Non-compliant medical balloon having an integral woven fabric layer

• US 7,309,324 B2
• Filed: 10/15/2004
• Issued: 12/18/2007
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Futuremed Interventional, Inc. (Biomerics LLC)
• Inventors: Davies, William F. Jr., Pepper, Lanny R., Hayes, Kelli
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/966,970
• Publication Number:
  US 20060085022A1
• Time in Patent Office: 1,159 Days
• Field of Search: 604/508, 604/509, 604/95.04, 604/96.01, 60410306-10309, 604/103.13, 604/103.12
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 29/04 Macromolecular materials
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• 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
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: B32B 2255/02 on fibrous or filamentary layer
• CPC Class Codes: B32B 2255/26 Polymeric coating
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 37/1284 Application of adhesive
• CPC Class Codes: B32B 37/16 with all layers existing as coherent layers before laminating
• CPC Class Codes: B32B 5/024 : Woven fabric
• CPC Class Codes: B32B 5/26 : another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12

Abstract

A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a woven fabric layer composed of at least two woven fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Claims

1. A non-compliant medical balloon, where the non-compliant medical balloon may be changed from a deflated state having a folded configuration to an inflated state having a smooth, unfolded configuration by increasing pressure within the balloon, comprising:

an inner wall formed of a flexible but substantially inelastic polymer material defining two spaced-apart cone portions and a barrel portion disposed therebetween;

an adhesive layer applied directly to the outer surface of the inner wall;

a woven fabric layer including at least one substantially inelastic fabric fiber interwoven with a second fabric fiber in a single fabric layer, wherein said first fabric fiber and said second fabric fiber define angles where they cross one another;

wherein the balloon can change between a deflated state having a folded configuration with balloon folds on the outer surface to an inflated state having an unfolded configuration with a substantially smooth outer surface by increasing the pressure within the inner wall; and

wherein the fibers of the woven fabric layer are affixed to the inner wall by the adhesive layer such that the angles between the first fabric fiber and the second fabric fiber remains substantially unchanged when the balloon changes from the deflated state to the inflated state.

2. The non-compliant medical balloon of claim 1, further comprising a binding layer on an outer surface of said woven fabric layer.

3. The non-compliant medical balloon of claim 2, wherein said fabric layer further includes a polymeric coating.

4. The non-compliant medical balloon of claim 2, wherein said binding layer is a polymeric coating.

5. The non-compliant medical balloon of claim 4, wherein said polymeric coating is formed of a polymer.

6. The non-compliant medical balloon of claim 4, wherein said polymeric coating is formed of a copolymer.

7. The non-compliant medical balloon of claim 1, further comprising a second fiber layer on said woven fabric layer.

8. The non-compliant medical balloon of claim 7, wherein said second fiber layer comprises a plurality of parallel hoop fibers.

9. The non-compliant medical balloon of claim 8, wherein said hoop fiber is substantially transverse to the longitudinal axis of the balloon.

10. The non-compliant medical balloon of claim 8, wherein said hoop fiber has a thickness of about 0.0005 inch.

11. The non-compliant medical balloon of claim 8, wherein said parallel hoop fibers have a wind density of approximately 50 wraps per inch.

12. The non-compliant medical balloon of claim 7, further comprising a third fiber layer on said second fiber layer.

13. The non-compliant medical balloon of claim 1, wherein said second fabric fiber is also an inelastic fiber.

14. The non-compliant medical balloon of claim 1, wherein said angles between the fibers of the woven fabric layer are substantially right angles.

15. The non-compliant medical balloon of claim 1, wherein said first fabric fiber interwoven in the woven fabric layer has a thickness of about 0.0005 inch.

16. The non-compliant medical balloon of claim 1, wherein said angles between the fibers of the woven fabric layer are about ten degrees.

17. A balloon catheter comprising:

a catheter tube having a distal end; and

a non-compliant balloon element attached to the distal end of said catheter tube, where the balloon element may be changed from a deflated state having a folded configuration with balloon folds on the outer surface to an inflated state having an unfolded configuration with a substantially smooth, unfolded outer surface by increasing pressure within the balloon element, and where the balloon element includes

an inner wall formed of a flexible but substantially inelastic polymer material defining two spaced-apart cone portions and a barrel portion disposed therebetween,

an adhesive layer applied directly to the outer surface of the inner wall,

a woven fabric layer including at least one substantially inelastic fabric fiber interwoven with a second fabric fiber in a single fabric layer, wherein said first fabric fiber and said second fabric fiber define angles where they cross one another, and

wherein the fibers of the woven fabric layer are affixed to the inner wall by the adhesive layer such that the angles between the first fabric fiber and the second fabric fiber remain substantially unchanged when the balloon element changes from the deflated state to the inflated state.

18. The balloon catheter of claim 17, further comprising a binding layer on an outer surface of said woven fabric layer.

19. The balloon catheter of claim 18, wherein said fabric layer further includes a polymeric coating.

20. The balloon catheter of claim 18, wherein said binding layer is a polymeric coating.

21. The balloon catheter of claim 20, wherein said polymeric coating is formed of a polymer.

22. The balloon catheter of claim 20, wherein said polymeric coating is formed of a copolymer.

23. The balloon catheter of claim 17, further comprising a second fiber layer on said woven fabric layer.

24. The balloon catheter of claim 23, wherein said second fiber layer comprises a plurality of parallel hoop fibers.

25. The balloon catheter of claim 24, wherein said hoop fiber is substantially transverse to the longitudinal axis of the balloon.

26. The balloon catheter of claim 24, wherein said hoop fiber has a thickness of about 0.0005 inch.

27. The balloon catheter of claim 24, wherein said parallel hoop fibers have a wind density of approximately 50 wraps per inch.

28. The balloon catheter of claim 24, further comprising a third fiber layer on said second fiber layer.

29. The balloon catheter of claim 17, wherein said second fabric fiber is also an inelastic fiber.

30. The balloon catheter of claim 17, wherein said angles between the fibers of the woven fabric layer are substantially right angles.

31. The balloon catheter of claim 17, wherein said first fabric fiber interwoven in the woven fabric layer has a thickness of about 0.0005 inch.

32. The balloon catheter of claim 17, wherein said angles between the fibers of the woven fabric layer are about ten degrees.

33. A non-compliant medical balloon, where the balloon may be changed from a deflated state having a folded configuration to an inflated state having an unfolded configuration by increasing the internal pressure, the balloon comprising:

a base layer formed of a flexible but substantially inelastic polymer material defining two spaced-apart cone portions and a barrel portion disposed therebetween;

a first adhesive layer applied to the surface of the base layer;

a first reinforcing layer affixed to the base layer by the first adhesive layer, the first reinforcing layer being one of either

a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and having a length substantially equal to the length of the long axis of the balloon and

a first woven fabric layer including at least one substantially inelastic fabric fiber interwoven with a second fabric fiber in a single fabric layer, the first fabric fiber and said second fabric fiber defining angles where they cross one another;

a second reinforcing layer being applied at least partially over the first reinforcing layer, the second reinforcing layer being one of either

at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon such that the circumferential inelastic fibers are evenly distributed along the length of the long axis of the balloon and

a second woven fabric layer including at least one substantially inelastic fabric fiber interwoven with a second fabric fiber in a single fabric layer, the first fabric fiber and said second fabric fiber defining angles where they cross one another;

at least one of the first and second reinforcing layers being one of the first and second woven fabric layers; and

a second adhesive layer affixing the second reinforcing layer to the first reinforcing layer;

wherein, when the balloon is in the deflated state, the outer surface of the balloon layer has a folded configuration of relatively small diameter, when the balloon is in a fully inflated state, the outer surface of the balloon layer has an unfolded configuration with a relatively large diameter, and when the balloon is fully inflated, it has a length and diameter that do not substantially change as the internal pressure increases, and wherein the angles between the first and second fibers in the first and second woven layers, if present, remain substantially unchanged when the balloon changes from the deflated state to the inflated state.