Inflatable imbibed polymer devices

• US 20080125710A1
• Filed: 08/07/2006
• Published: 05/29/2008
• Est. Priority Date: 08/07/2006
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Lentz, Brian C., Houghton, Michael, Hobson, Alex R., King, David R., Newcomb, Kenneth, Roeber, Peter J., Korleski, Joseph E., Streeter, John
• Granted Patent: US 9,180,279 B2
• Time in Patent Office: Days
• US Class Current: 604/103.01
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/126 having a macromolecular matrix
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• 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 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/1025 Connections between catheter tubes and inflation tubes
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• 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 25/1034 : Joining of shaft and balloon
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: B32B 1/00 : Layered products having a non-planar shape
• CPC Class Codes: B32B 1/08 : Tubular products
• CPC Class Codes: B32B 5/18 : characterised by features of a layer of foamed material
• CPC Class Codes: C08J 2327/18 : Homopolymers or copolymers of tetrafluoroethylene
• CPC Class Codes: C08J 2475/04 : Polyurethanes
• CPC Class Codes: C08J 7/0427 : with only one layer of a composition containing a polymer binder with more layers C08J7/042
• CPC Class Codes: C08J 7/048 : Forming gas barrier coatings
• CPC Class Codes: Y10T 428/1352 : Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/1386 : Natural or synthetic rubber or rubber-like compound containing

Abstract

The present invention provides a stretchable material suitable for use in an inflatable medical device. The stretchable material has at least one reinforcing polymer layer with a top and bottom side forming a porous matrix which is imbibed with a sealing material to infiltrate and substantially seal spaces of the porous matrix and extend beyond the reinforcing polymer layer to form a surface coating.

Claims

1. A stretchable material comprising a reinforcing polymer having a porous matrix with void spaces and a sealing material imbibed into the reinforcing polymer substantially sealing the porous matrix void spaces and extending beyond the reinforcing polymer matrix to form a surface coating.

2. The stretchable material of claim 1 wherein the surface coating possesses a greater strain capability than the sealing material.

3. The stretchable material of claim 1 wherein the sealing material is an elastomer.

4. The stretchable material of claim 1 wherein the sealing material is a nylon.

5. The stretchable material of claim 1 wherein the sealing material is a polyether block amide.

6. The stretchable material of claim 1 wherein the sealing material is a fluoropolymer.

7. The stretchable material of claim 1 wherein the polymer matrix is anisotropic material stretched in only one direction.

8. The stretchable material of claim 1 wherein the polymer matrix is isotropic.

9. A balloon catheter comprising a tubular catheter shaft having a longitudinal axis and an inflatable bladderless wrapped balloon affixed to the catheter shaft wherein the balloon comprises the stretchable material of claim 1.

10. The balloon catheter of claim 9 wherein a surface coating is formed on both sides of the reinforcing polymer layer.

11. The balloon catheter of claim 9 wherein said surface coating maintains a watertight matrix when the sealing material is stressed.

12. The balloon catheter of claim 9 wherein the sealing material is an elastomer.

13. The balloon catheter of claim 9 wherein the sealing material is an urethane.

14. The balloon catheter of claim 9 wherein the sealing material is a fluoropolymer.

15. The balloon catheter of claim 9 wherein the sealing material is a viscous flow material.

16. The balloon catheter of claim 9 wherein the sealing material is a nylon.

17. The balloon catheter of claim 9 wherein the sealing material is a polyether block amide.

18. The balloon catheter of claim 9 wherein the surface coating thickness is controlled to allow for controlled porosity when strained due to inflation.

19. The balloon catheter of claim 18 wherein the controlled porosity delivers a liquid in therapeutic quantities.

20. The balloon catheter of claim 19 wherein the therapeutic liquid weeps only when the balloon is inflated to high pressure.

21. A wrapped balloon wherein the strain on the wrap layers is lower than the radial strain on the balloon upon inflation.

22. A balloon of claim 21 wherein the balloon is wrapped at an angle less than 54 degrees and the wrap angle approaches 54 degrees upon inflation.

23. A balloon of claim 21 wherein the final diameter is determined by the change between the wrap angle and the diameter wherein the wrap angle approaches 54 degrees upon inflation.