WO1986003976A1 - Tissue storage system - Google Patents

Tissue storage system Download PDF

Info

Publication number
WO1986003976A1
WO1986003976A1 PCT/US1985/002535 US8502535W WO8603976A1 WO 1986003976 A1 WO1986003976 A1 WO 1986003976A1 US 8502535 W US8502535 W US 8502535W WO 8603976 A1 WO8603976 A1 WO 8603976A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
envelope
storage system
sheets
gas
Prior art date
Application number
PCT/US1985/002535
Other languages
French (fr)
Inventor
Jack Anthony
Anrold C. Bilstad
Wayne T. Leblong
Robert J. Kruger
Original Assignee
Baxter Travenol Laboratories, Inc.
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 Baxter Travenol Laboratories, Inc. filed Critical Baxter Travenol Laboratories, Inc.
Publication of WO1986003976A1 publication Critical patent/WO1986003976A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0236—Mechanical aspects
    • A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/10—Ultraviolet radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065—Peelable cover
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/314—Flexible bags or pouches

Definitions

  • the present invention relates to a system and method for storing material and, in particular, the storage, preservation and sterile presentation of human tissue.
  • tissue storage system that would allow sterilization of the system in a closed container such a ⁇ j, by radiation or ethylene oxide gas sterilization.
  • tissue storage system for storage in a non- sterile environment which would include a sterile con ⁇ tainer that would be presentable in a sterile environment, such as the sterile portion of an operating room, for presentation of the tissue.
  • a storage system is provided that is especially suitable for containing tissue.
  • the storage system includes an interior or first thin film container having a sealable opening for 5 containing tissue or other non-liquid material.
  • This container has a transparent portion for viewing the contents contained therein and a gas permeable portion to allow gas sterilization of the interior of the first container and its contents.
  • An exterior or second thin film container having a sealable opening for 5 containing tissue or other non-liquid material.
  • This container 10 is provided that is dimensioned to contain said first container.
  • This container also has a sealable opening and a transparent portion for viewing the contents in the first container when contained in the second container.
  • the opening of the exterior container should be large
  • the second container is constructed of material which provides an air and water or gas barrier for its contents when the container is sealed.
  • the exterior container can be constructed of thin film material that has a very high
  • the exterior container is gas impermeable.
  • gas impermeable means that the container material or the container has a water vapor permeability
  • the gas permeable portion of the first container will be a barrier for microorganisms.
  • the product will remain sterile.
  • the second or exterior container includes a gas permeable portion and is sealable in a first sealed position that allows gas sterilization of the first container and its contents through the gas permeable portion of the second container.
  • the second container is also sealable in a second sealed position in which the second container provides a gas barrier and is preferably gas impermeable.
  • the invention contemplates the placing of the tissue or other material in the first con- - tainer, sealing the first container and placing the first container in the second container and sealing the second container in the first sealed position.
  • the interior of the second container can then be sterilized, together with the first container and its contents.
  • the second container can be sealed in the _econd sealed posi ⁇ tion in which the second container is gas impermeable.
  • the transparent portions of the first and second containers allow the contents to be viewed when stored therein and a grid may be provided as part of the first container to permit sizing of the contents contained therein.
  • a grid may be provided as part of the first container to permit sizing of the contents contained therein.
  • the transparent portion of the first container or the second container may have the grid printed directly thereon.
  • the materials of the containers can be chosen to allow radiation sterilization (Gamma radiation, for example) of the containers and contents stored therein.
  • the first and second containers each comprise an envelope or a pouch.
  • the envelope or pouch may be constructed from two sheets of material that are joined together at the periphery of the sheets, each of the envelopes having a sealable opening. Other configu- rations may be used and are within the scope of the inven ⁇ tion.
  • the opening may comprise an unjoined peripheral portion of two sheets of material, or as a slit in one of the sheets, for example.
  • the sheets of material can be any desired shape, such as rectangular, triangular or circular, for example.
  • a storage system in accordance with a more specific embodiment of the present invention, includes a first, flexible, sealable envelope for contain ⁇ ing, for example, tissue, which comprises two sheets of material joined together at the periphery of the sheets with an unjoined peripheral region of the the sheets defining a sealable opening.
  • a first, flexible, sealable envelope for contain ⁇ ing, for example, tissue, which comprises two sheets of material joined together at the periphery of the sheets with an unjoined peripheral region of the the sheets defining a sealable opening.
  • One of the sheets is trans ⁇ parent for viewing tissue contained therein and the other of these sheets is ' gas permeable to allow gas steriliza- tion of the interior and its contents.
  • a second, flexible, sealable envelope is provided for containing the first envelope.
  • the second envelope includes first and second gas impermeable sheets of material joined together at the periphery of the sheets with an unjoined peripheral region of the sheets defining a sealable opening.
  • One of the sheets is transparent for viewing the contents contained within the first envelope.
  • the sealable opening of the second envelope is sealable in a first sealed position which allows the interior of the second envelope to be gas sterilized.
  • the second envelope is sealable in a second sealed position which provides gas impermeable container.
  • the first gas impermeable sheet includes a portion that extends beyond the second gas impermeable sheet at the sealable opening of the second envelope and the second envelope further includes a strip of gas permeable material bonded to and overlapping the second gas impermeable sheet at the sealable opening, the strip also overlapping the first gas impermeable sheet for defining with the first sheet the first sealed position.
  • the unjoined peripheral region of the second gas impermeable sheet defines with the first sheet the second sealed position.
  • each envelope is prefeably made of materials that are attachable by heat sealing.
  • the opening of each envelope is preferably heat sealable and may comprise an unjoined peripheral portion of two sheets which define the envelope.
  • the containers are constructed of flexible, thin-film material.
  • the envelopes are openable by peeling apart the joined sheets which define the envelopes.
  • the sheets of each envelope are joined together with at. least one V-shaped or chevron shaped seal for facilitating the opening of the envelopes and the sterile presentation of the tissue.
  • the materials of the containers generally should be suitable for medical applications.
  • the materials and thicknesses can be chosen to impart the desired strength, toughness, flexibility, gas permeability or impermeability, and resistance to high and low temperature.
  • the sheets utilized in making the containers or envelopes can consist of multiple thin layers of different materials of desired thicknesses, each material chosen to provide a specific property, such as gas impermeability, strength, toughness, resistance to puncture, and flexibility and strength at low temperature.
  • the sheets may be formed by bonding the different layers together, such as with a suitable adhesive material or by coextruding the various materials to form a sheet having layers of desired thickness.
  • a method of storing material, including tissue includes: (a) placing the material in a first sealable container or envelope as previously described; (b) sealing the material therein; (c) placing the first container in a second container or envelope as previously described which is sealable in a first sealed position which allows gas sterilization of the interior of the second container and sealable in a second sealed position in which the second container is gas impermeable; (d) sealing the second container; (e) sterilizing the interior and contents of the second container, including the first container and its contents.
  • step (d) the second container is sealed in the first sealed position and step (e) comprises gas sterilization.
  • a further step is included which comprises sealing the second -container in the second sealed position after gas - sterilization, allowing storage in a gas impermeable environment.
  • step (d) the second container is sealed in the second sealed position and step (e) comprises radiation sterilization.
  • steps (a)-(e) it is not necessary for steps (a)-(e) to occur sequentially, although they may occur in that sequence.
  • the first container would be placed within the second container prior to sealing the first container or prior to placing material in the first container.
  • the sterilization of the contents of the second container would occur prior to sealing the second con ⁇ tainer, if done without breaching the sterility of the container system.
  • Other sequences may also be feasible.- After sealing the material within the gas imper ⁇ meable environment, the material may be stored for the desired period of time at the desired temperature.
  • the storage system can be stored in a non-sterile environment and yet delivery and examination of the material or tissue within a sealed container can be made in a sterile environ ⁇ ment without breaching the sterility of that environment. This is accomplished by removing the first sealed container from the second sealed container in the non-sterile environ- ment and transferring the first sealed container to the sterile environment.
  • the material can then be examined in a sterile environment without the necessity of removing the material from the first sealed container, which is sterile.
  • the material can be removed from the first container in the sterile environment for its intended use.
  • the first containe'r is suitable for storing liquid.
  • the materials of the first container or envelope are selected such that they are gas impermeable.
  • such containers can be radiation sterilized.
  • Figure 1 illustrates a perspective front eleva- tion view, partially cut away, of the storage system in accordance with the present invention
  • Figure 2 illustrates a perspective rear elevation view of the storage system of Figure 1;
  • Figure 3 illustrates a perspective exploded view of the exterior or second container of the storage system
  • Figure 4 illustrates a plan view, partially cut away, of the exterior or second container of the storage system
  • Figure 5 illustrates in perspective view the insertion of tissue into the first or interior container of the storage system
  • Figure 6 illustrates a front elevation view of tissue stored within the first or interior container of the storage system
  • Figure 7 illustrates in perspective view the insertion of a sealed interior or first container being inserted into the exterior or second container of the storage system
  • Figure 8 illustrates in perspective view gas sterilization of the storage system of Figure 1;
  • Figure 9 illustrates in perspective the storage system of Figure 1 after sterilization and sealing of the exterior container in the gas impermeable or second sealed position
  • Figure 10 illustrates radiation sterilization of the contents of the storage system of Figure 1;
  • Figure 11 illustrates in perspective view opening of the exterior or second container of the storage system of Figure 1;
  • Figure 12 illustrates in perspective view opening of the interior or first container of the storage system of Figure 1.
  • Storage system 10 which is especially suited for storing tissue.
  • Storage system 10 includes interior or first envelope 12 and an exterior or second envelope 14.
  • First envelope 12 consists of two opposing rectangular sheets or webs of material 16 and 18. Sheets 16 and 18 are joined together at their periphery along three perimeter sides thereof, the unjoined fourth perimeter sides or peripheral region of sheets 16 and 18 define a sealable opening 20.
  • Sheet 16 is a flexible, thin film transparent sheet made up of several layers of thin film materials. Specifically, sheet 16 consists of an outer layer of nylon film having a thickness of about 0.001" and an inner layer of a heat sealable ethylene . vinyl acetate modified poly ⁇ ethylene with an ethylene vinyl acetate content of about 4.5% to 5% and a thickness of about 0.002". These layers are bonded together with a suitable adhesive for medical uses.
  • One especially suitable nylon film is marketed by the E.I. DuPont de Nemours Co. (DuPont) under the trademark Dartek® 66.
  • Especially suitable ethylene vinyl acetate modified polyethylene film is available from DuPont under the trademark Elvax®.
  • a polycarbonate resin can be used in place of the nylon and is commercially available under the trademark Lexan® of the General Electric Co.
  • a polyester film, such as DuPont Mylar®, can also be used as a replace ⁇ ment for the nylon film.
  • the nylon material is suitable for printing and is illustrated in Figure 1, the interior side of the nylon layer of sheet 16 has printed thereon a grid 22.
  • Grid 22 can be of the desired dimensions and as illustrated has a small grid scale of one centimeter per division and a large grid scale of five centimeters per division. If desired, the grid could be printed on the exterior of sheet 16, for example, or on second envelope 14.
  • sheet 16 is transparent to visible light so the contents can be viewed.
  • the materials of the containers are also capable of withstanding radiation sterilization such as gamma radiation.
  • Sheet 18 of envelope 12, more completely illu ⁇ strated in Figure 2 is flexible and gas permeable to allow gas sterilization of the interior of envelope 12.
  • gas sterilization is ethylene oxide sterilization, which is well known in the art.
  • Suitable materials for sheet 18 include, for example, spun bond polymer materials, such as spun bond polyolefin, and paper.
  • the paper is coated with a suitable material to allow heat sealing to sheet 18.
  • the entire surface of the paper may be coated or only the areas or zones that are intended to form a seal.
  • the paper is preferably coated over at least a portion thereof with the heat sealing material.
  • Suitable coating materials for heat sealing of paper include, for example, ethylene vinyl acetate, ethylene methylacrylate, ionomer resins such as Surlyn® resins and/or hot melt adhesives.
  • One especially suitable material for sheet 18 is marketed by E.I.
  • Tyvek® which is a spun bond polyethylene having a thickness of 0.008 inches and is a microorganism barrier.
  • the spun bond polymer material may have a coating thereover to facilitate peel ⁇ ing open the container.
  • the peelable seal provided by the coating material results in a seal of less strength than the strength of the spun bond polymer.
  • Such materials are well known in the art.
  • the peelable coating may be only on those portions that are intended to form a seal. Materials such as an ethylene vinyl acetate copolymer, with a vinyl acetate of 5-28% and preferably about 20%, can be used to provide a peelable seal.
  • sheets 18 and 16 are sealed -together with a seal 24 formed by application of heat to sheets 18 and 16 along the desired perimeter areas thereof.
  • a seal 24 formed by application of heat to sheets 18 and 16 along the desired perimeter areas thereof.
  • one side of sheets 16 and 18 will be sealed together with a chevron or V-shaped seal, referred to in Figure 2 by reference numeral 24a.
  • the angle of V-shaped seal 24a indicated by reference numeral 25 is about 160°.
  • V-shaped seal 24a facilitates the opening of envelope 12.
  • sheets 16 and 18 of envelope 12 can be constructed of gas imperme- able material, such as the previously described material of sheet 16 or other material which provides a desired barrier to liquid and gas, if desired.
  • gas imperme- able material such as the previously described material of sheet 16 or other material which provides a desired barrier to liquid and gas, if desired.
  • radiation sterilization would be used.
  • the other advantages of the storage system apply to this embodiment, which can be used to store liquid or other material, including tissue.
  • first envelope 12 opposite the end where opening 20 is located includes a line of perforations 26 that extends across the width of envelope 12.
  • the perforations allow end portion 27 to be folded over so that label 28, printed or affixed on sheet 18, is visible from the front of envelope 12.
  • Label 28 may contain desired information or blank space for a description of the contents of envelope 12, for example.
  • Sheet 18 may also have printed thereon another label 30, illustrated in Figure 2, having desired information.
  • Second envelope 14 includes a first sheet 32 and a second sheet 34 which are attached together about perimeter portions thereof along three perimeter sides thereof with a seal 40, which is a heat seal.
  • seal 40 includes along one side of first and second sheets 32 and 34 a chevron or V-shaped seal 40a for facilitating opening of second envelope 14 as illus ⁇ trated in Figure 10, in a manner similar to that described with respect to first envelope 12.
  • Angle 41 formed by V-shaped seal 40a of second envelope 14 is about 160°.
  • second envelope 14 is shown in greater detail in Figures 3 and 4. As illustrated therein, one end of sheet 34 extends beyond sheet 32. Gas permeable strip 36 overlaps and is attached to the end of sheet 32 is substantially coextensive with the portion of sheet 34 which extends beyond sheet 32. Strip 36 is attached to sheet 32 with a seal 43, which is a heat seal. Seal 40 also seals strip 36 along the sides of sheets 32 and 34 to which strip 36 is adjacent. By sealing sealable opening 38 in an area where second sheet 34 and gas permeable strip 36 overlap directly after placing contents therein, such as along line 42 of Figures 4 and 8, envelope 14 is sealed in a first sealed position.
  • First sheet 32 is a thin film, flexible, transparent sheet and is constructed in the illustrated embodiment of several layers of different material. Specifically, from outside to inside, the layers are a thin nylon film, a thin polyvinylidene chloride film and a thin film of a linear low density polyethylene material.
  • the combination of these layers provides a clear, tough, flexible sheet 32 which is crack resistant, even at extremely low temperature such as about -80°C. Further, it forms an excellent barrier to oxygen, water and other gases.
  • Each of the layers of sheet 32 are bonded together * using suitable adhesive material. If desired, polyester can be substituted for the nylon layer. Specific materials which are especially suitable for making sheet 32 include a nylon film marketed by
  • Suitable adhesive material for bonding the various layers of material include urethane and polyester adhesives. Several specific adhesives which may be used
  • Adkote 333 is believed to be a single component urethane adhesive and Adkote ® 548 and 575 are believed to be two component polyester adhesives. Other suitable adhesives will be known to those skilled in the art.
  • Second sheet 34 can be constructed of material similar to first sheet 32.
  • second sheet 34 is a laminated, flexible, thin film sheet that includes a foil layer that is sandwiched between a thin polyester layer and a linear low density polyethylene layer with the polyester layer forming the outer layer of sheet 34.
  • Especially suitable materials for sheet 34 include polyester material having a thickness of about
  • Suitable materials for forming a peelable coating on polyethylene are ethylene vinyl acetate copolymers having a vinyl acetate content of 5% to 28% and preferably about 20%.
  • Another suitable material is available from Rollprint Packaging Products, Inc. of Addison, Illinois under the trade designation RP-IA, which includes a solvent carrier. Good results have been obtained with application rates of from three to four pounds of RP-IA per 3000 square feet of sheet material.
  • Other suitable coatings for this purpose will be known to those skilled in the art.
  • Second envelope 14 may have printed or affixed thereon a suitable label 47, illustrated in Figure 2 on the reverse side of envelope 14.
  • tissue 48 is inserted into opening 20 of interior envelope 12.
  • seal line 50 is sealed along seal line 50, as illustrated in Figure 6. This may be accomplished by heat sealing, for example.
  • sealed interior envelope 12 is placed into exterior envelope 14 through opening 38 thereof with transparent sheets 16 and 32 in the same orientation for viewing the contents of envelope 12.
  • Exterior envelope is then sealed along seal line 42 which allows the interior of exterior envelope 14 to be gas sterilized since a gas passageway is provided to the interior of exterior envelope 14 through gas permeable strip 36.
  • Gas sterilization of the contents of exterior envelope 14 is illustrated in Figure 8.
  • exterior envelope 14 is sealed in the second sealed position which is gas impermeable, along line 46 as illustrated in Figure 9 creating a gas impermeable container.
  • FIG. 10 illustrates this procedure in which a radiation source 52 directs sterilizing radiation, such as gamma radiation 54 through the transparent sheets 32 and .16 of second envelope 14 and first envelope 12, respectively.
  • a radiation source 52 directs sterilizing radiation, such as gamma radiation 54 through the transparent sheets 32 and .16 of second envelope 14 and first envelope 12, respectively.
  • FIGs 11 and 12 illustrate the opening of tissue storage system 10.
  • exterior envelope 14 is opened by peeling apart first sheet 32 and second sheet 34.
  • the peeling apart is initiated along the side having V-shaped seal 40a.
  • First sheet 32 and second sheet 34 are peeled apart sufficiently to allow interior envelope 12 to be removed therefrom.
  • interior envelope 12 which has been sterilized, can be transferred to a sterile environment for opening.
  • interior envelope 12 is opened in the same manner as exterior envelope 14, preferably beginning with the side of interior envelope 12 that has V-shaped seal 24a. Sheets 16 and 18 are sufficiently peeled apart to allow tissue 48 to be conveniently removed therefrom.
  • tissue is used in a broad sense and includes any multicellular human or animal matter, such as skin, bone, dura matter, organs and organ parts, for example. It is to be understood that while the storage system of the invention is primarily intended for storing tissue numerous other types of material can be stored therein. ' By way of example only, and not as a limitation on the invention, the storage system of the present invention would be useful for storing surgical instruments and supplies, for storing industrial components and parts, for storing agricultural materials such as seeds and for storing nutritional products.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Surgery (AREA)
  • Dentistry (AREA)
  • Wood Science & Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Environmental Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medical Informatics (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Medicinal Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Packages (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

A storage system (10) includes an interior envelope (12) and an exterior envelope (14). Tissue or other material to be stored may be placed in interior envelope (12), sealed and placed in exterior envelope (14). Exterior envelope (14) is sealable in a first sealed position that allows gas sterilization of the interior of exterior envelope (14) and the contents contained therein. After sterilization, exterior envelope (14) is sealed in a gas impermeable position. Each of interior and exterior envelope (12, 14) have one side which is transparent. A grid (22) may be provided on the transparent side of interior envelope (12) for sizing tissue contained therein.

Description

FIELD OF THE INVENTION TISSUE STORAGE SYSTEM
The present invention relates to a system and method for storing material and, in particular, the storage, preservation and sterile presentation of human tissue.
BACKGROUND ART
Currently, no effective tissue storage system is available for general use. Individual clinics and hos¬ pitals devise their own methods. Often, relatively large glass jars or crocks are utilized. The use of such con¬ tainers is cumbersome and tedious, especially in a sterile environment, such as an operating room. Further, such containers are subject to breakage and it is difficult to sterilize them. It would be desirable to provide a tissue stor¬ age system that avoids the use of glass containers. Further, it would be desirable to provide a tissue storage system that would allow sterilization of the system in a closed container such aεj, by radiation or ethylene oxide gas sterilization. It would also be advantageous to provide a tissue storage system for storage in a non- sterile environment which would include a sterile con¬ tainer that would be presentable in a sterile environment, such as the sterile portion of an operating room, for presentation of the tissue.
While it has been known to store specimens in a polyester pouch, a storage system has not been heretofore provided which provides the desirable characteristics as previously described. DIΞCLOSURE OF THE INVENTION
In accordance with the present invention, a storage system is provided that is especially suitable for containing tissue. The storage system includes an interior or first thin film container having a sealable opening for 5 containing tissue or other non-liquid material. This container has a transparent portion for viewing the contents contained therein and a gas permeable portion to allow gas sterilization of the interior of the first container and its contents. An exterior or second thin film container
10 is provided that is dimensioned to contain said first container. This container also has a sealable opening and a transparent portion for viewing the contents in the first container when contained in the second container. The opening of the exterior container should be large
"15 enough to accommodate insertion of the interior container. The second container is constructed of material which provides an air and water or gas barrier for its contents when the container is sealed. The exterior container can be constructed of thin film material that has a very high
20 degree of gas impermeability, so that tissue cr other material can be stored for an extended period of time. Preferably, the exterior container is gas impermeable. As used herein, "gas impermeable" means that the container material or the container has a water vapor permeability
25 value of about 0.05 units or less (the units being grams- mi1/100 square inches/24 hours at 90% relative humidity, 37.8°C (100°F), using a Permatron-W instrument, manu¬ factured by Mocon Modern Controls, Inc., Minneapolis, Minnesota) and an oxygen permeability value of about 0.10
30 units or less (the units being cubic centimeters-mil/100 square centimeters/24 hours/atmosphere at 23°C (73°F), using ASTM test method D3985-81).
Preferably, the gas permeable portion of the first container will be a barrier for microorganisms. Thus, if either of the two containers is punctured, the product will remain sterile.
In accordance with a more specific embodiment of the present invention, the second or exterior container includes a gas permeable portion and is sealable in a first sealed position that allows gas sterilization of the first container and its contents through the gas permeable portion of the second container. The second container is also sealable in a second sealed position in which the second container provides a gas barrier and is preferably gas impermeable. Thus, the invention contemplates the placing of the tissue or other material in the first con- - tainer, sealing the first container and placing the first container in the second container and sealing the second container in the first sealed position. The interior of the second container can then be sterilized, together with the first container and its contents. Thereafter, the second container can be sealed in the _econd sealed posi¬ tion in which the second container is gas impermeable.
The transparent portions of the first and second containers allow the contents to be viewed when stored therein and a grid may be provided as part of the first container to permit sizing of the contents contained therein. For example, the transparent portion of the first container or the second container may have the grid printed directly thereon. The materials of the containers can be chosen to allow radiation sterilization (Gamma radiation, for example) of the containers and contents stored therein.
In accordance with one embodiment of the present invention, the first and second containers each comprise an envelope or a pouch. Advantageously, the envelope or pouch may be constructed from two sheets of material that are joined together at the periphery of the sheets, each of the envelopes having a sealable opening. Other configu- rations may be used and are within the scope of the inven¬ tion. The opening may comprise an unjoined peripheral portion of two sheets of material, or as a slit in one of the sheets, for example. The sheets of material can be any desired shape, such as rectangular, triangular or circular, for example.
In accordance with a more specific embodiment of the present invention, a storage system is provided that includes a first, flexible, sealable envelope for contain¬ ing, for example, tissue, which comprises two sheets of material joined together at the periphery of the sheets with an unjoined peripheral region of the the sheets defining a sealable opening. One of the sheets is trans¬ parent for viewing tissue contained therein and the other of these sheets is 'gas permeable to allow gas steriliza- tion of the interior and its contents. A second, flexible, sealable envelope is provided for containing the first envelope. The second envelope includes first and second gas impermeable sheets of material joined together at the periphery of the sheets with an unjoined peripheral region of the sheets defining a sealable opening. One of the sheets is transparent for viewing the contents contained within the first envelope. The sealable opening of the second envelope is sealable in a first sealed position which allows the interior of the second envelope to be gas sterilized. The second envelope is sealable in a second sealed position which provides gas impermeable container.
Preferably, the first gas impermeable sheet includes a portion that extends beyond the second gas impermeable sheet at the sealable opening of the second envelope and the second envelope further includes a strip of gas permeable material bonded to and overlapping the second gas impermeable sheet at the sealable opening, the strip also overlapping the first gas impermeable sheet for defining with the first sheet the first sealed position. The unjoined peripheral region of the second gas impermeable sheet defines with the first sheet the second sealed position.
The envelopes are prefeably made of materials that are attachable by heat sealing. Similarly, the opening of each envelope is preferably heat sealable and may comprise an unjoined peripheral portion of two sheets which define the envelope. Preferably, the containers are constructed of flexible, thin-film material.
In accordance with one embodiment, the envelopes are openable by peeling apart the joined sheets which define the envelopes. Preferably, the sheets of each envelope are joined together with at. least one V-shaped or chevron shaped seal for facilitating the opening of the envelopes and the sterile presentation of the tissue. The materials of the containers generally should be suitable for medical applications. The materials and thicknesses can be chosen to impart the desired strength, toughness, flexibility, gas permeability or impermeability, and resistance to high and low temperature. The sheets utilized in making the containers or envelopes can consist of multiple thin layers of different materials of desired thicknesses, each material chosen to provide a specific property, such as gas impermeability, strength, toughness, resistance to puncture, and flexibility and strength at low temperature. The sheets may be formed by bonding the different layers together, such as with a suitable adhesive material or by coextruding the various materials to form a sheet having layers of desired thickness.
In accordance with the invention, a method of storing material, including tissue, is provided that includes: (a) placing the material in a first sealable container or envelope as previously described; (b) sealing the material therein; (c) placing the first container in a second container or envelope as previously described which is sealable in a first sealed position which allows gas sterilization of the interior of the second container and sealable in a second sealed position in which the second container is gas impermeable; (d) sealing the second container; (e) sterilizing the interior and contents of the second container, including the first container and its contents. In one embodiment, in step (d) the second container is sealed in the first sealed position and step (e) comprises gas sterilization. In this embodiment, a further step is included which comprises sealing the second -container in the second sealed position after gas - sterilization, allowing storage in a gas impermeable environment. In accordance with another embodiment, in step (d) the second container is sealed in the second sealed position and step (e) comprises radiation sterilization.
It is not necessary for steps (a)-(e) to occur sequentially, although they may occur in that sequence. For example, the first container would be placed within the second container prior to sealing the first container or prior to placing material in the first container.
Similarly, the sterilization of the contents of the second container would occur prior to sealing the second con¬ tainer, if done without breaching the sterility of the container system. Other sequences may also be feasible.- After sealing the material within the gas imper¬ meable environment, the material may be stored for the desired period of time at the desired temperature. The storage system can be stored in a non-sterile environment and yet delivery and examination of the material or tissue within a sealed container can be made in a sterile environ¬ ment without breaching the sterility of that environment. This is accomplished by removing the first sealed container from the second sealed container in the non-sterile environ- ment and transferring the first sealed container to the sterile environment. The material can then be examined in a sterile environment without the necessity of removing the material from the first sealed container, which is sterile. The material can be removed from the first container in the sterile environment for its intended use.
In accordance with another embodiment of the invention, the first containe'r is suitable for storing liquid. In this embodiment, the materials of the first container or envelope are selected such that they are gas impermeable. In accordance with the invention, such containers can be radiation sterilized.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention can be more completely understood by reference to the accompanying drawings in which:
Figure 1 illustrates a perspective front eleva- tion view, partially cut away, of the storage system in accordance with the present invention;
Figure 2 illustrates a perspective rear elevation view of the storage system of Figure 1;
Figure 3 illustrates a perspective exploded view of the exterior or second container of the storage system;
Figure 4 illustrates a plan view, partially cut away, of the exterior or second container of the storage system;
Figure 5 illustrates in perspective view the insertion of tissue into the first or interior container of the storage system;
Figure 6 illustrates a front elevation view of tissue stored within the first or interior container of the storage system; Figure 7 illustrates in perspective view the insertion of a sealed interior or first container being inserted into the exterior or second container of the storage system;
Figure 8 illustrates in perspective view gas sterilization of the storage system of Figure 1;
Figure 9 illustrates in perspective the storage system of Figure 1 after sterilization and sealing of the exterior container in the gas impermeable or second sealed position; Figure 10 illustrates radiation sterilization of the contents of the storage system of Figure 1;
Figure 11 illustrates in perspective view opening of the exterior or second container of the storage system of Figure 1; and
Figure 12 illustrates in perspective view opening of the interior or first container of the storage system of Figure 1.
DETAILED DESCRIPTION
Referring now to the drawings generally and in particular to Figures 1 and 2, there is illustrated a storage system 10 which is especially suited for storing tissue. Storage system 10 includes interior or first envelope 12 and an exterior or second envelope 14. First envelope 12 consists of two opposing rectangular sheets or webs of material 16 and 18. Sheets 16 and 18 are joined together at their periphery along three perimeter sides thereof, the unjoined fourth perimeter sides or peripheral region of sheets 16 and 18 define a sealable opening 20.
Sheet 16 is a flexible, thin film transparent sheet made up of several layers of thin film materials. Specifically, sheet 16 consists of an outer layer of nylon film having a thickness of about 0.001" and an inner layer of a heat sealable ethylene. vinyl acetate modified poly¬ ethylene with an ethylene vinyl acetate content of about 4.5% to 5% and a thickness of about 0.002". These layers are bonded together with a suitable adhesive for medical uses. One especially suitable nylon film is marketed by the E.I. DuPont de Nemours Co. (DuPont) under the trademark Dartek® 66. Especially suitable ethylene vinyl acetate modified polyethylene film is available from DuPont under the trademark Elvax®. A polycarbonate resin can be used in place of the nylon and is commercially available under the trademark Lexan® of the General Electric Co. A polyester film, such as DuPont Mylar®, can also be used as a replace¬ ment for the nylon film. The nylon material is suitable for printing and is illustrated in Figure 1, the interior side of the nylon layer of sheet 16 has printed thereon a grid 22. Grid 22 can be of the desired dimensions and as illustrated has a small grid scale of one centimeter per division and a large grid scale of five centimeters per division. If desired, the grid could be printed on the exterior of sheet 16, for example, or on second envelope 14. Preferably, and as illustrated in Figure 1, sheet 16 is transparent to visible light so the contents can be viewed. The materials of the containers are also capable of withstanding radiation sterilization such as gamma radiation.
Sheet 18 of envelope 12, more completely illu¬ strated in Figure 2, is flexible and gas permeable to allow gas sterilization of the interior of envelope 12. One suitable type of gas sterilization is ethylene oxide sterilization, which is well known in the art.
Suitable materials for sheet 18 include, for example, spun bond polymer materials, such as spun bond polyolefin, and paper. Preferably, the paper is coated with a suitable material to allow heat sealing to sheet 18. The entire surface of the paper may be coated or only the areas or zones that are intended to form a seal. Thus, the paper is preferably coated over at least a portion thereof with the heat sealing material. Suitable coating materials for heat sealing of paper include, for example, ethylene vinyl acetate, ethylene methylacrylate, ionomer resins such as Surlyn® resins and/or hot melt adhesives. One especially suitable material for sheet 18 is marketed by E.I. DuPont deNemours under the name Tyvek®, which is a spun bond polyethylene having a thickness of 0.008 inches and is a microorganism barrier. The spun bond polymer material may have a coating thereover to facilitate peel¬ ing open the container. The peelable seal provided by the coating material results in a seal of less strength than the strength of the spun bond polymer. Such materials are well known in the art. The peelable coating may be only on those portions that are intended to form a seal. Materials such as an ethylene vinyl acetate copolymer, with a vinyl acetate of 5-28% and preferably about 20%, can be used to provide a peelable seal. Preferably, and as illustrated in Figure 2, sheets 18 and 16 are sealed -together with a seal 24 formed by application of heat to sheets 18 and 16 along the desired perimeter areas thereof. Preferably, one side of sheets 16 and 18 will be sealed together with a chevron or V-shaped seal, referred to in Figure 2 by reference numeral 24a. The angle of V-shaped seal 24a indicated by reference numeral 25 is about 160°. V-shaped seal 24a facilitates the opening of envelope 12. When sheets 16 and 18 are peeled apart beginning with the end of envelope 12 where seal 24a is located, as shown in Figure 12, seal 24a is gradually opened, thereby requiring less force than if seal 24a was configured as a straight line.
For the storage of liquid materials, sheets 16 and 18 of envelope 12 can be constructed of gas imperme- able material, such as the previously described material of sheet 16 or other material which provides a desired barrier to liquid and gas, if desired. In this embodiment, radiation sterilization would be used. The other advantages of the storage system apply to this embodiment, which can be used to store liquid or other material, including tissue.
As illustrated in Figures 1 and 2, the end of first envelope 12 opposite the end where opening 20 is located includes a line of perforations 26 that extends across the width of envelope 12. The perforations allow end portion 27 to be folded over so that label 28, printed or affixed on sheet 18, is visible from the front of envelope 12. Label 28 may contain desired information or blank space for a description of the contents of envelope 12, for example. Sheet 18 may also have printed thereon another label 30, illustrated in Figure 2, having desired information.
Referring to Figures 1 and 2, the front and rear of exterior or second envelope 14 are illustrated in perspective view. Second envelope 14 includes a first sheet 32 and a second sheet 34 which are attached together about perimeter portions thereof along three perimeter sides thereof with a seal 40, which is a heat seal. The unjoined fourth perimeter sides or peripheral region of first sheet 32 and second sheet 34, together with gas permeable strip 36, defines a sealable opening 38 of second envelope 14. Preferably, and as illustrated in Figures 1 and 2, seal 40 includes along one side of first and second sheets 32 and 34 a chevron or V-shaped seal 40a for facilitating opening of second envelope 14 as illus¬ trated in Figure 10, in a manner similar to that described with respect to first envelope 12. Angle 41 formed by V-shaped seal 40a of second envelope 14 is about 160°.
The construction of second envelope 14 is shown in greater detail in Figures 3 and 4. As illustrated therein, one end of sheet 34 extends beyond sheet 32. Gas permeable strip 36 overlaps and is attached to the end of sheet 32 is substantially coextensive with the portion of sheet 34 which extends beyond sheet 32. Strip 36 is attached to sheet 32 with a seal 43, which is a heat seal. Seal 40 also seals strip 36 along the sides of sheets 32 and 34 to which strip 36 is adjacent. By sealing sealable opening 38 in an area where second sheet 34 and gas permeable strip 36 overlap directly after placing contents therein, such as along line 42 of Figures 4 and 8, envelope 14 is sealed in a first sealed position. This allows the interior of second envelope 14 to admit sterilizing gas, such as ethylene oxide, to enter the interior of envelope 14 as illustrated in Figure 8 by arrows 44. When the desired- gas sterilization has been completed, second envelope 14 can be sealed in the second sealed position, where first sheet 32 and second sheet 34 directly overlap, such as along line 46 of Figure 4. First sheet 32 and second sheet 34 of second envelope 14 are gas impermeable. First sheet 32 is a thin film, flexible, transparent sheet and is constructed in the illustrated embodiment of several layers of different material. Specifically, from outside to inside, the layers are a thin nylon film, a thin polyvinylidene chloride film and a thin film of a linear low density polyethylene material. The combination of these layers provides a clear, tough, flexible sheet 32 which is crack resistant, even at extremely low temperature such as about -80°C. Further, it forms an excellent barrier to oxygen, water and other gases. Each of the layers of sheet 32 are bonded together* using suitable adhesive material. If desired, polyester can be substituted for the nylon layer. Specific materials which are especially suitable for making sheet 32 include a nylon film marketed by
S DuPont under the name Dartek having a thickness of about
0.001 inches, a polyvinylidene chloride (saran) marketed by Dow Chemical Company under the trade designation "XO
1621.10" having a thickness of about 0.002 inches and a linear low density polyethylene material marketed by
DuPont under the name Sclair SL3 having a thickness of about 0.002 inches.
Suitable adhesive material for bonding the various layers of material include urethane and polyester adhesives. Several specific adhesives which may be used
_ include available under the trademark Adkote 333, 548 and
_ 575 from the Morton Chemical Co. Adkote 333 is believed to be a single component urethane adhesive and Adkote ® 548 and 575 are believed to be two component polyester adhesives. Other suitable adhesives will be known to those skilled in the art.
Second sheet 34 can be constructed of material similar to first sheet 32. Preferably, second sheet 34 is a laminated, flexible, thin film sheet that includes a foil layer that is sandwiched between a thin polyester layer and a linear low density polyethylene layer with the polyester layer forming the outer layer of sheet 34.
Especially suitable materials for sheet 34 include polyester material having a thickness of about
0.00048 inches marketed by DuPont, 3M Co. and ICI Americas,
Inc. aluminum foil having a thickness of about 0.001 inches and a linear low density polyethylene material
_ marketed by DuPont under the name Sclair SL3 having a thickness of about 0.002 inches. The layers are bonded together with suitable adhesive material.
Preferably, at least the portions of sheets 32 and 34 that are sealed together have coated at the seal interface a coating that facilitates peeling apart of the joined sheets after heat sealing. The coating results in a bond between the two sheets that is of less strength than the strength of either of the sheets. Suitable materials for forming a peelable coating on polyethylene are ethylene vinyl acetate copolymers having a vinyl acetate content of 5% to 28% and preferably about 20%. Another suitable material is available from Rollprint Packaging Products, Inc. of Addison, Illinois under the trade designation RP-IA, which includes a solvent carrier. Good results have been obtained with application rates of from three to four pounds of RP-IA per 3000 square feet of sheet material. Other suitable coatings for this purpose will be known to those skilled in the art.
Second envelope 14 may have printed or affixed thereon a suitable label 47, illustrated in Figure 2 on the reverse side of envelope 14. Referring to Figure 5, there is illustrated tissue 48 being inserted into opening 20 of interior envelope 12. After insertion of tissue 48, interior envelope 12 is sealed along seal line 50, as illustrated in Figure 6. This may be accomplished by heat sealing, for example.
Thereafter, as illustrated in Figure 7, sealed interior envelope 12 is placed into exterior envelope 14 through opening 38 thereof with transparent sheets 16 and 32 in the same orientation for viewing the contents of envelope 12. Exterior envelope is then sealed along seal line 42 which allows the interior of exterior envelope 14 to be gas sterilized since a gas passageway is provided to the interior of exterior envelope 14 through gas permeable strip 36. Gas sterilization of the contents of exterior envelope 14 is illustrated in Figure 8.
After gas sterilization has been completed, exterior envelope 14 is sealed in the second sealed position which is gas impermeable, along line 46 as illustrated in Figure 9 creating a gas impermeable container.
If desired, as an alternative to gas steriliza¬ tion, the interior and contents of second envelope 14 can be radiation sterilized. Figure 10 illustrates this procedure in which a radiation source 52 directs sterilizing radiation, such as gamma radiation 54 through the transparent sheets 32 and .16 of second envelope 14 and first envelope 12, respectively.
Figures 11 and 12 illustrate the opening of tissue storage system 10. First, exterior envelope 14 is opened by peeling apart first sheet 32 and second sheet 34. Preferably, the peeling apart is initiated along the side having V-shaped seal 40a. First sheet 32 and second sheet 34 are peeled apart sufficiently to allow interior envelope 12 to be removed therefrom. Thereafter, .if desired, interior envelope 12, which has been sterilized, can be transferred to a sterile environment for opening. As illustrated in Figure 12, interior envelope 12 is opened in the same manner as exterior envelope 14, preferably beginning with the side of interior envelope 12 that has V-shaped seal 24a. Sheets 16 and 18 are sufficiently peeled apart to allow tissue 48 to be conveniently removed therefrom.
The storage system of the present invention is particularly suited for storing human tissue. As used herein, "tissue" is used in a broad sense and includes any multicellular human or animal matter, such as skin, bone, dura matter, organs and organ parts, for example. It is to be understood that while the storage system of the invention is primarily intended for storing tissue numerous other types of material can be stored therein.' By way of example only, and not as a limitation on the invention, the storage system of the present invention would be useful for storing surgical instruments and supplies, for storing industrial components and parts, for storing agricultural materials such as seeds and for storing nutritional products.
While the invention has been described with respect to preferred embodiments, it will be understood that the invention is capable of numerous changes, modifi¬ cations and rearrangements and such are intended to be covered by the appended claims.

Claims

1. A storage system comprising:
(a) a first thin film container for containing material, having a sealable opening and a transparent portion for viewing the material contained therein and a gas permeable portion to allow gas sterilization of the interior of said first container; and
(b) a second thin film container, dimensioned to contain said first container, having sealable opening and a transparent portion for viewing the material in said first container when contained in said second container, said second container providing a gas barrier when sealed.
2. The storage system of claim 1 wherein said second container includes a gas permeable portion and is sealable in a first sealed position that allows gas sterili¬ zation of the first container through said gas permeable portion of said second container, said second container being sealable in a second sealed position in which said second container provides a gas barrier.
3. The storage system of claim 1 wherein said transparent portions of said first and second containers are transparent to gamma radiation.
4. The storage system of claim 1 wherein said first and second containers each comprise an envelope.
5. The storage system of claim 1 wherein said first and second containers respectively comprise first and second envelopes, each envelope comprising two sheets of material joined together at the periphery of said sheets, each of said envelopes having a sealable opening.
6. The storage system of claim 5 wherein said sealable opening comprises a peripheral portion where said two sheets are not joined together.
7. The storage system of claim 5 wherein said sheets of said first and second envelopes are joined together by heat sealing.
8. The storage system of claim 5 wherein said first and second envelopes each include a V-shaped seal for facilitating opening of said envelopes.
9. The storage system of claim 6 wherein the opening of said second envelope is sealable in a first sealed position that allows gas sterilization of the interior of said second envelope and in a second sealed position in which said second envelope is gas impermeable.
10. The storage system of claim 5 wherein said first and second envelopes are rectangular.
11. The storage system of claim 5 wherein one sheet of each envelope is transparent.
12. The storage system of claim 5 wherein one sheet of material of said first envelope is gas permeable and the other sheet of material of said first envelope is transparent.
13. The storage system of claim 12 wherein said gas permeable sheet comprises spun bond polyolefin material.
14. The storage system of claim 12 wherein said gas permeable sheet comprises paper.
15. The storage system of claim 14 wherein material which allows said paper to be heat sealed to the other sheet of material of said first envelope is coated over at least a portion of said paper.
16. The storage system of claim 12 wherein said transparent sheet material of said first envelope comprises:
(a) a thin layer of material selected from the group consisting of nylon, polyester and polycarbonate resin; and (b) a thin layer of ethylene vinyl acetate modified polyethylene, said layers being bonded together.
17. The storage system of claim 5 wherein one sheet of said second envelope is transparent.
18. The storage system of claim 17 wherein said transparent sheet of said second envelope comprises, in sequential order:
(a) a thin layer selected from the group consist- ing of nylon and polyester;
(b) a thin layer of polyvinylidene chloride; and
(c) a thin layer of linear low density poly¬ ethylene, said layers being bonded together.
19. The storage system of claim 17 wherein the other sheet of said second envelope comprises, in sequential order, a thin layer of polyester or nylon material, a thin layer 'of aluminum, a thin layer of linear low --density • " polyethylene and a peelable coating over at least a por¬ tion of said polyethylene layer, said layers being bonded together.
20. A storage system comprising:
(a) a first flexible, sealable envelope for containing material, said first envelope comprising two sheets of material joined together at the periphery of said sheets, an unjoined peripheral region of said sheets defining a sealable opening, one of said sheets being transparent for viewing tissue contained therein and the other of said sheets being gas permeable to allow gas sterilization of the interior; and (b) a second, flexible, sealable envelope 'for containing said first envelope, said second envelope comprising first and second gas impermeable sheets of material joined together at the periphery of said sheets, an unjoined peripheral region of said sheets defining a sealable opening, both sheets being gas impermeable, one of said sheets being transparent for viewing material contained within said first envelope, the sealable opening of said second envelope being sealable in a first sealed position which allows the interior of said second envelope to be gas sterilized and in a second sealed position which is gas impermeable.
21. The storage system of claim 20 wherein said first gas impermeable sheet extends beyond said second gas impermeable sheet at the sealable opening of said second envelope, the storage system further comprising a strip of gas permeable material bonded to and overlapping said second gas impermeable sheet at the sealable opening of said second envelope which defines with said first sheet the first sealed position and the unjoined peripheral region of said second gas impermeable sheet defining with said first gas impermeable sheet the second sealed position.
22. The storage system of claim 20 wherein said first and second envelopes when sealed are openable by peeling apart the sheets of each envelope.
23. The storage system of claim 22 wherein the sheets of said first and second envelopes are joined together at one perimeter side in a V-shaped seal for facilitating peeling apart the sheets.
24. The storage system of claim 20 wherein the transparent sheet of said first envelope includes a grid for determining the size of material contained therein.
25. The storage system of claim 20 wherein the transparent sheet of said second envelope includes a grid for determining the size material contained therein.
_—
26. The storage system of claim 20 wherein said transparent sheets are transparent to sterilizing radiation.
27. The storage system of claim 20 wherein the sheets of said first and second envelopes are rectangular.
28. A method of storing material comprising the steps of: (a) placing the material in a first thin film container having a sealable opening and a transparent por- tion for viewing the material contained therein and a gas
permeable portion to allow gas sterilization of the interior of said first sealable container;
(b) sealing said first sealable container;
(c) placing said sealed first container in a second thin film container dimensioned to contain said first container, said second sealable container having a sealable opening and a transparent portion for viewing the material contained in said first container, said second container sealable in a first sealed position that allows gas sterilization of the interior and contents of the second container and sealable in a second sealed position in which said second container is gas impermeable;
(d) sealing said second container; and
(e) sterilizing the interior and contents of said second container, the first container and the material contained.
29. The method of claim 28 wherein said second container is sealed in said first sealed position in step (d) and gas sterilization is utilized in step (e), and after gas sterilization said method further comprises sealing said second container in said second sealed position.
30. The method of claim 29 wherein said gas sterilization comprises ethylene oxide sterilization.
31. The method of claim 28 wherein said second container is sealed in said second sealed position in step (d) and radiation sterilization is utilized in step (e).
32. The method of claim 31 wherein said radiation sterilization comprises Gamma radiation sterilization.
33. The method of claim 28 wherein said material comprises tissue.
34. A method of storing material and delivering the material in a sterile environment comprising storing the material as recited in claim 28 and further comprising removing the first sealed container from the second sealed container in a non-sterile environment, transferring the first sealed container to the sterile environment, opening the first sealed container and removing the material from the first container in the sterile environment for its intended use.
35. The method of claim 34 wherein the material comprises tissue.
36. The method of claim 34 wherein the material comprises a surgical instrument.
37. A storage system comprising:
(a) a first thin film container for containing liquid material, having a sealable opening and a transparent portion for viewing and radiation sterilizing the material contained therein, said first container providing a liquid barrier when sealed; and
(b) a second thin .film container, dimensioned to contain said first container, having a sealable opening and a transparent portion for viewing and radiation steriliz- ing the material in said first container when contained in said second container, said second container being gas impermeable when sealed.
PCT/US1985/002535 1984-12-27 1985-12-19 Tissue storage system WO1986003976A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US686,948 1984-12-27
US06/686,948 US4714595A (en) 1984-12-27 1984-12-27 Tissue storage system

Publications (1)

Publication Number Publication Date
WO1986003976A1 true WO1986003976A1 (en) 1986-07-17

Family

ID=24758406

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1985/002535 WO1986003976A1 (en) 1984-12-27 1985-12-19 Tissue storage system

Country Status (5)

Country Link
US (1) US4714595A (en)
EP (1) EP0207142A4 (en)
JP (1) JPS62501272A (en)
CA (1) CA1268154A (en)
WO (1) WO1986003976A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5040677A (en) * 1990-06-04 1991-08-20 Biosurface Technology, Inc. Container for storage and distribution of a skin wound dressing
WO1999037233A1 (en) * 1998-01-23 1999-07-29 Reprogenesis, Inc. Method and apparatus for aseptically packaging and dispensing live material
DE102009006470A1 (en) 2008-12-23 2010-08-19 Alkor Folien Gmbh Peelable film for fibrous substrates, composite of the film and a substrate and use thereof
EP3085331A1 (en) * 2015-04-23 2016-10-26 Sofradim Production A flat package for a surgical mesh and a method of packaging a surgical mesh in said package

Families Citing this family (57)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4844259A (en) * 1987-12-22 1989-07-04 Osteotech, Inc. Medical and surgical procedure pack
US5002735A (en) * 1988-07-12 1991-03-26 Mark T. Alberhasky Tissue analysis device
US5014494A (en) * 1988-09-27 1991-05-14 Sherwood Medical Company Method of sterilizing medical articles
US5092466A (en) * 1988-10-21 1992-03-03 Large Scale Biology Corportion Apparatus and method for storing samples of protein gene products, insert-containing cells or dna
US4874090A (en) * 1988-10-24 1989-10-17 American Sterilizer Company Self-seal sterilization pouch
US4951815A (en) * 1989-11-24 1990-08-28 Paul Ulbrich Medical glove and lubricant dispensing package
US5342673A (en) * 1993-02-23 1994-08-30 W. L. Gore & Associates, Inc. Sterilizable packaging material
US6406674B1 (en) 1993-06-30 2002-06-18 Kimberly-Clark Worldwide, Inc. Single step sterilization wrap system
US6123900A (en) * 1993-10-28 2000-09-26 Vellutato; Arthur L. Method of sterilization
US6203755B1 (en) * 1994-03-04 2001-03-20 St. Jude Medical, Inc. Electron beam sterilization of biological tissues
SE506058C2 (en) * 1996-02-28 1997-11-03 Tetra Laval Holdings & Finance Ways to sterilize closed packages
US5735609A (en) * 1996-07-16 1998-04-07 The West Company Container for holding sterilized elements
US5699909A (en) * 1996-08-07 1997-12-23 United States Surgical Corporation Surgical instrument package
US5863496A (en) * 1996-11-25 1999-01-26 Prepared Media Laboratory, Inc. Sterile packaging
EP0987991B1 (en) * 1997-06-09 2009-04-08 Kyphon SARL Systems for treating fractured or diseased bone using expandable bodies
US5879620A (en) * 1997-11-13 1999-03-09 Kimberly-Clark Worldwide, Inc. Sterilization wrap and procedures
US6878345B1 (en) * 1997-12-08 2005-04-12 Thomas W. Astle Ultra high throughput bioassay screening system
US6073767A (en) * 1998-05-29 2000-06-13 Kimberly-Clark Worldwide, Inc. Package and method to reduce bacterial contamination of sterilized articles
US6808691B1 (en) * 1998-10-12 2004-10-26 Arjo Wiggins Sealable sterilizing packaging material
DE19932458A1 (en) * 1999-07-12 2001-01-25 Rauscher & Co Package for storing sterile goods, device and method for producing such a package
US6419392B1 (en) * 2000-11-02 2002-07-16 Advanced Poly-Packaging, Inc. Web of sterile bags for automatic bagging equipment
US6854599B2 (en) * 2001-03-06 2005-02-15 Musculoskeletal Transplant Foundation Packaging system for frozen allograft tissue forms
US20030206825A1 (en) * 2001-11-28 2003-11-06 Vellutato Arthur L. Method of sterilization
WO2004025598A1 (en) * 2002-09-10 2004-03-25 3Si Security Systems, Inc. Shipping device end method for articles capable of releasing gas containing hazardous particulates
EP1592350A1 (en) * 2003-02-13 2005-11-09 Massn Medical Limited Pouch for packaging a medical device
US20040202993A1 (en) * 2003-04-10 2004-10-14 Poo Ramon E. Apparatus and method for organ preservation and transportation
US6996952B2 (en) * 2003-09-30 2006-02-14 Codman & Shurtleff, Inc. Method for improving stability and effectivity of a drug-device combination product
US20050079093A1 (en) * 2003-10-14 2005-04-14 Allegiance Corporation Sterilization wraps and methods for sterilizing articles
US20050268573A1 (en) * 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
US7922983B2 (en) 2005-07-28 2011-04-12 Kimberly-Clark Worldwide, Inc. Sterilization wrap with additional strength sheet
US7713686B2 (en) * 2004-12-03 2010-05-11 Biorep Technologies, Inc. Organ preservation container and method
ATE422852T1 (en) * 2004-12-08 2009-03-15 Perfecseal Inc STERILIZABLE HIGH OXYGEN BARRIER PACKAGE
US7790437B2 (en) * 2006-12-14 2010-09-07 Biorep Technologies, Inc. Organ transportation device
KR100794632B1 (en) * 2007-01-19 2008-01-14 주식회사 에프에스코리아 Sterilization packing case and method for packing thereof
DE102007004114B3 (en) * 2007-01-26 2008-02-14 Sartorius Biotech Gmbh Protected filter units e.g. for safety filtration, include two non-gas-permeable packaging materials
US8763351B2 (en) * 2007-07-05 2014-07-01 Greene, Tweed Technologies, Inc. Method of packaging for thin fragile parts
US7631760B2 (en) * 2008-02-07 2009-12-15 Amcor Flexibles Healthcare, Inc. Dual compartment pouch
EP2293821B1 (en) * 2008-06-09 2013-08-28 Becton Dickinson France Sterile packing and sterilization method using this packing
US9095324B2 (en) * 2008-06-20 2015-08-04 Boston Scientific Scimed, Inc. Package assembly
US20100122992A1 (en) 2008-11-14 2010-05-20 Veltek Associates, Inc. Apparatus and method for mixing and dispensing
US8465471B2 (en) 2009-08-05 2013-06-18 Rocin Laboratories, Inc. Endoscopically-guided electro-cauterizing power-assisted fat aspiration system for aspirating visceral fat tissue within the abdomen of a patient
US20110213336A1 (en) 2009-08-05 2011-09-01 Cucin Robert L Method of and apparatus for sampling, processing and collecting tissue and reinjecting the same into human patients
US8348929B2 (en) 2009-08-05 2013-01-08 Rocin Laboratories, Inc. Endoscopically-guided tissue aspiration system for safely removing fat tissue from a patient
US20110139650A1 (en) * 2009-12-15 2011-06-16 Amcor Flexibles, Inc. Sterilizable Package Having Breathable Membrane for the Packaging of Medical Devices
US8302773B1 (en) * 2011-04-25 2012-11-06 Cook Medical Technologies Llc Multi-compartment package assembly for medical implements
EP2570138A1 (en) * 2011-09-13 2013-03-20 Adam D. Sold Method and apparatus for handling non-sterilized objects in sterilized environment
US20140270583A1 (en) * 2013-03-15 2014-09-18 Edwin K. Anderson Dual Sterile Pouch and Sealing Mechanisms for the Containment of a Non-Sterile Device
US9427710B2 (en) * 2013-03-15 2016-08-30 Bemis Company, Inc. Radial filtration vent and medical device packaging
US10822150B2 (en) 2015-06-03 2020-11-03 Bemis Company, Inc. Package for indicating heat-seal condition
BR112019010835B1 (en) 2016-12-02 2022-07-05 Bemis Company, Inc PACKAGING TO INDICATE THERMAL SEALING CONDITION
US11375710B2 (en) 2017-01-10 2022-07-05 Musculoskeletal Transplant Foundation Packaging system for tissue grafts
US10695157B2 (en) 2017-01-10 2020-06-30 Musculoskeletal Transplant Foundation Packaging system for tissue grafts
US10582994B2 (en) 2018-03-06 2020-03-10 Musculoskeletal Transplant Foundation Implant packaging assembly
CA3105619A1 (en) * 2018-07-06 2020-01-09 Instant Systems, Inc. Sample container with peelable seal and access port
USD954993S1 (en) 2020-06-17 2022-06-14 Musculoskeletal Transplant Foundation Tissue graft retainer
US11890819B2 (en) 2021-03-24 2024-02-06 Instant Systems, Inc. Multi-chamber container for biological materials and compounded pharmaceuticals
WO2022261389A2 (en) 2021-06-11 2022-12-15 Instant Systems, Inc. Container for biological materials having multiple sealed portions

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3468471A (en) * 1965-06-24 1969-09-23 Fritz Linder Bacteriaproof plastic bag for articles to be sterilized
US3476506A (en) * 1965-04-14 1969-11-04 Andersen Prod H W Sterilization apparatus
US3494726A (en) * 1966-12-27 1970-02-10 Becton Dickinson Co Sterilizing method and sterilizing package
US3716961A (en) * 1970-12-29 1973-02-20 Procter & Gamble In-package sterilization
US3728839A (en) * 1971-04-29 1973-04-24 American Cyanamid Co Storage stable surgically absorbable polyglycolic acid products
US3815315A (en) * 1971-04-29 1974-06-11 American Cyanamid Co Ethylene oxide sterilization of moisture sensitive surgical elements
US4091921A (en) * 1975-08-21 1978-05-30 Faser Industries Sterilizable package and method
US4121714A (en) * 1977-03-23 1978-10-24 Faser Industries Sterilizable package with tear-off indicators
US4194622A (en) * 1978-07-03 1980-03-25 Faser Industries Sterilizable package and a method of packaging for sterilization

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3123210A (en) * 1964-03-03 Package and seal
US3403776A (en) * 1967-03-21 1968-10-01 Johnson & Johnson Sterile surgical package
US3460742A (en) * 1968-01-29 1969-08-12 Weck & Co Inc Edward Peelable transparent envelope for sterile articles
US3754700A (en) * 1969-06-25 1973-08-28 Rollprint Packaging Prod Inc Surgical pouches
US3604616A (en) * 1969-10-02 1971-09-14 Weck & Co Inc Edward Peelable envelope for sterile articles
US3685720A (en) * 1970-07-28 1972-08-22 Charles E Brady Package for sterilized products
US3768725A (en) * 1971-11-11 1973-10-30 Nat Distillers Chem Corp Breathable, sterilizable and peelable pouch and method of manufacture thereof
US3819106A (en) * 1972-04-12 1974-06-25 S Schuster Sample bag
US3891089A (en) * 1972-08-01 1975-06-24 Rexham Corp Peelable heat seals for packages
US3903335A (en) * 1973-04-27 1975-09-02 Mardon Flexible Packaging Ltd Heat sealed package
US3926311A (en) * 1974-08-22 1975-12-16 Vonco Products Inc Peel-seal containers
US4206844A (en) * 1977-01-04 1980-06-10 Toppan Printing Co., Ltd. Package for a sterilized material
US4276982A (en) * 1977-10-26 1981-07-07 Arvey Corporation Pressure sensitive tape closure pouch
US4190154A (en) * 1978-02-06 1980-02-26 Bausch & Lomb Incorporated Sterile package
US4306656A (en) * 1980-02-19 1981-12-22 Dahlem A Richard Medical pouches and a method of manufacturing such pouches
US4318506A (en) * 1980-05-27 1982-03-09 Arvey Corporation Three-fold closable pouch
US4323189A (en) * 1980-05-27 1982-04-06 Arvey Corporation Closable pouch
US4367816A (en) * 1981-06-10 1983-01-11 Wilkes Kenneth R Tear strip for gas sterilizable package and package
GB8308303D0 (en) * 1983-03-25 1983-05-05 Smiths Bros Whitehaven Ltd Pouches
US4482053A (en) * 1983-11-16 1984-11-13 Ethicon, Inc. Sealable container for packaging medical articles in sterile condition

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3476506A (en) * 1965-04-14 1969-11-04 Andersen Prod H W Sterilization apparatus
US3468471A (en) * 1965-06-24 1969-09-23 Fritz Linder Bacteriaproof plastic bag for articles to be sterilized
US3494726A (en) * 1966-12-27 1970-02-10 Becton Dickinson Co Sterilizing method and sterilizing package
US3716961A (en) * 1970-12-29 1973-02-20 Procter & Gamble In-package sterilization
US3728839A (en) * 1971-04-29 1973-04-24 American Cyanamid Co Storage stable surgically absorbable polyglycolic acid products
US3815315A (en) * 1971-04-29 1974-06-11 American Cyanamid Co Ethylene oxide sterilization of moisture sensitive surgical elements
US4091921A (en) * 1975-08-21 1978-05-30 Faser Industries Sterilizable package and method
US4121714A (en) * 1977-03-23 1978-10-24 Faser Industries Sterilizable package with tear-off indicators
US4194622A (en) * 1978-07-03 1980-03-25 Faser Industries Sterilizable package and a method of packaging for sterilization

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0207142A4 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5040677A (en) * 1990-06-04 1991-08-20 Biosurface Technology, Inc. Container for storage and distribution of a skin wound dressing
WO1999037233A1 (en) * 1998-01-23 1999-07-29 Reprogenesis, Inc. Method and apparatus for aseptically packaging and dispensing live material
DE102009006470A1 (en) 2008-12-23 2010-08-19 Alkor Folien Gmbh Peelable film for fibrous substrates, composite of the film and a substrate and use thereof
DE102009006470B4 (en) * 2008-12-23 2012-04-12 Alkor Folien Gmbh Peelable film for fibrous substrates, composite of the film and a substrate and use thereof
EP3085331A1 (en) * 2015-04-23 2016-10-26 Sofradim Production A flat package for a surgical mesh and a method of packaging a surgical mesh in said package
US11376109B2 (en) 2015-04-23 2022-07-05 Sofradim Production Flat package for a surgical mesh and a method of packaging a surgical mesh in said package

Also Published As

Publication number Publication date
EP0207142A4 (en) 1989-03-21
JPH0569548B2 (en) 1993-10-01
EP0207142A1 (en) 1987-01-07
CA1268154A (en) 1990-04-24
US4714595A (en) 1987-12-22
JPS62501272A (en) 1987-05-21

Similar Documents

Publication Publication Date Title
US4714595A (en) Tissue storage system
AU2020204234B2 (en) Medical device packaging
USRE36132E (en) Three envelope package for sterile specimens
US5590777A (en) Sterilizable flexible pouch package
EP0941731B1 (en) Flexible medical container packaging
US5590778A (en) Double-sterile package for medical apparatus and method of making
US5459978A (en) Sterilizable flexible peel-seal pouch package
US4637061A (en) Specimen, sample collection and transport container
US6251489B1 (en) Sterilizable flexible pouch package
US4367816A (en) Tear strip for gas sterilizable package and package
US4091921A (en) Sterilizable package and method
US4522302A (en) Pre-sterilized medical procedure kit packages
US6622864B1 (en) Moisture resistant package for storing sterile items
US3301392A (en) Nested package
US4523679A (en) Pre-sterilized medical procedure kit packages
US20080116106A1 (en) Packing and sterilizing a pen in a kit
US6189694B1 (en) Sterilizable flexible pouch package
EP0640332A1 (en) Wound dressing package
EP1592350A1 (en) Pouch for packaging a medical device
US4630448A (en) Container for storing solid living tissue portions
JPS59501862A (en) window bag for liquids
GB1580161A (en) Package and process for producing such a package
EP3085331B1 (en) A flat package for a surgical mesh and a method of packaging a surgical mesh in said package
US5816403A (en) Sterilizable container for sterile presentation of contents
WO2006013919A1 (en) Packaging container and medical packaging sheet

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): JP

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE FR GB IT LU NL SE

WWE Wipo information: entry into national phase

Ref document number: 1986900544

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1986900544

Country of ref document: EP

WWR Wipo information: refused in national office

Ref document number: 1986900544

Country of ref document: EP

WWW Wipo information: withdrawn in national office

Ref document number: 1986900544

Country of ref document: EP