Microbial barrier vented package for sterile medical devices and method of packaging

• US 5,868,244 A
• Filed: 12/01/1997
• Issued: 02/09/1999
• Est. Priority Date: 12/01/1997
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Reinhardt, William, Routh, Shakti, Pohle, Michael, Ivanov, Konstantin
• Primary Examiner(s): FIDEI, DAVID
• Application Number:
  US08/982,055
• Time in Patent Office: 435 Days
• Field of Search: 206/63.3, 206/438, 206/439, 53/415, 53/425, 53/432, 53/433
• US Class Current: 206/63.3
• CPC Class Codes: A61B 17/06133 of parallelepipedal shape, e.g. made of rectangular or slightly oval panels
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61L 2202/181 Flexible packaging means, e.g. permeable membranes, paper
• CPC Class Codes: B65B 11/50 Enclosing articles, or quantities of material, by disposing contents between two sheets, e.g. pocketed sheets, and securing their opposed free margins apparatus or devices for forming pockets in or from sheets, blanks or webs B65B47/00

Abstract

A package for sterilized, absorbable medical devices is disclosed. The package has a plurality of cavities in communication with a vent, wherein the vent is preferably centrally located. After sterilization, the package is sealed adjacent to the vent thereby providing individual hermetically sealed sterile cavities which are cut away from the package to form unitary packages.

Claims

1. A foil outer package for medical device packages, comprising:

a first substantially planar member comprising a foil, said planar member having at least two cavities formed therein for receiving a medical device in each cavity, wherein said planar member has an outer periphery, an outer side and an inner side;

a second substantially flat planar member comprising a foil, said second planar member having an outer periphery, an outer side and an inner side, said second member also having at least one vent opening therein, each said opening having a periphery;

a gas permeable microbial barrier membrane mounted to the second planar member about the periphery of each vent opening;

wherein the first planar member is mounted to the second planar member such that the outer peripheries are substantially in alignment, the inner surface of the first planar member being bonded to the inner surface of the second planar member adjacent to the outer peripheries of the planar members to form a gas impermeable peripheral seal, and the inner surface of the first planar member being further bonded to the inner surface of the second inner surface about each cavity to form a gas impermeable side seal adjacent to each cavity, said side seals having a first end and a second end, wherein the first end of each seal intersects the peripheral seal and the second end extends at least partially between adjacent cavities, thereby forming a manifold such that each cavity is in communication with the vent opening.

2. The package of claim 1 wherein each cavity has a shape selected from the group consisting of rectangular, oval, circular, square, polygonal, and combinations thereof.

3. The package of claim 1 wherein each cavity contains a medical device.

4. The package of claim 3 wherein the medical device comprises a surgical suture and surgical needle mounted thereto.

5. The outer package of claim 1 wherein the interior of the package is sterile.

6. The package of claim 4 wherein the suture and needle are in a package.

7. The package of claim 4 wherein the suture comprises an absorbable polymer.

8. The package of claim 1 wherein the package has an additional seal adjacent to each cavity, said seals intersecting the second end of each side seal and the peripheral seal, thereby hermetically sealing off each cavity such the cavities are no longer in communication with the central vent and each cavity is gas impervious and hermetically sealed.

9. The package of claim 7 wherein the package is cut into hermetically sealed unitary packages, each unitary package comprising a cavity.

10. The package of claim 1 wherein the vent opening is centrally located.

11. The package of claim 1 wherein the microbial barrier member is mounted to the interior of the second planar member.

12. The package of claim 1 wherein the vent opening has a shape selected form the group consisting of rectangular, square, round oval, polygonal and combinations thereof.

13. The package of claim 1 further containing at least one alignment hole therethrough surrounded by a seal.

14. The package of claim 1 wherein the outer periphery of the second planar member extends beyond the outer periphery of the first planar member, thereby forming at least one flap.

15. The package of claim 8 wherein the package has been cut to comprise

at least two individual hermetically sealed packages, wherein each package comprises a cavity;

and,

scrap.

16. The package of claim 1 wherein the foil is selected from the group consisting of metal foil, and gas impermeable polymer film and combinations thereof.

17. The package of claim 16, wherein the foil comprises an inner heat seal coating.

19. The package of claim 15 wherein compartment has a shape selected from the group consisting of rectangular, oval, circular, square, polygonal, and combinations thereof.

20. The package of claim 15 wherein each compartment contains a medical device.

21. The package of claim 15 wherein the medical device comprises a surgical suture and surgical needle.

22. The outer package of claim 15 wherein the interior of the package is sterile.

23. The package of claim 21 wherein the surgical suture and needle are in a package.

24. The package of claim 21 wherein the suture comprises an absorbable polymer.

25. The package of claim 15 wherein the package has an additional seal adjacent to each compartment, said seals intersecting the second end of each side seal and the peripheral seal, thereby hermetically sealing off each compartment such the compartments are no longer in communication with the central vent through the manifold and each compartment is gas impervious and hermetically sealed.

26. The package of claim 25 wherein the package is cut into hermetically sealed unitary packages, each unitary package comprising a compartment.

27. The package of claim 15 wherein the vent opening is centrally located.

28. The package of claim 15 wherein the microbial barrier member is mounted to the interior of the second planar member.

29. The package of claim 15 wherein the vent opening has a shape selected form the group consisting of rectangular, square, round, oval, polygonal and combinations thereof.

30. The package of claim 15 further containing at least one alignment hole therethrough surrounded by a seal.

31. The package of claim 15 wherein the outer periphery of the second planar member extends beyond the outer periphery of the first planar member, thereby forming at least one flap.

32. The package of claim 25 wherein the package has been cut to comprise

at least two individual hermetically sealed packages, wherein each individual package comprises a compartment;

and,

scrap.

36. The package of claim 23 wherein the cavity has a shape selected form the group consisting of rectangular, oval, circular, square, polygonal, and combinations thereof.

37. The package of claim 23 wherein the cavity contains a medical device.

38. The package of claim 25 wherein the medical device comprises a surgical suture and surgical needle mounted thereto.

39. The outer package of claim 23 wherein the interior of the package is sterile.

40. The package of claim 26 wherein the suture and needle are in a package.

41. The package of claim 26 wherein the suture comprises an absorbable polymer.

42. The package of claim 23 wherein the package has an additional seal adjacent to the cavity, said seal intersecting the peripheral seal, thereby hermetically sealing off each cavity such the cavity is no longer in communication with the vent and the cavity is gas impervious.

43. The package of claim 29 wherein the package is cut away form the vent to form a hermetically sealed unitary package.

18. A foil outer package for medical device packages, comprising:

a first substantially planar member comprising a foil, wherein said planar member has an outer periphery, an outer side and an inner side;

a second substantially flat planar member comprising a foil, said second planar member having an outer periphery, an outer side and an inner side, said second member also having at least one vent opening therein, each said opening having a periphery;

a gas permeable membrane mounted to the second planar member about the periphery of each vent opening;

wherein the first planar member is mounted to the second planar member such that the outer peripheries are substantially in alignment, the inner surface of the first planar member being bonded to the inner surface of the second planar member adjacent to the outer peripheries of the planar members to form a gas impermeable peripheral seal, and the inner surface of the first planar member being further bonded to the inner surface of the second inner surface to form at least two compartments bounded by gas impermeable side seals adjacent to each compartment, said side seals having a first end and a second end, wherein the first end of each seal intersects the peripheral seal and the second end extends at least partially between adjacent compartments, thereby forming a manifold such that each compartment is in communication with the at least one vent opening.

33. The package of claim 18 wherein the foil is selected from the group consisting of metal foil, gas impermeable polymer film and combinations thereof.

34. The package of claim 18, wherein the foil comprises an inner heat seal coating.

35. A foil outer package for a medical device package, comprising:

a first substantially planar member comprising a foil, said planar member having a cavity formed therein for receiving a medical device, wherein said planar member has an outer periphery, an outer side and an inner side;

a second substantially flat planar member comprising a foil, said second planar member having an outer periphery, an outer side and an inner side, said second member also having an interior vent opening therein, each said opening having a periphery;

a gas permeable membrane mounted to the second planar member about the periphery of the vent opening;

wherein the first planar member is mounted to the second planar member such that the outer peripheries are substantially in alignment, the inner surface of the first planar member is bonded to the inner surface of the second planar member adjacent to the outer peripheries of the planar members to form a gas impermeable peripheral seal such that the cavity is in communication with the vent opening.

44. A method of packaging a medical device in an outer foil package, said method comprising:

providing a first substantially planar member, said member having an inner side, an outer side and an outer periphery;

forming a plurality of cavities in said first planar member, said cavities suitable for receiving a surgical suture package, said cavities formed on the inner side of the planar member;

inserting a medical device in each cavity;

providing a second substantially planar member having an outer periphery, an outer side and a top side;

cutting a hole having an outer periphery into the second planar member, said hole centrally located therein;

mounting a gas permeable member over the opening, and sealing the member about the periphery of the opening, thereby providing a central vent;

aligning the first and second planar members such that the outer peripheries are substantially in registration;

sealing the inner sides of the planar members to form an outer gas impervious outer seal, and sides seals adjacent to each cavity, such that each cavity has an opening in communication with the central vent;

sealing off the openings in each cavity such that the cavity is bounded by gas impervious seals thereby hermetically sealing each cavity; and

,

forming hermetically sealed unitary suture packages from the multicavity package by cutting the package adjacent to each cavity such that each unitary package comprises a cavity bounded by gas impervious seals.

45. A method of packaging a medical device in an outer foil package, said method comprising:

providing a first substantially planar member, said member having an inner side, an outer side and an outer periphery;

locating a plurality of compartments in said first planar member, said compartments suitable for receiving a surgical suture package

inserting a medical device in each compartment;

providing a second substantially planar member having an outer periphery, an outer side and a top side;

cutting a hole having an outer periphery into the second planar member, said hole centrally located therein;

mounting a gas permeable member over the opening, and sealing the member about the periphery of the opening, thereby providing a central vent;

aligning the first and second planar members such that the outer peripheries are substantially in registration;

sealing the inner sides of the planar members to form an outer gas impervious outer seal, and sides seals adjacent to each compartment, such that each compartment has an opening in communication with the central vent;

sealing off the openings in each compartment such that each compartment is bounded by gas impervious seals thereby hermetically sealing each compartment; and

,

forming hermetically sealed unitary suture packages from the multicompartment package by cutting the package adjacent to each compartment such that each unitary package comprises a compartment bounded by gas impervious seals.