WO2018151809A1 - Tissue storage during surgery - Google Patents

Tissue storage during surgery Download PDF

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Publication number
WO2018151809A1
WO2018151809A1 PCT/US2018/000019 US2018000019W WO2018151809A1 WO 2018151809 A1 WO2018151809 A1 WO 2018151809A1 US 2018000019 W US2018000019 W US 2018000019W WO 2018151809 A1 WO2018151809 A1 WO 2018151809A1
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WO
WIPO (PCT)
Prior art keywords
container
pounds
support
retention compartment
lid
Prior art date
Application number
PCT/US2018/000019
Other languages
French (fr)
Inventor
Brian G. CUDDY
Byron N. BAILEY
Original Assignee
Clinical Biotechnology Research Institute At Rsfh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Clinical Biotechnology Research Institute At Rsfh filed Critical Clinical Biotechnology Research Institute At Rsfh
Publication of WO2018151809A1 publication Critical patent/WO2018151809A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096Casings for storing test samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/36Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for collecting or disposing of used articles
    • A61B50/37Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for collecting or disposing of used articles for absorbent articles, e.g. bandages, garments, swabs or towels

Definitions

  • the present invention relates to protecting a surgically-removed medical tissue sample from contamination, damage, or loss during a medical procedure by placing the medical tissue sample in a sterile container with distinguishing characteristics and a closure device.
  • tissue from one part of a patient's body is removed for a brief time, and grafted to another part of the patient's body, such as, for example, for facial or breast reconstruction, coronary bypass surgery, or for various types of grafts.
  • traumatic injuries can result in the near-amputation of, for example, fingers, toes, and ears.
  • a regrafted ear for example, can save a patient from disfigurement and the risks associated with transplanting a synthetic, allographic, or xenographic substitute.
  • a craniotomy will be used to illustrate one device of the invention and its use.
  • a section of the skull called a bone flap
  • the skin and muscles are lifted off the bone and folded back, and small burr holes are made in the skull with a drill.
  • a special saw is inserted through the burr holes, and is used to cut the outline of a bone flap.
  • the cut bone flap is lifted and removed to expose the protective covering of the brain called the dura. Typically the bone flap is safely stored until it is replaced at the end of the procedure.
  • the retractors holding the brain are removed and the dura is closed with sutures.
  • the bone flap is replaced back in its original position and secured to the skull with titanium plates and screws. The muscles and skin are sutured back together.
  • the sterile surgical procedure pack referenced above is illustrated in US patent 4,844,259, and discloses use of surgical procedure packs for the surgical removal of a medical tissue sample and a packaging means for long term storing and transporting said sample.
  • This reference does not disclose a device or method to use for short term storage during a surgical procedure, nor try to solve the problem of safeguarding the medical tissue sample during the surgical procedure.
  • the laparotomy pad may become blood soaked and can be misplaced or mixed in with similar pads, or can be inadvertently dropped on the floor, exposing the bone flap to damage or contamination. Since the laparotomy pad does not contain any markings that indicate the contents of the pad, or colors to distinguish it from other pads, it blends in with other materials and pads on a surgical tray or surgical table. Due to these conditions, it is likely that the laparotomy pad containing the bone flap could be mixed in with other pads in the operating room which may cause confusion or inadvertent damage to the human tissue that is important for a successful surgical closure.
  • Some embodiments of the present invention provide containers for storing a tissue sample during a medical procedure, one such container comprising: a retention
  • the retention compartment for receiving and storing the tissue sample
  • the retention compartment having a rim
  • a cover comprising a lid, a hinge, and optionally a stationary piece; the lid rotatably affixed to the hinge; the cover permanently affixed to the retention compartment; the cover permanently affixed to the retention compartment; the lid further comprising a seal to engage the rim thereby impermeably enclosing the retention compartment.
  • Other embodiments relate to methods of storing a tissue sample during a medical procedure, one such method comprising: obtaining a container having an interior; placing the tissue sample into the interior of the container; impermeably enclosing the interior of the container; and storing the tissue sample in the container.
  • Still other embodiments provide a support adapted to stabilize a container for storing a tissue sample during surgery, the support comprising a plurality of elongated arms and optionally a base member, wherein the plurality of elongated arms and the base member if present form a stable platform for resting the support on a horizontal surface.
  • FIG 1 is a perspective view of one embodiment of the invention, a sterile container with attached lid as it would be received in the operating room.
  • FIG 2 is a perspective view of the sterile container of FIG 1 , illustrating the lid in the open position.
  • FIG 3 is a perspective view of another embodiment of the present invention for storing a tissue sample such as a bone flap during a surgical procedure.
  • FIG 4 is a perspective view of the embodiment of FIG 3, illustrating a bone flap covered with a saline solution.
  • FIG 5 is a perspective view of a sealed container stored on a surgical tray or table.
  • FIG 6 is a partial cross-sectional view of a portion of a container depicting the lid in engagement with the container.
  • FIG 7 is a partial cross-sectional view of another container depicting the lid in engagement with the container.
  • FIG 8 is a perspective view of the sterile container of FIG 2, illustrating the container further comprising an absorbent pad positioned in the retention compartment, with a non-skid surface affixed to the bottom portion of the exterior of the container,
  • FIG 9 is a perspective view of another embodiment of the present invention, illustrating container retention compartment with a narrow top and a wide base to enhance the stability of the container.
  • FIG 10 is a partial cross-sectional view illustrating a portion of the container depicted in FIG 9.
  • FIG 11 is a partial cross-sectional view illustrating another container further comprising a stabilizing structure extending laterally from the bottom of the container to stabilize the container against tipping.
  • FIG 12 is a perspective view of another embodiment of the present invention, illustrating a container having a retention compartment with a rectangular shape.
  • FIG 13 is a perspective view of the container of FIG 12, illustrating the lid in the open position.
  • FIG 14 is a perspective view of the container of FIG 2, illustrating a container
  • FIG 15 is a top view of container 1500, illustrating the lid in the open position.
  • FIG 16 is a bottom view of container 1500, illustrating the lid in the open position.
  • FIG 17 is a view of the left side of container 1500, illustrating the lid in the open position (right side view is a mirror image).
  • FIG 18 is a front view of container 1500 with attached lid.
  • FIG 19 is a back view of container 1500 with attached lid.
  • FIG 20 is a top view of support 2000.
  • FIG 21 is a bottom view of support 2000.
  • FIG 22 is a left side view of support 2000 (right, front and back views are substantially identical).
  • FIG 23 is a top view of container 1500 with attached support 2000, depicting support 2000 in engagement with container 1500.
  • FIG 24 is a bottom view of the container 1500 with attached support 2000, depicting the support 2000 in engagement with the container 1500.
  • FIG 25 is a left side view of container 1500 with attached support 2000, depicting support 2000 in engagement with container 1500 (right side view is mirror image).
  • FIG 26 is a front view of container 1500 with attached support 2000.
  • FIG 27 is a back view of container 1500 with attached support 2000.
  • FIG 28 is a top view of basket 2800 with perforations (bottom view appears substantially identical to top view).
  • FIG 29 is a right side view of basket 2800 with perforations (left side view is mirror image).
  • FIG 30 is a front view of basket 2800 with perforations (back view is mirror image).
  • FIG 31 is a top view of basket 3100 comprising two or more
  • FIG 32 is a bottom view of basket 3100 comprising two or more
  • FIG 33 is a right side view of basket 3100 comprising two or more subcompartments (left side view is mirror image).
  • FIG 34 is a front view of basket 3100 comprising two or more
  • FIG 35 is a partial view of the container 1500 and support 2000, depicting the support 2000 engaging the container 1500 by snapping together.
  • FIG 36 is a partial view of a container 3600 and support 3601 , depicting the support 3601 in engagement with the container 3600 by sliding together.
  • FIG 37 is a partial view of container 3700 and support 3701 , depicting the support 3701 in engagement with the container 3700 by frictional engagement.
  • FIG 38 is a partial view of container 3800 and support 3801 , depicting the support 3801 in engagement with the container 3800 by gravity.
  • FIG. 39 is a perspective view of container 3600 and support 3601 , depicting bacteriostatic insert 3926 in the retention compartment, further comprising basket 2800 with perforations.
  • FIG. 40 is a partial perspective view of container 3600 and support 3601 , depicting basket 3100 comprising two or more subcompartments.
  • FIG. 41 is a view of support 4100 comprising support clips 4120 and 4121.
  • FIG. 42 is a bottom view of container 4200 comprising support engagement structures 4280 and 4281.
  • FIG 43 is a view of container 4200 with attached support 4100, depicting support 4100 engaged with container 4200 by twisting one or more rotating clips 4120 and 4121 to lock container 4200 to support 4100.
  • FIG 44 is a view of basket 4400, depicting gasket 4425 in engagement with the uppermost surfaces of the dividing walls of the subcompartments.
  • FIG 45 is a view of container 4500 and basket 4510, depicting gasket 4525 in engagement with the interior surface of lid 4514.
  • FIG 46 is a view of container 4600 comprising elongated arms extending laterally from the bottom of the container to stabilize the container against tipping.
  • the present invention relates to protecting a surgically removed medical tissue sample from contamination, damage, or loss during a medical procedure by placing the medical tissue sample in a sterile container with distinguishing characteristics and a closure device.
  • a medical tissue sample is the cranial bone flap removed during a craniotomy.
  • Any suitable tissue sample can be temporarily stored, according to various embodiments of the present invention.
  • bone, cartilage, skin, muscle, tendon, entire organs or a portion thereof, a vein, an artery, a nerve, and combinations thereof that have been harvested for a graft can be stored until transplanted to the surgical site.
  • Facial features such as ears and noses, teeth, fingers, toes, limbs and portions thereof can be protected in certain embodiments.
  • the invention is not limited to use during a craniotomy, and the container is not limited to a specific shape, this procedure will be used in the detailed description to follow, to illustrate a device of the invention and its use.
  • a container for storing a tissue sample during a medical procedure comprising: a retention compartment for receiving and storing the tissue sample, the retention compartment having a rim; a cover comprising a lid, a hinge, and optionally a stationary piece; the lid rotatably affixed to the hinge; the cover permanently affixed to the retention compartment; the lid further comprising a seal to engage the rim thereby impermeably enclosing the retention compartment.
  • Any suitable material can be used for the various parts of the container.
  • the container comprises one or more polymer materials. Any suitable polymer material or polymer materials can be used, such as, for example, polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
  • the retention compartment receives and stores the tissue sample during the surgical procedure.
  • the retention compartment represents the inside of the container, and thereby protects and maintains the tissue sample.
  • the rim of the retention compartment can be of any suitable configuration, so that the lid can impermeably enclose the retention compartment. In some cases, this is done with a seal on the lid engaging the rim of the retention compartment. The precise structures of the seal and the rim are not significant, so long as they engage, and enclose the tissue sample.
  • the lid being rotatably affixed to a hinge allows the container to be opened and closed as desired.
  • the cover comprising the lid, the hinge, and optionally the stationary piece, is permanently affixed to the retention compartment, so the lid is not easily separated from the container.
  • Any suitable hinge configuration can be used, and more than one hinge mechanism may be involved.
  • a hinge comprises a thinner region of the material or materials of the cover, such as plastic, that allows the lid to rotate about the hinge to open and close the lid.
  • pin and slot structures, or other suitable physical structures form the hinge.
  • the hinge can locate between the lid and the stationary piece, in some cases, or between the lid and the retention compartment, in other cases that do not have a stationary piece.
  • Covers including optional stationary pieces appear in FIGs 1 -5, 8- 9; covers without a stationary piece appear in FIGs 12-13, for illustration.
  • the optional stationary piece can have any suitable shape, and illustrates that any suitable configuration comprising a lid and a hinge forming a cover permanently affixed to the retention compartment can be used.
  • the container can comprise a transparent material, such as for example, glass or transparent polymer, so that the contents of the container can be readily identified without opening the container and risking contamination of the tissue sample.
  • the retention compartment, the lid, or both, in addition to any other part of the container can be made of or comprise transparent material.
  • the container can comprise a translucent material, such as for example, frosted glass or translucent polymer, so that the contents of the container can be identified or at least visualized without opening the container and risking contamination of the tissue sample.
  • the retention compartment, the lid, or both, in addition to any other part of the container can be made of or comprise translucent material.
  • the container is sterile when it is presented for use in an operating room or other suitable context. Sterilization can occur according to any suitable procedure.
  • sterile manufacture can employ clean rooms, cleaned or purified starting materials, sustained high temperatures sufficient for killing microbes, and combinations thereof to improve the cleanliness or even sterilize the container.
  • a container comprising at least one distinguishing feature.
  • a problem in an operating room or an emergency room when a tissue sample is set aside relates to the identification of that tissue sample's location.
  • certain embodiments of the present invention provide a container readily identifiable as the location of the tissue sample. Any suitable distinguishing feature can be used.
  • Some containers comprise at least one distinguishing feature chosen from: color, label, shape, and combinations thereof. Color can be associated with the container through any suitable means, such as, for example, the material used to make the container or a part thereof has a colorant included in the material, such as is known in polymer article manufacture. Or, adhesive labels or tape can impart a color to the container.
  • Containers of the present invention can have any suitable shape. In some cases, a container having a distinct shape can be used. Suitable shapes include, but are not limited to: polygons, semicircles, stars, cross shapes, flat-bottom bowls, squares, rectangles, and the like.
  • some containers further comprise one or more locking mechanisms to secure the lid to the rim when the seal is engaged to the rim. Any suitable locking mechanisms can be used. In certain instances, a snap, a latch, a collar, a push button lock, a flange with corresponding retention surfaces, a lock member with a receiving member, a tab with teeth to engage corresponding teeth, and the like can be used.
  • a suitable fluid can be added to the container before or after placing the tissue sample in the container.
  • the container can comprise at least one absorbent pad in the retention compartment to receive the tissue sample. Any suitable absorbent pad can be used. For example, gauze, sterile gauze, hydrophilic polyester, and combinations thereof can be used as an absorbent pad.
  • the absorbent pad comprises at least one hydro-swellable polymer, either alone or in combination with other suitable materials. Any suitable hydro-swellable polymer can be used. In some cases, the hydro-swellable polymer is chosen from polyacrylic acid, polyacrylamide,
  • polysaccharide poly-hydroxy propyl methacrylate, and combinations of two or more thereof.
  • the interior of the retention compartment comprises one or more antimicrobial coatings.
  • Any suitable antimicrobial coatings can be used, alone or in combination.
  • the anti-microbial coating is chosen from silver sulfadiazine, silver nitrate, silver halide, silver acid salt, chlorhexidine
  • the interior of the retention compartment comprises an insert treated with a bacteriostatic agent.
  • bacteriostatic agent can be used, alone or in combination.
  • the bacteriostatic agent is chosen from sulfonamides, tetracyclines, trimethoprim, clindamycin, macrolides and combinations thereof.
  • the bacteriostatic agent or agents can be present in any suitable amount in any suitable composition.
  • the bacteriostatic agent is present in an aqueous or non-aqueous composition in a concentration of at least 0.1 mg per liter of composition, and the composition is made to contact the insert so the insert comprises an effective amount of the bacteriostatic agent.
  • the insert can include any suitable materials, such as, for example, gauze, sterile gauze, hydrophilic polyester, at least one hydro-swellable polymer as mentioned above, and
  • an insert treated with a bacteriostatic agent can be used in combination with an absorbent pad.
  • the absorbent pad can be treated with at least one bacteriostatic agent, and thereby function as an absorbent pad and a bacteriostatic insert.
  • some containers can comprise one or more non-skid surfaces on the exterior bottom of the retention compartment.
  • a non-skid surface can cover any suitable portion of the bottom, such as a small portion of the bottom, or most of the bottom. Any suitable non-skid surface can be used, alone or in combination.
  • the material used to make the retention compartment can be designed to include ridges, bumps, or other protrusions that impart a non-skid quality to the container.
  • one or more rubber or rubber-like pads can be adhered to the bottom to create the non-skid surface(s). Care may be taken, in some cases, to select a non-skid surface that allows for sterilization of the container without damaging the non-skid surface.
  • the retention compartment comprises a wall having a base, a top, and a wall thickness, and the wall thickness is greater at the base than at the top. To measure the wall thickness at the base, the measurement should be made at the wall above the bottom surface of the retention container. See FIG 10.
  • one or more stabilizing structures are affixed to the base of the retention compartment.
  • a stabilizing structure such as a "foot” or a "donut,” or a plurality of elongated arms, extends laterally from the bottom of the retention compartment and thereby stabilizes the container against tipping.
  • the addition of stabilizing structure can occur when the container is molded, or stabilizing structure can be added once the container has been made.
  • the basket can comprise at least one perforated side wall, or can comprise a perforated bottom wall.
  • the perforated walls can be used alone so that only one wall contains perforations, or in combination so that one or more side walls and optionally the bottom wall contain perforations.
  • the perforated walls can allow fluid in the retention compartment to flow through the basket, keeping the tissue sample submerged in liquid. If the basket does not have distinct side walls and bottom walls, such as when the basket has a curved or spherical shape, it can be said that the basket comprises a wall that can have perforations on one or more portions of the wall or on substantially the entire wall.
  • the basket can comprise two or more
  • the basket may comprise one or more gaskets to impermeably enclose the two or more
  • the lid may comprise one or more gaskets removably attached to the interior of the lid to impermeably enclose the two or more subcompartments when engaged with the lid.
  • the two or more subcompartments are marked with tissue sample identification information.
  • the dividing walls can have any suitable height, and can be the same or different in that respect. In one instance, at least one of the dividing walls has a height substantially the same as the height of the retention compartment. In another instance, at least one of the dividing walls has a height substantially less that the height of the retention compartment. In yet another instance, at least one of the dividing walls has a height approximately half the height of the retention compartment.
  • the subcompartments can allow for storage of one or more tissue samples during a surgical procedure, or for storage of a tissue specimen in preparation for biopsy.
  • the basket can comprise a finger hole to provide ease of removal from the retention compartment.
  • a finger hole or similar feature allows a user to grab the basket.
  • the basket can comprise a ridge for enabling removal of the basket from the retention compartment. A ridge or similar feature eases separation of the basket from the retention compartment, so it is less likely for them to become stuck together or hard to separate in an operating room
  • the basket comprises one or more polymer materials, metals, or combinations thereof.
  • Any suitable polymer material or polymer materials may be used, such as, for example, polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
  • the basket can comprise one or more gaskets engaging the uppermost surfaces of the dividing walls separating subcompartments.
  • a gasket or similar feature prevents leakage of fluids or tissue from one sub-compartment into a second subcompartment, so it is less likely for materials contained in one or more subcompartments to become cross- contaminated.
  • Any suitable material can be used for a gasket.
  • a gasket comprises one or more polymer materials, metals, or
  • Any suitable polymer material or polymer materials may be used, such as, for example, polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
  • the interior of the lid can comprise one or more gaskets engaging the uppermost surfaces of the dividing walls separating subcompartments.
  • one or more gaskets attached to the uppermost surfaces of the dividing walls can engage the interior of the lid when the lid is closed, thereby impermeably enclosing the subcompartments.
  • a gasket or similar feature prevents leakage of fluids or tissue from one subcompartment into a second subcompartment, so it is less likely for materials contained in one or more subcompartments to become cross-contaminated.
  • a gasket can have any suitable shape.
  • a gasket can have an annular shape.
  • a gasket comprises a monolith of resilient material, for example, attached to the interior of the lid that impedes fluid transfer from one subcompartment to another. Any suitable material can be used for a gasket.
  • a gasket comprises one or more polymer materials, metals, or combinations thereof. Any suitable polymer material or polymer materials may be used, such as, for example, polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
  • the container comprises at least one stabilizing structure affixed to the base of the retention compartment, such as a "foot” or a “donut,” as described above.
  • the container is adapted to engage a support that comprises
  • the elongated arms and the base member form a stable platform for resting the support on a horizontal surface.
  • the plurality of elongated arms can be substantially two-dimensional, and engage the container fairly close to the horizontal surface on which the support rests. Or, one or more elongated arms can rise vertically from the horizontal surface, and engage the container close to and/or further from the horizontal surface.
  • the plurality of elongated arms may comprise one or more container engagement structures, which can be present at or near the horizontal surface or further from it, for example. In other cases, the plurality of elongated arms comprises one or more container engagement structures, which can be present at or near the ends of the plurality of elongated arms, for example.
  • the container engagement structures can be of any suitable configuration, so that the container can engage with the elongated arms. Suitable container engagement structures include, for example, ledges, protrusions, recesses, and combinations thereof.
  • the plurality of elongated arms can extend laterally from the bottom of the retention compartment and thereby stabilize the container against tipping.
  • the addition of the elongated arms can occur when the container is molded, or stabilizing support can be added once the container has been made.
  • the container comprises one or more support engagement structures on the retention compartment.
  • the support engagement structures can be of any suitable configuration, so that the elongated arms of the support can engage with the container.
  • Suitable support engagement structures include, for example, ledges, protrusions, recesses, and combinations thereof.
  • the rim of the container can be adapted to engage the plurality of elongated arms. Additionally, the rim can be adapted to engage the one or more container engagement structures. Additional embodiments relate to methods of engaging the container with the support. Any suitable engagement can secure the container to the support. In one instance, the container and support can engage by snapping together. In another instance, the container and support can engage by adhesion. Any suitable adhesive can be used to engage the container and support, and such adhesives can be permanent or reusable adhesives. Pressure-sensitive adhesives, acrylics, urethanes, epoxies, and ethylene vinyl acetate adhesives, and combinations thereof may be mentioned. In another instance, the container and support can engage by sliding together.
  • the container and support can engage by gravity. In still yet another instance, the container and support can engage by frictional engagement. In still another embodiment, the container and support can employ one or more complimentary rotating clips, such that an operator places the container and support together and twists one or more rotating clips to lock the container to the support. Optionally, this can be accomplished with one or more screws, bolts, or similar connectors holding the container to the support.
  • a further embodiment provides complementary rotate-to-lock structures on the container and on the support, which operate by placing the container and support together and rotating the container relative to the support to lock the two together. In yet another embodiment, the container and support can employ complimentary tracks, such that an operator places the container and support together and slides one or more tracks to lock the container to the support.
  • Complimentary tracks can slide together with any suitable motion, such as, for example, a linear or two-dimensional motion, a rotational motion, or a combination thereof. If a rotational motion can be used, such complementary tracks also can be described as rotate-to-lock structures.
  • Combinations of means for engaging the container with the support also can be employed. It can be beneficial, in certain instances, for the stable platform to have a dimension greater than a corresponding dimension of the container to improve the stability of the container. In other words, in certain instances, the stable platform can be wider or longer in some respect than the container.
  • a dimension greater than a corresponding dimension of the container to improve the stability of the container.
  • the stable platform can be wider or longer in some respect than the container.
  • corresponding dimension indicates that the same dimension is being measured and compared on the support as on the container.
  • the length of an edge of the stable platform will be greater than the length of the corresponding edge of the container.
  • the horizontal surface area of the stable platform will be greater than the corresponding horizontal surface area of the container. It is not necessary that all dimensions of the support be greater than all corresponding dimensions of the container.
  • FIG. 24 shows a container that may have a larger surface area on its bottom-most horizontal surface than its support, but the support has at least one length measured along the elongated arms that is greater than the corresponding dimension of the container, which would be a diagonal measurement across its bottom.
  • the support comprises metal, plastic, or a combination thereof.
  • Any suitable metal can be used, such as, for example, stainless steel, aluminum, tin, titanium, alloys, and combinations thereof.
  • the alloy can be a mixture of any suitable metals, such as those known in the art.
  • Stainless steels are a class of alloys.
  • the support can have any suitable weight. In some cases, the support ranges from 0.1 pounds - 10 pounds.
  • the support has a thickness ranging from 1 mm - 5 cm.
  • Additional embodiments relate to methods of storing a tissue sample during a medical procedure.
  • One such method comprises obtaining a container having an interior; placing the tissue sample into the interior of the container; impermeably enclosing the interior of the container; and storing the tissue sample in the container.
  • Impermeably enclosing the interior means that fluid cannot flow into or out of the container.
  • the tissue sample is protected from dehydration and unnecessary risk of contamination.
  • Further protection from dehydration of the tissue sample is provided by optionally irrigating the tissue sample before impermeably enclosing the interior.
  • Any suitable fluid can be used to irrigate the tissue sample.
  • irrigating comprises contacting the tissue sample with water, saline, sterile water, sterile saline, or a combination thereof.
  • a tissue sample can be stored for any suitable duration. In some cases, the storing occurs in less than twelve hours, less than six hours, or less than three hours.
  • the tissue sample is typically harvested at the beginning of the surgical procedure, and may need to be securely stored for a period of time before being attached to the surgical area. It is also possible for a tissue sample to be surgically or otherwise removed from a patient, temporarily stored in a container of the present invention, and transported, such as for example, from one operating room to another, or from the scene of an accident to an emergency room.
  • tissue sample comprises bone, cartilage, skin, muscle, tendon, an entire organ, a portion of an organ, a vein, an artery, a nerve, or a combination of any of the foregoing.
  • tissue sample comprises one or more ears, a nose, one or more teeth, one or more fingers, one or more toes, one or more limbs, one or more partial limbs, or a combination of two or more thereof.
  • Additional embodiments relate to methods of storing an implantable device prior to or during a medical procedure.
  • One such method comprises obtaining a container having an interior; placing the implant into the interior of the container; impermeably enclosing the interior of the container; and storing the implantable device in the container.
  • Impermeably enclosing the interior means that fluid cannot flow into or out of the container. By stopping both air and liquid from entering or leaving the container, the implantable device is protected from dehydration and unnecessary risk of contamination.
  • Further preparation of the implantable device is provided by optionally irrigating the implantable device before impermeably enclosing the interior. Any suitable fluid can be used to irrigate the implantable.
  • irrigating comprises contacting the tissue sample with water, saline, sterile water, sterile saline, antibiotic solution or a combination thereof.
  • the device comprises a shunt, a pump, a tube, an artificial joint, an artificial disc, a reconstructive implant, a plate, a screw, a rod, a lens, or a combination of any of the foregoing.
  • cooling the container may involve contacting the container with an ice-water
  • composition such as an ice water bath.
  • tissue sample is returned to the patient. Perhaps the tissue sample has been traumatically injured or amputated. Or, perhaps the tissue sample has been removed from the patient so that underlying tissue and organs can be accessed. In still other situations, for example, tissue from one part of the patient has been removed to be grafted onto another location on or in the patient's body, such as a leg vein graft for use in coronary bypass surgery. Similarly, tissue such as adipose tissue may be removed from one part of the patient to use for breast or facial reconstructive surgery. Accordingly, some instances of the present invention involve storing the tissue sample and then surgically returning the tissue sample to the patient.
  • a sterilized container for the short term storage of a removed bone flap during a surgical procedure is provided.
  • Certain embodiments of the present invention relate to methods of making the containers, baskets, supports, and other components as described herein. Any suitable methods of manufacture can be employed, such as, for example, those currently known by persons of ordinary skill in the art.
  • Polymer components for example, can be injection molded, extrusion molded, blow molded, 3D printed, milled, or a combination thereof.
  • Metal components for example, can be molded, machined, 3D printed, or a combination thereof.
  • a sterile container 10 to use for storage of the bone flap during a craniotomy, or of another tissue sample during a medical procedure.
  • the container 10 comprises a retention compartment 12 with an attached cover 13, said container 10 being constructed of an impermeable material, such as a plastic material, optionally with a fluorescent color.
  • Cover 13, comprising lid 14, hinge 34, and stationary piece 17, is permanently affixed to the retention compartment 12.
  • Lid 14 is rotatably affixed to hinge 34. Since the lid 14 impermeably encloses the retention compartment 12, the rim of the retention compartment 12 and the seal of lid 14 are not visible.
  • a container 11 similar to container 10, has an interior 18.
  • the lid 14 has a seal 20 to securely close the lid 14 by engaging rim 25, thereby impermeably enclosing the retention compartment 12.
  • the lid 14 has a seal 20 to securely close the lid 14 by engaging rim 25, thereby impermeably enclosing the retention compartment 12.
  • Retention compartment 12 contains a locking mechanism 22 and is rotatably affixed to hinge 34, which together with stationary piece 17 form the cover 13 that is permanently affixed to retention compartment 12.
  • Retention compartment 12 contains receiving member 44 to engage with locking mechanism 22 to securely seal lid 14 to retention compartment 12.
  • a fluorescent-colored container 15 which is like containers
  • FIG 3 a preferred form of the fluorescent colored container 11 is illustrated in FIG 3 wherein the storing means is shown as being formed when the lid 14 is sealed onto retention compartment 24 and secured with locking mechanism 22.
  • the container 15 may be of any size sufficient to contain a medical sample.
  • a process for storing the surgically removed bone flap for short term storage during the medical procedure whereby the bone flap remains safe from contamination, damage or loss.
  • container 16 similar to container 11 of Fig. 2, comprises retention compartment 12 for receiving and storing bone flap 28 and having a rim (not visible), lid 14 rotatably affixed to hinge 34, wherein with hinge 34 and stationary piece 17 form cover 13 that is permanently affixed to retention compartment 12.
  • Container 16 has interior 18 defined by retention compartment 12 and lid 14.
  • Sterile saline 30 is added to retention compartment 12 sufficient to irrigate bone flap 28.
  • Interior 18 of container 16 is impermeably enclosed by closing lid 14 so the seal (not shown) of lid 14 engages the rim (not shown) of retention compartment 12, and locking the locking mechanism 22.
  • Bone flap 28 can now be stored in container 16 until it is needed again, for example, on surgical table 32 as shown in Fig. 5.
  • an ice-water bath can cool container 16 by contacting the outside of retention compartment 12.
  • Locking mechanism 22 comprises lock member 42 which is attached to lid 14 and receiving member 44 which is attached to container 12.
  • Lock member 42 is configured to engage with receiving member 44 to establish a secure lock that is configured to prevent inadvertent opening of container 11 , which could result in spillage and/or contamination of the container contents.
  • FIG 7 partial cross sectional view of another container 50, reveals an alternate locking mechanism 56 to secure lid 54 to retention compartment 52 when lid 54 is engaged.
  • Lid 54 is configured to engage flange 58 with retention surfaces 59, 60 on retention compartment 52 to establish a secure lock to prevent inadvertent opening of container 50, which could result in spillage and/or
  • retention surfaces 59, 60 may have grooves, indentations, or recesses that can be configured to receive a portion of flange 58.
  • container 65 similar to container 11 of FIG 2, has an interior 18 with an absorbent pad 62 positioned in the interior portion of the bottom of retention compartment 12 to receive the tissue sample. Additionally, a non-skid surface 64 is affixed to the exterior portion of the bottom of container 65 to reduce or prevent slippage of container 65 on any work surface, such as a surgical table.
  • container 70 represents another embodiment similar to container 11 of FIG 2, whereby retention compartment 72 is narrower at top 86 and wider at base 88 to stabilize retention compartment 72 and prevent tipping of container 70. Additionally, interior 84 of retention compartment 72 maintains the same internal dimensions from top 86 to base 88, resulting in thicker external dimensions surrounding base 88.
  • the cross-sectional view of a portion of container 70 illustrates a retention compartment 72 comprises a wall 74 having a base 88, a top 86, and a varying wall thickness, wherein the wall thickness is greater at the base 88 than at the top 86. That difference in wall thickness serves to stabilize retention compartment 72 and prevent tipping of container 70. Thickness arrow 99 located at bottom 88 measures a greater wall thickness than thickness arrow 98 located at top 86.
  • FIG 11 provides a partial cross-sectional view of container 90 which further comprises stabilizing structure 92 at base 94 of retention compartment 96.
  • Stabilizing structure 92 extends from bottom of retention compartment 96 and serves to stabilize container 90 against tipping.
  • container 100 represents another embodiment, wherein container 100 comprises a rectangular shaped retention compartment 120 with an attached cover 130, said container 100 being constructed of an impermeable material, such as a plastic material, optionally with a fluorescent color.
  • Cover 130 comprises lid 140 and hinge 340. Cover 130 is permanently affixed to the retention compartment 120 at hinge 340. Lid 140 is rotatably affixed to hinge 340. Since the lid 140 impermeably encloses the retention compartment 120, the rim of the retention compartment 120 and the seal of lid 140 are not visible.
  • a container 100 similar to container 100 in FIG 12, has an interior 180.
  • the lid 140 has a seal 210 to securely close lid 140 by engaging rim 250, thereby impermeably enclosing the retention compartment 120.
  • the lid 140 contains a locking mechanism 220 and is rotatably affixed to hinge 340, which together form cover 130 that is permanently affixed to retention compartment 120.
  • Retention compartment 120 contains receiving member 440 to engage with locking mechanism 220 to securely seal lid 140 to retention compartment 120.
  • container 150 similar to container 13 of FIG 2, has an interior 180 with a bacteriostatic insert 260 positioned in the interior portion of the bottom of retention compartment 240.
  • Locking mechanism 220 is positioned on lid 140 to securely seal lid 140 to retention compartment 240.
  • Lid 140 is rotatably affixed to hinge 340.
  • FIGs 15-19 show container 1500 which comprises a retention compartment 1512 with an attached cover 1513, said container 1500 being constructed of an impermeable material, such as a plastic material, optionally with a fluorescent color.
  • Cover 1513 comprising lid 1514 and hinge 1534, is permanently affixed to the retention compartment 1512.
  • the lid 1514 has a seal 1520 to securely close the lid 1514 by engaging rim 1525, thereby impermeably enclosing the retention
  • the lid 1514 contains locking mechanisms 1521 , 1522, and 1523, and is rotatably affixed to hinge 1534, which form the cover 1513 that is permanently affixed to retention compartment 1512.
  • Retention compartment 1512 contains receiving members 1543, 1544, and 1545 to engage with locking mechanisms 1521 , 1522, and 1523, respectively, to securely seal lid 1514 to retention compartment 1512.
  • retention compartment 1512 contains tabs 1580, 1581 , 1582, and 1583 to engage a support (not shown).
  • FIG 15 is a top view of container 1500;
  • FIG 16 is a bottom view of container 1500;
  • FIG 17 is a view of the left side of container (right side view is mirror image) of container 1500;
  • FIG 18 is a front view of container 1500; and
  • FIG 19 is a back view of container 1500.
  • FIGs. 20-22 show support 2000, which reveals a plurality of elongated arms 2050, 2051 , 2052 and 2053 and base member 2015, which form stable platform
  • FIG 20 is a top view of support 2000;
  • FIG 21 is a bottom view of support 2000; and
  • FIG 22 is a left side view of support 2000 (right, front and back views are substantially identical).
  • FIGs 23-27 show container 1500 with attached support 2000, depicting support 2000 in engagement with container 1500. In addition, retention
  • compartment 1512 contains support engagement structures 1580, 1581 , 1582, and 1583 to engage container engagement structures 2070, 2071, 2072, and 2073, respectively, on support 2000.
  • FIG 23 is a top view of container 1500 with attached support 2000;
  • FIG 24 is a bottom view of container 1500 with attached support 2000,
  • FIG 25 is a view of the left side of container (right side view is mirror image) of container 1500 with attached support 2000,
  • FIG 26 is a front view of container 1500 with attached support 2000, and
  • FIG 27 is a back view of container 1500 with attached support 2000. It can be seen, for example in FIG 25, that stable platform 2010 is wider than container 1500 at the lowermost horizontal dimension.
  • stable platform 2010 has a dimension greater than a corresponding dimension of container 1500 that improves the stability of the container 1500 when engaged to support 2000.
  • FIGs 28-30 show basket 2800 that can be removably placed in a retention compartment (not shown) to receive a tissue sample, comprising perforated side walls 2891 , 2892, 2893, and 2894, said basket 2800 being constructed of an impermeable material, such as a plastic material.
  • Perforations 2801 are holes drilled or molded into basket 2800.
  • basket 2800 comprises perforated bottom wall 2895, which provides a substantially horizontal surface when deployed in a container (not shown) that is placed on a horizontal surface such as surgical table 32.
  • FIG 28 is a top view of basket 2800 with perforations 2801 (bottom view appears substantially identical to top view)
  • FIG 29 is a right side view of basket 2800 with perforations 2801 (left side view is mirror image)
  • FIG 30 is a front view of basket 2800 with perforations 2801 (back view is mirror image).
  • FIGs 31-34 show basket 3100 that can be removably placed in the retention compartment (not shown) to receive one or more tissue samples comprises subcompartments 3162, 3163, 3165, and 3164, formed by dividing walls 3160 and 3161. Basket 3100 comprises finger hole 3166 for enabling removal of basket 3100 from the retention compartment.
  • subcompartments 3162, 3163, 3165, and 3164 are marked with tissue sample identification information 3167, 3168, 3169, and 3170, respectively.
  • FIG 31 is a top view of basket 3100 with subcompartments
  • FIG 32 is a bottom view of basket 3100 with subcompartments
  • FIG 33 is a right side view of basket 3100 with subcompartments (left side view is mirror image)
  • FIG 34 is a front view of basket 3100 with subcompartments (back view is mirror image).
  • FIG 35 illustrates a partial view of container 1500 and support 2000.
  • Lid 1514 contains locking mechanism 1521
  • retention compartment 1512 contains receiving member 1543 to engage with locking mechanisms 1521 to securely seal lid 1514 to retention compartment 1512.
  • Lid 1514 is in the closed position.
  • support 2000 comprises elongated arm 2050 and a base member (not shown), which form a platform (not shown) for resting support 2000 on a horizontal surface.
  • elongated arm 2050 comprises container engagement structure 2070 at or near the end of the elongated arm to engage with the support engagement structure 1580. It can be said that container engagement structure 2070 is a protrusion.
  • Container engagement structure 2070 engages with support
  • FIG 36 illustrates a partial view of container 3600 and support 3601.
  • Lid 3614 contains locking mechanism 3621
  • retention compartment 3612 contains receiving member 3643 to engage with locking mechanism 3621 to securely seal lid 3614 to retention compartment 3612.
  • Lid 3614 is in the open position.
  • support 3601 comprises elongated arm 3650 and base member (not shown), which form a stable platform (not shown) for resting support 3601 on a horizontal surface.
  • elongated arm 3650 comprises container engagement structure 3670 at or near the end of the elongated arm to engage with the support engagement structure 3680.
  • Container engagement structure 3670 engages with support engagement structure 3680 by sliding together. It can be said that container engagement structure 3670 is a ledge, and support engagement structure 3680 is a recess.
  • FIG 37 illustrates a partial view of container 3700 and support 3701.
  • Lid 3714 contains locking mechanisms 3721 and 3722
  • retention compartment 3712 contains receiving members 3743 and 3744 to engage with locking mechanisms 3721 and 3722 to securely seal lid 3714 to retention compartment 3712.
  • Retention compartment 3712 contains support engagement structures 3780 and 3782 to engage support 3701.
  • Support 3701 comprises a plurality of elongated arms 3750 and 3752 and base member 3715, which form stable platform 3710 for resting support 3701 on a horizontal surface.
  • the plurality of elongated arms comprises container engagement structures 3770 and 3772 at or near the ends of the plurality of elongated arms 3750 and 3752, respectively, to engage with support engagement structures 3780 and 3782, respectively, by frictional engagement. It can be said that container engagement structure 3770 is a protrusion, and support engagement structure 3780 is a recess.
  • FIG 38 illustrates a partial view of container 3800 and support 3801.
  • Lid 3814 contains locking mechanisms 3821 and 3822
  • retention compartment 3812 contains receiving members 3843 and 3844 to engage with locking mechanisms 3821 and 3822 respectively to securely seal lid 3814 to retention compartment 3812.
  • Support 3801 comprises a plurality of elongated arms 3850 and 3852 and base member 3815, which form stable platform 3810 for resting support 3801 on a horizontal surface.
  • the plurality of elongated arms comprises container engagement structures 3870 and 3872 at or near the ends of the plurality of elongated arms 3850 and 3852, respectively, to engage with support engagement structures 3870 and 3872 that engages with structures 3880 and 3882, respectively, by gravity.
  • the partial view of container 3600 and support 3601 comprises a retention compartment 3612 with bacteriostatic insert 3926 and basket 2800.
  • Cover 3613 comprising lid 3614 and hinge 3634, is permanently affixed to the retention compartment 3612.
  • Lid 3614 has a seal 3620 to securely close lid 3614 by engaging rim 3625, thereby impermeably enclosing the retention compartment 3612.
  • the lid 3614 contains locking mechanisms 3622 and 3623 and is rotatably affixed to hinge 3634.
  • Retention compartment 3612 contains receiving member 3644 and 3645 to engage with locking mechanisms 3622 and 3623
  • retention compartment 3612 contains support engagement structures 3681 and 3683 to engage support 3601.
  • Support 3601 comprises a plurality of elongated arms 3651 and 3653 and base member 3615 which form stable platform 3610 for resting support 3601 on a horizontal surface.
  • the plurality of elongated arms comprises container engagement structure 3671 and 3673 at or near the ends of the plurality of elongated arms 3651 and 3653 respectively.
  • Container engagement structure 3673 engages with support engagement structures 3681 and 3683.
  • the partial view of container 3600 and support 3601 comprises a retention compartment 3612 with basket 3100 with one or more subcompartments 3162, 3163, 3165, and 3164, formed by dividing walls 3160 and 3161.
  • Dividing walls 3160 and 3161 are substantially the same height as the height of retention compartment 3612.
  • Basket 3100 comprises finger hole 3166 for enabling removal of basket 3100 from retention compartment 3612.
  • subcompartments 3164 and 3165 are marked with tissue sample identification information 3167 and 3168.
  • retention compartment 3612 contains support engagement structures 3681 and 3683 to engage support 3601.
  • Support 3601 comprises a plurality of elongated arms 3651 and 3653 and base member 3615 which form stable platform 3610 for resting support 3601 on a horizontal surface.
  • the plurality of elongated arms 3651 and 3653 comprise container engagement structure 3671 and 3673 at or near the ends of the plurality of elongated arms 3651 and 3653 respectively.
  • Container engagement structure 3763 engages with support engagement structures 3681 and 3683.
  • FIG. 41 shows support 4100, which reveals a plurality of elongated arms
  • Platform 4110 comprises support clips 4120 and 4121 to engage container 4200 (not shown).
  • support 4100 engages container 4200 (not shown) fairly close to the horizontal surface on which support 4100 rests.
  • Support clips 4120 and 4121 represent tracks that complement corresponding structure on container 4200 (not shown), such that an operator places container 4200 and support 4100 together and rotationally slides support clips 4120 and 4121 with corresponding structure (4280, 4281 ; see FIG 42) on container 4200 to lock container 4200 to support 4100.
  • FIG 42 is a bottom view of container 4200 comprising an attached cover
  • Cover 4213 comprising lid 4214 and hinge 4234, is permanently affixed to the retention compartment 4212.
  • the lid 4214 has a seal 4220 to securely close the lid 4214 by engaging rim 4225, thereby impermeably enclosing the retention
  • lid 4214 contains locking mechanisms 4221, 4222, and 4223, and is rotatably affixed to hinge 4234.
  • Retention compartment 4212 contains receiving members 4243, 4244, and 4245 to engage with locking mechanisms 4221 , 4222, and 4223, respectively, to securely seal lid 4214 to retention compartment 4212.
  • container 4200 comprises support engagement structures 4280 and 4281 to engage support clips 4120 and 4121 (not shown), respectively, on support 4100 (not shown). Support engagement structures 4280 and 4281 , together with support clips 4120 and 4121 can be described as complementary rotate-to-lock structures.
  • FIG 43 is a view of the left side of container 4200 with attached support 4100, depicting support 4100 in engagement with container 4200.
  • Container 4200 comprises an attached cover 4213.
  • Cover 4213 comprising lid 4214 and hinge
  • the lid 4214 has a seal 4220 to securely close the lid 4214 by engaging rim 4225, thereby impermeably enclosing the retention compartment 4212.
  • the lid 4214 contains locking mechanisms 4221 , 4222, and 4223 (not shown), and is rotatably affixed to hinge 4234.
  • Retention compartment 4212 contains receiving members 4243, 4244, and 4245 (not shown) to engage with locking mechanisms 4221 , 4222, and 4223, respectively, to securely seal lid 4214 to retention compartment 4212.
  • container 4200 comprises support engagement structures 4280 and 4281 (not shown) to engage with support clips 4120 and 4121 , by rotating support clips 4120 and 4121 with support engagement structures 4280 and 4281 , respectively, to lock container 4200 to support 4100.
  • stable platform 4110 is wider than container 4200 at the lowermost horizontal dimension.
  • stable platform 4110 has a dimension greater than a corresponding dimension of container 4200 that improves the stability of the container 4200 when engaged to support 4100.
  • FIG. 44 is a perspective view of basket 4400, that can be removably placed in a retention compartment of a container (not shown) to receive one or more tissue samples, comprising subcompartments 4462, 4463, 4465, and 4464, formed by dividing walls 4460 and 4461.
  • Basket 4400 comprises structures 4450 and 4451 , positioned on top of dividing walls 4460 and 4461 , respectively, to receive gasket 4425.
  • FIG. 45 is a top plan view of container 4500 and basket 4510, that can be removable placed in the retention compartment (not shown) of container 4500 to receive one or more tissue samples, basket 4510 comprising subcompartments
  • Lid 4514 comprises a gasket 4525 to impermeably close subcompartments 4562, 4563, 4564, and 4565 by engaging gasket 4525 with the top edges of dividing walls 4560 and 4561.
  • FIG. 46 is a perspective view of container 4600 with elongated arms 4650, 4651 , 4652, and 4653.
  • Container 4600 is a single-piece article, conceptually similar to container 90 shown in FIG. 11.
  • Container 4600 comprises an attached cover
  • Cover 4613 comprising lid 4614 and hinge 4634, is permanently affixed to the retention compartment 4612.
  • the lid 4614 has a seal 4620 to securely close the lid
  • the lid 4614 contains locking mechanisms 4621 , 4622, and 4623, and is rotatably affixed to hinge 4634.
  • Retention compartment 4612 contains receiving members 4643, 4644 (not shown), and 4645 (not shown) to engage with locking mechanisms 4621 , 4622, and 4623, respectively, to securely seal lid 4614 to retention compartment 4612.
  • Plurality of elongated arms 4650, 4651, 4652 (not shown), and 4653 (not shown) extend laterally from the base of the retention compartment 4612 to stabilize the container against tipping.
  • Embodiment 1 A container for storing a tissue sample during a medical procedure, the container comprising:
  • a retention compartment for receiving and storing the tissue sample, the retention compartment having a rim;
  • a cover comprising a lid, a hinge, and optionally a stationary piece
  • the lid rotatably affixed to the hinge
  • the lid further comprising a seal to engage the rim thereby impermeably enclosing the retention compartment.
  • Embodiment 2 The container of embodiment 1 , wherein the retention compartment comprises a polymer material.
  • Embodiment 3 The container of embodiment 2, wherein the polymer material is chosen from polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
  • Embodiment 4 The container of any one of embodiments 1-3, wherein the container is sterile.
  • Embodiment 5 The container of any one of embodiments 1-4, further comprising at least one distinguishing feature chosen from: color, label, shape, and combinations thereof.
  • Embodiment 6. The container of any one of embodiments 1 -5, further comprising at least one locking mechanism to secure the lid to the rim when the seal is engaged to the rim.
  • Embodiment 7. The container of any one of embodiments 1-6, wherein the container comprises a transparent material, a translucent material, or a combination thereof.
  • Embodiment 8 The container of embodiment 7, wherein the lid comprises a transparent material, a translucent material, or a combination thereof.
  • Embodiment 9 The container of any one of embodiments 7-8, wherein the retention compartment comprises a transparent material, a translucent material, or a combination thereof.
  • Embodiment 10. The container of any one of embodiments 1 -9, further comprising at least one absorbent pad in the retention compartment to receive the tissue sample.
  • Embodiment 11 The container of embodiment 10, wherein the absorbent pad comprises at least one hydro-swellable polymer.
  • Embodiment 12 The container of embodiment 11 , wherein the hydro-swellable polymer is chosen from polyacrylic acid, polyacrylamide, polysaccharide, poly- hydroxypropyl methacrylate, and combinations of two or more thereof.
  • Embodiment 13 The container of any one of embodiments 10-12, wherein the at least one absorbent pad comprises at least one bacteriostatic agent in an amount effective to reduce or eliminate bacterial contamination of the container.
  • Embodiment 14 The container of any one of embodiments 1-11 , further comprising at least one bacteriostatic insert in the retention compartment comprising at least one bacteriostatic agent in an amount effective to reduce or eliminate bacterial contamination of the container.
  • Embodiment 15 The container of any one of embodiments 13-14, wherein the bacteriostatic agent is chosen from sulfonamides, tetracyclines, trimethoprim, clindamycin, macrolides and combinations thereof.
  • Embodiment 16 The container of embodiment 15, wherein the bacteriostatic agent is clindamycin.
  • Embodiment 17 The container of any one of embodiments 1-16, wherein the retention compartment comprises a wall having a base, a top, and a varying wall thickness, wherein the wall thickness is greater at the base than at the top.
  • Embodiment 18 The container of any one of embodiments 1-17, further comprising at least one basket removably placed in the retention compartment to receive the tissue sample.
  • Embodiment 19 The container of embodiment 18, wherein the basket comprises at least one perforated side wall.
  • Embodiment 20 The container of any one of embodiments 18-19, wherein the basket comprises a perforated bottom wall.
  • Embodiment 21 The container of any one of embodiments 18-20, wherein the basket comprises two or more subcompartments formed by one or more dividing walls.
  • Embodiment 22 The container of embodiment 21 , wherein the two or more subcompartments are marked with tissue sample identification information.
  • Embodiment 23 The container of any one of embodiments 21-22, wherein at least one of the one or more dividing walls has a height substantially the same as the height of the retention compartment.
  • Embodiment 24 The container of any one of embodiments 21-23 wherein at least one of the one or more dividing walls has a height substantially less that the height of the retention compartment.
  • Embodiment 25 The container of any one of embodiments 21-24, wherein at least one of the at one or more dividing walls has a height approximately half the height of the retention compartment.
  • Embodiment 26 The container of any one of embodiments 18-25, wherein the at least one basket comprises a finger hole for enabling removal of the basket from the retention compartment.
  • Embodiment 27 The container of any one of embodiments 18-26, wherein the at least one basket comprises a ridge for enabling removal of the basket from the retention compartment.
  • Embodiment 28 The container of any one of embodiments 18-27, wherein the at least one basket comprises a polymer material.
  • Embodiment 29. The container of embodiment 28, wherein the polymer material is chosen from polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
  • Embodiment 30 The container of any one of embodiments 1-29, further comprising at least one stabilizing structure affixed to the base of the retention compartment.
  • Embodiment 31 The container of any one of embodiments 1-30, wherein the container is adapted to engage a support comprising a plurality of elongated arms and optionally a base member, wherein the plurality of elongated arms and optionally the base member form a stable platform for resting the support on a horizontal surface.
  • Embodiment 32 The container of embodiment 31 , wherein the plurality of elongated arms comprise one or more container engagement structures.
  • Embodiment 33 The container of embodiment 32, wherein the one or more container engagement structures are present at or near the ends of the plurality of elongated arms.
  • Embodiment 34 The container of any one of embodiments 32-33, wherein the one or more container engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
  • Embodiment 35 The container of any one of embodiments 31 -34, wherein the container comprises one or more support engagement structures on the retention compartment.
  • Embodiment 36 The container of embodiment 35, wherein the one or more support engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
  • Embodiment 37 The container of any one of embodiments 31-36, wherein the rim is adapted to engage the plurality of elongated arms.
  • Embodiment 38 The container of any one of embodiments 32-37, wherein the rim is adapted to engage the one or more container engagement structures.
  • Embodiment 39 The container of any one of embodiments 31-38, wherein the container and support engage by snapping together.
  • Embodiment 40 The container of any one of embodiments 31-39, wherein the container and support engage by sliding together.
  • Embodiment 41 The container of any one of embodiments 31-40, wherein the container and support engage by gravity.
  • Embodiment 42. The container of any one of embodiments 31 -41 , wherein the container and support engage by frictional engagement.
  • Embodiment 43. The container of any one of embodiments 31-42, wherein the stable platform has a dimension greater than a corresponding dimension of the container to improve the stability of the container.
  • Embodiment 44 The container of any one of embodiments 31 -43, wherein the support comprises metal, plastic, or a combination thereof.
  • Embodiment 45 The container of embodiment 44, wherein the metal is chosen from stainless steel, aluminum, tin, titanium, alloys, and combinations thereof.
  • Embodiment 46 The container of any one of embodiments 31-45, wherein the support weighs no more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
  • Embodiment 47 The container of any one of embodiments 31-46, wherein the support weighs equal to or more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
  • Embodiment 48 The container of any one of embodiments 31-47, wherein the support has a thickness no greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm.
  • Embodiment 49 The container of any one of embodiments 31-48, wherein the support has a thickness equal to or greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm.
  • Embodiment 50 A method of storing a tissue sample during a medical procedure, comprising:
  • Embodiment 51 The method of embodiment 50, further comprising irrigating the tissue sample before impermeably enclosing the interior.
  • Embodiment 52 The method of embodiment 51 , wherein the irrigating comprises contacting the tissue sample with water, saline, sterile water, sterile saline, or a combination thereof.
  • Embodiment 53 The method of any one of embodiments 50-52, wherein the storing occurs in less than twelve hours.
  • Embodiment 54 The method of embodiment 53, wherein the storing occurs in less than six hours.
  • Embodiment 55 The method of embodiment 53 wherein the storing occurs in less than three hours.
  • Embodiment 56 The method of any one of embodiments 50-55, wherein the tissue sample comprises bone, cartilage, skin, muscle, tendon, an entire organ, a portion of an organ, a vein, an artery, a nerve, or a combination of any of the foregoing.
  • Embodiment 57 The method of any one of embodiments 50-56, wherein the tissue sample comprises one or more ears, a nose, one or more teeth, one or more fingers, one or more toes, one or more limbs, one or more partial limbs, or a combination of two or more thereof.
  • Embodiment 58 The method of any one of embodiments 50-55, further comprising cooling the container.
  • Embodiment 59 The method of embodiment 58, wherein the cooling comprises contacting the container with an ice-water composition.
  • Embodiment 60 The method of any one of embodiments 50-59, further comprising: after the storing, surgically returning the tissue sample to the patient.
  • Embodiment 61 The method of any one of embodiments 50-60, wherein the storing uses the container of any one of embodiments 1-49.
  • Embodiment 62 The method of making the container of any one of embodiments 1- 49, comprising permanently affixing the cover to the retention compartment.
  • Embodiment 63 A basket adapted to be inserted into the retention compartment of a container for storing a tissue sample during surgery, the basket containing:
  • Embodiment 64 The basket of embodiment 63, wherein the basket comprises perforations.
  • Embodiment 65 The basket of any one of embodiments 63-64, wherein the interior surface comprises at least one substantially horizontal surface.
  • Embodiment 66 The basket of any one of embodiments 63-65, wherein the basket comprises two or more subcompartments formed by at least one dividing wall.
  • Embodiment 67 The basket of any one of embodiments 63-66, wherein the two or more subcompartments are marked with tissue sample identification information.
  • Embodiment 68 The basket of any one of embodiments 66-67, wherein at least one of the at least one dividing walls has a height substantially the same as the height of the basket.
  • Embodiment 69 The basket of any one of embodiments 66-68, wherein at least one of the at least one dividing walls has a height substantially less than the height of the basket.
  • Embodiment 70 The basket of any one of embodiments 66-68, wherein at least one of the at least one dividing walls has a height approximately half the height of the basket.
  • Embodiment 71 The basket of any one of embodiments 63-70, further comprising a finger hole for enabling removal of the basket from the container.
  • Embodiment 72 The basket of any one of embodiments 63-71 , further comprising a ledge for enabling removal of the basket from the container.
  • Embodiment 73 The basket of any one of embodiments 63-72, wherein the container is the container of any one of embodiments 1-49.
  • Embodiment 74 A support adapted to stabilize a container for storing a tissue sample during surgery, the support comprising:
  • the plurality of elongated arms and optionally the base member form a stable platform for resting the support on a horizontal surface.
  • Embodiment 75 The support of embodiment 74, wherein the plurality of elongated arms comprise one or more container engagement structures.
  • Embodiment 76. The support of embodiment 75, wherein the one or more container engagement structures comprise engagement structures at or near the ends of the plurality of elongated arms.
  • Embodiment 77. The support of any one of embodiments 75-76, wherein the one or more container engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
  • Embodiment 78 The support of any one of embodiments 74-77, wherein the container comprises one or more support engagement structures on a retention compartment.
  • Embodiment 79 The support of embodiment 78, wherein the one or more support engagement structures is chosen from ledges, tabs, slots, and combinations thereof.
  • Embodiment 80 The support of any one of embodiments 74-79, wherein the container and support engage by snapping together.
  • Embodiment 81 The support of any one of embodiments 74-80, wherein the container and support engage by sliding together.
  • Embodiment 82 The support of any one of embodiments 74-81 , wherein the container and support engage by gravity.
  • Embodiment 83 The support of any one of embodiments 74-82, wherein the container and support engage by frictional engagement.
  • Embodiment 84 The support of any one of embodiments 74-83, wherein the stable platform has a dimension greater than a corresponding dimension of the container to improve the stability of the container.
  • Embodiment 85 The support of any one of embodiments 74-84, wherein the support comprises metal, plastic, or a combination thereof.
  • Embodiment 86. The support of embodiment 85, wherein the metal is chosen from stainless steel, aluminum, tin, titanium, alloys, and combinations thereof.
  • the support of any one of embodiments 74-86 wherein the support weighs no more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
  • Embodiment 88 The support of any one of embodiments 74-87, wherein the support weighs equal to or more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
  • Embodiment 89 The support of any one of embodiments 74-88, wherein the support has a thickness no greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm.
  • Embodiment 90 The support of any one of embodiments 74-89, wherein the support has a thickness equal to or greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm.
  • Embodiment 91 The container of any one of embodiments 21-49, wherein the basket comprises a gasket attached to the one or more dividing walls.
  • Embodiment 92. The container of embodiment 91 , wherein the gasket engages the lid of the container, thereby impermeably enclosing the two or more
  • Embodiment 93 The container of any one of embodiments 32-49, wherein the one or more container engagement structures are present at or near a horizontal surface on which the support rests.
  • Embodiment 94 The container of any one of embodiments 31-49 and 91-93, wherein the container and support engage by adhesion.
  • Embodiment 95 The container of any one of embodiments 31-49 and 91-94, wherein the container and support engage by twisting one or more rotating clips to lock the container to the support.
  • Embodiment 96 A method of storing an implantable device prior to or during a medical procedure, comprising:
  • Embodiment 97 The method of embodiment 96, further comprising irrigating the implantable device before impermeably enclosing the interior.
  • Embodiment 98 The method of embodiment 97, wherein the irrigating comprises contacting the device with water, saline, sterile water, sterile saline, antibiotic solution or a combination thereof.
  • Embodiment 99 The method of any one of embodiments 96-98, wherein the storing occurs in less than twelve hours.
  • Embodiment 100 The method of embodiment 99, wherein the storing occurs in less than six hours.
  • Embodiment 101 The method of embodiment 99 wherein the storing occurs in less than three hours.
  • Embodiment 102 The method of any one of embodiments 96-101 , wherein the device comprises a shunt, a pump, a tube, an artificial joint, an artificial disc, a reconstructive implant, a plate, a screw, a rod, a lens, or a combination of any of the foregoing.
  • Embodiment 103 The method of any one of embodiments 96-102, wherein the storing uses the container of any one of embodiments 1-49 and 91-95.
  • Embodiment 104 The basket of any one of embodiments 66-73, wherein the basket comprises a gasket attached to one or more dividing walls.
  • Embodiment 105 The basket of embodiment 104, wherein the gasket is adapted to engage the lid of the container, thereby impermeably enclosing the two or more subcompartments.
  • Embodiment 106 The support of any one of embodiments 75-90, wherein the one or more container engagement structures comprise engagement structures at or near a horizontal surface on which the support rests.
  • Embodiment 107 The support of embodiment 106, wherein the one or more container engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
  • Embodiment 108 The support of any one of embodiments 106-107, wherein the container comprises one or more support engagement structures on a retention compartment.
  • Embodiment 109 The support of embodiment 108, wherein the one or more support engagement structures is chosen from ledges, tabs, slots, and combinations thereof.
  • Embodiment 1 10. The support of any one of embodiments 106-109, wherein the container and support engage by snapping together. Embodiment 1 11. The support of any one of embodiments 106-110, wherein the container and support engage by adhesion. Embodiment 1 12. The support of any one of embodiments 106-111 , wherein the container and support engage by twisting one or more rotating clips to lock the container to the support.
  • Embodiment 1 13 The container of any one of embodiments 21-49 and 91-95, wherein the lid comprises a gasket attached to the interior of the lid.
  • Embodiment 1 14. The container of embodiment 113, wherein the gasket engages the one or more dividing walls of the basket when the lid is closed, thereby impermeably enclosing the two or more subcompartments.
  • Embodiment 1 15. The container of any one of embodiments 30-49 and 91-95, wherein the stabilizing structure comprises a plurality of elongated arms extending laterally from the base of the retention compartment to form a stable platform for resting the container on a horizontal surface.
  • Embodiment 1 16. The container of any one of embodiments 31-49 and 91-95, wherein the container and support engage by sliding one of more tracks to lock the container to the support.
  • Embodiment 117. The container of any one of embodiments 31-49, 91-95, and 116, wherein the container and the support engage by contacting complementary rotate- to-lock structures on the container and the support, and rotating the container relative to the support to lock the container to the support.

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Abstract

Containers and methods protect surgically-removed tissue such as cranial bone flaps, or implantable devices, for limited times during surgery. In some cases, tissue protected in such a container can be returned to the patient, lessening the need for synthetic, allographic, or xenographic alternatives.

Description

TISSUE STORAGE DURING SURGERY
Cross-Reference to Related Applications
This application claims benefit of priority under PCT Chapter I, Article 8, and 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/459,723 entitled, "TISSUE STORAGE DURING SURGERY," filed February 16, 2017, which is incorporated herein by reference in its entirety.
Copyright Notice
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.
Field of the Invention
The present invention relates to protecting a surgically-removed medical tissue sample from contamination, damage, or loss during a medical procedure by placing the medical tissue sample in a sterile container with distinguishing characteristics and a closure device.
Background of the Invention
In surgical and emergent medical procedures, it often becomes necessary to set aside tissue that will be reused in a patient. For example, in a craniotomy, a cranial bone flap can be removed and set aside, only to be returned to the patient near the conclusion of the procedure. In another example, tissue from one part of a patient's body is removed for a brief time, and grafted to another part of the patient's body, such as, for example, for facial or breast reconstruction, coronary bypass surgery, or for various types of grafts. In still another example, traumatic injuries can result in the near-amputation of, for example, fingers, toes, and ears. It may be desirable in a given case to temporarily remove the injured tissue from the patient, clean and prepare the wound, and then regraft the injured tissue to the prepared wound. A regrafted ear, for example, can save a patient from disfigurement and the risks associated with transplanting a synthetic, allographic, or xenographic substitute.
A craniotomy will be used to illustrate one device of the invention and its use. During a craniotomy, a section of the skull, called a bone flap, is removed to access the brain underneath. The skin and muscles are lifted off the bone and folded back, and small burr holes are made in the skull with a drill. A special saw is inserted through the burr holes, and is used to cut the outline of a bone flap. The cut bone flap is lifted and removed to expose the protective covering of the brain called the dura. Typically the bone flap is safely stored until it is replaced at the end of the procedure.
Once the repair of the underlying tissues is complete, the retractors holding the brain are removed and the dura is closed with sutures. The bone flap is replaced back in its original position and secured to the skull with titanium plates and screws. The muscles and skin are sutured back together.
There are several known methods for preserving a cranial bone flap for extended storage periods, but methods for storing bone flaps for a shorter time period, such as during a craniotomy, presents a difficult and unmet challenge. The longer term storage options may be required in the event of a craniectomy, where the bone flap is not replaced during the surgical event. These longer term storage options may include placing the bone under the subcutaneous abdominal tissue, preservation of bone in the subgaleal space on the edges of the craniotomy, freezing of the bone flap as referenced in US patent 8,382,844, and discarding the flap and replacing with a synthetic material.
In the event of shorter term storage, such as that required during the period of a surgical procedure, there is a need to safely store a medical tissue sample during the surgical procedure. One current practice in the operating room is to store the bone flap in a moistened laparotomy pad, or some other pouch or container that is commonly found in a sterile surgical procedure pack. As the surgery nears completion, the bone flap is removed from the pad for reattachment to the skull.
The sterile surgical procedure pack referenced above is illustrated in US patent 4,844,259, and discloses use of surgical procedure packs for the surgical removal of a medical tissue sample and a packaging means for long term storing and transporting said sample. This reference does not disclose a device or method to use for short term storage during a surgical procedure, nor try to solve the problem of safeguarding the medical tissue sample during the surgical procedure.
There are several disadvantages to storing a bone flap in the aforementioned laparotomy pad. The laparotomy pad may become blood soaked and can be misplaced or mixed in with similar pads, or can be inadvertently dropped on the floor, exposing the bone flap to damage or contamination. Since the laparotomy pad does not contain any markings that indicate the contents of the pad, or colors to distinguish it from other pads, it blends in with other materials and pads on a surgical tray or surgical table. Due to these conditions, it is likely that the laparotomy pad containing the bone flap could be mixed in with other pads in the operating room which may cause confusion or inadvertent damage to the human tissue that is important for a successful surgical closure. This could result in surgical time delays to look for the lost or misplaced laparotomy pad that contains the bone flap. It is also likely that the pad could be inadvertently picked up or moved, causing the bone flap to fall out of the laparotomy pad and onto the floor, which is an unsterile
environment. At a minimum, this could contaminate the bone, resulting in the need for cleaning, which would add time to the surgical procedure. In a worst case scenario, this could cause damage to the bone, resulting in the need to create a synthetic replacement, which would increase the time the patient is under sedation.
Another disadvantage to storing a bone flap in the aforementioned laparotomy pad is that the laparotomy pad containing the bone flap may be mistakenly thrown away or discarded during surgery. If this is not detected, this will result in the need for a synthetic implant with the same issues as noted above. Summary of the Invention
Unexpectedly, Applicants have invented devices and methods for storing tissue during surgery or other medical procedures, or for short durations. Some embodiments of the present invention provide containers for storing a tissue sample during a medical procedure, one such container comprising: a retention
compartment for receiving and storing the tissue sample, the retention compartment having a rim; a cover comprising a lid, a hinge, and optionally a stationary piece; the lid rotatably affixed to the hinge; the cover permanently affixed to the retention compartment; the cover permanently affixed to the retention compartment; the lid further comprising a seal to engage the rim thereby impermeably enclosing the retention compartment.
Other embodiments relate to methods of storing a tissue sample during a medical procedure, one such method comprising: obtaining a container having an interior; placing the tissue sample into the interior of the container; impermeably enclosing the interior of the container; and storing the tissue sample in the container.
Further embodiments provide a basket adapted to be inserted into the retention compartment of a container for storing a tissue sample during surgery, the basket containing an interior surface for receiving the tissue sample.
Still other embodiments provide a support adapted to stabilize a container for storing a tissue sample during surgery, the support comprising a plurality of elongated arms and optionally a base member, wherein the plurality of elongated arms and the base member if present form a stable platform for resting the support on a horizontal surface.
Brief Description of the Drawings
FIG 1 is a perspective view of one embodiment of the invention, a sterile container with attached lid as it would be received in the operating room.
FIG 2 is a perspective view of the sterile container of FIG 1 , illustrating the lid in the open position.
FIG 3 is a perspective view of another embodiment of the present invention for storing a tissue sample such as a bone flap during a surgical procedure.
FIG 4 is a perspective view of the embodiment of FIG 3, illustrating a bone flap covered with a saline solution.
FIG 5 is a perspective view of a sealed container stored on a surgical tray or table.
FIG 6 is a partial cross-sectional view of a portion of a container depicting the lid in engagement with the container.
FIG 7 is a partial cross-sectional view of another container depicting the lid in engagement with the container.
FIG 8 is a perspective view of the sterile container of FIG 2, illustrating the container further comprising an absorbent pad positioned in the retention compartment, with a non-skid surface affixed to the bottom portion of the exterior of the container,
FIG 9 is a perspective view of another embodiment of the present invention, illustrating container retention compartment with a narrow top and a wide base to enhance the stability of the container.
FIG 10 is a partial cross-sectional view illustrating a portion of the container depicted in FIG 9.
FIG 11 is a partial cross-sectional view illustrating another container further comprising a stabilizing structure extending laterally from the bottom of the container to stabilize the container against tipping.
FIG 12 is a perspective view of another embodiment of the present invention, illustrating a container having a retention compartment with a rectangular shape.
FIG 13 is a perspective view of the container of FIG 12, illustrating the lid in the open position.
FIG 14 is a perspective view of the container of FIG 2, illustrating a container
150 further comprising a bacteriostatic insert in the retention compartment.
FIG 15 is a top view of container 1500, illustrating the lid in the open position. FIG 16 is a bottom view of container 1500, illustrating the lid in the open position.
FIG 17 is a view of the left side of container 1500, illustrating the lid in the open position (right side view is a mirror image).
FIG 18 is a front view of container 1500 with attached lid.
FIG 19 is a back view of container 1500 with attached lid.
FIG 20 is a top view of support 2000.
FIG 21 is a bottom view of support 2000.
FIG 22 is a left side view of support 2000 (right, front and back views are substantially identical).
FIG 23 is a top view of container 1500 with attached support 2000, depicting support 2000 in engagement with container 1500.
FIG 24 is a bottom view of the container 1500 with attached support 2000, depicting the support 2000 in engagement with the container 1500. FIG 25 is a left side view of container 1500 with attached support 2000, depicting support 2000 in engagement with container 1500 (right side view is mirror image).
FIG 26 is a front view of container 1500 with attached support 2000.
FIG 27 is a back view of container 1500 with attached support 2000.
FIG 28 is a top view of basket 2800 with perforations (bottom view appears substantially identical to top view).
FIG 29 is a right side view of basket 2800 with perforations (left side view is mirror image).
FIG 30 is a front view of basket 2800 with perforations (back view is mirror image).
FIG 31 is a top view of basket 3100 comprising two or more
subcompartments.
FIG 32 is a bottom view of basket 3100 comprising two or more
subcompartments.
FIG 33 is a right side view of basket 3100 comprising two or more subcompartments (left side view is mirror image).
FIG 34 is a front view of basket 3100 comprising two or more
subcompartments (back view is mirror image).
FIG 35 is a partial view of the container 1500 and support 2000, depicting the support 2000 engaging the container 1500 by snapping together.
FIG 36 is a partial view of a container 3600 and support 3601 , depicting the support 3601 in engagement with the container 3600 by sliding together.
FIG 37 is a partial view of container 3700 and support 3701 , depicting the support 3701 in engagement with the container 3700 by frictional engagement.
FIG 38 is a partial view of container 3800 and support 3801 , depicting the support 3801 in engagement with the container 3800 by gravity.
FIG. 39 is a perspective view of container 3600 and support 3601 , depicting bacteriostatic insert 3926 in the retention compartment, further comprising basket 2800 with perforations.
FIG. 40 is a partial perspective view of container 3600 and support 3601 , depicting basket 3100 comprising two or more subcompartments.
FIG. 41 is a view of support 4100 comprising support clips 4120 and 4121. FIG. 42 is a bottom view of container 4200 comprising support engagement structures 4280 and 4281.
FIG 43 is a view of container 4200 with attached support 4100, depicting support 4100 engaged with container 4200 by twisting one or more rotating clips 4120 and 4121 to lock container 4200 to support 4100.
FIG 44 is a view of basket 4400, depicting gasket 4425 in engagement with the uppermost surfaces of the dividing walls of the subcompartments.
FIG 45 is a view of container 4500 and basket 4510, depicting gasket 4525 in engagement with the interior surface of lid 4514.
FIG 46 is a view of container 4600 comprising elongated arms extending laterally from the bottom of the container to stabilize the container against tipping.
Detailed Description of the Invention
The present invention relates to protecting a surgically removed medical tissue sample from contamination, damage, or loss during a medical procedure by placing the medical tissue sample in a sterile container with distinguishing characteristics and a closure device. In one application, a medical tissue sample is the cranial bone flap removed during a craniotomy. Any suitable tissue sample can be temporarily stored, according to various embodiments of the present invention. For example, bone, cartilage, skin, muscle, tendon, entire organs or a portion thereof, a vein, an artery, a nerve, and combinations thereof that have been harvested for a graft can be stored until transplanted to the surgical site. Facial features such as ears and noses, teeth, fingers, toes, limbs and portions thereof can be protected in certain embodiments. Although the invention is not limited to use during a craniotomy, and the container is not limited to a specific shape, this procedure will be used in the detailed description to follow, to illustrate a device of the invention and its use.
As stated above, certain embodiments of the present invention relate to a container for storing a tissue sample during a medical procedure, the container comprising: a retention compartment for receiving and storing the tissue sample, the retention compartment having a rim; a cover comprising a lid, a hinge, and optionally a stationary piece; the lid rotatably affixed to the hinge; the cover permanently affixed to the retention compartment; the lid further comprising a seal to engage the rim thereby impermeably enclosing the retention compartment. Any suitable material can be used for the various parts of the container. In some cases, for example, the container comprises one or more polymer materials. Any suitable polymer material or polymer materials can be used, such as, for example, polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
The retention compartment receives and stores the tissue sample during the surgical procedure. Generally speaking, the retention compartment represents the inside of the container, and thereby protects and maintains the tissue sample. The rim of the retention compartment can be of any suitable configuration, so that the lid can impermeably enclose the retention compartment. In some cases, this is done with a seal on the lid engaging the rim of the retention compartment. The precise structures of the seal and the rim are not significant, so long as they engage, and enclose the tissue sample.
The lid being rotatably affixed to a hinge allows the container to be opened and closed as desired. The cover comprising the lid, the hinge, and optionally the stationary piece, is permanently affixed to the retention compartment, so the lid is not easily separated from the container. Any suitable hinge configuration can be used, and more than one hinge mechanism may be involved. In some cases, a hinge comprises a thinner region of the material or materials of the cover, such as plastic, that allows the lid to rotate about the hinge to open and close the lid. In other cases, pin and slot structures, or other suitable physical structures, form the hinge. The hinge can locate between the lid and the stationary piece, in some cases, or between the lid and the retention compartment, in other cases that do not have a stationary piece. Covers including optional stationary pieces appear in FIGs 1 -5, 8- 9; covers without a stationary piece appear in FIGs 12-13, for illustration. The optional stationary piece can have any suitable shape, and illustrates that any suitable configuration comprising a lid and a hinge forming a cover permanently affixed to the retention compartment can be used.
It can be beneficial, in certain instances, for the container to comprise a transparent material, such as for example, glass or transparent polymer, so that the contents of the container can be readily identified without opening the container and risking contamination of the tissue sample. Accordingly, the retention compartment, the lid, or both, in addition to any other part of the container, can be made of or comprise transparent material. In other instances, the container can comprise a translucent material, such as for example, frosted glass or translucent polymer, so that the contents of the container can be identified or at least visualized without opening the container and risking contamination of the tissue sample. Accordingly, the retention compartment, the lid, or both, in addition to any other part of the container, can be made of or comprise translucent material.
Sometimes, the container is sterile when it is presented for use in an operating room or other suitable context. Sterilization can occur according to any suitable procedure. For example, sterile manufacture can employ clean rooms, cleaned or purified starting materials, sustained high temperatures sufficient for killing microbes, and combinations thereof to improve the cleanliness or even sterilize the container.
Further instances of the present invention provide a container comprising at least one distinguishing feature. A problem in an operating room or an emergency room when a tissue sample is set aside relates to the identification of that tissue sample's location. Accordingly, certain embodiments of the present invention provide a container readily identifiable as the location of the tissue sample. Any suitable distinguishing feature can be used. Some containers comprise at least one distinguishing feature chosen from: color, label, shape, and combinations thereof. Color can be associated with the container through any suitable means, such as, for example, the material used to make the container or a part thereof has a colorant included in the material, such as is known in polymer article manufacture. Or, adhesive labels or tape can impart a color to the container. In addition, the container can have a special surface or an adhesive label affixed thereto so the container can be labeled to identify the contents. Containers of the present invention can have any suitable shape. In some cases, a container having a distinct shape can be used. Suitable shapes include, but are not limited to: polygons, semicircles, stars, cross shapes, flat-bottom bowls, squares, rectangles, and the like.
It may be desirable to augment the engagement of the lid with the retention compartment by adding one or more locking mechanisms to the container. One or more locking mechanisms may further protect the tissue sample by avoiding accidentally knocking the tissue sample out of the container should the container fall or be jostled. Therefore, some containers further comprise one or more locking mechanisms to secure the lid to the rim when the seal is engaged to the rim. Any suitable locking mechanisms can be used. In certain instances, a snap, a latch, a collar, a push button lock, a flange with corresponding retention surfaces, a lock member with a receiving member, a tab with teeth to engage corresponding teeth, and the like can be used.
It may be desirable to irrigate the tissue sample, in some uses of the containers of the present invention. In one instance, a suitable fluid can be added to the container before or after placing the tissue sample in the container. In another instance, the container can comprise at least one absorbent pad in the retention compartment to receive the tissue sample. Any suitable absorbent pad can be used. For example, gauze, sterile gauze, hydrophilic polyester, and combinations thereof can be used as an absorbent pad. Sometimes, the absorbent pad comprises at least one hydro-swellable polymer, either alone or in combination with other suitable materials. Any suitable hydro-swellable polymer can be used. In some cases, the hydro-swellable polymer is chosen from polyacrylic acid, polyacrylamide,
polysaccharide, poly-hydroxy propyl methacrylate, and combinations of two or more thereof.
In some cases, the interior of the retention compartment comprises one or more antimicrobial coatings. Any suitable antimicrobial coatings can be used, alone or in combination. In some cases, the anti-microbial coating is chosen from silver sulfadiazine, silver nitrate, silver halide, silver acid salt, chlorhexidine
dihydrochloride, chlorhexidine diacetate, taurolidine citrate solution, copper carbonates, thiabendazole, silver salicylates, and combinations thereof.
Optionally, the interior of the retention compartment comprises an insert treated with a bacteriostatic agent. Any suitable bacteriostatic agent can be used, alone or in combination. In some cases, the bacteriostatic agent is chosen from sulfonamides, tetracyclines, trimethoprim, clindamycin, macrolides and combinations thereof. The bacteriostatic agent or agents can be present in any suitable amount in any suitable composition. In some cases, the bacteriostatic agent is present in an aqueous or non-aqueous composition in a concentration of at least 0.1 mg per liter of composition, and the composition is made to contact the insert so the insert comprises an effective amount of the bacteriostatic agent. The insert can include any suitable materials, such as, for example, gauze, sterile gauze, hydrophilic polyester, at least one hydro-swellable polymer as mentioned above, and
combinations thereof. In some cases, an insert treated with a bacteriostatic agent can be used in combination with an absorbent pad. In other cases, the absorbent pad can be treated with at least one bacteriostatic agent, and thereby function as an absorbent pad and a bacteriostatic insert.
Certain embodiments relate to containers having structure that imparts greater stability. For example, some containers can comprise one or more non-skid surfaces on the exterior bottom of the retention compartment. A non-skid surface can cover any suitable portion of the bottom, such as a small portion of the bottom, or most of the bottom. Any suitable non-skid surface can be used, alone or in combination. For example, the material used to make the retention compartment can be designed to include ridges, bumps, or other protrusions that impart a non-skid quality to the container. In other cases, one or more rubber or rubber-like pads can be adhered to the bottom to create the non-skid surface(s). Care may be taken, in some cases, to select a non-skid surface that allows for sterilization of the container without damaging the non-skid surface.
Further embodiments relate to containers having a greater stability against tipping. This can be accomplished by any suitable means. In some cases, the retention compartment comprises a wall having a base, a top, and a wall thickness, and the wall thickness is greater at the base than at the top. To measure the wall thickness at the base, the measurement should be made at the wall above the bottom surface of the retention container. See FIG 10. In other cases, one or more stabilizing structures are affixed to the base of the retention compartment. A stabilizing structure, such as a "foot" or a "donut," or a plurality of elongated arms, extends laterally from the bottom of the retention compartment and thereby stabilizes the container against tipping. The addition of stabilizing structure can occur when the container is molded, or stabilizing structure can be added once the container has been made.
It may be desirable to secure the tissue sample in the container by adding a basket in the retention compartment. In one embodiment, the basket can comprise at least one perforated side wall, or can comprise a perforated bottom wall. The perforated walls can be used alone so that only one wall contains perforations, or in combination so that one or more side walls and optionally the bottom wall contain perforations. The perforated walls can allow fluid in the retention compartment to flow through the basket, keeping the tissue sample submerged in liquid. If the basket does not have distinct side walls and bottom walls, such as when the basket has a curved or spherical shape, it can be said that the basket comprises a wall that can have perforations on one or more portions of the wall or on substantially the entire wall.
In another embodiment, the basket can comprise two or more
subcompartments formed by one or more dividing walls. In addition, the basket may comprise one or more gaskets to impermeably enclose the two or more
subcompartments when engaged with the lid. Gaskets employed in such
embodiments keep the fluids and other contents of one subcompartment from contacting the contents of another subcompartment. In some cases, the lid may comprise one or more gaskets removably attached to the interior of the lid to impermeably enclose the two or more subcompartments when engaged with the lid. Optionally, the two or more subcompartments are marked with tissue sample identification information. The dividing walls can have any suitable height, and can be the same or different in that respect. In one instance, at least one of the dividing walls has a height substantially the same as the height of the retention compartment. In another instance, at least one of the dividing walls has a height substantially less that the height of the retention compartment. In yet another instance, at least one of the dividing walls has a height approximately half the height of the retention compartment. The subcompartments can allow for storage of one or more tissue samples during a surgical procedure, or for storage of a tissue specimen in preparation for biopsy.
Further embodiments of the present invention provide one or more features on the basket for enabling removal of the basket from the retention compartment. For example, the basket can comprise a finger hole to provide ease of removal from the retention compartment. A finger hole or similar feature allows a user to grab the basket. In yet another example, the basket can comprise a ridge for enabling removal of the basket from the retention compartment. A ridge or similar feature eases separation of the basket from the retention compartment, so it is less likely for them to become stuck together or hard to separate in an operating room
environment. Any suitable material can be used for the basket. In some cases, for example, the basket comprises one or more polymer materials, metals, or combinations thereof. Any suitable polymer material or polymer materials may be used, such as, for example, polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
Still further embodiments of the present invention provide one or more features on the basket for impermeably enclosing the subcompartments when the lid is engaged with the retention compartment. For example, the basket can comprise one or more gaskets engaging the uppermost surfaces of the dividing walls separating subcompartments. A gasket or similar feature prevents leakage of fluids or tissue from one sub-compartment into a second subcompartment, so it is less likely for materials contained in one or more subcompartments to become cross- contaminated. Any suitable material can be used for a gasket. In some cases, for example, a gasket comprises one or more polymer materials, metals, or
combinations thereof. Any suitable polymer material or polymer materials may be used, such as, for example, polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
Yet further embodiments of the present invention provide one or more features on the container lid for impermeably enclosing the subcompartments when the lid is engaged with the retention compartment. For example, the interior of the lid can comprise one or more gaskets engaging the uppermost surfaces of the dividing walls separating subcompartments. Alternatively, one or more gaskets attached to the uppermost surfaces of the dividing walls can engage the interior of the lid when the lid is closed, thereby impermeably enclosing the subcompartments. A gasket or similar feature prevents leakage of fluids or tissue from one subcompartment into a second subcompartment, so it is less likely for materials contained in one or more subcompartments to become cross-contaminated. A gasket can have any suitable shape. In some cases, a gasket can have an annular shape. In other cases, a gasket comprises a monolith of resilient material, for example, attached to the interior of the lid that impedes fluid transfer from one subcompartment to another. Any suitable material can be used for a gasket. In some cases, for example, a gasket comprises one or more polymer materials, metals, or combinations thereof. Any suitable polymer material or polymer materials may be used, such as, for example, polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
Additional embodiments relate to containers having a greater stability against tipping. This can be accomplished by any suitable means. In some cases, the container comprises at least one stabilizing structure affixed to the base of the retention compartment, such as a "foot" or a "donut," as described above. In other cases, the container is adapted to engage a support that comprises
a plurality of elongated arms and optionally a base member. The elongated arms and the base member form a stable platform for resting the support on a horizontal surface. The plurality of elongated arms can be substantially two-dimensional, and engage the container fairly close to the horizontal surface on which the support rests. Or, one or more elongated arms can rise vertically from the horizontal surface, and engage the container close to and/or further from the horizontal surface. The plurality of elongated arms may comprise one or more container engagement structures, which can be present at or near the horizontal surface or further from it, for example. In other cases, the plurality of elongated arms comprises one or more container engagement structures, which can be present at or near the ends of the plurality of elongated arms, for example. The container engagement structures can be of any suitable configuration, so that the container can engage with the elongated arms. Suitable container engagement structures include, for example, ledges, protrusions, recesses, and combinations thereof.
In yet other cases, the plurality of elongated arms can extend laterally from the bottom of the retention compartment and thereby stabilize the container against tipping. The addition of the elongated arms can occur when the container is molded, or stabilizing support can be added once the container has been made.
In other cases, the container comprises one or more support engagement structures on the retention compartment. The support engagement structures can be of any suitable configuration, so that the elongated arms of the support can engage with the container. Suitable support engagement structures include, for example, ledges, protrusions, recesses, and combinations thereof.
In yet other cases, the rim of the container can be adapted to engage the plurality of elongated arms. Additionally, the rim can be adapted to engage the one or more container engagement structures. Additional embodiments relate to methods of engaging the container with the support. Any suitable engagement can secure the container to the support. In one instance, the container and support can engage by snapping together. In another instance, the container and support can engage by adhesion. Any suitable adhesive can be used to engage the container and support, and such adhesives can be permanent or reusable adhesives. Pressure-sensitive adhesives, acrylics, urethanes, epoxies, and ethylene vinyl acetate adhesives, and combinations thereof may be mentioned. In another instance, the container and support can engage by sliding together. In yet another instance, the container and support can engage by gravity. In still yet another instance, the container and support can engage by frictional engagement. In still another embodiment, the container and support can employ one or more complimentary rotating clips, such that an operator places the container and support together and twists one or more rotating clips to lock the container to the support. Optionally, this can be accomplished with one or more screws, bolts, or similar connectors holding the container to the support. A further embodiment provides complementary rotate-to-lock structures on the container and on the support, which operate by placing the container and support together and rotating the container relative to the support to lock the two together. In yet another embodiment, the container and support can employ complimentary tracks, such that an operator places the container and support together and slides one or more tracks to lock the container to the support. Complimentary tracks can slide together with any suitable motion, such as, for example, a linear or two-dimensional motion, a rotational motion, or a combination thereof. If a rotational motion can be used, such complementary tracks also can be described as rotate-to-lock structures.
Combinations of means for engaging the container with the support also can be employed. It can be beneficial, in certain instances, for the stable platform to have a dimension greater than a corresponding dimension of the container to improve the stability of the container. In other words, in certain instances, the stable platform can be wider or longer in some respect than the container. As used herein, a
"corresponding dimension" indicates that the same dimension is being measured and compared on the support as on the container. For example, in certain instances, the length of an edge of the stable platform will be greater than the length of the corresponding edge of the container. For another example, the horizontal surface area of the stable platform will be greater than the corresponding horizontal surface area of the container. It is not necessary that all dimensions of the support be greater than all corresponding dimensions of the container. For example, FIG. 24 shows a container that may have a larger surface area on its bottom-most horizontal surface than its support, but the support has at least one length measured along the elongated arms that is greater than the corresponding dimension of the container, which would be a diagonal measurement across its bottom.
Any suitable material can be used for the support. In some cases, for example, the support comprises metal, plastic, or a combination thereof. Any suitable metal can be used, such as, for example, stainless steel, aluminum, tin, titanium, alloys, and combinations thereof. The alloy can be a mixture of any suitable metals, such as those known in the art. Stainless steels are a class of alloys.
The support can have any suitable weight. In some cases, the support ranges from 0.1 pounds - 10 pounds.
Any suitable thickness can be used for the support. In some cases the support has a thickness ranging from 1 mm - 5 cm.
Additional embodiments relate to methods of storing a tissue sample during a medical procedure. One such method comprises obtaining a container having an interior; placing the tissue sample into the interior of the container; impermeably enclosing the interior of the container; and storing the tissue sample in the container. Impermeably enclosing the interior means that fluid cannot flow into or out of the container. By stopping both air and liquid from entering or leaving the container, the tissue sample is protected from dehydration and unnecessary risk of contamination. Further protection from dehydration of the tissue sample is provided by optionally irrigating the tissue sample before impermeably enclosing the interior. Any suitable fluid can be used to irrigate the tissue sample. For example, in some cases, irrigating comprises contacting the tissue sample with water, saline, sterile water, sterile saline, or a combination thereof.
A tissue sample can be stored for any suitable duration. In some cases, the storing occurs in less than twelve hours, less than six hours, or less than three hours. The tissue sample is typically harvested at the beginning of the surgical procedure, and may need to be securely stored for a period of time before being attached to the surgical area. It is also possible for a tissue sample to be surgically or otherwise removed from a patient, temporarily stored in a container of the present invention, and transported, such as for example, from one operating room to another, or from the scene of an accident to an emergency room.
Any suitable tissue sample can be stored in the various embodiments of the present invention. In some cases, the tissue sample comprises bone, cartilage, skin, muscle, tendon, an entire organ, a portion of an organ, a vein, an artery, a nerve, or a combination of any of the foregoing. In other cases, the tissue sample comprises one or more ears, a nose, one or more teeth, one or more fingers, one or more toes, one or more limbs, one or more partial limbs, or a combination of two or more thereof.
Additional embodiments relate to methods of storing an implantable device prior to or during a medical procedure. One such method comprises obtaining a container having an interior; placing the implant into the interior of the container; impermeably enclosing the interior of the container; and storing the implantable device in the container. Impermeably enclosing the interior means that fluid cannot flow into or out of the container. By stopping both air and liquid from entering or leaving the container, the implantable device is protected from dehydration and unnecessary risk of contamination. Further preparation of the implantable device is provided by optionally irrigating the implantable device before impermeably enclosing the interior. Any suitable fluid can be used to irrigate the implantable. For example, in some cases, irrigating comprises contacting the tissue sample with water, saline, sterile water, sterile saline, antibiotic solution or a combination thereof.
Any suitable implantable device can be stored in the various embodiments of the present invention. In some cases, the device comprises a shunt, a pump, a tube, an artificial joint, an artificial disc, a reconstructive implant, a plate, a screw, a rod, a lens, or a combination of any of the foregoing.
It may be desirable to cool the container while the container is storing a tissue sample. Accordingly, further embodiments relate to cooling the container. Any suitable method can be used to cool a container and the tissue sample therein. For example, cooling may involve contacting the container with an ice-water
composition, such as an ice water bath. Further embodiments of the present invention relate to situations where the tissue sample is returned to the patient. Perhaps the tissue sample has been traumatically injured or amputated. Or, perhaps the tissue sample has been removed from the patient so that underlying tissue and organs can be accessed. In still other situations, for example, tissue from one part of the patient has been removed to be grafted onto another location on or in the patient's body, such as a leg vein graft for use in coronary bypass surgery. Similarly, tissue such as adipose tissue may be removed from one part of the patient to use for breast or facial reconstructive surgery. Accordingly, some instances of the present invention involve storing the tissue sample and then surgically returning the tissue sample to the patient. Any suitable techniques can be used to return the tissue sample to the patient, and those techniques may depend on the nature of the tissue sample, the location to which the sample will be placed, the history of the tissue sample, and other factors. In accordance with the present invention, and in one embodiment thereof, a sterilized container for the short term storage of a removed bone flap during a surgical procedure is provided.
Certain embodiments of the present invention relate to methods of making the containers, baskets, supports, and other components as described herein. Any suitable methods of manufacture can be employed, such as, for example, those currently known by persons of ordinary skill in the art. Polymer components, for example, can be injection molded, extrusion molded, blow molded, 3D printed, milled, or a combination thereof. Metal components, for example, can be molded, machined, 3D printed, or a combination thereof. Some methods relate to methods of making a container as described herein, one such method comprising permanently affixing the cover to the retention compartment.
Referring to FIG 1 , there is generally provided a sterile container 10 to use for storage of the bone flap during a craniotomy, or of another tissue sample during a medical procedure. The container 10 comprises a retention compartment 12 with an attached cover 13, said container 10 being constructed of an impermeable material, such as a plastic material, optionally with a fluorescent color. Cover 13, comprising lid 14, hinge 34, and stationary piece 17, is permanently affixed to the retention compartment 12. Lid 14 is rotatably affixed to hinge 34. Since the lid 14 impermeably encloses the retention compartment 12, the rim of the retention compartment 12 and the seal of lid 14 are not visible.
As illustrated in FIG 2, a container 11 , similar to container 10, has an interior 18. The lid 14 has a seal 20 to securely close the lid 14 by engaging rim 25, thereby impermeably enclosing the retention compartment 12. In addition, the lid 14
contains a locking mechanism 22 and is rotatably affixed to hinge 34, which together with stationary piece 17 form the cover 13 that is permanently affixed to retention compartment 12. Retention compartment 12 contains receiving member 44 to engage with locking mechanism 22 to securely seal lid 14 to retention compartment 12.
In accordance with another embodiment of the present invention, a means for storing the surgically removed bone, as well as process for short term storage during the medical procedure whereby the bone flap remains safeguarded from
contamination, damage, or loss, is provided.
Referring to FIG 3, a fluorescent-colored container 15, which is like containers
10 and 11 of Figs. 1 -2, and has an antimicrobial coating 26 in the interior 18 of retention compartment 24. For the purposes of the present invention, and in order to provide a suitable storing receptacle, a preferred form of the fluorescent colored container 11 is illustrated in FIG 3 wherein the storing means is shown as being formed when the lid 14 is sealed onto retention compartment 24 and secured with locking mechanism 22. The container 15 may be of any size sufficient to contain a medical sample.
In still a further embodiment of the present invention, a process is provided for storing the surgically removed bone flap for short term storage during the medical procedure whereby the bone flap remains safe from contamination, damage or loss.
Referring to FIG 4, container 16, similar to container 11 of Fig. 2, comprises retention compartment 12 for receiving and storing bone flap 28 and having a rim (not visible), lid 14 rotatably affixed to hinge 34, wherein with hinge 34 and stationary piece 17 form cover 13 that is permanently affixed to retention compartment 12. Container 16 has interior 18 defined by retention compartment 12 and lid 14. When the bone flap 28 is removed from the patient and needs to be stored for a short period of time, bone flap 28 is placed into the interior 18 of container 16. Sterile saline 30 is added to retention compartment 12 sufficient to irrigate bone flap 28. Interior 18 of container 16 is impermeably enclosed by closing lid 14 so the seal (not shown) of lid 14 engages the rim (not shown) of retention compartment 12, and locking the locking mechanism 22. Bone flap 28 can now be stored in container 16 until it is needed again, for example, on surgical table 32 as shown in Fig. 5.
Optionally, an ice-water bath can cool container 16 by contacting the outside of retention compartment 12.
Referring to FIG 6, the cross-sectional view of a portion of container 11 , reveals locking mechanism 22 to secure lid 14 to retention compartment 12 when lid 14 is engaged. Locking mechanism 22 comprises lock member 42 which is attached to lid 14 and receiving member 44 which is attached to container 12. Lock member 42 is configured to engage with receiving member 44 to establish a secure lock that is configured to prevent inadvertent opening of container 11 , which could result in spillage and/or contamination of the container contents.
Referring to FIG 7, partial cross sectional view of another container 50, reveals an alternate locking mechanism 56 to secure lid 54 to retention compartment 52 when lid 54 is engaged. Lid 54 is configured to engage flange 58 with retention surfaces 59, 60 on retention compartment 52 to establish a secure lock to prevent inadvertent opening of container 50, which could result in spillage and/or
contamination of the container contents. Additionally, retention surfaces 59, 60 may have grooves, indentations, or recesses that can be configured to receive a portion of flange 58.
Referring to FIG 8, container 65, similar to container 11 of FIG 2, has an interior 18 with an absorbent pad 62 positioned in the interior portion of the bottom of retention compartment 12 to receive the tissue sample. Additionally, a non-skid surface 64 is affixed to the exterior portion of the bottom of container 65 to reduce or prevent slippage of container 65 on any work surface, such as a surgical table.
Referring to FIG 9, container 70 represents another embodiment similar to container 11 of FIG 2, whereby retention compartment 72 is narrower at top 86 and wider at base 88 to stabilize retention compartment 72 and prevent tipping of container 70. Additionally, interior 84 of retention compartment 72 maintains the same internal dimensions from top 86 to base 88, resulting in thicker external dimensions surrounding base 88. Referring to FIG 10, the cross-sectional view of a portion of container 70 illustrates a retention compartment 72 comprises a wall 74 having a base 88, a top 86, and a varying wall thickness, wherein the wall thickness is greater at the base 88 than at the top 86. That difference in wall thickness serves to stabilize retention compartment 72 and prevent tipping of container 70. Thickness arrow 99 located at bottom 88 measures a greater wall thickness than thickness arrow 98 located at top 86.
FIG 11 provides a partial cross-sectional view of container 90 which further comprises stabilizing structure 92 at base 94 of retention compartment 96.
Stabilizing structure 92 extends from bottom of retention compartment 96 and serves to stabilize container 90 against tipping.
Referring to FIG 12, container 100 represents another embodiment, wherein container 100 comprises a rectangular shaped retention compartment 120 with an attached cover 130, said container 100 being constructed of an impermeable material, such as a plastic material, optionally with a fluorescent color. Cover 130 comprises lid 140 and hinge 340. Cover 130 is permanently affixed to the retention compartment 120 at hinge 340. Lid 140 is rotatably affixed to hinge 340. Since the lid 140 impermeably encloses the retention compartment 120, the rim of the retention compartment 120 and the seal of lid 140 are not visible.
As illustrated in FIG 13, a container 100, similar to container 100 in FIG 12, has an interior 180. The lid 140 has a seal 210 to securely close lid 140 by engaging rim 250, thereby impermeably enclosing the retention compartment 120. In addition, the lid 140 contains a locking mechanism 220 and is rotatably affixed to hinge 340, which together form cover 130 that is permanently affixed to retention compartment 120. Retention compartment 120 contains receiving member 440 to engage with locking mechanism 220 to securely seal lid 140 to retention compartment 120.
Referring to FIG 14, container 150, similar to container 13 of FIG 2, has an interior 180 with a bacteriostatic insert 260 positioned in the interior portion of the bottom of retention compartment 240. Locking mechanism 220 is positioned on lid 140 to securely seal lid 140 to retention compartment 240. Lid 140 is rotatably affixed to hinge 340. FIGs 15-19 show container 1500 which comprises a retention compartment 1512 with an attached cover 1513, said container 1500 being constructed of an impermeable material, such as a plastic material, optionally with a fluorescent color. Cover 1513, comprising lid 1514 and hinge 1534, is permanently affixed to the retention compartment 1512. The lid 1514 has a seal 1520 to securely close the lid 1514 by engaging rim 1525, thereby impermeably enclosing the retention
compartment 1512. In addition, the lid 1514 contains locking mechanisms 1521 , 1522, and 1523, and is rotatably affixed to hinge 1534, which form the cover 1513 that is permanently affixed to retention compartment 1512. Retention compartment 1512 contains receiving members 1543, 1544, and 1545 to engage with locking mechanisms 1521 , 1522, and 1523, respectively, to securely seal lid 1514 to retention compartment 1512. In addition, retention compartment 1512 contains tabs 1580, 1581 , 1582, and 1583 to engage a support (not shown). FIG 15 is a top view of container 1500; FIG 16 is a bottom view of container 1500; FIG 17 is a view of the left side of container (right side view is mirror image) of container 1500; FIG 18 is a front view of container 1500; and FIG 19 is a back view of container 1500.
FIGs. 20-22 show support 2000, which reveals a plurality of elongated arms 2050, 2051 , 2052 and 2053 and base member 2015, which form stable platform
2010 for resting support 2000 on a horizontal surface. In addition, the plurality of elongated arms 2050, 2051 , 2052 and 2053 comprise container engagement structures 2070, 2071 , 2072, and 2073, respectively, at or near the ends of the plurality of elongated arms. FIG 20 is a top view of support 2000; FIG 21 is a bottom view of support 2000; and FIG 22 is a left side view of support 2000 (right, front and back views are substantially identical).
FIGs 23-27 show container 1500 with attached support 2000, depicting support 2000 in engagement with container 1500. In addition, retention
compartment 1512 contains support engagement structures 1580, 1581 , 1582, and 1583 to engage container engagement structures 2070, 2071, 2072, and 2073, respectively, on support 2000. FIG 23 is a top view of container 1500 with attached support 2000; FIG 24 is a bottom view of container 1500 with attached support 2000, FIG 25 is a view of the left side of container (right side view is mirror image) of container 1500 with attached support 2000, FIG 26 is a front view of container 1500 with attached support 2000, and FIG 27 is a back view of container 1500 with attached support 2000. It can be seen, for example in FIG 25, that stable platform 2010 is wider than container 1500 at the lowermost horizontal dimension. Thus, stable platform 2010 has a dimension greater than a corresponding dimension of container 1500 that improves the stability of the container 1500 when engaged to support 2000.
FIGs 28-30 show basket 2800 that can be removably placed in a retention compartment (not shown) to receive a tissue sample, comprising perforated side walls 2891 , 2892, 2893, and 2894, said basket 2800 being constructed of an impermeable material, such as a plastic material. Perforations 2801 are holes drilled or molded into basket 2800. In addition, basket 2800 comprises perforated bottom wall 2895, which provides a substantially horizontal surface when deployed in a container (not shown) that is placed on a horizontal surface such as surgical table 32. FIG 28 is a top view of basket 2800 with perforations 2801 (bottom view appears substantially identical to top view), FIG 29 is a right side view of basket 2800 with perforations 2801 (left side view is mirror image), and FIG 30 is a front view of basket 2800 with perforations 2801 (back view is mirror image).
FIGs 31-34 show basket 3100 that can be removably placed in the retention compartment (not shown) to receive one or more tissue samples comprises subcompartments 3162, 3163, 3165, and 3164, formed by dividing walls 3160 and 3161. Basket 3100 comprises finger hole 3166 for enabling removal of basket 3100 from the retention compartment. In addition, subcompartments 3162, 3163, 3165, and 3164 are marked with tissue sample identification information 3167, 3168, 3169, and 3170, respectively. FIG 31 is a top view of basket 3100 with subcompartments; FIG 32 is a bottom view of basket 3100 with subcompartments; FIG 33 is a right side view of basket 3100 with subcompartments (left side view is mirror image), and FIG 34 is a front view of basket 3100 with subcompartments (back view is mirror image).
FIG 35 illustrates a partial view of container 1500 and support 2000. Lid 1514 contains locking mechanism 1521 , and retention compartment 1512 contains receiving member 1543 to engage with locking mechanisms 1521 to securely seal lid 1514 to retention compartment 1512. Lid 1514 is in the closed position. In addition, support 2000 comprises elongated arm 2050 and a base member (not shown), which form a platform (not shown) for resting support 2000 on a horizontal surface. In addition, elongated arm 2050 comprises container engagement structure 2070 at or near the end of the elongated arm to engage with the support engagement structure 1580. It can be said that container engagement structure 2070 is a protrusion. Container engagement structure 2070 engages with support
engagement structure 1580 by snapping together.
FIG 36 illustrates a partial view of container 3600 and support 3601. Lid 3614 contains locking mechanism 3621 , and retention compartment 3612 contains receiving member 3643 to engage with locking mechanism 3621 to securely seal lid 3614 to retention compartment 3612. Lid 3614 is in the open position. In addition, support 3601 comprises elongated arm 3650 and base member (not shown), which form a stable platform (not shown) for resting support 3601 on a horizontal surface. In addition, elongated arm 3650 comprises container engagement structure 3670 at or near the end of the elongated arm to engage with the support engagement structure 3680. Container engagement structure 3670 engages with support engagement structure 3680 by sliding together. It can be said that container engagement structure 3670 is a ledge, and support engagement structure 3680 is a recess.
FIG 37 illustrates a partial view of container 3700 and support 3701. Lid 3714 contains locking mechanisms 3721 and 3722, and retention compartment 3712 contains receiving members 3743 and 3744 to engage with locking mechanisms 3721 and 3722 to securely seal lid 3714 to retention compartment 3712. Retention compartment 3712 contains support engagement structures 3780 and 3782 to engage support 3701. Support 3701 comprises a plurality of elongated arms 3750 and 3752 and base member 3715, which form stable platform 3710 for resting support 3701 on a horizontal surface. The plurality of elongated arms comprises container engagement structures 3770 and 3772 at or near the ends of the plurality of elongated arms 3750 and 3752, respectively, to engage with support engagement structures 3780 and 3782, respectively, by frictional engagement. It can be said that container engagement structure 3770 is a protrusion, and support engagement structure 3780 is a recess.
FIG 38 illustrates a partial view of container 3800 and support 3801. Lid 3814 contains locking mechanisms 3821 and 3822, and retention compartment 3812 contains receiving members 3843 and 3844 to engage with locking mechanisms 3821 and 3822 respectively to securely seal lid 3814 to retention compartment 3812. Support 3801 comprises a plurality of elongated arms 3850 and 3852 and base member 3815, which form stable platform 3810 for resting support 3801 on a horizontal surface. The plurality of elongated arms comprises container engagement structures 3870 and 3872 at or near the ends of the plurality of elongated arms 3850 and 3852, respectively, to engage with support engagement structures 3870 and 3872 that engages with structures 3880 and 3882, respectively, by gravity.
Referring to FIG 39, the partial view of container 3600 and support 3601 comprises a retention compartment 3612 with bacteriostatic insert 3926 and basket 2800. Cover 3613, comprising lid 3614 and hinge 3634, is permanently affixed to the retention compartment 3612. Lid 3614 has a seal 3620 to securely close lid 3614 by engaging rim 3625, thereby impermeably enclosing the retention compartment 3612. In addition, the lid 3614 contains locking mechanisms 3622 and 3623 and is rotatably affixed to hinge 3634. Retention compartment 3612 contains receiving member 3644 and 3645 to engage with locking mechanisms 3622 and 3623
respectively to securely seal lid 3614 to retention compartment 3612. In addition, retention compartment 3612 contains support engagement structures 3681 and 3683 to engage support 3601. Support 3601 comprises a plurality of elongated arms 3651 and 3653 and base member 3615 which form stable platform 3610 for resting support 3601 on a horizontal surface. In addition, the plurality of elongated arms comprises container engagement structure 3671 and 3673 at or near the ends of the plurality of elongated arms 3651 and 3653 respectively. Container engagement structure 3673 engages with support engagement structures 3681 and 3683.
Referring to FIG 40, the partial view of container 3600 and support 3601 comprises a retention compartment 3612 with basket 3100 with one or more subcompartments 3162, 3163, 3165, and 3164, formed by dividing walls 3160 and 3161. Dividing walls 3160 and 3161 are substantially the same height as the height of retention compartment 3612. Basket 3100 comprises finger hole 3166 for enabling removal of basket 3100 from retention compartment 3612. In addition, it can be seen that subcompartments 3164 and 3165 are marked with tissue sample identification information 3167 and 3168. In addition, retention compartment 3612 contains support engagement structures 3681 and 3683 to engage support 3601. Support 3601 comprises a plurality of elongated arms 3651 and 3653 and base member 3615 which form stable platform 3610 for resting support 3601 on a horizontal surface. In addition, the plurality of elongated arms 3651 and 3653 comprise container engagement structure 3671 and 3673 at or near the ends of the plurality of elongated arms 3651 and 3653 respectively. Container engagement structure 3763 engages with support engagement structures 3681 and 3683.
FIG. 41 shows support 4100, which reveals a plurality of elongated arms
4150, 4151 , 4152, 4153, and base member 4115, which form stable platform 4110 for resting support 4100 on a horizontal surface. Platform 4110 comprises support clips 4120 and 4121 to engage container 4200 (not shown). In addition, support 4100 engages container 4200 (not shown) fairly close to the horizontal surface on which support 4100 rests. Support clips 4120 and 4121 represent tracks that complement corresponding structure on container 4200 (not shown), such that an operator places container 4200 and support 4100 together and rotationally slides support clips 4120 and 4121 with corresponding structure (4280, 4281 ; see FIG 42) on container 4200 to lock container 4200 to support 4100.
FIG 42 is a bottom view of container 4200 comprising an attached cover
4213. Cover 4213, comprising lid 4214 and hinge 4234, is permanently affixed to the retention compartment 4212. The lid 4214 has a seal 4220 to securely close the lid 4214 by engaging rim 4225, thereby impermeably enclosing the retention
compartment 4212. In addition, the lid 4214 contains locking mechanisms 4221, 4222, and 4223, and is rotatably affixed to hinge 4234. Retention compartment 4212 contains receiving members 4243, 4244, and 4245 to engage with locking mechanisms 4221 , 4222, and 4223, respectively, to securely seal lid 4214 to retention compartment 4212. In addition, container 4200 comprises support engagement structures 4280 and 4281 to engage support clips 4120 and 4121 (not shown), respectively, on support 4100 (not shown). Support engagement structures 4280 and 4281 , together with support clips 4120 and 4121 can be described as complementary rotate-to-lock structures.
FIG 43 is a view of the left side of container 4200 with attached support 4100, depicting support 4100 in engagement with container 4200. Container 4200 comprises an attached cover 4213. Cover 4213, comprising lid 4214 and hinge
4234, is permanently affixed to the retention compartment 4212. The lid 4214 has a seal 4220 to securely close the lid 4214 by engaging rim 4225, thereby impermeably enclosing the retention compartment 4212. In addition, the lid 4214 contains locking mechanisms 4221 , 4222, and 4223 (not shown), and is rotatably affixed to hinge 4234. Retention compartment 4212 contains receiving members 4243, 4244, and 4245 (not shown) to engage with locking mechanisms 4221 , 4222, and 4223, respectively, to securely seal lid 4214 to retention compartment 4212. In addition, container 4200 comprises support engagement structures 4280 and 4281 (not shown) to engage with support clips 4120 and 4121 , by rotating support clips 4120 and 4121 with support engagement structures 4280 and 4281 , respectively, to lock container 4200 to support 4100. It can be seen that stable platform 4110 is wider than container 4200 at the lowermost horizontal dimension. Thus, stable platform 4110 has a dimension greater than a corresponding dimension of container 4200 that improves the stability of the container 4200 when engaged to support 4100.
FIG. 44 is a perspective view of basket 4400, that can be removably placed in a retention compartment of a container (not shown) to receive one or more tissue samples, comprising subcompartments 4462, 4463, 4465, and 4464, formed by dividing walls 4460 and 4461. Basket 4400 comprises structures 4450 and 4451 , positioned on top of dividing walls 4460 and 4461 , respectively, to receive gasket 4425.
FIG. 45 is a top plan view of container 4500 and basket 4510, that can be removable placed in the retention compartment (not shown) of container 4500 to receive one or more tissue samples, basket 4510 comprising subcompartments
4562, 4563, 4564, and 4565 and dividing walls 4560 and 4561. Lid 4514 comprises a gasket 4525 to impermeably close subcompartments 4562, 4563, 4564, and 4565 by engaging gasket 4525 with the top edges of dividing walls 4560 and 4561.
FIG. 46 is a perspective view of container 4600 with elongated arms 4650, 4651 , 4652, and 4653. Container 4600 is a single-piece article, conceptually similar to container 90 shown in FIG. 11. Container 4600 comprises an attached cover
4613. Cover 4613, comprising lid 4614 and hinge 4634, is permanently affixed to the retention compartment 4612. The lid 4614 has a seal 4620 to securely close the lid
4614, thereby impermeably enclosing the retention compartment 4612. In addition, the lid 4614 contains locking mechanisms 4621 , 4622, and 4623, and is rotatably affixed to hinge 4634. Retention compartment 4612 contains receiving members 4643, 4644 (not shown), and 4645 (not shown) to engage with locking mechanisms 4621 , 4622, and 4623, respectively, to securely seal lid 4614 to retention compartment 4612. Plurality of elongated arms 4650, 4651, 4652 (not shown), and 4653 (not shown) extend laterally from the base of the retention compartment 4612 to stabilize the container against tipping.
Embodiments
Embodiment 1. A container for storing a tissue sample during a medical procedure, the container comprising:
a retention compartment for receiving and storing the tissue sample, the retention compartment having a rim;
a cover comprising a lid, a hinge, and optionally a stationary piece,
the lid rotatably affixed to the hinge;
the cover permanently affixed to the retention compartment;
the lid further comprising a seal to engage the rim thereby impermeably enclosing the retention compartment.
Embodiment 2. The container of embodiment 1 , wherein the retention compartment comprises a polymer material. Embodiment 3. The container of embodiment 2, wherein the polymer material is chosen from polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
Embodiment 4. The container of any one of embodiments 1-3, wherein the container is sterile.
Embodiment 5. The container of any one of embodiments 1-4, further comprising at least one distinguishing feature chosen from: color, label, shape, and combinations thereof. Embodiment 6. The container of any one of embodiments 1 -5, further comprising at least one locking mechanism to secure the lid to the rim when the seal is engaged to the rim. Embodiment 7. The container of any one of embodiments 1-6, wherein the container comprises a transparent material, a translucent material, or a combination thereof.
Embodiment 8. The container of embodiment 7, wherein the lid comprises a transparent material, a translucent material, or a combination thereof.
Embodiment 9. The container of any one of embodiments 7-8, wherein the retention compartment comprises a transparent material, a translucent material, or a combination thereof. Embodiment 10. The container of any one of embodiments 1 -9, further comprising at least one absorbent pad in the retention compartment to receive the tissue sample.
Embodiment 11. The container of embodiment 10, wherein the absorbent pad comprises at least one hydro-swellable polymer.
Embodiment 12. The container of embodiment 11 , wherein the hydro-swellable polymer is chosen from polyacrylic acid, polyacrylamide, polysaccharide, poly- hydroxypropyl methacrylate, and combinations of two or more thereof.
Embodiment 13. The container of any one of embodiments 10-12, wherein the at least one absorbent pad comprises at least one bacteriostatic agent in an amount effective to reduce or eliminate bacterial contamination of the container. Embodiment 14. The container of any one of embodiments 1-11 , further comprising at least one bacteriostatic insert in the retention compartment comprising at least one bacteriostatic agent in an amount effective to reduce or eliminate bacterial contamination of the container. Embodiment 15. The container of any one of embodiments 13-14, wherein the bacteriostatic agent is chosen from sulfonamides, tetracyclines, trimethoprim, clindamycin, macrolides and combinations thereof.
Embodiment 16. The container of embodiment 15, wherein the bacteriostatic agent is clindamycin.
Embodiment 17. The container of any one of embodiments 1-16, wherein the retention compartment comprises a wall having a base, a top, and a varying wall thickness, wherein the wall thickness is greater at the base than at the top.
Embodiment 18. The container of any one of embodiments 1-17, further comprising at least one basket removably placed in the retention compartment to receive the tissue sample.
Embodiment 19. The container of embodiment 18, wherein the basket comprises at least one perforated side wall. Embodiment 20. The container of any one of embodiments 18-19, wherein the basket comprises a perforated bottom wall.
Embodiment 21. The container of any one of embodiments 18-20, wherein the basket comprises two or more subcompartments formed by one or more dividing walls.
Embodiment 22. The container of embodiment 21 , wherein the two or more subcompartments are marked with tissue sample identification information. Embodiment 23. The container of any one of embodiments 21-22, wherein at least one of the one or more dividing walls has a height substantially the same as the height of the retention compartment. Embodiment 24. The container of any one of embodiments 21-23 wherein at least one of the one or more dividing walls has a height substantially less that the height of the retention compartment. Embodiment 25. The container of any one of embodiments 21-24, wherein at least one of the at one or more dividing walls has a height approximately half the height of the retention compartment.
Embodiment 26. The container of any one of embodiments 18-25, wherein the at least one basket comprises a finger hole for enabling removal of the basket from the retention compartment.
Embodiment 27. The container of any one of embodiments 18-26, wherein the at least one basket comprises a ridge for enabling removal of the basket from the retention compartment.
Embodiment 28. The container of any one of embodiments 18-27, wherein the at least one basket comprises a polymer material. Embodiment 29. The container of embodiment 28, wherein the polymer material is chosen from polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
Embodiment 30. The container of any one of embodiments 1-29, further comprising at least one stabilizing structure affixed to the base of the retention compartment.
Embodiment 31. The container of any one of embodiments 1-30, wherein the container is adapted to engage a support comprising a plurality of elongated arms and optionally a base member, wherein the plurality of elongated arms and optionally the base member form a stable platform for resting the support on a horizontal surface. Embodiment 32. The container of embodiment 31 , wherein the plurality of elongated arms comprise one or more container engagement structures.
Embodiment 33. The container of embodiment 32, wherein the one or more container engagement structures are present at or near the ends of the plurality of elongated arms.
Embodiment 34. The container of any one of embodiments 32-33, wherein the one or more container engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
Embodiment 35. The container of any one of embodiments 31 -34, wherein the container comprises one or more support engagement structures on the retention compartment.
Embodiment 36. The container of embodiment 35, wherein the one or more support engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof. Embodiment 37. The container of any one of embodiments 31-36, wherein the rim is adapted to engage the plurality of elongated arms.
Embodiment 38. The container of any one of embodiments 32-37, wherein the rim is adapted to engage the one or more container engagement structures.
Embodiment 39. The container of any one of embodiments 31-38, wherein the container and support engage by snapping together.
Embodiment 40. The container of any one of embodiments 31-39, wherein the container and support engage by sliding together.
Embodiment 41. The container of any one of embodiments 31-40, wherein the container and support engage by gravity. Embodiment 42. The container of any one of embodiments 31 -41 , wherein the container and support engage by frictional engagement. Embodiment 43. The container of any one of embodiments 31-42, wherein the stable platform has a dimension greater than a corresponding dimension of the container to improve the stability of the container.
Embodiment 44. The container of any one of embodiments 31 -43, wherein the support comprises metal, plastic, or a combination thereof.
Embodiment 45. The container of embodiment 44, wherein the metal is chosen from stainless steel, aluminum, tin, titanium, alloys, and combinations thereof. Embodiment 46. The container of any one of embodiments 31-45, wherein the support weighs no more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
Embodiment 47. The container of any one of embodiments 31-46, wherein the support weighs equal to or more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
Embodiment 48. The container of any one of embodiments 31-47, wherein the support has a thickness no greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm. Embodiment 49. The container of any one of embodiments 31-48, wherein the support has a thickness equal to or greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm. Embodiment 50. A method of storing a tissue sample during a medical procedure, comprising:
obtaining a container having an interior;
placing the tissue sample into the interior of the container;
impermeably enclosing the interior of the container; and
storing the tissue sample in the container.
Embodiment 51. The method of embodiment 50, further comprising irrigating the tissue sample before impermeably enclosing the interior. Embodiment 52. The method of embodiment 51 , wherein the irrigating comprises contacting the tissue sample with water, saline, sterile water, sterile saline, or a combination thereof.
Embodiment 53. The method of any one of embodiments 50-52, wherein the storing occurs in less than twelve hours.
Embodiment 54. The method of embodiment 53, wherein the storing occurs in less than six hours. Embodiment 55. The method of embodiment 53 wherein the storing occurs in less than three hours.
Embodiment 56. The method of any one of embodiments 50-55, wherein the tissue sample comprises bone, cartilage, skin, muscle, tendon, an entire organ, a portion of an organ, a vein, an artery, a nerve, or a combination of any of the foregoing.
Embodiment 57. The method of any one of embodiments 50-56, wherein the tissue sample comprises one or more ears, a nose, one or more teeth, one or more fingers, one or more toes, one or more limbs, one or more partial limbs, or a combination of two or more thereof.
Embodiment 58. The method of any one of embodiments 50-55, further comprising cooling the container.
Embodiment 59. The method of embodiment 58, wherein the cooling comprises contacting the container with an ice-water composition. Embodiment 60. The method of any one of embodiments 50-59, further comprising: after the storing, surgically returning the tissue sample to the patient.
Embodiment 61. The method of any one of embodiments 50-60, wherein the storing uses the container of any one of embodiments 1-49.
Embodiment 62. The method of making the container of any one of embodiments 1- 49, comprising permanently affixing the cover to the retention compartment.
Embodiment 63. A basket adapted to be inserted into the retention compartment of a container for storing a tissue sample during surgery, the basket containing:
an interior surface for receiving the tissue sample.
Embodiment 64. The basket of embodiment 63, wherein the basket comprises perforations.
Embodiment 65. The basket of any one of embodiments 63-64, wherein the interior surface comprises at least one substantially horizontal surface.
Embodiment 66. The basket of any one of embodiments 63-65, wherein the basket comprises two or more subcompartments formed by at least one dividing wall.
Embodiment 67. The basket of any one of embodiments 63-66, wherein the two or more subcompartments are marked with tissue sample identification information. Embodiment 68. The basket of any one of embodiments 66-67, wherein at least one of the at least one dividing walls has a height substantially the same as the height of the basket.
Embodiment 69. The basket of any one of embodiments 66-68, wherein at least one of the at least one dividing walls has a height substantially less than the height of the basket. Embodiment 70. The basket of any one of embodiments 66-68, wherein at least one of the at least one dividing walls has a height approximately half the height of the basket.
Embodiment 71. The basket of any one of embodiments 63-70, further comprising a finger hole for enabling removal of the basket from the container.
Embodiment 72. The basket of any one of embodiments 63-71 , further comprising a ledge for enabling removal of the basket from the container. Embodiment 73. The basket of any one of embodiments 63-72, wherein the container is the container of any one of embodiments 1-49.
Embodiment 74. A support adapted to stabilize a container for storing a tissue sample during surgery, the support comprising:
a plurality of elongated arms and optionally a base member,
wherein the plurality of elongated arms and optionally the base member form a stable platform for resting the support on a horizontal surface.
Embodiment 75. The support of embodiment 74, wherein the plurality of elongated arms comprise one or more container engagement structures. Embodiment 76. The support of embodiment 75, wherein the one or more container engagement structures comprise engagement structures at or near the ends of the plurality of elongated arms. Embodiment 77. The support of any one of embodiments 75-76, wherein the one or more container engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
Embodiment 78. The support of any one of embodiments 74-77, wherein the container comprises one or more support engagement structures on a retention compartment.
Embodiment 79. The support of embodiment 78, wherein the one or more support engagement structures is chosen from ledges, tabs, slots, and combinations thereof.
Embodiment 80. The support of any one of embodiments 74-79, wherein the container and support engage by snapping together.
Embodiment 81. The support of any one of embodiments 74-80, wherein the container and support engage by sliding together.
Embodiment 82. The support of any one of embodiments 74-81 , wherein the container and support engage by gravity. Embodiment 83. The support of any one of embodiments 74-82, wherein the container and support engage by frictional engagement.
Embodiment 84. The support of any one of embodiments 74-83, wherein the stable platform has a dimension greater than a corresponding dimension of the container to improve the stability of the container.
Embodiment 85. The support of any one of embodiments 74-84, wherein the support comprises metal, plastic, or a combination thereof. Embodiment 86. The support of embodiment 85, wherein the metal is chosen from stainless steel, aluminum, tin, titanium, alloys, and combinations thereof. Embodiment 87. The support of any one of embodiments 74-86, wherein the support weighs no more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
Embodiment 88. The support of any one of embodiments 74-87, wherein the support weighs equal to or more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
Embodiment 89. The support of any one of embodiments 74-88, wherein the support has a thickness no greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm.
Embodiment 90. The support of any one of embodiments 74-89, wherein the support has a thickness equal to or greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm.
Embodiment 91. The container of any one of embodiments 21-49, wherein the basket comprises a gasket attached to the one or more dividing walls. Embodiment 92. The container of embodiment 91 , wherein the gasket engages the lid of the container, thereby impermeably enclosing the two or more
subcompartments. Embodiment 93. The container of any one of embodiments 32-49, wherein the one or more container engagement structures are present at or near a horizontal surface on which the support rests. Embodiment 94. The container of any one of embodiments 31-49 and 91-93, wherein the container and support engage by adhesion.
Embodiment 95. The container of any one of embodiments 31-49 and 91-94, wherein the container and support engage by twisting one or more rotating clips to lock the container to the support.
Embodiment 96. A method of storing an implantable device prior to or during a medical procedure, comprising:
obtaining a container having an interior;
placing the implantable device into the interior of the container;
impermeably enclosing the interior of the container; and
storing the tissue sample in the container.
Embodiment 97. The method of embodiment 96, further comprising irrigating the implantable device before impermeably enclosing the interior.
Embodiment 98. The method of embodiment 97, wherein the irrigating comprises contacting the device with water, saline, sterile water, sterile saline, antibiotic solution or a combination thereof.
Embodiment 99. The method of any one of embodiments 96-98, wherein the storing occurs in less than twelve hours.
Embodiment 100. The method of embodiment 99, wherein the storing occurs in less than six hours.
Embodiment 101. The method of embodiment 99 wherein the storing occurs in less than three hours. Embodiment 102. The method of any one of embodiments 96-101 , wherein the device comprises a shunt, a pump, a tube, an artificial joint, an artificial disc, a reconstructive implant, a plate, a screw, a rod, a lens, or a combination of any of the foregoing.
Embodiment 103. The method of any one of embodiments 96-102, wherein the storing uses the container of any one of embodiments 1-49 and 91-95. Embodiment 104. The basket of any one of embodiments 66-73, wherein the basket comprises a gasket attached to one or more dividing walls.
Embodiment 105. The basket of embodiment 104, wherein the gasket is adapted to engage the lid of the container, thereby impermeably enclosing the two or more subcompartments.
Embodiment 106. The support of any one of embodiments 75-90, wherein the one or more container engagement structures comprise engagement structures at or near a horizontal surface on which the support rests.
Embodiment 107. The support of embodiment 106, wherein the one or more container engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
Embodiment 108. The support of any one of embodiments 106-107, wherein the container comprises one or more support engagement structures on a retention compartment.
Embodiment 109. The support of embodiment 108, wherein the one or more support engagement structures is chosen from ledges, tabs, slots, and combinations thereof.
Embodiment 1 10. The support of any one of embodiments 106-109, wherein the container and support engage by snapping together. Embodiment 1 11. The support of any one of embodiments 106-110, wherein the container and support engage by adhesion. Embodiment 1 12. The support of any one of embodiments 106-111 , wherein the container and support engage by twisting one or more rotating clips to lock the container to the support.
Embodiment 1 13. The container of any one of embodiments 21-49 and 91-95, wherein the lid comprises a gasket attached to the interior of the lid.
Embodiment 1 14. The container of embodiment 113, wherein the gasket engages the one or more dividing walls of the basket when the lid is closed, thereby impermeably enclosing the two or more subcompartments.
Embodiment 1 15. The container of any one of embodiments 30-49 and 91-95, wherein the stabilizing structure comprises a plurality of elongated arms extending laterally from the base of the retention compartment to form a stable platform for resting the container on a horizontal surface.
Embodiment 1 16. The container of any one of embodiments 31-49 and 91-95, wherein the container and support engage by sliding one of more tracks to lock the container to the support. Embodiment 117. The container of any one of embodiments 31-49, 91-95, and 116, wherein the container and the support engage by contacting complementary rotate- to-lock structures on the container and the support, and rotating the container relative to the support to lock the container to the support. As previously stated, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various forms. It will be appreciated that many modifications and other variations stand within the intended scope of this invention as claimed below. Furthermore, the foregoing description of various embodiments does not necessarily imply exclusion. For example, "some" embodiments may include all or part of "other" and "further" embodiments within the scope of this invention. In addition, "a" does not mean "one and only one;" "a" can mean "one and more than one."

Claims

What is claimed is:
1. A container for storing a tissue sample during a medical procedure, the container comprising:
a retention compartment for receiving and storing the tissue sample, the retention compartment having a rim;
a cover comprising a lid, a hinge, and optionally a stationary piece,
the lid rotatably affixed to the hinge;
the cover permanently affixed to the retention compartment;
the lid further comprising a seal to engage the rim thereby impermeably enclosing the retention compartment.
2. The container of claim 1 , wherein the retention compartment comprises a polymer material.
3. The container of claim 2, wherein the polymer material is chosen from
polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
4. The container of claim 1 , wherein the container is sterile.
5. The container of claim 1 , further comprising at least one distinguishing feature chosen from: color, label, shape, and combinations thereof.
6. The container of claim 1 , further comprising at least one locking mechanism to secure the lid to the rim when the seal is engaged to the rim.
7. The container of claim 1 , wherein the container comprises a transparent material, a translucent material, or a combination thereof.
8. The container of claim 1 , wherein the lid comprises a transparent material, a translucent material, or a combination thereof.
9. The container of any one of claims 7-8, wherein the retention compartment comprises a transparent material, a translucent material, or a combination thereof.
10. The container of claim 1 , further comprising at least one absorbent pad in the retention compartment to receive the tissue sample.
11. The container of claim 10, wherein the absorbent pad comprises at least one hydro-swellable polymer.
12. The container of claim 11 , wherein the hydro-swellable polymer is chosen from polyacrylic acid, polyacrylamide, polysaccharide, poly-hydroxypropyl methacrylate, and combinations of two or more thereof.
13. The container of claim 10, wherein the at least one absorbent pad comprises at least one bacteriostatic agent in an amount effective to reduce or eliminate bacterial contamination of the container.
1 . The container of claim 1 , further comprising at least one bacteriostatic insert in the retention compartment comprising at least one bacteriostatic agent in an amount effective to reduce or eliminate bacterial contamination of the container.
15. The container of any one of claims 13-14, wherein the bacteriostatic agent is chosen from sulfonamides, tetracyclines, trimethoprim, clindamycin, macrolides and combinations thereof.
16. The container of claim 15, wherein the bacteriostatic agent is clindamycin.
17. The container of claim 1 , wherein the retention compartment comprises a wall having a base, a top, and a varying wall thickness, wherein the wall thickness is greater at the base than at the top.
18. The container of claim 1 , further comprising at least one basket removably placed in the retention compartment to receive the tissue sample.
19. The container of claim 18, wherein the basket comprises at least one perforated side wall.
20. The container of any one of claims 18-19, wherein the basket comprises a perforated bottom wall.
21. The container of claim 18, wherein the basket comprises two or more subcompartments formed by one or more dividing walls.
22. The container of claim 21 , wherein the two or more subcompartments are marked with tissue sample identification information.
23. The container of claim 21 , wherein at least one of the one or more dividing walls has a height substantially the same as the height of the retention compartment.
24. The container of claim 21 , wherein at least one of the one or more dividing walls has a height substantially less that the height of the retention compartment.
25. The container of claim 21 , wherein at least one of the at one or more dividing walls has a height approximately half the height of the retention compartment.
26. The container of claim 18, wherein the at least one basket comprises a finger hole for enabling removal of the basket from the retention compartment.
27. The container of claim 18, wherein the at least one basket comprises a ridge for enabling removal of the basket from the retention compartment.
28. The container of claim 18, wherein the at least one basket comprises a polymer material.
29. The container of claim 28, wherein the polymer material is chosen from polystyrene, polyethylene, polypropylene, polyurethane, nylon, silicone, and combinations thereof.
30. The container of claim 1 , further comprising at least one stabilizing structure affixed to the base of the retention compartment.
31. The container of claim 1 , wherein the container is adapted to engage a support comprising a plurality of elongated arms and optionally a base member, wherein the plurality of elongated arms and optionally the base member form a stable platform for resting the support on a horizontal surface.
32. The container of claim 31 , wherein the plurality of elongated arms comprise one or more container engagement structures.
33. The container of claim 32, wherein the one or more container engagement structures are present at or near the ends of the plurality of elongated arms.
34. The container of any one of claims 32-33, wherein the one or more container engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
35. The container of claim 31 , wherein the container comprises one or more support engagement structures on the retention compartment.
36. The container of claim 35, wherein the one or more support engagement structures is chosen from ledges, protrusions, recesses, and combinations thereof.
37. The container of claim 31 , wherein the rim is adapted to engage the plurality of elongated arms.
38. The container of claim 32, wherein the rim is adapted to engage the one or more container engagement structures.
39. The container of claim 31 , wherein the container and support engage by snapping together.
40. The container of claim 31 , wherein the container and support engage by sliding together.
41. The container of claim 31 , wherein the container and support engage by gravity.
42. The container of claim 31 , wherein the container and support engage by frictional engagement.
43. The container of claim 31 , wherein the stable platform has a dimension greater than a corresponding dimension of the container to improve the stability of the container.
44. The container of claim 31 , wherein the support comprises metal, plastic, or a combination thereof.
45. The container of claim 44, wherein the metal is chosen from stainless steel, aluminum, tin, titanium, alloys, and combinations thereof.
46. The container of claim 31 , wherein the support weighs no more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds, 0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
47. The container of claim 31 , wherein the support weighs equal to or more than 0.1 pound, 0.2 pounds, 0.3 pounds, 0.4 pounds, 0.4 pounds, 0.5 pounds, 0.6 pounds,
0.7 pounds, 0.8 pounds, 0.9 pounds, 1.0 pounds, 1.1 pounds, 1.2 pounds, 1.3 pounds, 1.4 pounds, 1.5 pounds, 1.6 pounds, 1.7 pounds, 1.8 pounds, 1.9 pounds, 2.0 pounds, 2.5 pounds, 3.0 pounds, 5 pounds, or 10 pounds.
48. The container of claim 31 , wherein the support has a thickness no greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm.
49. The container of claim 31 , wherein the support has a thickness equal to or greater than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm.
50. The container of claim 21 , wherein the basket comprises a gasket attached to the one or more dividing walls.
51. The container of claim 50, wherein the gasket engages the lid of the container, thereby impermeably enclosing the two or more subcompartments.
52. The container of claim 32, wherein the one or more container engagement structures are present at or near the horizontal surface on which the support rests.
53. The container of claim 31 , wherein the container and support engage by adhesion.
54. The container of claim 31 , wherein the container and support engage by twisting one or more rotating clips to lock the container to the support.
55. The container of claim 21 , wherein the lid comprises a gasket attached to the interior of the lid.
56. The container of claim 55, wherein the gasket engages the one or more dividing walls of the basket when the lid is closed, thereby impermeably enclosing the two or more subcompartments.
57. The container of claim 30, wherein the stabilizing structure comprises a plurality of elongated arms extending laterally from the base of the retention compartment to form a stable platform for resting the container on a horizontal surface.
58. The container of claim 31 , wherein the container and support engage by sliding one or more tracks to lock the container to the support.
59. The container of claim 31 , wherein the container and support engage by engaging complementary rotate-to-lock structures on the container and the support, and rotating the container relative to the support to lock the container to the support.
60. A method of storing a tissue sample during a medical procedure, comprising: obtaining the container of claim 1 ; the container having an interior;
placing the tissue sample into the interior of the container;
impermeably enclosing the interior of the container; and
storing the tissue sample in the container.
61. The method of claim 60, further comprising irrigating the tissue sample before impermeably enclosing the interior.
62. The method of claim 61 , wherein the irrigating comprises contacting the tissue sample with water, saline, sterile water, sterile saline, or a combination thereof.
63. The method of any one of claims 60-62, wherein the storing occurs in less than twelve hours.
64. The method of claim 63, wherein the storing occurs in less than six hours.
65. The method of claim 63 wherein the storing occurs in less than three hours.
66. The method of claim 60, wherein the tissue sample comprises bone, cartilage, skin, muscle, tendon, an entire organ, a portion of an organ, a vein, an artery, a nerve, or a combination of any of the foregoing.
67. The method of claim 60, wherein the tissue sample comprises one or more ears, a nose, one or more teeth, one or more fingers, one or more toes, one or more limbs, one or more partial limbs, or a combination of two or more thereof.
68. The method of claim 60, further comprising cooling the container.
69. The method of claim 68, wherein the cooling comprises contacting the container with an ice-water composition.
70. The method of claim 60, further comprising:
after the storing, surgically returning the tissue sample to the patient.
71. A method of making the container of claim 1 , comprising permanently affixing the cover to the retention compartment.
72. A method of storing an implantable device prior to or during a medical procedure, comprising:
obtaining the container of claim 1 , wherein the container comprises an interior;
placing the implantable device into the interior of the container;
impermeably enclosing the interior of the container; and
storing the tissue sample in the container.
73. The method of claim 72, further comprising irrigating the implantable device before impermeably enclosing the interior.
74. The method of claim 73, wherein the irrigating comprises contacting the device with water, saline, sterile water, sterile saline, antibiotic solution or a combination thereof.
75. The method of claim 72, wherein the storing occurs in less than twelve hours.
76. The method of claim 75, wherein the storing occurs in less than six hours.
77. The method of claim 75, wherein the storing occurs in less than three hours.
78. The method of claim 72, wherein the device comprises a shunt, a pump, a tube, an artificial joint, an artificial disc, a reconstructive implant, a plate, a screw, a rod, a lens, or a combination of any of the foregoing.
PCT/US2018/000019 2017-02-16 2018-02-16 Tissue storage during surgery WO2018151809A1 (en)

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US11771514B1 (en) 2019-08-22 2023-10-03 Clinical Biotechnology Research Institute At Rsfh Containers and methods for tissue storage during surgery

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