Inflatable imbibed polymer devices

• US 9,878,133 B2
• Filed: 07/07/2016
• Issued: 01/30/2018
• 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: Hobson, Alex R., Houghton, Michael, King, David R., Korleski, Jr., Joseph E., Lentz, Brian C., Newcomb, Kenneth, Roeber, Peter J., Streeter, John
• Primary Examiner(s): AUGHENBAUGH, WALTER
• Application Number:
  US15/204,902
• Publication Number:
  US 20160317717A1
• Time in Patent Office: 572 Days
• 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 balloon comprising:

a wrapped composite membrane including a reinforcing layer and a polymer layer, the reinforcing layer including a porous material having void spaces, the polymer layer being formed from a polymeric material that substantially fills the void spaces of the reinforcing layer and extends beyond the reinforcing layer to define the polymer layer,

wherein the balloon is configured to inflate to a working diameter in response to introduction of a fluid at a first pressure, wherein the fluid begins to perfuse through the wrapped composite membrane of the balloon at a second pressure, the second pressure being at least equal to or greater than the first pressure.

2. The balloon of claim 1, wherein the polymer layer has a thickness sufficient to provide for small openings to occur in the polymer layer when strained due to inflation.

3. The balloon of claim 1, wherein the fluid is a gas.

4. The balloon of claim 1, wherein the fluid is a liquid.

5. The balloon of claim 1, wherein the fluid comprises a therapeutic liquid agent.

6. The balloon of claim 1, wherein the fluid comprises water.

7. The balloon of claim 1, wherein the fluid inflates the balloon.

8. The balloon of claim 1, wherein the composite membrane is tubular.

9. The balloon of claim 1, wherein the composite membrane comprises a tubular structure.

10. The balloon of claim 9, wherein the tubular structure comprises sealed ends.

11. The balloon of claim 1, wherein the second pressure is at least 10 atm.

12. A balloon comprising a porous membrane including a porous microstructure and an elastomeric material that substantially fills voids in the porous microstructure and extends beyond the porous microstructure, the porous membrane being configured to inflate to a working diameter in response to introduction of a fluid at a first pressure, wherein the fluid begins to substantially perfuse through the porous microstructure and elastomeric material of the balloon at a second pressure, the second pressure being at least equal to or greater than the first pressure, wherein the second pressure is at least 10 atm.

13. The balloon of claim 12, the elastomeric material extending beyond the porous microstructure has a thickness sufficient to provide for small openings to occur in the elastomeric material extending beyond the porous microstructure when strained due to inflation.

14. The balloon of claim 12, wherein the fluid is a gas.

15. The balloon of claim 12, wherein the fluid is a liquid.

16. The balloon of claim 12, wherein the fluid comprises water.

17. The balloon of claim 12, wherein the fluid comprises a therapeutic liquid agent.

18. The balloon of claim 12, wherein the fluid inflates the balloon.

19. The balloon of claim 12, wherein the porous membrane is tubular.

20. The balloon of claim 12, wherein the porous membrane comprises a tubular structure.

21. The balloon of claim 20, wherein the tubular structure comprises sealed ends.