Puncture resistant balloon catheter

• US 5,613,979 A
• Filed: 11/01/1993
• Issued: 03/25/1997
• Est. Priority Date: 11/29/1989
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Johnson, Jeffrey A., Trotta, Thomas
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/146,587
• Time in Patent Office: 1,240 Days
• Field of Search: 606/191-195, 604/96-103, 604/264, 604/265
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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

A balloon catheter having an inflatable balloon in which the outer surface of the inflatable balloon is surrounded by an elastomeric sleeve. The sleeve is attached throughout at least a majority of its area to the balloon outer surface to provide pin hole and abrasion resistance. Preferably, the inflatable balloon is made of a flexible material of less elasticity than the material of the elastomeric sleeve. Thus the balloon expands to a generally limited maximum transverse dimension, while the collapse of the balloon is facilitated by the elastomeric sleeve.

Claims

1. A balloon catheter, which comprises a flexible, elongated member, an inflatable balloon carried on the elongated member to define an inflation chamber within said balloon, an inflation conduit extending along said elongated member and communicating with the inflation chamber, said inflatable balloon being made of a flexible, relatively inelastic plastic essentially free of holes and having an outer surface surrounded by an elastomeric sleeve, said sleeve being bonded throughout at least a majority of its area to said balloon outer surface to provide pin hole and abrasion resistance.

5. The balloon catheter of claim 1 in which said inflatable balloon comprises a continuous, non-fibrous plastic tube.

6. A balloon catheter, which comprises:

a flexible, elongated member;

an inflatable balloon carried on the elongated member;

an inflation chamber defined within said balloon;

an inflation conduit communicating with the inflation chamber;

said inflatable balloon being made of a first flexible plastic material; and

a second, different plastic material co-extruded with said first plastic material for providing pin hole and/or abrasion resistance to said first plastic material.

2. The balloon catheter of claim 10 in which said inflatable balloon is made of a flexible material of less elasticity than the material of said elastomeric sleeve.

3. The balloon catheter of claim 10 in which said elastomeric sleeve and said balloon are together defined by a coextruded tube.

4. The balloon catheter of claim 3 in which the outer surface of said elastomeric sleeve carries a layer comprising a therapeutic or lubricating agent.

7. A balloon catheter as defined by claim 6, said second plastic material having greater flexibility than said first plastic material.

8. A balloon catheter as defined by claim 6, said second plastic material having greater elongation than said first plastic material.

9. A balloon catheter as defined by claim 6, said first plastic material comprising nylon.

10. A balloon catheter as defined by claim 6, said second plastic material comprising an elastomeric material.

11. A balloon catheter as defined by claim 6, said second plastic material being more elastic than said first plastic material.

12. A balloon catheter as defined by claim 6, said second plastic material being more resistant to pin holes than said first plastic material.

13. A balloon catheter as defined by claim 6, said second plastic material being more resistant to abrasion than said first plastic material.

14. A balloon catheter as defined by claim 6, in which said second plastic material overlies said first plastic material.

15. A balloon catheter, which comprises:

a flexible, elongated member;

an inflatable balloon carried on the elongated member;

an inflation chamber defined within said balloon;

an inflation conduit communicating with the inflation chamber;

said inflatable balloon being made of a first flexible, relatively inelastic biaxially oriented plastic material; and

a second different plastic material co-extruded with said first plastic material for providing pin hole and/or abrasion resistance to said first plastic material.

16. A balloon catheter which comprises a flexible, elongated member, an inflatable balloon carried on the elongated member to define an inflation chamber within said balloon, and an inflation conduit extending along said member and communicating with the inflation chamber, said inflatable balloon being made of a flexible, relatively inelastic biaxially oriented plastic essentially free of holes and having an outer surface surrounded by an elastomeric sleeve, said sleeve being bonded throughout at least a majority of its area to said balloon outer surface to provide pinhole and abrasion resistance.

17. A balloon catheter which comprises a flexible, elongated member, an inflatable balloon carried on the elongated member to define an inflation chamber within said balloon, and an inflation conduit extending along said member and communicating with the inflation chamber, said inflatable balloon being surrounded by an elastomeric sleeve to provide pinhole and abrasion resistance, said balloon and sleeve being together defined by a co-extruded tube, said balloon being made of a flexible, relatively inelastic biaxially oriented plastic material.

18. A method of forming a balloon catheter comprising a flexible, elongated member carrying an inflatable balloon, comprising the steps of:

providing a first flexible plastic material;

providing a second, different plastic material; and

co-extruding said first and second plastic materials to form said inflatable balloon with said second plastic material serving to provide pinhole and/or abrasion resistance to said first plastic material.

19. A method of making a balloon catheter comprising a flexible elongated member carrying an inflatable balloon, the method steps comprising:

providing a flexible, relatively inelastic biaxially oriented plastic essentially free of holes;

applying to said biaxially oriented plastic an elastomeric sleeve to provide pinhole and abrasion resistance.

20. A method of forming a balloon catheter comprising a flexible elongated member carrying an inflatable balloon, which comprises the steps of:

providing a first flexible plastic material;

providing a second, different plastic material;

co-extruding said first flexible plastic material with said second, different plastic material to form a co-extruded tube; and

stretching the co-extruded tube to orient the balloon material.

21. A method of forming a balloon catheter comprising a flexible, elongated member carrying an inflatable balloon, comprising the steps of:

providing a first plastic material;

providing a second, different plastic material; and

co-extruding said first and second plastic materials and forming a triple layer balloon.

22. A method of forming a balloon catheter comprising a flexible, elongated member carrying an inflatable balloon, comprising the steps of:

providing a plurality of plastic materials; and

co-extruding said plastic materials and forming a triple layer balloon.

23. A method of forming a balloon catheter comprising a flexible, elongated member carrying an inflatable balloon, comprising the steps of:

providing a first plastic material;

providing a second, different plastic material;

co-extruding said first and second plastic materials; and

inflating and stretching the plastic materials to form a biaxially oriented triple layer balloon.

24. A method of forming a balloon catheter comprising a flexible, elongated member carrying an inflatable balloon, comprising the steps of:

providing a plurality of plastic materials;

co-extruding said plastic materials; and

inflating and stretching the plastic materials to form a biaxially oriented triple layer balloon.

25. A catheter for medical purposes, said catheter comprising:

a tubular member having a distal end and at least one lumen disposed therethrough;

a balloon having at least one open end, said open end being sealed at a joint to said distal end, the interior of said balloon being in communication with said lumen, said balloon having an elongated tubular body and comprising a plurality of co-extruded layers of different polymeric materials, at least one of said layers being a polymer that is sealed by heat to said tubular member.

26. A catheter for medical purposes, said catheter comprising:

a tubular member having a distal end and at least one lumen disposed therethrough;

a balloon having at least one open end, said open end being sealed at a joint to said distal end, the interior of said balloon being in communication with said lumen, said balloon having an elongated tubular body and comprising a plurality of co-extruded layers of different polymeric materials, at least one of said layers being a base structural layer and the other of said layers being formed of a polymer which will make the balloon more resistant to abrasion and pinhole formation.