AU2009332549B2 - Single use sterilization container - Google Patents

Single use sterilization container Download PDF

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Publication number
AU2009332549B2
AU2009332549B2 AU2009332549A AU2009332549A AU2009332549B2 AU 2009332549 B2 AU2009332549 B2 AU 2009332549B2 AU 2009332549 A AU2009332549 A AU 2009332549A AU 2009332549 A AU2009332549 A AU 2009332549A AU 2009332549 B2 AU2009332549 B2 AU 2009332549B2
Authority
AU
Australia
Prior art keywords
lid
tray
lock
container
sterilization
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
AU2009332549A
Other versions
AU2009332549A1 (en
Inventor
Joseph A. Cesa
Laureen C. Clark
John K. Clay
Steven Scott Friderich
Sean P. Gorman
David Hernandez
Denise E. O'connor
Corina Schwarz
Tara Denise Smith
James Troy Starkey
Daniel P. Sterling
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
O&M Halyard International ULC
Original Assignee
O&M Halyard International ULC
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
Priority claimed from US12/317,657 external-priority patent/US7942264B2/en
Application filed by O&M Halyard International ULC filed Critical O&M Halyard International ULC
Publication of AU2009332549A1 publication Critical patent/AU2009332549A1/en
Application granted granted Critical
Publication of AU2009332549B2 publication Critical patent/AU2009332549B2/en
Assigned to KIMBERLY-CLARK WORLDWIDE, INC. reassignment KIMBERLY-CLARK WORLDWIDE, INC. Request to Amend Deed and Register Assignors: KIMBERLY-CLARK WORLDWIDE, INC.
Assigned to AVENT, INC. reassignment AVENT, INC. Request for Assignment Assignors: KIMBERLY-CLARK WORLDWIDE, INC.
Assigned to O&M HALYARD INTERNATIONAL UNLIMITED COMPANY reassignment O&M HALYARD INTERNATIONAL UNLIMITED COMPANY Request for Assignment Assignors: AVENT, INC.
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment
    • 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
    • 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
    • A61B50/34Baskets
    • 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
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0058Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by translation
    • A61B2050/006Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by translation perpendicular to the lid plane, e.g. by a downward movement
    • 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
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065Peelable cover
    • 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
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0067Types of closures or fasteners
    • A61B2050/0083Snap connection
    • 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
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0089Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover having permanent closure means
    • 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
    • A61B2050/3007Stackable casings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0814Preventing re-use
    • 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
    • A61B50/33Trays
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/027Packaging in aseptic chambers
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T292/00Closure fasteners
    • Y10T292/08Bolts
    • Y10T292/1095Seal-rupturing devices
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T292/00Closure fasteners
    • Y10T292/48Seals

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Packages (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Closures For Containers (AREA)
  • Containers Opened By Tearing Frangible Portions (AREA)

Abstract

A non-reusable, locking container for sterilizing and storing surgical materials and presenting surgical materials in a sterilized condition. The non-reusable, locking sterilization container includes a tray, a lid, a permeable filter, a non-reusable lock and a frangible release that limit the container to only a single sterilization cycle or single use.

Description

WO 2010/073197 PCT/IB2009/055829 SINGLE USE STERILIZATION CONTAINER This application is a continuation-in-part of, and claims priority to, U.S. Serial No. 12/317,657 entitled "Sterilization Container With Peel Top" by Steven Scott Friderich et il., which is hereby incorporated by reference for all purposes. BACKGROUND Sterilization of items used in medical procedures is vital to minimizing the spread f harmful and infectious microbes to patients. Typically, the items used in medical procedures are wrapped with a sterilization wrap made of a gas permeable material or laced in a reusable vented rigid sterilization container. These sterilization wraps or ;terilization containers preserve sterility of the items contained therein, as well as the interior portion of these wraps or containers, after the wraps or containers and their respective contents have been channeled through a sterilization process. During a typical ;terilization process, the sterilization wraps or vented rigid sterilization containers are laced into a sterilization chamber, and the gas permeable material in the sterilization wrap >r vents within the rigid sterilization container allow a gas sterilant to contact the item(s) to >e sterilized in the sterilization container. Examples of current gas sterilization procedures include, gas plasma sterilization, steam sterilization, ethylene oxide sterilization, hydrogen peroxide sterilization, and ozone ;terilization. Other sterilization procedures, such as irradiation have also been used. Although utilization of sterilization wrap and/or use of vented rigid reusable sterilization containers are generally effective, there are certain disadvantages associated with each of these items. Sterilization wraps are made of a relatively thin, inexpensive, flexible material and have generally low initial cost. However, items to be sterilized are often placed within a metal sterilization tray prior to wrapping the items with sterilization wrap. These sterilization trays have pointed edges or other features that may concentrate forces and generate very small tears or snags if the wrap contacts these features. When wrapped trays are transported on carts or stacked prior to sterilization or after sterilization, other sources 1 100063770 of very small tears or breaches in the barrier may develop in the wrap due to pressure or impact. These tears may allow bacteria or other harmful substances to contaminate the items which results in added expense because the items to be sterilized will need to re-handled and re sterlized at an additinal cost, An additional issue with the use of sterilizaion wraps is a lack of vibiity. Because sterilization wraps generally are not made oftransparent material, the medical professional utilzing it cannot visually inspect the items contained therein for content or for assurance that the steriization procedure has been completed- This can lead to a medical professional opening the wrong sterilization tray during a procedure and/or lead to lack of confidence that the tray is truly sterilized. As a resul trays and articles may require unnecessary rehanding and re sterihzation which wastes both economic and time resources, With regard to reusable vented rigid steilization containers although generally effective these containers must be thoroughly maintained and cleaned between uses so that they may be re-used. In contrast sterilzation wrap is typical discarded after a single use; Reusable sterilization containers require significant amounts of hospital economic and time resources because staffing levels often need to be increased in order to process and maintain these rigid containers fo re-se. Additionally; the longer the containers are in use, the less confidence cinicians have in the sterilization efficacy of the containers. Limately, these containers must be repaired, rconditioned, or discarded, Thus, there remains a need in the art for sterilzation containers that are economical provide ease of visual inspection, and that impart confidence in sterlty among clinicians As used herein, except where the context requires otherwise the erm "comprise" and vacations of the term, such as "comprising', "omprses" and "Comprised", are not intended to exclide other additives, components, integers or steps. 5 Reference to any prior artin the specificaton is not, and should not be taken as, an acknowledgment or any fbrm of suggestion that this prior art forms part of the common general knowledge in any juridiction or that this prior art could reasonably be expected to be understood, regarded as relevant and, in case of plural pieces of prior art, combined by a skilled person in the art. 2 1000637760 SUMMARY According to a first embodIment of the invention, there is provided a non-reusable, rocking container for sterizing and storing surgical materials and presenting surgical materials in a steri ized condition, the contaner composing: 5 a tray comprising a base, a plurality of sides each having a proximal portion in. communication with the base and a distal portion away from the base, and arm defined by the distal potions of the sides, the rim comparing a lower portion of a barrier; a lid comprising a central portion, and a lipthe lip comprising an upper portion of a barrier, wherein the lid and he tray together defrie a chamber for containing surgical materials and wherein the lip and the rim together form a barrier to inhibit the passage of microorganisms ito the chamber between a tray and lid secured together; a permeable filter providing a path for a sterat to enter the chamber from outsIde the container and for maintaining aseptic conditions inside the chamber after sterilization: a nonwreusablelock for securing the tray and toe lid together, the no reusable lok S comprising an upper lock element forming a portion of the lid, and a lower lock element forming a portion of the tray, he lower and upper lock elements ixedly engaging ito a non reusable lock when the lid is mated to the tray to seal the container: and a frangibe release in communication with the noneusable lock for irreversibly detaching the non-reusable lock from only one of the tray or the lid such that the non-rusab e .0 lock remains joined to the other upon separation of the tray and lid to access the chamber after sterilization, herein (a) the lo lock element is incorporated in the rin of the tray (b) the upper lock element is incorporated in a peripheral portion of the lid that surrounds the central portion of he lid and includes the lip ) the frangible release is a tangible region defined in the lid which separates the peripheral portion of the lid from the central portion of the lid, and 25 (d) the central portion of the lid further comprises a means for removal of the central portion by activation of the fIrangIbe region, whereby the peripheral portion of the id and the rim of the tray fixedly engage into a non-reusable lock when the lid is mated to the tray to seal the container and whereby acivation of the frangible region irreversibly detaches the central portion of the id while the non-reusable lock remains joined to the tray, 3 000 637760 According to another embodiment of the invention, there is provided a non-reusable, locking container for sterilzing and storing surgical materials and presenting surgical material n a sterilizedcndition, the container comprising: a tray conising a base a plurality of sides each having a proxmal portion in S communication with the base and a distal portion away from the base, and a rim defined by the distal portions of the sides, the rim comprising a lower pordon of a barrier; a lid composing a central portion and a lip, the hp comprising an upper portion of a barrier, wherein the lid and the tray together define a chamber for containing surgical material and wherein thelip and the rim together form a harrier to inhibit the passage of microorganisms C into the chamber between a tray and lid soured together; a permeable fiter providing a path for a sterilant to enterhe chamber from outside the container and for maintaining aseptic conditions inside the chamber after sterilization a nonreusable lock lbr securing the tray and the lid together, the non-reusable lock comprising an upper lock element forming a portion of the id and a lower lock element s forming a portion of the tray, the lower and upper lock elements fixedly engaging into a non reusable lock when the lid is mated to the tray to seal the container; and a frangble release in communication with the nonreusable lock for irreversibly detaching the non-reusable lock from only one of the tray or the lid such that the nonreusable lock remains joined to the other upon separation of the tray and id to access the chamber after o sterilization herein (a) the lower lok cement is incorporated in the distal portions of the sides of the tray and includes the rim of the tray, (b) the Upper lock element is incorporated in a peripheral portion of the ild that surrounds the central portion of the lid and includes thelip. (c) the frangible release is a frangible region defined in the distal portions of the sides of the tray and which separates the rim of the tray from proximal portions of the sides of the tray, and (d) 25 the distal portions of the sides of the tray further comprises a means for removal of the lid and the rim ofthe tray by acivation of the frangible region, whereby the rim of the tray and the peripheral portion of the lid fixedly engage into a non-reusable lock when the ld is meed to the tray to seal the container and whereby activadon of the frangibe region ireversibly detaches the rim from the tray while the non-reusable lock remains joined to the lid 4 100063760 Herein described is a non-reusable locking container for sterilizing and storing surgical materials and aseptically opening and aseptically presenting surgical materals in a sterilized condition. The non-reusable, locking sterilization container includes a combination of elements that limit the container to only a single sterilization cycle or single use Generally speaking, the 5 non-reusable, locking sterilization container includes a tray a lid, a permeable fiter a non reusable ock and a frangibie release, The tray includes a base, a plurality oxides each having a proximal portion in communication with the base and a distal portion away from the base, and a rim defined by the distal portions of the sides The rim forms or includes a lower portion of a barrier. The lid includes a central portion and a lip, the lip forms or includes an upper portion ofa barrier. When the li and the tray are secured together, they define a chamber for containing Surgical materials. When the lip and the rim are propedy secured together, they forn a barrier to inhibit the passage of microorganisms into the chamber between the tray and lid. The barrier may define a tortuous path from the outsde of the container to the chamber to inhibit the 5 passage of micoorganisms. Ahematively and/or additional the barier may provide a seal between the tray and the lid to inhibit the passage of microorganisms. This seal may be provided various sealing materials or mechanismssuch as, for example a gasket, pliable material and/or heat sensitive material, According to an embodiment described herein the lid may further include a plurality of .0 sides having a proximal portion in communication with the centralone and a distal portion away from the central zone, I such embodinents, the lip may be defined by the distal portions of the sides. in other words, instead of the ld being relatively fiat or planar, the ld may have a more three-dimensional configuration such that it has a length, width and a height, h some embodimentse the d may have a greater height (e, greater three-dinensionality) than the tray. 25 The permeable filer provides a path for a sterilant to enter the chamber from outside the contaier. he permeable finer also maintains aseptic conditions inside the chamber after sterllation by allowing gases such as air to enter or exit the chamber withoutailow passage of microorganisms. The permeable fiter is desirable located in the central portion of the lid and is located in communication with one or more openings and/or passages between the outside of the 30 container and the chamber. However, the permeable filterand the openings) and/or passages) 5 1000637760 in communication with the filter may be located in other portions of the lid or even the tray. The permeable filter may be a conventional filter material used for sterilization container applications. It should be inexpensive enough to be discarded or recycled with the tray and the lid after a single use.xemplary filter materials include, for example, nonwoven filter materials such as polyolefn mentlown materials and nonwoven laminate materials such as laminates of spunbond materials and men biown materials. The nonreusablelock is used to secure the tray and the lid together.As described herein the non-reusable lock includes an upper lock element forming a portion of the lid, and a lower lock element forming a portion of the tray. When the lid is mated to the tray to seal the 0 container, the lower and upper lock elements fixedly engage into a non-reusable lock TIhat is, the upper and lower lock elements cannot be ready disengaged without damaging or destroying the ck ador portions o the try or lid. In some embodiments, the lower lock element may be formed substantially or completely out of a portion of the tray and the upper lock element may be formed substantially or completely out of a portion of the l. S While a Angle non-eusable lock may be used, it may be desirable to employ multiple non-reusable locks at various locations in securing the lid and the tray together in some embodiments, the non-reusable lock includes upper and lower lock elements that mechanically interlock to fixedly engage into a non-reusable lock to secure the lid and the tray together. The upper and power lock elements may interlock as a tab and slot fitting such that it becomes 0 fixedly engaged. In some embodiments descrbed herein the onreusable lock includes lock elements that employ a material which is heat activated during steam sterilization (eg.steam sterilization) to fiXedly engage into a non-reusable lock to sectcure the lid and the tray together Such heat activated material may be a shape changeable element an adhesive or combinations thereof. It 25 is contemplated that the non-reusable lock may employ combinations of mechanically interlocking elements and heat activated elements. For example, a container may employ one or more different types of mechanically interlocking upper and lower lock elements (eg, a tab and slot type lock and a bayonet type lock) such that it utilizes different mechanical types of fixedly engaged nonreusable locks. Alternatively and/or additionally, the same container could employ 30 one or more different types of heat activated upper and lower lock elements such that it utilizes 6 1000637760 different heat activated types of fixedly engaged non-reusale locks. Moreoverthe same container could employ upper and lower lock elements that combine mechanicalyintedocking features and heat activated features that i utilizes different hybrid (e.g., combined mechanical and heat activated) types of fixedly engaged non-reusabl locks, 5 According to an aspect described herein, the heat activated, shape changeable material or adhesive may be in the form of polyolefins, block copolymers. resins, waxes and combinations thereof Desirably, these materials wil have a meking point of less than 134 degrees centigrade. The frangible release is an element that is general more readily and easily broken or 0 fractured than the other components ofthe non-reusable lock, the tray or the lid Generally speaking, frangible release miscommunication with the non-reusable lock and pon activation is used to irreversibly detach the non-reusable lock from only one of the tray or the lid such that the non-reusable lock remains joined to the other upon separation of the tray and lid to access the chamber aner sterilization. That is, if the non-reusable lock is irreversibly detached from the 5 tray utilizing the frangible release, the noneusabl lock remains joined to the lid. Alternatively, if the non-reusable lock is irreversibly detached from the lid utilizing the frangible releaSe, the non-eusabe loek remainsjoined to the tray The fungible relase may be activated by travel or movement of the non-reusable lock away fom the tray or ld. The franible relase may be a frangible region that is defined in or otherwise in communicatin with an upper lock element 0 and/or a lower lock element and may be a phrality of nangibe elements or features such as, for exanpk from scores, perforatons, embossments seams or combinations thereof, in an embodiment described herein, the sterilization container may be configured such that; (a) the lower lock element is incorporated in the rim ofithe tray. (b) the upper lock element is incorporated in a peripheral portion of the lid that surrounds the centralportion ofthe 25 lid and includes the lip, (c) the frangbl release is a frangibe region defined in the lid which separates the peripherl pordon of the lid fomihe central portion ofthe lid ,and (dythe central portion of the Id further includes a means for removing of the central portion by activation of thfranbee regon. In such n embent, thepriheral portion of thelid and therim ofthe tray fixedly engage into a no-eual lc hen the lid is mated to the tray to seal the 7 000637763 container and activaon of the frangible region irreversibly detaches the central portion of the lid while the non-reusable loc emainsjoined to the tray. in yet another embodiment described herein, the steiliation container may be configured such that (a) the lower lock element is incorporated in the distal portions of the sides 5 of the tray and includes the rim of t tray, (b) the upper lock element is incorporated in a peripheral portion of the lid that surrounds the central portion of the lid and includes the lip of the lid (c) he frangible release is a frangible region defIned in the distal portions of the sides of the tray and which separates the rim of the tray from proximal portions of the sides of the tray and (d) the distal portions of the sides of the tray further includes a means foi removal of the lid 0 and the rim of the tray by activadon of the frangible region, in such an embodiment, the Am of the tray and the peripheral portion ofthe lid fixedly engage into a non-eusable lock when the lid is mated to the tray to seal the container and activation of the frangible region irreversibly detaches the rim from the tray while the non-reusable lock remains joined to the lid. Generally speaking, in these embodiment the frangible region that is defined in or S otherwise in communication with the respective portions of the lid or the tray may include a pluaty of frangile elements or features such as, for example, from scores 1 perforations, embossments. seams or combinations thereof The means for removal ofthe central portion of the id in one of the embodiments or the rim ofthe tray and the lid on another of the embodiments may be; for eamniple, a hook, handle, a tab, a pull, or grip, a inger slot or the lke O and combinations thereof The container may further include sterilzation wrap attached to the peripheral portion of the lid and positioned in communication with a bottom side of the lid so that the sterilization wrap remains attached to the peripheral portion of the lid during irreversible detachment of the central portion of the lid and is presented for unfolding after the central portion ofthe lid is 25 removed General speaking. the container may desirably be formed of or include sections containing, a substantially transparent material adapted to withstand exposure to steamethylene oxide, or other forms of steriation without degradation of the tray. 'This allows the contents of the container to be at leas partially visible after sterilization of the container and prior to 30 removal of thelid. Desirably, the container may be made of a recyclable material such as, for 7A 100063760 example, a thermoplastic polymeric material. Exemplary materials include, but are not limited to, polypropylene, polyethylene polyester and olefinic copolymers and the like The material used to fbrm the sterlization container may result in a sterilization container tha is substantahy rigid or may have pordons of the container that are substantially rigid while other portions are less than substantially rigid or are more flexible. The present description also encompasses a system or method for sterlizing surgical materials. The system includes: (a) providing the nnreusablelocking steriliation container as general described above: (b) placing sugical materials Aside the non-reusableocking sterilization container and mang the ld and the tray so the upper and lower lock elements fixedly engage into a non-reusable ock thereby securing the lid and the tray together to seal the sterilization container; (c) inserting the sterilzation container into a sterilization chamber for a length of time sufficient to sterile the surgical materials and then removing the sterilization container from the sterilization chamber; and (J) activating the frangible release in communication with the non-reusablelock to ireversibly detach the non-reusabl lock from only one of the trayor the lid such that the nonreusable lock mains joined to the other upon separation of the tray and ld to access the chamber after sterization. The system may further include providing instructions and/or indicia regarding accessing te sterlized items by a tin the frangible release in communication with the nonreusabe lock ieversibly detaCh the nonreusable lock from Only One of the tray or the Ild such that the non-reusable lock remains joined to the other upon separation of the tray and lid to access the chamber after sterilization The system may also include storing the sterilization container after removal from the sterilization chamber and inspecting the non-reusable lock prior to activating the frangible release. 78 WO 2010/073197 PCT/IB2009/055829 BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is an illustration showing a cross-sectional view of an exemplary non reusable, locking sterilization container. FIG. 2 is an illustration showing a cross-sectional view of an exemplary non reusable, locking sterilization container. FIG. 3 is an illustration showing a perspective view of an exemplary non-reusable, locking sterilization container in which the lid and the tray are separated. FIG. 4 is an illustration showing a perspective view of an exemplary non-reusable, locking sterilization container in which the lid and the tray are secured together. FIG. 5 is an illustration of a detail of an exemplary lower lock element of a non reusable, locking sterilization container. FIG. 6 is an illustration of a detail of an exemplary upper lock element of a non reusable, locking sterilization container. FIG. 7 is an illustration of an exemplary upper lock element and an exemplary lower lock element in alignment prior to engagement. FIG. 8 is an illustration of an exemplary upper lock element and an exemplary lower lock element engaged to form a portion of an exemplary non-reusable lock. FIG. 9 is an illustration of a detail of an exemplary upper lock element and an exemplary lower lock element after engagement. FIG. 10 is an illustration showing a cross-section of an exemplary upper lock element and an exemplary lower lock element engaged to form a portion of an exemplary non-reusable lock. FIG. 11 is an illustration showing an exemplary frangible release associated with an exemplary lower lock element. FIG. 12 is an illustration showing an exemplary hinge associated with an exemplary upper lock element. FIG. 13 is an illustration showing a side view of an exemplary upper lock element and an exemplary lower lock element engaged to form a non-reusable lock. FIG. 14 is an illustration showing a side view of an exemplary non-reusable lock in which an exemplary frangible release is irreversibly detached. 8 WO 2010/073197 PCT/IB2009/055829 FIG. 15 is an illustration showing a perspective view of a non-reusable lock on one corner of an exemplary container after the frangible release has been activated. FIG. 16 is an illustration showing a perspective view of another configuration of an exemplary lower lock element and an exemplary upper lock element. FIG. 17 is an illustration showing a perspective view of another configuration of an exemplary lower lock element and an exemplary upper lock element joined to form a non reusable lock. FIG. 18 is an illustration showing a perspective view of a non-reusable lock on an exemplary container after the frangible release has been activated. FIG. 19 is an illustration showing a cross-sectional view of an exemplary container in which exemplary lower lock elements also include a heat-activated shape changeable element. FIG. 20 is an illustration showing a cross-sectional view of an exemplary container showing a detail of the respective upper and lower lock elements. FIG. 21 is an illustration showing a cross-sectional view of an exemplary container in which successful heat activation of shape changeable elements. FIG. 22 is an illustration showing a cross-sectional view of the irreversible detachment of a frangible release. FIG. 23 is an illustration showing a cross-sectional view of a detail of an exemplary lower lock element and an exemplary upper lock element. FIG. 24 is an illustration showing a cross-sectional view of another detail of an exemplary lower lock element and an exemplary upper lock element. FIG. 25 is an illustration showing a cross-sectional view of another detail of an exemplary lower lock element and an exemplary upper lock element that have been engaged to form a non-reusable lock. FIG. 26 is an illustration showing a cross-sectional view of another exemplary upper lock element and exemplary lower lock element having structural features that are designed to interlock. 9 WO 2010/073197 PCT/IB2009/055829 FIGS. 27A, B and C are illustrations of certain details of exemplary upper and lower lock elements that combine mechanically interlocking features and heat activated features. FIGS. 28A, B and C are illustrations of certain details of exemplary upper and lower lock elements in which the mechanically interlocking features and heat activated features engage the upper and lower lock elements into a non-reusable lock. FIG. 29 is a perspective view of an exemplary single use sterilization container which includes a filter in communication with the central portion of the lid. FIG. 30 is an illustration of exemplary single use sterilization containers after use. FIG. 31 is a perspective view of an exemplary single use sterilization container which includes a sterilization wrap attached to the peripheral portion of the lid. DETAILED DESCRIPTION The present invention provides a non-reusable, locking container for sterilizing and touringg surgical materials and aseptically opening and aseptically presenting surgical materials in a sterilized condition. These sterilization containers impart an increased -onfidence in sterility among clinicians. The invention will be described with reference to the following description and Figures which illustrate certain embodiments. It will be apparent to those skilled in the art [hat these embodiments do not represent the full scope of the invention which is broadly applicable in the form of variations and equivalents as may be embraced by the claims appended hereto. Furthermore, features described or illustrated as part of one embodiment may be used with another embodiment to yield still a further embodiment. It is intended that the scope of the claims extend to all such variations and embodiments. Referring now to FIG. 1, there is illustrated in cross-sectional view an exemplary non-reusable, locking sterilization container 10 that includes a combination of elements that limit the container 10 to only a single sterilization cycle or single use. Generally speaking, the non-reusable, locking sterilization container 10 includes a tray 12, a lid 14, a permeable filter 16, a non-reusable lock 18 and a frangible release which is not shown in FIG. 1 but is illustrated in greater detail in FIGS. 5, 11, 13 and 14. 10 WO 2010/073197 PCT/IB2009/055829 The tray 12 includes a base 22, a plurality of sides 24 each having a proximal portion 26 in communication with the base 22 and a distal portion 28 away from the base, and a rim 30 defined by the distal portions 28 of the sides. The rim 30 forms or includes a lower portion 32 of a barrier 34. The lid 14 includes a central portion 36 and a lip 38, the lip forms or includes an upper portion 40 of a barrier 34. When the lid 12 and the tray 14 are secured together, they define a chamber 42 for containing surgical materials. When the lip 38 and the rim 30 are properly secured together, they form a barrier 34 to inhibit the passage of microorganisms into the chamber 42 between the tray 12 and lid 14. The barrier 34 may desirably define a tortuous path from the outside of the container to the chamber to inhibit the passage of microorganisms as generally illustrated in FIG. 1 and FIG. 2. Alternatively and/or additionally the barrier may provide a seal between the tray and the lid to inhibit the passage of microorganisms. This seal may be provided various sealing materials or mechanisms such as, for example, a gasket, pliable material and/or heat sensitive material that is adapted to melt, deform or otherwise change shape to block to the passage of microorganisms between the tray and the lid in to the chamber. According to an embodiment of the invention, the lid 14 may further include a plurality of sides 60 having a proximal portion 62 in communication with the central portion 36 and a distal portion 64 away from the central portion 36 (which may also be referred to as a central zone 36). In such embodiments, the lip 38 may be defined by the distal portions 64 of the sides 60. In other words, instead of the lid 14 being relatively flat or planar as illustrated in FIG. 1, the lid 14 may have a more three-dimensional configuration such that it has a length, width and a height as illustrated in FIGS. 2 and 3. In some embodiments, the lid 14 may have a greater height (i.e., greater three dimensionality) than the tray 12. For example, FIG. 2 shows this feature in a cross sectional view of an exemplary non-reusable, locking sterilization container and FIG. 3 shows this feature in a perspective view of an exemplary non-reusable, locking sterilization container. That is, the lid has a greater height dimension than the tray. The permeable filter 16 provides a path for a sterilant to enter the chamber 42 from outside the container 10. The permeable filter 16 also maintains aseptic conditions inside 11 WO 2010/073197 PCT/IB2009/055829 the chamber 42 after sterilization by allowing gases such as air to enter or exit the chamber without allow passage of microorganisms. The permeable filter 16 is desirably located in the central portion 36 of the lid 14 and is located in communication with one or more openings and/or passages 70 between the outside of the container 10 and the chamber 42 . However, the permeable filter 16 and the opening(s) and/or passage(s) 70 in communication with the filter may be located in other portions of the lid 14 or even the tray 12. The permeable filter may be a conventional filter material used for sterilization container applications. It should be inexpensive enough to be discarded or recycled with the tray and the lid after a single use. Exemplary filter materials include, for example, nonwoven filter materials such as polyolefin meltblown materials and nonwoven laminate materials such as laminates of spunbond materials and meltblown materials. A non-reusable lock 18 is used to secure the tray 12 and the lid 14 together. According to the invention, the non-reusable lock includes an upper lock element 100 that may form a portion of the lid 14, and a lower lock element 102 that may form a portion of the tray 12. When the lid 14 is mated to the tray 12 to seal the container, the lower and upper lock elements (100 and 102, respectively) fixedly engage into a non-reusable lock 18. That is, the upper and lower lock elements (100 and 102, respectively) engage in a manner that cannot be readily disengaged without damaging or destroying the lock and/or portions of the tray or lid rendering the lock "non-reusable". In some embodiments of the invention, the lower lock element 102 may be formed substantially or completely out of a portion of the tray 12 and the upper lock element 100 may be formed substantially or completely out of a portion of the lid 14 as illustrated in FIG. 3. While a single non-reusable lock 18 may be used, it may be desirable to employ multiple non-reusable locks at various locations in securing the lid 14 and the tray 12 together as illustrated at, for example, FIG. 4 in which non-reusable locks 18 are present at the corners of the container 10. In some embodiments of the invention, the non-reusable lock includes upper and lower lock elements (100 and 102, respectively) that mechanically interlock to fixedly engage into a non-reusable lock to secure the lid and the tray together. The upper and lower lock elements may interlock as a tab and slot fitting such that it becomes fixedly engaged. For example, FIG. 5 illustrates a side view generally showing a 12 WO 2010/073197 PCT/IB2009/055829 lower lock element 102 which is formed into the side corner of a tray 12. Generally speaking, this lower lock element 102 is in the form of an extension 104 of the side of the tray 14 having a slot 106 defined by a rib or projection 110 of the extension 104. Referring to FIG. 6, there is shown in side view an upper lock element 100 in the form of a tab or bayonet extension 108 having a catch 112 that is adapted to fit into and engage the slot 106 of the lower lock element 102. An example of an embodiment of how the upper lock element 100 and lower lock element 102 may engage is illustrated in FIGS. 7 and 8. Referring to FIG. 7, an upper lock element 100 and a lower lock element 102 are aligned by bringing the lid 14 and the tray 12 together. As the lid 14 and the tray 12 are mated, the catch 112 at the end of the tab or bayonet 108 of the upper lock element 102 is introduced into the slot 106 defined by a rib or projection 110 of the extension 104 of the lower lock element 102 so that the catch 112 is engaged by the slot 106 as illustrated in FIG. 8 to form a non-reusable lock 18. FIG. 10 provides a different cross-section illustration showing the upper lock element 100 and the lower lock element 102 engaged to form a non-reusable lock. The catch 112 and/or a portion of the rib or projection 110 defining the slot 106 are configured flex or deform to allow engagement and so that the components cannot be reversed without destroying either the rib or projection 110 defining slot 106 and/or the catch 112 as illustrated in FIG. 9. Because the engagement of the upper lock element 100 and the lower lock element 102 is configured so it cannot be non-destructively disengaged by reversing the force used to engage the elements or simply pulling the lid from the tray, the contain utilizes a frangible release 200 which is an element associated with the non reusable lock 18 that is generally more readily and easily broken or fractured than the other components of the non-reusable lock 18, the tray 12 or the lid 14. Generally speaking, frangible release 200 is in communication with the non-reusable lock 18 and, upon activation, is used to irreversibly detach the non-reusable lock 18 from only one of the tray 12 or the lid 14 such that the non-reusable lock 18 remains joined to the other upon separation of the tray 12 and lid 14 to access the chamber 42 after sterilization. That is, if the non-reusable lock 18 is irreversibly detached from the tray 12 utilizing a frangible release 200, the non-reusable lock 18 remains joined to the lid 14. Alternatively, if the 13 WO 2010/073197 PCT/IB2009/055829 non-reusable lock 18 is irreversibly detached from the lid 14 utilizing a frangible release 200, the non-reusable lock 18 remains joined to the tray 12. In an aspect of the present invention, the frangible release 200 may be activated by travel or movement of the non reusable lock away from the tray or lid. Alternatively and/or additionally, the frangible release may be activated by twisting of the non-reusable lock. The frangible release 200 may be a frangible region that is defined in or otherwise in communication with an upper lock element and/or a lower lock element and may be a plurality of frangible elements or features such as, for example, from scores, perforations, embossments, seams or combinations thereof. Referring now to FIG. 11, a lower lock element 102 has a frangible release 200 associated with it at the location where the lower lock element 102 is connected with the tray 12. The frangible release 200 may be a series of perforations, a score line or may be a feature such as a region of thinness in the material of the lower lock element 102 at the location where it is connected with the tray 12. The corresponding upper lock element 100 is illustrated in FIG. 12 and has portion such as, for example, a living hinge 202 in the form of a thin, flexible region that allows the upper lock element 100 to bend or rotate without breaking or separating like the frangible release 200. The living hinge 202 need only be configured to bend or rotate once without breaking since the non-reusable lock is used only once. FIG. 13 is a side view illustration showing an exemplary upper lock element 100 and lower lock element 102 mated or engaged to form a non-reusable lock 18. FIG. 14 is a side view illustration showing an exemplary upper lock element 100 and lower lock element 102 mated or engaged to form a non-reusable lock 18 and in which the frangible release 200 is irreversibly broken, separated or detached at the location where the lower lock element 102 is connected with the tray 12 and the living hinge 202 associated with the upper lock element 100 has sufficient flexibility to bend and maintain attachment to the lid 14. FIG. 15 is an illustration showing a non-reusable lock 18 on one corner of the container 10 after the frangible release 200 has been activated to irreversibly detach the non-reusable lock 18 from the tray 12 while the non-reusable lock 18 remains attached to the lid 14. 14 WO 2010/073197 PCT/IB2009/055829 In an aspect of the present invention, the sterilization container 10 may be configured such that: (a) the lower lock element 102 is incorporated in the rim of the tray 12, (b) the upper lock element 100 is incorporated in a peripheral portion of the lid 14 that surrounds the central portion of the lid and includes the lip, (c) the frangible release 200 is a frangible region 204 defined in the lid which separates the peripheral portion of the lid from the central portion of the lid, and (d) the central portion of the lid further includes a means for removing 206 of the central portion by activation of the frangible region as generally shown in FIG. 16. In such an embodiment, the peripheral portion of the lid and the rim of the tray fixedly engage into a non-reusable lock when the lid is mated to the tray to seal the container as shown in FIG. 17. Activation of the frangible region irreversibly detaches the central portion of the lid while the non-reusable lock remains joined to the tray as shown in FIG. 18. According to the invention, the sterilization container may be configured such that: (a) the lower lock element is incorporated in the distal portions of the sides of the tray and includes the rim of the tray, (b) the upper lock element is incorporated in a peripheral portion of the lid that surrounds the central portion of the lid and includes the lip of the lid, (c) the frangible release is a frangible region defined in the distal portions of the sides of the tray and which separates the rim of the tray from proximal portions of the sides of the tray, and (d) the distal portions of the sides of the tray further includes a means for removal of the lid and the rim of the tray by activation of the frangible region. In such an embodiment, the rim of the tray and the peripheral portion of the lid fixedly engage into a non-reusable lock when the lid is mated to the tray to seal the container and activation of the frangible region irreversibly detaches the rim from the tray while the non-reusable lock remains joined to the lid. Generally speaking, in these embodiments, the frangible region that is defined in or otherwise in communication with the respective portions of the lid or the tray may include a plurality of frangible elements or features such as, for example, from scores, perforations, embossments, seams or combinations thereof. The means for removal of the central portion of the lid in one of the embodiments or the rim of the tray and the lid on 15 WO 2010/073197 PCT/IB2009/055829 another of the embodiments may be, for example, a hook, handle, a tab, a pull, or grip, a finger slot or the like and combinations thereof. In an aspect of the present invention, the container may further include sterilization wrap attached to the peripheral portion of the lid and positioned in communication with a bottom side of the lid so that the sterilization wrap remains attached to the peripheral portion of the lid during irreversible detachment of the central portion of the lid and is presented for unfolding after the central portion of the lid is removed. Generally speaking, the container may desirably be formed of, or include sections containing, a substantially transparent material adapted to withstand exposure to steam, ethylene oxide, or other forms of sterilization without degradation of the tray. This allows the contents of the container to be at least partially visible after sterilization of the container and prior to removal of the lid. Desirably, the container may be made of a recyclable material such as, for example, a thermoplastic polymeric material. Exemplary materials include, but are not limited to, polypropylene, polyethylene, polyesters, certain thermoplastic polyurethanes, olefinic copolymers and the like. In another aspect of the invention, the material used to form the sterilization container may result in a sterilization container that is substantially rigid or may have portions of the container that are substantially rigid while other portions are less than substantially rigid or are more flexible. While portions of the container may be flexible, it is necessary that the container have sufficient rigidity that at least one container may be stacked on top of another container during storage at normal storage room temperatures which may range from about 60'F to about 85'F. Desirably, the container may have sufficient rigidity that at least one container may be stacked on top of another container during heat sterilization conditions at temperatures greater than about degrees 273'F (134'C). In some embodiments of the invention, the non-reusable lock 18 includes lock elements that employ a material which is heat activated during sterilization (e.g., steam sterilization) to fixedly engage into a non-reusable lock to secure the lid and the tray together. Such heat activated material may be a shape changeable element, an adhesive, or combinations thereof. According to the invention, the heat of steam sterilization provides the energy source necessary to melt, soften, deform or to induce deformation of the shape 16 WO 2010/073197 PCT/IB2009/055829 of at least one element involved in engaging lock components together. Examples of deformation that may be used to engage lock components together include, but are not limited to, melting, plastic flow, shrinkage, warping, expansion, twisting, kinking, and melding. Accordingly, a shape changeable element is an element that melts, softens, or otherwise deforms under the the heat of sterilization, and more desirably, the level of heat provided by steam sterilization so that the element flows, shrinks, sags, warps, expands twists, kinks, melds or bonds to engage lock components together. Suitable shape changeable elements for inclusion in lock components that engage are made from thermoplastic materials, specifically those with Ball & Ring Softening Points (i.e., Ball & Ring Melt Points) as determined in accordance with ASTM E28 in a range from about 135'F (59'C) to about 300'F (149'C). For example, the materials may have Ball & Ring Softening Points (i.e., Ball & Ring Melt Points) as determined in accordance with ASTM E28 between about 266'F (130'C) and about 300'F (149'C). As another example, the materials may have Ball & Ring Softening Points (i.e., Ball & Ring Melt Points) as determined in accordance with ASTM E28 at or below 273'F (134'C). The Ball and Ring Softening Point is a method of determining the softening point of thermoplastics. Generally speaking, a specimen is cast or molded inside a ring of metal with an inside diameter of about 16 mm and dimension of about 2.4 mm thick by about 6.4 mm deep. This ring is placed above a metal plate in a fluid heating bath (~1 gm/cc liquid bath), and a 9.5 mm diameter steel ball weighing 3.5 grams is placed in the center of the specimen. The softening point is considered to be the temperature of the fluid when the ball penetrates the specimen and touches the lower plate. The test can be automated and may be conducted with equipment such as a Ring And Ball Automatic Softening Point Tester available from Mastrad Ltd of Douglas, United Kingdom (Catalog Number 10036000 Automatic Ring & Ball Tester Model D36-EN1427) or a Petrotest@ RK5A Softening Point Tester available from Petrotest@ Instruments GmbH & Co. KC of Dahlewitz, Germany - generally in accordance with ASTM D36 or ASTM E28. Generally speaking, such materials are solids that resist force-induced deformation at room and ambient storage temperatures. As they approach their Ball & Ring Softening Points, these materials dimensionally deform in response to applied forces. The 17 WO 2010/073197 PCT/IB2009/055829 requirement that suitable thermoplastic materials for use as shape changeable elements have Ball & Ring Softening Points at or below 273F (134'C) ensures that heat, time, and other environmental conditions typical of steam sterilization will provide the necessary missing amounts of energy to induce transformation of the shape changeable elements in the lock components from their pre-sterilization shape to another shape that promotes engagement of contacting lock components. After sufficient heat dissipation at the conclusion of the sterilizing step, the transformed shape changeable element solidifies into a final shape. According to an aspect of the invention, the heat activated, shape changeable material or adhesive may be in the form of polyolefins, block copolymers, resins, waxes and combinations thereof. Desirably, these materials will have a melting point below 273F (134'C). One category of thermoplastic materials suitable for use as the shape changeable elements are hot melt adhesives. Examples of specific hot melt adhesives that comply with the Ball & Ring Softening Point criteria, can form acceptable pre-sterilization shape changeable elements, and can transform during steam sterilization into desirable final shapes are thermoplastic hot melt adhesives 3796; 3792; 3789; 3764; 3762; 3750; 3747; 3738; 3794; 3798LM; 3792LM; 3776LM; 3762LM; 3755LM; 3750LM; 611 1HT; and 6116 available from 3M Company of St. Paul, Minnesota. It is contemplated that these materials may have an associated color or other additive that aids in quick determination of appropriate heat activation and lock component engagement. It is contemplated that the non-reusable lock 18 may employ combinations of mechanically interlocking elements and heat activated elements. For example, a container may employ one or more different types of mechanically interlocking upper and lower lock elements (e.g., a tab and slot type lock) such that it utilizes different mechanical types of fixedly engaged non-reusable locks. Alternatively and/or additionally, the same container could employ one or more different types of heat activated upper and lower lock elements such that it utilizes different heat activated types of fixedly engaged non-reusable locks. Moreover, the same container could employ upper and lower lock elements that combine mechanically interlocking features and heat activated features that it utilizes 18 WO 2010/073197 PCT/IB2009/055829 different hybrid (e.g., combined mechanical and heat activated) types of fixedly engaged non-reusable locks. Referring now to FIGS. 19-2 1, the non-reusable lock may include lock elements that employ a material which is heat activated during sterilization to fixedly engage into a non-reusable lock to secure the lid and the tray together. More particularly, FIGS. 19-21 are illustrations showing a cross-sectional view of container 10 with a lid 14 and its respective upper lock elements 100 and a tray 12 with its respective lower lock elements 102 and their relative positioning before closing, before heat activation of the lock components and during opening. FIGS. 19-21 illustrate an example in which a shape changeable element 300 that is heat activated such that it deforms and changes shape is configured to directly engage the lock elements 100 and 102 together and provide visual and tactile cues regarding the engagement of the non-reusable lock. FIG. 19 shows an initial cross-sectional illustration of a container 10 with a lid 14 and its respective upper lock elements 100 and a tray 12 with its respective lower lock elements 102 and which also has a shape changeable element 300 attached to the lower lock elements 102. The upper lock elements 100 are part of the lid 14 and are on a periphery 302 of the lid 14 and may be in the form of apertures 304 defined by the material of the periphery 302 of the lid. The lid and tray and respective lock elements are positioned to align the respective lock elements for subsequent contact with each other. Features such as, for example, the barrier 34 formed by portions of the lip of the lid and rim of the tray are not illustrated. FIG. 20 shows the lid 14 closed on the tray 12 with their respective lock elements 100 and 102 in contact with each other but without successful engagement of the lock elements. Portions of the periphery 302 of the lid 14 deflect due to contact of the respective lock elements 100 and 102. The deflection establishes a visual and tactile cue that engagement of the lock elements has not occurred. This deflection illustrates that the force of the upper lock element 100 against the lower lock element 102 as well as the force of gravity are insufficient to accomplish successful engagement of the upper and lower lock elements. 19 WO 2010/073197 PCT/IB2009/055829 FIG. 21 shows the results of successful heat activation of one or more shape changeable elements 300 such that it deforms and changes shape to directly engage the lock elements 100 and 102 together and provide visual and tactile cues regarding the engagement of the non-reusable lock. Heat applied over time from the sterilization cycle adds to the forces generated by the deflection of the upper lock element 100 to engage the upper lock element with the lower lock element 102. In contrast with the corresponding positions of FIG. 20, the one or more shape changeable elements 300 of the lower lock elements 102 have deformed in and through the apertures of the upper lock elements 100. The final shape of the shape changeable elements 300 is visible in the apertures 304 and, by filling the apertures 304, is tactilely apparent. The previous deflections of the peripheral portions 302 of the lid 14 have abated; these changes contribute additional visual and tactile cues indicating that the upper lock elements 100 and the lower lock elements 102 are engaged to form a non-reusable lock 18. With dissipation of the heat and setting or hardening of the shape changeable elements 300, a final shape is achieved, effectively joining the lid 14 and the base 12 to form a container 10. Depending on the type of materials selected for the shape changeable element 300, the engagement may be mechanical/ structural in nature, the engagement may be primarily adhesive in nature, or the engagement may have both aspects present. FIG. 22 is an illustration showing the irreversible detachment of a frangible release 200 located at the interface between the lower lock element 102 and the tray 12. The failure occurs as the result of an application of forces to open the container 10. Irreversible detachment of the frangible release 200 also provides an additional tactile cue concerning engagement of the upper lock element 100 and the lower lock element 102 into a non reusable lock 18. In contrast to FIG. 19, irreversible detachment of the frangible release 200 results in the non-reusable lock 18 being clearly attached to the lid 14 by way of the upper lock element 100 through the living hinge 202 the engaged lock components thus creating a distinctly different lid and base set. That is, the lid 14 with its respective upper lock elements 100 and the tray 12 with its respective lower lock elements 102 that are brought together as shown in FIG. 19 to form the container 10 prior to heat activation are different from the lid 14 with the attached non-reusable lock 18 containing the upper lock 20 WO 2010/073197 PCT/IB2009/055829 elements 100, the lower lock elements 102 and the shape changeable element 300 that is separated from the tray 12 which no longer has the lower lock elements 102 that were irreversibly detached at the frangible release 200. FIGS. 23-25 represent cross-sectional illustrations of a specific detail of a combination of upper lock elements 100 and lower lock elements 102 having a different configuration than those illustrated in FIGS. 19-22. The tray 12 and lid 14 (not shown) each have respective lower lock elements 102 and upper lock elements 100. Each lower lock element 102 defines a lower cavity 306 in which walls 308 define an aperture 310 and each upper lock element 100 defines an upper cavity 312 in which walls 314 define an aperture 316. The aperture 310 of the lower cavity 306 and the aperture 316 of the upper cavity 312 align and are in communication when positioned against each other. FIG. 23 shows a small detail of the lower lock element 102 and upper lock element 100 aligned for subsequent contact such that the aperture 310 of the lower cavity 306 and the aperture 316 of the upper cavity 312 align. In this configuration; the upper lock element 100 holds the shape changeable element 300 so that it visibly and tactilely protrudes from the upper lock element. FIG. 24 shows the lower lock element 102 and upper lock element 100 aligned such that the aperture 310 of the lower cavity 306 and the aperture 316 of the upper cavity 312 are in communication. In this configuration, gravity becomes a significant factor in carrying out successful engagement of the upper and lower lock elements as the shape changeable element 300 is configured to melt and flow. Referring now to FIG. 25, there is shown a cross-sectional illustration of the lower lock element 102 and upper lock element 100 that have been engaged to form a non reusable lock 18. After a sufficient amount of heat is provided to make the shape changeable element 300 fluid-like, the shape changeable element 300 deforms downwards into the upper cavity 312 and through the aligned apertures 316 and 310 into the lower cavity 306. After heat is dissipated and the shape changeable element 300 is hardened into a new shape defined by the walls of the cavities 306 and 312 and the apertures 310 and 316, the respective upper and lower lock components 100 and 102 are engaged into a non reusable lock 18. Depending on the type of materials selected for the shape changeable element 300, the engagement may be mechanical/ structural in nature, the engagement 21 WO 2010/073197 PCT/IB2009/055829 may be primarily adhesive in nature, or the engagement may have both aspects present. The recess of the final shape contrasts with its initial position and provides visual and tactile cues that engagement has occurred and that any contents within the container should be sterile because the sterilization conditions were required to change the shape of the shape changeable element 300. Other embodiments are contemplated in which the lock components of lids and trays may be engaged successfully regardless of the container orientation with respect to gravity. For example, FIG. 26 is an illustration of one such configuration. In this configuration, the upper lock element 100 and the lower lock element 102 have structural features that are designed to interlock and utilize a shape changeable element 300 having relatively strong adhesive qualities. The upper lock element 100 has a peripheral lip portion 400 that is flexible. The lower lock element which connects to the tray 12 by way of a frangible release 200 includes a channel feature 402 that partially obscures a shape changeable element 300. The frangible release 200 of the lower lock component 102 is less flexible than the living hinge 202 of the upper lock component. FIG. 26 shows the lid and tray and respective components properly aligned for subsequent contact of the lock components. Generally speaking, when the lid and tray are positioned so that their lock elements contact with each other, the peripheral lip portion 400 of the upper lock element 100 deflects in response to the channel feature 402 and the shape changeable element 300 of the lower lock element 102. As heat is applied during the sterilization cycle, heat-induced deformation of the shape changeable element 300 and the spatial change in the peripheral lip portion 400 allows the upper lock element 100 to seat within the channel feature 402 of the lower lock element. This seating of the peripheral lip portion 400 within the channel feature 402 of the lower lock element provides a visual cue about the engagement state. Once the heat from the sterilization cycle dissipates, the shape changeable element 300 achieves its final shape and its adhesive qualities ensure that the seated position of the peripheral lip portion 400 within the channel feature 402 is maintained at opening forces that cause the frangible release 200 to allow the lower lock element 102 to irreversibly detach from the tray 12. 22 WO 2010/073197 PCT/IB2009/055829 In an aspect of the present invention, the shape changeable element 300 may be subject to an applied mechanical force such as, for example, a compressive force such as a spring under tension, a metal band or other element that provides resistance to compression. When heat sterilization conditions provide sufficient heat for the shape changeable element 300 to deform, the applied mechanical force (e.g., compressive force) may displace the shape changeable element 300 so that the upper lock element and the lower lock element are engaged to form a non-reusable lock. Desirably, the transformation of the shape changeable element into a final shape after the heat of steam sterilization and the compressive forces have dissipated results in a configuration in which the final shape protrudes into voids, cavities or other structures of each upper and lower lock element forming the physical engagement of the lock elements and also providing visual and tactile cues that lock engagement and steam sterilization conditions have occurred. It is also contemplated that the design of the upper and lower lock elements and the shape changeable elements can be configured so that engagement of the lock elements takes place without obvious dimensional changes. Without a visually obvious difference in its final shape, an additional element, a color change element is desirably included in at least one lock element and is visible from an external vantage point. For example, the upper lock element may include a color change element that is visible externally upon activation and which also forms part of the structure of the lock element, shown as the cover material, which partially encloses this lock component's shape changeable element. This arrangement may involve engagement via cohesive and adhesive forces. An equally feasible alternative to this arrangement is to rely on engagement only through adhesive forces that are generated by or increased through steam sterilization conditions. For example, the lower lock element may lack a shape changeable element but a shape changeable element may be integrated in the upper lock element. Engagement is achieved by adhesion between the surface of the lower lock element and the shape changeable element integrated in the upper lock element. Alternatively and/or additionally, a shape changeable element may be integrated in both the upper and lower lock elements and engagement is achieved by adhesion between the shape changeable elements integrated in both the upper lock element and the lower lock element. 23 WO 2010/073197 PCT/IB2009/055829 Referring now to FIGS. 27A-C, there is illustrated certain details of upper and lower lock elements that combine mechanically interlocking features and heat activated features (i.e., combined mechanical and heat activated features) that permit the upper and lower lock elements to fixedly engage into a non-reusable lock. FIG. 27A illustrates a perspective view of an upper lock element 100 in the form of a tab or bayonet extension 108 having a catch 112 that is fitted into and reversibly engaged with the slot 106 defined by the shape changeable element in the form of a rib or projection 110 of the lower lock element 102 prior to heat activation of that rib or projection 110. An example of an embodiment of how the upper lock element 100 and lower lock element 102 are engaged prior to heat activation is illustrated in FIGS. 27B and 27C. FIG. 27B is an illustration showing a perspective view of a portion of an upper lock element and a lower lock element that were brought together so the catch 112 at the end of the tab or bayonet 108 of the upper lock element is introduced into the slot 106 defined by a shape changeable rib or projection 110 of the lower lock element so that the catch 112 is engaged by the slot 106. FIG. 27C is an illustration showing a perspective view of a detail of how the upper and lower lock elements may be disengaged prior to heat activation of the shape changeable rib or projection 110. In FIG. 27C, it can be seen that the slot 106 defined by the shape changeable rib or projection 110 is sufficiently large to allow flexing of the tab or bayonet 108 so that the catch 112 can be brought behind the shape changeable rib or projection 110 prior to heat activation so that the combination of the upper lock element 100 and the lower lock element 102 do not yet form a non-reusable lock. FIGS. 28A-C provides certain details of upper and lower lock elements in which the mechanically interlocking features and heat activated features (i.e., combined mechanical and heat activated features) fixedly engage the upper and lower lock elements into a non reusable lock. FIG. 28A illustrates a perspective view of an upper lock element 100 in the form of a tab or bayonet extension 108 having a catch 112 that is fitted into and fixedly engaged with the narrowed slot defined by the shape changeable rib or projection 110 of the lower lock element 102 after heat activation. That is, the shape changeable rib or projection 110 is deformed, curled, sagged or otherwise altered by heat activation so it 24 WO 2010/073197 PCT/IB2009/055829 narrows the dimensions of the slot 106 such that the clearance between the catch 112 and the rib or projection 110 is insufficient for the upper lock element 100 to be released from the lower lock element 102 without destroying the two components. Further detail of how the upper lock element 100 and lower lock element 102 are engaged after heat activation is illustrated in FIGS. 28B and 28C. FIG. 28B is an illustration showing a perspective view of a portion of an upper lock element and a lower lock element after heat activation. As can be seen, the shape changeable rib or projection 110 has been altered by heat activation such that the catch 112 at the end of the tab or bayonet 108 of the upper lock element is fixedly engaged in the slot 106 defined by shape changeable rib or projection 110. FIG. 28C is an illustration showing a perspective view of the elements after heat activation of the rib or projections 10. In FIG. 28C, the tab or bayonet 108 has been flexed but the deformation of the shape changeable rib or projection 110 resulting from heat activation is large enough that the catch 112 cannot be brought behind the rib or projection 110. As a result, the combination of the upper lock element 100 and the lower lock element 102 are fixedly engaged to form a non-reusable lock. Of course, other configurations are contemplated. For example, the tab or bayonet 108 may be a shape changeable tab or bayonet which is heat activated so it deforms in a manner that fixedly engages the upper lock element and the lower lock element into a non reusable lock. As another example, the tab or bayonet 108 and rib the or projections 10may each be a shape changeable element that is heat activated so they deform together in a manner that fixedly engages the upper lock element and the lower lock element into a non reusable lock. The present invention also encompasses a system or method for sterilizing surgical materials. The system includes: (a) providing the non-reusable, locking sterilization container as generally described above; (b) placing surgical materials inside the non reusable, locking sterilization container and mating the lid and the tray so the upper and lower lock elements fixedly engage into a non-reusable lock thereby securing the lid and the tray together to seal the sterilization container; (c) inserting the sterilization container into a sterilization chamber for a length of time sufficient to sterilize the surgical materials 25 WO 2010/073197 PCT/IB2009/055829 and then removing the sterilization container from the sterilization chamber; and (d) activating the frangible release in communication with the non-reusable lock to irreversibly detach the non-reusable lock from only one of the tray or the lid such that the non-reusable lock remains joined to the other upon separation of the tray and lid to access the chamber after sterilization. According to the invention, the system may further include providing instructions and/or indicia regarding accessing the sterilized items by activating the frangible release in communication with the non-reusable lock to irreversibly detach the non-reusable lock from only one of the tray or the lid such that the non-reusable lock remains joined to the other upon separation of the tray and lid to access the chamber after sterilization. The system may also include storing the sterilization container after removal from the sterilization chamber and inspecting the non-reusable lock prior to activating the frangible release. Turning to FIG. 29, a single use sterilization container is provided. The sterilization -ontainer includes a tray 510 and a lid 520. The tray may be made of a rigid material that Ls substantially transparent. That is, the tray may be made of a material that allows a viewer of the tray to visualize the contents of the tray by utilizing normal human visual icuity without opening the tray. Further, the rigid material of tray should allow the tray to withstand the temperature required for sterilization of the tray without degradation of the tray. That is, the tray (and the lid) should be able to withstand sterilization temperatures of from about 135'F (59'C) for some gas or plasma sterilization processes to about 300'F '149'C) for certain steam sterilization processes without melting, bending, or losing strength . For example, the materials used for the tray and the lid should be able to withstand steam sterilization temperatures ranging from about 266'F (130 C) to about 300'F (149'C) without melting, bending, or losing strength. As another example, the materials used for the tray and the lid should be able to withstand steam sterilization temperatures of about 273'F (134C) without melting, bending, or losing strength. Suitable materials for use in the tray include, but are not limited to, various plastics including polyethylenes and polypropylenes. 26 WO 2010/073197 PCT/IB2009/055829 The tray may be a variety of shapes and sizes including, but not limited to, circular, longn, trapezoidal, triangular, rectangular, and square. Additionally, the tray includes a >ase 530 a rim 540 and may comprises a plurality of sides 520. Regardless of the shape, size, or number of sides, the tray should be adapted to receive a lid 560 in communication with it. Like the tray, the lid may also be composed of i rigid material that may or may not be transparent, such as, for example, various plastics including polypropylene and polyethylene. Regardless of the type of material that makes up the lid, the lid should include a top side 570, bottom side 580, central portion 600 and peripheral portion 590. In practice, medical instruments for use during a sterilization procedure are placed inside the tray 510. typical gas sterilization procedures include, for example, gas plasma sterilization, steam sterilization, ethylene oxide sterilization, hydrogen peroxide sterilization, and ozone sterilization. Once the instruments are placed with the tray, the lid is then snapped onto the tray irior to entering a sterilization chamber. Desirably the lid will include one or more locking mechanisms that allow the peripheral portion of the lid to fixedly engage the rim of the tray. That is, the peripheral portion locks together with the tray and cannot be removed without sufficient force necessary to destroy either a portion of the locking mechanism, the rim, the lid, or combinations thereof so that the tray cannot be easily reconditioned repaired >r reused. Turning to FIG. 31, suitable locking mechanisms include, but are not limited to projections that extend from the peripheral portion of the lid and that fixedly engage the rim of the tray. These projections include, but are not limited to, cantilevered projections 510. Returning to FIG. 29, the central portion of the lid may also include at least one >pening 620 therein and filter 630 which is at least in partial communication with the at least one opening, either on the bottom side or top side of the lid. The opening(s) and filter llow the sterilant to pass through the outside of the sterilization container into the inside of the sterilization container where the medical instruments may be contacted with the sterilant during the sterilization process. 27 WO 2010/073197 PCT/IB2009/055829 Turning to FIG. 31, as an alternative to a filter, a sterilization wrap 640 may be in :ommunication with the bottom side of the lid and attached to the peripheral portion of the id. Similar to a filter, the sterilization wrap and opening(s) allow the sterilant to pass through the outside of the sterilization container into the inside of the sterilization container where the medical instruments may be contacted with the sterilant during the sterilization process. Virtually any gas permeable material may be used in conjunction with or as alternative to a filter or sterilization wrap, provided that the material is permeable to a sterilizing gas but impermeable to airborne microbes, bacteria, viruses and mixtures thereof. Suitable gas permeable materials useable in the present invention include, for -xample, medical grade paper, nonwoven materials and other similar gas permeable materials. Generally, gas permeable materials which may be used in the present invention are permeable to water vapor and have a minimum water vapor transmission rate (WVTR) Af about 300 g/m 2 /24 hours, calculated in accordance with ASTM Standard E96-80. Suitable medical grade paper includes, for example, AMCOR PLP reinforced coated paper available from AMCOR, Limited. Suitable nonwoven materials useable as the gas permeable material of the sterilization container of the present invention include, for example, air laid nonwoven webs, spunbond nonwoven webs, meltblown nonwoven webs, bonded-carded-webs, aydroentangled nonwoven webs, spunlace webs and the like. The method of manufacturing -ach of these materials is known in the art. Laminates of these materials may also be used. Of these nonwoven materials, the fibrous material web may comprise a nonwoven meltblown web. Meltblown fibers are formed by extruding a molten thermoplastic material through a plurality of fine, usually circular, die capillaries as molten fibers into converging igh velocity gas (e.g. air) streams that attenuate the fibers of molten thermoplastic material to reduce their diameter, which may be to microfiber diameter. Thereafter, the meltblown fibers are carried by the high velocity gas stream and are deposited on a collecting surface to form a web of randomly disbursed meltblown fibers. Such a process is disclosed, for example, in U.S. Pat. No. 3,849,241 to Butin, et al. Generally speaking, meltblown fibers may be microfibers that may be continuous or discontinuous, and are 28 WO 2010/073197 PCT/IB2009/055829 generally smaller than 10 microns in diameter, and are generally tacky when deposited onto i collecting surface. The nonwoven material web may be a nonwoven spunbond web. Spunbonded Fibers are small diameter substantially continuous fibers that are formed by extruding a molten thermoplastic material from a plurality of fine, usually circular, capillaries of a ;pinnerette with the diameter of the extruded fibers then being rapidly reduced as by, for -xample, eductive drawing and/or other well-known spunbonding mechanisms. The production of spun-bonded nonwoven webs is described and illustrated, for example, in U.S. Pat. No. 4,340,563 to Appel, et al., U.S. Pat. No. 3,692,618 to Dorschner, et al., U.S. Pat. No. 3,802,817 to Matsuki et al., U.S. Pat. No. 3,338,992 to Kinney, U.S. Pat. No. 3,341,394 to Kinney, U.S. Pat. No. 3,502,763 to Hartman, U.S. Pat. No. 3,502,538 to Levy, U.S. Pat. No. 3,542,615 to Dobo, et al., and U.S. Pat. No. 5,382,400 to Pike, et al. Spunbond fibers are generally not tacky when they are deposited onto a collecting surface. Spunbond fibers can sometimes have diameters less than about 40 microns, and are often >etween about 5 to about 20 microns. The nonwoven material web may also comprise a laminate material such as a ;punbond/meltblown/spunbond, or SMS, material. A typical SMS material is described in U.S. Pat. No. 4,041,203 to Brock et al. Other SMS products and processes are described, for example, in U.S. Pat. No. 5,464,688 to Timmons et al.; U.S. Pat. No. 5,169,706 to Collier et al.; and U.S. Pat. No. 4,766,029 to Brock et al. Generally, an SMS material will :onsist of a meltblown web sandwiched between two exterior spunbond webs. Such SMS laminates are available commercially from Kimberly-Clark Corporation under marks such is Kimguard@. The spunbonded layers on the SMS laminates provide durability and the internal meltblown layer provides porosity. As discussed above, once the sterilization containers of the present invention :ontaining the items to be sterilized are placed within the sterilization chamber, the ;terilization chamber is closed and a gas sterilant is introduced into the container. The amount of time the items in the compartment are subjected to the gas sterilant depends on various factors, including the type of gas sterilant used, the number of medical instruments laced in the sterilization container as well as other factors. Those skilled in the art will be 29 WO 2010/073197 PCT/IB2009/055829 able to determine the appropriate amount of time the gas sterilant should remain in the :hamber based on these and other factors. Once sterilized, the sterilization containers are removed from the chamber and the sterilization container with the sterilized items contained therein are stored or placed for ase. Turning to FIG. 30, after use, the medical instruments are cleaned and the sterilization :ontainers may be stacked and disposed of or recycled. Returning to FIGS. 29 and 31, advantageously, the central portion of the lid is defined by a frangible region having a plurality of frangible elements 650. These frangible -lements may include, but are not limited to scores, perforations, embossments, seams or :ombinations thereof as known in the art. These frangible elements create a weaker, less sturdy region within the lid of the container which is adapted to tear or rupture upon application of sufficient force. That is, the frangible region should rupture with the use of ordinaryy force applied to it by a medical or hospital worker. Additionally, the central portion may include a means for removal 660 of the :entral portion. The means for removal may be a hook, handle, tab, body parts, or the like. rhe frangible region may be activated by applying force or pressure to the frangible -lements by use of the means for removal. That is, the frangible region should rupture with the use of ordinary force applied to it by a medical or hospital worker, i.e. one hand applying force to the means for removal. Advantageously the force required for removal >f the central portion is concentrated near the means for removal. This lowers the force required for removal. After activation of the frangible region, the central portion of the lid is permanently removed. Thus, after sterilization, and upon removal of the central portion from the lid, the central portion cannot be rejoined with the lid to create a closed sterilization container, and the sterilization container cannot be reused. This is a safety feature designed to prevent the accidental use of non-sterile medical instruments. Of note, although the frangible region should be flexible enough to allow ease of removal of the central portion, it should be sturdy enough for sterilization containers to be stored, stacked, and/or handled without rupturing the frangible region. Additionally, the Filter 630 or sterilization wrap 640 should overlap the frangible region so that bacteria or 30 WO 2010/073197 PCT/IB2009/055829 other harmful material does not pass through the frangible elements into the inside of the sterilization container after a sterilization procedure has been completed. As shown in FIG. 31, in embodiments where a sterilization wrap is utilized the sterilization wrap is folded and attached to the peripheral portion of the lid. Upon removal >f the central portion of the lid, the sterilization wrap may be unfolded outward to cover the ion-sterile sides and edges of the sterilization container. This allows the clinician to safely nd confidently remove the medical instruments from the sterilization container without compromising the sterility of the instruments. In addition to the sterilization containers described above, the present invention compasses a method for sterilizing items for use in a medical procedure. This method includes providing a sterilization container having a tray having a plurality of sides, a base nd a rim. The tray may be formed of a substantially transparent material adapted to withstand exposure to steam and ethylene oxide sterilization without degradation of the tray. The sterilization container also includes a lid having a top side, a bottom side, a peripheral portion, and a central portion. The peripheral portion of the lid, which is adapted to fixedly engage the rim of the tray, includes a locking mechanism that engages the rim. The central portion of the lid includes at least one opening therein. The central optionn is further defined by a frangible region comprising a plurality of frangible elements nd includes a means for removal of the central portion by activation of the frangible region. The sterilization container also includes a filter positioned in communication with i side of the lid. The filter is gas permeable and is adapted for removal with the central optionn when access to medical instruments is desired. The method also includes placing medical instruments inside the sterilization container; inserting the sterilization container into a sterilization chamber for a length of time sufficient to sterilize the medical instruments; and removing the sterilization container from said sterilization chamber. The method may further include the step of providing instructions regarding accessing the ;terilized items by removing the central portion with the means for removal of the central portion by activation of the frangible region. 31

Claims (5)

  1. 7. The container of claim 6wherein the material that is heat activated during steam sterilization is selected fom a shape changeable element, an adhesive, or combinations thereof 20 8. The container of claim 7, wherein the shape changeable material or adhesive is selected fhom polyolefins, block copolymers, resins, waxes and combinations thereof 9, The container of claim 8 where the shape changeable material or adhesive has a melting point of less than 134 degrees Centigrade.
  2. 10. The container of any one of the preceding claims, where the frangibte release is 25 activated by travel or movement of the non-reusable 'ock away from the tray or lid. ,3 100037760
  3. 11. The container of any one of the preceding claims, wherein the fler is in the central portion of the id. 12 The container of any one of the preceding claims, wherein the frangible region comprises a plurality of frangible elements selected from scores, perforations, embossments seems or 5 combinations thereof.
  4. 13. The container of any one of the preceding claims, wherein the means for removalof the central portion is a hook, handle ar a tan.
  5. 14. The container ofany one of the preceding claims, further comprising sterilzation wrap attached to the peripheral portion of the lid and positioned in communication vith a bottom side 0 of the lid so that the sterilization wrap remains attached to the peripheral portion of the lid during irreversible detachment of the central portion of the lid and is presented for unfolding after the central portion of the lid is removed. 15 A nonAeusable, locking container for sterilizing and storing surgical materials and presenting surgical materias in a sterilized condition, the container comprising 5 a tray comprising a base, a plurality of sides each having a proximal portion in commuication with the base and a distal portion away from the base. and a rim defined by the distal portions of the sides, the rim comprising a lower portion of a barrier; a lid comprising a central portion, and a lp, the lip comprising an upper portion of a barrier wherein the id and the tay together define a chamber for containing surgical materials 20 and wherein the lip and the rim together form a barrier to inhibit the passage of microorganisms into the chamber between a tray and lid secured together; a permeable fiter providing a path for a steri plant to emer the chamber from outside the container and for maintaining aseptic conditions inside the chamber after sterilization; a non-reusable lock for securing the tray and the lid together, the non-eusable lock 25 comprising an upper lock element forming a portion of the lid, and a lower lock cement forming, a portion of the tray the lover and upper lock elements fiXedly engaging into a neusabl lock when thelid is mated to the tray to seal the container; and S4 1000637760 a frangible release in communication with the non-rusable lock for irreversibly detaching the noneusable lock from only one of the tray Or the lid such that the non-reusable lock remainS joined to the other upon separation of the tray and ld to access the chamber after sterilization; wherein: (a) the lower lock element is incorporated in the distal portions of the sides of the tray S and comprises the rim of the tray, (b) the upper lock element is incorporated in a peripheral portion of the lid that surrounds the central portion of the lid and comprises thelip, (c) the frangible release is a frangible region defined in he distal portions of the sideAS of the tray and which separates the rim of the tray Rom proximal portions of the sides of the tray, and (d) the distal portions of the sides of the tray further acomprisesameans for removal of the lid and the 0 rim of t ray by activation of the frangible region, whereby the rim of the tray and the peripheral portion of the lid fixedly engage into a non-reusable lock when the lid is mated to the tray to seal the container and Whereby activation of the frangible region irreversibly detaches the rim from the tray while the non-reusable lock remains joined to the lid 35
AU2009332549A 2008-12-24 2009-12-17 Single use sterilization container Ceased AU2009332549B2 (en)

Applications Claiming Priority (5)

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US12/317,657 2008-12-24
US12/317,657 US7942264B2 (en) 2008-12-24 2008-12-24 Sterilization container with peel top
US12/639,350 2009-12-16
US12/639,350 US8623289B2 (en) 2008-12-24 2009-12-16 Single use sterilization container
PCT/IB2009/055829 WO2010073197A2 (en) 2008-12-24 2009-12-17 Single use sterilization container

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Families Citing this family (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006512691A (en) 2002-10-22 2006-04-13 アイシス テクノロジーズ Non-peripheral processing control module with improved heat dissipation characteristics
AU2003284329A1 (en) 2002-10-22 2004-05-13 Isys Technologies Robust customizable computer processing system
KR101279726B1 (en) 2002-10-22 2013-06-27 제이슨 에이. 설리반 Systems and methods for providing a dynamically modular processing unit
BR112012006113A2 (en) * 2009-09-18 2016-06-07 Depuy Products Inc disposable orthopedic surgery kit and components
US10390867B2 (en) 2009-09-18 2019-08-27 Biomet C.V. Bone plate system and method
SE535456C2 (en) 2010-10-18 2012-08-14 Swedish Match North Europe Ab Child safe container
GB2475948B (en) * 2010-10-27 2012-02-08 Inov8 Medical Solutions Ltd Single-use storage device for an endoscope
GB2485818B (en) * 2010-11-25 2013-03-27 Medicart Int Ltd Container for medical accessory processing
US20120152289A1 (en) * 2010-12-21 2012-06-21 Tara Denise Smith Sterilization Container With Disposable Liner
US20140079589A1 (en) * 2011-05-26 2014-03-20 3M Innovative Properties Company Self-sealing filter for sterilization
US20150078961A1 (en) * 2011-08-19 2015-03-19 Noxilizer, Inc. Sterile barrier packaging system
TWI528892B (en) * 2012-03-07 2016-04-11 Plant culture box
US20140306586A1 (en) * 2013-01-07 2014-10-16 Jason A. Sullivan Systems and methods for providing modular packaging
US9427710B2 (en) 2013-03-15 2016-08-30 Bemis Company, Inc. Radial filtration vent and medical device packaging
WO2015076780A1 (en) * 2013-11-19 2015-05-28 Perfecseal, Inc A vented rigid gas sterilization packaging tray
US9724438B2 (en) 2014-01-29 2017-08-08 Turbett Surgical LLC Sterilizing method and apparatus
US10391435B2 (en) 2014-01-29 2019-08-27 Turbett Surgical LLC Sterilizing method and apparatus
US10881997B2 (en) 2014-01-29 2021-01-05 Turbett Surgical, Inc. Method of sterilization verification
US9616368B2 (en) 2014-01-29 2017-04-11 Turbett Surgical LLC Sterilizing method and apparatus
DK3174489T3 (en) 2014-07-31 2020-11-16 Turbett Surgical Inc METHOD AND DEVICE FOR LOADING
JP6796579B2 (en) * 2014-09-12 2020-12-09 マーサー テクノロジーズ リミテッド Sterilization container, sterilization method and sterilization equipment
JP6443739B2 (en) * 2014-12-11 2018-12-26 大日本印刷株式会社 Microbe culture sheet
AU2016346311B2 (en) * 2015-10-30 2020-12-03 O&M Halyard International Unlimited Company Sterilization packaging systems
GB2549083B (en) 2016-03-29 2020-12-09 Hpc Healthline Uk Ltd A disposable container for surgical instruments
US10874473B2 (en) * 2016-04-28 2020-12-29 Daikyo Seiko Ltd. Container
US20170348477A1 (en) * 2016-06-06 2017-12-07 Sharon Tomlinson Container for enclosing a medical device
US10987103B2 (en) * 2017-06-27 2021-04-27 Ethicon Llc Powered surgical instrument with latching feature preventing removal of battery pack
EP3831414B1 (en) * 2017-06-30 2023-03-29 O&M Halyard, Inc. Filter-gasket assembly with seal and placement indicator for sterilization rigid container
CN111479529B (en) * 2017-07-19 2024-07-09 特贝特手术公司 Sterilizing package system
JP7399936B2 (en) 2018-03-23 2023-12-18 ログ10 ベー.フェー. Method and system for reprocessing reusable medical devices
NL2020655B1 (en) * 2018-03-23 2019-10-02 Log10 B V A method and system for reprocessing reusable medical instruments
DE102018110662A1 (en) * 2018-05-03 2019-11-07 Aesculap Ag sterile containers
WO2020026118A1 (en) 2018-07-31 2020-02-06 O&M Halyard International Unlimited Company Seal integrity indicators for sterilization containers
CA3119237A1 (en) 2018-11-09 2020-05-14 O&M Halyard, Inc. Closure mechanisms and seal integrity indicators for sterilization containers
US10939975B2 (en) 2019-03-06 2021-03-09 O&M Halyard, Inc. Disposable gasket-filter assembly with seal integrity indication for sterilization container with slidable lock handles
WO2020198666A2 (en) * 2019-03-27 2020-10-01 Stryker Corporation Autoclavable container for sterilizing a wirelessly chargeable battery
IT201900025867A1 (en) * 2019-12-31 2021-07-01 Vetreria Di Borgonovo S P A SEALED FOOD CONTAINER WITH AUTOMATIC VALVE FOR DISCHARGING THE STEAM PRODUCED BY HEATING THE FOOD, IN PARTICULAR IN A MICROWAVE OVEN, AND RELATIVE AUTOMATIC STEAM DISCHARGE VALVE
US12296144B2 (en) 2020-08-27 2025-05-13 Covalon Technologies Ltd. Guard for adaptor in an intravenous line
EP4066863A1 (en) * 2021-03-30 2022-10-05 Sartorius Biohit Liquid Handling Oy A package, a method and use
US11738914B2 (en) 2021-11-18 2023-08-29 Yeti Coolers, Llc Container and latching system

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4022324A (en) * 1975-04-10 1977-05-10 Schuster Samuel J Sealed container for storing medical and/or bio-medical articles in sterile condition and having removable cover
US4915913A (en) * 1984-05-22 1990-04-10 Genesis Medical Corporation Medical sterilizer device with improved latch mechanism
WO1995020529A1 (en) * 1994-01-28 1995-08-03 Ab Cerbo A package with a reclosable lid
US6087548A (en) * 1996-02-15 2000-07-11 Levy; Alfred Method and assembly for sterilizing contaminated waste
JP2001286538A (en) * 2000-04-10 2001-10-16 Uni Charm Corp Medical sterile bag
US20050194387A1 (en) * 2004-03-08 2005-09-08 Banks Percival C. Protected seal for a filtered vent in a sterilization container

Family Cites Families (87)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2990948A (en) 1958-04-04 1961-07-04 Johnson & Johnson Sterile package
US3338992A (en) 1959-12-15 1967-08-29 Du Pont Process for forming non-woven filamentary structures from fiber-forming synthetic organic polymers
US3502763A (en) 1962-02-03 1970-03-24 Freudenberg Carl Kg Process of producing non-woven fabric fleece
US3502538A (en) 1964-08-17 1970-03-24 Du Pont Bonded nonwoven sheets with a defined distribution of bond strengths
US3341394A (en) 1966-12-21 1967-09-12 Du Pont Sheets of randomly distributed continuous filaments
US3542615A (en) 1967-06-16 1970-11-24 Monsanto Co Process for producing a nylon non-woven fabric
US3478868A (en) 1967-09-01 1969-11-18 Interstate Folding Box Co Sterilizable containers
US3849241A (en) 1968-12-23 1974-11-19 Exxon Research Engineering Co Non-woven mats by melt blowing
DE2048006B2 (en) 1969-10-01 1980-10-30 Asahi Kasei Kogyo K.K., Osaka (Japan) Method and device for producing a wide nonwoven web
DE1950669C3 (en) 1969-10-08 1982-05-13 Metallgesellschaft Ag, 6000 Frankfurt Process for the manufacture of nonwovens
US3806618A (en) * 1971-02-21 1974-04-23 Robalex Inc Method of heating a package of food
US3770119A (en) 1971-08-23 1973-11-06 Baxter Laboratories Inc Medical procedure tray
GB1453447A (en) 1972-09-06 1976-10-20 Kimberly Clark Co Nonwoven thermoplastic fabric
US3954174A (en) 1974-09-23 1976-05-04 Becton, Dickinson And Company Unitary two-compartment package for sterile surgical articles
US3946872A (en) 1974-09-27 1976-03-30 Alcan Aluminum Corporation Sealable and sterilizable package
US3946871A (en) 1974-09-27 1976-03-30 Alcan Aluminum Corporation Sealable and sterilizable package
US4042109A (en) 1976-01-21 1977-08-16 C. R. Bard, Inc. Medical procedure package
US4049121A (en) 1976-07-14 1977-09-20 Baxter Travenol Laboratories, Inc. Moisture detection system for a sterile package
US4124141A (en) 1977-07-11 1978-11-07 Armentrout James L Sterile container
US4340563A (en) 1980-05-05 1982-07-20 Kimberly-Clark Corporation Method for forming nonwoven webs
US4417658A (en) 1982-03-22 1983-11-29 Surgicot, Inc. Self-sealing sterilization bag
US4509196A (en) 1983-06-30 1985-04-02 Arvey Corporation Tamper-indicating self-sealing pouch
US4466552A (en) 1983-08-08 1984-08-21 American Hospital Supply Corporation Sterilization container formed of nonwoven material
US4553669A (en) 1983-09-15 1985-11-19 American Hospital Supply Corporation Sterilization container formed of nonwoven material
US4671943A (en) 1984-04-30 1987-06-09 Kimberly-Clark Corporation Sterilization and storage container
US4644586A (en) 1984-10-25 1987-02-17 Kimberly-Clark Corporation Combination sterilization and infectious waste disposal container
US4728504A (en) 1984-11-05 1988-03-01 Nichols Robert L Stackable medical instrument sterilizer container
US4783321A (en) 1984-12-18 1988-11-08 Instrumed, Inc. Sterlization container system
US4661326A (en) 1985-02-25 1987-04-28 Herbert Schainholz Sterilization container
DE3623568A1 (en) 1985-08-27 1987-03-12 Sengewald Karl H Gas sterilizable packaging
US4625885A (en) * 1986-03-20 1986-12-02 Nichols Robert L Controlled-release security band for sterilization container
US4660721A (en) 1986-04-07 1987-04-28 Cvp Systems, Inc. Sterilization package
US4706839A (en) 1986-10-31 1987-11-17 Instrumed, Inc. Closures and methods of closure for a sterilization container system
DE3637687A1 (en) * 1986-11-05 1988-05-19 Basf Ag CONTAINER FOR MEDICAL MATERIAL
US4766029A (en) 1987-01-23 1988-08-23 Kimberly-Clark Corporation Semi-permeable nonwoven laminate
FI873939A0 (en) 1987-09-11 1987-09-11 Ahlstroem Oy STERILIZERSFOERPACKNING FOER ENGAONGSBRUK.
US4903837A (en) 1988-08-16 1990-02-27 Kimberly-Clark Corporation Apparatus for dispensing and accounting absorbent surgical articles
US4919888A (en) 1988-09-06 1990-04-24 Instrumed, Inc. Seals and method of sealing for a sterilization container system
US4927073A (en) 1988-10-13 1990-05-22 Ruth Esposito Foldable and sterilizable compartmentalized organizer
US4858821A (en) 1988-11-14 1989-08-22 Baxter International Inc. Package and lid with controlled tearing means
US5169706A (en) 1990-01-10 1992-12-08 Kimberly-Clark Corporation Low stress relaxation composite elastic material
US5464688A (en) 1990-06-18 1995-11-07 Kimberly-Clark Corporation Nonwoven web laminates with improved barrier properties
US5069355A (en) 1991-01-23 1991-12-03 Sonoco Products Company Easy-opening composite closure for hermetic sealing of a packaging container by double seaming
US5227074A (en) 1991-03-04 1993-07-13 Monarch Products, Inc. Filter for medical instrument sterilization containers and method for removing moisture and contaminants therefrom
US5382400A (en) 1992-08-21 1995-01-17 Kimberly-Clark Corporation Nonwoven multicomponent polymeric fabric and method for making same
TW294632B (en) 1993-02-05 1997-01-01 Otsuka Pharma Factory Inc
US5342673A (en) 1993-02-23 1994-08-30 W. L. Gore & Associates, Inc. Sterilizable packaging material
US5392917A (en) 1993-08-03 1995-02-28 Ethicon, Inc. Easy open 1-2-3 instrumentation package
WO1995023617A1 (en) 1994-03-04 1995-09-08 Nordpunkt Ag Sterilization container
DE4428291A1 (en) 1994-08-10 1996-02-15 Borries Horst Von Packaging for items to be sterilized
US5595786A (en) 1995-06-07 1997-01-21 Contec, Inc. Of Spartanburg Method of preparing surface for receiving a coating and apparatus therefor
US5830547A (en) 1996-07-12 1998-11-03 Rexam Medical Packaging, Inc. Peel-open package
US5968459A (en) 1998-02-12 1999-10-19 Case Medical, Inc. Filtered flash sterilization apparatus
AUPP189798A0 (en) 1998-02-19 1998-03-12 Sheiman, Vladimir Method of disinfection and sterilisation and a device to realise the method
US6048503A (en) 1998-03-31 2000-04-11 Riley Medical, Inc. Sterilization container
US6312646B2 (en) 1998-08-17 2001-11-06 Enviromedical Systems, Inc. Sterilization of elongate lumens
US6162395A (en) 1998-08-17 2000-12-19 Enviromedical Systems, Inc. Sterilization of elongate lumens
US20030118491A1 (en) 1998-08-26 2003-06-26 Frieze Marcia A. Filtered gas plasma sterilization container with improved circulation
US6312645B1 (en) 1998-12-30 2001-11-06 Ethicon, Inc. Container with collapsible pouch for cleaning or sterilization
US6319481B1 (en) 2000-03-14 2001-11-20 Percival C. Banks Sterilization container
US6439625B1 (en) 2000-03-23 2002-08-27 Medin Corporation Tamper-proof seal and method for using same
US6880869B2 (en) * 2000-03-23 2005-04-19 Medin Corporation Tamper-proof seal and method for using same
JP3792484B2 (en) * 2000-05-30 2006-07-05 川本産業株式会社 Sterile packaging container
US6629602B1 (en) 2000-11-20 2003-10-07 Becton, Dickinson And Company Clear medical packaging
FR2816925B1 (en) 2000-11-20 2003-02-14 Becton Dickinson France PACKAGING FOR PRODUCTS TO BE STERILIZED USING A HIGH TEMPERATURE STERILIZING FLUID
FR2816926B1 (en) 2000-11-20 2003-02-14 Becton Dickinson France MULTIFUNCTIONAL PACKAGING, AND MORE PARTICULARLY PACKAGING INTENDED TO TRANSPORT STERILIZED OR PRODUCTS INTENDED TO BE STERILIZED
US20020098139A1 (en) 2001-01-22 2002-07-25 Beverly Sparks Resposable sterilization and transport unit
US6561352B2 (en) 2001-01-30 2003-05-13 Alan Sherman Sharps disposal
DE10156935B4 (en) 2001-11-15 2004-02-26 Aesculap Ag & Co. Kg A sterile container
US20050238530A1 (en) 2001-11-16 2005-10-27 Case Medical Inc. Rigid reusable sterilization container with thermostatic valve
US20030143136A1 (en) 2002-01-25 2003-07-31 Regan Timothy P. Instrument sterilization roll
US6889839B1 (en) 2002-05-07 2005-05-10 Perfecseal, Inc. Suspension package
US7114617B2 (en) 2002-07-02 2006-10-03 Csl Limited Container
US7300637B2 (en) 2002-09-30 2007-11-27 Ethicon, Inc. Sterilization container kit
US7946443B2 (en) 2003-04-03 2011-05-24 Stull Technologies, Inc. Removable and reusable container closure with vent
US7066329B2 (en) 2003-07-21 2006-06-27 Riley Medical, Inc. Medical instrument holding and presentation system
US20050268573A1 (en) 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
US7350688B2 (en) 2005-01-06 2008-04-01 Kraft Foods Holdings, Inc. Resealable food container
US7467710B2 (en) * 2005-05-04 2008-12-23 Ethicon, Inc. Molded package
EP1762503A1 (en) 2005-09-07 2007-03-14 Alcan Technology & Management Ltd. Sterilizable semi-rigid container with lid and label
US20070092398A1 (en) 2005-10-25 2007-04-26 Mcdonald Duane L Pouch for sterilization of medical products
US20070095699A1 (en) 2005-10-27 2007-05-03 Case Medical, Inc. Armoured sterilization case tray with internal wrap/filter
PL1962712T3 (en) 2005-12-06 2011-03-31 Fabio Sgarabottolo Disposable safety "patient kit" for medical devices
US7905353B2 (en) 2006-06-30 2011-03-15 Greatbatch Ltd. Stackable containment trays and cases with slide latches
US8241587B2 (en) 2008-12-24 2012-08-14 Kimberly-Clark Worldwide, Inc. Collapsible sterilization container
US7942264B2 (en) 2008-12-24 2011-05-17 Kimberly-Clark Worldwide, Inc. Sterilization container with peel top
US20100158751A1 (en) 2008-12-24 2010-06-24 Steven Scott Friderich Single use sterilization container

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4022324A (en) * 1975-04-10 1977-05-10 Schuster Samuel J Sealed container for storing medical and/or bio-medical articles in sterile condition and having removable cover
US4915913A (en) * 1984-05-22 1990-04-10 Genesis Medical Corporation Medical sterilizer device with improved latch mechanism
WO1995020529A1 (en) * 1994-01-28 1995-08-03 Ab Cerbo A package with a reclosable lid
US6087548A (en) * 1996-02-15 2000-07-11 Levy; Alfred Method and assembly for sterilizing contaminated waste
JP2001286538A (en) * 2000-04-10 2001-10-16 Uni Charm Corp Medical sterile bag
US20050194387A1 (en) * 2004-03-08 2005-09-08 Banks Percival C. Protected seal for a filtered vent in a sterilization container

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