Apparatus and related methods for reducing fluid in a biopsy tissue processing system to improve imaging quality

Abstract

A tissue holder assembly includes a base including a bottom member, a central hub extending upwardly from the bottom member, and a circumferential sidewall extending upwardly from the bottom member and radially spaced apart from the central hub, the circumferential sidewall encircling the central hub and defining an interior region configured to receive a cylindrical tissue holder; the base further including an elevated platform spaced upwardly from the bottom member, the central hub extending through a central opening of the platform and configured to support the tissue holder; the bottom member, the central hub, and the circumferential sidewall collectively defining an annular fluid channel located below the platform; wherein the fluid channel extends around the central hub from the platform opening to a fluid outlet port in the circumferential sidewall; the base further including a flow comb located below the platform opening and extending into the fluid channel.

Description

[0001] Relevant application materials

[0002] This application claims priority to U.S. Provisional Application US62 / 941,395, filed November 27, 2019, pursuant to 35 U.S.SC §119. Technical Field

[0003] This disclosure generally relates to the preparation of biopsy tissue samples for imaging, and more specifically, to apparatus and methods for reducing fluid in the imaging field of a biopsy tissue processing apparatus such that the fluid does not interfere with the imaging of tissue samples in the tissue processing apparatus. Background Technology

[0004] A biopsy is a well-known medical procedure that involves removing tissue from a living body and examining it for diagnostic studies, such as determining the presence, cause, or extent of a disease. For example, a biopsy of human breast tissue can be performed to diagnose breast cancer or other diseases. Generally, biopsies can be performed via open surgery or percutaneous methods. An open surgery biopsy procedure involves making an open incision at the site of interest, cutting a tissue sample, and removing the tissue through the open incision. A percutaneous biopsy is performed by inserting a biopsy device with a needle and cutting mechanism through a small incision and advancing the needle and cutting mechanism to the site of interest. The cutting mechanism then cuts the tissue sample, and the biopsy device captures the tissue sample and removes it through a small incision. Percutaneous biopsy devices have been used in various ways to remove the tissue sample, such as simply removing the percutaneous biopsy device along with the captured tissue sample through a small incision, or transporting the tissue sample through a device (e.g., using a vacuum to aspirate the sample), in which the tissue sample can be removed through a tube or pulled into a container. One advantage of removing tissue samples from the biopsy device is that multiple samples can be collected without having to remove the biopsy device.

[0005] The tissue sample is then examined for diagnosis by imaging it using X-rays (although earlier X-ray imaging systems recorded on film, more recent X-ray imaging systems are digital and use semiconductor receptors to record), MRI (magnetic resonance imaging), or other suitable imaging devices. For example, the tissue sample can be placed on an imaging substrate (such as a tissue slide or membrane) and then placed in an imaging device to take an image.

[0006] Automated biopsy and imaging systems for performing biopsies and imaging tissue samples have also been disclosed. For example, U.S. Patent 9,492,130 B2 discloses an integrated biopsy analysis system comprising: a biopsy excision tool; a tissue sample transfer mechanism for automatically transferring the excised tissue sample from the biopsy excision tool to an analysis / imaging unit; and an analysis / imaging system for automatically analyzing the tissue sample, such as imaging using an X-ray imaging device. The entire contents of U.S. Patent 9,492,130 B2 are incorporated herein by reference. The disclosed biopsy analysis system excises a tissue sample and transfers and places the excised tissue sample into a tissue sample holder having multiple tissue receiving slots for holding multiple different tissue samples. The imaging unit is configured to acquire images of the tissue samples in the tissue sample holder, such as by acquiring a separate image of each tissue sample in a corresponding tissue receiving slot of the tissue sample holder. The integrated biopsy system includes: a biopsy apparatus for performing a biopsy, and an imaging system for acquiring an image of each biopsy tissue sample. The excised tissue samples are each transferred to a sample container in the tissue sample processing device and then imaged by an imaging system while in the sample container. Various fluids are present during the excision of the tissue sample and the transport of the tissue sample from the biopsy site on the patient to the tissue sample processing device. For example, bodily fluids such as blood and surgical solutions such as saline, anesthetics, and biological fluids may be present at the biopsy site (or even flowing through the biopsy device) when collecting and / or aspirating tissue samples from the biopsy device. Because the biopsy sample is transported from the biopsy site to the tissue sample processing device via a vacuum through fluid pathways (e.g., tubing, flow channels, etc.), these fluids are stored together with the tissue sample in the tissue sample processing device.

[0007] It has been found that fluid in the imaging field (the area imaged by the imaging device) interferes with the imaging process, thus reducing image quality, compared to images acquired without fluid in the imaging field. For example, when acquiring images using an imaging device such as an X-ray imaging device, droplets within the imaging field (such as fluid adhering to the bottom of a tissue sample holder, fluid adhering to the bottom of the housing holding the tissue sample holder, or even fluid adhering to the surface of the lid above the tissue sample holder) can appear as artifacts that obscure the image of the tissue of interest. Images of the sample tissue can be more effective for diagnosis if the sample tissue stands out with optimal contrast and clarity from any surrounding structures or surrounding fluid, and any tissue with features indicative of cancer (such as calcification) stands out from normal tissue. Artifacts in the image, for example, can include the container (in which the tissue sample is imaged) and other background elements (such as fluid transported with the tissue sample). In addition to effective diagnosis, it is important to confirm that high-quality images have been acquired for immediate evaluation of procedures, including accurately locating any lesions and determining whether any additional samples need to be collected. High-quality images further improve patient comfort by reducing the time patients are under pressure during biopsy and reduce the likelihood of patients needing to return to repeat the procedure due to insufficient images or incorrect tissue retrieval.

[0008] Therefore, various embodiments of the invention disclosed herein relate to apparatus and methods for reducing fluid from the imaging field of a tissue processing device, including preventing fluid from entering the imaging field and / or removing fluid that has entered the imaging field.

[0009] A tissue retainer assembly includes a base comprising a bottom member, a central hub extending upward from the bottom member, and circumferential sidewalls extending upward from the bottom member and radially spaced from the central hub, the circumferential sidewalls surrounding the central hub and defining an interior region configured to receive a cylindrical tissue retainer; the base also includes a raised platform spaced upward from the bottom member, an upper portion of the central hub extending through a central opening of the platform, wherein the central hub is configured to support the tissue retainer; the bottom member, the central hub, and the circumferential sidewalls collectively define an annular fluid channel located below the platform, the fluid channel being in fluid communication with the platform opening; wherein the fluid channel extends from the platform opening around the central hub to a fluid outlet port in the circumferential sidewalls; and wherein the base also includes a flow comb located below the platform opening and extending into the fluid channel.

[0010] Optionally, the comb has an arc shape.

[0011] Optionally, the flow comb includes at least four flow channels.

[0012] Optionally, the comb may include a hydrophobic coating and / or an anti-coating coating.

[0013] Alternatively, the fluid channel is configured to provide unidirectional fluid flow around the central hub via an angular range of at least 180°.

[0014] Optionally, the fluid channels are configured to provide unidirectional fluid flow around the central hub within an angular range of 270° ± 20°.

[0015] Optionally, the central hub of the base includes a mandrel configured to receive a tissue retainer, and wherein a platform extends circumferentially about at least a majority of the space between the central hub and the circumferential sidewalls.

[0016] Optionally, the tissue retainer assembly further includes a pressurization chamber and a suction port, the pressurization chamber being in fluid communication with a fluid channel and the suction port being configured to provide suction within the pressurization chamber.

[0017] Optionally, the pressurization chamber is higher than the circumferential sidewall of the base.

[0018] Optionally, the tissue retainer assembly also includes a tissue retainer configured to be placed in an internal region, the tissue retainer having a plurality of tissue storage compartments, wherein the bottom of the tissue retainer includes a filter that allows fluid in one or more of the tissue storage compartments to flow through it.

[0019] Optionally, the tissue retainer assembly also includes a cover configured to be detachably attached to the base, wherein the cover includes a tissue inlet port configured to deliver a tissue sample at a location above the platform opening.

[0020] Optionally, the length of the flow comb is longer than the size of the platform opening measured along the longitudinal axis of the fluid channel.

[0021] A tissue retainer assembly includes: a base including a bottom member, a central hub extending upward from the bottom member, and a circumferential sidewall extending upward from the bottom member and radially spaced from the central hub, the circumferential sidewall surrounding the central hub and defining an interior region configured to receive a cylindrical tissue retainer; the base also includes an elevated platform spaced upward from the bottom member, an upper portion of the central hub extending through a central opening of the platform, wherein the central hub is configured to support the tissue retainer; the bottom member, the central hub, and the circumferential sidewall together define an annular fluid channel located below the platform, the fluid channel being in fluid communication with an opening in the platform; wherein the fluid channel extends from the platform opening around the central hub to a fluid outlet in the circumferential sidewall; and wherein the tissue retainer assembly also includes a pressurization chamber located outside the circumferential sidewall, wherein the pressurization chamber is in fluid communication with the fluid channel and with a suction port configured to provide suction in the pressurization chamber.

[0022] Alternatively, the suction port is located at one end of the pressurization chamber.

[0023] Optionally, the pressurization chamber is higher than the circumferential sidewall of the base.

[0024] Optionally, the suction port is also configured to provide suction in the fluid channel.

[0025] Alternatively, the fluid channel is configured to provide unidirectional fluid flow around the central hub via an angular range of at least 180°.

[0026] Optionally, the fluid channels are configured to provide unidirectional fluid flow around the central hub within an angular range of 270° ± 20°.

[0027] Optionally, the central hub of the base includes a mandrel configured to receive a tissue retainer, and wherein a platform extends circumferentially about at least a majority of the space between the central hub and the circumferential sidewalls.

[0028] Optionally, the tissue retainer assembly also includes a flow comb below the platform opening, the flow comb extending within the fluid channel.

[0029] Optionally, the length of the flow comb is longer than the size of the platform opening measured along the longitudinal axis of the fluid channel.

[0030] A tissue retainer assembly includes: a base including a bottom member, a central hub extending upward from the bottom member, and a circumferential sidewall extending upward from the bottom member and radially spaced from the central hub, the circumferential sidewall surrounding the central hub and defining an interior region configured to receive a cylindrical tissue retainer; the base also includes an elevated platform spaced upward from the bottom member, an upper portion of the central hub extending through a central opening of the platform, wherein the central hub is configured to support the tissue retainer; the bottom member, the central hub, and the circumferential sidewall together define an annular fluid channel located below the platform, the fluid channel being in fluid communication with the platform opening; wherein the fluid channel extends from the platform opening around the central hub to a fluid outlet port in the circumferential sidewall, thereby providing unidirectional fluid flow around the central hub of the base.

[0031] Alternatively, the fluid channel is configured to provide unidirectional fluid flow around the central hub via an angular range of at least 180°.

[0032] Optionally, the fluid channels are configured to provide unidirectional fluid flow around the central hub within an angular range of 270° ± 20°.

[0033] Optionally, the tissue retainer assembly also includes a flow comb below the platform opening, the flow comb extending within the fluid channel.

[0034] Optionally, the comb has an arc shape.

[0035] Optionally, the flow comb includes at least four flow channels.

[0036] Optionally, the length of the flow comb is longer than the size of the platform opening measured along the longitudinal axis of the fluid channel.

[0037] Optionally, the tissue retainer assembly also includes a pressure chamber, wherein a fluid passage is in fluid communication with the pressure chamber.

[0038] Other and further aspects and features will become apparent from the following detailed description. Attached Figure Description

[0039] The accompanying drawings illustrate the design and practicality of the embodiments, wherein similar elements are indicated by common reference numerals. These figures are not necessarily drawn to scale. To better understand how the above and other advantages and objectives are achieved, a more detailed description of the embodiments shown in the accompanying drawings will be given. These drawings illustrate exemplary embodiments only and should not be considered as limiting the scope of the invention.

[0040] Figure 1 The components of a tissue retainer assembly, including a base, a cap, and a tissue retainer, are shown.

[0041] Figure 2 The assembled Figure 1 Tissue retainer components;

[0042] Figure 3 It shows Figure 1 Tissue retainer;

[0043] Figure 4 It includes Figure 1 A schematic diagram of a biopsy system with a tissue retainer assembly;

[0044] Figure 5 It shows Figure 1 A partially transparent view of the tissue retainer component;

[0045] Figure 6 It shows Figure 1 The tissue retainer assembly, which does not have a cover for the tissue retainer assembly;

[0046] Figure 7 It shows Figure 1 A partially transparent view of the base of the tissue retainer component;

[0047] Figure 8 It shows Figure 1 The base of the tissue retainer assembly is shown in particular, with a base having a platform;

[0048] Figure 9 It shows Figure 8 The base, specifically showing the platform with the base removed;

[0049] Figure 10 It shows Figure 1 A partial cross-sectional view of the tissue retainer assembly, without the cover of the tissue retainer assembly;

[0050] Figure 11 It shows Figure 1 Another partial cross-sectional view of the tissue retainer assembly;

[0051] Figure 12 It shows Figure 11 A partial cross-sectional view of the tissue retainer assembly, particularly showing the direction of fluid flow;

[0052] Figure 13 The following diagrams are shown for use and / or operation. Figure 1 A flowchart of the method for the tissue retainer component;

[0053] Figure 14 Another tissue retainer assembly with a base, a cap, and a tissue retainer is shown;

[0054] Figure 15 It shows Figure 14The tissue retainer assembly, specifically showing the tissue retainer assembly with its cover removed;

[0055] Figure 16 A partially transparent view of the base of another tissue retainer component is shown;

[0056] Figure 17 It shows Figure 16 The tissue retainer assembly, which has no tissue retainer and partially shows the cap; and

[0057] Figure 18 A method for removing fluid from a tissue retainer is shown. Detailed Implementation

[0058] Various embodiments are described below with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements with similar structures or functions are indicated by the same reference numerals throughout the drawings. It should also be noted that the drawings are intended only to facilitate the description of embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. Furthermore, the illustrated embodiments do not need to have all the aspects or advantages shown. Aspects or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment and can be implemented in any other embodiment, even if not so stated or explicitly described.

[0059] Figure 1-3 An embodiment of a tissue retainer assembly 10 for receiving multiple tissue samples is shown. The tissue retainer assembly 10 includes a housing 12 having a base 14 and a cover 16 detachably attached to the base 14. The base 14 and the attached cover 16 form an interior or chamber encapsulating a tissue retainer 18. The base 14 has a hub 35 with a spindle 36 receiving a hub 38 of the tissue retainer 18, allowing the tissue retainer 18 to rotate relative to the housing 12 about an axis 20. In other words, the base 14 and cover 16 remain stationary while the tissue retainer 18 rotates within the chamber formed by the base 14 and cover 16. The tissue retainer 18 can be rotated using any suitable actuator and may include a magnet detected by a Hall effect sensor to identify when the tissue retainer is in its initial position.

[0060] The base 14 has a bottom member 43 and circumferential sidewalls 41 extending upward from the bottom member 43. The bottom member 43 may include a generally flat plate. The bottom member 43 has a plurality of retaining clips 45a, 45b that are detachably attached to the tissue biopsy system 50 (see...). Figure 1 and 4The mandrel 36 is attached to and extends upward from the bottom member 43. The tissue retainer 18 has a bottom 21 and circumferential sidewalls 25 extending upward from the bottom 21. The tissue retainer 18 has a plurality of tissue storage compartments 22 (in this case, the tissue retainer 18 has 13 tissue storage compartments 22, but any number of tissue storage compartments 22 can be used) arranged at an angle around the tissue retainer 18. The tissue storage compartments 22 are defined by radial partition walls 23 that extend radially from the hub 38 to the circumferential sidewalls 25. The tissue storage compartments 22 (also referred to as tissue containers 22) are separated and partially formed by the radially extending compartment walls 23. In an exemplary embodiment, the tissue retainer 18 has a circular shape such that the tissue storage compartments 22 are wedge-shaped (i.e., pie-shaped, part of a circle) or part of an annulus if the central portion of each tissue storage compartment 22 does not extend all the way to the axis 20. The tissue container 22 is connected to the hub 38 of the tissue retainer 18, which is centered at axis 20. The hub 38 is circular and has an opening that allows the mandrel 36 of the base 14 to pass through for assembly.

[0061] The bottom 21 of the tissue retainer 18 has a tissue filter 24 comprising porous filter material. The tissue filter 24 may be a single filter, such as a filter sheet covering the entire bottom of the tissue retainer 18. Alternatively, the tissue filter 24 may be a separate filter disposed on the bottom of each tissue storage compartment 22.

[0062] The tissue retainer assembly 10 also includes a platform 70 having a platform opening 72 and a fluid channel 78 located below the platform 70 (see the dashed arrow pointing to the fluid channel 78 below the platform 70). The platform 70 has a planar horizontal surface. In some embodiments, the bottom of the tissue retainer 18 may rest on the planar horizontal surface of the platform 70 when the tissue retainer 18 is rotated relative to the base 14. In other embodiments, the bottom of the tissue retainer 18 may be spaced apart from the planar horizontal surface of the platform 70 by a small distance, such as less than 0.5 mm, less than 0.2 mm, less than 0.1 mm, or less than 0.05 mm. The platform 70 extends around a hub 35. In particular, the platform has a central opening that allows the upper portion of the hub to extend through it. The fluid channel 78 extends circumferentially around the hub 35 of the base 14 below the platform 70 and is in fluid communication with a pressurization chamber 80 at the base 14. A suction line 48 is coupled to the pressurization chamber 80 for applying suction within the pressurization chamber 80 and the fluid channel 78. The tissue retainer assembly 10 also includes a flow comb 74 below the platform opening 72. In some embodiments, the flow comb 74 extends from the platform opening 72 into a fluid channel 78. During use, fluid from the tissue retainer 18 is drawn into the platform opening 72 due to suction applied to the fluid channel 78 by the suction line 48. The flow comb 74 disperses the fluid, and the fluid is transported by the fluid channel 78 around the hub 35 to the pressurization chamber 80. The pressurization chamber 80 allows a certain amount of fluid to be collected while fluid is drawn from the pressurization chamber 80 by the suction line 48 via the outlet port 44 (also referred to as the vacuum port 44). In some embodiments, the outlet port 44 has an inner diameter of 0.26 inches. In other embodiments, the inner diameter of the outlet port 44 may have other dimensions, which may be greater than or less than 0.26 inches.

[0063] The fluid passage 78 can extend circumferentially around the hub 35, allowing the fluid in the fluid passage 78 of the base 14 to travel a certain angular distance around the hub 35 to reach the pressurization chamber 80. For example... Figure 1 As shown, the fluid passage 78 extends circumferentially about 270° around the hub 35 and an angular distance of about 270° to reach the pressurization chamber 80. It should be understood that the pressurization chamber can be located at any other point along the fluid path, and the fluid passage 78 can extend through other angular ranges. For example, in other embodiments, the fluid passage 78 can extend around the hub 35 through an angle of at least 30° and at most 300°. Furthermore, in the illustrated embodiment, the platform 70 extends circumferentially around most of the space between the hub 35 and the circumferential sidewall 41. In other embodiments, the platform 70 can extend around the hub 35 beyond the illustrated range, and / or may include perforations, holes, and / or slits to allow liquid to flow through the platform 70 into the fluid passage.

[0064] like Figure 1As shown, the tissue holder assembly 10 also includes an imaging platform 71 corresponding to an imaging position for imaging a tissue sample. The tissue holder assembly 10 includes an imager located below the imaging platform 71. Specifically, when a tissue sample in the tissue holder 18 is placed above the imaging platform 71, it can then be imaged by the imager below the imaging platform 71. In some embodiments, the imaging platform 71 is a molded part with a solid wall that rises above the bottom member 43 to prevent fluid buildup in and around the imaging area. During use, one of the tissue storage compartments 22 containing the tissue sample to be imaged is placed above the imaging platform 71. In some cases, a filter 24 at the bottom of the tissue holder 18 may sit flush with the imaging platform 71. It should be noted that the imaging platform 71 is a separate component from the platform 70 and does not define any fluid channels.

[0065] like Figure 1 As shown, the cover 16 also includes a protrusion 92 that defines an arcuate compartment corresponding to the imaging position of the tissue sample. Specifically, imaging can be performed to image the tissue sample when one of the tissue storage compartments 22 containing the tissue sample is positioned below the protrusion 92 and above the imaging platform 71. The cover 92 also includes an anchoring portion 98 configured to engage with a protrusion 99 at the circumferential sidewall 41 of the base 14. To lock the cover 16 against the base 14, the cover 16 can be positioned above the base 14 to cover the circumferential sidewall 41, and then the cover 16 can be rotated relative to the base 14 to position the anchoring portion 98 around the protrusion 99, thereby locking the cover 16 against the base 14. In the illustrated embodiment, two anchoring portions 98 are provided on opposite sides of the cover 16 for engaging with corresponding protrusions 99 on opposite sides of the circumferential sidewall 41. In other embodiments, more than two anchoring portions 98 or only one anchoring portion 98 may be present. Similarly, in other embodiments, there may be two or more protrusions 99 or only one protrusion 99.

[0066] In some embodiments, the platform opening 72, fluid channel 78, and flow comb 74 can be considered part of a fluid removal mechanism. The fluid removal mechanism is configured to remove fluid from a filter 24 located below the bottom of a plurality of tissue storage compartments 22 to improve the image quality of tissue samples acquired in the tissue storage compartments. In other embodiments, structures involved in defining the fluid channel 78 can also be considered part of the fluid removal mechanism. For example, the platform 78 above the fluid channel 78, the bottom member of the base 14 below the fluid channel 78, or both can be considered part of the fluid removal mechanism. In other embodiments, the pressurization chamber 80, the suction line 48, or both can be considered part of the fluid removal mechanism.

[0067] The tissue retainer assembly 10 has a tissue sample inlet port 42 (also called inlet port 42) at the cap 16, and an inlet tube 46 is connected to the tissue sample inlet port 42 (see Figure 1 and Figure 4 The other end of the inlet tube 46 is connected to the biopsy excision tool 60 (see...). Figure 4 This allows tissue samples removed by the biopsy excision tool 60 to be transported through the inlet tube 46 from the biopsy excision tool 60 to the tissue holder assembly 10 and into one of the tissue storage compartments 22. The outlet port 44 of the tissue holder assembly 10 is connected to an aspiration tube 48. The other end of the aspiration tube 48 is connected to an aspiration canister 62 or another suitable vacuum source (see [link to document]). Figure 4 The outlet port 44 draws liquid and / or other materials from the base 14 via the fluid channel 78 and the pressurization chamber 80, and also provides a vacuum in the chamber formed by the housing 12 for drawing tissue samples through the inlet port 42 for storage in the corresponding tissue storage compartment 22 of the tissue holder 18.

[0068] refer to Figure 4 A schematic diagram of a tissue biopsy system 50 is shown. Although Figure 4 The schematic diagram only shows certain features of the biopsy system 50, but the biopsy system 50 can be a biopsy system disclosed in U.S. Patent 9,492,130 B2 cited above, and can include any features disclosed therein. The biopsy system 50 includes a tissue retainer assembly 10 attached to a biopsy excision tool 60 and an aspiration canister 62. The biopsy system 50 also includes an imaging unit 64 configured to capture images of tissue samples contained in each tissue storage compartment 22. The imaging unit 64 has an imaging device 66 (such as an X-ray imaging device 66) or other suitable imaging device for capturing images. The imaging device 66 has an imaging field in which it can acquire images of material located within the imaging field.

[0069] Now refer to Figures 5 to 12 The tissue retainer assembly 10 is described in more detail. Figure 5 Show Figures 1 to 2 A partially transparent view of the tissue retainer assembly 10. As shown, the cover 16 is illustrated as partially transparent, allowing the tissue retainer 18 beneath the cover 14 to be seen. Figure 6 The tissue retainer assembly 10 is shown with the cover 16 removed. As shown, the circumferential sidewall 41 of the base 14 defines a space for receiving the tissue retainer 18. When the tissue retainer 18 is rotatably coupled to the base 14, the tissue retainer 18 is separated from the circumferential sidewall 41 of the base 14 by a gap 90. This allows the tissue retainer 18 to rotate undisturbed relative to the base 14. Figure 7The base 14 of the tissue retainer assembly 10 is shown, with the cover 16 and tissue retainer 18 removed. As shown, the platform 70 of the base 14 of the tissue retainer assembly 10 is presented in a partially transparent manner to illustrate a portion of the comb 74 beneath the platform 70.

[0070] Figure 8 The base 14 of the tissue retainer assembly 10 is shown, with the platform 70 partially transparently represented. In the illustrated embodiment, a platform opening 72 is formed between one end of the platform 70 and the imaging platform 71. In other embodiments, the platform opening 72 may be formed within the platform 70 without utilizing the imaging platform 71.

[0071] Figure 9 The base 14 of the tissue retainer assembly 10 is shown, specifically with the platform 70 removed from the base 14. The extent of the imaging platform 71 and the flow comb 74 can be seen. As shown, the base 14 includes a bottom member 76 surrounded by circumferential sidewalls 41 of the base 14. The height of the bottom member 76 is less than the height of the flow comb 74. In some embodiments, the imaging platform 71 and / or the flow comb 74 may be molded together with the bottom member 76 of the base 14. As shown, the flow comb 74 has an arcuate shape that allows fluid to be delivered from the platform opening 72 along a curved path into the fluid channel 78. In the illustrated embodiment, the flow comb 74 has six parallel flow channels 75. In other embodiments, the flow comb 74 may have more than six parallel flow channels 75 (e.g., seven, eight, nine channels, etc.) or fewer than six flow channels 75 (e.g., five, four, three, two channels). In some cases, the flow comb 74 may include at least four flow channels. Furthermore, in the illustrated embodiment, the length of the flow comb 74 is longer than the dimension of the platform opening 72 measured along the longitudinal axis of the fluid channel 78. In other embodiments, the length of the flow comb 74 is shorter than or the same as the dimension of the platform opening 72 measured along the longitudinal axis of the fluid channel 78. Moreover, in the illustrated embodiment, a first portion of the flow comb 74 adjacent to the platform opening 72 may have a first slope that is approximately perpendicular (e.g., 90° ± 20°), a second portion of the flow comb 74 following the first portion may have a second slope that is approximately 45° ± 20°, and a third portion of the flow comb 74 following the second portion and extending within the fluid channel 78 may have a third slope that is approximately 0° ± 20°. In other embodiments, the flow comb 74 may have other inclined profiles. In some embodiments, surface treatments may be applied to the flow comb 74 to facilitate fluid flow on the flow comb 74. For example, in some embodiments, an anticoagulant coating, a hydrophobic coating, or other treatments may be applied to the surface of the flow comb 74.

[0072] like Figure 10As shown, the bottom member 76 and the platform 70 together define a fluid passage 78. When the tissue retainer 18 is coupled to the base 14, the platform 70 and the fluid passage 78 are located below the tissue retainer 18. The fluid passage 78 is configured to provide suction for delivering fluid through the fluid passage 78. As used herein, the term "fluid passage" can be any passage capable of delivering fluid, such as a gas (e.g., air) and / or a liquid.

[0073] Figure 11 A partial cross-sectional view of the tissue retainer assembly 10 is shown, particularly illustrating the tissue retainer 18 mounted within the interior defined by the base 14 and the cover 16. The cover 16 of the tissue retainer assembly 10 includes a protrusion 94 configured to engage with an opening 96 at the hub 38 of the tissue retainer 18. The lower portion of the hub 38 of the tissue retainer 18 has an opening for receiving a hub 35 of the base 14. The hub 38 also has a groove for receiving a spindle 36 of the base 14. Rotation of the spindle 38 will cause the tissue retainer 18 to rotate relative to the base 14. The protrusion 94 from the cover 16 and the hub 35 of the base 14 extend from opposite directions into the hub 38 of the tissue retainer 18, thereby stabilizing the tissue retainer 18 as it is rotated by the spindle 36. Therefore, the tissue retainer 18 is detachably coupled to the spindle 36 (drive member) at the base 14 and configured to selectively rotate by the spindle 36 about an axis that is substantially orthogonal (e.g., 90° ± 10°) relative to the bottom member 76.

[0074] like Figure 11 As shown, the inlet port 42 at the cover 16 is radially aligned with the corresponding tissue storage compartment 22, and also radially aligned with the platform opening 72 formed at least partially together with the platform 70. Therefore, when a tissue sample and fluid are delivered together into the inlet port 42, the tissue sample and fluid will be stored in the corresponding tissue storage compartment 22. The tissue sample will be received by the filter 24 at the bottom of the tissue holder 18, while the fluid will flow out through the filter 24 and through the platform opening 72 of the platform 70. During use of the tissue holder assembly 10, suction will be provided within the fluid channel 78 to assist in drawing fluid from the bottom of the tissue holder 18 into the platform opening 72.

[0075] Figure 12 It shows Figure 11 A partial cross-sectional view of the tissue retainer assembly 10, particularly showing the direction of fluid flow. As shown, fluid originates from the biopsy device 60 ( Figure 4Tissue samples and fluid (as shown) enter the tissue holder assembly 10 via inlet port 42. The tissue sample is stored in one of the tissue storage compartments 22 within the tissue holder 18. A filter 24 at the bottom of the tissue holder 18 prevents the tissue sample from exiting through the bottom of the tissue holder 18, while allowing fluid to pass through. Due to suction provided in the fluid channel 78, fluid enters the platform opening 72 at the platform 70 and is dispersed by the flow comb 74 inside the fluid channel 78. Then, due to the suction force within the fluid channel 78, the fluid is conveyed through the fluid channel 78 and exits via outlet port 97 at the circumferential sidewall 41 of the base into the pressurization chamber 80. The pressurization chamber 80 allows a certain amount of fluid to be collected while simultaneously discharging fluid from the pressurization chamber 80 via outlet port 44 (as shown). Figure 1 (As shown) It is drawn into the suction line 48.

[0076] Reference Figure 13 The method 100 for using and operating the tissue retainer assembly 10 will now be described. At item 102, the tissue retainer assembly 10 is installed into an automated biopsy system 50, such as the system described in the aforementioned U.S. Patent 9,492,130B2, wherein a biopsy excision tool 60 is connected to an inlet tube 46 and a vacuum source is connected to a suction tube 48. The tissue retainer assembly 10 or only the tissue retainer 18 (e.g., the tissue retainer 18 may be installed into the tissue retainer assembly, which is installed in the automated biopsy system 50) may be manually installed into the automated biopsy system 50, or the automated biopsy system 50 may include a robot configured to automatically install the tissue retainer assembly 10 or only the tissue retainer 18 into the automated biopsy system 50.

[0077] At item 104, the tissue holder 18 is rotated to position the first tissue storage compartment 22 in the loading position of the tissue holder 18, such that tissue samples delivered through the inlet port 42 are stored in the first tissue storage compartment of the tissue holder 18. When the first tissue storage compartment 22 is in the loading position, it is also located above the platform opening 72.

[0078] At item 106, a first tissue sample is removed using a biopsy excision tool 62, and the first tissue sample is transported through an inlet tube 46 and an inlet port 42 and stored in the first tissue storage compartment 22 of the tissue holder 18.

[0079] At item 108, fluid residue accumulated on the bottom surface of the filter 24 below the first tissue storage compartment 22 is removed. Specifically, suction is applied in the fluid channel 78 to draw fluid from the bottom of the first tissue storage compartment 22 into the platform opening 72. The fluid is then delivered to the pressurization chamber 80 via the fluid channel 78 and extracted from the pressurization chamber 80 via the suction line 48. The flow of fluid in item 108 can be... Figure 12 The process occurs as shown. In the illustrated embodiment, fluid is delivered counterclockwise through the channel opening 72 in the fluid channel 78 to reach the pressurization chamber 80. In other embodiments, the position of the pressurization chamber 80 relative to the platform opening 72 can be changed, and the configuration of the flow comb 74 can be reversed, such that fluid is delivered clockwise through the channel opening 72 in the fluid channel 78 to reach the pressurization chamber 80.

[0080] return Figure 13 At item 110, the first tissue storage compartment 22 is positioned in the imaging field of the imaging unit 64 to obtain an image of the first tissue sample in the first tissue storage compartment 22. The imaging field may be positioned adjacent to the platform opening 72. In the illustrated embodiment, after aspiration is applied to remove fluid from the bottom of the first tissue storage compartment 22 (when the first tissue storage compartment 22 is in the loading position), the tissue holder 18 may be rotated clockwise to move the first tissue storage compartment 22 from the loading position above the platform opening 72 to the imaging position above the surface 71. Thus, in some embodiments, fluid travels counterclockwise in the fluid channel 78, and the tissue holder 18 rotates clockwise. Alternatively, the tissue holder 18 may rotate counterclockwise.

[0081] At item 112, an image of the first tissue sample is acquired using imaging unit 64.

[0082] At item 114, the tissue holder 18 is rotated to position the second tissue storage compartment 22 in the loading position of the tissue holder 18, such that a tissue sample delivered through the inlet port 42 can be stored in the second tissue storage compartment 22. This positioning can occur during the same movement as at item 110. In other words, when the first tissue storage compartment 22 is moved to the imaging position, the second tissue storage compartment 22 can be positioned in the loading position. When the second tissue storage compartment 22 is in the loading position, it is located above the platform opening 72.

[0083] At item 116, the second tissue sample is removed using the biopsy excision tool 60, and the second tissue sample is transported through the inlet tube 46 and the inlet port 42 and stored in the second tissue storage compartment 22 of the tissue holder 18.

[0084] At item 118, fluid residue accumulated on the bottom surface of the filter 24 below the second tissue storage compartment 22 is removed. Specifically, suction is applied in the fluid channel 78 to draw fluid from the bottom of the second tissue storage compartment 22 into the platform opening 72. The fluid is then delivered to the pressurization chamber 80 via the fluid channel 78 and extracted from the pressurization chamber 80 via the suction line 48. The flow of fluid in item 108 can be... Figure 12 It occurs as shown.

[0085] return Figure 13 At item 120, the second tissue storage compartment 22 is positioned within the imaging field of the imaging unit 64 to obtain an image of the second tissue sample in the second tissue storage compartment 22. Similarly, the imaging field can be positioned just past the platform opening 72.

[0086] At item 122, an image of the second tissue sample is acquired using imaging unit 64. This process is repeated until all desired tissue samples have been acquired, stored in tissue storage compartments 22, and images of all corresponding tissue samples in each tissue storage compartment 22 have been acquired.

[0087] Alternatively, images of the tissue samples in the tissue storage compartments 22 can be acquired after all samples have been acquired. First, all tissue samples are acquired and stored in their respective tissue storage compartments 22 by rotating each tissue storage compartment 22 to the loading position, removing the tissue sample, and storing the tissue sample in its corresponding tissue storage compartment 22. Then, the tissue holder 18 is rotated to remove fluid from each tissue container 22 in the tissue holder 18 and the tissue samples in the tissue holder assembly 10 are imaged. The tissue samples can be imaged all at once by taking a single image of all tissue containers 22 in the tissue holder 18, processing the images to identify the individual tissue containers 22, and separating the individual images from the individual tissue containers 22. Alternatively, the tissue holder 18 can be rotated to acquire individual images of each container until images of all corresponding tissue samples in each tissue container 22 have been captured. In yet another embodiment, the tissue holder assembly 10 is placed in an imaging unit, such as an X-ray imaging device. In a manual system, the filter assembly 10 can be manually installed in the imaging unit 54.

[0088] In an automated integrated system such as the one described above, the tissue holder assembly 10 is already located in the imaging unit 64 during biopsy resection, or a robot can place the tissue holder assembly 10 in the imaging unit 64. The tissue holder 18 is then rotated to move the tissue storage compartment 22 across the platform opening 72 to remove fluid, positioning the tissue storage compartment 22 in the imaging position, and images are acquired using the imaging unit 64. This process is repeated for each tissue storage compartment 22 containing the tissue sample to be imaged.

[0089] It should be noted that the platform 70 of the fluid removal system is advantageous because it holds the fluid below it and protects the tissue retainer 18 from the fluid's influence. Without the platform 70, fluid could splash onto the imaging platform 71 when it enters the fluid retainer assembly 10 and during fluid transfer. Furthermore, the platform 70 is advantageous because it prevents the housing 12 from becoming filled with fluid during use. Without the platform 70, excess fluid could accumulate within the housing 12 and potentially rise to a level that causes the tissue sample in the tissue retainer 18 to float. Moreover, it is advantageous that the fluid channel 78 extends at least partially around the hub 35 of the base 14 because it provides a channel length that allows some fluid to be collected and prevents excessive fluid buildup. Additionally, the flow comb 74 is advantageous because it breaks the fluid into finer droplets, allowing for easier aspiration of fluid through the suction force within the fluid channel 78. The flow comb 74 also allows the fluid to flow more easily within the fluid channel 78.

[0090] It should be noted that the tissue retainer assembly 10 is not limited to the configuration shown in the examples above, and the tissue retainer assembly 10 may have other configurations in other embodiments. For example, in other embodiments, the cover 16 of the tissue retainer assembly 10 may have an inclined cover portion that at least partially defines an arcuate compartment for protecting the inlet port (tissue entry port) 42. Figure 14 Another tissue retainer assembly 10 according to a different embodiment is shown. Except that the cap 16 has an inclined cap portion 200, the tissue retainer assembly 10 is similar to the referenced one. Figures 1 to 3 The tissue retainer assembly described is identical. The sloping cover portion 200 at least partially defines the arcuate compartment protecting the inlet port 42. The sloping cover portion 200 is advantageous because the slope allows fluid to flow away. In other embodiments, the cover portion 200 may have other shapes. For example, in other embodiments, the cover portion 200 corresponding to the imaging space may be dome-shaped, pyramidal, trapezoidal, or other shapes.

[0091] Figure 14 Tissue retainer assembly and reference Figures 1 to 3The described embodiment also differs in that the pressurization chamber 80 has different dimensions and shape. Specifically, Figure 14 The volume of the pressurization chamber 80 is larger than that of the pressurization chamber previously described. Furthermore, Figure 14 The pressurization chamber 80 has a height higher than the circumferential sidewall 41 of the base 14 (see...). Figure 15 ). Figure 15 The diagram shows Figure 14 The tissue retainer assembly 10 is shown, particularly with the cover 16 removed. As shown, the pressurization chamber 80 has an opening 300 for receiving fluid from a fluid channel 78 (not shown) below the platform 70. The opening 300 and the outlet port 44 are located at opposite ends of the pressurization chamber 80. After use, fluid from the bottom of the tissue retainer 18 enters the platform opening 72 and is dispersed by a flow comb 74 within the fluid channel 78 (not shown) below the platform 70. Figure 15 As shown, suction in fluid passage 78 causes fluid to be transported along fluid passage 78 extending circumferentially around hub 35. The fluid then enters opening 300 located in the wall of pressurization chamber 80 to reach the cavity in pressurization chamber 80. It is then extracted from pressurization chamber 80 via outlet port 44. The path of the fluid is indicated by dashed arrow 210 in the figure.

[0092] Figures 16 to 17 Another tissue retainer assembly 10 according to a different embodiment is shown. Except that the pressure chamber 80 has a different size and shape, the tissue retainer assembly 10 is similar to the reference one. Figures 1 to 3 The tissue retainer components described are the same. Specifically, Figures 16 to 17 The volume of the pressurization chamber 80 is larger than that of the previous reference. Figure 1-3 The described pressurization chamber 80 has a large volume. Furthermore, Figure 16 The height of the pressurization chamber 80 is higher than the height of the circumferential sidewall 41 of the base 41. For example... Figure 16 As shown, the pressurization chamber 80 includes a wall with a first opening 300 in fluid communication with a fluid passage 78 below the platform 70. The pressurization chamber 80 also includes a second opening 302 in fluid communication with an outlet port 44. Figure 16 In the figure, platform 70 is shown with a partially transparent construction to reveal the components beneath the platform. As shown, tissue retainer assembly 10 includes channel sidewalls 310, 312, which are connected to platform 70 and bottom member 76 (e.g., Figure 17 (As shown) Collaboration to define fluid channel 78.

[0093] During use, fluid enters the platform opening 72 and is dispersed by the flow comb 74 within the fluid channel 78 below the platform 70. For example... Figure 16As shown, suction in the fluid channel 78 causes fluid to be transported along the fluid channel 78 extending circumferentially around the hub 35. The fluid then enters the first opening 300 in the wall of the pressurization chamber 80 to reach the cavity in the pressurization chamber 80. The fluid is then drawn out from the second opening 302 in the pressurization chamber 80 and exits via the outlet port 44. The path of the fluid is indicated by the dashed arrow 210 in the figure.

[0094] like Figure 17 As shown, the tissue retainer assembly 10 also includes a pressure chamber cover 320 for covering the pressure chamber 80. The platform 70 and channel sidewalls 310, 312 are removed to reveal the bottom member 76 of the base 14.

[0095] In other embodiments, sidewalls 310, 312 are optional, and the outer wall of hub 35 and the inner surface of circumferential sidewall 41 may define the width of fluid passage 78.

[0096] The tissue retainer assembly 10 may have other configurations in other embodiments and should not be limited to the described embodiments. For example, in one or more embodiments described herein, the comb 74 is optional, and the tissue retainer assembly 10 may not include the comb 74. Furthermore, in other embodiments, the pressure chamber 80 is optional, and the tissue retainer assembly 10 may not include the pressure chamber 80. In this case, the suction line 48 may be coupled to the circumferential sidewall 41 of the base 14, and the circumferential sidewall 41 of the base 14 may include an opening for coupling the suction line 48. In other embodiments, the pressure chamber 80 may be positioned remotely from the base 14. For example, the suction line 48 may be coupled to the pressure chamber 80 remotely from the base 14, and another suction line coupled to the pressure chamber 80 may apply suction to remove fluid from within the pressure chamber 80.

[0097] Figure 18 A method 1800 for removing fluid from a tissue retainer is illustrated. Method 1800 is performed using a tissue retainer assembly 10. Method 1800 includes receiving a tissue sample and fluid by the tissue retainer, wherein the tissue retainer includes a bottom having a filter, and wherein the tissue retainer is rotatably coupled to a base of the tissue retainer assembly having a hub (item 1802). Method 1800 further includes applying aspiration to remove fluid from the bottom of the tissue retainer, wherein aspiration is applied through a fluid channel below a platform beneath the tissue retainer of the tissue retainer assembly (item 1804). Method 1800 further includes conveying the removed fluid via the fluid channel, wherein the removed fluid is conveyed unidirectionally by the fluid channel around the hub of the base (item 1806).

[0098] Optionally, in method 1800, the removed fluid is conveyed to a pressurization chamber. Optionally, method 1800 further includes dispersing the fluid via a flow comb. Optionally, method 1800 further includes a platform opening, wherein the flow comb extends below the platform opening and within a fluid channel. Optionally, in method 1800, the tissue retainer assembly includes a base having a base member, the base member and the platform defining a fluid channel, wherein fluid is conveyed between the base member and the platform. Optionally, in method 1800, the removed fluid is conveyed along an arcuate path. Optionally, method 1800 further includes a platform opening, wherein the tissue retainer assembly includes a cap having a tissue inlet port, and wherein the method further includes conveying a tissue sample onto the tissue retainer at a location above the platform opening via the tissue inlet port.

[0099] Although specific embodiments have been shown and described, it should be understood that this is not intended to limit the claimed invention to the preferred embodiments, and it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the claimed invention. Therefore, the specification and drawings are to be considered illustrative rather than restrictive. The claimed invention is intended to cover alternatives, variations, and equivalents.

Claims

1. A tissue retainer assembly (10), the tissue retainer assembly comprising: The base (14) includes a bottom member (43), a central hub (35) extending upward from the bottom member, and circumferential sidewalls (41) extending upward from the bottom member (43) and radially spaced from the central hub (35), the circumferential sidewalls (41) surrounding the central hub (35) and defining an interior region configured to accommodate a cylindrical tissue retainer (18); The base (14) also includes an elevated platform (70) spaced upward from the bottom member (43), the upper portion of the central hub (35) extending through a central opening of the platform, wherein the central hub (35) is configured to support a tissue retainer (18); The bottom component (43), the central hub (35), and the circumferential sidewall (41) together define an annular fluid channel located below the platform (70), which is in fluid communication with the platform opening (72); The fluid channel extends from the platform opening (72) around the central hub (35) to a fluid outlet port in the circumferential sidewall; and The base (14) is characterized in that it further includes a flow comb (74) located below the platform opening (72) and extending into the fluid channel.

2. The tissue retainer assembly according to claim 1, wherein, The comb has an arc shape.

3. The tissue retainer assembly according to claim 1, wherein, The flow comb includes multiple flow channels.

4. The tissue retainer assembly of claim 1, wherein, The comb includes a hydrophobic coating.

5. The tissue retainer assembly according to claim 1, wherein, The comb includes an anticoagulant coating.

6. The tissue retainer assembly of claim 1, wherein, The fluid channel is configured to provide unidirectional fluid flow around the central hub, through an angular range of at least 30°.

7. The tissue retainer assembly of claim 1, wherein, The central hub of the base includes a mandrel configured to receive the tissue retainer.

8. The tissue retainer assembly of claim 1, wherein, The platform extends at least most of the circumferentially around the space between the central hub and the circumferential sidewalls.

9. The tissue retainer assembly of claim 1, further comprising a pressurization chamber and a suction port, the pressurization chamber being in fluid communication with the fluid channel, and the suction port being configured to provide suction in the pressurization chamber.

10. The tissue retainer assembly of claim 9, wherein, The height of the pressurization chamber is greater than the height of the circumferential sidewall of the base.

11. The tissue retainer assembly of claim 1, further comprising the tissue retainer configured to be placed in the internal region, the tissue retainer having a plurality of tissue storage compartments, wherein the bottom of the tissue retainer includes a filter that allows fluid in one or more of the tissue storage compartments to flow through the filter.

12. The tissue retainer assembly of claim 1, further comprising a cover configured to be detachably attached to the base, wherein the cover includes a tissue inlet port configured to deliver a tissue sample at a location above the platform opening.

13. The tissue retainer assembly of claim 1, wherein, The length of the flow comb is longer than the size of the platform opening as measured along the longitudinal axis of the fluid channel.

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