Tissue sample holder with enhanced features

Abstract

The biopsy device comprises a main body, a needle, a cutter, an analysis area, a valve and a tissue sample holder. The cutter is movable relative to the needle and communicates with the needle to transport a tissue sample. The analysis area is arranged at the proximal side of the cutter and communicates with the needle to receive a tissue sample cut by the cutter for analysis by a user. The valve is arranged at the proximal side of the analysis area and is configured to alternate between an open configuration and a closed configuration. The tissue sample holder is arranged at the proximal side of the valve and is fixedly attached to the main body. The valve is configured to allow analysis of a sample arranged in the analysis area when the valve is in the closed configuration and to allow the tissue sample to pass into the tissue sample holder when the valve is in the open configuration.

Description

[0001] This application is a divisional application of Chinese invention patent application 201780025090.1, filed on April 28, 2017, and entitled “Tissue Sample Holder with Enhanced Features”.

[0002] priority

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 329,346, filed on April 29, 2016, entitled “Tissue Sample Holder with Enhanced Features,” the disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0004] Various devices have been used to obtain biopsy samples in various medical procedures in various ways (including open and percutaneous methods). For example, some biopsy devices can be fully operable by the user using a single hand, and one or more biopsy samples can be captured from the patient by a single insertion. In addition, some biopsy devices can be tethered to a vacuum module and / or a control module, such as for fluid (e.g., pressurized air, saline, atmosphere, vacuum, etc.) transmission, for power communication, and / or for command communication, etc. Other biopsy devices can be fully or at least partially operable without being tethered or otherwise connected to another device. The biopsy device can be used under stereotactic guidance, ultrasound guidance, MRI guidance, positron emission mammography ("PEM" guidance), breast specific gamma imaging ("BSGI") guidance, or other methods.

[0005] The current state-of-the-art technology for performing breast biopsy is to use a vacuum-assisted breast biopsy device. The current textbook in this field is "Vacuum-Assisted Breast Biopsy with Va ... ”, copyright 2013, Deviceor Medical Germany GmBh, published in Germany by Springer MedizinVerlag, authors: Markus Hahn, Anne Tardivon and Jan Casselman, ISBN 978-3-642-34270-7.

[0006] Only exemplary biopsy devices and biopsy system components are disclosed in the following: U.S. Patent No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue,” issued on June 18, 1996; U.S. Patent No. 5,928,164, entitled “Apparatus for Automated Biopsy and Collection of Soft Tissue,” issued on July 27, 1999; U.S. Patent No. 6,017,316, entitled “Vacuum Control System and Method for Automated Biopsy Device,” issued on January 25, 2000; U.S. Patent No. 6,086,544, entitled “Control Apparatus for an Automated Surgical Biopsy Device,” issued on July 11, 2000; U.S. Patent No. 6,086,544, entitled “Fluid Collection Apparatus for a Surgical No. 6,162,187, entitled “Device”; No. 6,432,065, entitled “Method for Using a Surgical Biopsy System with Remote Control for Selecting an Operational Mode”, issued on August 13, 2002; No. 6,626,849, entitled “MRI Compatible Surgical Biopsy Device”, issued on September 11, 2003; No. 6,752,768, entitled “Surgical Biopsy System with Remote Control for Selecting an Operational Mode”, issued on June 22, 2004; No. 7,442,171, entitled “Remote Thumbwheel for a Surgical Biopsy Device”, issued on October 8, 2008; No. 7,648,466, entitled “Manually Rotatable Piercer”, issued on January 19, 2010;U.S. Patent No. 7,837,632, entitled “Biopsy Device Tissue Port Adjustment,” issued on November 23, 2010; U.S. Patent No. 7,854,706, entitled “Clutch and Valving System for Tetherless Biopsy Device,” issued on December 1, 2010; U.S. Patent No. 7,914,464, entitled “Surgical Biopsy Systemwith Remote Control for Selecting an Operational Mode,” issued on March 29, 2011; U.S. Patent No. 7,938,786, entitled “Vacuum Timing Algorithm for Biopsy Device,” issued on May 10, 2011; U.S. Patent No. 8,083,687, entitled “Tissue Biopsy Device with Rotatably Linked Thumbwheel and Tissue Sample Holder,” issued on December 21, 2011; U.S. Patent No. 8,083,687, entitled “Biopsy Sample No. 8,118,755, entitled “Tetherless Biopsy Device with Reusable Portion,” issued on June 26, 2012; No. 8,206,316, entitled “Biopsy Device with Rotatable Tissue Sample Holder,” issued on August 14, 2012; No. 8,251,916, entitled “Revolving Tissue SampleHolder for Biopsy Device,” issued on August 28, 2012; No. 8,454,531, entitled “Icon-Based User Interface on Biopsy System Control Module,” issued on June 4, 2013, published on May 21, 2009; and No. 8,454,531, entitled “Biopsy Marker Delivery System,” issued on September 10, 2013. No. 8,532,747, entitled “Biopsy Device with Discrete Tissue Chambers,” issued on April 22, 2014; No. 8,702,623, entitled “Biopsy Device with Discrete Tissue Chambers,” issued on April 22, 2014;U.S. Patent No. 8,764,680, entitled “Handheld Biopsy Device with Needle Firing,” issued on June 11, 2014; U.S. Patent No. 8,801,742, entitled “Needle Assembly and Blade Assembly for Biopsy Device,” issued on August 12, 2014; U.S. Patent No. 8,858,465, entitled “Biopsy Device with Motorized Needle Firing,” issued on October 14, 2014; U.S. Patent No. 8,938,285, entitled “Access Chamber and Markers for Biopsy Device,” issued on January 20, 2015; U.S. Patent No. 9,095,326, entitled “Biopsy System with Vacuum Control Module,” issued on August 4, 2015; and U.S. Patent No. 9095326, entitled “Biopsy System with Vacuum Control Module,” issued on August 4, 2015. ;

[0007] The disclosures of each of the above-cited US patents are incorporated herein by reference. Additional exemplary biopsy devices and biopsy system components are disclosed in the following: U.S. Patent Publication No. 2006 / 0074345, entitled “Biopsy Apparatus and Method,” published on April 6, 2006 and now abandoned; U.S. Patent Publication No. 2008 / 0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,” published on September 4, 2008; U.S. Patent Publication No. 2009 / 0131821, entitled “Graphical User Interface For Biopsy System Control Module,” published on May 21, 2009, now abandoned; U.S. Patent Publication No. 2010 / 0152610, entitled “Hand Actuated Tetherless Biopsy Device with Pistol Grip,” published on June 17, 2010, now abandoned; U.S. Patent Publication No. 2010 / 0152610, entitled “Hand Actuated Tetherless Biopsy Device with Pistol Grip,” published on June 24, 2010, now abandoned; U.S. Patent Publication No. 2010 / 0152611, entitled “Biopsy Device with Central No. 2010 / 0160819, entitled “Biopsy Device Tissue Sample Holder with Bulk Chamber and Pathology Chamber,” published on February 28, 2013, and now abandoned; No. 2013 / 0053724, entitled “Biopsy Device Tissue Sample Holder with Bulk Chamber and Pathology Chamber,” published on May 3, 2016, and to be issued as U.S. Patent No. 9,326,755; No. 2013 / 0144188, entitled “Biopsy Device With Slide-In Probe,” published on June 6, 2013; and No. 2013 / 0324882, entitled “Control for Biopsy Device,” published on December 5, 2013.

[0008] The disclosures of each of the above-cited U.S. Patent Application Publications, U.S. Non-Provisional Patent Applications, and U.S. Provisional Patent Applications are incorporated herein by reference.

[0009] While several systems and methods for obtaining biopsy samples have been made and used, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] While the specification concludes with claims that particularly point out and distinctly claim this technology, it is believed that this technology will be better understood from the following description of certain aspects taken in conjunction with the accompanying drawings, in which like reference numerals refer to like elements, and in which:

[0011] Figure 1 A perspective view of a probe for use with a biopsy device described and shown in U.S. Publication No. 2014 / 0039343, “Biopsy System,” published on February 6, 2014 is depicted. Figures 1 to 12 The published U.S. patent application is incorporated by reference in its entirety.

[0012] Figure 2 Depicted Figure 1 An exploded perspective view of a tissue sample holder of a probe;

[0013] Figure 3 Depicted Figure 2 A perspective view of a sample basket of a tissue sample holder;

[0014] Figure 4 Depicted Figure 1 A perspective exploded view of a sample management component of a probe;

[0015] Figure 5 Depicted Figure 4 A front elevation view of a sample management assembly;

[0016] Figure 6 Depicted Figure 4 A perspective partial cutaway view of a sample management assembly;

[0017] Figure 7 Depicted Figure 1 A side cross-sectional view of a probe, wherein the cross section is along Figure 1 Line 19-19 of is obtained and the sample management assembly is in a tissue blocking configuration;

[0018] Figure 8 Depicted Figure 1 A rear elevation view of the probe, wherein Figure 3 The sample basket is removed and the sample management assembly is in a tissue blocking configuration;

[0019] Fig. 9 Depicted Figure 1 another cross-sectional view of the probe of the embodiment of the present invention, wherein the sample management component is in the tissue delivery configuration;

[0020] Fig.10 Depicted Figure 1 Another rear elevation view of the probe, wherein Figure 3The sample basket is removed and the sample management assembly is in a tissue transport configuration;

[0021] Fig.11 Depicted with Figure 2 A perspective view of an optional probe for use with a biopsy device;

[0022] Fig.12 Depicted with Fig.11 An exploded perspective view of a tissue sample holder for use with a probe;

[0023] Fig.13 Depicted Fig.12 A perspective view of a cover of a tissue sample holder;

[0024] Fig.14 Depicted Fig.13 A perspective cross-sectional view of the outer cover of Fig.13 The line 26-26 is obtained;

[0025] Fig.15 Depicted with Fig.12 A perspective view of a sample management assembly for use with a tissue sample holder;

[0026] Fig.16 Depicted Fig.11 A side cross-sectional view of a probe, wherein the cross section is along Fig.11 Line 28-28 is obtained and the sample management assembly is in a tissue occluding configuration;

[0027] Fig.17 Depicted Fig.11 a front elevation view of the probe with the sample basket removed and the sample management assembly in a tissue blocking configuration;

[0028] Fig.18 Depicted Fig.11 another side cross-sectional view of the probe of the invention, wherein the sample management assembly is in a tissue delivery configuration;

[0029] Fig.19 Depicted Fig.11 another front elevation view of the probe with the sample basket removed and the sample management assembly in the tissue transport configuration;

[0030] Fig. 20 Depicted for incorporation Fig.12 A perspective view of another aspect of an optional sample management assembly in a tissue sample holder of;

[0031] Fig.21 depicts a perspective view of an optional tissue sample holder for use with either probe;

[0032] Fig. 22Depicted Fig.21 An exploded perspective view of a tissue sample holder;

[0033] Fig.23 Depicted with Fig.21 A perspective view of a sample management assembly for use with a tissue sample holder;

[0034] Fig.24 Depicted Fig.21 a partial cross-sectional side view of a tissue sample holder of , wherein the sample management assembly is in a first sample receiving configuration;

[0035] Fig.25 Depicted Fig.21 a front elevation view of a tissue sample holder with the sample basket removed and the sample management assembly in a second sample receiving configuration;

[0036] Fig.26 Depicted Fig.21 another partial cross-sectional side view of a tissue sample holder of , wherein the sample management assembly is in a second sample receiving configuration;

[0037] Fig. 27 Depicted Fig.21 another front elevation view of the tissue sample holder of FIG. 1 with the sample basket removed and the sample management assembly in a second sample receiving configuration;

[0038] Fig.28 Depicted is a perspective view of an exemplary alternative tissue sample holder for use with either probe.

[0039] Fig.29 Depicted Fig.28 A perspective exploded view of a tissue sample holder;

[0040] Fig.30 Depicted Fig.28 A perspective cross-sectional view of a tissue sample holder, wherein the cross section is along Fig.28 The line 42-42 is obtained;

[0041] Fig.31 Depicted Fig.28 A front elevation view of a cover of a tissue sample holder;

[0042] Fig.32 Depicted Fig.31 a rear elevation view of the outer cover;

[0043] Fig.33 Depicted Fig.31 A perspective cross-sectional view of the outer cover of Fig.32 The line 45-45 is obtained;

[0044] Fig.34 Depicted with Fig.40 A perspective view of a sample management assembly for use with a tissue sample holder;

[0045] Fig.35 Depicted Fig.34 A front elevation view of a rotating cam plate of a sample management assembly;

[0046] Fig.36 Depicted Fig.34 A front elevation view of a fixed cam plate of a sample management assembly;

[0047] Fig.37 Depicted Fig.34 a perspective view of a sample management assembly of FIG. 1 with at least some of the cam plates removed;

[0048] Fig.38 Depicted Fig.28 A front elevation view of a tissue sample holder;

[0049] Fig.39 Depicted Fig.28 A rear elevation view of a tissue sample holder with the sample basket removed;

[0050] Fig.40 Depicted Fig.34 A front elevation view of a sample management assembly of the embodiment of the present invention, wherein the sample management assembly is in a tissue receiving position;

[0051] Fig.41 Depicted Fig.34 Another front elevation view of the sample management assembly of the embodiment of the present invention, wherein the sample management assembly is in an intermediate position;

[0052] Fig.42 Depicted Fig.34 Yet another front elevation view of a sample management assembly of the embodiment of the present invention, wherein the sample management assembly is in a first tissue ejection position;

[0053] Fig.43 Depicted Fig.34 yet another front elevation view of a sample management assembly of the invention, wherein the sample management assembly is in a second tissue ejection position;

[0054] Fig.44 Depicted is a perspective view of yet another exemplary alternative tissue sample holder for use with either probe.

[0055] Fig.45 Depicted Fig.44 An exploded perspective view of a tissue sample holder;

[0056] Fig.46 Depicted with Fig.44A perspective view of a sample management assembly for use with a tissue sample holder;

[0057] Fig.47 Depicted Fig.46 A side cross-sectional view of a sample management assembly, the cross section being along Fig.46 The line 59-59 is obtained; and

[0058] Fig.48 Describes Fig.46 Another perspective view of a sample management component of FIG. 1 , wherein the sample management component is in a tissue release configuration.

[0059] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be performed in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the technology and, together with the description, serve to explain the principles of the technology; however, it should be understood that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0060] The following description of certain aspects of the technology should not be used to limit its scope. Other aspects, features, embodiments and advantages of the technology will become clear to those skilled in the art from the following description, and the following description is one of the best modes for carrying out the technology by way of illustration. As will be appreciated, the technology described herein can have other different and obvious aspects, all of which do not deviate from the technology. Therefore, the drawings and description should be regarded as illustrative and not restrictive in nature.

[0061] U.S. Publication No. 2014 / 0039343, “Biopsy System,” published on February 6, 2014 Figures 1 to 12 An exemplary biopsy system is described.As previously noted, the published US patent application is incorporated by reference in its entirety.

[0062] Figure 1Shown is an exemplary optional probe (1100), which can be easily incorporated into the biopsy device described in U.S. Publication No. 2014 / 0039343. It should be understood that, except as otherwise described herein, the probe (1100) is substantially the same as the probe described in U.S. Publication No. 2014 / 0039343. Different from the probe in U.S. Publication No. 2014 / 0039343, the probe (1100) of this aspect is generally configured to allow the use of the tissue analysis features described in more detail below to analyze tissue samples separately. The probe (1100) is further configured to store tissue samples in batch configuration. As will be described in more detail below, the probe (1100) generally includes a feature that allows a single tissue sample to be temporarily separated and subsequently deposited in a single batch tissue chamber (1346).

[0063] The probe (1100) of this aspect includes a needle (1110) extending distally from the probe (1100), which is inserted into the tissue of the patient to obtain a tissue sample. These tissue samples are deposited in the tissue sample holder (1300) at the proximal end of the probe (1100). About the probe described in U.S. Publication No. 2014 / 0039343, a vacuum control module can be coupled with the probe (1100) via a valve assembly and a pipe (1020, 1030), and the vacuum control module is operable to selectively provide vacuum, saline, atmosphere and lead to the probe (1100). The probe (1100) also includes a top shell (1102) or a main body that generally defines the outer surface of the probe (1100), for grasping by an operator to manipulate the needle (1110). Although not shown, it should be understood that the probe (1100) includes a gear or other features similar to the gear described in U.S. Publication No. 2014 / 0039343. With respect to the probe described in US Publication No. 2014 / 0039343, such gears and / or other features may be operable to drive a cutter actuation mechanism in probe (1100) to rotate and translate a cutter (not shown) disposed within needle (1110).

[0064] The needle (1110) is substantially the same as the needle described in U.S. Publication No. 2014 / 0039343. For example, the needle (1110) of the present aspect includes a cannula (1113) having a puncturing tip (1112), an outer hole (1114) located near the tip (1112). Although not shown, it should be understood that in some aspects, the needle (1110) also includes a hub member (not shown) similar to the hub member described in U.S. Publication No. 2014 / 0039343. As similarly described in U.S. Publication No. 2014 / 0039343 regarding the tip, the tip (1112) of the needle (1110) is configured to puncture and penetrate tissue without requiring a large amount of force and without requiring the tip (1112) to be pre-formed in the tissue prior to insertion.

[0065] The lateral aperture (1114) is also substantially similar to the lateral aperture described in U.S. Publication No. 2014 / 0039343. For example, the size of the lateral aperture (1114) is set to receive prolapsed tissue during the operation of the biopsy device described in U.S. Publication No. 2014 / 0039343. Although not shown, it should be understood that the hollow tubular cutter (not shown) is disposed in the needle. The cutter of this aspect is substantially similar to the cutter described in U.S. Publication No. 2014 / 0039343, so that the cutter is operable to rotate and translate relative to the needle (1110) and pass through the lateral aperture (1114) to cut off the tissue sample from the tissue protruding from the lateral aperture (1114). With respect to rotating around the longitudinal axis of the needle (1110) to orient the lateral aperture (1114) at any desired axial position, the needle (1110) of this aspect is similar to the needle described in U.S. Publication No. 2014 / 0039343.

[0066] As described above, the probe (1100) includes a housing (1102) that supports the internal components of the probe (1100). The needle (1110) protrudes distally from the housing (1102) and is supported by the housing (1102) so that an operator can manipulate the needle (1110) by gripping the housing (1102). Unlike the housing described in U.S. Publication No. 2014 / 0039343, the housing (1102) of the present invention includes a tissue window (1103). As will be described in more detail below, the tissue window (1103) provides a tissue analysis feature by providing a transparent window through which an operator can observe a single tissue sample.

[0067] The proximal end of housing (1102) supports a tissue sample holder (1300) similar to the tissue sample holder described in U.S. Publication No. 2014 / 0039343. However, unlike the tissue sample holder described in U.S. Publication No. 2014 / 0039343, the tissue sample holder (1300) of the present invention is configured to store tissue samples in a single batch tissue sample chamber (1346). Figure 2 As best seen in FIG. 1 , tissue sample holder ( 1300 ) includes sealing member ( 1170 ), sample basket ( 1330 ), sample management assembly ( 1310 ), and housing ( 1302 ). Sealing member ( 1170 ) of the present aspect is substantially the same as the sealing member described in U.S. Publication No. 2014 / 0039343 .

[0068] The sealing member (1170) of this aspect includes a longitudinally extending cutter seal (1172) that receives a cutter disposed in the needle (1110) and seals the exterior of the cutter. The proximal end of the cutter is held within the cutter seal through the entire travel range of the cutter, such that the cutter seal (1172) remains fluid-tight when the cutter is actuated to perform tissue sampling. Also like the sealing member described in U.S. Publication No. 2014 / 0039343, with respect to the needle, an opening (not shown) is positioned at the proximal end of the cutter seal (1172). As will be described in more detail below, the opening is configured to align with a specific portion of the sample management assembly (1310) to transfer a tissue sample to the sample basket (1330).

[0069] The sealing member (1170) further includes a first vacuum opening (1174) and a second vacuum opening (1176). The first vacuum opening (1174) is positioned below the cutter seal (1172). The first vacuum opening (1174) is substantially similar to the opening of the sealing member described in U.S. Publication No. 2014 / 0039343. However, unlike the sealing member described in U.S. Publication No. 2014 / 0039343, the sealing member (1170) of the present aspect further includes a second vacuum opening (1176) disposed near the bottom of the sealing member (1170). As will be described in more detail below, both the first vacuum opening (1174) and the second vacuum opening (1176) are in communication with the axial tube (1020) to provide vacuum to the basket (1330) and the cutter of the needle (1110).

[0070] Unlike the sealing member described in U.S. Publication No. 2014 / 0039343, the sealing member (1170) of the present aspect is made of a substantially transparent material. It should be understood that in the present aspect, the sealing member (1170) is substantially transparent to allow the operator to see the tissue sample disposed in the sealing member (1170). As will be described in more detail below, this feature can be used in combination with the tissue analysis feature described in more detail below. The term "substantially transparent" used herein should be understood to generally include a transparent or perspective sealing member (1170). However, it should be understood that the term "substantially transparent" should not necessarily be limited to being merely transparent. For example, in some aspects, the sealing member (1170) may include certain optical coatings that can affect the transparency of the sealing member (1170) by limiting the light of certain wavelengths that penetrate the sealing member (1170), thereby enhancing the visualization or analysis of the tissue sample.

[0071] Sample basket (1330) Figure 31300 . The basket (1330) is generally configured to hold a plurality of tissue samples in a single tissue sample chamber (1346). As can be seen, the basket (1330) includes a handle (1332), a proximal wall (1334). The handle (1332) extends proximally from the proximal wall (1334) and is configured to be grasped by an operator to manipulate the basket (1330). The proximal wall (1334) defines a channel (1343) along an outer edge of a distal surface of the proximal wall (1334). The channel (1343) is configured to receive at least a portion of the housing (1302) to fluidly seal the proximal end of the tissue sample holder (1300) when the basket (1330) is disposed in the housing (1302). Although not shown, it should be understood that the channel (1343) may be provided with a gasket or other sealing element to further facilitate the seal between the basket (1330) and the housing (1302).

[0072] A pair of sidewalls (1344) and lower base (1340) extend distally from proximal wall (1334). In this aspect, sidewalls (1344) and lower base (1340) are defined by a single semicircular member. However, it should be understood that in other aspects, sidewalls (1344) and lower base (1340) are defined by a square or rectangular cross section more discretely. In any case, intermediate base (1342) is disposed above lower base (1340). Lower base (1340) and intermediate base (1342) are parallel to each other and laterally spaced apart from each other to define a vacuum channel (1349) therebetween. As will be described in more detail below, vacuum channel (1349) is configured to transmit vacuum to collect tissue samples through a plurality of openings (1345) in intermediate base (1342).

[0073] The distal wall (1336) extends upward from the distal end of the intermediate base plate (1342). The distal wall (1336) further extends laterally from the side wall (1344). The distal wall (1336) of this aspect defines a semicircular shape configured to abut against the sample management assembly (1310), as will be described in more detail below. The distal wall (1336), the proximal wall (1334), the side wall (1344) and the intermediate base plate (1342) together define a tissue sample chamber (1346). The tissue sample chamber (1346) is generally configured to receive a plurality of tissue samples therein. In this aspect, the tissue sample chamber (1346) is configured to receive any tissue sample between about 20 to about 50. Of course, in other aspects, the tissue sample chamber (1346) can be configured to receive any other suitable number of tissue samples.

[0074] An upper portion of the distal wall (1336) includes a tissue opening (1338) therein. Additionally, because the distal wall (1336) terminates below the intermediate floor (1342), a vacuum opening (1347) is defined in the distal end of the basket (1330) between the intermediate floor (1342) and the lower floor (1340). As will be described in greater detail below, the tissue opening (1338) is generally configured to be selectively placed in communication with the cutter and the axial tube (1020) via the sample management assembly (1310). Similarly, the vacuum opening (1347) is generally configured to be selectively placed in communication with the axial tube (1020) via the sample management assembly (1310). The selective communication between the tissue opening (1338) and the vacuum opening (1347) generally allows the tissue sample chamber (1346) to receive a tissue sample therein when such tissue sample is obtained via the needle (1110) and axially transported through the cutter.

[0075] Sample management component (1310) such as Figure 4 As shown in . As can be seen, the sample management assembly (1310) includes a first rotatable member (1312) and a second rotatable member (1322). The first rotatable member (1312) includes a front screen body (1313) that is generally coin-shaped. The front screen body (1313) defines an inner vacuum ring (1314) and an outer tissue manipulation ring (1316). The inner vacuum ring (1314) includes a plurality of vacuum openings (1315) extending through the front screen body (1313) and surrounding the interior of the front screen body (1313) 360°. As will be described in more detail below, the vacuum openings (1315) are generally configured to connect the vacuum continuously from the axial tube (1020) to the interior of the cutter disposed in the needle (1110).

[0076] The outer tissue manipulation ring (1316) includes an alternating arrangement of filter portions (1318) and tissue openings (1317). In particular, each filter portion (1318) includes an array of openings (1319) extending through the front screen body (1313), which is arranged in a pattern that roughly corresponds to the outer diameter of the cutter disposed in the needle (1110). As will be described in more detail below, each filter portion (1318) is generally configured to prevent a tissue sample from moving through the first rotatable member (1312), but allows vacuum and / or fluid flow. In contrast, the tissue opening (1317) includes a single opening extending through the front screen body (1313), the size of which is generally set to correspond to the outer diameter of the cutter disposed in the needle (1110). Therefore, the tissue opening (1317) is generally configured to allow fluid, vacuum, and tissue samples to pass through the front screen body (1313).

[0077] As described above, the filter portions (1318) and tissue openings (1317) are arranged in an alternating annular array around the front sieve body (1313). Each filter portion (1318) and tissue opening (1317) is positioned equidistantly around the front sieve body (1313) near the outer edge of the front sieve body (1313). It should be understood that each filter portion (1318) and tissue opening (1317) extends through the front sieve body (1313) in a direction parallel to the axis of rotation of the front sieve body (1313). Therefore, as will be described in more detail below, the rotation of the front sieve body (1313) is generally configured to cause a particular filter portion (1318) or tissue opening (1317) to be indexed together with the tissue opening (1338) of the tissue sample holder (1300). As will be described in greater detail below, this alternating relationship of filter portions (1318) and tissue openings (1317) is generally configured to allow sample management assembly (1310) to selectively block a tissue sample from entering tissue sample holder (1300).

[0078] The first rotatable member (1312) further includes a central shaft (1320) and a pair of attachment features (1321). The central shaft (1320) is substantially similar to the central shaft described in U.S. Publication No. 2014 / 0039343 with respect to the manifold. In particular, the central shaft (1320) is configured to engage with the gripping features (1184) ( Figure 2 ) is coupled to provide rotation of first rotatable member (1312) when gear (1182) rotates. Of course, in other aspects, any other suitable features for rotating first rotatable member (1312) may be used, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0079] The attachment features (1321) of the present aspect include notches on opposite sides of the first rotatable member (1312). The attachment features (1321) allow the first rotatable member (1312) to be fastened to the second rotatable member (1322). Therefore, it should be understood that the first rotatable member (1312) and the second rotatable member (1322) are configured to rotate together in response to the rotation of the central axis (1320). Although not shown, it should be understood that the attachment features (1321) may include other additional features, such as clips, retainers, fasteners, etc., to facilitate the attachment between the first rotatable member (1312) and the second rotatable member (1322).

[0080] Similar to the first rotatable member (1312), the second rotatable member (1322) includes a rear screen body (1323) that is generally coin-shaped. The rear screen body (1323) includes an array of alternating tissue receiving portions (1324) and fluid portions (1327). The tissue receiving portions (1324) are generally configured to guide fluid and tissue through the rear screen body (1323). In particular, each tissue receiving portion (1324) includes a tissue opening (1325) and a plurality of vacuum openings (1326). Each tissue opening (1325) extends through the rear screen body (1323) and corresponds in size to each of the tissue openings (1317) described above. As described above similarly to the tissue openings (1317), the size of the tissue openings (1325) of the second rotatable member (1322) is generally set to correspond to the outer diameter of the cutter disposed in the needle (1110), so that each tissue opening (1317) is configured to receive a tissue sample therethrough. As will be described in greater detail below, this allows the tissue sample to traverse first rotatable member (1312) and then second rotatable member (1322) before ultimately being deposited in tissue sample holder (1300).

[0081] The vacuum opening (1326) of each tissue receiving portion (1324) is configured to allow vacuum to flow through the rear screen body (1323) of the second rotatable member (1322). As will be described in more detail below, this allows vacuum and / or fluid to pass through the second rotatable member (1322) and into the tissue sample holder (1300). The vacuum in the tissue sample holder (1300) is then transferred to the cutter disposed within the needle (1110) via the corresponding tissue opening (1325).

[0082] Each fluid portion (1327) is generally configured to redirect fluid flow relative to the second rotatable member (1322), thereby preventing vacuum and / or fluid flow from entering the tissue sample holder (1300). In particular, each fluid portion (1327) includes a recess (1328) that is generally trapezoidal or teardrop shaped. The inner edge of each recess (1328) is rounded to facilitate fluid flow within each recess (1328). Of course, in other aspects, the inner edge of each recess (1328) can be straight or include some other structural shape. Each angled leg of the trapezoidal shape of each recess (1328) is radially angled to the circular cross-sectional shape of the rear screen body (1323). As shown in FIG. Figure 5As best seen in FIG. 1 , the inner and narrower portion of each recess (1328) is configured to communicate with the vacuum opening (1315) of the first rotatable member (1312). The outer and wider portion of each recess (1328) is configured to communicate with the opening (1319) of the corresponding filter portion (1318) in the first rotatable member (1312). Thus, as will be described in more detail below, each recess (1328) is configured to redirect vacuum and / or fluid from the vacuum opening (1315) of the first rotatable member (1312) to the opening (1319) of the corresponding filter portion (1318) in the first rotatable member (1312).

[0083] Similar to the first rotatable member (1312) described above, the second rotatable member (1322) also includes attachment features (1329) on opposite sides of the rear screen body (1323). Similar to the attachment features (1321) described above, the attachment features (1329) of the present aspect include recesses in the rear screen body (1323). Each attachment feature (1329) is configured to engage with a corresponding attachment feature (1321) of the first rotatable member (1312) to secure the second rotatable member (1322) to the first rotatable member (1312). Therefore, it should be understood that the first rotatable member (1312) and the second rotatable member (1322) are generally fixed together so that the first rotatable member (1312) and the second rotatable member (1322) rotate together when the central axis (1320) rotates.

[0084] like Figure 6 As best seen in the drawings, the first rotatable member (1312) and the second rotatable member (1322) are generally configured to be fastened together. When fastened together, the vacuum ring (1314) of the first rotatable member (1312) communicates with the recesses (1328) and vacuum openings (1326) of the second rotatable member (1322). Thus, when vacuum is communicated through a particular portion of the vacuum ring (1314), the vacuum will communicate through the vacuum openings (1315) of the vacuum ring (1314) to a corresponding array of recesses (1328) or vacuum openings (1326) of the second rotatable member (1322).

[0085] Also like Figure 6As can be seen in FIG. 1 , each tissue opening (1317) of first rotatable member (1312) is in communication with a corresponding tissue opening (1325) of second rotatable member (1322). Likewise, each filter portion (1318) of first rotatable member (1312) is in communication with a corresponding recess (1328) of second rotatable member (1322). Thus, as first rotatable member (1312) alternates between filter portion (1318) and tissue opening (1317), there is a corresponding alternation between communication with a corresponding recess (1328) and tissue opening (1325) of second rotatable member (1322). As will be described in greater detail below, this alternating relationship allows sample management assembly (1310) to selectively enable and disable communication between tissue sample holder (1300) and a cutter disposed within needle (1110).

[0086] Figures 7 to 10 Exemplary operation of sample management assembly (1310) to collect tissue samples into tissue sample holder (1300) is shown. In particular, as shown in FIG. Figure 7 and Figure 8 As can be seen in Figure 1, sample management assembly (1310) initially begins in a sample blocking state. In the sample blocking state, sample management assembly (1310) is rotated to align filter portion (1318) of first rotatable member (1312) with cutter seal (1172) of sealing member (1170). Because filter portion (1318) includes vacuum opening array (1319), tissue sample is generally blocked from entering tissue sample holder (1300) through filter portion (1318). Additionally, when in the blocking state, vacuum ring (1314) of first rotatable member (1312) is aligned with vacuum opening (1174) of sealing member (1170), thereby allowing vacuum from axial tube (1020) to pass through vacuum opening (1174) of sealing member (1170) and vacuum opening (1315) in vacuum ring (1314) of first rotatable member (1312).

[0087] Also in the blocked state, second rotatable member (1322) is rotated so that recess (1328) corresponding to a given filter portion (1318) is aligned with cutter seal (1172) and vacuum opening (1174) of seal member (1170). Because vacuum opening (1174) is in communication with axial tube (1020), vacuum will be communicated through axial tube (1020), through vacuum opening (1315) of vacuum ring (1314), and into recess (1328). The vacuum is then directed through recess (1328) to opening (1319) in filter portion (1318) of first rotatable member (1312) and into cutter seal (1172) of seal member (1170), and then ultimately transmitted to the cutter disposed in needle (1110). It should therefore be appreciated that when sample management assembly (1310) is in the tissue occluding state, vacuum is directed through sample management assembly (1310) to the cutter without passing through tissue sample holder (1300).

[0088] When a tissue sample is collected using the cutter while sample management assembly (1310) is in an obstructed state, the tissue sample is transported through the cutter to the cutter seal (1172) of sealing member (1170) using a vacuum redirected by recess (1328) of second rotatable member (1322). Filter portion (1318) blocks further movement of the tissue sample, thereby retaining the tissue sample within cutter seal (1172) of sealing member (1170). Because sealing member (1170) of the present aspect is generally transparent, the tissue sample may be observed and at least partially analyzed through tissue window (1103) in housing (1102) of probe (1100).

[0089] To transfer a tissue sample to tissue sample holder (1300), sample management assembly (1310) is rotated to Fig. 9 and Fig.10 To transition sample management assembly (1310) to the tissue delivery position, first rotatable member (1312) and second rotatable member (1322) are indexed to align the next adjacent tissue opening (1317, 1325) with the cutter disposed in needle (1110). In particular, as shown in FIG. Fig. 9As can be seen in FIG. 1 , first rotatable member (1312) is rotated to align a given tissue opening (1317) with cutter seal (1172) of seal member (1170). Vacuum ring (1314) remains aligned with first vacuum opening (1174) of seal member (1170), but a new opening (1315) is exposed as a result of the rotation of first rotatable member (1312). Another tissue opening (1317) on the opposite side of first rotatable member (1312) is also aligned with second vacuum opening (1176) of cutter seal (1172).

[0090] As first rotatable member (1312) rotates, second rotatable member (1322) also rotates to index the next adjacent tissue opening (1325) with the cutter disposed in needle (1110) via sealing member (1170). Because tissue openings (1317, 1325) of first rotatable member (1312) and second rotatable member (1322) are indexed with the cutter disposed in needle (1110) via sealing member (1170), a tissue sample severed by the cutter may travel through tissue openings (1317, 1325) and into tissue sample chamber (1346) of tissue sample holder (1300). In particular, to transfer the tissue sample into tissue sample holder (1300), vacuum is passed from axial tube (1020) through first and second vacuum openings (1174, 1176) into sealing member (1170). The vacuum traveling through first vacuum opening (1174) of sealing member (1170) is then transmitted through vacuum opening (1315) in vacuum ring (1314) of first rotatable member (1312) and vacuum opening (1326) in second rotatable member (1322). From vacuum opening (1326) in second rotatable member (1322), the vacuum travels into tissue sample holder (1300), where negative pressure is established to induce vacuum through tissue openings (1317, 1325) of first and second rotatable members (1312, 1322) in communication with cutter seal (1172) of sealing member (1170).

[0091] In addition to the vacuum path described above, the vacuum traveling through the second vacuum opening (1176) of the sealing member (1170) is transmitted through the tissue openings (1317, 1325) of the first and second rotatable members (1312, 1322) that are in communication with the second vacuum opening (1176). The vacuum is then directed through the vacuum opening (1347) of the basket (1330) and through the vacuum channel (1349). The vacuum may then travel upward through the opening (1345) in the middle floor (1342) of the basket (1330). In some aspects, such transmission of the vacuum through the middle floor (1342) may direct the tissue sample downward into the bottom of the basket (1330). Additionally, excess fluid collected during the biopsy procedure may be drained from the tissue sample holder (1300) through the middle floor (1342).

[0092] Once the tissue sample has been collected in the tissue sample holder (1300), the sample management assembly (1310) can be rotated again to transition back to the tissue blocking position described above. Because the various features of the first rotatable member (1312) and the second rotatable member (1322) are arranged in an alternating configuration, it should be understood that the sample management assembly (1310) can be rotated in any direction to transition between the tissue blocking position and the tissue transport position. In some aspects, the first rotatable member (1312) and the second rotatable member (1322) are rotated continuously in a single direction to transition the sample management assembly (1310) between the tissue blocking position and the tissue transport position. Of course, such an operating mode is merely optional, and in other aspects, the first rotatable member (1312) and the second rotatable member (1322) can be rotated in any suitable direction and in any suitable order.

[0093] In some cases, it may be desirable to include other forms of tissue sample analysis in addition to or in place of the visual analysis described in U.S. Publication No. 2014 / 0039343 regarding probe (1100) within the biopsy device. For example, in some aspects, a bioimpedance sensor can be used to identify certain physical characteristics of a tissue sample. For the purposes of this patent application, a "bioimpedance sensor" is defined as a "sensor that measures how mammalian tissue resists a tiny applied alternating current." In such aspects, a sensor can be positioned within a biopsy device to obtain impedance measurements of a given tissue sample. These impedance measurements can then be compared with known impedance values ​​for healthy and abnormal tissues to identify whether a given tissue sample may include any abnormalities (e.g., calcification, etc.).

[0094] An exemplary probe for tissue sample analysis using bioimpedance is described below. It should be understood that the various optional probes described below can be easily incorporated into the biopsy device described in U.S. Publication No. 2014 / 0039343. It should also be understood that the various components and probes described above and / or in U.S. Publication No. 2014 / 0039343 can be easily incorporated into the optional probe described below. In view of the teachings herein, various suitable ways of combining the above and following teachings will be clear to those of ordinary skill in the art. It should also be understood that the following teachings can be easily combined with the various teachings of the references cited herein.

[0095] Fig.11 Shown is an exemplary optional probe (2100), which can be easily incorporated into the biopsy device described in U.S. Publication No. 2014 / 0039343. It should be understood that, except as otherwise described herein, the probe (2100) is substantially the same as the probe described in U.S. Publication No. 2014 / 0039343. Different from the probe in U.S. Publication No. 2014 / 0039343, the probe (2100) of this aspect is generally configured to allow another tissue analysis feature to be described in more detail below to analyze tissue samples separately. The probe (2100) is further configured to store tissue samples in batch configuration. As will be described in more detail below, the probe (2100) generally includes a feature that allows a single tissue sample to be temporarily separated and then deposited in a single batch tissue chamber (2346).

[0096] The probe (2100) of this aspect includes a needle (2110) extending distally from the probe (2100), which is inserted into the tissue of the patient to obtain a tissue sample. These tissue samples are deposited in the tissue sample holder (2300) at the near end of the probe (2100). As described similarly about the probe in U.S. Publication No. 2014 / 0039343, a vacuum control module can be coupled with the probe (2100) via a valve assembly and one or more pipes (2020), and the vacuum control module is operable to selectively provide vacuum, saline, atmosphere and lead to the probe (2100). The probe (2100) also includes a top shell (2102) or a main body that generally defines the outer surface of the probe (2100), for grasping by the operator to manipulate the needle (2110). Although not shown, it should be understood that the probe (2100) includes a gear or other features similar to the gear described in U.S. Publication No. 2014 / 0039343. As similarly described with respect to a probe in U.S. Publication No. 2014 / 0039343, such gears and / or other features are operable to drive a cutter actuation mechanism in probe (2100) to rotate and translate a cutter (not shown) disposed within needle (2110). Additionally, such gears and / or other features are operable to drive tissue sample holder (2300), as described in greater detail below.

[0097] The needle (2110) is substantially the same as the needle described above and / or in U.S. Publication No. 2014 / 0039343. For example, the needle (2110) of the present aspect includes a cannula (2113) having a puncturing tip (2112), an outer hole (2114) located near the tip (2112). Although not shown, it should be understood that in some aspects, the needle (2110) also includes a hub member (not shown) similar to the hub member described in U.S. Publication No. 2014 / 0039343. As described similarly to the tip in U.S. Publication No. 2014 / 0039343, the tip (2112) of the present aspect is configured to puncture and penetrate tissue without requiring a large amount of force and without requiring pre-forming an opening in the tissue prior to inserting the tip (2112).

[0098] The lateral aperture (2114) is also substantially similar to the lateral aperture described in U.S. Publication No. 2014 / 0039343. For example, the size of the lateral aperture (2114) is set to receive prolapsed tissue during the operation of the biopsy device. Although not shown, it should be understood that the hollow tubular cutter (not shown) is disposed in the needle. The cutter of this aspect is substantially similar to the cutter described in U.S. Publication No. 2014 / 0039343, so that the cutter is operable to rotate and translate relative to the needle (2110) and to cut off the tissue sample from the tissue protruding from the lateral aperture (2114) through the lateral aperture (2114). Also as described similarly to the probe in U.S. Publication No. 2014 / 0039343, the needle (2110) of this aspect is configured to rotate around the longitudinal axis of the needle (2110) to orient the lateral aperture (2114) at any desired axial position.

[0099] As described above, the probe (2100) includes a housing (2102) that supports the internal components of the probe (2100). The needle (2110) protrudes distally from the housing (2102) and is supported by the housing (2102) so that an operator can manipulate the needle (2110) by gripping the housing (2102). Unlike the housing described in U.S. Publication No. 2014 / 0039343, the housing (2102) of the present invention includes a tissue analysis portion (2103). As will be described in more detail below, the tissue analysis portion (2103) provides a tissue analysis feature that uses bioimpedance to analyze tissue samples. In addition, in some aspects, at least a portion of the tissue analysis portion (2103) may be transparent to provide a means for analyzing a single tissue sample by visual inspection in addition to bioimpedance.

[0100] The proximal end of housing (2102) supports a tissue sample holder (2300) similar to the tissue sample holder described in U.S. Publication No. 2014 / 0039343. However, unlike the tissue sample holder described in U.S. Publication No. 2014 / 0039343, tissue sample holder (2300) of the present invention is configured to store tissue samples in a single batch tissue sample chamber (2346). Fig.12As best seen in FIG. 2 , tissue sample holder ( 2300 ) includes a sample basket ( 2330 ), a sample management assembly ( 2310 ), and a housing ( 2302 ). Sample basket ( 2330 ) is substantially similar to the sample basket described in U.S. Publication No. 2014 / 0039343 . For example, basket ( 2330 ) is generally configured to hold multiple tissue samples in a single tissue sample chamber ( 2346 ). As can be seen, basket ( 2330 ) includes a handle ( 2332 ) and a proximal wall ( 2334 ). The handle ( 2332 ) extends proximally from the proximal wall ( 2334 ) and is configured to be grasped by an operator to manipulate the basket ( 2330 ). The proximal wall ( 2334 ) defines a channel ( 2343 ) along an outer edge of a distal surface of the proximal wall ( 2334 ). Channel (2343) is configured to receive at least a portion of housing (2302) to fluidly seal the proximal end of tissue sample holder (2300) when basket (2330) is disposed in housing (2302). Although not shown, it will be appreciated that channel (2343) may be provided with a gasket or other sealing element to further facilitate sealing between basket (2330) and housing (2302).

[0101] A pair of sidewalls (2344) and lower base plate (2340) extend distally from proximal wall (2334). In this aspect, sidewalls (2344) and lower base plate (2340) are defined by a single semicircular member. However, it should be understood that in other aspects, sidewalls (2334) and lower base plate (2340) are defined by a square or rectangular cross section more discretely. In any case, middle base plate (2342) is disposed above lower base plate (2340). Lower base plate (2340) and middle base plate (2342) are parallel to each other and laterally spaced apart from each other to define a vacuum channel (2349) therebetween. As will be described in more detail below, vacuum channel (2349) is configured to transmit vacuum to collect tissue samples through a plurality of openings (2345) in middle base plate (2342).

[0102] The distal wall (2336) extends upward from the distal end of the intermediate base plate (2342). The distal wall (2336) further extends laterally from the side wall (2344). The distal wall (2336) of this aspect defines a semicircular shape configured to abut against the sample management assembly (2310), as will be described in more detail below. The distal wall (2336), the proximal wall (2334), the side wall (2344) and the intermediate base plate (2342) together define the tissue sample chamber (2346). The tissue sample chamber (2346) is generally configured to receive a plurality of tissue samples therein. In this aspect, the tissue sample chamber (2346) is configured to receive any tissue sample between about 20 to about 50. Of course, in other aspects, the tissue sample chamber (2346) can be configured to receive any other suitable number of tissue samples.

[0103] The upper portion of the distal wall (2336) includes a tissue opening (2338) therein. In addition, because the distal wall (2336) terminates below the intermediate floor (2342), a vacuum opening (2347) is defined in the distal end of the basket (2330) between the intermediate floor (2342) and the lower floor (2340). As will be described in more detail below, the tissue opening (2338) is generally configured to be selectively placed in communication with the cutter via the sample management assembly (2310). Similarly, the vacuum opening (2347) is generally configured to be selectively placed in communication with the tube (2020) via the sample management assembly (2310). The selective communication between the tissue opening (2338) and the vacuum opening (2347) generally allows the tissue sample chamber (2346) to receive a tissue sample therein when such a tissue sample is obtained via the needle (2110) and axially transported through the cutter.

[0104] The outer cover (2302) is as follows Figure 12 to Figure 14 As can be seen, housing (2302) is generally cylindrical in shape and is configured to receive basket (2330) and sample management assembly (2310) through open proximal end (2303). At the distal end of housing (2302), a vacuum port (2304) extends through housing (2302) to allow vacuum to be transmitted into housing (2302) via tube (2020), as will be described in more detail below.

[0105] The sample analysis assembly (2305) extends distally from the housing (2302). The sample analysis assembly (2305) is generally configured to analyze a single tissue sample as it is collected by the needle (2110) and the cutter disposed within the needle (2110). The sample analysis assembly (2305) includes a gear opening (2306), a cutter opening (2307), and two bioimpedance electrodes (2309). As will be described in more detail below, the gear opening (2306) extends through the sample analysis assembly (2305) so that at least a portion of the sample management assembly (2310) can extend out of the housing (2302) and mechanically communicate with the biopsy device.

[0106] The cutter opening (2307) is communicated with a cutter channel (2308) that extends through the sample analysis assembly (2305). The cutter channel (2308) is similar to the cutter seal described above and / or in U.S. Publication No. 2014 / 0039343 regarding the sealing member described above and in U.S. Publication No. 2014 / 0039343. For example, the cutter channel (2308) is configured to receive a cutter disposed in the needle (2110) within the entire range of motion of the cutter, such that a sealing path exists between the outer hole (2114) and the proximal end of the cutter. In addition, in some cases, the sample analysis assembly (2305) is constructed of a transparent material such that the interior of the cutter channel (2308) is visible to an operator for visual analysis of a single tissue sample.

[0107] The interior of the cutter channel (2308) is as follows Fig.14 As best seen in the figure. As can be seen, the electrode (2309) extends from the outside of the sample analysis component (2305) through the sample analysis component (2305), so that at least a portion of each electrode (2309) extends to the inside of the cutter channel (2308). In this aspect, each electrode (2309) is positioned inside the cutter channel (2308) to make substantial physical contact with the tissue sample when the tissue sample passes through or is present in the cutter channel (2308). As will be described in more detail below, the electrode (2309) is generally configured to be coupled to the biopsy device as described in U.S. Publication No. 2014 / 0039343 via any suitable electrical coupling, so that the impedance of a given tissue sample can be measured. The measured impedance of a given tissue sample can then be analyzed via a biopsy device and / or a control module to identify various characteristics of a given tissue sample (e.g., to detect calcification and / or other abnormalities).

[0108] In the present aspect, the electrode (2309) extends from the cutter channel (2308) along the outer surface of the tissue analysis component (2305) and around the underside of the gear opening (2306). Additionally, the electrode (2309) of the present aspect is partially embedded into the outer surface of the tissue analysis component (2305). In other aspects, the electrode (2309) may simply be fastened to the outer surface of the tissue analysis component (2305) without being embedded into the surface at all. In still other aspects, the electrode (2309) may be completely embedded in the structure of the tissue analysis component (2305).

[0109] The electrode (2309) of the present aspect is exposed to the exterior of the tissue analysis assembly (2305) to facilitate electrical connection with the biopsy device. For example, in some cases, certain features of the biopsy device include electrical contacts corresponding to the electrode (2309), such that when the probe (2100) is connected to the biopsy device, the electrical contacts of the electrode (2309) can communicate with the biopsy device. To further facilitate electrical contact, it should be understood that in some aspects, the biopsy device or tissue analysis assembly (2305) can include various electrical connection features, such as brushes, slip rings, etc.

[0110] Regardless of how the electrode (2309) specifically achieves electrical continuity with the biopsy device, it should be understood that ultimately impedance information from the collected tissue sample is transmitted from the electrode (2309) to the biopsy device and / or control module. This information can then be used to provide real-time analysis of the collected tissue sample. In only one aspect, the impedance information is used to detect the presence of cancer cells in the biopsy sample. Of course, in view of the teachings herein, it will be clear to one of ordinary skill in the art that any other suitable use of the impedance information may be used.

[0111] Sample management component (2310) such as Fig.15 As shown in . As can be seen, the sample management assembly (2310) includes a rotatable member (2312). The rotatable member (2312) includes a body (2313) that is generally coin-shaped, wherein the rotating member (2320) extends distally from the body (2313). The body (2313) defines a tissue manipulation ring (2314). The tissue manipulation ring (2314) includes a filter portion (2316) and a transport portion (2318). The filter portion (2316) includes a plurality of vacuum holes (2317) arranged in an annular shape pattern axially around the body (2313). The vacuum holes (2317) are configured together to receive vacuum and fluid passing therethrough, but prevent tissue from passing therethrough. In contrast, the transport portion (2318) includes a single opening (2319) that is sized to receive a tissue sample passing therethrough. The delivery portion (2318) is positioned along the same circular path as the vacuum aperture (2317) such that the delivery portion (2318) interrupts at least a portion of the filter portion (2316).

[0112] Both the filter portion (2316) and the transport portion (2318) are positioned a distance from the center of the body (2313) such that the filter portion (2316) or the transport portion (2318) can be aligned with the cutter channel (2308) of the tissue analysis assembly (2305). However, whether the filter portion (2316) or the transport portion (2318) is indexed with the cutter channel (2308) of the tissue analysis assembly (2305) depends on the rotational orientation of the rotatable member (2312). Therefore, it should be understood that the body (2313) is generally configured to selectively block or unblock the delivery of a tissue sample to the tissue sample chamber (2346) based on the rotation of the rotatable member (2312).

[0113] Additionally, it should be appreciated that vacuum port (2304) of housing (2302) is oriented a distance from the center of rotatable member (2312) that is the same distance from the center of rotatable member as cutter channel (2308). Thus, vacuum port (2304) is in continuous communication with tissue sample holder (2300) via filter portion (2316) or transport portion (2318).

[0114] As described above, the rotating member (2320) extends distally from the body (2313). The rotating member (2320) includes a toothed portion (2321) at its distal end. When the sample management assembly (2310) is disposed within the housing (2302), the rotating member (2320) extends through the gear opening (2306) of the tissue analysis assembly (2305) to allow mechanical communication between the toothed portion (2321) and a corresponding gear and / or other feature of the biopsy device. Thus, the rotating member (2320) is configured to actuate the sample management assembly (2310) via rotation of the rotating member (2320).

[0115] Figures 16 to 19 Exemplary operation of the sample management assembly to collect a tissue sample in a tissue sample holder (2300) is shown. In particular, as shown in FIG. Fig.16 and Fig.17As can be seen in Figure 2, sample management assembly (2310) initially begins in a sample blocked state. In the sample blocked state, sample management assembly (2310) is rotated to align filter portion (2316) of rotatable member (2312) with cutter channel (2308) of tissue analysis assembly (2305). Because filter portion (2316) includes a plurality of vacuum openings (2317), tissue sample is generally blocked from entering tissue sample holder (2300) by filter portion (2316). However, due to the presence and position of vacuum port (2304) of housing (2302), vacuum is continuously transmitted from tube (2020) to tissue sample holder (2300) via vacuum port (2304). Thus, when the sample management assembly (2310) is in a sample occlusion state, vacuum can be transmitted to the cutter through the vacuum port (2304) via the vacuum channel (2349) in the basket (2330), the opening (2345) in the intermediate bottom plate (2342), and the opening (2317) in the filter portion (2316).

[0116] When the cutter is used to collect tissue samples while the sample management assembly (2310) is in a blocked state, the tissue sample is transported through the cutter to the cutter channel (2308) of the tissue analysis assembly (2305) using a vacuum from the tube (2020) via the vacuum port (2304). The filter portion (2316) blocks further movement of the tissue sample, thereby retaining the tissue sample within the cutter channel (2308) of the tissue analysis assembly (2305). While the tissue sample is blocked from entering the tissue sample chamber (2346) of the tissue sample holder (2300), the electrode (2309) protruding into the cutter channel (2308) can be used to analyze the tissue sample. In this aspect, impedance-related data is collected to detect the presence of cancer and / or other tissue abnormalities. The sample management assembly (2310) can remain in a blocked state during the sample analysis procedure. In aspects where the tissue analysis assembly (2305) includes a transparent material, the tissue sample can be additionally visually analyzed during this period.

[0117] To transfer a tissue sample to tissue sample holder (2300), sample management assembly (2310) is rotated to Fig.18 and Fig.19 To transition sample management assembly (2310) to the tissue delivery position, rotatable member (2312) is indexed to align delivery portion (2318) with cutter channel (2308). In particular, as shown in FIG. Fig.19As seen in FIG, rotating member (2112) is rotated to align opening (2319) of transport portion (2318) with cutter channel (2308). With opening (2319) of transport portion (2318) aligned with cutter channel (2308), tissue samples may freely pass through sample management assembly (2310) where they are deposited in tissue sample chamber (2346) under the influence of a vacuum delivered from tube (2020) via port (2304) in housing (2302).

[0118] Once the tissue sample has been collected in the tissue sample holder (2300), the sample management assembly (2310) can be rotated again to convert back to the tissue blocking position described above. It should be understood that the sample management assembly (2310) can be rotated in any direction to convert between the tissue blocking position and the tissue delivery position. In addition, the operator can repeat the procedure of collecting samples, analyzing samples, and then delivering them to the tissue sample holder (2300) as needed until the biopsy procedure is completed, or until the tissue sample chamber (2346) is filled to capacity with tissue samples. In the event that the tissue sample chamber (2346) is filled to capacity, the basket (2330) can be removed from the housing (2302) and emptied and reinserted, or replaced with a brand new basket (2330). Although the tissue analysis assembly (2305) is described herein as being usable in conjunction with the sample management assembly (2310), it should be understood that such limitation is not intended. For example, in some aspects, the sample analysis component (2305) can be readily usable with the sample management component (1310) described above or any other sample management component described herein. Of course, given the teachings herein, it will be apparent to one of ordinary skill in the art that various other methods and / or procedures may be used.

[0119] Fig. 20 An optional rotatable member (2512) is depicted that can be easily incorporated into the sample management assembly (2310) described above or any other sample management assembly described herein. The rotatable member (2512) is substantially the same as the rotatable member (2312) described above, except that the pivoting screen body (2513) of the rotatable member (2512) only extends a portion of a circle rather than a complete circle. In particular, the rotatable member (2512) of the present aspect includes a pivoting screen body (2513) and a rotating member (2520) extending distally from the pivoting screen body (2513). The rotating member (2520) includes a toothed portion (2521) and is substantially the same as the rotating member (2320) described above, such that the rotating member (2520) will not be described in further detail herein.

[0120] The pivoting screen body (2513) includes a generally triangular cross-sectional shape extending radially outward from the axial center of the rotating ember (2520). The pivoting screen body (2513) includes a filter belt (2516) disposed near the outer edge of the pivoting screen body (2513). The filter belt (2516) is substantially similar to the filter portion (2316) described above with respect to the rotatable member (2312), except that the filter belt (2516) only extends a small angular distance relative to the filter portion (2316). Like the filter portion (2316), the filter belt (2516) includes a plurality of openings (2517) that are configured to allow vacuum and fluid flow, but prevent the flow of tissue samples. Thus, the rotatable member (2512) is configured to substantially prevent the flow of tissue samples to the tissue sample holder (2300) when the filter belt (2516) is aligned with the cutter channel (2308) of the sample analysis assembly (2305).

[0121] In use, rotatable member (2512) functions similarly to that described above with respect to rotatable member (2312). For example, rotatable member (2512) is rotated via rotation member (2520) to align filter belt (2516) with cutter channel (2307) of sample analysis assembly (2305) to place sample management assembly (2310) in a tissue occlusion state. However, because rotatable member (2512) omits structure similar to delivery portion (2318) of rotatable member (2312), rotatable member (2512) is merely rotated without being aligned with cutter channel (2307) to allow a tissue sample to be delivered to tissue sample holder (2300), thereby transitioning sample management assembly (2310) to a delivery state.

[0122] As described above, in some cases, it may be desirable to collect tissue samples in a single batch chamber. However, when collecting tissue samples in batches, it may still be desirable to perform at least some tissue analysis as each tissue sample is collected. Therefore, an alternative configuration may be desirable to perform analysis of a single tissue sample in real time during a breast biopsy procedure.

[0123] In addition, in some cases, tissue sample may show the trend of adhesion or adhesion to the different surfaces of tissue sample holder, and these tissue sample holders are similar to the tissue sample holder described in top and / or U.S. Publication No. 2014 / 0039343.Therefore, in some respects, it may be desirable to include the feature for handling tissue, and these features overcome the trend on the surface that tissue sample adheres and / or adheres to tissue sample holder.Various optional sample management components are described below.This type of optional sample management component is configured to include the feature of batch storage and single tissue sample analysis for tissue sample.In addition, this type of optional sample management component is configured to include the feature of handling tissue sample, to overcome the problem relevant to the tissue characteristic described in top and / or U.S. Publication No. 2014 / 0039343.

[0124] It should be understood that the various optional tissue management components described below can be easily incorporated into the biopsy device and any of the probes described above and / or in U.S. Publication No. 2014 / 0039343. It should also be understood that the various components of the probe described above and / or in U.S. Publication No. 2014 / 0039343 can be easily incorporated into the optional sample management components described below. In view of the teachings herein, various suitable ways in which the above and below teachings can be combined will be clear to those of ordinary skill in the art. It should also be understood that the following teachings can be easily combined with various teachings of the references cited herein.

[0125] Figure 21 to Figure 22 An optional sample management assembly (3310) is shown that can be easily incorporated into any probe described above and / or in U.S. Publication No. 2014 / 0039343. The sample management assembly (3310) is incorporated into a tissue sample holder (3300) that is substantially similar to the tissue sample holder described above and / or in U.S. Publication No. 2014 / 0039343. It should be understood that unless otherwise specifically stated herein, the tissue sample holder (3300) is the same as the tissue sample holder described above and / or in U.S. Publication No. 2014 / 0039343. For example, the tissue sample holder (3300) of the present aspect is configured to store tissue samples in a single batch tissue sample chamber (3346). As Fig. 22 As best seen in , tissue sample holder ( 3300 ) includes a sample basket ( 3330 ), a sample management assembly ( 3310 ), and a housing ( 3302 ).

[0126] The sample basket (3330) is substantially similar to the sample baskets (1330, 2330) described above and / or in U.S. Publication No. 2014 / 0039343. For example, the basket (3330) is generally configured to hold multiple tissue samples in a single tissue sample chamber (3346). As can be seen, the basket (3330) includes a handle (3332) and a proximal wall (3334). The handle (3332) extends proximally from the proximal wall (3334) and is configured to be grasped by an operator to manipulate the basket (3330). As will be described in more detail below, the handle (3332) of the present aspect is additionally configured to provide a fluid channel function. The proximal wall (3334) defines a channel (not shown) along the outer edge of the distal side of the proximal wall (3334). The channel is configured to receive at least a portion of housing (3302) to fluidly seal the proximal end of tissue sample holder (3300) when basket (3330) is disposed in housing (3302). Although not shown, it will be appreciated that the channel may be provided with a gasket or other sealing element to further facilitate sealing between basket (3330) and housing (3302).

[0127] A pair of side walls (3344) and a lower floor (3340) extend distally from the proximal wall (3334). In the present aspect, the side walls (3344) and the lower floor (3340) are defined by a single semicircular shaped member. However, it should be understood that in other aspects, the side walls (3334) and the lower floor (3340) are more discretely defined by a square or rectangular cross-section. Although not shown, it should be understood that the basket (3330) of the present aspect includes an intermediate floor (not shown) disposed above the lower floor (3340), as similarly described above with respect to baskets (1330, 2330).

[0128] The distal wall (3336) is disposed at the distal end of the basket (3330). The distal wall (3336) of the present aspect defines a semicircular shape configured to receive at least a portion of the sample management assembly (3310), as will be described in more detail below. The distal wall (3336), the proximal wall (3334), the side wall (3344), and the intermediate floor together define a tissue sample chamber (3346). The tissue sample chamber (3346) is generally configured to receive a plurality of tissue samples therein. In the present aspect, the tissue sample chamber (3346) is configured to receive any number of tissue samples between about 20 and about 50. Of course, in other aspects, the tissue sample chamber (3346) may be configured to receive any other suitable number of tissue samples.

[0129] The outer cover (3302) of the present aspect is substantially similar to the outer covers (1302, 2302) described above. For example, the outer cover (3302) of the present aspect includes a generally hollow cylindrical shape configured to receive the basket (3330) and the sample management assembly (3310). However, unlike the outer covers (1302, 2302) described above, the outer cover (3302) of the present aspect is directly connected to the tube (3020) to directly provide a vacuum to the outer cover (3302). Although the outer cover (3302) of the present aspect is shown as being directly connected to the tube (3020), it should be understood that such limitation is not intended. For example, in some aspects, the tube (3020) is connected to the outer cover (3302) and the rest of the tissue sample holder (3300), as described above with respect to the tissue sample holder (1300, 2300).

[0130] Sample management component (3310) such as Fig.23 . As can be seen, sample management assembly (3310) generally includes a sample receiving portion (3312) and a drive portion (3320) extending proximally from sample receiving portion (3312). Sample receiving portion (3312) has a shape generally characterized by a triangular prism having a rounded top that corresponds to the cylindrical shape of housing (3302). Sample receiving portion (3312) of the present aspect comprises a substantially transparent material. The transparency of sample receiving portion (3312) is generally sufficient to allow visual analysis of a tissue sample received therein.

[0131] The sample receiving portion (3312) includes two sample chambers (3314, 3316) positioned adjacent to each other. Each sample chamber (3314, 3316) extends longitudinally through the sample receiving portion (3312) from one end to the other, such that each sample chamber (3314, 3316) opens on the proximal end and the distal end of the sample receiving portion (3312). The longitudinal extension of each sample chamber (3314, 3316) is generally along an axis that is parallel to the longitudinal axis of the cutter of any one or more probes described above and / or in U.S. Publication No. 2014 / 0039343. In addition, the longitudinal extension of each sample chamber (3314, 3316) is generally parallel but offset relative to the rotational axis defined by the drive portion (3320).

[0132] Each sample chamber (3314, 3316) is generally configured to receive a single tissue sample therein. As will be described in more detail below, each sample chamber (3314, 3316) is generally positioned to selectively align with the cutter of one or more probes described above and / or in U.S. Publication No. 2014 / 0039343 when the sample receiving portion (3312) rotates via the drive portion (3320). When the selected chamber (3314, 3316) is aligned with any one or more cutters of the previously described probe, the misaligned chamber (3316, 3314) acts as a vacuum channel, so that the fluid first passes through the cutter and enters the selected chamber (3314, 3316), and then enters the misaligned chamber (3316, 3314). As will also be described in more detail below, the fluid channel feature of the handle (3332) of the sample basket (3330) facilitates the passage of fluid in this way.

[0133] It should be understood that any of the probes used in the present invention and / or U.S. Publication No. 2014 / 0039343 can be modified for use with the sample management assembly (3310). For example, Fig.24 As can be seen in the drawings, the sample receiving portion (3312) is typically positioned proximally from the proximal end of any probe. To accommodate this positioning while maintaining communication with the cutter of a given probe, the particular probe used includes an extension member, tube, cannula, or device extending proximally from the proximal end of the probe. As will be described in more detail below, this configuration allows the sample receiving portion (3312) to eject a tissue sample distally out of a given sample chamber (3314, 3316).

[0134] The drive portion (3320) generally includes a cylindrical shaft (3321) and a gear portion (3322). The shaft (3321) extends distally from the sample receiving portion (3312) and is integrally constructed therewith. The gear portion (3322) is disposed on the distal end of the shaft (3321). The gear portion (3322) is generally configured to interact with corresponding components of the biopsy device to allow the sample management assembly (3310) to selectively rotate around a rotation axis defined by the distal extension of the cylindrical shaft (3321). As will be described in more detail below, this selective rotation of the sample management assembly (3310) allows each chamber (3314, 3316) of the sample receiving portion (3312) to be indexed to communicate with a cutter of one or more probes described above and / or in U.S. Publication No. 2014 / 0039343.

[0135] Figure 24 to Figure 27 An exemplary operation of sample management assembly (3310) to deposit a plurality of tissue samples into sample basket (3330) is shown. In particular, as shown in FIG. Fig.24 and Fig.25As can be seen, sample management assembly (3310) is initially rotated into position relative to any one or more probes to align sample chamber (3316) with the cutter. Rotation of sample management assembly (3310) is accomplished via drive portion (3320) that is actuated by some drive component of the biopsy device, as described above and / or in U.S. Publication No. 2014 / 0039343.

[0136] Once the sample chamber (3316) is Fig.24 In the embodiment of the present invention, the sample management assembly (3310) is configured to receive a first tissue sample. In particular, in order to receive the first tissue sample, a cutter of any one or more probes described above and / or in U.S. Publication No. 2014 / 0039343 is used to cut off the first tissue sample. A vacuum is applied to the tube (3020) to cause the first tissue sample to be transported through the cutter and into the sample chamber (3316). During this process, the vacuum passes through the tube (3020) and enters the sample basket (3330). Once entering the sample basket (3330), the vacuum enters the chamber (3314). The vacuum is then transferred from the chamber (3314) to the chamber (3316) via a fluid passage (3333) defined by the handle (3332) of the sample basket (3330). Finally, the vacuum reaches the cutter through the sample chamber (3316). It will therefore be appreciated that sample chambers (3314, 3316) and fluid passageway (3333) collectively define a fluid passage from tube (3020) to cutter, such as Fig.24 As indicated by the arrow in .

[0137] Once the first tissue sample is received in sample chamber (3316), the transparency of sample receiving portion (3312) and the transparency of outer cup (3302) allow an operator to analyze the first tissue sample by visually inspecting the sample. Additionally, it should be appreciated that in some aspects, sample chambers (3314, 3316) are equipped with sensors, such as bioimpedance sensors similar to those described above with respect to probe (2100). In still other aspects, it will be apparent to one of ordinary skill in the art in view of the teachings herein that sample chambers (3314, 3316) are equipped with any other suitable sample analysis features.

[0138] Once the operator has fully analyzed the first tissue sample received in sample chamber (3316), sample management assembly (3310) may then be reconfigured to receive a second tissue sample. Fig.26 and Fig. 27As best seen in FIG. 3 , sample management assembly (3310) is reconfigured to receive a second tissue sample by rotating sample management assembly (3310) via drive portion (3320). The rotation aligns sample chamber (3314) with the cutter of any one or more of the probes described above. Thus, sample receiving portion (3312) is positioned such that a second tissue sample can be received in sample chamber (3314).

[0139] To receive a second tissue sample, vacuum is again applied to tube (3020) to transport the second tissue sample through the cutter and into sample chamber (3314). This involves a pneumatic circuit that is substantially similar to that described above with respect to Fig.24 3300), the vacuum passes through the entry chamber (3316). The vacuum is then transferred from the chamber (3316) to the chamber (3314) via the fluid passage (3333) defined by the handle (3332) of the sample basket (3330). Finally, the vacuum passes through the sample chamber (3314) to the cutter. Because the sample chamber (3316) is already occupied by a tissue sample, it should be understood that the present pneumatic circuit has the dual purpose of receiving a second tissue sample in the sample chamber (3314) and ejecting a first tissue sample from the sample chamber (3314) (e.g., Fig.26 ). Thus, when sample chamber (3314) receives the second tissue sample, the first tissue sample is ejected from sample chamber (3316) substantially simultaneously. It should be appreciated that when the first tissue sample is ejected from sample chamber (3316), the first tissue sample is deposited in sample basket (3330) for storage until completion of the biopsy procedure or until sample basket (3330) is emptied.

[0140] Once the second tissue sample is received in the sample chamber (3314), the second tissue sample may be analyzed as discussed above with respect to the first tissue sample. At the conclusion of the tissue analysis, the sample management assembly (3310) may be returned to the sample chamber (3314). Fig.24 and Fig.25 . Additional tissue samples can then be obtained and analyzed by repeating the above procedure. Thus, by alternating between Fig.24 and Fig.25 ,as well as Fig.26 and Fig. 27 The sample management component (3310) between the configurations shown in the figure can be used to obtain and analyze multiple tissue samples. The operator can use this process until the desired number of tissue samples are obtained and analyzed.

[0141] In some cases, challenges may be encountered in manipulating tissue samples. For example, a generally moist tissue sample may sometimes exhibit an attractive force to relatively dry surfaces within components of a biopsy device or other components described herein. In other words, a tissue sample may sometimes be sticky or tacky. Therefore, in some devices, it may be desirable to include a mechanism suitable for manipulating tissue while overcoming the attractive forces sometimes encountered by a tissue sample.

[0142] Figures 16 to 18 An exemplary optional tissue sample holder (4300) is shown that can be easily incorporated into any of the probes described above. The tissue sample holder (4300) includes a sample management assembly (4310) that is generally configured to provide single tissue sample analysis while overcoming certain difficulties associated with manipulating tissue samples that have a tendency to adhere to surfaces within the tissue sample holder (4300). It should be understood that unless otherwise specifically stated herein, the tissue sample holder (4300) is the same as the tissue sample holders (1300, 2300, 3300) described above. For example, the tissue sample holder (4300) of the present aspect is configured to store tissue samples in a single batch sample chamber (4346). As Fig.29 As best seen in FIG. 4 , tissue sample holder (4300) includes a rotating member (4180), a sealing member (4170), a sample basket (4330), a sample management assembly (4310), and a housing (4302). The rotating member (4180) is substantially identical to the rotating member described in U.S. Publication No. 2014 / 0039343, except that the rotating member (4180) of the present aspect includes a second gear (4184) in place of the gripping feature (184) described in U.S. Publication No. 2014 / 0039343. As will be described in more detail below, the second gear (4184) is generally configured to drive various components of the sample management assembly (4310) when the biopsy device acts on the first gear (4182) of the rotating member (4170). Sealing member (4170) of the present aspect is substantially identical to the sealing member described in US Publication No. 2014 / 0039343, such that additional details of sealing member (4170) will not be described herein.

[0143] The sample basket (4330) is substantially similar to the sample baskets (1330, 2330, 3330) described above. For example, the basket (4330) is generally configured to hold multiple tissue samples in a single sample chamber (4346). As can be seen, the basket (4330) includes a handle (4332) and a proximal wall (4334). The handle (4332) extends proximally from the proximal wall (4334) and is configured to be grasped by an operator to manipulate the basket (4330). The proximal wall (4334) is configured to seal with the inner diameter of the outer cover (4302) along the outer edge of the proximal wall (4334). Therefore, it should be understood that in some aspects, the outer edge of the proximal wall (4334) may include certain sealing features, such as gaskets, sealing members, channels, etc. The proximal wall (4334) further includes an axial opening (4343) extending through at least a portion of the proximal wall (4334). The shaft opening (4343) of this aspect comprises a countersunk hole that extends through only a portion of the proximal wall (4334). It should be understood that in other aspects, the shaft opening (4343) optionally extends through the entire thickness of the proximal wall (4334). As will be described in more detail below, the shaft opening (4343) is generally positioned and configured to support various components of the sample management assembly (4310).

[0144] A pair of side walls (4344) and a lower floor (4340) extend distally from the proximal wall (4334). In the present aspect, the side walls (4344) and the lower floor (4340) are defined by a single semicircular shaped member. However, it should be understood that in other aspects, the side walls (4334) and the lower floor (4340) are more discretely defined by a square or rectangular cross-section. Although not shown, it should be understood that in some aspects, the basket (4330) further includes an intermediate floor (not shown) or other vacuum control features disposed above the lower floor (4340), as described above and / or similarly with respect to baskets (1330, 2330) in U.S. Publication No. 2014 / 0039343. In the case where such an intermediate floor is incorporated into the basket (4330), it should be understood that these aspects may include ventilation openings or other features to direct fluid flow through the basket (4330).

[0145] The distal wall (4336) is disposed at the distal end of the basket (4330). The distal wall (4336) of the present aspect defines a semicircular shape configured to receive at least a portion of the sample management assembly (4310), as will be described in more detail below. The distal wall (4336), the proximal wall (4334), the side wall (4344), and the intermediate floor together define a tissue sample chamber (4346). The tissue sample chamber (4346) is generally configured to receive a plurality of tissue samples therein.

[0146] In one aspect, the tissue sample chamber (4346) is configured to receive any number of tissue samples from about 1 to about 50. In another aspect, the tissue sample chamber (4346) is configured to receive any number of tissue samples from about 10 to about 50. In one aspect, the tissue sample chamber (4346) is configured to receive any number of tissue samples from about 20 to about 50. In one aspect, the tissue sample chamber (4346) is configured to receive any number of tissue samples from about 25 to about 50.

[0147] The housing (4302) of the present aspect is substantially similar to the housings described above. For example, the housing (4302) of the present aspect includes a generally hollow cylindrical shape configured to receive the basket (4330) and the sample management assembly (4310). However, unlike the housings (1302, 2302, 3302) described above, the housing (4302) of the present aspect includes certain features configured to engage the sample management assembly (4310) or support its operation. For example, Fig.32 and Fig.33 As best seen in FIG. 4 , the housing (4302) includes a distal wall (4303) disposed proximal to the distal end of the housing (4302). The distal wall (4303) includes a cutter hole (4304), an axis opening (4305), and an axis pin (4306). The cutter hole (4304) is configured to communicate with a cutter of any of the probes described above and / or in U.S. Publication No. 2014 / 0039343 via a sealing member (4170). Thus, the cutter hole (4304) provides an opening that allows a tissue sample to pass through the distal wall (4303) so as to be manipulated via the sample management assembly (4310). Although not shown, it should be understood that in some aspects, the cutter hole (4304) includes features configured to facilitate a seal between the cutter hole (4304) and the sealing member (4170).

[0148] The shaft opening (4305) extends completely through the distal wall (4303). The shaft opening (4305) generally comprises a circular shape that is configured to provide an opening for at least a portion of certain drive components of the sample management assembly (4310) to pass through the distal wall (4303). As will be described in more detail below, this feature of the distal wall (4303) allows rotational forces to be transmitted through the distal wall (4303) to drive various components of the sample management assembly (4310).

[0149] The axle pin (4306) typically includes a cylindrical protrusion extending distally from the distal wall (4303). As with the axle opening (4305) described above, the axle pin (4306) is typically associated with certain drive components of the sample management assembly (4310). As will be described in more detail below, the axle pin (4306) provides a mechanical ground for certain drive components of the sample management assembly (4310) to be rotatably attached thereto. The axle opening (4305) and the axle pin (4306) are typically spaced apart from each other to support such an arrangement.

[0150] Fig.32 and Fig.33 The interior of the housing (4302) is shown. As can be seen, the interior of the housing (4302) includes a first rotation lock (4307) and a second rotation lock (4309). Each rotation lock (4307, 4309) is generally configured to engage a portion of the sample management component (4310). As will be described in more detail below, such engagement prevents rotation of certain components of the sample management component (4310) so that the sample management component (4310) can manipulate the tissue sample. In accordance with this purpose, the first rotation lock (4307) includes a protrusion (4308) that is generally configured to correspond to certain geometric features of the sample management component (4310), as will be described in more detail below.

[0151] like Fig.33 As best seen in FIG. 4 , each rotation lock (4307, 4309) extends proximally from distal wall (4303) through substantially the entire length of housing (4302), wherein each rotation lock (4307, 4309) terminates just distal to the proximal end of housing (4302). Additionally, each rotation lock (4307, 4309) extends inwardly from the inner diameter of housing (4302). As will be described in greater detail below, this proximal and inward extension of each rotation lock (4307, 4309) is configured to allow each rotation lock (4307, 4309) to engage certain geometric features of sample management assembly (4310).

[0152] Sample management component (4310) such as Fig.344320). As can be seen, the sample management assembly (4310) includes a series of alternating cam plates (4312, 4320). Typically, the sample management assembly (4310) includes a plurality of rotating cam plates (4312) and a plurality of fixed cam plates (4320). In this aspect, each cam plate (4312, 4320) of a given type is typically identical to other cam plates (4312, 4320) of the same type. Thus, the sample management assembly (4310) of this aspect is comprised of two different cam plates (4312, 4320) repeated in an alternating manner. Although only two different cam plates (4312, 4320) are used in this aspect, it should be understood that in other aspects, many different cam plates (4312, 4320) are incorporated into the sample management assembly (4310) without departing from the functionality described below. All of the cam plates (4312, 4320) are axially connected via a drive shaft (4316). As will be described in greater detail below, drive shaft (4316) is generally configured to rotate rotating cam plate (4312) while maintaining stationary cam plate (4320) fixed within housing (4302).

[0153] A single rotating cam plate (4312) such as Fig.35 As shown in . As can be seen, the rotating cam plate (4312) generally includes a cylindrical or coin-shaped configuration. The rotating cam plate (4312) includes a tissue opening (4313) and an axis opening (4314). The tissue opening (4313) includes a U-shaped opening. As will be described in more detail below, each tissue opening (4313) of each rotating cam plate (4312) is aligned to jointly define a tissue manipulation feature (4319). Therefore, the size of each tissue opening (4313) is generally set to receive a single tissue sample. Optionally, in other aspects, the size of each tissue opening (4313) is set to receive multiple tissue samples while still maintaining the same functionality described in more detail below.

[0154] The shaft opening (4314) includes a generally circular shape having a flat surface (4315) on an adjacent side of the shaft opening (4314). As will be described in more detail below, the shaft opening (4314) is configured to correspond to the shape of the outer diameter of the drive shaft (4316). Therefore, it should be understood that the shaft opening (4314) is configured to cooperate with the drive shaft (4316). In addition, due to the presence of the flat surface (4315), the shaft opening (4314) is configured to engage the drive shaft (4316) so that rotation of the drive shaft causes rotation of the rotating cam plate (4312). It should be understood that although the shaft opening (4314) is shown as having a specific geometric shape, any other suitable irregular geometric shape can be used. For example, in some aspects, the shaft opening (4314) is configured with a starburst pattern that is configured to engage corresponding splines on the exterior of the drive shaft (4316). Similarly, in other aspects, shaft opening (4314) is configured with a keyway configured to engage a corresponding key protruding from an exterior of drive shaft (4316). Of course, any other suitable geometry for shaft opening (4314) may be used as would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0155] Fixed cam plate (4320) as Fig.36 4329. As can be seen, the fixed cam plate (4320) includes a cam portion (4322), a locking portion (4324), and an axis opening (4329). The cam portion (4322) extends about 275° around the outer circumference of the cam plate (4320) before switching to the locking portion (4324). In other aspects, the particular amount of the outer circumference of the cam plate (4320) through which the cam portion (4322) extends can be anywhere between about 270° to about 330°. As the cam portion (4322) extends around the outer circumference of the cam plate (4320), the cam portion (4322) gradually extends outward. In other words, as the cam portion (4322) extends in a clockwise direction around the outer circumference of the cam plate (4320), the radius of the cam plate (4320) increases. As will be described in greater detail below, the cam portions (4322) cause the effective size of the tissue opening (4313) of the rotating cam plates (4312) to decrease as each rotating cam plate (4312) rotates relative to each fixed cam plate (4320). At the maximum radius of the cam portions (4322), the radius of the fixed cam plates (4320) is substantially equal to the radius of the tissue opening (4313) of the rotating cam plates (4312), such that the effective size of the tissue opening (4313) will be substantially zero when aligned with the maximum radius of the cam portions (4322).

[0156] The locking portion (4324) extends outward from the center of the rotating cam plate (4320) to a radius that is substantially equal to the inner radius of the outer cover (4302). The locking portion (4324) of this aspect includes a first lock opening (4326) and a second lock opening (4328). The lock openings (4326, 4328) are generally configured to receive the rotation locks (4307, 4309) of the outer cover. In particular, the first lock opening (4326) is configured to receive the protrusion (4308) of the first rotation lock (4307). In addition, the first lock opening (4326) extends inward from the flat portion (4327) of the locking portion (4324) so ​​that the flat portion (4327) is adjacent to the first rotation lock (4307). Similarly, the second lock opening (4328) is configured to receive the second rotation lock (4309) of the outer cover (4302). The engagement between the lock openings (4326, 4328) and the rotation locks (4307, 4309) holds the locking portion (4324) in a fixed position. As will be described in more detail below, this feature allows the rotating cam plate (4312) to rotate relative to the fixed cam plate (4320) to manipulate the tissue sample.

[0157] The shaft opening (4329) of the fixed cam plate (4320) is generally circular in shape. Similar to the shaft opening (4314) described above with respect to the rotating cam plate (4312), the shaft opening (4329) of the fixed cam plate (4320) is configured to receive the drive shaft (4316). However, because the shaft opening (4329) of the fixed cam plate (4320) is circular in shape and features similar to the flat surface (4315) are omitted, the drive shaft (4316) is free to rotate relative to the shaft opening (4329). Because each fixed cam plate (4320) is generally fixed relative to the housing (4302), it should be understood that each fixed cam plate (4320) is generally used to stabilize the drive shaft (4316) when the drive shaft rotates within the shaft opening (4329), thereby maintaining the axial position of the drive shaft (4316).

[0158] Fig.37A partial view of a drive shaft (4316) is shown with some cam plates (4312, 4320) attached to the drive shaft (4316) and some cam plates (4312, 4320) removed from the drive shaft (4316). As can be seen, the drive shaft (4316) includes a generally cylindrical structure extending through a length greater than the combined length of the cam plates (4312, 4320). The generally cylindrical shape of the drive shaft (4316) is limited on both sides of the drive shaft (4316) by a pair of flat surfaces (4317). The flat surfaces (4317) are generally configured to key with corresponding flat surfaces (4315) of the shaft opening (4314) of each rotating cam plate (4312). Therefore, the drive shaft (4316) is configured to transmit torque to each rotating cam plate (4312), thereby causing each rotating cam plate (4312) to rotate.

[0159] Drive shaft (4316) further includes a gear (4318) integrally formed in the distal end of drive shaft (4316). Gear (4318) is configured to engage with rotation member (4180) to transmit rotational force from the biopsy device to drive shaft (4316). Fig.38 As can be seen in FIG, when the sample management assembly (4310) is fully assembled within the housing (4302), the drive shaft (4316) protrudes distally through the shaft opening (4305) of the distal wall (4303) of the housing (4302). Accordingly, the rotation member (4180) is rotationally mounted on the pin (4306) of the housing (4302) such that the rotation member (4180) can rotate relative to the housing (4302). The rotation member (4180) is thereby positioned to engage the gear (4318) of the drive shaft (4316) to rotate the drive shaft (4316) relative to the housing (4302).

[0160] Fig.39 The sample management component (4310) is shown relative to Fig.38 , fully assembled in housing (4302) in the direction opposite to the view shown in FIG. 1 . As can be seen, when sample management assembly (4310) is disposed within housing (4302), each fixed cam plate (4320) is held in place by rotation locks (4307, 4309) of housing (4302). Fixed cam plates (4320) correspondingly maintain the axial position of drive shaft (4316) such that drive shaft (4316) is aligned with shaft opening (4305) of housing (4302). Rotating cam plates (4312) are correspondingly held in place by drive shaft (4316) such that each tissue opening (4313) is configured to align with cutter aperture (4304) of housing (4302) (assuming that rotating cam plates (4312) are rotated to Fig.39 ) as shown in the figure.

[0161] Figure 40 to Figure 43 An exemplary mode of operation of the sample management component (4310) is shown. Fig.40 As can be seen in Figure 4, sample management assembly (4310) initially begins with each tissue opening (4313) positioned to align with the 12 o'clock position. Although not shown, it should be understood that in this position, each tissue opening (4313) of rotating cam plates (4312) is aligned with cutter aperture (4304) of housing (4302). Thus, the combined tissue manipulation features (4319) of all rotating cam plates (4312) are aligned with cutter aperture (4304), thus placing sample management assembly (4310) in a configuration to receive a tissue sample.

[0162] By rotating the drive shaft (4316) and thereby rotating the rotating cam plate (4312), the organizer assembly (4310) can be switched to Fig.40 12 o'clock position shown in . Once positioned, a biopsy device equipped with any of the probes described above and / or in U.S. Publication No. 2014 / 0039343 can be used to obtain a tissue sample. The tissue sample can then be transferred through the cutter, through the distal wall (4303) of the outer cover (4302) and into the tissue manipulation feature (4319) defined by the rotating cam plate (4312). Once the tissue sample is placed therein, the operator can inspect the tissue sample by visual inspection. It should be understood that, like the outer cover similar to the description above, the outer cover (4302) is transparent. In addition, in other aspects, the sample management component (4310) is optionally equipped with various other tissue analysis features described herein.

[0163] Once the operator has completed the analysis, he or she may wish to deposit the tissue sample into sample basket (4330) and thereby prepare sample management assembly (4310) to receive another tissue sample. To deliver the tissue sample into sample basket (4330), rotating cam plate (4312) is rotated via drive shaft (4316). In particular, as shown in FIG. Figure 41 to Figure 43 It can be seen that the drive shaft (4316) rotates in a counterclockwise direction via the rotating member (4180) to drive each rotating cam plate (4312) in a rotational motion relative to each fixed cam plate (4320). As each rotating cam plate (4312) rotates relative to each fixed cam plate (4320), the effective size of the tissue manipulation feature (4319) gradually decreases due to the gradual increase in the radius of each fixed cam plate (4320).

[0164] Once each rotating cam plate (4312) rotates to Fig.42, the tissue sample can fall into the sample basket (4330) under gravity. However, depending on the specific characteristics of the tissue sample, in some cases the tissue sample may be sensitive to light adhesion, such that gravity is insufficient to release the tissue sample into the sample basket (4330). Additionally, in some uses, the tissue sample holder (4300) can be oriented such that gravity can release the tissue sample into the sample basket (4330). Fig.42 In such cases, the weight of the tissue sample will not force the tissue sample into the sample basket (4330), regardless of the characteristics of the tissue sample. In such cases, the rotation of the rotating cam plate (4312) can continue relative to the fixed cam plate (4320) until Fig.43 Position shown.

[0165] Once the rotating cam plate (4312) has been rotated to Fig.43 , the effective size of the tissue manipulation feature (4319) is reduced to nearly zero, such that each tissue opening (4313) of each rotating cam plate (4312) is substantially disposed within the fixed cam plate (4320). Fig.43 As the fixed cam plates (4320) are rotated to the position shown in FIG. 1 , each fixed cam plate (4320) will begin to engage the tissue sample and thereby mechanically force the tissue sample away from the rotating cam plate (4312). Once the tissue sample is separated from the rotating cam plate (4312), the tissue sample will fall into the sample basket (4330) or remain slightly adhered to the fixed cam plate (4312). The rotating cam plate (4312) can then continue to rotate back to the position shown in FIG. Fig.40 , where the sample handling feature (4319) has cleared the tissue sample and is ready to receive another tissue sample.

[0166] Once the sample handling feature (4319) has been cleared through the above sequence by rotation of the rotating cam plate (4312), another tissue sample may be collected and deposited in the sample basket (4330) by following the same sequence described above. The sequence may then be repeated until the sample basket (4330) is full, or until the operator completes the biopsy procedure.

[0167] Figure 45 to Figure 46An optional sample management assembly (5310) is shown that can be easily incorporated into any of the probes described above and / or in U.S. Publication No. 2014 / 0039343. The sample management assembly (5310) is incorporated into a tissue sample holder (5300) that is substantially similar to the tissue sample holders (1300, 2300) described above. It should be understood that unless otherwise specifically stated herein, the tissue sample holder (5300) is the same as the tissue sample holders (1300, 2300) described above. For example, the tissue sample holder (5300) of the present aspect is configured to store tissue samples in a single batch tissue sample chamber (5346). As Fig.45 As best seen in FIG. 1 , the tissue sample holder (5300) includes a sample basket (5330), a sample management assembly (5310), and a housing (5302). The sample basket (5330) is substantially similar to the sample baskets (1330, 2330) described above. For example, the basket (5330) is generally configured to hold multiple tissue samples in a single tissue sample chamber (5346). As can be seen, the basket (5330) includes a handle (5332) and a proximal wall (5334). The handle (5332) extends proximally from the proximal wall (5334) and is configured to be grasped by an operator to manipulate the basket (5330). As will be described in more detail below, the handle (5332) of the present aspect is additionally configured to provide a fluid channeling function. The proximal wall (5334) defines a channel (not shown) along an outer edge of a distal surface of the proximal wall (5334). The channel is configured to receive at least a portion of housing (5302) to fluidly seal the proximal end of tissue sample holder (5300) when basket (5330) is disposed in housing (5302). Although not shown, it will be appreciated that the channel may be provided with a gasket or other sealing element to further facilitate sealing between basket (5330) and housing (5302).

[0168] A pair of side walls (5344) and a lower floor (5340) extend distally from the proximal wall (5334). In the present aspect, the side walls (5344) and the lower floor (5340) are defined by a single semicircular shaped member. However, it should be understood that in other aspects, the side walls (5334) and the lower floor (5340) are more discretely defined by a square or rectangular cross-section. Although not shown, it should be understood that in some aspects, the basket (5330) includes an intermediate floor (not shown) disposed above the lower floor (5340), as similarly described above with respect to baskets (1330, 2330).

[0169] The distal wall (5336) is disposed at the distal end of the basket (5330). The distal wall (5336) of the present aspect defines a semicircular shape configured to receive at least a portion of the sample management assembly (5310), as will be described in more detail below. The distal wall (5336), the proximal wall (5334), the side wall (5344), and the intermediate floor together define a tissue sample chamber (5346). The tissue sample chamber (5346) is typically configured to receive a plurality of tissue samples therein. In the present aspect, the tissue sample chamber (5346) is configured to receive any number of tissue samples between about 20 and about 50. Of course, in other aspects, the tissue sample chamber (5346) may be configured to receive any other suitable number of tissue samples.

[0170] The outer cover (5302) of this aspect is substantially similar to the outer cover (1302, 2302) described above. For example, the outer cover (5302) of this aspect includes a generally hollow cylindrical shape configured to receive a basket (5330) and a sample management assembly (5310). In addition, the outer cover (5302) of this aspect is substantially transparent to allow analysis of tissue samples through the outer cover (5302). However, unlike the outer covers (1302, 2302) described above, the outer cover (5302) of this aspect is directly connected to the tube (5020) to directly provide a vacuum to the outer cover (5302). Although the outer cover (5302) of this aspect is shown as being directly connected to the tube (5020), it should be understood that such a limitation is not intended. For example, in some aspects, the tube (5020) is connected to the outer cover (5302) and the rest of the tissue sample holder (5300), as described above with respect to the tissue sample holder (1300, 2300).

[0171] The sample management assembly (5310) is generally configured to selectively deposit tissue samples into the sample basket (5330) while overcoming difficulties associated with the tendency of tissue samples to slightly adhere or stick to surfaces. Figure 45 to Figure 47 As best seen in Figure 5, sample management assembly (5310) generally includes a sample receiving member (5312) and a release member (5320). The sample receiving member (5312) of the present aspect extends proximally from any of the probes described above and / or in U.S. Publication No. 2014 / 0039343. To allow analysis of any tissue sample received in the sample receiving member (5312), it should be understood that the sample receiving member (5312) is generally transparent. Thus, an operator can visually analyze tissue samples as they are collected in the sample receiving member (5312).

[0172] The sample receiving member (5312) of the present invention is directly connected to the cutter of any of the probes described above and / or in U.S. Publication No. 2014 / 0039343. In particular, Fig.47As can be seen in the figure, the distal end of the sample receiving member (5312) includes a sample channel (5313), which is configured to transfer the tissue sample to the inner chamber (5318) defined by the tissue receiving member (5312). In order to receive the tissue sample, the sample receiving member (5312) generally includes a hollow box or container with a substantially trapezoidal cross-sectional shape. In this aspect, the size of the inner chamber (5318) is generally set to receive at least one tissue sample. In other aspects, the size of the inner chamber (5318) is set to receive any suitable number of tissue samples. Optionally, in other aspects, the size of the inner chamber (5318) is set to closely approach the size of a single tissue sample, so that the size of the inner chamber (5318) is set to receive only a single tissue sample.

[0173] To complete the vacuum circuit between the cutter and the tube (5020), the sample receiving member (5312) includes a fluid filter (5314) disposed on the distal end of the sample receiving member (5312). The fluid filter (5314) includes a plurality of openings (5316) extending through the proximal end of the sample receiving member (5312). The openings (5216) are generally sized to allow fluid or tissue particles to flow therethrough, but to block tissue samples.

[0174] The underside of the sample receiving member (5312) includes an open bottom (5319). As will be described in more detail below, the open bottom (5319) is typically closed by a release member (5320). However, during operation of the sample management assembly (5310), the release member (5320) can move relative to the sample receiving member (5312) to expose the open bottom (5319). Therefore, it should be understood that the open bottom (5319) is typically selectively convertible between open and closed configurations to allow for the receipt and release of tissue samples.

[0175] The release member (5320) includes a blocking portion (5322) and an actuating portion (5326). The blocking portion (5322) includes a solid block having a generally triangular cross-sectional shape. The blocking portion (5322) defines an upper surface (5324) that is configured to correspond to the size and shape of the open bottom (5319) in the sample receiving member (5312). Although not shown, it should be understood that in some aspects, the upper surface (5324) includes certain sealing features configured to seal the open bottom (5319) relative to the interior of the housing (5302), such as gaskets, wiper seals, etc. In view of the teachings herein, various sealing features that can be incorporated into the upper surface (5324) will be clear to those of ordinary skill in the art.

[0176] The actuating portion (5326) of the release member (5320) extends distally from the blocking portion (5322). The actuating portion (5326) is generally configured to transmit torque to the blocking portion (5322), thereby rotating the blocking portion (5322). In particular, the distal end of the actuating portion (5326) is equipped with a gear (5328). The gear (5328) is configured to be driven by various components of the biopsy device, so that the biopsy device can drive the gear (5328) via the actuating portion (5326) to rotate the blocking portion (5322). As will be described in more detail below, this allows the biopsy device to selectively block and unblock the open bottom (5319) of the sample receiving member (5312) using the release member (5320).

[0177] By comparison Figure 46 to Figure 48 , an exemplary mode of operation of the sample management component (5310) can be seen. Fig.46 As can be seen in FIG, tissue management assembly (5310) initially begins in a tissue receiving state. In the tissue receiving state, release member (5320) is positioned such that blocking portion (5322) is positioned directly below open bottom (5319) of sample receiving member (5312) to substantially seal open bottom (5319).

[0178] When sample management assembly (5310) is in the tissue receiving state, one or more tissue samples may be transferred from the cutter and into the interior chamber (5318) of the sample receiving member (5312). In particular, a vacuum may be applied to tube (5020) and travel into housing (5302). The vacuum may then pass through opening (5316) of fluid filter (5314) and into the interior chamber (5318). Because the interior chamber (5318) is in direct communication with the cutter via sample passage (5313), the vacuum will pass through the interior chamber (5318) and into the cutter to transfer the one or more tissue samples into the interior chamber (5318).

[0179] Once one or more tissue samples are received within the internal chamber (5318), the operator can visually analyze the one or more tissue samples. It should be understood that in some aspects, the sample receiving member (5312) is also equipped with various other sample analysis features described herein (e.g., bioimpedance). Therefore, during this stage, any other sample analysis features can also be used to analyze the one or more tissue samples.

[0180] At the end of sample analysis, the operator may need to empty the contents of the internal chamber (5318) into the sample basket (5330). To empty the internal chamber (5318), the operator may selectively convert the sample management assembly (5310) into a sample basket (5330). Fig.48. In the sample release configuration shown in . In the sample release configuration, the release member (5320) rotates relative to the sample receiving member (5312) via the gear (5328) to expose the open bottom (5319) of the sample receiving member (5312). This will allow one or more tissue samples to fall into the sample basket (5330). In addition, if any tissue sample adheres or otherwise adheres to the upper surface (5324) of the blocking portion (5322), such sample will be removed when the blocking portion (5322) rotates relative to the sample receiving member (5312). In particular, because the upper surface (5324) is closely associated with the open bottom (5319), when the upper surface (5324) moves relative to the open bottom (5319), the sample receiving member (5312) will push any tissue sample off the upper surface (5324).

[0181] Once the one or more tissue samples have been deposited in sample basket (5330), sample management component (5310) may return to the Fig.46 Once the sample receiving state is returned, another tissue sample can be obtained by repeating the above process. The operator can repeat this process multiple times until the sample basket (5330) is full or until the biopsy procedure is completed.

[0182] The following examples relate to various non-exhaustive ways in which the teachings of this article can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be proposed at any time in this application or in subsequent applications of this application. There is no intention to abandon the claims. The following examples are provided for illustrative purposes only. It is expected that the various teachings of this article can be arranged and applied in many other ways. It is also expected that some changes may omit certain features mentioned in the following examples. Therefore, unless the inventor or the inventor's interested successor clearly indicates this at a later date, the aspects or features mentioned below should not be considered critical. If any claims proposed in this application or subsequent applications related to this application include additional features beyond those mentioned below, it should not be inferred that those additional features are added for any reason related to patentability.

[0183] Example 1

[0184] A biopsy device comprises: (a) a body; (b) a needle extending distally from the body; (c) a cutter movable relative to the needle and connected to the needle for delivering a tissue sample; and (d) an analysis area disposed proximal to the cutter and connected to the needle for receiving a tissue sample cut by the cutter for analysis by a user; (e) a valve disposed proximal to the analysis area and configured to alternate between an open configuration and a closed configuration; and (f) a tissue sample holder disposed proximal to the valve and fixedly attached to the body, wherein the valve is configured to allow analysis of a sample disposed in the analysis area when the valve is in the closed configuration and to allow the tissue sample to pass into the tissue sample holder when the valve is in the open configuration.

[0185] Example 2

[0186] A biopsy device as described in Example 1, wherein at least a portion of the tissue sample holder is releasably attached to the body.

[0187] Example 3

[0188] A biopsy device as described in Example 2, wherein the valve includes a removable filter, wherein the analysis area defines a single tissue sample chamber, and wherein the single tissue sample chamber is selectively connected to the tissue sample holder via selective movement of the filter.

[0189] Example 4

[0190] A biopsy device as described in Example 1, wherein the valve includes a first disc, wherein the first disc includes a plurality of outer filter portions and a plurality of openings, wherein each outer filter portion is positioned adjacent to a corresponding opening such that the plurality of outer filter portions and the plurality of openings form an alternating arrangement.

[0191] Example 5

[0192] The biopsy device of Example 4 wherein the first disk is configured to rotate relative to the cutter to continuously and alternately align the outer filter portions or openings with the cutter.

[0193] Example 6

[0194] A biopsy device as described in Example 5, wherein the valve is configured to provide the closed configuration when the outer filter portion of the first disk is aligned with the cutter, and wherein the valve is configured to provide the open configuration when the opening of the first disk is aligned with the cutter.

[0195] Example 7

[0196] A biopsy device as described in Example 6, wherein the valve further includes a second disk, wherein the second disk includes a plurality of vacuum chambers and a plurality of openings.

[0197] Example 8

[0198] A biopsy device as described in Example 7, wherein the first disk is fixedly fastened to the second disk.

[0199] Example 9

[0200] A biopsy device as described in Example 7, wherein each vacuum chamber of the second disk is configured to correspond to a corresponding outer filter portion of the first disk, and wherein each opening of the second disk is configured to correspond to a corresponding opening of the second disk.

[0201] Example 10

[0202] A biopsy device as described in Example 9, wherein the first disk further includes a filter ring, wherein the filter ring is defined by a plurality of vacuum openings extending through the first disk, and wherein each vacuum chamber of the second disk is configured to redirect vacuum flow through the filter ring of the first disk to a corresponding filter portion of the first disk.

[0203] Embodiment 11

[0204] A biopsy device as described in any one or more of Examples 1 to 10, wherein the analysis area includes a sample window, wherein the sample window is configured to allow visual analysis of a tissue sample.

[0205] Example 12

[0206] A biopsy device as described in any one or more of Examples 1 to 11, wherein the analysis area includes one or more electrodes, wherein the one or more electrodes are configured to detect impedance of a tissue sample.

[0207] Embodiment 13

[0208] A biopsy device as described in Example 1, wherein the tissue sample holder includes an outer cup and a bulk tissue sample basket removably disposed within the outer cup.

[0209] Embodiment 14

[0210] A biopsy device as described in Example 13, wherein the outer cup is releasably attached to the body.

[0211] Embodiment 15

[0212] The biopsy device of Example 13, wherein the bulk tissue sample basket defines a sample collection area, wherein the sample collection area is sized to receive from about 10 to about 50 tissue samples.

[0213] Example 16

[0214] A biopsy system comprising: (a) a biopsy device, wherein the biopsy device comprises: (i) a body, (ii) a needle, (iii) a cutter, wherein the needle extends from the body to collect a tissue sample using the cutter, (iv) a sample analyzer, wherein the sample analyzer comprises a door, wherein the door is configured to selectively prevent movement of the tissue sample within the sample analyzer for analysis, (v) a tissue sample holder, wherein the tissue sample holder is in communication with the sample analyzer, wherein the tissue sample holder is configured to receive the tissue sample after being analyzed by the sample analyzer; and (b) a control module, wherein the control module is in communication with the biopsy device.

[0215] Embodiment 17

[0216] A biopsy system as described in Example 16, wherein the door is configured to transition between open and closed positions to selectively block a tissue sample prior to delivery to the tissue sample holder.

[0217] Embodiment 18

[0218] A tissue sample holder as described in Example 16, wherein the analyzer further includes a sample lumen and a first detector connected to the control module, wherein the first detector protrudes into the first lumen, and wherein the first lumen is connected to the cutter to receive the tissue sample therein.

[0219] Embodiment 19

[0220] A tissue sample holder as described in Example 16, wherein the sample analyzer includes a tissue window, wherein the tissue window is disposed within the body of the biopsy device and is sealed relative to the exterior of the biopsy device.

[0221] Embodiment 20

[0222] A biopsy device comprising: (a) a body; (b) a needle; (c) a cutter; and (d) a tissue processing assembly in communication with the cutter, wherein the tissue processing assembly comprises: (i) a sample viewer integrated into the body, wherein the sample viewer is configured to allow analysis of a tissue sample when the tissue processing assembly receives the tissue sample from the cutter, (ii) a batch collection tray, wherein the batch collection tray is configured to receive a plurality of tissue samples, and (iii) a tissue door, wherein the tissue door is positioned between the tissue analysis feature and the batch collection tray, wherein the tissue door is configured to selectively control the transport of tissue samples between the sample viewer and the batch collection tray.

[0223] Embodiment 21

[0224] A tissue sample holder comprising: (a) an outer cover; (b) a tissue receiving member; and (c) a sample management assembly, wherein the sample management assembly includes a first plurality of plates and a second plurality of plates, wherein each plate of the first plurality of plates is alternately disposed between each plate of the second plurality of plates, wherein the first plurality of plates is configured to rotationally move relative to the second plurality of plates to manipulate a tissue sample into the tissue receiving member.

[0225] Embodiment 22

[0226] A tissue sample holder as described in Example 21, wherein each plate of the first plurality of plates includes a tissue recess, wherein the tissue recess of each plate is configured to align with the tissue recesses of other first plurality plates to define a tissue manipulation chamber.

[0227] Embodiment 23

[0228] A tissue sample holder as described in Example 22, wherein the tissue manipulation chamber is configured to receive a single tissue sample.

[0229] Embodiment 24

[0230] A tissue sample holder as described in any one or more of Examples 21 or 22, wherein the tissue manipulation chamber is configured to move relative to the second plurality of plates in response to movement of the first plurality of plates.

[0231] Embodiment 25

[0232] A tissue sample holder as described in Example 24, wherein each tissue groove of each plate of the first plurality of plates is configured to gradually retract relative to the second plurality of plates as the first plurality of plates moves relative to the second plurality of plates.

[0233] Embodiment 26

[0234] A tissue sample holder as described in Example 25, wherein retraction of each tissue recess of each plate of the first plurality of plates is configured to gradually reduce the effective size of the tissue manipulation chamber.

[0235] Embodiment 27

[0236] As a tissue sample holder as described in any of Examples 21 to 26, the outer cup includes a first member and a second member, wherein each of the first member and the second member is configured to engage each plate of the second plurality of plates.

[0237] Embodiment 28

[0238] A tissue sample holder as described in Example 27, wherein the first member and the second member are configured to hold each plate of the second plurality of plates in a single position relative to the first plurality of plates.

[0239] Embodiment 29

[0240] A tissue sample holder as described in any one or more of Examples 21 to 28, wherein the sample management assembly further comprises a drive shaft, wherein the drive shaft connects the first plurality of plates and the second plurality of plates.

[0241] Embodiment 30

[0242] A tissue sample holder as described in Example 29, wherein the drive shaft is keyed to the first plurality of plates such that the drive shaft is configured to transmit rotational motion to the first plurality of plates.

[0243] Embodiment 31

[0244] The tissue sample holder of Example 30, wherein the drive shaft is configured to rotate relative to the second plurality of plates.

[0245] Embodiment 32

[0246] The tissue sample holder of any one or more of Examples 21 to 30 further comprises a sample analysis component, wherein the sample analysis component is associated with the sample management component.

[0247] Embodiment 33

[0248] A tissue sample holder as described in Example 32, wherein the sample analysis component is configured to allow visual analysis of the tissue sample.

[0249] Embodiment 34

[0250] A tissue sample holder as described in any one or more of Examples 32 or 33, wherein the sample analysis component is configured to allow bioimpedance analysis of the tissue sample.

[0251] It should be understood that any patent, publication, or other public material (in whole or in part) said to be incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials set forth in this disclosure. Therefore, and to the extent necessary, the disclosure as expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof said to be incorporated herein by reference but conflicting with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.

[0252] Embodiments of the present invention have application in traditional endoscopic and open surgical instrumentation as well as in robotic-assisted surgery.

[0253] Only by way of aspect, the embodiments described herein can be processed before surgery. First, new or used instruments can be obtained and cleaned if necessary. Then the instruments can be sterilized. In a sterilization technique, the instruments are placed in a closed and sealed container such as a plastic or TYVEK bag. The container and the instruments can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. Radiation may kill bacteria on the instruments and in the container. The sterilized instruments can then be stored in a sterile container. The sealed container can keep the instruments sterile until it is opened in a medical institution. Any other technology known in the art can also be used to sterilize the equipment, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0254] The embodiments of the equipment disclosed herein can be repaired for reuse after at least one use. Re-repairing can include any combination of disassembly equipment steps, followed by cleaning or replacement of specific parts, and subsequent reassembly. In particular, the embodiments of the equipment disclosed herein can be disassembled, and specific pieces or parts of any number of equipment can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, the embodiments of the equipment can be reassembled in a re-repairing mechanism for subsequent use, or reassembled by a surgical team immediately before a surgical operation. It will be appreciated by those skilled in the art that the re-repairing of equipment can utilize various techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting re-repaired equipment are all within the scope of the present application.

[0255] Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several such potential modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the aspects, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in accordance with the following claims and should be understood not to be limited to the details of the structure and operation shown and described in this specification and drawings.

Claims

1. A biopsy device comprising: (a) Subject; (b) a needle extending distally from the body and defining a longitudinal axis; (c) a cutter movable relative to the needle; as well as (d) a tissue management component in communication with the cutter, the tissue management component comprising: (i) a sample viewer integrated into the body, the sample viewer configured to allow analysis of each of a plurality of tissue samples as the tissue management assembly receives each of the tissue samples from the cutter, (ii) a sample basket defining a batch sample chamber configured to receive the plurality of tissue samples, and (iii) a tissue door positioned between the sample viewer and the sample basket along the longitudinal axis of the needle, the tissue door being configured to selectively control the transport of each of the plurality of tissue samples between the sample viewer and the sample basket.

2. The biopsy device of claim 1, the sample viewer integrated into a proximal portion of the body such that the sample viewer is proximal to the sample basket.

3. The biopsy device of claim 1, the sample viewer comprising one or more sensors incorporated into a portion of the sample viewer.

4. The biopsy device of claim 3, the one or more sensors comprising a bioimpedance sensor configured to identify one or more physical characteristics of each of the plurality of tissue samples.

5. The biopsy device of claim 1, the tissue door comprising a removable filter, the sample viewer defining a single tissue sample chamber, the single tissue sample chamber selectively communicating with the sample basket via selective movement of the filter.

6. The biopsy device of claim 5 , wherein the removable filter comprises a first disk comprising a plurality of outer filter portions and a plurality of openings, each outer filter portion being positioned adjacent to a corresponding opening such that the plurality of outer filter portions and the plurality of openings form an alternating arrangement.

7. The biopsy device of claim 6, the first disk being configured to rotate relative to the cutter to continuously and alternately align the outer filter portions or openings with the cutter.

8. The biopsy device of claim 7, the tissue door being configured to provide a closed configuration when the outer filter portion of the first disk is aligned with the cutter, the tissue door being further configured to provide an open configuration when the opening of the first disk is aligned with the cutter.

9. The biopsy device of claim 8, the removable filter further comprising a second disk, the second disk comprising a plurality of vacuum chambers and a plurality of openings.

10. The biopsy device of claim 9, the first disk being fixedly secured to the second disk.

11. The biopsy device of claim 1 , the sample basket comprising a door, a pair of side walls, and a distal wall, the door, the pair of side walls, and the distal wall defining the batch sample chamber, the distal wall comprising a single tissue opening for receiving each of the plurality of tissue samples.

12. The biopsy device of claim 11 , the bottom plate of the sample basket comprising a plurality of vacuum openings, the distal wall further comprising a vacuum channel configured to receive a vacuum to transmit the vacuum from the vacuum channel into the batch sample chamber through the plurality of vacuum openings of the bottom plate.

13. The biopsy device of claim 1, the tissue management assembly further comprising a delivery tube in communication with the cutter to transfer tissue samples from the cutter to the sample basket.

14. The biopsy device of claim 13, the delivery tube extending from the sample viewer to the cutter.

15. The biopsy device of claim 14, the delivery tube having a cutter seal configured to sealingly engage the cutter.

16. A biopsy device comprising: (a) Subject; (b) a needle extending distally from the body and defining a longitudinal axis; (c) cutters; as well as (d) a tissue processing assembly in communication with the cutter, the tissue processing assembly comprising a tissue door, the tissue door including a removable filter, the removable filter being configured to transition between a tissue transport configuration and a tissue blocking configuration, the tissue door being positioned along the longitudinal axis of the needle between a sample window and a batch collection tray, the tissue door being configured to selectively block each of a plurality of tissue samples when the removable filter is in the tissue transport configuration to allow visual inspection of each tissue sample using the sample window.

17. The biopsy device of claim 16, the tissue processing assembly further comprising the sample window and a tissue sample holder having the bulk collection tray, the sample window, the tissue sample holder and the tissue door all being aligned with the longitudinal axis defined by the needle.

18. The biopsy device of claim 16, the removable filter configured to transition between the tissue transport configuration and the tissue blocking configuration based on movement of the cutter.

19. The biopsy device of claim 16, the removable filter comprising one or more ventilation openings configured to allow vacuum to flow through the tissue door and into the cutter when the removable filter is in the sample blocking configuration.

20. A biopsy system comprising: (a) A biopsy device, wherein the biopsy device comprises: (i) the subject, (ii) a needle, the needle defining a longitudinal axis, (iii) a cutter, the needle extending from the body to collect a tissue sample using the cutter, (iv) a sample analyzer comprising a door and a detector, the door being configured to selectively prevent movement of a tissue sample within the sample analyzer for analysis using the detector, and (v) a tissue sample holder, the door being positioned between the detector and the tissue sample holder along the longitudinal axis of the needle, the tissue sample holder being in communication with the sample analyzer, the tissue sample holder being configured to receive a tissue sample after being analyzed by the sample analyzer; and (b) a control module, wherein the control module is in communication with the biopsy device.

21. The biopsy system of claim 20, the door configured to transition between open and closed positions to selectively block a tissue sample prior to delivery to the tissue sample holder.

22. The biopsy system of claim 20, the analyzer further comprising a sample lumen, the detector being in communication with the control module, the detector protruding into the sample lumen, the sample lumen being in communication with the cutter to receive a tissue sample therein.

23. The biopsy system of claim 22, the detector comprising a pair of bioimpedance electrodes, a portion of each bioimpedance electrode extending into the sample lumen to physically contact a tissue sample received in the sample lumen.

24. The biopsy system of claim 23, the pair of bioimpedance electrodes being in communication with the control module, the control module being configured to measure impedance associated with the tissue sample using the pair of bioimpedance electrodes.

25. The biopsy system of claim 23, wherein the pair of bioimpedance electrodes are in communication with the control module, the control module being configured to generate a measured impedance associated with the tissue sample using the pair of bioimpedance electrodes, the control module being further configured to identify one or more characteristics of the tissue sample using the measured impedance.

26. The biopsy system of claim 23, the pair of bioimpedance electrodes being in communication with the control module, the control module being configured to generate a measured impedance associated with the tissue sample using the pair of bioimpedance electrodes, the control module being further configured to detect one or more calcifications disposed within the tissue sample using the measured impedance.

27. The biopsy system of claim 23, wherein a portion of each bioimpedance electrode of the pair of bioimpedance electrodes is exposed to the exterior of the sample analyzer.

28. The biopsy system of claim 23, wherein a portion of each bioimpedance electrode of the pair of bioimpedance electrodes is exposed to the outside of the sample analyzer to define a connecting portion of each bioimpedance electrode, and the connecting portion of each bioimpedance electrode is configured to engage a portion of the body to connect current to the body.

29. The biopsy system of claim 20, the sample analyzer comprising a tissue window disposed within the body of the biopsy device and sealed relative to an exterior of the biopsy device.

30. A biopsy device comprising: (a) Subject; (b) a needle extending distally from the body; (c) a cutter defining a delivery axis and movable relative to the needle and in communication with the needle for delivering a tissue sample; (d) an inspection window disposed in the body proximal to the cutter, the inspection window being configured to receive a tissue sample cut by the cutter for visual inspection by a user; (e) a sample management assembly disposed proximal to the inspection window and configured to transition between a tissue delivery configuration and a tissue blocking configuration; as well as (f) a tissue sample holder disposed proximally of the sample management assembly, the sample management assembly being disposed between the inspection window and the tissue sample holder along the transport axis, the sample management assembly being configured to allow visual inspection of the tissue sample disposed in the inspection window when the sample management assembly is in the sample blocking configuration, and being configured to allow the tissue sample to pass along the transport axis defined by the cutter and into the tissue sample holder when the sample management assembly is in the transport configuration.

31. The biopsy device of claim 30, the sample management assembly comprising a filter portion having a plurality of openings configured to facilitate vacuum flow through the sample management assembly when the sample management assembly is in the tissue blocking configuration.

32. The biopsy device of claim 31, the sample management assembly comprising a rotatable disk defining the filter portion.

33. The biopsy device of claim 30, at least a portion of the sample management assembly being configured to move relative to the body to transition the sample management assembly between the tissue transport configuration and the tissue blocking configuration.

34. A biopsy device comprising: (a) Subject; (b) a needle extending distally from the body; (c) a cutter defining a sampling axis and movable relative to the needle and in communication with the needle for delivering a tissue sample; (d) a visual inspection area disposed in the body, the visual inspection area comprising an inspection window, the visual inspection area being configured to receive a tissue sample cut by the cutter for visual inspection through the inspection window; (e) a sample management assembly configured to transition between a tissue delivery configuration and a tissue blocking configuration; as well as (f) a tissue sample holder, the sample management assembly being disposed along the sampling axis between the inspection window and the tissue sample holder, the sample management assembly being configured to allow visual inspection of the sample disposed in the visual inspection area when the sample management assembly is in the tissue blocking configuration, and being configured to allow passage of the tissue sample into the tissue sample holder when the sample management assembly is in the transport configuration.

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