1. Field of the Invention
The present invention relates to a biopsy tissue handling apparatus, biopsy kits, and methods of processing tissue specimens.
2. Description of the Related Art
Endoscopic ultrasound biopsy needles are utilized for fine needle biopsy (FNB) of liver tissue, submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. Once the tissue sample has been obtained within the needle, the physician needs to transfer the specimen to the pathology lab in an effective and efficient manner. There are currently methods in which to make this transition of the specimen from the needle to the pathologist. However, this is often a tedious task as care must be taken to not fracture the frail specimens (fresh liver specimens are especially frail). Often the transition to pathology fragments the sample making evaluation much more difficult. This failure to securely transition the core sample to the pathologist can provide the impression that the needle is suboptimal and itself is fragmenting the tissue. Additionally, separating blood clots from the specimen(s) to be evaluated is not trivial.
In view of the difficulty in transferring intact and clot-free tissue specimens from a biopsy needle to a pathology lab using current techniques, there is a need for improved devices and techniques for handling, processing, and transferring fresh tissue specimens without damaging or degrading the specimens.
The invention generally relates to a kit and device for processing a tissue specimen (e.g., liver tissue) obtained from a biopsy needle to separate a tissue core—destined for a pathology lab—from unwanted clot material without damage to the tissue core. In one aspect, this invention provides a biopsy kit including a biopsy tissue handling device having a first well, a second well, a third well, and a channel network connecting the wells such that there is fluid communication between the wells. The first, second, and third wells each has a bottom, a side wall, and an upward facing opening. In certain embodiments the channel network has first, second, and third channels, each channel having a first end connected, respectively, to the first, second, or third wells, where the second ends of the channels connect to form an intersection point. In other embodiments, the channel network has first and second channels, each channel having first ends connected, respectively, to the first and second wells, where the second ends of the first and second channels connect to the third well such that the third well comprises a part of the fluid communication between the first and second wells.
In another aspect, the invention provides a method of processing a tissue specimen by obtaining a tissue specimen having a core and a clot, transferring the tissue specimen to a biopsy tissue handling device according to the invention, manipulating the tissue specimen to separate the tissue core from the clot. In certain embodiments, the separated tissue core is transferred to a pathology cassette.
The embodiments are described with reference to the drawings in which like elements are referred to by like numerals. The relationship and functioning of the various elements of the embodiments are better understood by the following detailed description. However, the embodiments as described below are by way of example only, and the invention is not limited to the embodiments illustrated in the drawings. It should also be understood that the drawings are not to scale and in certain instances details have been omitted, which are not necessary for an understanding of the embodiments, such as conventional details of fabrication and assembly.
An exemplary embodiment of a biopsy tissue handling device 10 is shown in
The first channel 60 in
An alternate embodiment of a biopsy tissue handling device 10 is shown in
Another alternate embodiment of a biopsy tissue handling device 10 is shown in
In
The first well 20 may include a grate or grill 100 (
The second well 30 may house a tissue receptacle or platform upon which a tissue core 120 may be positioned following processing in the channel network 50, where the core 120 is separated away from the clot 130. For example, the receptacle in the second well 30 may be a first sponge 110 (
Another alternate embodiment of a biopsy tissue handling device 10 is configured as a packaging tray to hold medical instruments used in conjunction with a system of wells and channels shown in the examples in
Generally, the manner in which a medical instrument or tissue manipulation tool is held in the packaging tray is not critical. The medical instruments or tissue manipulation tools may be held in place with holders such as fasteners, ties, clips, recessed pockets, etc. Examples of packaging systems for medical devices may be found in the following U.S. Pat. Nos.: 4,736,850; 3,851,649 and 5,031,775. The configuration of the holders may be determined by the exact configuration of the specific medical instrument that it is designed to hold. Recessed pockets may be molded into a packaging tray to releasably hold medical instruments placed into individual recessed pockets in the tray. Relative to the plane of the packaging tray, the recessed pockets may hold the medical instruments below the plane, in the plane, or above the plane. For example, elevated pockets may be molded onto a packaging tray such that the medical instruments may be held planar to the surface of the packaging tray or reside above the planar surface of the packaging tray. Elevated pockets may be designed to have a configuration suited to releasably hold a medical instrument that may be snapped into the elevated pocket. The pockets are generally in the shape of the particular instrument which they are designed to contain. It is not necessary that the pocket be shaped to mate exactly with the instruments which they are adapted to receive. The pocket may be of the same depth as most of the instruments that it is designed to receive or it may extend below the depth of the instrument so that a user may remove the instruments by reaching under the instruments held in the pocket. Alternatively, the pocket may have a shallower depth than the instruments such that part of the instruments projects beyond the pocket. Recessed pockets may be used in combination with other holders, e.g., ties, fasteners, etc.
The biopsy tissue handling device may be made out of any suitable material that is compatible with pathology procedures including exposure to solvents and sterilization agents, e.g., plastics, polymers (e.g., polypropylene, PVC, PETG), glass, metal. Medical grade plastics may be used as described in McKeen, Handbook of Polymer Applications in Medicine and Medical Devices, 2014, Ch. 3, pp. 21-53. (http://dx.doi.org/10.1016/B978-0-323-22805-3.00003-7). The biopsy tissue handling device and kit may likewise be sterilized prior to use.
In operation, a tissue specimen 115 obtained from a biopsy needle may be transferred to the first well 20 of the biopsy tissue handling device 10. In the first well, the tissue specimen 115 may be deposited on an optional grate 100 bathed in sterile solution 140. The tissue specimen 115 may then be maneuvered into the first channel 60 of the channel network 50 for processing. In the first channel 60, the tissue specimen 115 may be positioned in the main branch 66 adjacent an optional transverse groove 90 such that the tissue core 120 and clot 130 are on opposite sides of the groove (
An advantage of the invention over simple transfer of a tissue core from one container to another is that the biopsy tissue handling device allows processing of the delicate tissue specimen 115 with minimal lifting movements. The invention allows the tissue specimen 115 or tissue core 120 to be maneuvered through the channels of the channel network 50 such that the tissue core 120 may be deposited directly onto the sponge 110 located in the second well 30 without lifting the tissue core 120 and risking damage to the sample. Maintaining the integrity of the tissue core is expected to improve the quality and accuracy of the pathology assessment.
The dimensions of the wells, channels, and grooves of the biopsy tissue handling device may be sized as appropriate for the particular tissue processing application. Although the shapes of the wells (including bottoms and side walls), channel (including branches), and grooves are shown as generally square or rectangular, the shapes are not particularly important and may also be oval, round (as shown in well 40 in
In one embodiment is provided a method of processing a tissue specimen comprising: (a) obtaining a tissue specimen 115 (e.g., a liver biopsy sample), the tissue specimen comprising a tissue core 120 and a clot 130; (b) transferring the tissue specimen 115 to a biopsy tissue handling device 10, the biopsy tissue handling device 10 comprising a channel network 50, a first well 20 and a second well 30, each well having a bottom, a side wall, and an upward facing opening, the first well 20 being in fluid communication with the second well 30 through the channel network 50, the tissue specimen 115 being transferred to the first well 20 of the biopsy handling device 10; (c) manipulating the tissue specimen to separate the tissue core 120 from the clot 130; and (d) transferring the separated tissue core through the channel network 50 to the second well 30.
In a sub-embodiment, the tissue specimen is separated into the tissue core and clot in the first channel.
In a sub-embodiment is provided a method where a tissue receptacle, such as a first sponge 110, is removably disposed in the second well 30 and the separated tissue core 120 is transferred through the channel network 50 onto the first sponge 110 in the second well 30. In other embodiments, other types of receptacles or platforms may be used other than the sponge to provide a surface onto which the core may be positioned, e.g., a piece of filter, other type of paper, a specimen cassette, a glass slide.
In a further sub-embodiment is provided a method where the biopsy tissue handling device 10 further comprises a third well 40, the third well having a bottom, a side wall, and an upward facing opening; and after separation of the tissue core from the clot, the third well receives the clot and the second well receives the tissue core.
In a further sub-embodiment is provided a method wherein the channel network comprises a main branch; and one or more transverse grooves, the one or more transverse grooves being in fluid communication with and disposed at an angle relative to the main branch. According to this sub-embodiment, the tissue core is separated from the clot at the one or more transverse grooves with a cutting tool having a cutting edge sized to fit in the one or more transverse grooves.
In a further sub-embodiment is provided a method wherein the channel network comprises: a first channel, the first channel having a first end and a second end, the first end being connected to the first well; a second channel, the second channel having a first end and a second end, the first end being connected to the second well; and a third channel, the third channel having a first end and a second end, the first end being connected to the third well; the second end of each of the first, second, and third channels being connected to form an intersection point. According to this sub-embodiment, after separation of the tissue core from the clot, the third well receives the clot through the third channel, and the second well receives the tissue core through the second channel. The embodiments of
In a further sub-embodiment is provided a method wherein the channel network comprises: a first channel, the first channel having a first end and a second end, the first end being connected to the first well; and a second channel, the second channel having a first end and a second end, the first end being connected to the second well; the second end of each of the first and second channels being connected to the third well, such that the third well comprises an intersection point situated between the first and second wells, where the third well forms part of the fluid communication between the first and second wells. According to this sub-embodiment, after separation of the tissue core from the clot, the tissue core and clot may be transferred to the third well, and the tissue core then further transferred into the second channel and then into the second well. Thus, the second well receives the tissue core through the second channel, and the clot is received in the third well. The embodiment of
In a further sub-embodiment is provided a method wherein the first channel further comprises: a main branch; and one or more transverse grooves, the one or more transverse grooves being in fluid communication with and disposed at an angle relative to the main branch of the first channel. According to this sub-embodiment, the tissue core is separated from the clot at the one or more transverse grooves with a cutting tool having a cutting edge sized to fit in the one or more transverse grooves. The embodiments of
In a further sub-embodiment is provided a method wherein the channel network comprises: a first channel, the first channel having a first end and a second end, the first end being connected to the first well; a second channel, the second channel having a first end and a second end, the first end being connected to the second well; a third channel, the third channel having a first end and a second end, the first end being connected to the third well; the second end of each of the first, second, and third channels being connected to form an intersection point; the channel network further comprising a side groove that is disposed at the intersection point of the first, second, and third channels. According to this sub-embodiment, the tissue core is separated from the clot at the side groove with the cutting tool being accommodated within the side groove and the intersection point, or optionally further within the first, second, or third channels, depending on the size of the cutting tool and the angle of the side groove relative to the individual channels. The embodiment of
In a further sub-embodiment is provided a method wherein the sponge, filter paper, glass slide, or other type of platform or receptacle and the separated tissue core are transferred from the second well to a pathology cassette.
The above figures and disclosure are intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in the art. All such variations and alternatives are intended to be encompassed within the scope of the attached claims. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the attached claims.
The present patent document claims the benefit of the filing date under 35 U.S.C. §119(e) of Provisional U.S. Patent Application Ser. No. 62/153,284, filed Apr. 27, 2015, which is hereby incorporated by reference.
Number | Date | Country | |
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62153284 | Apr 2015 | US |