Catheter balloon with a discontinuous elastomeric outer layer

• US 6,695,809 B1
• Filed: 09/13/1999
• Issued: 02/24/2004
• Est. Priority Date: 09/13/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Lee, Jeong S.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/394,653
• Time in Patent Office: 1,625 Days
• Field of Search: 604/96.01, 604/103.05, 604/103.06, 604/103.09, 604/103.11, 604/103.13, 604/103.08, 606/108, 606/192, 606/194
• US Class Current: 604/96.01
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/12 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• 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 2025/1075 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

Abstract

An intraluminal balloon catheter with an elongated shaft, and an inflatable balloon on the shaft which has an inner layer and a discontinuous outer layer formed at least in part of an elastomeric polymeric material. In a presently preferred embodiment, the catheter is a stent delivery catheter with a stent disposed on the balloon in contact with at least a section of the discontinuous outer layer of the balloon. The discontinuous outer layer of the balloon may comprise fibers or strands of the elastomeric material woven into a braided, webbed, meshed, wrapped or wound outer layer of the balloon.

Claims

1. A balloon catheter, comprising:

a) an elongated shaft having a proximal end, a distal end, and at least one lumen extending therein; and

b) a balloon inflatable from an unexpanded configuration to an expanded configuration and a having a continuous inner layer configured to retain inflation fluid, and a discontinuous outermost layer bonded to an outer surface of the inner layer and extending about an entire circumference of said inner layer and longitudinally along at least a section of the inner layer and formed at least in part of a woven elastomeric polymeric material.

2. The balloon catheter of claim 1, wherein the woven elastomeric polymeric material comprises fibers having a transverse dimension of at least about 0.2 mm.

3. The balloon catheter of claim 1, wherein the woven elastomeric polymeric material comprises fibers having a dimension of about 0.02 mm to about 0.05 mm.

4. The balloon catheter of claim 1, wherein the woven elastomeric polymeric material comprises fibers and forms a mesh having openings between adjacent fibers.

5. The balloon catheter of claim 4 wherein the openings are about 0.25 to about 2.0 mm in length.

6. The balloon catheter of claim 1 wherein the discontinuous outer layer extends at least over a working length of the balloon.

7. The balloon catheter of claim 1 wherein the discontinuous outer layer of the balloon has a length about equal to a length of the inner layer of the balloon.

8. The balloon catheter of claim 1 wherein in the elastomeric polymeric material is a thermoplastic elastomer selected from the group consisting of polyester, polyamide, polyether block amide, and polyurethane.

9. The balloon catheter of claim 1 wherein the inner layer is formed of a polymeric material.

10. The balloon catheter of claim 9 wherein the inner layer polymeric material forms a semicompliant or a noncompliant inner layer.

11. The balloon catheter of claim 10 wherein the inner layer polymeric material comprises a high molecular weight, orientable, semicrystalline polymer.

12. The balloon catheter of claim 10 wherein the inner layer polymeric material is selected from the group consisting of polyolefin, polyethyleneterephthalate, nylon, polybutyleneterephthalate, PEN, polyetherether ketone, and polyurethane.

13. The balloon catheter of claim 9 wherein the inner layer polymeric material is compatible with the outer layer elastomeric polymeric material.

14. The balloon catheter of claim 13 wherein the inner layer polymeric material comprises a polyamide and the outer layer elastomeric polymeric material comprises polyether block amide.

15. A stent delivery catheter, comprising:

a) an elongated shaft having a proximal end, a distal end, and inflation lumen extending within at least a portion of a distal shaft section to a location spaced proximally from the distal end;

b) an inflatable balloon on the distal shaft section being inflatable from an unexpanded configuration to an expanded configuration and having an inner layer and a discontinuous outer layer, said discontinuous outer layer being formed at least in part of an elastomeric polymeric material, said discontinuous outer layer extending around an entire circumference of at least a section of the balloon; and

c) a stent disposed about said balloon, said stent having an inner surface in contact with said discontinuous layer, said stent contacting said discontinuous outer layer around an entire circumference of at least a section of the stent, said contacting occurring when said balloon is in the unexpanded and expanded configurations.

16. The stent delivery catheter of claim 15 wherein the discontinuous outer layer comprises woven fibers of the elastomeric polymeric material.

17. The stent delivery catheter of claim 16 wherein the woven fibers form a mesh having openings between adjacent fibers, and the stent comprises an open-walled structure, the mesh openings having a length not greater than openings in a wall of the stent.