High-strength, thin-walled single piece catheters

• US 5,411,477 A
• Filed: 05/10/1993
• Issued: 05/02/1995
• Est. Priority Date: 05/11/1990
• 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): Rosenbaum, C. Fred
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/059,725
• Time in Patent Office: 722 Days
• Field of Search: 604/96, 606/192, 606/194, 264/520-524, 264/528, 264/529, 264/535, 425/526
• US Class Current: 604/103.13
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• 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 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• 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 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• 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 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An integral, single-piece, high-strength, thin-walled, inflatable catheter is disclosed. The catheter has one end partially or entirely closed, and is at least uniaxially oriented along its entire length. The method and apparatus for making the catheter is also disclosed. The catheters of this invention have a calculated radial tensile strength of about 10,000 psi or greater at every point along the catheter.

Claims

1. A unitary, integral and seamless catheter comprising self supporting robing having one closed end, said tubing comprising a tubular wall wherein at least a part of said tubular wall defines a balloon portion having a wall thickness on the order of 1.5 mils or less, and another part of said tubular wall defines said closed end portion, both of said portions being integrally formed with said tubular wall, further wherein said tubing consists essentially of an orientable polymeric material which has been biaxially oriented along substantially the entire length of said tubular wall and said closed end portion, said catheter having an overall longitudinal dimension at least double the longitudinal dimension of said balloon wall portion and also being sufficiently thin-walled so that said tubing is flexible, inflatable and collapsible.

2. The catheter of claim 1, wherein said tubing includes a body portion and a balloon portion.

3. Catheter according to claim 2 further wherein said body portion has a longitudinal dimension substantially greater than the outside diameter of said tubing.

4. Catheter according to claim 3 wherein said longitudinal dimension of said body portion is at least four times the outside diameter of said tubing.

5. The catheter of claim 2, wherein the tubing is dimensioned so that the outer diameter to wall thickness ratio of said body portion is between 25 and 750, and outer diameter to wall thickness ratio of said balloon portion is between 150 and 1500.

6. The catheter of claim 1, wherein said polymeric tubing consists essentially of polyethylene terephthalate.

7. The catheter of claim 1, wherein said tubing is heat set after being biaxially formed.

8. The catheter of claim 1, wherein the tubing is dimensioned so that the outer diameter to wall thickness ratio of at least a portion of said tubing is between 25 and 1500.

9. The catheter of claim 1, wherein said closed end is rounded.

10. The catheter of claim 1, wherein said closed end is tapered toward the longitudinal axis of said tubing.

11. The catheter of claim 1, wherein said closed end is curved about the longitudinal axis of said tubing.

12. The catheter of claim 1, wherein the radial tensile strength of said material is about 10,000 psi or greater.

13. A unitary, integral and seamless balloon catheter consisting essentially of an orientable polymeric tubing comprising a balloon portion and proximal and distal body portions at the respective ends of said balloon portion, said distal body portion terminating at a closed end curved about the longitudinal axis of said tubing in a direction concave with respect to said balloon portion, further wherein said catheter has been biaxially oriented along its entire length and distal end and has an overall longitudinal dimension at least double the longitudinal dimension of said balloon portion.

14. Catheter according to claim 13 wherein the sum of the longitudinal dimensions of said proximal and distal body portions is equal to or greater than the longitudinal dimension of said balloon portion.

15. Catheter according to claim 14 further wherein said catheter has an overall longitudinal dimension substantially greater than the outside diameter of said tubing.

16. The catheter of claim 13, wherein said polymeric tubing consists essentially of polyethylene terephthalate.

17. Balloon dilatation catheter apparatus comprising:

(a) elongated, flexible, thin-walled, substantially inelastic polymeric tubing having an open proximal end, a biaxially oriented closed distal end, and an interior passageway having a substantially constant tubing diameter when said apparatus is inflated, said passageway being defined by biaxially-oriented tubing wall means;

(b) a very thin-walled, flexible, high strength, substantially inelastic polymeric balloon which is readily inflatable under fluid pressure and readily collapsible under vacuum, said balloon being located between the proximal and distal ends of said tubing, said balloon comprising an interior having a substantially constant balloon diameter that is substantially independent of the fluid inflation pressure when said apparatus is inflated, said balloon diameter being greater than said tubing diameter, and said balloon being defined by biaxially-oriented balloon wall means having a thickness of about 1.5 mils or less; and

(c) integrally formed biaxially-oriented wall means joining said tubing wall means to said balloon wall means in a unitary, integral and seamless construction, further wherein said catheter apparatus has an overall longitudinal dimension at least double the longitudinal dimension of said balloon.

18. Catheter apparatus according to claim 17 wherein the apparatus has an overall longitudinal dimension substantially greater than the outside diameter of said tubing.

19. Catheter apparatus according to claim 18 wherein said longitudinal dimension of the apparatus is at least four times the outside diameter of said tubing.

20. Catheter apparatus according to claim 18 wherein said longitudinal dimension of the apparatus is about two thousand times the outside diameter of said tubing.

21. Balloon dilatation catheter apparatus according to claim 17 further wherein the ratio of said tubing diameter to the thickness of said tubing wall means is between 25 and 750.

22. Balloon dilatation catheter apparatus according to claim 17 further wherein the ratio of said balloon diameter to the thickness of said balloon wall means is between 150 and 1500.

23. Balloon dilatation catheter apparatus according to claim 17 further wherein the ratio of said tubing diameter to the thickness of said tubing wall means is between 25 and 750, and the ratio of said balloon diameter to the thickness of said balloon wall means is between 150 and 1500.

24. Balloon dilatation catheter apparatus according to claim 17 wherein said tubing and said balloon consist essentially of polyethylene terephthalate.

25. Balloon dilatation catheter apparatus according to claim 17 wherein said tubing and said balloon have been heat set after being biaxially oriented.

26. A high-strength, thin-walled catheter made by the process of:

(a) heating a thin-walled tubular element having a tubular wall, a sealed distal end integrally formed with the tubular wall and an open proximal end and consisting essentially of orientable polymer to a temperature between the first and second order polymer transition temperatures;

(b) axially orienting the entire heated tubular element including the sealed distal end;

(c) radially orienting the entire heated tubular element including the sealed distal end by introducing a pressurized fluid into said tubing through the open proximal end thereof;

such that the steps (b) and (c) of orienting the tubular element stretches the element so that at least a portion of the stretched tubular element forms a balloon portion having a wall thickness less than or equal to 1.5 mils, the outer diameter to wall thickness ratio of said balloon portion is between 25 and 1500, the sealed distal end is biaxially oriented and said catheter has an overall longitudinal dimension at least double the longitudinal dimension of said balloon portion.

27. The catheter of claim 26, wherein said steps (b) and (c) include the steps of orienting the tubular element so as to form at least one body portion and a balloon portion, wherein the outer diameter to wall thickness ratio of said body portion is between 25 and 750 and said balloon portion is between 150 and 1500.

28. Catheter according to claim 26 wherein said orientable polymer consists essentially of polyethylene terephthalate.