Clear package for bioabsorbable articles

• US 5,322,161 A
• Filed: 11/30/1992
• Issued: 06/21/1994
• Est. Priority Date: 11/30/1992
• Status: Expired due to Term

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Brown, David L., Shichman, Daniel, Malinowski, Stanley J.
• Primary Examiner(s): Foster, Jimmy G.
• Application Number:
  US07/982,825
• Time in Patent Office: 568 Days
• Field of Search: 53/400, 53/425, 53/426, 53/428, 53/455, 206/204, 206/205, 206/328, 206/339, 206/340, 206/363, 206/364, 206/438, 206/439, 206/484, 206/484.1
• US Class Current: 206/204
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0688 Packages or dispensers for surgical staplers
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3004 containing desiccant means, e.g. desiccant pouches
• CPC Class Codes: A61B 2050/3015 transparent
• 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 2/206 Ethylene oxide
• CPC Class Codes: B32B 15/082 comprising vinyl resins; comprising acrylic resins
• CPC Class Codes: B32B 15/088 comprising polyamides
• CPC Class Codes: B32B 2307/7246 Water vapor barrier
• CPC Class Codes: B32B 2311/24 Aluminium
• CPC Class Codes: B32B 2323/046 LDPE, i.e. low density polyethylene
• CPC Class Codes: B32B 2379/08 Polyimides
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/06 as the main or only constituent of a layer, which is next to another layer of the same or of a different material next to a layer of a particular substance B32B9/045; next to a bituminous or tarry layer B32B11/046; next to a water setting substance layer B32B13/12; next to a metal layer B32B15/08; next to a glass layer B32B17/10; next to a layer formed of natural mineral fibres or particles B32B19/045; next to a wood layer B32B21/08; next to a cellulosic plastic layer B32B23/08; next to a natural or synthetic rubber layer B32B25/08
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 27/34 : comprising polyamides
• CPC Class Codes: B65D 81/266 : for absorbing gases, e.g. oxygen absorbers or desiccants B65D51/244, B65D51/30 take precedence

Abstract

A flexible package of low moisture permeability suitable for packaging moisture sensitive materials and devices such as bioabsorbable surgical staples and clips and instruments containing these devices includes a first panel fabricated from a substantially transparent polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, the first panel having a measurable moisture vapor transmission rate and being bonded along its edges to the edges of a second panel fabricated from either (i) a transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel; or (ii) an opaque, flexible metal foil laminate to form a contents-enclosing pouch therebetween, the pouch containing a quantity of desiccant and at least one sterile moisture-sensitive material or device, e.g., the aforesaid bioabsorbable staples, clips or instruments containing such staples or clips.

Claims

1. A flexible package which comprises a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, said first panel having a measurable moisture vapor transmission rate, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-enclosing pouch therebetween, the pouch containing a quantity of desiccant and at least one sterile moisture-sensitive device or material, the desiccant being provided as at least one discrete desiccant unit loosely contained within the pouch or in a fixed location therein, the desiccant unit itself comprising a pouch made from a material having a moisture vapor transmission rate of about 1 g/100 in² /24 hrs with the desiccant contained within a pouch of the desiccant unit.

2. The package of claim 1 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halopolymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin.

3. The package of claim 1 wherein at least said first panel transparent polymeric laminate film includes a layer formed from polyethylene terephthalate.

4. The package of claim 1 wherein the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide.

5. The package of claim 1 wherein the inorganic moisture vapor transmission barrier layer is formed from at least one oxide of silicon, aluminum and zirconium containing a metal dopant.

6. The package of claim 1 wherein the second panel is fabricated from an aluminum foil laminate.

7. The package of claim 1 wherein the second panel is fabricated from an aluminum foil laminate possessing a low density polyethylene layer on one side and a polyamide layer on the other.

8. The package of claim 1 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.1 g/100 in² /24 hrs.

9. The package of claim 1 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.05 g/100 in² /24 hrs.

10. The package of claim 1, wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.025 g/100 in² /24 hrs.

11. The package of claim 1 wherein the desiccant is at least one material selected from the group consisting of silica gel and molecular sieve.

12. The package of claim 1 wherein the desiccant includes a material which indicates by change of color when the capacity of the desiccant for absorbing moisture has been effectively exhausted.

13. The package of claim 1, wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate and the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve.

14. The package of claim 1 wherein the first panel is bonded to the second panel through a heat sealable coating composition applied to one or both mutually contacting surfaces of the panels.

15. The package of claim 1, wherein the first panel is peelable from the second panel.

16. The package of claim 1 wherein the moisture sensitive device is a bioabsorbable hemostatic or wound closure device.

17. The package of claim 1 wherein the moisture sensitive device is a bioabsorbable clip or staple.

18. The package of claim 1 wherein the moisture sensitive device is a bioabsorbable clip or staple stored within an apparatus for applying the clip or staple.

19. The package of claim 1 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.

20. A flexible package which comprises a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, said first panel having a measurable moisture vapor transmission rate, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-enclosing pouch therebetween, the pouch containing a quantity of desiccant and at least one sterile moisture-sensitive device or material, and a removable header at least partially fabricated from a gas permeable sheet material which is a barrier to microorganisms, one end of the header being attached to the opening of the package and the other end of the header being open or sealed.

21. The package of claim 20 wherein the gas permeable sheet of the header is a spunbonded polyethylene.

22. The package of claim 20 from which the header has been removed with the exception of a residual strip of header material.

23. The package of claim 20 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.

24. A method of packaging a moisture-sensitive device or material which comprises:

a) providing an open flexible package comprising a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-receiving open pouch therebetween;

b) placing at least one moisture-sensitive device or material and a quantity of desiccant within the pouch, the desiccant being provided as at least one discrete desiccant unit loosely contained within the pouch or in a fixed location therein, the desiccant unit itself comprising a pouch made from a material having a moisture vapor transmission rate of about 1 g/100 /in² /24 hrs with the desiccant contained within a pouch of the desiccant unit;

c) sealing the pouch; and

,

d) sterilizing the contents of the package.

25. The method of claim 24 wherein at least said first transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halopolymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin.

26. The method of claim 24 wherein at least said first transparent polymeric laminate film includes a layer formed from polyethylene terephthalate.

27. The method of claim 24 wherein the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide.

28. The method of claim 24 wherein the inorganic moisture vapor transmission barrier layer is formed from at least one oxide of silicon, aluminum and zirconium containing a metal dopant.

29. The method of claim 24 wherein the second panel is fabricated from an aluminum foil laminate.

30. The method of claim 24 wherein the second panel is fabricated from an aluminum foil laminate possessing a low density polyethylene layer on one side and a polyamide layer on the other.

31. The method of claim 24 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.1 g/100 in² /24 hrs.

32. The method of claim 24 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.05 g/100 in² /24 hrs.

33. The method of claim 24 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.025 g/100 in² /24 hrs.

34. The method of claim 24 wherein the desiccant is at least one material selected from the group consisting of silica gel and molecular sieve.

35. The method of claim 24 wherein the desiccant includes a material which indicated by change of color when the capacity of the desiccant for absorbing moisture has been effectively exhausted.

36. The method of claim 24 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.

37. The method of claim 24 wherein the first panel is bonded to the second panel through a heat sealable coating composition applied to one or both mutually containing surfaces of the panels.

38. The method of claim 24 wherein the first panel is peelable from the second panel.

39. The method of claim 24 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.

40. A method of packaging a moisture-sensitive device or material which comprises:

a) providing an open flexible package comprising a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) a substantially transparent flexible polymeric film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-receiving open pouch therebetween, and a header at least partially fabricated from a gas permeable sheet material which is a barrier to microorganisms, one end of the header being attached to the opening of the package and the other end of the header being open;

b) placing at least one moisture-sensitive device or material and a quantity of desiccant within the open pouch;

c) sealing the open end of the header;

d) introducing a sterilizing gas into the pouch through the gas permeable sheet of the header to sterilize the contents of the package;

e) removing the sterilizing gas from the pouch following sterilization of its contents;

f) sealing the package; and

,

g) removing at least part of the header.

41. The method of claim 40 wherein the gas permeable sheet of the header is a spunbonded polyethylene.

42. The method of claim 40 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.