Absorbent medical articles

• US 20040133143A1
• Filed: 12/19/2002
• Published: 07/08/2004
• Est. Priority Date: 12/19/2002
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Scholz, Matthew T., Burton, Scott A., Stickels, Steven C.
• Granted Patent: US 7,612,248 B2
• Time in Patent Office: Days
• US Class Current: 602/58
• CPC Class Codes: A61F 13/0203 with fluid retention members
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: A61L 15/42 Use of materials characterised by their function or physical properties liquid bandages A61L26/00
• CPC Class Codes: A61L 15/58 Adhesives

Abstract

Medical articles including an absorbent layer, a backing layer and an optional liquid permeable facing layer are disclosed. The construction of the medical article is such that volumetric expansion of the absorbent layer is allowed in directions parallel to the surface of the backing layer as the absorbent layer absorbs moisture. The medical article may include a debonding agent located between the absorbent layer and the backing layer. The absorbent layer is operably attached to the backing layer. When the absorbent layer absorbs moisture, e.g., wound exudate, at least a portion of the absorbent layer detaches from the backing layer such that the absorbent layer can expand and move relative to the backing. The debonding agent facilitates this change from attachment to detachment of the absorbent layer to the backing. The medical articles of the present invention may also be constructed such that a portion of the front surface of the backing layer located directly opposite the absorbent layer is free of adhesive. The adhesive free area or areas may be provided in place of a physical debonding agent or in addition to a physical debonding agent.

Claims

1. A medical article comprising:

a backing layer comprising backing adhesive on a front surface of the backing layer;

a liquid permeable facing layer;

an absorbent layer located between the backing layer and the facing layer, wherein a back surface of the absorbent layer faces the front surface of the backing layer; and

a water soluble film located between the front surface of the backing layer and the back surface of the absorbent layer.

2. A medical article according to claim 1, wherein the combination of the backing layer, the facing layer, the absorbent layer, and the water soluble film are transparent when the absorbent layer has absorbed 100 wt-% isotonic saline solution.

3. A medical article according to claim 1, wherein the water soluble film is coextensive with the back surface of the absorbent layer.

4. A medical article according to claim 1, wherein the water soluble film comprises a polyvinylalcohol film.

5. A medical article according to claim 1, wherein the water soluble film is a film selected from the group consisting of polyvinylpyrrolidone, polyvinylalcohol, hydrophilic polyurethanes, hydrophilic hydroxyalkylesters of poly(meth)acrylic acid and copolymers thereof, and hydrophilic polyether-polyamide polymers, as well as blends, mixtures and laminates thereof.

6. A medical article according to claim 1, wherein a back surface of the facing layer is operably attached to the front surface of the backing layer about a periphery of the absorbent layer.

7. A medical article according to claim 1, wherein the backing layer and the backing adhesive extend past a perimeter of the facing layer such that the backing layer and the backing adhesive form a frame about the periphery of the facing layer.

8. A medical article according to claim 1, wherein the backing layer and the backing adhesive extend past a perimeter of the facing layer such that the backing layer and the backing adhesive form a frame about the periphery of the facing layer, and wherein a back surface of the facing layer is operably attached to the front surface of the backing layer about a periphery of the absorbent layer.

9. A medical article according to claim 1, wherein the water soluble film is operably attached to the back surface of the absorbent layer.

10. A medical article according to claim 1, wherein the water soluble film and the facing layer are operably attached to the backing layer by the backing adhesive.

11. A medical article according to claim 1, further comprising facing adhesive on a front surface of the facing layer.

12. A medical article according to claim 1, wherein the backing layer is moisture vapor permeable.

13. A medical article according to claim 1, wherein the facing layer comprises a moisture vapor permeable film.

14. A medical article according to claim 1, wherein the facing layer comprises a film that comprises a plurality of openings formed therethrough.

15. A medical article according to claim 1, wherein the absorbent layer comprises a gel material comprising a homopolymer or copolymer of a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric random alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group.

16. A medical article according to claim 1, wherein the absorbent layer comprises a gel material comprising a copolymer prepared from monomers comprising a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group;

a monofunctional poly(alkylene oxide) monomer; and

a polar monomer.

17. A medical article according to claim 1, wherein the absorbent layer comprises a gel material comprising a homopolymer or copolymer prepared from monomers comprising about 5 wt-% to 100 wt-% of a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group;

0 wt-% to about 80 wt-% of a monofunctional poly(alkylene oxide) monomer; and

0 wt-% to about 40 wt-% of a polar monomer.

18. A medical article according to claim 1, wherein the absorbent layer comprises a gel material comprising a polymerized multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group.

19. A medical article comprising:

a backing layer comprising backing adhesive on a front surface of the backing layer;

a liquid permeable facing layer;

an absorbent layer located between the backing layer and the facing layer, wherein a back surface of the absorbent layer faces the front surface of the backing layer; and

a debonding agent located between the front surface of the backing layer and the back surface of the absorbent layer;

wherein the back surface of the absorbent layer is operably attached to the front surface of the backing layer before the medical article is applied to a patient, and wherein at least a portion of the back surface of the absorbent layer is detached from the front surface of the backing layer when the absorbent layer has absorbed 100 wt-% or more of water.

20. A medical article according to claim 19, wherein the combination of the backing layer, the facing layer, the absorbent layer, and the debonding agent are transparent when the absorbent layer has absorbed 100 wt-% of isotonic saline solution.

21. A medical article according to claim 19, wherein the debonding agent is water soluble.

22. A medical article according to claim 21, wherein the absorbent layer is substantially free of water before the medical article is applied to a patient.

23. A medical article according to claim 19, wherein the debonding agent is water soluble and further wherein the debonding agent comprises a layer that is coextensive with the back surface of the absorbent layer.

24. A medical article according to claim 19, wherein the debonding agent comprises water soluble particulates.

25. A medical article according to claim 19, wherein the debonding agent comprises a water insoluble structure.

26. A medical article according to claim 19, wherein the debonding agent comprises a fibrous structure.

27. A medical article according to claim 19, wherein the debonding agent comprises a water soluble foam layer.

28. A medical article according to claim 19, wherein a back surface of the facing layer is operably attached to the front surface of the backing layer about a periphery of the absorbent layer.

29. A medical article according to claim 19, wherein the backing layer and the backing adhesive extend past a perimeter of the facing layer such that the backing layer and the backing adhesive form a frame about the periphery of the facing layer.

30. A medical article according to claim 19, wherein the backing layer and the backing adhesive extend past a perimeter of the facing layer such that the backing layer and the backing adhesive form a frame about the periphery of the facing layer, and wherein a back surface of the facing layer is operably attached to the front surface of the backing layer about a periphery of the absorbent layer.

31. A medical article according to claim 19, wherein the debonding agent is operably attached to the back surface of the absorbent layer.

32. A medical article according to claim 19, wherein the debonding layer and the facing layer are operably attached to the backing layer by the backing adhesive.

33. A medical article according to claim 19, further comprising facing adhesive on a front surface of the facing layer.

34. A medical article according to claim 19, wherein the backing layer is moisture vapor permeable.

35. A medical article according to claim 19, wherein the facing layer comprises a moisture vapor permeable film.

36. A medical article according to claim 19, wherein the facing layer comprises a film that comprises a plurality of openings formed therethrough.

37. A medical article according to claim 19, wherein the absorbent layer comprises a gel material comprising a homopolymer or copolymer of a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average/molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric random alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group.

38. A medical article according to claim 19, wherein the absorbent layer comprises a gel material comprising a copolymer prepared from monomers comprising a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group;

a monofunctional poly(alkylene oxide) monomer; and

a polar monomer.

39. A medical article according to claim 19, wherein the absorbent layer comprises a gel material comprising a homopolymer or copolymer prepared from monomers comprising about 5 wt-% to 100 wt-% of a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group;

0 wt-% to about 80 wt-% of a monofunctional poly(alkylene oxide) monomer; and

0 wt-% to about 40 wt-% of a polar monomer.

40. A medical article according to claim 19, wherein the absorbent layer comprises a gel material comprising a polymerized multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group.

41. A medical article comprising:

a moisture vapor permeable backing layer comprising backing adhesive on a front surface of the backing layer;

a liquid permeable facing layer comprising a film that comprises a plurality of openings formed therethrough and facing adhesive on a front surface of the facing layer, wherein the backing layer and the backing adhesive extend past a perimeter of the facing layer such that the backing layer and the backing adhesive form a frame about the periphery of the facing layer;

an absorbent layer located between the backing layer and the facing layer, wherein a back surface of the absorbent layer faces the front surface of the backing layer, wherein a back surface of the facing layer is attached to the front surface of the backing layer about a periphery of the absorbent layer, and wherein the absorbent layer is substantially free of water before the medical article is applied to a patient; and

a water soluble debonding agent located between the front surface of the backing layer and the back surface of the absorbent layer;

wherein the back surface of the absorbent layer is operably attached to the front surface of the backing layer before the medical article is applied to a patient, and wherein at least a portion of the back surface of the absorbent layer is detached from the front surface of the backing layer when the absorbent layer has absorbed 100 wt-% or more of water;

and wherein the combination of the backing layer, the facing layer, the absorbent layer, and the debonding agent are transparent when the absorbent layer has absorbed 100 wt-% isotonic saline solution.

42. A medical article comprising:

a backing layer comprising backing adhesive on a front surface of the backing layer;

an absorbent layer located proximate the front surface of the backing layer, wherein a back surface of the absorbent layer faces the front surface of the backing layer; and

a debonding agent located between the front surface of the backing layer and the back surface of the absorbent layer;

wherein the back surface of the absorbent layer is operably attached to the front surface of the backing layer before the medical article is applied to a patient, and wherein at least a portion of the back surface of the absorbent layer is detached from the front surface of the backing layer when the absorbent layer has absorbed 100 wt-% or more of water.

43. A medical article according to claim 42, wherein the combination of the backing layer, the absorbent layer, and the debonding agent are transparent when the absorbent layer has absorbed 100 wt-% of isotonic saline solution.

44. A medical article according to claim 42, wherein the debonding agent is water soluble.

45. A medical article according to claim 42, wherein the absorbent layer is substantially free of water before the medical article is applied to a patient.

46. A medical article according to claim 42, wherein the debonding agent is water soluble and further wherein the debonding agent comprises a layer that is coextensive with the back surface of the absorbent layer.

47. A medical article according to claim 42, wherein the debonding agent comprises water soluble particulates.

48. A medical article according to claim 42, wherein the debonding agent comprises a water insoluble structure.

49. A medical article according to claim 42, wherein the debonding agent comprises a fibrous structure.

50. A medical article according to claim 42, wherein the debonding agent comprises a water soluble foam layer.

51. A medical article according to claim 42, wherein the backing layer and the backing adhesive extend past a perimeter of the absorbent layer such that the backing layer and the backing adhesive form a frame about the periphery of the absorbent layer.

52. A medical article according to claim 42, wherein the debonding layer is operably attached to the backing layer by the backing adhesive.

53. A medical article according to claim 42, wherein the backing layer is moisture vapor permeable.

54. A medical article according to claim 42, wherein the absorbent layer comprises a gel material comprising a homopolymer or copolymer of a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric random alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group.

55. A medical article according to claim 42, wherein the absorbent layer comprises a gel material comprising a copolymer prepared from monomers comprising a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group;

a monofunctional poly(alkylene oxide) monomer; and

a polar monomer.

56. A medical article according to claim 42, wherein the absorbent layer comprises a gel material comprising a homopolymer or copolymer prepared from monomers comprising about 5 wt-% to 100 wt-% of a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group;

0 wt-% to about 80 wt-% of a monofunctional poly(alkylene oxide) monomer; and

0 wt-% to about 40 wt-% of a polar monomer.

57. A medical article according to claim 42, wherein the absorbent layer comprises a gel material comprising a polymerized multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group.

58. A medical article comprising:

a backing substrate;

a liquid permeable facing layer;

an absorbent layer located between the backing substrate and the facing layer, wherein a back surface of the absorbent layer faces the front surface of the backing substrate; and

backing adhesive on the front surface of the backing substrate, wherein the backing adhesive occupies an edge zone on the front surface of the backing substrate surrounding the absorbent layer, and further wherein a portion of the front surface of the backing substrate located directly opposite the absorbent layer is free of the backing adhesive.

59. A medical article according to claim 58, wherein all of the front surface of the backing substrate located directly opposite the absorbent layer is free of the backing adhesive.

60. A medical article according to claim 58, wherein the backing adhesive is located between the absorbent layer and the backing substrate about the perimeter of the absorbent layer such that the perimeter of the absorbent layer is operably attached to the backing substrate by the backing adhesive.

61. A medical article according to claim 58, wherein the backing adhesive is strip coated on the front surface of the backing substrate located directly opposite the absorbent layer.

62. A medical article according to claim 58, wherein the backing adhesive is located in one or more discrete areas on the front surface of the backing substrate located directly opposite the absorbent layer.

63. A medical article according to claim 58, wherein the combination of the backing layer, the facing layer, and the absorbent layer are transparent when the absorbent layer has absorbed 100 wt-% isotonic saline solution.

64. A medical article according to claim 58, wherein a back surface of the facing layer is operably attached to the front surface of the backing substrate about a periphery of the absorbent layer.

65. A medical article according to claim 58, wherein the backing substrate and the backing adhesive extend past a perimeter of the facing layer such that the backing substrate and the backing adhesive form a frame about the periphery of the facing layer.

66. A medical article according to claim 58, wherein the backing substrate and the backing adhesive extend past a perimeter of the facing layer such that the backing substrate and the backing adhesive form a frame about the periphery of the facing layer, and wherein a back surface of the facing layer is operably attached to the front surface of the backing substrate about a periphery of the absorbent layer.

67. A medical article according to claim 58, further comprising facing adhesive on a front surface of the facing layer.

68. A medical article according to claim 58, wherein the backing layer is moisture vapor permeable.

69. A medical article according to claim 58, wherein the facing layer comprises a moisture vapor permeable film.

70. A medical article according to claim 58, wherein the facing layer comprises a film that comprises a plurality of openings formed therethrough.

71. A medical article according to claim 58, wherein the absorbent layer comprises a gel material comprising a homopolymer or copolymer of a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric random alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group.

72. A medical article according to claim 58, wherein the absorbent layer comprises a gel material comprising a copolymer prepared from monomers comprising a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group;

a monofunctional poly(alkylene oxide) monomer; and

a polar monomer.

73. A medical article according to claim 58, wherein the absorbent layer comprises a gel material comprising a homopolymer or copolymer prepared from monomers comprising about 5 wt-% to 100 wt-% of a multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group;

0 wt-% to about 80 wt-% of a monofunctional poly(alkylene oxide) monomer; and

0 wt-% to about 40 wt-% of a polar monomer.

74. A medical article according to claim 58, wherein the absorbent layer comprises a gel material comprising a polymerized multifunctional poly(alkylene oxide) free-radically polymerizable macromonomer having a weight average molecular weight of at least about 2000, wherein the multifunctional poly(alkylene oxide) macromonomer comprises a copolymeric alkylene oxide moiety of the formula:

—

(—

CH(R¹)—

CH₂—

O—

)_m . . . (—

CH₂—

CH₂—

O—

)_n—

wherein the mole ratio of m;

n is within a range of about 1;

9 to about 9;

1; and

R¹ is a (C1-C4)alkyl group.