Passive perfusion angioplasty catheter

• US 5,308,356 A
• Filed: 02/25/1993
• Issued: 05/03/1994
• Est. Priority Date: 02/25/1993
• Status: Expired due to Fees

• Current Assignee: Joseph L. Blackshear, Perry L. Blackshear Jr
• Original Assignee: Joseph L. Blackshear, Perry L. Blackshear Jr
• Inventors: Blackshear, Perry L. Jr., Blackshear, Joseph L.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/022,573
• Time in Patent Office: 432 Days
• Field of Search: 606/191, 606/194, 606/195, 604/96-101, 128/207.15
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/107 having a longitudinal slit in the balloon
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A passive perfusion angioplasty catheter is provided which includes an elongated flexible member defining an inflation lumen and an inflatable balloon member affixed to a distal end of the flexible member for pressing against an interior wall of an artery. The balloon member defines at least one passage between a surface thereof and the interior wall permitting blood to flow therethrough when the balloon member is pressed against the interior wall. A method of percutaneous transluminal angioplasty is also provided.

Claims

1. A passive perfusion angioplasty catheter comprising:

an elongated flexible member defining an inflation lumen; and

inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface,

said balloon means comprising at least one inflatable lobe, said at least one passage being a helical groove defined by said at least one lobe, a band being helically wound about a longitudinal axis of said balloon means, ends of said band being affixed to said flexible member, thereby defining a helical lobe and said helical groove.

2. The catheter claimed in claim 1, wherein said band is affixed to said flexible member by distal and proximal wraps.

3. The catheter claimed in claim 1, wherein said balloon means is made from one of polyvinyl chloride, polyethylene, polyethylene terephthalate and polyolefin copolymer.

4. The catheter claimed in claim 1, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

5. The catheter claimed in claim 1, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

6. The catheter claimed in claim 1, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

7. The catheter claimed in claim 1, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

8. A passive perfusion angioplasty catheter comprising:

an elongated flexible member defining an inflation lumen; and

inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, said balloon means including a plurality of lobes defining first and second helical passages.

9. The catheter as claimed in claim 8, wherein said helical passages are defined by winding first and second bands helically about said balloon means, said first band being wound helically clockwise about a longitudinal axis of said balloon means, said second band being wound helically counterclockwise about the longitudinal axis of said balloon means, ends of said first and second bands being affixed to said flexible member, said first and second bands also defining said plurality of lobes.

10. The catheter as claimed in claim 9, wherein said bands are affixed to said flexible member by distal and proximal wraps.

11. The catheter as claimed in claim 2 or 10, wherein said wraps are made from one of polyethylene terephthalate and polyolefin copolymer.

12. The catheter as claimed in claim 8, wherein said balloon means is made from one of polyvinyl chloride, polyethylene, polyethylene terephthalate and polyolefin copolymer.

13. The catheter as claimed in claim 8, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

14. The catheter as claimed in claim 8, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

15. The catheter as claimed in claim 8, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

16. The catheter as claimed in claim 8, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

17. A passive perfusion angioplasty catheter comprising:

an elongated flexible member defining an inflation lumen; and

inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface,

said balloon means comprising at least one inflatable lobe, said at least one passage being a helical groove defined by said at least one lobe, said balloon means comprises at least one inflatable lobe portion, said inflatable lobe portion being formed so as to have a material thickness less than remaining portions thereof, whereby during inflation of said balloon means, lobe portions distent to a greater extent than said remaining portions.

18. The catheter as claimed in claim 17, wherein a portion of said balloon means defining said at least one passage has a thickness between 0.006 and 0.012 cm and a portion of said balloon means defining said lobes has a thickness between 0.001 and 0.003 cm, whereby said passage portion expanding less than said lobe portion upon inflation of said balloon means.

19. The catheter as claimed in claim 17, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

20. The catheter as claimed in claim 17, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

21. The catheter as claimed in claim 17, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

22. The catheter as claimed in claim 17, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

23. A passive perfusion angioplasty catheter comprising:

an elongated flexible member defining an inflation lumen; and

inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface,

said balloon means including a plurality of S-shaped pleats defined in the periphery thereof when said balloon means is in a relaxed state, each said pleat having a radius of curvature of 2.5 to 5 times a thickness of the balloon means material.

24. The catheter as claimed in claim 23, wherein said pleats have a height of 4r_c +δ

in said relaxed state,

where r_c is the radius of curvature of said pleat,

and δ

is the thickness of said pleat.

25. The catheter as claimed in claim 23, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

26. The catheter as claimed in claim 23, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

27. The catheter as claimed in claim 23, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

28. The catheter as claimed in claim 23, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

29. A passive perfusion angioplasty catheter comprising:

an elongated flexible member defining an inflation lumen;

inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining a plurality of passages between an exterior thereof and said interior surface of said arterial lumen for permitting blood to flow past said balloon means when said balloon means is pressed against said interior surface, at least some of said passages being defined longitudinally and at least some of said passages being defined circumferentially, of said balloon means; and

means defining a cavity, said cavity extending longitudinally of said balloon means and being disposed between said balloon means and said flexible member.

30. The catheter as claimed in claim 29, wherein said flexible member further includes a guide wire lumen one of coaxial with and adjacent to said inflation lumen.

31. The catheter as claimed in claim 29, wherein said inflation lumen further includes a plurality of inflation ports for inflating said balloon means.

32. The catheter as claimed in claim 29, wherein said balloon means comprises a single balloon member disposed in surrounding relation to said flexible member.

33. The catheter as claimed in claim 29, wherein said balloon means comprises a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

34. A passive perfusion angioplasty catheter comprising:

an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and

inflatable balloon means, the distal end of which being affixed to the core tube while the proximal end is sealed to the concentric tube such that an interior of the balloon means being a continuation of the inflation lumen, the formed shape consisting of a pleated cylindrical balloon in which the pleats have a radius r_c and the polymer has a thickness, δ

, and, as cast, the pleated balloon will, when collapsed onto a surface of the core tube of said flexible member give a deflated profile 4r_c +δ

greater than a radius of said core tube of said flexible member, and when fully inflated will produce a smooth unpleated balloon surface with surface area approximately that of the cast pleated area.

35. A catheter as in claim 34, wherein depending on the polymer chosen, the ratio r_c /δ

is such that yield strain of the polymer is not exceeded when the pleat is flexed from fully pleated to fully open or unpleated, with 2<

r_c /δ

<

5.

36. A catheter as in claim 34, wherein the pleats are sufficient to prevent formation of wings which exist in a deflated unpleated balloon.

37. A catheter as claimed in claim 34 wherein the deflated pleated balloon is wrapped by a confining at least one elastomeric band such that when the balloon is inflated to an intermediate pressure, single or multiple helical grooves are formed allowing passage for blood flow while distending artery walls.

38. A catheter as claimed in claim 37, wherein said at least one elastomeric band is made to stretch with further inflation pressure allowing the balloon to exert a higher distending pressure to the artery momentarily while maintaining diminishing passive perfusion until full inflation is reached, reduction in pressure restoring the flow passage while maintaining distending pressure.

39. A catheter as claimed in claim 34, wherein the deflated pleated balloon is wrapped by confining at least one axial elastomeric band such that when the balloon is inflated to an intermediate pressure, single or multiple axial grooves are formed by restraining said axial elastomeric band at axial intervals by radial elastomeric bands allowing passage for blood flow while distending artery walls.

40. A catheter as claimed in claim 39 wherein said at least one elastomeric band is made to stretch with further inflation pressure allowing the balloon to exert a higher distending pressure to the artery momentarily while maintaining diminishing passive perfusion until full inflation is reached, reduction in pressure restoring the flow passage while maintaining distending pressure.

41. A passive perfusion angioplasty catheter comprising:

an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and

inflatable balloon means, the distal end of which being affixed to the core tube while the proximal end is sealed to the concentric tube such that an interior of the balloon means being a continuation of the inflation lumen, said balloon means distending the surrounding arterial walls while allowing an open passage to remain between a distended artery wall and one of a depressed groove and set of grooves formed by the balloon means allowing blood to flow past a surface of the balloon means, said balloon means being fabricated from a polymer having an elastic modulus substantially greater than arterial tissue and is thermally pressure formed to assume a desired shape upon inflation, the formed shape consisting of a partially pleated balloon in which the pleats have a radius r_c and the polymer a thickness, δ

, as cast the pleated balloon will, when collapsed onto a surface of the interior tube of said flexible member give a deflated profile 4r_c +δ

greater than a radius of said core tube of said flexible member, and when fully inflated will produce an unpleated balloon surface with surface area approximately that of the cast pleated area and with single or multiple grooves formed by the unpleated, undistended portion of a polymeric tube from which the balloon is blown.

42. A catheter as claimed in claim 41, wherein the grooves are assured against collapse as inflation pressure is increased by having side walls whose tangents pass on a near side of the catheter centerline and a radial component of stress is maintained by intermittent bands for axial grooves or by adequate pitch when helical grooves are employed.

43. A catheter as claimed in claim 42, wherein the grooves provide an optimum shape for delivering blood from one side of the balloon to the other, each groove wall has a single tangent and said tangent passes substantially through the catheter centerline, said optimum shape in a filled wedge with a half angle of 37°

±

2°

.

44. A catheter as claimed in claim 42, wherein the grooves provide an optimum shaped passage for delivering blood from one side of the balloon to the other, said optimum shape being defined for any distribution of side wall slope as the shape providing a maximum hydraulic diameter for the passage bounded by the bottom and side walls of the balloon groove on each side and capped by a taut artery wall on top, said hydraulic diameter being defined as four times the passage cross sectional area divided by the passage perimeter.

45. A passive perfusion angioplasty catheter comprising:

an elongated flexible member having one of a core tube and cylinder and a concentric tube defining an inflation lumen; and

a manifold connecting inflatable grooved balloon means, distal ends of which being affixed to the core tub while proximal ends thereof being sealed to the concentric tube by way of the manifold such that an interior of the balloon means is a continuation of the inflation lumen, said grooved balloon means distending surrounding arterial walls while allowing an open passage to remain between the distended artery wall and a depressed groove or set of grooves formed by the balloon means and valleys between the balloon means allowing blood to flow past the balloon means surface.

46. A catheter as claimed in claim 45, wherein the balloon means includes a plurality of balloons, each balloon having one of a single groove, two groves and three grooves disposed helically or axially with circumferential band pattern.

47. A catheter as claimed in claim 45, wherein the balloon means includes a plurality of balloons, the balloons being cast as pleated or unpleated elongated circular cylinders with the grooves formed by elastomeric wraps.

48. A catheter as claimed in claim 45, wherein the balloon means includes a plurality of balloons, the balloons being cast as pleated or unpleated elongated circular cylinders with the grooves formed during a blowing process.

49. A catheter as claimed in claim 45, wherein flow resistance for a summation of grooves is equal or less than flow resistance distal to an arterial treatment site.

50. A passive perfusion angioplasty catheter comprising:

an elongated flexible member having one of a core tube defining a lumen; and

inflatable balloon means having one of a pleated and unpleated grooved balloon being blown into a mold thereof directly from the lumen, said balloon being sucked into the lumen and threaded to an occluded site where, upon being pressurized, the balloon evaginates forming a grooved balloon providing passive perfusion when opening tightly occluded vessels.

51. A passive perfusion angioplasty catheter as claimed in claim 50 wherein the grooves are assured against collapse as inflation pressure is increased by having side walls whose tangents pass on a near side of the catheter centerline and a radial component of stress is maintained by intermittent bands for axial grooves or by adequate pitch when helical grooves are employed.

52. A passive perfusion angioplasty catheter as claimed in claim 51 wherein the grooves provide an optimum shaped passage for delivering blood from one side of the balloon to the other, said optimum shape being defined for any distribution of side wall slope as the shape providing a maximum hydraulic diameter for the passage bounded by the bottom and side walls of the balloon groove on each side and capped by a taut artery wall on top, said hydraulic diameter being defined as four times the passage cross sectional area divided by the passage perimeter.

53. A method of percutaneous transluminal angioplasty comprising the steps of:

providing a catheter having an elongated flexible member defining an inflation lumen and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface, said balloon means having a plurality of lobes defining first and second helical passages, said helical passages being defined by helically winding first and second bands about said balloon means, said first band being wound helically clockwise about a longitudinal axis of said balloon means, said second band being wound helically counterclockwise about the longitudinal axis of said balloon means, ends of said first and second bands being affixed to said flexible member, said first and second bands also defining said plurality of lobes;

inserting said catheter into an artery so that said balloon means is disposed at point were blood flow is restricted;

inflating and expanding said balloon means so that said balloon means presses against the interior surface of the arterial lumen to reduce a constriction in the artery; and

permitting blood to flow in said at least one passage so as to flow past said balloon means.

54. The method as claimed in claim 53, wherein the step of providing a catheter includes providing said balloon means having a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.

55. A method of percutaneous transluminal angioplasty comprising the steps of:

providing a catheter having an elongated flexible member defining an inflation lumen and inflatable balloon means affixed to a distal end of said flexible member for pressing against an interior surface of an arterial lumen, said balloon means defining at least one passage between an exterior thereof and said interior surface, said balloon means having at least one inflatable lobe, said at least one passage being a helical groove defined by said at least one lobe, a band being helically wound about a longitudinal axis of said balloon means, ends of said band being affixed to said flexible member, thereby defining a helical lobe and helical groove;

inserting said catheter into an artery so that said balloon means is disposed at point were blood flow is restricted;

inflating and expanding said balloon means so that said balloon means presses against the interior surface of the arterial lumen to reduce a constriction in the artery; and

permitting blood to flow in said at least one passage so as to flow past said balloon means.

56. The method as claimed in claim 55, wherein the step of providing a catheter includes providing said balloon means having a plurality of balloon members disposed in an array about said flexible member, said flexible member having a plurality of inflation lumens, each said balloon member being operatively coupled to one of said plurality of inflation lumens.