MEDICAL DEVICE PACKAGING

• US 20120305426A1
• Filed: 06/02/2011
• Published: 12/06/2012
• Est. Priority Date: 06/02/2011
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Valaie, Arman H., Palmreuter, Matthew J.
• Granted Patent: US 8,365,910 B2
• Time in Patent Office: Days
• US Class Current: 206/363
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/182 Rigid packaging means
• CPC Class Codes: B65B 55/02 Sterilising, e.g. of complete packages
• CPC Class Codes: B65B 55/08 by irradiation
• CPC Class Codes: B65B 55/10 by liquids or gases
• CPC Class Codes: B65D 2251/0031 Membrane
• CPC Class Codes: B65D 2251/0093 Membrane
• CPC Class Codes: B65D 43/0202 without integral tamper element
• CPC Class Codes: B65D 51/185 the outer closure being a foil membrane
• CPC Class Codes: B65D 81/18 providing specific environment for contents, e.g. temperature above or below ambient with thermal insulation B65D81/38; ice-boxes with cooling means F25D

Abstract

A package for containing a medical device can have a bottom portion and inner and outer lids releasably sealed to the bottom portion. The bottom portion defines a cavity for receiving a medical device. A flange extends outward sidewalls of the bottom portion and includes an inner flange portion and an outer flange portion. The inner flange portion can be recessed below the outer flange portion. The sealed inner lid permits passage of sterilization. The outer lid provides a moisture-resistant barrier to the package. A corner portion of the outer lid can extend past a corner of the bottom portion. Upon application of a withdrawing force sufficient to break the seals, the inner lid and the outer lid are together capable of being peeled from the bottom portion.

Claims

1. A package for containing a medical device, comprising:

a bottom portion including sidewalls and a bottom wall to define a cavity to receive a medical device, a flange extending outward from top edges of the sidewalls, the flange comprising an inner flange portion and an outer flange portion;

an inner lid releasably sealed to the inner flange portion at a first sealed region, the inner lid comprising a sterilizable material that is permeable to a sterilizing gas to allow the medical device to be sterilized when the inner lid is sealed to the bottom portion, the inner lid and the bottom portion forming a microbial-resistant, sterile enclosure for the medical device; and

an outer lid overlying the inner lid and releasably sealed with an adhesive to at least the outer flange portion at a second sealed region, the outer lid having an environmental member comprising a moisture-resistant material, the outer lid configured to maintain a moisture content within the enclosure for the medical device at a desirable level,

wherein a corner portion of the outer lid extends past a corner of the flange of the bottom portion, wherein a channel is formed in the outer flange portion at the corner of the flange of the bottom portion, and a portion of the inner lid protrudes within the channel to form a first tab, wherein the corner portion of the outer lid overlies the first tab, and is sealably attached to the first tab, wherein upon application of a withdrawing force to the corner portion of the outer lid sufficient to break at least one of the first and second sealed regions, the inner lid and the outer lid are capable of being peeled together from the bottom portion.

2. The package of claim 1, wherein the outer lid comprises a metal foil.

3. The package of claim 1, wherein at least one of the inner lid and the outer lid comprises a heat-sealable adhesive coating.

4. The package of claim 1, wherein the outer lid comprises a multi-laminate structure, and the moisture-resistant material comprises a desiccant layer of the multi-laminate structure.

5. The package of claim 4, wherein the multi-laminate structure of the outer lid comprises a metal foil layer arranged to capture the desiccant layer between the inner lid and the metal foil layer.

6. The package of claim 1, wherein the inner flange portion is recessed below the outer flange portion.

7-8. -8. (canceled)

9. A package for containing a drug-coated medical device, comprising:

a bottom tray including sidewalls and a bottom wall to define a cavity to receive a drug-coated medical device, a flange extending outward from top edges of the sidewalls, the flange comprising an inner flange portion and an outer flange portion, the inner flange portion recessed below the outer flange portion;

an inner lid releasably sealed to the recessed inner flange portion at a first sealed region, the inner lid comprising a sterilizable material to allow the drug-coated medical device to be sterilized when the inner lid is sealed to the bottom tray, the inner lid and the bottom tray forming a microbial-resistant, sterile enclosure for the drug-coated medical device; and

an outer lid overlying the inner lid and releasably sealed to at least one of the outer flange portion and the inner lid at a second sealed region, the outer lid comprising an outermost layer and a desiccant layer positioned between the outermost layer and the inner lid, the outer lid configured to maintain a moisture content within the enclosure for the drug-coated medical device at a desirable level for extending a shelf-life of the drug-coated medical device;

wherein a corner portion of the outer lid extends past a corner of the flange of the bottom tray, wherein a channel is formed in the outer flange portion at the corner of the flange of the bottom tray, and a portion of the inner lid protrudes within the channel to form a first tab, wherein the corner portion of the outer lid overlies the first tab, and is sealably attached to the first tab, wherein upon application of a withdrawing force to the corner portion of the outer lid sufficient to break at least one of the first and second sealed regions, the inner lid and the outer lid are capable of being peeled together from the bottom tray.

10. The package of claim 9, wherein the outer lid comprises a metal foil layer, and the desiccant layer is positioned between the inner lid and the metal foil layer.

14. The package of claim 9, wherein the inner lid has a thickness substantially identical to a recessed distance of the inner flange portion, such that a top surface of the outer flange portion is substantially coplanar with an upper surface of the inner lid.

15. The package of claim 9, wherein the outer lid is releasably sealed to both of the outer flange portion and the inner lid at the second sealed region.

11. (canceled)

12. A package for containing a drug-coated medical device, comprising:

a bottom tray including sidewalls and a bottom wall to define a cavity to receive a drug-coated medical device, a flange extending outward from top edges of the sidewalls, the flange comprising an inner flange portion and an outer flange portion, the inner flange portion recessed below the outer flange portion;

an inner lid releasably sealed to the recessed inner flange portion at a first sealed region, the inner lid comprising a sterilizable material to allow the drug-coated medical device to be sterilized when the inner lid is sealed to the bottom portion, the inner lid and the bottom portion forming a microbial-resistant, sterile enclosure for the drug-coated medical device; and

an outer lid overlying the inner lid and releasably sealed to at least one of the outer flange portion and the inner lid at a second sealed region, the outer lid having an environmental member comprising a moisture-resistant material, the outer lid configured to maintain a moisture content within the enclosure for the drug-coated medical device at a desirable level for extending a shelf-life of the drug-coated medical device,

wherein the outer lid comprises a metal foil layer and the moisture-resistant material comprises a desiccant layer, the metal foil layer arranged to capture the desiccant layer between the inner lid and the metal foil layer,

wherein a corner portion of the outer lid extends past a corner of the flange of the bottom tray, wherein upon application of a withdrawing force to the corner portion of the outer lid, the inner lid and the outer lid together are capable of being peeled from the bottom tray,

wherein a channel is formed in the outer flange portion at the corner of the flange of the bottom tray, and a portion of the inner lid protrudes within the channel to form a first tab, wherein the corner portion of the outer lid overlies the first tab, and is sealably attached to the first tab.

13. (canceled)

16-21. -21. (canceled)