotate and/or translate the cutter (150). Still other suitable ways in which cutter (150) may be actuated will be apparent to those of ordinary skill in the art in view of the teachings herein.

C. Exemplary tissue sample holder Assembly

The tissue sample holder (300) of the present example provides a plurality of discrete chambers configured to receive tissue samples severed by the cutter (150) and delivered proximally through the lumen (151) of the cutter (150). Specifically, and as will be described in greater detail below, the tissue sample holder (300) includes a tissue receiving tray (330) that is removably engaged with the rotatable member (310). The rotatable member (310) is removably engaged with a gripping feature (184) of the rotating member (180). The rotating member (180) is longitudinally fixed relative to the chassis (106), but is rotatable relative to the chassis (106). The rotating member (180) includes an integral gear (182), the integral gear (182) meshing with a gear (240) of the case (200) when the probe (100) and the case (200) are coupled together. The gears (182, 240) cooperate to rotate the rotatable member (310) in order to index the tissue chamber relative to the cavity (151) of the cutter (150), as will be described in greater detail below. A transparent cover (302) is positioned around the rotatable member (310) and removably secured to the chassis (106). While the bayonet feature provides a coupling between the cover (302) and the chassis (106), it should be understood that any suitable type of coupling may be used. The rotatable member (310) is free to rotate within the cover (302). However, the rotatable member (310) is engaged with the cover (302) such that when the cover (302) is removed from the chassis (106), the rotatable member (310) will decouple relative to the chassis (106). In other words, the rotatable member (310) may be selectively coupled to the chassis (106) and removed relative to the chassis (106) by coupling the cover (302) to the chassis (106) and removing the cover from the chassis (106).

As best seen in fig. 12, the rotatable member (310) of the present example generally comprises a rotatable member and defines a plurality of chambers in the form of channels (312), the channels (312) extending longitudinally through the rotatable member (310) and being angularly aligned about a central axis of the rotatable member (310). A lateral groove (314) (fig. 11) is associated with a distal portion of each channel (312). A shelf (316) demarcates between each channel (312) and the associated lateral groove (314). As will be described in more detail below, the channel (312) receives the tray (330), while the groove (314) provides a pneumatic channel. Additional channels (313) and grooves (315) are associated with the plug (360), as will also be described in more detail below. The rotatable member (310) further includes a central shaft (320), the central shaft (320) configured to removably engage the gripping feature (184). As described above, the central shaft (320) couples with the gripping feature (184) when the outer cup (302) couples with the chassis (106). Engagement between the central shaft (320) and the gripping feature (184) provides rotation of the rotatable member (310) as the gear (182) rotates.

As best seen in fig. 10-11, the sealing member (170) is disposed at a proximal end of the chassis (106) and interfaces with a distal face of the rotatable member (310). In this example, the sealing member (170) comprises rubber, but it should be understood that any other suitable material may be used. The seal member (170) includes a longitudinally extending cutter seal (172), the cutter seal (172) receiving the cutter (150) and sealing against an exterior of the cutter (150). The proximal end of the cutter (150) is retained within the cutter seal (172) throughout the range of travel of the cutter (150). During this full range of motion, including during rotation and translation of the cutter (150), the cutter seal (172) maintains a fluid-tight seal against the cutter (150). An opening (174) is positioned at a proximal end of the cutter seal (170). This opening (174) is configured to align with any channel (312, 313) located at the 12 o' clock position. Another opening (176) is positioned below the opening (174). The opening (176) is configured to align with any recess (314, 315) located at the 12 o' clock position. As best seen in fig. 9 and 11, opening (176) is in fluid communication with port (178), which port (178) is coupled with tube (20). Thus, the sealing member (170) provides fluid communication between the tube (20) and any groove (314, 315) located at the 12 o' clock position. As will be described in greater detail below, the rotatable member (310) further provides fluid communication between such grooves (314, 315) at the 12 o' clock position and associated channels (312, 313); and thereby further provides fluid communication to the cavity (151) of the cutter (150). In other words, the sealing member (170) and the rotatable member (310) cooperate to provide fluid communication between the tube (20) and the cavity (151) of the cutter (150) via any channels (312, 313) and grooves (314, 315) located at the 12 o' clock position. It will be appreciated that the sealing member (170) of the present example maintains a fluid tight seal against the distal face of the rotatable member (310), even when the rotatable member (310) is rotated relative to the sealing member (170).

As noted above, tissue sample holder tray (330) is configured to removably engage rotatable member (310). Each tissue sample holder tray (330) of the present example includes a handle (332), a proximal wall (334), and a plurality of tabs (340) extending distally from the proximal wall (334). The strips (340) are sized and configured for insertion into associated channels (312) of the rotatable member (310). Each strip (340) includes a pair of side walls (344) and a bottom panel (342). Each pair of side walls (344) and each floor (342) together define a corresponding tissue sample chamber (346). An opening (348) is provided at a distal end of each tissue sample chamber (346). The opening is sized and positioned to correspond with the opening (174) of the sealing member (170). Thus, the lumen (151) of the cutter (150) is in fluid communication with the tissue sample chamber (346) of the strip (340) inserted into the channel (312) at the 12 o' clock position. As best seen in fig. 11, the strips (340) are configured such that a distal portion of each strip (340) receives support from a corresponding shelf (316) of the rotatable member (310). Each bottom plate (342) includes a plurality of openings (345), the plurality of openings (345) providing fluid communication between tissue sample chambers (346) of the strip (340) and lateral grooves (314) of channels (312) associated with the strip (340). Thus, vacuum, atmospheric air, etc., delivered to opening (176) via tube (20) is further delivered to lumen (151) of cutter (150) via lateral recess (314), opening (345) and tissue sample chamber (346). During operation of biopsy device (10), a tissue sample severed by the distal edge (152) of cutter (150) is conveyed proximally through the lumen (151) of cutter (150) and then deposited into tissue sample chamber (346) aligned with lumen (151) of cutter (150). The rotatable member (310) rotates to sequentially align the tissue sample chambers (346) with the cavities (151) of the cutter (150), thereby enabling several tissue samples to be separately deposited in different tissue sample chambers (346) during operation of the biopsy device (10). Body fluids, saline, etc. drawn through cavity (151) will pass through tissue sample holder (300) and tube (20) and ultimately be deposited in vacuum canister (70).

Each strip (340) further comprises a pair of pressure seals (343, 349), which pair of pressure seals (343, 349) seals against the interior of the channel (312) when the strip (340) is fully inserted into the channel (312). The pressure seals (343, 349) provide a fluid-tight seal for the tissue sample chamber (346) and further provide a frictional resistance that resists removal of the strip (340) from the rotatable member (310). The handle (332) is configured to facilitate removal of the strip (340) from the rotatable member (310), such as during or after a biopsy procedure, to retrieve or otherwise directly view a tissue sample deposited in the tissue sample chamber (346). The tray (330) also includes a digital marker (338) associated with each tissue sample chamber (346). Additionally, the tray (330) includes a hold-down region (336) that facilitates flattening the tray (330). In particular, the pinched regions (336) provide sufficient flexibility to enable the tray (330) to form an arcuate configuration for insertion into the rotatable member (310); while also enabling the tray (330) to form a generally flat configuration, such as after removal of the tray (330) from the rotatable member (310), for inspection of tissue samples in the tray (330).

It should be understood that the rotatable member (310) and/or tray (330) may be configured in numerous other ways. By way of example only, the rotatable member (310) and/or tray (330) may be configured in accordance with at least some of the teachings of U.S. patent publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. As another merely illustrative example, the rotatable member (310) and/or tray (330) may be configured in accordance with at least some of the teachings of U.S. patent No. 8,702,623, the disclosure of which is incorporated herein by reference. It should also be understood that tissue sample holder (300) does not necessarily require positioning chamber (346) coaxially with cavity (151) of cutter (150). The tissue sample holder (300) may index the chamber (346) relative to the cutter (150) in any other suitable manner. For example, the chamber (346) may extend along an axis that is always offset from the axis of the cavity (151), along an axis that is oblique or perpendicular to the axis of the cavity (151), or along other axes. Similarly, it will be appreciated that the rotatable member (310) may rotate about an axis that is oblique or perpendicular to the axis of the cavity (151). Still other suitable configurations will be apparent to those of ordinary skill in the art in view of the teachings herein.

As best seen in fig. 12, and as noted above, the tissue sample holder (300) of the present example includes a plug (360) that is received in a dedicated channel (313) of the rotatable member (310). The plug (360) includes a handle (362) and a longitudinally extending body (364). The body (364) extends through a portion of the length of the channel (313) terminating distally at a longitudinal location corresponding to the proximal end of the groove (315). The plug (360) includes a pair of seals (366, 368), the pair of seals (366, 368) sealing against the interior of the channel (313) when the plug (360) is fully inserted into the channel (313). The seals (366, 368) thus keep the channel (313) fluid tight when the plug (360) is inserted into the channel (313). A channel (313) is configured to receive a shaft of a biopsy site marker applicator. The channel (313) may also receive instruments for delivering drugs or the like to the biopsy site. By way of example only, the channel (313) may receive an adapter configured to provide an interface between the channel (313) and a conventional drug delivery device. Examples of such adapters and other uses/configurations of channels like channel (313) are described in U.S. patent No. 8,118,755, the disclosure of which is incorporated herein by reference. The plug (360) and/or channel (313) may also be configured and operable in accordance with at least some of the teachings of U.S. patent No. 8,938,285, the disclosure of which is incorporated herein by reference. Still other suitable configurations will be apparent to those of ordinary skill in the art in view of the teachings herein. In some other versions, the plug (360) and/or the channel (313) are simply omitted.

As described above, the tissue sample holder (300) is typically configured to individually collect a plurality of tissue samples in a discrete tissue sample tray (330). However, it should be understood that in some instances it may be desirable to collect multiple tissue samples in a single chamber. By way of example only, such a feature may be desirable where a tissue sample is collected for the purpose of removing tissue from a patient only, and not for diagnostic purposes. Of course, in such cases, the tissue sample collected in the single chamber may be used later for diagnostic purposes, even if the original intent was solely for tissue removal. Additionally or in the alternative, when collecting tissue samples for diagnostic purposes, some operators may prefer to collect multiple tissue samples in a single chamber rather than in separate chambers. In still other cases, the operator may wish to alternate between the above modes in order to briefly analyze tissue sample quality using a single tissue sample collection mode, and then proceed to a batch tissue sample collection mode for collecting tissue samples in the same general anatomical region. Thus, it will be appreciated that in some instances it may be desirable to include a bulk tissue collection device in a tissue sample holder similar to the tissue sample holder (300) described above.

Exemplary imaging System

In some cases, it may be beneficial to examine recently biopsied tissue specimens on-the-fly by certain imaging modalities to quickly analyze and assess tissue properties. However, operators are limited in the speed at which the imaging device can analyze the tissue sample due to the time elapsed to extract the tissue sample from the biopsy device, place the tissue sample in the test receptacle, and then insert the test receptacle into the imaging system to produce an image of the specimen for analysis. Biopsy devices adapted to be directly associated with an imaging system may be beneficial in reducing the amount of time and effort required to analyze a tissue sample during a biopsy procedure. Furthermore, being able to take an instantaneous image of a tissue specimen recently biopsied from the patient allows the operator to confirm whether the target tissue was successfully acquired in each tissue extraction situation, thereby reducing the number of tissue samples extracted from the patient.

In biopsy devices such as the device (10) described above, it may be beneficial to configure components of the device, such as the tissue sample holder (300), to cooperate with certain imaging modalities, thereby simplifying the process by which an operator obtains and views graphical representations or other images of biopsy tissue specimens. This approach may eliminate several intermediate steps required to generate an image of a biopsy specimen, and thus maximize the effectiveness of analyzing characteristics of a patient tissue sample. It may also be desirable to integrate the imaging system and biopsy device into a single assembly, while in other cases it may be desirable to have the biopsy device function in association with a separate imaging modality.

The following description provides various examples of biopsy devices and corresponding imaging systems that are cooperatively configured to produce an image of a recently biopsied tissue sample prior to removal of a specimen from the biopsy device. Finally, the association of the biopsy device with certain imaging modalities may be beneficial to ensure that the operator is able to receive any relevant data from the generated images in a timely manner. It should be understood that the imaging system described below may be readily incorporated into any of the various biopsy devices (10) described above, and may be utilized in any of the various surgical procedures described in the various references described herein. Other suitable ways in which the biopsy devices and imaging systems described below may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

A. Biopsy device with sensor receiving cavity

As shown in fig. 13-15, an exemplary imaging system (550) includes a sensor (552) and an imaging device (560). In this example, the sensor (552) is typically configured as a digital sensor, but in other examples, the sensor (552) may comprise any other suitable sensor. For example, in some examples, sensor (552) includes a Charge Coupled Device (CCD) sensor, a Complementary Metal Oxide Semiconductor (CMOS) sensor, an indium gallium arsenide sensor, a conventional film, and/or any other sensor that will be apparent to one of ordinary skill in the art. Specifically, as shown in fig. 13-14, the sensor (552) includes electronic circuitry (553), an imager (554), a fiber optic plate (555), and a scintillator (556) enclosed within a housing (557). The sensor (552) is a diagnostic imaging sensor operable to digitally convert and transmit data.

Although not shown, it is understood that the sensor (552) may include additional or alternative internal components in addition to those depicted. For example, the sensor (552) may include components corresponding to those included in an interline transfer CCD sensor, a frame transfer CCD sensor, an on-chip a/D conversion CMOS sensor, an off-chip a/D conversion CMOS sensor, those used in Short Wave Infrared (SWIR) imaging or thermal imaging. Such internal components of the sensor (552) may include various transistors, pixels (photodiodes or photo-capacitors), and/or other components as will be apparent to those of ordinary skill in the art. The size and shape of the pixels in the sensor (552) may be varied to optimize, among other things, imaging optics, saturation capability, and signal-to-noise ratio, resolution, spatial frequency, and contrast. The overall size of the sensor (552) may also be varied to optimize the field of view of the system. By way of example only, the size of the sensor (552) may be set to 1/4 ", 1/3", 1/2 ", 1/1.8", 2/3 ", 1", 1.2 "or any other size as would be apparent to one of ordinary skill in the art.

As seen in fig. 15, the imaging device (560) includes a head (562), a base (564), and an extension arm (566) extending therebetween. The extension arm (566) is configured to extend and pivot about the base (564) to allow selective positioning of the head (562). The imaging device (560) is operable to communicate with the sensor (552) by: a high energy beam (e.g., x-rays, etc.) is emitted through the air until it encounters the sensor (552) (see fig. 18). In particular, the head (562) is configured to emit a high energy beam outward upon actuation of the imaging device (560). As will be described in greater detail below, any intermediate objects, i.e., biopsy tissue samples, positioned between the head (562) and the sensor (552) will interact with the high energy radiation emitted by the imaging device (560) and be identified and delineated in the corresponding images generated by the imaging system (550). By way of example only, the imaging system (550) may be operable to generate x-ray images (e.g., radiographic images), optical coherence tomography images, multi-picture or video, high definition ultrasound images, or other images as will be apparent to one of ordinary skill in the art in view of the teachings herein.

Fig. 16A shows a biopsy device (510), the biopsy device (510) including needles (511) attached on distal ends and tissue sample holders (530) attached on proximal ends, respectively. It is to be understood that biopsy device (510), needle (511), and tissue sample holder (530) of this example may be configured and operable like biopsy device (10), needle (110), and tissue sample holder (300), respectively, described above, except for the differences explicitly noted herein. As best seen in fig. 17A, tissue sample holder (530) includes an internal cavity (531), the internal cavity (531) being centrally located with respect to a plurality of tissue sample chambers (546). The internal cavity (301) is sized and shaped to receive the sensor (552) therein.

In this example, an operator grasps the biopsy device (510), inserts a needle (511) into a breast of a patient, and collects one or more tissue samples (30) from the patient. Such tissue samples (30) may be pneumatically deposited in tissue sample holders (530). Rather than the operator detaching the tissue sample holder (530) from the biopsy device (510) to retrieve the tissue sample (30) for analysis, the sensor (552) is slidably advanced toward the distal end of the biopsy device (510), as seen in fig. 16A. In particular, fig. 16B shows sensor (552) aligned with tissue sample holder (530), such that sensor (552) is received by biopsy device (510) within tissue sample holder (530). As best seen in fig. 17A, sensor (552) is slidably received within interior cavity (531) of tissue sample holder (530) such that sensor (552) is aligned with and faces one or more tissue sample chambers (546). In this example, sensor (552) faces upward from within internal cavity (531), towards one or more tissue sample chambers (546) located directly above sensor (552), as seen in fig. 17B. In this alignment, sensor (552) is ideally positioned to image a tissue sample (30) deposited within tissue sample chamber (546) in fluid communication with needle (511).

Although the sensor (552) in this example is sized to extend adjacent to one or more tissue sample chambers (546), it should be understood that the sensor (552) may be sized and shaped to extend adjacent to more or fewer tissue sample chambers (546). For example, the sensor (552) may be sized and shaped to enable a single tissue sample (30) deposited within a separate tissue sample chamber (546) to be imaged at once. Alternatively, the sensor (552) may have a larger size and shape such that multiple tissue samples (30) respectively contained in multiple tissue sample chambers (546) may be imaged simultaneously.

With the sensor (552) inserted within the internal cavity (531) of the tissue sample holder (530), the operator selectively positions the imaging device (560) directly over the tissue sample holder (530) such that the tissue sample chamber (546) containing the tissue sample (30) is positioned between the sensor (552) and the head (562), as seen in fig. 17C. In this case, the operator activates the imaging system (550) to emit x-ray radiation from the imaging device (560) toward the tissue sample (30) until the sensor (552) is encountered, as seen in fig. 18. The tissue sample (30) absorbs some of the energy or radiation emitted by the head (562) and the x-rays received by the sensor (552) are processed by the imaging system (550) to generate a corresponding image. In this example, the imaging system (550) is operable to emit x-ray radiation from the head (562) to the sensor (552) to generate an x-ray image. Although not shown, it is understood that the imaging system (550) may be operable to generate other images including, but not limited to, optical coherence tomography images, multi-picture or video, high definition ultrasound images, or other images as will be apparent to one of ordinary skill in the art in view of the teachings herein.

Thus, the imaging system (550) immediately generates images of the tissue sample (30) for timely review and evaluation by an operator. In this example, an operator can generate an image of the sample (30) without first detaching the tissue sample holder (530) from the biopsy device (510) to subsequently remove the tissue sample (30) from the tissue sample chamber (546) for subsequent placement into an inspection receptacle (not shown). The operator rotates the tissue sample holder (530) relative to the body of the biopsy device (510) such that the tissue sample chamber (546) is repositioned. In this case, a different tissue sample chamber (546) is positioned directly above the sensor (552) such that the tissue sample (30) located within this tissue sample chamber (546) is now positioned between the head (562) and the sensor (552) for testing. The operator may continue to rotate the tissue sample holder (530) while maintaining the sensor (552) in a fixed orientation (face up) to effectively image a plurality of tissue samples (30) deposited into individual tissue sample chambers (546) of the tissue sample holder (530). Alternatively, the orientation of the tissue sample holder (530) may remain stationary as the operator rotates the sensor (552) within the interior cavity (531). In this case, although not shown, the imaging device (560) is similarly realigned relative to the tissue sample holder (530), thereby directing the head (562) toward the front of the sensor (552).

In some examples, imaging device (560) may be integrated into a patient support system or other system associated with biopsy device (510) to facilitate multiple uses of imaging device (560). For example, in some instances, biopsy device (510) is used in conjunction with a stereotactic imaging system such as a MAMMOTEST stereotactic biopsy table manufactured by Devicor Medical Products, inc. In such systems, an x-ray source similar to the imaging device (560) is mounted on a rotating arm to orient the x-ray source relative to the patient. In the case of using such a stereotactic imaging system, an x-ray source may be configured in place of the imaging device (560). In such instances, the stereotactic imaging system may be modified to provide increased flexibility for movement of the x-ray source relative to the biopsy device (510).

As shown in fig. 18, imaging system (550) may be in communication with control module (400) to facilitate coordination between biopsy device (510) and imaging system (550). For example, in some instances, the imaging system (550) includes a computer (555), the computer (555) configured for image processing and control of the imaging device (560). In such a configuration, the computer (555) typically controls the acquisition and processing of the x-ray images. The computer (555) may further communicate with the control module (400) to send signals to the control module (400) and receive signals from the control module (400). In one exemplary use, such communication between the control module (400) and the computer (555) may be used to automate the imaging process. For example, in some applications, the control module (400) may be configured to provide an indication to the computer (555) when a biopsy sample has been collected. In response to such communication, the computer (555) may then automatically begin an imaging process to acquire images of the collected tissue sample. Thus, communication between the computer (555) and the control module (400) may be configured to provide automated imaging in real-time.

B. Biopsy device with integral digital sensor

Fig. 19 shows an exemplary alternative biopsy device (600) comprising a probe (610), a holster (620), and a tissue sample holder (630). Biopsy device (600) and tissue sample holder (630) may be configured and operable just like biopsy device (10) and tissue sample holder (300), respectively, described above, except as otherwise described below. The biopsy device (600) further comprises a tissue sample window (604), the tissue sample window (604) being disposed proximal to a distal end of the probe (610). An exemplary Biopsy Device including a tissue sample window may be constructed in accordance with the teachings of U.S. application No. 62/505,571 entitled "Biopsy Device with simple Sleeve" filed on 2017, 5, month 17, the disclosure of which is incorporated herein by reference.

In some examples, the tissue sample window (604) exposes a door assembly (not shown) so that the operator can see the door assembly through the probe (610). The door assembly is generally configured to selectively prevent movement of the severed tissue sample (30) within the fluid conduit between the cutter and the tissue sample holder (630). The door assembly enables an operator to temporarily stop the advancement of the tissue sample (30) for visual inspection through the tissue sample window (604) of the probe (610). At least a portion of the door assembly is coupled to the cutter to transmit rotational and translational movement of the door assembly to the cutter. It will therefore be appreciated that rotation and translation of the cutter drive member (not shown) results in corresponding rotation and translation of the cutter via the coupling between at least a portion of the gate portion and at least a portion of the gate assembly. In some examples, the door assembly may be constructed in accordance with the teachings of U.S. application No. 62/429,379 entitled "Apparatus to all Biopsy Sample Visualization During tissue removal" filed on 2 d 2016, the disclosure of which is incorporated herein by reference.

As best seen in fig. 20, biopsy device (600) includes a sensor (652) proximate the distal end of probe (610). A sensor (652) is positioned below the tissue sample window (604). It should be understood that the sensor (652) of this example may be configured and operable like the sensor (552) described above, except for the differences explicitly noted herein. The sensor (652) has a longitudinal length that is substantially equal to or greater than the length of the tissue sample window (604) such that any tissue sample (30) contained within the tissue sample window (604) does not exceed the size of the sensor (652), thereby ensuring that a complete image of the tissue sample (30) can be obtained. The sensor (652) is a diagnostic imaging sensor operable to digitally convert and transmit data. The sensor (652) is a reusable sensor such that the sensor (652) is operable to be inserted into the probe (610) prior to a medical procedure and subsequently removed from the biopsy device (600) after the procedure.

In this example, after the needle (611) is inserted into the patient's breast to collect the tissue sample (30), the tissue sample (30) is directed to the tissue sample window (604) before being deposited into the tissue sample holder (630). In this case, as seen in fig. 20, the operator selectively positions imaging device (560) directly over tissue sample window (604) containing tissue sample (30) such that tissue sample (30) is positioned between sensor (652) and head (562). In this case, the operator activates the imaging system (550) to emit x-ray radiation from the imaging device (560) toward the tissue sample (30) until the sensor (652) is encountered, thereby generating an image of the tissue sample (30). Thus, an operator can analyze the tissue characteristics of the sample (30) without having to collect the sample (30) within the tissue sample holder (630) and then remove the tissue sample (30) for subsequent placement into a test receptacle (not shown) for imaging by the imaging system (550). Once an image of the tissue sample (30) has been generated from the imaging system (550), the operator actuates a door assembly (not shown) of the biopsy device (600), thereby transferring the tissue sample (30) out of the tissue sample window (604) and into the tissue sample holder (630). In this case, the operator may continue to actuate the cutter (611) of the needle within the patient, thereby drawing a second tissue sample (30) into the tissue sample window (604) for examination.

In some cases, it may be desirable to position the tissue sample window distally adjacent to the tissue sample holder and proximally relative to the needle so that the operator may examine the most recently biopsied tissue sample (30) at the proximal end of the biopsy device that is closer to the operator. In this case, the proximal positioning of the tissue sample window may provide the operator with an improved view of the tissue sample (30) stored therein, as the tissue sample window and the operator are closer together. As shown in fig. 21, biopsy device (670) includes a tissue sample window (674) that is proximally positioned relative to a proximal end of device (670) such that tissue sample window (674) still receives tissue sample (30) from needle (676) prior to depositing tissue sample (30) in tissue sample holder (678). In some examples, tissue sample window (674) may be associated with a door assembly (not shown) incorporated into a portion of probe (610). The door assembly is generally configured to selectively prevent movement of the severed tissue sample (30) within the fluid conduit between the cutter and the tissue sample holder (678). The door assembly enables an operator to temporarily stop the advancement of the tissue sample (30) for visual inspection through the tissue sample window (674). In some examples, the door assembly may be constructed in accordance with the teachings of U.S. application No. 62/429,379 entitled "Apparatus to low biopsis sampling vibration music Removal" filed on 2.2016, the disclosure of which is incorporated herein by reference. Alternatively, biopsy device (670) may be completely free of door assemblies, allowing severed tissue sample (30) to travel freely to tissue sample holder (678).

As best seen in fig. 22, sensor (682) is adjacent to the proximal end of probe (672). As similarly shown in fig. 20, sensor (682) is positioned below tissue sample window (674) and has a longitudinal length that is substantially equal to or greater than the length of tissue sample window (674). Thus, any tissue sample (30) contained within the tissue sample window (674) will not extend beyond the size of the sensor (682), thereby ensuring that a complete image of the tissue sample (30) is generated during each instance. In this example, after the needle (676) is inserted into the patient's breast to collect the tissue sample (30), the tissue sample (30) is directed to the tissue sample window (674) before being deposited into the tissue sample holder (678). In this case, the operator selectively positions the imaging device (560) directly over a tissue sample window (674) containing the tissue sample (30) such that the tissue sample (30) is positioned between the sensor (682) and the head (562). With the tissue sample window (674) positioned proximally relative to the biopsy device (670), the operator can easily position the imaging device (550) adjacent to the tissue sample (30) because the tissue sample window (674) is generally closer to the operator than the tissue sample window (604) of the biopsy device (600).

Once the imaging device (560) is positioned as desired, the operator activates the imaging system (550) to emit x-ray radiation from the imaging device (560) toward the tissue sample (30) until the sensor (682) is encountered, thereby producing an image of the tissue sample (30). Thus, an operator can analyze tissue characteristics of the sample (30) without having to collect the sample (30) within the tissue sample holder (678) and then remove the tissue sample (30) for subsequent placement into a test receptacle (not shown) for imaging by the imaging system (550). Once an image of the tissue sample (30) has been generated from the imaging system (550), the operator actuates a door assembly (not shown) of the biopsy device (670), thereby transferring the tissue sample (30) out of the tissue sample window (674) and into the tissue sample holder (678). In this case, the operator may continue to actuate the cutter (676) of the needle within the patient, thereby extracting a second tissue sample (30) from the patient and into the tissue sample window (674) for examination.

C. Tissue sample holder with integral digital sensor

Fig. 23 shows an exemplary biopsy device (710) and an exemplary imaging system (750). The biopsy device (710) includes needles (711) attached on the distal end and tissue sample holders (730) attached on the proximal end, respectively. It is to be understood that biopsy device (710), needle (711), and tissue sample holder (730) of this example may be configured and operable like biopsy device (10), needle (110), and tissue sample holder (300), respectively, described above, except for the differences explicitly noted herein. The imaging system (750) includes an imaging device (760) and a sensor (752). It should be understood that the imaging system (750), imaging device (760), and sensor (752) of this example may be configured and operable like the imaging system (550), imaging device (560), and sensor (552) described above, except for the differences explicitly noted herein. The imaging device (760) is a handheld device that includes a head (762), an external backscatter shield (764), a handle (766), and an actuation feature (768). The imaging device (760) is operable to communicate with the sensor (752) by: x-ray energy or radiation is emitted through the air until it encounters the sensor (752). The head (762) is configured to emit an energy beam outward upon actuation of an imaging device (760) via an actuation feature (768). An external backscatter shield (764) is positioned proximate to the head (762) and substantially surrounding the head (762) such that the head (762) is separated from the remainder of the imaging device (760) by the external backscatter shield (764). When the imaging device (760) is actuated, the external backscatter shield (764) is operable to protect an operator from exposure to radiation emitted by the head (762).

As best seen in fig. 24, tissue sample holder (730) includes a plurality of tissue sample chambers (746) and a single sensor (752) positioned therein. Specifically, sensor (752) is positioned directly below tissue sample chamber (746) at the top of tissue sample holder (730). The sensor (752) is fixedly secured within the tissue sample holder (730) such that the sensor (752) maintains a relative position within the tissue sample holder (730) as the tissue sample chamber (746) rotates within the tissue sample holder (730). In this case, the sensor is aligned with and faces one or more tissue sample chambers (746) directly above the sensor (752) and facing the front face of the sensor (752). In this alignment, the sensor (752) is ideally positioned to image a tissue sample (30) deposited within a tissue sample chamber (746) in fluid communication with the needle (711). Although sensor (752) in this example is sized to extend adjacent to one or more tissue sample chambers (746), it should be understood that sensor (752) may be sized and shaped to extend adjacent to more or fewer tissue sample chambers (746). For example, the sensor (752) may be sized and shaped to enable a single tissue sample (30) deposited within a separate tissue sample chamber (746) to be imaged at one time. Alternatively, the sensor (752) may have a larger size and shape such that multiple tissue samples (30) respectively contained in multiple tissue sample chambers (746) may be imaged simultaneously.

Although not shown, it is understood that tissue sample holder (730) may include a plurality of sensors (752) positioned respectively under a plurality of tissue sample chambers (746). In this case, sensor (752) is secured to tissue sample chamber (746) such that rotation of tissue sample chamber (746) within tissue sample holder (730) effects simultaneous rotation of sensor (752). Thus, rather than requiring the imaging device (760) to be directed to the top of the tissue sample holder (730) and towards the front of a sensor (752) securely fixed in the tissue sample holder (730), the imaging device (760) may be positioned at any angle relative to the tissue sample holder (730) depending on the particular tissue sample chamber (746) the operator wishes to image.

In this example, once the operator collects one or more tissue samples (30) from the patient through biopsy device (710), imaging device (760) is selectively positioned directly over tissue sample holder (730) such that tissue sample chamber (746) containing tissue samples (30) is positioned between sensor (752) and head (762), as seen in fig. 24. In this case, the operator activates the imaging system (750) via the actuation feature (768) to emit x-ray radiation from the imaging device (760) toward the tissue sample (30) until the sensor (752) is encountered. The tissue sample (30) interacts with radiation emitted by the head (762) and a corresponding image is thus generated by the imaging system (750). In the present example, the imaging system (750) is operable to emit x-ray radiation from the head (762) to the sensor (752) to generate an x-ray image, however, it should be understood that the imaging system (750) may be operable to generate other images using various alternative imaging modalities. By way of further example only, the imaging system (750) may be operable to generate optical coherence tomography images, multi-picture or video, high definition ultrasound images, or other images as will be apparent to one of ordinary skill in the art in view of the teachings herein.

An imaging system (750) generates images of the tissue sample (30) for timely review and evaluation by an operator. Rather than the operator detaching the tissue sample holder (730) from the biopsy device (710) to retrieve the tissue sample (30) for analysis, the operator simply rotates the tissue sample chamber (746) to analyze a second tissue sample (30) contained within the tissue sample holder (730). In this example, an operator can generate an image of the sample (30) without first detaching the tissue sample holder (730) from the biopsy device (710) to subsequently remove the tissue sample (30) from the tissue sample chamber (746) for subsequent placement into an inspection receptacle (not shown). With the sensor (752) fixedly secured within the tissue sample holder (730), an operator can always align the head (762) of the imaging device (760) with the top of the tissue sample holder (730) to analyze subsequent tissue samples after rotating the tissue sample chamber (746) within the tissue sample holder (730) such that a different tissue sample (30) is located between the head (762) and the sensor (752).

In this case, the operator may take a single tissue sample (30) from the patient and deposit the sample (30) into the tissue sample chamber (746) for immediate examination by the imaging device (760). Once an image of the tissue sample (30) is generated, the operator may rotate the tissue sample holder (730) such that the empty tissue sample chamber (746) becomes aligned with the needle (711). In this case, the operator may take a subsequent tissue sample (30) from the patient and deposit the sample (30) into an empty tissue sample chamber (746) for subsequent testing. This method may be repeated for each tissue sample (30) extracted from the patient. Alternatively, the operator may first extract a plurality of tissue samples (30) and deposit them into tissue sample chambers (746), respectively, prior to utilizing the imaging device (760). In this case, with each tissue sample chamber (746) containing an individual tissue sample (30) therein, once an image of the current tissue sample chamber (746) has been taken, the operator may individually image each tissue sample (30) with the imaging device (460) by rotating the tissue sample holder (730) to the next tissue sample chamber (746).

D. Imaging device with tissue sample support arm

Fig. 25 shows an exemplary imaging system (850) comprising an imaging device (860), an extension arm (854), and a support member (856). The imaging system (850) and imaging apparatus (860) may be configured and operable just like the imaging system (550) and imaging apparatus (760) described above, respectively, except as otherwise described below. The imaging device (860) is a handheld device that includes a head (862), an external backscatter shield (864), a handle (866), and an actuation feature (868). The head (862) is configured to emit energy or radiation outward upon actuation of the imaging device (860) via the actuation feature (868). Similar to the imaging apparatus (760), an external backscatter shield (864) of the imaging apparatus (860) is positioned adjacent to the head (862) and substantially surrounds the head (862) such that the head (862) is separated from the rest of the imaging apparatus (860) by the external backscatter shield (864).

When the imaging device (860) is actuated, the external backscatter shield (864) is operable to protect an operator from radiation exposure emitted by the head (862). Extension arms (854) are attached on the proximal end to an external backscatter shield (864) and on the distal end to a support member (856), respectively. The extension arm (854) positions the support member (856) distal to the head (852) such that the extension arm (854) is configured to hold the support member (856) along a direct line of sight of the imaging device (860). Extension arm (854) is configured to be adjustable from an extended position, as shown in fig. 25, to a retracted position, as shown in fig. 26. With extension arm (854) in the extended position, imaging device (860) is operable to receive tissue sample holder (300) between head (862) and support member (856). In this case, with tissue sample holder (300) positioned in extension arm (854), extension arm (854) is operable to retract support member (856) toward head (862) to securely clamp tissue sample holder (300) to imaging device (860).

The support member (856) is in the form of a backplate that includes a sensor (852) integrally positioned therein. It should be understood that the sensor (852) of this example may be configured and operable as the sensor (552) described above, except for the differences explicitly noted herein. The sensor (852) is centrally located on the support member (856) and is sized and shaped to correlate with the size and shape of the tissue sample holder (300) such that any tissue sample (30) contained within the tissue sample holder (300) is completely contained within the perimeter dimension of the sensor (852). Although not shown, it is understood that the sensor (852) may be sized somewhat larger than the tissue sample holder (300). The imaging device (860) is operable to communicate with the sensor (852) by: the emitted radiation passes through the air until it encounters a sensor (852).

It should be understood that with the tissue sample holder (300) positioned entirely between the sensor (852) and the imaging device (860), the imaging system (850) is operable to capture images of any tissue sample (30) contained within the tissue sample holder (300). In other words, the tissue sample holder (300) may receive one or more tissue samples (30) therein for imaging by the imaging system (850). For example, the tissue sample holder (300) may comprise a single tissue sample (30), a plurality of tissue samples (30), or may be completely filled with numerous tissue samples (30) in each tissue sample chamber of the tissue sample holder (300). Thus, when the entire tissue sample holder (300) is positioned between the sensor (852) and the imaging device (860), the imaging system (850) is operable to accurately image a plurality of tissue samples (30) contained within the tissue sample holder (300).

In this example, after the operator collects the tissue sample (30) from the patient and the tissue sample (30) is deposited within the tissue sample holder (300), the tissue sample holder (300) is detached from the biopsy device (10) and subsequently positioned within the imaging device (860). Alternatively, although not shown, it is understood that the imaging system (850) may be used with the tissue sample holder (300) still attached to the biopsy device (10). In this case, with the tissue sample holder (300) attached to the proximal end of the biopsy device (10), the imaging device (860) engages the proximal end of the biopsy device (10) at the location of the tissue sample holder (300). In either case, tissue sample holder (300) is selectively positioned between support member (856) and head (852). With tissue sample holder (300) positioned therebetween, extension arm (864) is manipulated to transition extension arm (864) from the extended position (see fig. 25) to the retracted position (see fig. 26). In this case, the tissue sample holder (300) is securely grasped to the imaging device (860) such that the tissue sample (30) is positioned between the sensor (852) and the head (862), as seen in fig. 26. An operator activates the imaging system (850) via the actuation feature (868) to emit x-ray radiation from the imaging device (860) toward the tissue sample (30) until the sensor (852) is encountered. The tissue sample (30) and the sensor (852) interact with radiation emitted by the head (862) and corresponding images are thus generated by the imaging system (850).

The imaging system (850) is operable to emit an x-ray beam from the head (862) to the sensor (852) to generate an x-ray image. Alternatively, it should be understood that the imaging system (850) may be operable to generate other images via various alternative imaging modalities. By way of further example only, the imaging system (850) may be configured to generate optical coherence tomography, multi-picture or video, high definition ultrasound images, or other images as will be apparent to one of ordinary skill in the art in view of the teachings herein. With the images of the tissue sample (30) generated by the imaging system (850), an operator can view and evaluate characteristics of the tissue sample (30) without having to separately remove the tissue sample (30) from the tissue sample holder (300) for subsequent placement into an inspection container for imaging.

To verify a subsequent tissue sample (30), the operator adjusts extension arm (854) to the extended position, thereby releasing tissue sample holder (300) from secure engagement with imaging system (850). The operator then removes the initial tissue sample (30) from the tissue sample holder (300), and then reattaches the tissue sample holder (300) to the biopsy device (10). In this case, a second tissue sample (30) is taken from the patient and deposited into a tissue sample holder (300). With a new tissue sample (30) received within the tissue sample holder (300), the operator detaches the tissue sample holder (300) from the biopsy device (10) and selectively positions the tissue sample holder (300) between the head (862) and the support member (856). Thus, an operator can generate an image of the sample (30) without having to individually remove each tissue sample (30) from the tissue sample holder (300) and then place the sample (30) into an inspection container (not shown). In effect, the imaging system (850) provides for the immediate imaging of the tissue sample (30) contained within the tissue sample holder (300).

In some cases, a plurality of tissue samples (30) are taken and stored in the tissue sample holder (300) prior to imaging the samples (30) with the imaging device (860), enabling an operator to examine each sample (30) contained within the tissue sample (300) at once. Thus, the operator does not need to remove each tissue sample (30) individually from the tissue sample holder (300) and reattach the tissue sample holder (300) to the biopsy device (10) to extract a subsequent specimen from the patient. In practice, the operator may first extract a plurality of tissue samples (30) prior to utilizing the imaging device (860). Once the plurality of tissue samples (30) are deposited within the tissue sample holder (300), the imaging device (860) may be used to image the plurality of tissue samples by: the tissue sample holder (300) is rotated relative to the imaging device (860) to sequentially align the tissue sample (30) with the imaging device (860) for imaging.

Fig. 27 shows an exemplary alternative imaging system (950) that includes an imaging device (960), an extension arm (954), and a support member (956). The imaging system (950) and the imaging apparatus (960) may be configured and operable just like the imaging system (550) and the imaging apparatus (760), respectively, described above, except as otherwise described below. The imaging device (960) is a handheld device including a head (962), an external backscatter shield (964), a handle (966), and an actuation feature (968). The head (962) is configured to emit energy or radiation outward upon actuation of the imaging device (960) via the actuation feature (968). Similar to the imaging apparatus (760, 860), an external backscatter shield (964) of the imaging apparatus (960) is positioned adjacent to the head (962) and substantially surrounds the head (962) such that the head (962) is separated from the remainder of the imaging apparatus (960) by the external backscatter shield (964). As described above, the external backscatter shield (964) is operable to protect an operator from exposure to radiation emitted by the head (962) when the imaging device (960) is actuated.

Extension arms (954) are attached to the imaging device (960) on the proximal end and to the support member (956) on the distal end, respectively. The extension arm (954) positions the support member (956) distal to the head (952) such that the extension arm (954) is configured to hold the support member (856) along a direct line of sight of the imaging device (960). Support member (956) is a rotating mandrel sized and shaped to fit into tissue sample holder (300). In other words, support member (956) is configured to be received within tissue sample holder (300) such that tissue sample holder (300) can be attached to imaging device (960) by slidably engaging support member (956), as seen in fig. 29. The support member (956) includes a digital sensor (952) integrally positioned therein. It should be understood that the digital sensor (952) of this example may be configured and operable as the sensor (552) described above, except for the differences explicitly noted herein. Sensor (952) is housed within support member (956) and is sized and shaped substantially equal to or larger than tissue sample chamber (346) of tissue sample holder (300) such that the size of tissue sample (30) housed within tissue sample holder (346) will not exceed the size of digital sensor (952), thereby ensuring that a complete image of tissue sample (30) can be obtained. The imaging device (960) is operable to communicate with the digital sensor (952) by: the radiation is emitted through the air until it encounters the sensor (952).

In this example, an operator collects a tissue sample (30) from a patient using biopsy device (10), and tissue sample (30) is deposited within tissue sample holder (300). The operator then detaches the tissue sample holder (300) from the biopsy device (10), and subsequently attaches the tissue sample holder (300) to the imaging device (960). Specifically, as seen in fig. 28, tissue sample holder (300) is slidably inserted onto support member (956). With tissue sample holder (300) engaged to support member (956), tissue sample holder (300) is securely fixed to imaging device (960) and positioned distally relative to head (962). An operator activates the imaging system (950) via the actuation feature (968) to emit x-ray radiation from the imaging device (960) toward the tissue sample (30) until encountering the digital sensor (952). The tissue sample (30) and the sensor (952) interact with radiation emitted by the head (962) and corresponding images are thus generated by the imaging system (950).

In some cases, a plurality of tissue samples (30) are extracted and deposited into the tissue sample holder (300) prior to imaging the samples (30) with the imaging device (960), enabling an operator to examine each sample (30) contained within the tissue sample holder (300) in a single imaging sequence. Thus, the operator does not need to remove each tissue sample (30) individually from the tissue sample holder (300) and reattach the tissue sample holder (300) to the biopsy device (10) to extract a subsequent specimen from the patient. In practice, the operator may first extract a plurality of tissue samples (30) before utilizing the imaging device (960). In this case, the operator rotates tissue sample holder (300) around support member (956) to realign tissue sample chambers (346) so that different tissue sample chambers (346) are positioned in direct line of sight with head (962) of imaging device (960).

Similar to the imaging system (850) described above, the imaging system (950) is operable to emit x-ray radiation from the head (962) to the sensor (952), thereby generating an x-ray image. Alternatively, it should be understood that the imaging system (950) may be operable to generate other images via various alternative imaging modalities. By way of example only, suitable imaging modalities may include optical coherence tomography, multi-picture or video, high definition ultrasound, or other imaging modalities as will be apparent to those of ordinary skill in the art in view of the teachings herein. With the image of the tissue sample (30) generated by the imaging system (950), an operator can view and evaluate characteristics of the tissue sample (30) without having to separately remove the tissue sample (30) from the tissue sample holder (300) for subsequent placement into an inspection container for imaging.

As discussed above, to verify subsequent tissue samples (30), the operator rotates tissue sample holder (300) around support member (956) until alternative tissue sample chamber (346) is positioned between head (962) and digital sensor (952). The operator then actuates the imaging device (960) to take images of different tissue samples (30) contained within the alternative tissue sample chambers (346). Alternatively, the imaging system (950) may be utilized with a tissue sample holder (300) that is still attached to the biopsy device (10). Although not shown, it should be understood that, in this example, support member (956) is received within tissue sample holder (300) at a proximal end attached to biopsy device (10) opposite the distal end. In this case, the tissue sample chamber (346) is rotated relative to the biopsy device (10) such that each tissue sample (30) contained within the tissue sample holder (300) is imaged by the imaging device (960). In other cases, the imaging device (960) is rotated about the tissue sample holder (300) to image each tissue sample chamber (346) containing a tissue sample (30).

V. exemplary combination

The following examples relate to various non-exhaustive methods that may combine or apply the teachings herein. It should be understood that the following examples are not intended to limit the coverage of any claims that may be presented at any time or in subsequent applications of the present application. There is no intention to disclaim disclaimer. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features mentioned in the following embodiments. Thus, none of the aspects or features mentioned below should be considered critical unless the inventors or their successor explicitly indicate so later. If any claims are made in this application or in subsequent documents related to this application that include additional features beyond those mentioned below, then it should not be assumed that these additional features were added for any reason related to patentability.