Inflatable imbibed polymer devices

• US 9,180,279 B2
• Filed: 08/07/2006
• Issued: 11/10/2015
• 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, Joseph E. Jr., Lentz, Brian C., Newcomb, Kenneth, Roeber, Peter J., Streeter, John
• Primary Examiner(s): Aughenbaugh, Walter B
• Application Number:
  US11/500,794
• Publication Number:
  US 20080125710A1
• Time in Patent Office: 3,382 Days
• Field of Search: 428/35.7, 604/103.06
• US Class Current: 1/1
• 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 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 wrapped layers of a composite film including a reinforcing polymer layer sandwiched between a first surface coating and a second surface coating, said first and second surface coatings each being a continuous polymer layer of a sealing material having been imbibed into the reinforcing polymer to substantially seal void spaces in said reinforcing layer and extend beyond the reinforcing polymer layer to form said first and second surface coatings.

2. The balloon catheter of claim 1 wherein the first surface coating and the second surface coating maintain a watertight matrix when the sealing material is stressed.

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

4. The balloon catheter of claim 1 wherein the sealing material is a fluoropolymer.

5. The balloon catheter of claim 1 wherein the sealing material is a viscous flow material.

6. The balloon catheter of claim 1 wherein the first surface coating and the second surface coating become porous upon inflation.

7. The balloon catheter of claim 6 wherein the first surface coating and the second surface coating allow for delivery of a therapeutic liquid.

8. The balloon catheter of claim 7 wherein the therapeutic liquid weeps only when the balloon is inflated above a pressure that strains the first surface coating and the second surface coating to allow said first and second surface coatings to become porous.

9. The balloon catheter of claim 1, wherein the reinforcing polymer comprises a stretchable anisotropic material.

10. The balloon catheter of claim 1, wherein the reinforcing polymer comprises PTFE with a longitudinal expansion ratio greater than a transverse expansion ratio.