Biopsy device with sample collection container

Abstract

The present application discloses a sample collection container for a biopsy device, which includes a sample capture body, which defines an internal space. The sample capture body is made of fabric and has an internal sample capture surface, which at least partially surrounds the internal space. The fabric has at least one fold.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] none. Technical Field

[0003] The present invention relates to a biopsy device for collecting tissue samples, and more particularly, to a biopsy device with a sample collection container. Background Art

[0004] Biopsy can be performed on the patient to help determine whether the cells in the tissue lesion to be biopsied are cancerous. A typical biopsy device can include a handheld driver assembly and a disposable biopsy probe assembly, which is arranged to be releasably attached to the driver assembly. The biopsy probe assembly can include a biopsy stylet coaxial with the cutting cannula. The biopsy stylet can include a tubular component having a lumen, a distal puncture tip, and a sample port, which is used to receive the tissue to be sampled. The cutting cannula can be a tubular component with a distal cutting edge, which moves axially above the sample port for cutting off the tissue received in the sample port. The handheld driver assembly can include a vacuum source so that the cut tissue sample is moved to a sample reservoir by vacuum. The sample reservoir can include a detachable plastic sample container so that the tissue sample is collected. The sample container is inserted in the fluid path between the sample port of the biopsy stylet and the vacuum source. Therefore, the sample container typically has a vent grid to facilitate vacuum communication between the sample port of the biopsy stylet and the vacuum source, and to facilitate transfer of the tissue sample from the sample port of the biopsy stylet to the sample container.

[0005] However, it has been observed that microcalcifications may stick to the holes of the sample container. In this case, additional effort and imaging of the sample container is required to ensure that the microcalcifications are actually biopsied and collected during processing. When using such sample containers, imaging of microcalcifications may be difficult because the sample can stick to the holes of the sample container. Moreover, the microcalcifications may also pass through the holes of the sample container and cannot be used for diagnostic evaluation.

[0006] There is a need in the art for a biopsy device having a sample collection container configured to capture all tissue sample fragments, including microcalcifications. Summary of the invention

[0007] The present invention provides a biopsy device having a sample collection container configured to capture all tissue sample fragments, including microcalcifications.

[0008] In one form, the present invention is directed to a specimen collection container for a biopsy device, the specimen collection container comprising a specimen capture body defining an interior space. The specimen capture body is made of fabric and has an interior specimen capture surface that at least partially surrounds the interior space. The fabric has at least one fold.

[0009] In another form, the present invention relates to a biopsy device, which includes a driver assembly and a biopsy probe assembly. The driver assembly includes a housing having a proximal end. A vacuum source is contained within the housing. The biopsy probe assembly is releasably mounted on the housing. The biopsy probe has an elongated sample receiving component and a cutting cannula coaxial with the elongated sample receiving component. The sample receiver is removably mounted on the proximal end of the housing. The sample receiver is fluidically connected to each of the biopsy probe assembly and the vacuum source. A sample collection container is removably carried by the sample receiver. The sample collection container includes a sample capture body that defines an internal space. The sample capture body is made of fabric and has an internal sample capture surface that at least partially surrounds the internal space. The fabric has at least one fold.

[0010] An advantage of the present invention is that the sample capture body can be unfolded to remove any tissue sample received by the sample capture body and then refolded and reused to capture additional tissue samples from the same patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The above and other features and advantages of the present invention and the manner of achieving them will become more apparent, and the present invention will be better understood by referring to the following description of the embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0012] Figure 1 is a schematic diagram of a biopsy device having a sample collection container according to aspects of the present invention;

[0013] Figure 2 yes Figure 1 A side view of a portion of a biopsy probe assembly of a biopsy device having a sample receiving component and a cutting cannula, wherein the cutting cannula is retracted to an open position to expose a tissue receiving recess of the sample receiving component;

[0014] Figure 3 yes Figure 1 and 2 a side view of a portion of a biopsy probe assembly of a biopsy device, wherein the cutting cannula is moved over the tissue receiving recess of the sample receiving component to an extended position so as to cover the tissue receiving recess;

[0015] Figure 4A yes Figure 1A side view of a sample receiver of a biopsy device, wherein the sample receiver carries a sample collection container arranged according to aspects of the present invention, and a sample capture body of the sample collection container is in an assembled state;

[0016] Figure 4B yes Figure 4A A top view of a sample collection container according to aspects of the present invention, the sample collection container has a frame and a sample capture body;

[0017] Figure 5 yes Figure 4B A top view of a frame having a plurality of mechanical fasteners;

[0018] Fig. 6A yes Figure 4A and 4B A view of the rectangular pre-assembly shape of the specimen capturing body;

[0019] Figure 6B yes Figure 4A and 4B The specimen captures a view of the intermediate assembly shape of the body, where Fig. 6A The rectangular pre-assembly shape is folded along the folding line and adhesively attached to the opposite end surface portions;

[0020] Figure 7 yes Figure 1 A side view of a sample receiver of a biopsy device, wherein the sample receiver carries a sample collection container arranged according to another embodiment of an aspect of the present invention, and a sample capture body of the sample collection container is in an assembled state;

[0021] Figure 8 yes Figure 7 A side view of a sample collection container, the sample collection container from Figure 7 The sample collection container is removed from a sample receiver, and the sample collection container has a frame attached to the sample capture body;

[0022] Fig. 9 yes Figure 8 An exploded view of a sample collection container showing the frame separated from the sample capture body, and the sample capture body is in an assembled state;

[0023] Fig.10 yes Fig. 9 A top view of the frame;

[0024] Fig.11 yes Fig. 9 an enlarged perspective view of a sample capture body of FIG. 1 , wherein the sample capture body is in an assembled state; and

[0025] Fig.12 yes Figure 7-91 and 11 are views of the rectangular pre-assembly shape of the specimen capture body, showing the fold / crease lines that determine the crease / crease locations of the specimen capture body.

[0026] Corresponding reference numerals indicate corresponding parts throughout the drawings.The examples set out herein represent embodiments of the invention, and these examples are not to be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION

[0027] Reference will now be made to the accompanying drawings, and more particularly to the Figure 1 , a biopsy device 10 is shown according to an embodiment of the present invention.

[0028] Biopsy device 10 includes a driver assembly 12 and a biopsy probe assembly 14. Driver assembly 12 is configured to provide operational control of biopsy probe assembly 14.

[0029] Driver assembly 12 has a housing 16 that is configured (e.g., ergonomically designed) to be grasped by a user, such as a physician. Housing 16 defines a cavity 18 in which biopsy probe assembly 14 is at least partially located when biopsy probe assembly 14 is attached to driver assembly 12, whereupon biopsy probe assembly 14 is in driving connection with driver assembly 12.

[0030] The driver assembly 12 includes a user interface 20, a controller circuit 22, an electromechanical driver 24, a vacuum source 26, and a sample receiver 28. The controller circuit 22, the electromechanical driver 24, and the vacuum source 26 are each contained within the housing 16. The sample receiver 28 is removably mounted on the proximal end 16-1 of the housing 16 and extends distally into the compartment 18. The sample receiver 28 can be, for example, a removable tray that carries a removable sample collection container 30 configured according to aspects of the present invention.

[0031] The user interface 20 is positioned so as to be accessible to a user from the outside relative to the housing 16. The user interface 20 may be in the form of a touch screen display configured to receive operating commands from a user, such as via one or more buttons, and to display visual indicators on the display, such as one or more lights, text and / or icons, to display information to the user.

[0032] The controller circuit 22 is electrically and communicatively connected to each of the user interface 20, the electromechanical driver 24, and the vacuum source 26 via a communication link (e.g., wire cables and / or printed circuit traces). The controller circuit 22 may include, for example, a microprocessor circuit 22-1 and an electronic memory circuit 22-2. The controller circuit 22 is configured to execute program instructions to communicate with the user interface 20 and to execute program instructions to control the electromechanical driver 24 and the vacuum source 26 to perform functions related to the collection of a biopsy tissue sample during a biopsy procedure.

[0033] Electromechanical drive 24 is drivingly coupled to biopsy probe assembly 14 (indicated by dashed lines at interface 24 / 38) and to vacuum source 26 (indicated by dashed lines between 24 and 26) for selectively and operatively controlling biopsy probe assembly 14 and vacuum source 26. Electromechanical drive 24 may include, for example, one or more linear drives that convert rotary motion into linear motion (e.g., worm gear arrangements, rack and pinion arrangements, solenoid-slide arrangements, etc.) and a rotary drive that may include one or more gears, gear trains, belt / pulley arrangements, etc., for performing operations of biopsy probe assembly 14 and / or vacuum source 26.

[0034] Vacuum source 26 may be, for example, a peristaltic pump, a diaphragm pump, a syringe-type pump, etc. Vacuum source 26 may be integrated into driver assembly 12. Alternatively, vacuum source 26 may be integrated as part of biopsy probe assembly 14. In the present embodiment, vacuum source 26 is configured to generate negative pressure (vacuum).

[0035] Sample receiver 28 is sealingly engaged and fluidly connected to each of biopsy probe assembly 14 and vacuum source 26 to define a fluid passage 32 (indicated by a dashed line) between biopsy probe assembly 14 and vacuum source 26. Sample receiver 28 is in fluid communication with vacuum source 26 via conduit 33. Sample collection container 30, which is removably carried by sample receiver 28, is disposed between biopsy probe assembly 14 and vacuum source 26, and fluid passage 32 passes through sample collection container 30.

[0036] The biopsy probe assembly 14 is releasably attached to the driver assembly 12. The biopsy probe assembly 14 is intended to be used on a single patient and is therefore disposed of after use. The biopsy probe assembly 14 includes a frame 34, a biopsy probe 36, and a probe driver 38. The biopsy probe 36 includes an elongated sample receiving member 40 and a cutting cannula 42 that is operatively connected to the probe driver 38.

[0037] In the present embodiment, the probe driver 38 includes at least one gear connected to each of the sample receiving member 40 and the cutting cannula 42 to effectuate respective rotational movement of each of the sample receiving member 40 and the cutting cannula 42. In addition, the probe driver 38 includes a worm gear to facilitate longitudinal movement of the cutting cannula 42 relative to the sample receiving member 40. When the biopsy probe assembly 14 is attached to the driver assembly 12, the probe driver 38 is drivably engaged with the electromechanical driver 24 of the driver assembly 12.

[0038] The sample receiving part 40 and the cutting cannula 42 are mounted as a coaxial unit on the frame 34. The sample receiving part 40 and the cutting cannula 42 are coaxially arranged with respect to the longitudinal axis 44 and can move relative to each other along the longitudinal axis 44. Figure 1 In the embodiment of the present invention, the sample receiving component 40 is located within the lumen 42-1 of the cutting cannula 42, and the cutting cannula 42 can slide axially over the outer surface of the sample receiving component 40. Alternatively, it is contemplated that the coaxial structure can be configured such that the cutting cannula 42 is resized and positioned within the lumen 40-4 of the sample receiving component 40 for axial sliding movement within the lumen 40-4 of the sample receiving component 40.

[0039] exist Figure 1 In the illustrated embodiment, for example, the sample receiving component 40 may include, for example, an elongated cylindrical tube, such as a metal tube formed of stainless steel, having a proximal end 40-1, a distal portion 40-2, a tissue receiving groove 40-3, and a lumen 40-4 (indicated by a dotted line). The tissue receiving groove 40-3 is formed in the side wall of the elongated cylindrical tube, such as by cutting off a portion of the side wall so as to expose the distal portion of the lumen 40-4. The puncture tip 46 is connected to the distal portion 40-2 at the distal side of the tissue receiving groove 40-3 so as to close the distal portion 40-2. The lumen 40-4 extends from the tissue receiving groove 40-3 to the proximal end 40-1 and may be sealedly connected to the removable sample receiver 28, such as by an O-ring or a rubber sleeve, so that the fluid passage 32 extends to the tissue receiving groove 40-3.

[0040] The cutting cannula 42 may be a cylindrical tube, such as a metal tube formed of stainless steel, having a lumen 42-1 and a distal cutting edge 42-2. In this embodiment, the sample receiving member 40 is located in the lumen 42-1 of the cutting cannula 42 so that the cutting cannula 42 slides longitudinally on the sample receiving member 40 and can rotate around the sample receiving member 40 to cut off the tissue received in the tissue receiving groove 40-3.

[0041] The piercing tip 46 is a sharp tip configured to penetrate tissue so as to position the tissue receiving recess 40-3 at the biopsy site. The tissue receiving recess 40-3 is configured to receive tissue to be biopsied and collect tissue samples cut from the tissue by the cutting cannula 42 during the biopsy process.

[0042] Also refer to Figure 2 and 3 The sample receiving member 40 and the cutting cannula 42 may be in a first relative position 48 ( Figure 2 ) and the second relative position 50 ( Figure 3 ) move relative to each other. Figure 2In the first relative position 48, the cutting cannula 42 is retracted to the open position to expose the tissue receiving groove 40-3 of the sample receiving part 40 so that the sample receiving part 40 can receive the tissue to be biopsied. Before or during the retraction of the cutting cannula 42, a vacuum can be applied by driving the vacuum source 26 to pull the tissue near the tissue receiving groove 40-3 into the tissue receiving groove 40-3.

[0043] refer to Figure 3 , in the second relative position 50, the cutting cannula 42 moves over the tissue receiving recess 40-3 to the extended position so as to cover the tissue receiving recess 40-3 of the sample receiving member 40. Therefore, when the cutting cannula 42 moves over the tissue receiving recess 40-3 so as to cover the tissue receiving recess 40-3, any tissue present in the tissue receiving recess 40-3 is severed by the distal cutting edge 42-2 of the cutting cannula 42, and the severed tissue sample is received in the lumen 40-4 of the sample receiving member 40 adjacent to the tissue receiving recess 40-3.

[0044] Refer to Figure 1 The vacuum applied by the vacuum source 26 then transports the tissue sample through the lumen 40 - 4 of the sample receiving component 40 and expels the tissue sample from the proximal end 40 - 1 of the sample receiving component 40 into the sample collection container 30 .

[0045] Figure 4A and 4B An embodiment of a sample collection container 30 arranged in accordance with aspects of the present invention is shown. In this embodiment, the sample collection container 30 is loaded sideways into the sample receiver 28 and is suspended above the floor 28-1 of the sample receiver 28 by a support ledge 28-2 that projects inwardly from the inner side wall of the sample receiver 28.

[0046] refer to Figure 4A and 4B The sample collection container 30 includes a frame 52 and a sample capture body 54. The frame 52 can be made of plastic or metal. The sample capture body 54 is made of fabric, such as polypropylene woven fabric. The fabric is a fine woven fabric to prevent microcalcification from passing through the fabric.

[0047] The sample capture body 54 is removably attached to the frame 52. When assembled, the sample capture body 54 defines an interior space 54-1 that remains open when the sample capture body 54 is attached to the frame 52. The sample capture body 54 has an interior sample capture surface 54-2 that at least partially surrounds the interior space 54-1, and in this embodiment the sample capture body defines an opening 54-3 at an upper portion 54-4 of the interior space 54-1. In this embodiment, the fabric has a single fold (pleat) 54-5 (see FIG. Figure 4A ), the crease is formed at the folding line 55 (see FIG. 6 ).

[0048] Also refer to Figure 5 In this embodiment, the frame 52 is an annular member 52-1 having a frame opening 52-2, and has at least two mounting protrusions (referred to as a group of mounting protrusions 52-3) extending outward from the annular member 52-1. Figure 4A The mounting projection 52-3 is positioned to engage the support ledge 28-2 of the sample receiver 28 to suspend the sample capture body 54 above the bottom plate 28-1 of the sample receiver 28. The ring member 52-1 has a mounting surface 52-4 surrounding the frame opening 52-2.

[0049] The mounting surface 52-4 has a releasable attachment means which is arranged to be releasably attached to the fabric of the sample capture body 54. The releasable attachment means can be, for example, a non-permanent adhesive or a mechanical fastener 52-5. In this embodiment, the mechanical fastener 52-5 is arranged around the frame opening 52-2, for example near the frame opening 52-2, and is in the form of a plurality of clamping points which are arranged to be attached to the fabric of the sample capture body 54. The clamping points forming the mechanical fasteners 52-5 can be, for example, a plurality of narrow grooves into which the fabric of the sample capture body 54 is pushed, for example by poking with a narrow blunt instrument. Alternatively, each mechanical fastener 52-5 can be formed as a burr protrusion, for example, forming a plurality of pairs of barbs which protrude away from the mounting surface 52-4 of the annular member 52-1 so as to engage with the fabric of the sample capture body 54, for example by hooking.

[0050] 4-6B, the sample capture body 54 has an assembly shape (FIG. 4), an intermediate assembly shape ( Figure 6B ) and pre-assembly shape ( Fig. 6A ). In this embodiment, reference Fig. 6AThe sample capture body 54 has a rectangular pre-assembly shape having a first side edge 54-6, a second side edge 54-7, a third side edge 54-8, and a fourth side edge 54-9. The first side edge 54-6 is orthogonal to the third side edge 54-8 and the fourth side edge 54-9. The second side edge 54-7 is orthogonal to the third side edge 54-8 and the fourth side edge 54-9, and the second side edge 54-7 is laterally spaced from the first side edge 54-6.

[0051] The rectangular pre-assembly shape of the fabric of the sample capture body 54 has a first end surface portion 56-1 near the first side edge 54-6. The first end surface portion 56-1 is divided at the fold line 55 to define a first attachment surface portion 56-2 and a second attachment surface portion 56-3. The second end surface portion 58-1 is near the second side edge 54-7. The second end surface portion 58-1 is divided at the fold line 55 to define a third attachment surface portion 58-2 and a fourth attachment surface portion 58-3. At least one of the first attachment surface portion 56-2 and the second attachment surface portion 56-3 is coated with a non-permanent adhesive, sometimes also referred to as a "repositionable adhesive" in the art. Similarly, at least one of the third attachment surface portion 58-2 and the fourth attachment surface portion 58-3 is coated with a non-permanent adhesive.

[0052] refer to Fig. 6A and 6B In order to form the sample capture body 54, the rectangular assembly front piece is folded at the folding line 55 so as to produce a crease (pleat) 54-5, wherein the first attachment surface portion 56-2 is attached to the second attachment surface portion 56-3 by an adhesive, and the third attachment surface portion 58-2 is attached to the fourth attachment surface portion 58-3 by an adhesive, wherein the third side edge 54-8 and the fourth side edge 54-9 are oriented to form an opening 54-3 at the upper portion of the inner space 54-1. Preferably, in the assembly shape shown in FIG. 4, the fabric of the sample capture body 54 having the pleats 54-5 forms an upwardly extending V-shape, which will cause the tissue particles of the collected tissue sample to be consolidated (i.e., gathered) at the pleats 54-5.

[0053] To assemble the specimen collection container 30, the end portion of the specimen capture body 54 having the third side edge 54-8 and the fourth side edge 54-9 (i.e., opposite the fold line 55) is passed through the opening 52-2 of the annular member 52-1, so that the fabric is pleated to form a plurality of side undulations 60 along the sides of the specimen capture body 54 (see FIG. Figure 4A The portion of the sample capture body 54 that extends through the opening 52 - 2 of the annular member 52 - 1 is folded to engage with a plurality of mechanical fasteners 52 - 5 of the mounting surface 52 - 4 of the annular member 52 - 1 of the frame 52 .

[0054] A method of collecting a tissue sample using the biopsy device 10 having the sample collection container 30 is described below. A biopsy is performed using the biopsy device 10 to receive a tissue sample and to transfer the received tissue sample to the sample collection container 30 by vacuum-assisted transport. Preferably, the V-shape of the fabric of the sample capture body 54 extending upward from the pleats 54-5 will cause tissue particles of the collected tissue sample to consolidate (i.e., collect) at the pleats 54-5. The sample collection container 30 containing the tissue sample is removed from the biopsy device 10. The sample capture body 54 is then removed from the frame 52, i.e., disengaged from the frame 52. The pleated fabric forming the sample capture body 54 is then unfolded by separating the bonds at the first end surface portion 56-1 and the second end surface portion 58-1 to facilitate removal of consolidated tissue particles associated with the received tissue sample from, for example, the inner sample capture surface 54-2 adjacent to the pleats 54-5.

[0055] When necessary, the sample collection container 30 can be reassembled by reversing the disassembly process so that the current frame 52 and the sample capture body 54 can be reused, and then reinstalled into the biopsy device 10 for collecting the next tissue sample. Alternatively, the sample collection container 30 can be reassembled using the current frame 52 and the new sample capture body 54.

[0056] Figure 7 An embodiment of a specimen collection container 130 arranged in accordance with aspects of the present invention is shown. In this embodiment, the specimen collection container 130 is side-loaded into the specimen receiver 28 and is suspended above the floor 28-1 of the specimen receiver 28 by a support ledge 28-2 that projects inwardly from the inner side wall of the specimen receiver 28.

[0057] Also refer to Figure 8-10 The sample collection container 130 includes a frame 132 and a sample capture body 134. The frame 132 can be made of plastic or metal. The sample capture body 134 is made of fabric, such as polypropylene woven fabric. The fabric is a fine woven fabric to prevent microcalcification from passing through the fabric.

[0058] The frame 132 includes an annular member 132-1 and a cylindrical sleeve 132-2 connected to the annular member 132-1. The annular member 132-1 and the cylindrical sleeve 132-2 define a frame opening 132-3. The annular member 132-1 has a driving surface 132-4. The cylindrical sleeve 132-2 has a mounting surface 132-5 for mounting the sample capture body 134.

[0059] The mounting surface 132-5 has a releasable attachment means that is configured to releasably attach to the fabric of the sample capture body 134. The releasable attachment means may be, for example, a non-permanent adhesive or a mechanical fastener. The mechanical fastener may be configured to include a plurality of mechanical fasteners, such as those described above for Figure 5 The mechanical fastener 52-5 of the embodiment is described so as to engage with the fabric of the sample capture body 134, such as by hooking.

[0060] According to the present embodiment, the biopsy device 10 further includes a rotational driver 62 for applying a driving force to a driving surface 132-4 of the annular member 132-1 of the frame 132 of the sample collection container 130 so as to achieve a one-to-one rotational correspondence between the incremental (indexed) rotation of the tissue receiving recess 40-3 of the sample receiving member 40 about the longitudinal axis 44 (e.g., in the rotational direction 44-1) and the rotation of the sample collection container 130 about the rotational axis 64 (e.g., in the rotational direction 64-1) (see also FIG. Figure 1 Thus, when the tissue receiving recess 40-3 of the sample receiving component 40 is indexed and rotated (e.g., through a plurality of angular positions about the longitudinal axis 44) by the operation of the controller circuit 22 and the electromechanical driver 24, the sample collection container 130 is indexed and rotated to a corresponding angular position by the rotation driver 62 so as to isolate and identify the tissue samples collected at each specific angular position of the tissue receiving recess 40-3 of the sample receiving component 40.

[0061] The application of the driving force from the rotary drive 62 to the driving surface 132-4 of the annular member 132-1 of the frame 132 of the sample collection container 130 can be by a friction drive, such as a rubber wheel or a gear drive, which has a driving roller or gear fixed to the sample receiving member 40. It should be understood that the rotary drive 62 includes a suitable gear device to rotate the tissue receiving recess 40-3 of the sample receiving member 40 in increments (indexes) about the longitudinal axis 44 (see also Figure 1 ) and the rotation of the sample collection container 130 about the rotation axis 64 (see Figure 7 ) to achieve a suitable one-to-one rotation correspondence between them.

[0062] The cannula extension 66 is slidably received over the proximal end 40-1 of the sample receiving member 40. The cannula extension 66 is mounted in a fixed relationship to the sample receiver 28 so that the sample receiving member 40 can be rotated about the longitudinal axis 44 within the cannula extension 66, thereby facilitating the rotational positioning of the tissue receiving recess 40-3 of the sample receiving member 40 at a suitable angular position. After the tissue sample is severed and a vacuum is applied to the sample receiver 28, the severed tissue sample is transported to the sample collection container 130 by the vacuum through the cannula extension 66, and the sample collection container 130 is rotationally indexed about the rotation axis 64 in unison with the rotational indexing of the tissue receiving recess 40-3 of the sample receiving member 40 by operation of the rotary drive 62.

[0063] exist Figure 7-12 In the embodiment, the sample capture body 134 has an assembly shape ( Figure 7 , 8 , 9 and 11) and pre-assembly shape ( Fig.12 ).

[0064] exist Figure 7-12 In the embodiment, the sample capture body 134 has an assembly shape ( Figure 7 , 8 , 9 and 11) and pre-assembly shape ( Fig.12 ). In this embodiment, reference Fig.12 The sample capture body 134 has a rectangular pre-assembly shape, having a first elongated side edge 134-1, a second elongated side edge 134-2, a first transverse edge 134-3, and a second transverse edge 134-4. The first elongated side edge 134-1 is orthogonal to the first transverse edge 134-3 and the second transverse edge 134-4. Also, the second elongated side edge 134-2 is orthogonal to the first transverse edge 134-3 and the second transverse edge 134-4, and the second elongated side edge 134-2 is spaced apart from the first elongated side edge 134-1 in the width direction. The first end surface portion 134-5 is adjacent to the first transverse edge 134-3, and the second end surface portion 134-6 is adjacent to the second transverse edge 134-4. The first end surface portion 134-5 and / or the second end surface portion 134-6 have a non-permanent adhesive, such as a non-permanent adhesive layer.

[0065] The elongated fold line 134-7 is defined between the first elongated side edge 134-1 and the second elongated side edge 134-2. Fig.12 The rectangular pre-assembly shape shown in FIG. 1 is divided into a first region 134-8 between the first elongated side edge 134-1 and the elongated fold line 134-7 and a second region 134-9 between the elongated fold line 134-7 and the second elongated side edge 134-2.

[0066] refer to Fig.12 , a plurality of pairs of fold lines 136-1, 136-2, 136-3, 136-4, 136-5, 136-6, 136-7, 136-8, 136-9, 136-10 are located in the second region 134-9, which respectively define the sample capture body 134 for assembly (see Fig.11 ) of the corresponding folds (folds) of the fold lines. The multiple pairs of fold lines 136-1, 136-2, 136-3, 136-4, 136-5, 136-6, 136-7, 136-8, 136-9, 136-10 each include a first fold line 138 and a second fold line 140. In the present embodiment, each fold line 138, 140 extends from the elongated fold line 134-7 to the second elongated side edge 134-2, and each pair of fold lines 138 / 140 in the multiple pairs of fold lines 136-1, 136-2, 136-3, 136-4, 136-5, 136-6, 136-7, 136-8, 136-9, 136-10 is connected at only one end at the elongated fold line 134-7 to form a plurality of right-angled triangle patterns, such as Fig.12 as shown in .

[0067] During the assembly process, Fig.12 The rectangular assembly front piece shown in FIG. 1 is creased at an elongated fold line 134-7 and folded alternately at pleat lines 138, 140 to form a plurality of annular structures (see FIG. 1 ). Fig.11 ), these annular structures define a plurality of sample pockets 142-1, 142-2, 142-3, 142-4, 142-5, 142-6, 142-7, 142-8, 142-9, 142-10 arranged in an annular pattern along the elongated fold line 134-7, wherein the first end surface portion 134-5 is adhesively attached to the second end surface portion 134-6 to complete the assembly of the sample capture body 134. In this embodiment, the plurality of sample pockets 142-1, 142-2, 142-3, 142-4, 142-5, 142-6, 142-7, 142-8, 142-9, 142-10 define a plurality of interior spaces, and the plurality of sample pockets each have an interior sample capture surface 144 (see FIG. 144 ) that at least partially surrounds the corresponding interior space. Fig.11 ). In the present embodiment, a plurality of sample bags 142-1, 142-2, 142-3, 142-4, 142-5, 142-6, 142-7, 142-8, 142-9, 142-10 are arranged to receive tissue samples from each of the ten angular positions (e.g., angular positions 1-10) of the tissue receiving recess 40-3 of the sample receiving member 40 around the longitudinal axis 44. It should be understood that the number of sample bags may be increased or decreased from the number of the present embodiment, if desired.

[0068] In this embodiment, when assembled, the sample capture body 134 has a circular side wall at the first region 134-8 that transitions at a circular crease (fold) at the elongated fold line 134-7 to an annular pleated wall formed at the second region 134-9. Fig.11 As shown in FIG, the annular pleat wall is oriented at an acute angle at the circular crease at the elongated fold line 134-7 relative to the circular sidewall at the first region 134-8.

[0069] Refer to Figure 7-9 To complete the assembly of the sample collection container 130 , the first region 134 - 8 of the fabric of the sample capture body 134 is attached to the mounting surface 132 - 5 of the frame 132 by a non-permanent adhesive or mechanical fasteners to form the sample collection container 130 .

[0070] Thus, preferably, the sample capture body 134 can be separated and unfolded from the frame 132 to assist in removing any tissue samples received by the multiple sample pockets 142-1, 142-2, 142-3, 142-4, 142-5, 142-6, 142-7, 142-8, 142-9, 142-10 of the sample capture body 134, and then refolded along the fold / crease lines, reattached to the frame 132, and reused to capture additional tissue samples from the same patient.

[0071] As an alternative to the above, it is contemplated that in some embodiments it may be desirable to use the specimen capture body 134 without the frame 132 .

[0072] As yet another alternative, it is contemplated that the side structure of the sample capture body 54 or sample capture body 134 may be reinforced, such as by a wire frame, such as a wire spiral, to maintain an open top for receiving a tissue sample. Also, it is contemplated that in some embodiments, such reinforcement may be provided in addition to or in lieu of the various frames described above.

[0073] The following items are also relevant to the present invention:

[0074] In one form, the present invention relates to a sample collection container for a biopsy device. In particular, the sample collection container is configured for use with a biopsy device. The sample collection container comprises a sample capture body defining an interior space. The sample capture body is made of a fabric and has an interior sample capture surface, which at least partially surrounds the interior space. The fabric has at least one fold. The fabric may be configured to prevent microcalcifications from passing through the fabric. In particular, the fabric is a (fine) woven fabric.

[0075] Optionally, the specimen collection container may include a frame to which the specimen capture body may be removably attached.

[0076] In a preferred embodiment, the fabric has a rectangular pre-assembly shape, including a first side edge, a second side edge, a third side edge, and a fourth side edge. In one embodiment, for example, the first side edge is orthogonal to the third side edge and the fourth side edge, and the second side edge is orthogonal to the third side edge and the fourth side edge. The second side edge is laterally spaced from the first side edge. The first end surface portion is adjacent to the first side edge. The first end surface portion is separated at a fold line to define a first attachment surface portion and a second attachment surface portion. The second end surface portion is adjacent to the second side edge. The second end surface portion is separated at a fold line to define a third attachment surface portion and a fourth attachment surface portion. The rectangular pre-assembly piece is folded at the fold line to create a crease, and the first attachment surface portion is attached to the second attachment surface portion by an adhesive, and the third attachment surface portion is attached to the fourth attachment surface portion by an adhesive, wherein the third side edge and the fourth side edge are oriented to form an opening.

[0077] Variations may include a frame. The frame may be an annular member having a mounting surface that surrounds the frame opening. The annular surface may have a mechanical fastener, optionally a plurality of mechanical fasteners surrounding the frame opening, configured to attach to the fabric. In one embodiment, for example, each of the plurality of mechanical fasteners may be a slot formed in the mounting surface. In another embodiment, for example, each of the plurality of mechanical fasteners may be a burr protrusion that protrudes away from the mounting surface to engage with the fabric.

[0078] In any of the foregoing variations, the fabric may have at least one or more side undulations.

[0079] Moreover, the fabric may have a plurality of pleats. For example, the plurality of pleats may be arranged in a circular pattern.

[0080] In one embodiment, the sample capture body can have a circular sidewall that transitions to an annular pleated wall at a circular crease. The annular pleated wall can be oriented at an acute angle relative to the circular sidewall at the crease. The annular pleated wall can have a plurality of pleats that form a plurality of cavities that are arranged in an annular pattern.

[0081] The fabric of the sample collection container can have a rectangular pre-assembly shape, the rectangular pre-assembly shape including a first elongated side edge, a second elongated side edge, a first transverse edge, and a second transverse edge. In one embodiment, for example, the first elongated side edge is orthogonal to the first transverse edge and the second transverse edge, and the second elongated side edge is orthogonal to the first transverse edge and the second transverse edge. The second elongated side edge is spaced apart from the first elongated side edge. The first end surface portion is adjacent to the first transverse edge, and the second end surface portion is adjacent to the second transverse edge, wherein at least one of the first end surface portion and the second end surface portion has a non-permanent adhesive. An elongated fold line is defined between the first elongated side edge and the second elongated side edge. The elongated fold line divides the rectangular pre-assembly shape into a first region between the first elongated side edge and the elongated fold line and a second region between the elongated fold line and the second elongated side edge. A plurality of pairs of fold lines are arranged in the second region, wherein each fold line extends from the elongated fold line to the second side edge. Each pair of fold lines is connected at the elongated fold line at only one end so as to form a triangular pattern. The rectangular assembly front piece is creased at the elongated folding lines and folded alternately at the crease lines to form an annular structure. The first end surface portion may be adhesively attached to the second end surface portion.

[0082] The first area of ​​fabric of the specimen capture body may be attached to the frame by a non-permanent adhesive or mechanical fasteners.

[0083] The present invention also relates to a biopsy device. The biopsy device includes a driver assembly, which includes a housing having a proximal end. A vacuum source can be contained in the housing. A biopsy probe assembly is releasably mounted on the housing. The biopsy probe has an elongated sample receiving component and a cutting cannula coaxial with the elongated sample receiving component. The sample receiver can be removably mounted on the proximal end of the housing. The sample receiver is fluidically connected to the biopsy probe assembly and the vacuum source. A sample collection container is removably carried by the sample receiver. The sample collection container includes a sample capture body, which defines an internal space. The sample capture body is made of fabric and has an internal sample capture surface, which at least partially surrounds the internal space. The fabric has at least one fold. The sample collection container can be arranged according to any of the aforementioned embodiments, implementations and / or their variations.

[0084] The present invention also relates to the use of a sample collection container in a biopsy device. For example, the present invention relates to the use of a sample collection container for a biopsy device, the sample collection container comprising a sample capture body, the sample capture body defining an internal space, the sample capture body being made of fabric and having an internal sample capture surface, the internal sample capture surface at least partially surrounding the internal space, the fabric having at least one fold, wherein the biopsy device comprises a driver assembly, the driver assembly comprising: a housing having a proximal end; a vacuum source, the vacuum source being contained within the housing; a biopsy probe assembly, the biopsy probe assembly being releasably mounted on the housing, the biopsy probe having an elongated sample receiving part and a cutting cannula coaxial with the elongated sample receiving part; and a sample receiver, the sample receiver being detachably mounted on the proximal end of the housing, the sample receiver being in fluid communication with each of the biopsy probe assembly and the vacuum source; wherein the sample collection container is detachably carried by the sample receiver. The sample collection container can be arranged according to any of the aforementioned embodiments, implementations and / or their variations.

[0085] Relative modifiers such as "near" and other degree terms used herein will indicate the permissible variation of the characteristic modified. It will not be limited to the absolute value or characteristic it modifies, but has more physical or functional characteristics different from its opposite meaning, and is close to or similar to such physical or functional characteristics.

[0086] Although the present invention has been described for a number of embodiments, the present invention may be further varied within the spirit and scope of the present disclosure. Therefore, this application will cover any variations, uses or changes of all the present inventions using the general principles of the present invention. Moreover, this application will cover content that is different from the present disclosure as known or customary in the art to which the present invention belongs and falls within the scope of the appended claims.

Claims

1. A sample collection container for a biopsy device, the sample collection container comprising: a sample capture body defining an interior space, the sample capture body being made of a fabric and having an interior sample capture surface at least partially surrounding the interior space, the fabric having a fold, the sample capture body having a pair of opposing surfaces extending from the fold; a frame to which the sample capture body is removably attached, the frame being an annular member having a frame opening and having at least two mounting protrusions extending outwardly from the annular member, wherein the mounting protrusions are configured to engage with a support ledge of a sample receiver, The sample collection container is detachably carried by a sample receiver, and the sample receiver is detachably mounted on the proximal end of a housing of a drive assembly of a biopsy device.

2. The sample collection container according to claim 1, wherein: The fabric has a rectangular pre-assembly shape comprising: a first side edge, a second side edge, a third side edge, and a fourth side edge, the first side edge being orthogonal to the third side edge and the fourth side edge, the second side edge being orthogonal to the third side edge and the fourth side edge, and the second side edge being laterally spaced apart from the first side edge; a first end surface portion adjacent the first side edge, the first end surface portion being split at the fold line to define a first attachment surface portion and a second attachment surface portion; a second end surface portion adjacent the second side edge, the second end surface portion being split at the fold line to define a third attachment surface portion and a fourth attachment surface portion; wherein a rectangular assembly front piece is folded at a folding line to create a crease, wherein a first attachment surface portion is attached to a second attachment surface portion by an adhesive, and a third attachment surface portion is attached to a fourth attachment surface portion by an adhesive, wherein the third side edge and the fourth side edge are oriented to form an opening.

3. The sample collection container according to claim 2, wherein: The annular member has a mounting surface surrounding the frame opening, the mounting surface having a plurality of mechanical fasteners around the frame opening, the plurality of mechanical fasteners being configured to attach to the fabric.

4. The sample collection container according to claim 3, wherein: The plurality of mechanical fasteners are each a slot formed in the mounting surface.

5. The sample collection container according to claim 3, wherein: The plurality of mechanical fasteners are each a burr projection that projects away from a mounting surface so as to engage a fabric.

6. The specimen collection container according to claim 1, wherein: The fabric has a plurality of side undulations.

7. The specimen collection container according to claim 1, wherein: The sample capture body has a circular sidewall that transitions to an annular pleated wall at a circular crease.

8. The sample collection container according to claim 7, wherein: The annular pleat walls are oriented at an acute angle relative to the circular side walls at the circular creases.

9. The sample collection container according to claim 7 or 8, wherein: The annular pleated wall has a plurality of pleats forming a plurality of cavities arranged in an annular pattern.

10. A biopsy device, comprising: a driver assembly comprising a housing having a proximal end; a vacuum source contained within the housing; a biopsy probe assembly releasably mounted on the housing, the biopsy probe having an elongated sample receiving member and a cutting cannula coaxial with the elongated sample receiving member; a sample receiver removably mounted on the proximal end of the housing, the sample receiver being in fluid communication with each of the biopsy probe assembly and the vacuum source; and a sample collection container, the sample collection container being detachably carried by the sample receiver, the sample collection container comprising a sample capture body defining an interior space, the sample capture body being made of a fabric and having an interior sample capture surface, the interior sample capture surface at least partially surrounding the interior space, the fabric having at least one fold; a frame to which the sample capture body is removably attached, the frame being an annular member having a frame opening and having at least two mounting protrusions extending outwardly from the annular member, wherein the mounting protrusions are configured to engage with a support ledge of a sample receiver, The sample collection container is detachably carried by a sample receiver, and the sample receiver is detachably mounted on the proximal end of a housing of a drive assembly of a biopsy device.

11. The biopsy device of claim 10, wherein: The sample collection container is provided according to any one of claims 2-9.

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