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Title:
FILTER-GASKET ASSEMBLY WITH SEAL AND PLACEMENT INDICATOR FOR STERILIZATION RIGID CONTAINER
Document Type and Number:
WIPO Patent Application WO/2019/006079
Kind Code:
A4
Abstract:
Sterilization packaging systems with features for sealing a volume against an ingress of contaminants are provided. Such features include a sealing assembly including a gasket and a sheet of filter material. The sealing assembly seals a lid to a seal rim of a base. The gasket has an upper surface, outer edge, and inner edge. The upper surface of the gasket comprises a first row of alternating protrusions and indentations and a second row of alternating protrusions and indentations that define a channel therebetween. The sheet of filter material extends from an inner edge of the gasket. The gasket completely surrounds the sheet of filter material, wherein the indentations and channel facilitate delivery of a sterilization agent through the filter material. A sterilization assembly including a lid having a plurality of protrusions in its upper surface in conjunction with a gasket having a smooth upper surface is also provided.

Inventors:
SPENCER ANTHONY S (US)
POTNIS PRASAD S (US)
NASH CHRISTENA K (US)
WU KUN-CHI (US)
LIN BRIAN E (US)
CHANG SHARON S (US)
Application Number:
PCT/US2018/039930
Publication Date:
April 04, 2019
Filing Date:
June 28, 2018
Export Citation:
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Assignee:
O&M HALYARD INT UNLIMITED CO (IE)
International Classes:
A61L2/07; A61B50/00; A61L2/20; A61L2/26; B01D46/00; B01D46/10
Attorney, Agent or Firm:
RICHMOND, Allison, L. et al. (US)
Download PDF:
Claims:
AMENDED CLAIMS

received by the International Bureau on 15 February 2019 (15.02.2019)

WHAT IS CLAIMED IS:

1 . A sterilization packaging system having a volume for containing items to be sterilized, the sterilization packaging system comprising:

a lid having an upper surface defining a perimeter and a lip extending downward from the perimeter, wherein the lip includes a plurality of upper openings and a plurality of lower openings;

a base having a lower surface, a first sidewall, a second sidewall, a third sidewall, and a fourth side wall extending from the lower surface, wherein the first sidewall, the second sidewall, the third sidewall, and the fourth sidewall terminate at a seal rim defining a perimeter; and

a sealing assembly, wherein the sealing assembly seals the lid to the seal rim of the base, the sealing assembly comprising:

a gasket having an upper surface, an outer edge, and an inner edge, wherein the upper surface of the gasket comprises a first row of alternating protrusions and indentations and a second row of alternating protrusions and indentations that define a channel therebetween,

a sheet of filter material extending from an inner edge of the gasket, wherein the gasket completely surrounds and partially overlaps the sheet of filter material, wherein the indentations and channel facilitate the delivery of sterilization agent through the sheet of filter material when the sterilization packaging system is sealed with the sealing assembly.

2. The sterilization packaging system of claim 1 , wherein a visual indicator is present on the outer edge of the gasket.

3. The sterilization packaging system of claim 2, wherein the visual indicator is visible from the lower opening in the lip when the sterilization packaging system is adequately sealed by the sealing assembly.

4. The sterilization packaging system of claim 2 or 3, wherein the visual indicator protrudes from the lower opening in the lip when the sterilization packaging system is adequately sealed by the sealing assembly.

5. The sterilization packaging system of any one of the preceding claims, wherein the seal rim comprises an upper horizontal flange, wherein the upper surface of the gasket, the outer edge of the gasket, and the inner edge of the gasket define a recess for receiving the upper horizontal flange.

6. The sterilization packaging system of any one of the preceding claims, wherein the gasket comprises a first gasket material and a second gasket material.

7. The sterilization packaging system of claim 6, wherein the first gasket material is less compressible and more rigid than the second gasket material.

8. The sterilization packaging system of claim 6 or 7, wherein the inner edge of the gasket is defined by the first filter material.

9. The sterilization packaging system of any one of claims 6 to 8, wherein the first gasket material comprises a rigid polymer and the second gasket material comprises a foam.

10. The sterilization packaging system of any one of the preceding claims, wherein the sheet of filter material is corrugated.

1 1 . The sterilization packaging system of any one of the preceding claims, wherein the sheet of filter material extends in a longitudinal direction and a transverse direction, wherein one or more longitudinal support members is disposed on a surface of the sheet of filter material in the longitudinal direction and one or more transverse support members is disposed on the surface of the sheet of filter material in the transverse direction.

12. The sterilization packaging system of any one of the preceding claims, wherein the sealing assembly provides a continuous sealing interface between the lid and the base of the sterilization packaging system.

13. The sterilization packaging system of any one of the preceding claims, wherein the sealing assembly is disposable.

14. The sterilization packaging system of any one of the preceding claims, wherein the lid and the base are reusable.

15. The sterilization packaging system of any one of the preceding claims, wherein the gasket includes a pair of interior facing opposing tabs.

16. The sterilization packaging system of any one of the preceding claims, wherein the seal rim comprises an outer vertical flange and a lower horizontal flange, wherein an angle formed between the outer vertical flange and the lower horizontal flange ranges from 65° to 90°.

17. The sterilization packaging system of any one claims 1 to 15, wherein the seal rim comprises an outer vertical flange and a lower horizontal flange, wherein the outer vertical flange includes a curved section having an area of compression that forms a point of tangency with the gasket.