Stent lining

• US 6,890,339 B2
• Filed: 01/31/2002
• Issued: 05/10/2005
• Est. Priority Date: 12/15/1989
• Status: Expired due to Fees

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Barry, James J., Sahatjian, Ronald A., Palasis, Maria
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/059,420
• Publication Number:
  US 20020091375A1
• Time in Patent Office: 1,195 Days
• Field of Search: 606/192, 606/194, 606/198, 606/191, 623/1.11, 623/1.46, 623/1.18, 128/898
• US Class Current: 606/194
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 38/49 Urokinase; Tissue plasminogen activator
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: A61L 33/0023 using a quaternized group or a protonated amine group of the substrate
• CPC Class Codes: A61L 33/0029 using an intermediate layer of polymer
• CPC Class Codes: A61L 33/0047 : Enzymes, e.g. urokinase, streptokinase
• CPC Class Codes: A61M 16/0481 : through the cuff wall
• CPC Class Codes: A61M 2025/0046 : Coatings for improving slidability
• CPC Class Codes: A61M 2025/0057 : Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/09183 : having tools at the distal tip
• CPC Class Codes: A61M 2025/1013 : with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1093 : having particular tip characteristics
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: C08L 33/02 : Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08L 35/00 : Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a carboxyl radical, and containing at least one other carboxyl radical in the molecule, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers

Abstract

The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.

Claims

1. A method for lining a stent, comprising:

(a) providing a catheter assembly comprising a balloon at least a portion of which is coated with a hydrogel, wherein said hydrogel is crosslinked, wherein an expansible stent is mounted on said balloon in a contracted condition,

(b) introducing said assembly into a body lumen, and

(c) inflating said balloon to lodge said stent in said body lumen and to release said hydrogel from said coated portion to an inner surface of said stent as a lining.

2. The method of claim 1, wherein said body lumen is a blood vessel.

3. The method of claim 2, wherein said vessel is an occluded artery.

4. The method of claim 1 wherein said hydrogel is selected from the group consisting of a polyacid, cellulosic polymer, collagen, gelatin, albumin, alginate, poly-2-hydroxymethyl methyl acrylate (HEMA), polyvinylpyrrolidone, maleic anhydride polymer, polyamide, polyacrylamide, polyvinyl alcohol, polyethylene glycol, polyethylene oxide, and polysaccharide.

5. The method of claim 1 wherein said hydrogel is poly acrylic acid).

6. The method of claim 1 wherein said poly (acrylic acid) is cross-linked.

7. The method of claim 1 wherein said hydrogel is hyaluronic acid.

8. The method of claim 7 wherein said hyaluronic acid is cross-linked.

9. The method of claim 1 wherein said hydrogel is derivatized albumin.

10. The method of claim 1 wherein said hydrogel an acrylic acid.

11. The method of claim 1 wherein said hydrogel is polyanhydride.

12. The method of claim 1 wherein said catheter further comprises a sheath for covering at least a portion of said balloon which is coated with said hydrogel.

13. The method of claim 12 comprising removing said sheath prior to inflating said balloon.

14. The method of claim 1 wherein said stent is a permeable stent.

15. The method of claim 1 wherein said hydrogel comprises a therapeutic agent.

16. The method of claim 15 wherein said therapeutic agent is an anti-thrombogenic agent.

17. The method of claim 16 wherein said anti-thrombogenic agent is selected from the group consisting of heparin, PPACK, enoxaprin, aspirin, and hirudin.

18. The method of claim 15 wherein the therapeutic agent is a thrombolytic agent.

19. The method of claim 18 wherein the thrombolytic agent is selected from the group consisting of urokinase, streptokinase, and tissue plasminogen activator.

20. The method of claim 1 wherein said catheter comprises a plurality of delivery ports.

21. The method of claim 20, wherein said delivery port is located proximal to said balloon, upstream of said stent with respect to blood flow, such that hydrogel administered via said delivery port is carried by blood flow to said inner surface of said stent.

22. A method of lining a stent positioned in a body lumen, comprising:

(a) providing a catheter comprising a balloon at least a portion of which is coated with a hydrogel, wherein said hydrogel is selected from the group consisting of a polyacid, cellulosic polymer, collagen, gelatin, albumin, alginate, poly-2-hydroxymethyl methyl acrylate (HEMA), polyvinylpyrrolidone, maleic anhydride polymer, polyamide, polyacrylamide, polyvinyl alcohol, polyethylene glycol, polyethylene oxide, and polysaccharide,

(b) introducing said catheter into said body lumen,

(c) advancing said catheter in said body lumen until said coated portion is positioned proximate to an inner surface of said stent; and

(d) inflating said balloon to release said hydrogel from said coated portion to said inner surface of said stent as a lining.

23. The method of claim 22, wherein said body lumen is a blood vessel.

24. The method of claim 23, wherein said vessel is an occluded artery.

25. The method of claim 22 wherein said hydrogel is crosslinked.

26. The method of claim 22 wherein said hydrogel is poly (acrylic acid).

27. The method of claim 22 wherein said poly (acrylic acid) is cross-linked.

28. The method of claim 22 wherein said hydrogel is hyaluronic acid.

29. The method of claim 28 wherein said hyaluronic acid is cross-linked.

30. The method of claim 22 wherein said hydrogel is derivatized albumin.

31. The method of claim 22 wherein said hydrogel an acrylic acid.

32. The method of claim 22 wherein said hydrogel is polyanhydride.

33. The method of claim 22 wherein said catheter further comprises a sheath for covering at least a portion of said balloon which is coated with said hydrogel.

34. The method of claim 33 comprising removing said sheath prior to inflating said balloon.

35. The method of claim 22 wherein said stent is a permeable stent.

36. The method of claim 22 wherein said hydrogel comprises a therapeutic agent.

37. The method of claim 36 wherein said therapeutic agent is an anti-thrombogenic agent.

38. The method of claim 37 wherein said anti-thrombogenic agent is selected from the group consisting of heparin, PPACK, enoxaprin, aspirin, and hirudin.

39. The method of claim 36 wherein the therapeutic agent is a thrombolytic agent.

40. The method of claim 39 wherein the thrombolytic agent is selected from the group consisting of urokinase, streptokinase, and tissue plasminogen activator.

41. The method of claim 22 wherein said catheter comprises a plurality of delivery ports.

42. The method of claim 41, wherein said delivery port is located proximal to said balloon, upstream of said stent with respect to blood flow, such that hydrogel administered via said delivery port is carried by blood flow to said inner surface of said stent.

43. A method of lining a stent positioned in a body lumen, comprising:

(a) providing a catheter comprising a balloon and a delivery port, wherein said balloon comprises a first layer and a second outer apertured layer overlying said delivery port,

(b) introducing said catheter into said body lumen,

(c) advancing said catheter in said body lumen until said outer apertured layer is positioned proximate to an inner surface of said stent;

(d) delivering a hydrogel into a space between said first layer and said second outer apertured layer, wherein said hydrogel is selected from the group consisting of a polyacid, cellulosic polymer, collagen, gelatin, albumin, alginate, poly-2-hydroxyethyl methyl acrylate (HEMA), polyvinylpyrrolidone, maleic anhydride polymer, polyamide, polyacrylamide, polyvinyl alcohol, polyethylene glycol, polyethylene oxide, and polysaccharide; and

(e) inflating said balloon to press said hydrogel through said outer apertured layer, wherein said hydrogel is deposited on said inner surface of said stent as a lining.

44. The method of claim 43, wherein said body lumen is a blood vessel.

45. The method of claim 44, wherein said vessel is an occluded artery.

46. The method of claim 43 wherein said hydrogel is crosslinked.

47. The method of claim 43 wherein said hydrogel is poly (acrylic acid).

48. The method of claim 43 wherein said poly (acrylic acid) is cross-linked.

49. The method of claim 43 wherein said hydrogel is hyaluronic acid.

50. The method of claim 49 wherein said hyaluronic acid is cross-linked.

51. The method of claim 43 wherein said hydrogel is derivatized albumin.

52. The method of claim 43 wherein said hydrogel is an acrylic acid.

53. The method of claim 43 wherein said hydrogel is polyanhydride.

54. The method of claim 43 wherein said catheter further comprises a sheath for covering at least a portion of said balloon which is coated with said hydrogel.

55. The method of claim 54, comprising removing said sheath prior to inflating said balloon.

56. The method of claim 43 wherein said stent is a permeable stent.

57. The method of claim 43 wherein said hydrogel comprises a therapeutic agent.

58. The method of claim 57 wherein said therapeutic agent is an anti-thrombogenic agent.

59. The method of claim 58 wherein said anti-thrombogenic agent is selected from the group consisting of heparin, PPACK, enoxaprin, aspirin, and hirudin.

60. The method of claim 57 wherein the therapeutic agent is a thrombolytic agent.

61. The method of claim 60 wherein the thrombolytic agent is selected from the group consisting of urokinase, streptokinase, and tissue plasminogen activator.

62. The method of claim 43 wherein said catheter comprises a plurality of said delivery ports.

63. The method of claim 62, wherein said delivery port is located proximal to said balloon, upstream of said stent with respect to blood flow, such that hydrogel administered via said delivery port is carried by blood flow to said inner surface of said stent.

64. A method of selectively lining a permeable stent to treat an aneurism, comprising:

(a) providing a catheter comprising a balloon at least a portion of which is coated with a hydrogel, wherein said hydrogel is selected from the group consisting of a polyacid, cellulosic polymer, collagen, gelatin, albumin, alginate, poly-2-hydroxyethyl methyl acrylate (HEMA), polyvinylpyrrolidone, maleic anhydride polymer, polyamide, polyacrylamide, polyvinyl alcohol, polyethylene glycol, polyethylene oxide, and polysaccharide;

(b) introducing said catheter into an aneurismal blood vessel comprising said permeable stent in the region of said aneurism,

(c) advancing said catheter in said vessel until said coated portion is positioned proximate to said aneurism; and

(d) inflating said balloon to release said hydrogel from said coated portion to an inner surface of said stent proximate to said aneurism to selectively line said stent, wherein said hydrogel renders said surface impermeable thereby reducing blood flow into said aneurism.

65. The method of claim 64 wherein said hydrogel is crosslinked.

66. The method of claim 64 wherein said hydrogel is poly (acrylic acid).

67. The method of claim 66 wherein said poly (acrylic acid) is cross-linked.

68. The method of claim 64 wherein said hydrogel is hyaluronic acid.

69. The method of claim 68 wherein said hyaluronic acid is cross-linked.

70. The method of claim 64 wherein said hydrogel is derivatized albumin.

71. The method of claim 64 wherein said hydrogel an acrylic acid.

72. The method of claim 64 wherein said hydrogel is polyanhydride.

73. The method of claim 64 wherein said catheter further comprises a sheath for covering at least a portion of said balloon which is coated with said hydrogel.

74. The method of claim 73, comprising removing said sheath prior to inflating said balloon.

75. The method of claim 64 wherein said hydrogel comprises a therapeutic agent.

76. The method of claim 75 wherein said therapeutic agent is an anti-thrombogenic agent.

77. The method of claim 76 wherein said anti-thrombogenic agent is selected from the group consisting of heparin, PPACK, enoxaprin, aspirin, and hirudin.

78. The method of claim 75 wherein the therapeutic agent is a thrombolytic agent.

79. The method of claim 78 wherein the thrombolytic agent is selected from the group consisting of urokinase, streptokinase, and tissue plasminogen activator.

80. The method of claim 64 wherein said catheter comprises a plurality of delivery ports.

81. The method of claim 80, wherein said delivery port is located proximal to said balloon, upstream of said stent with respect to blood flow, such that hydrogel administered via said delivery port is carried by blood flow to said inner surface of said stent.