Multi-balloon catheter with hydrogel coating

• US 7,060,051 B2
• Filed: 09/24/2002
• Issued: 06/13/2006
• Est. Priority Date: 09/24/2002
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Palasis, Maria
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/253,597
• Publication Number:
  US 20040059290A1
• Time in Patent Office: 1,358 Days
• Field of Search: 604/96.01, 604/49.01, 604/101.01, 604/101.13, 604/109.05, 604/103.06, 604/509, 604/101.02, 604/101.03, 604/101.04, 604/101.05
• US Class Current: 604/101.01
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• 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 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• 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

Abstract

In one aspect of the invention a multi-balloon catheter, such as a double-balloon catheter, with coating comprising a hydrogel polymer on the exterior surface of the occlusion balloons is provided. The balloons may be inflated inside the lumen to occlude a plaque-affected segment of the lumen thereby forming a lumen space between the balloons, wherein this plaque-affected lumen segment may be treated with a biologically active agent. The presence of the coating can reduce de-nuding of healthy endothelial lumen tissue after contact with the inflated balloons during the occlusion. In another aspect of the invention, a method is provided for using a multi-balloon catheter having a coating comprising a hydrogel polymer for treating a plaque-affected lumen segment, the method reducing the subsequent de-nuding or injury to healthy endothelial tissue that is contacted by the balloon during occlusion.

Claims

1. A balloon catheter for occluding two ends of a portion of a blood vessel and treating the occluded portion of the blood vessel comprising:

a first balloon and a second balloon, each having an exterior surface and a catheter segment connectively placed therebetween; and

a coating comprising a hydrogel polymer applied to the exterior surfaces of each of the balloons,

wherein said catheter segment is capable of delivering a biologically active agent to the occluded portion of the blood vessel and wherein said balloons are capable of being inflated and deflated within the blood vessel, and when the balloons are inflated, form a substantially fluid-tight, closed space between the first and second balloons.

2. The balloon catheter of claim 1, wherein said coating is between about 1.0 and about 10.0 micrometers in thickness.

3. The balloon catheter of claim 1, wherein said catheter segment comprises an inner lumen, and a catheter wall and wherein at least one port extends through the wall to the exterior of the catheter segment, said port permitting the biologically active agent to pass through from the inner lumen to the exterior of the catheter segment.

4. The balloon catheter of claim 1, wherein said biologically active agent is an anti-inflammatory drug comprising heparin, PpacK (dextro-phenylalanine proline argine chloromethylketone), enoxaprin, hirudin or aspirin.

5. The balloon catheter of claim 1, wherein said biologically active agent is an anti-proliferative agent comprising monoclonal antibodies capable of blocking smooth muscle cell proliferation, heparin or enoxaprin.

6. The balloon catheter of claim 1, wherein said hydrogel polymer comprises poly-carboxylic acids, celluosic polymers, gelatin polyvinyl-pyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, or polyethylene oxides.

7. The balloon catheter of claim 6, wherein said poly-carboxylic acid is a polyacrylic acid.

8. The balloon catheter of claim 1, wherein the thickness of the coating in a swelled, uncompressed state is between about 10 to about 50 microns.

9. The balloon catheter of claim 1 which comprises a third-balloon disposed between the first and second balloons and a catheter segment connectively placed between the first and third balloons and a catheter segment connectively placed between the second and third balloons.

10. A balloon catheter for occluding two ends of a portion of a blood vessel and treating the occluded portion of the blood vessel comprising:

a first balloon and a second balloon, each having an exterior surface and a catheter segment connectively placed therebetween; and

a coating comprising a hydrogel polymer applied to the exterior surfaces of each of the balloons,

wherein said catheter segment is capable of delivering a biologically active agent to the occluded portion of the blood vessel and wherein said balloons are capable of being inflated and deflated within the blood vessel, and when both balloons are inflated, form a substantially fluid-tight, closed space between the first and second balloon, and wherein said coating is substantially free of any biologically active agent.

11. The balloon catheter of claim 10, wherein said coating is between about 1.0 and about 10.0 micrometers in thickness.

12. The balloon catheter of claim 10, wherein said catheter segment comprises an inner lumen, and a catheter wall and wherein at least one port extends through the wall to the exterior of the catheter segment, said port permitting the biologically active agent to pass through from the inner lumen to the exterior of the catheter segment.

13. The balloon catheter of claim 10, wherein said biologically active agent is an anti-inflammatory drug comprising heparin, PpacK (dextro-phenylalanine proline argine chloromethylketone), enoxapirin, hirudin or aspirin.

14. The balloon catheter of claim 10, wherein said biologically active agent is an anti-proliferative agent comprising monoclonal antibodies capable of blocking smooth muscle cell proliferation, heparin or enoxaprin.

15. The balloon catheter of claim 10, wherein said hydrogel polymer comprises poly-carboxylic acids, celluosic polymers, gelatin polyvinyl-pyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, or polyethylene oxides.

16. The balloon catheter of claim 15, wherein said poly-carboxylic acid is a polyacrylic acid.

17. The balloon catheter of claim 10, wherein the thickness of the coating in a swelled, uncompressed state is between about 10 to about 50 microns.

18. The balloon catheter of claim 10 which comprises a third-balloon disposed between the first and second balloons and a catheter segment connectively placed between the first and third balloons and a catheter segment connectively placed between the second and third balloons.

19. A method for treating a body lumen using a double-balloon catheter that maintains the integrity of the endothelial cells of the inner wall of the body lumen, the method comprising:

(a) inserting a catheter having at least two balloons into the body lumen, wherein the balloons are coated with a coating comprising a hydrogel polymer;

(b) inflating both balloons to contact the endothelial cells of the inner wall of the body lumen;

(c) forming a substantially closed space between the balloons within the body lumen; and

(d) providing a biologically active agent into the closed space.

20. The method of claim 19, wherein the coating is between about 1.0 and about 10.0 micrometers in thickness.

21. The method of claim 19, wherein the step of providing a biologically active agent is accomplished by providing a catheter segment between the two balloons, wherein the catheter segment has an inner lumen and a catheter wall, and at least one port extending through the wall, said port permitting the biologically active agent to pass through from the inner catheter lumen to the exterior of the catheter segment.

22. The method of claim 19, wherein the biologically active agent is an anti-inflammatory drug selected from the group consisting of heparin, PpacK (dextro-phenylalanine proline argine chloromethylketone), enoxaprin, hirudin and aspirin.

23. The method of claim 19, wherein the biologically active agent is an anti-proliferative agent selected from the group consisting of monoclonal antibodies capable of blocking smooth muscle cell proliferation, heparin and enoxaprin.

24. The method of claim 19, wherein said hydrogel polymer is selected from the group consisting of poly-carboxylic acids, celluosic polymers, gelatin polyvinyl-pyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, and polyethylene oxides.

25. The method of claim 24, wherein said poly-carboxylic acid is a polyacrylic acid.

26. The method of claim 19, wherein the thickness of the coating in a swelled, uncompressed state is between about 10 to about 50 microns.

27. A method for treating a body lumen using a double-balloon catheter that maintains the integrity of the endothelial cells of the inner wall of the body lumen, the method comprising:

(a) inserting a catheter having at least two balloons into the body lumen, wherein the balloons are coated with a coating comprising a hydrogel polymer, and wherein said coating is substantially free of any biologically active agent;

(b) inflating both balloons to contact the endothelial cells of the inner wall of the body lumen;

(c) forming a substantially closed space between the balloons within the body lumen; and

(d) providing a biologically active agent into the closed space.

28. The method of claim 27, wherein the coating is between about 1.0 and about 10.0 micrometers in thickness.

29. The method of claim 27, wherein the step of providing a biologically active agent is accomplished by providing a catheter segment between the two balloons, wherein the catheter segment has an inner lumen and a catheter wall, and at least one port extending through the wall, said port permitting the biologically active agent to pass through from the inner catheter lumen to the exterior of the catheter segment.

30. The method of claim 27, wherein the biologically active agent is an anti-inflammatory drug selected from the group consisting of heparin, PpacK (dextro-phenylalanine proline argine chloromethylketone), enoxaprin, hirudin and aspirin.

31. The method of claim 27, wherein the biologically active agent is an anti-proliferative agent selected from the group consisting of monoclonal antibodies capable of blocking smooth muscle cell proliferation, heparin and enoxaprin.

32. The method of claim 27, wherein said hydrogel polymer is selected from the group consisting of poly-carboxylic acids, celluosic polymers, gelatin polyvinyl-pyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, and polyethylene oxides.

33. The method of claim 32, wherein said poly-carboxylic acid is a polyacrylic acid.

34. The method of claim 27, wherein the thickness of the coating in a swelled, uncompressed state is between about 10 to about 50 microns.