Medical balloon and method of making same

• US 5,569,195 A
• Filed: 05/03/1994
• Issued: 10/29/1996
• Est. Priority Date: 08/13/1992
• Status: Expired due to Term

• Current Assignee: Vention Medical Advanced Components, Inc. (Nordson Corporation)
• Original Assignee: Mark A. Saab
• Inventors: Saab, Mark A.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/238,267
• Time in Patent Office: 910 Days
• Field of Search: 604/96, 604/101, 606/191, 606/192, 606/194
• US Class Current: 604/103.13
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/0025 having a collapsible lumen
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Multi-lumen balloons for use as or in conjunction with balloon dilation catheters, and methods for making such balloons, are disclosed.

Claims

1. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of blow molding every lumen of a multi-lumen, tubular element comprising orientable polymer so as to expand each of said lumens and to orient the polymer in at least one direction thereby forming a tubular segment comprising multiple lumens of oriented polymer having the properties of being very thin-walled, flexible, high strength, substantially inelastic, readily inflatable under fluid pressure, and readily collapsible under vacuum, said lumens further being integrally formed with one another.

2. Medical apparatus prepared according to claim 1 further wherein the interior portions of adjacent lumens are separated by a single-layer, integrally formed sidewall.

3. Medical apparatus prepared according to claim 2 wherein each said integrally formed sidewall has a thickness of less than 0.0015 inches.

4. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of blow molding every lumen of a multi-lumen, tubular element comprising orientable polymer in conjunction with stretching said tubular element, so as to expand each of said lumens and to biaxially orient the polymer in at least one direction thereby forming a very thin-walled tubular segment comprising multiple lumens of oriented polymer integrally formed with one another.

5. Medical apparatus prepared according to claim 4 further wherein the interior portions of adjacent lumens are separated by a single-layer, integrally formed sidewall.

6. Medical apparatus prepared according to claim 5 further wherein each said integrally formed sidewall has a thickness of less than 0.0015 inches.

7. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of:

(a) blow molding a tubular element comprising an orientable polymer, wherein said tubular element comprises a multi-lobed structure having a central lumen, a number n of discrete, outwardly-projecting peripheral lobes surrounding said central lumen, each said lobe further comprising a lumen, and total of n distinct open spaces between adjacent lobes, whereby n is an integer, so as to expand each of said lumens and to orient said polymer in at least one direction thereby forming a tubular segment comprising multiple lumens of oriented polymer, said lumens being integrally formed with one another, and leaving a total of n open spaces between adjacent lobes of said segment; and

(b) heat-shrinking a larger-diameter thermoplastic sleeve over said tubular segment so as to enclosed said n open spaces thereby creating n additional lumens inside said sleeve.

8. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of blow molding a tubular element comprising a orientable polymer while said tubular element is positioned inside a larger-diameter thermoplastic sleeve;

wherein said tubular element comprises a multi-lobed structure having a central original lumen, a number n of discrete, outwardly projecting peripheral lobes surrounding said central lumen, each said lobe further comprising an original lumen, and a total of n distinct open spaces between adjacent lobes, whereby n is an integer;

said blow molding being continued until each of the original lumens expands such that the outer wall of each peripheral lobe merges into the inner wall of said thermoplastic sleeve whereby the formerly n open spaces become n new lumens.

9. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of:

(a) heat-shrinking a thin-walled thermoplastic film over an assembly comprising a tubular balloon with one or more forming mandrels positioned adjacent an outer wall of said balloon, at least one of said mandrels being positioned adjacent an outer wall of said balloon in a helical pattern so as to form a spiral adjacent lumen around the outer wall of said balloon; and

, (b) removing said forming mandrels to leave a number of lumens corresponding to the number of forming mandrels, each said lumen being integrally formed with said outer wall.

10. Medical apparatus prepared according to claim 9 further including the step of creating pinholes along the length of said spiral adjacent lumen.

11. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of:

(a) heat-shrinking a thin-walled thermoplastic film over an assembly comprising a tubular balloon with one or more forming mandrels positioned adjacent an outer wall of said balloon, wherein said thermoplastic film comprises the same material as said balloon; and

, (b) removing said forming mandrels to leave a number of lumens corresponding to the number of forming mandrels, each said lumen being integrally formed with said outer wall.

12. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of:

(a) positioning an assembly comprising a substantially inelastic tubular balloon of an oriented polymer with one or more forming mandrels positioned adjacent an exterior surface of a wall of said balloon inside a larger-diameter thermoplastic sleeve;

(b) heat-shrinking said thermoplastic sleeve until the inner surface of said sleeve merges into the exterior surface of said tubular balloon thereby covering each said forming mandrel; and

, (c) removing said forming mandrels to leave a number of lumens corresponding to the number of forming mandrels, each said lumen being integrally formed with and adjacent to the exterior surface of said balloon.

13. Medical apparatus prepared according to claim 12 wherein said balloon comprises a thermoplastic polymeric material that has been expanded and oriented in at least one direction.

14. Medical apparatus prepared according to claim 12 wherein said balloon comprises a thermoplastic polymeric material that has been biaxially oriented.

15. Medical apparatus prepared according to claim 12 wherein said balloon has the properties of being very thin-walled, flexible, high strength, and substantially inelastic, comprising an inflatable interior which is readily inflatable under fluid pressure and readily collapsible under vacuum.

16. Medical apparatus prepared according to claim 12 wherein said balloon comprises at least a sidewall having a thickness of less than 0.0015 inches.

17. Medical apparatus prepared according to claim 12 wherein at least one of said mandrels runs along the entire length of said balloon so as to form an adjacent lumen that runs along the length of said balloon.

18. Medical apparatus prepared according to claim 12 wherein at least one of said mandrels runs along only part of the length of said balloon so as to form an adjacent lumen that runs along only part of the length of said balloon.

19. Medical apparatus prepared according to claim 12 wherein at least one of said mandrels is of substantially uniform cross-section along its length so as to form an adjacent lumen that has a substantially uniform cross-section along the length of said balloon.

20. Medical apparatus prepared according to claim 12 wherein at least one of said mandrels tapers in diameter along its length so as to form an adjacent lumen that tapers in diameter along the length of said balloon.

21. Medical apparatus prepared according to claim 12 wherein said thermoplastic sleeve comprises a material different from that of said balloon.

22. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of:

(a) expanding a thin-walled thermoplastic film inside an assembly comprising a tubular balloon with one or more forming mandrels positioned adjacent an inner wall of said balloon, wherein said thermoplastic film comprises the same material as said balloon; and

, (b) removing said forming mandrels to leave a number of lumens corresponding to the number of forming mandrels, each said lumen being integrally formed with said inner wall.

23. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of:

(a) positioning a smaller-diameter thermoplastic sleeve inside an assembly comprising a substantially inelastic tubular balloon of an oriented polymer with one or more forming mandrels positioned adjacent an interior surface of a wall of said balloon;

(b) heating and expanding said thermoplastic sleeve until the outer surface of said sleeve merges into the interior surface of said balloon thereby covering each said forming mandrel; and

, (c) removing said forming mandrels to leave a number of lumens corresponding to the number of forming mandrels, each said lumen being integrally formed with and adjacent to the interior surface of said balloon.

24. Medical apparatus prepared according to claim 23 wherein said balloon comprises a thermoplastic polymeric material that has been expanded and oriented in at least one direction.

25. Medical apparatus prepared according to claim 23 wherein said balloon comprises a thermoplastic polymeric material that has been biaxially oriented.

26. Medical apparatus prepared according to claim 23 wherein said balloon has the properties of being very thin-walled, flexible, high strength, and substantially inelastic, comprising an inflatable interior which is readily inflatable under fluid pressure and readily collapsible under vacuum.

27. Medical apparatus prepared according to claim 23 wherein said balloon comprises at least a sidewall having a thickness of less than 0.0015 inches.

28. Medical apparatus prepared according to claim 23 wherein at least one of said mandrels runs along the entire length of said balloon so as to form an adjacent lumen that runs along the length of said balloon.

29. Medical apparatus prepared according to claim 23 wherein at least one of said mandrels runs along only part of the length of said balloon so as to form an adjacent lumen that runs along only part of the length of said balloon.

30. Medical apparatus prepared according to claim 23 wherein at least one of said mandrels is of substantially uniform cross-section along its length so as to form an adjacent lumen that has a substantially uniform cross-section along the length of said balloon.

31. Medical apparatus prepared according to claim 23 wherein at least one of said mandrels tapers in diameter along its length so as to form an adjacent lumen that tapers in diameter along the length of said balloon.

32. Medical apparatus prepared according to claim 23 wherein said thermoplastic sleeve comprises a material different from that of said balloon.

33. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of expanding thermoplastic tubing along an inner wall of a tubular balloon to form one or more interior lumens, each said lumen being integrally formed with said inner wall.

34. Medical apparatus prepared according to claim 33 wherein said balloon comprises a thermoplastic polymeric material that has been expanded and oriented in at least one direction.

35. Medical apparatus prepared according to claim 33 wherein said balloon comprises a thermoplastic polymeric material that has been biaxially oriented.

36. Medical apparatus prepared according to claim 33 wherein said balloon has the properties of being very thin-walled, flexible, high strength, and substantially inelastic, comprising an inflatable interior which is readily inflatable under fluid pressure and readily collapsible under vacuum.

37. Medical apparatus prepared according to claim 33 wherein said balloon comprises a sidewall having a thickness of less than 0.0015 inches.

38. Medical apparatus prepared according to claim 33 wherein said thermoplastic tubing comprises the same material as said balloon.

39. Medical apparatus prepared according to claim 33 wherein said thermoplastic tubing comprises a material different from that of said balloon.

40. Medical apparatus prepared according to claim 33 wherein a plurality of sections of thermoplastic tubing are simultaneously expanded inside said balloon.

41. Medical apparatus prepared according to claim 40 wherein at least two of said sections of thermoplastic tubing comprise different materials.