Balloon catheter device

• US 6,923,827 B2
• Filed: 11/20/2002
• Issued: 08/02/2005
• Est. Priority Date: 09/18/1995
• Status: Expired due to Fees

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Laguna, Alvaro J., Campbell, Carey V., Spencer, Mark S.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US10/300,056
• Publication Number:
  US 20030074016A1
• Time in Patent Office: 986 Days
• Field of Search: 604 9601-104, 604507-510, 604/164.1, 606/108, 606190-200, 623/1.1, 623 111- 154, 623/11.11, 623/900, 623/902, 600/201, 600/204, 600/207, 600/210
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0039 differing in diameter
• 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 29/12 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• 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 25/1034 Joining of shaft and balloon
• CPC Class Codes: C08L 27/12 containing fluorine atoms
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/1359 Three or more layers [continuous layer]

Abstract

Balloon catheters having the strength and maximum inflated diameter characteristics of an angioplasty balloon and having the recovery characteristics during deflation of an elastic embolectomy balloon. The balloon catheter can be made in very small sizes and has a lubricious and chemically inert outer surface. The balloon catheter is easy to navigate through tortuous passageways, is capable of rapid inflation and deflation and has high burst strengths. Balloon covers having these same characteristics are also described for use with conventional embolectomy balloons or angioplasty balloons.

Claims

1. A method of installing a stent within a patient'"'"'s body, comprising:

a) providing a catheter system, comprising;

i) a tubular catheter shaft having a longitudinal axis with a proximal end and a distal end, said catheter shaft having an inflation lumen extending from an inflation port and extending distally to a location proximally spaced from the distal end;

ii) an inflatable balloon affixed near the distal end of the catheter shaft, said balloon having an interior chamber in fluid communication with the inflation lumen, wherein said balloon is formed of a polyurethane, wherein said balloon has a preinflated shape, said shape having a substantially circular cross-section; and

wherein said balloon has opposing ends affixed to the catheter shaft, said balloon having a length measured between said opposing ends, wherein the length varies less than ten percent between when the balloon is in a deflated state and when the balloon is inflated to a pressure of 8 atmospheres; and

iii) an expandable stent disposed about and mounted onto the balloon;

b) inserting the catheter system into the patient'"'"'s body;

c) inflating the balloon to produce radial expansion of the balloon and the stent mounted thereon; and

d) deflating the balloon to its preinflated shape.

2. The method of claim 1, wherein the balloon length varies less than five percent between when the balloon is in a deflated state and when the balloon is inflated to a pressure of 8 atmospheres.

3. A method of installing a stent within a patient'"'"'s body, comprising:

a) providing a catheter system, comprising;

i) a tubular catheter shaft having a longitudinal axis with a proximal end and a distal end, said catheter shaft having an inflation lumen extending from an inflation port and extending distally to a location proximally spaced from the distal end;

ii) an inflatable balloon affixed near the distal end of the catheter shaft, said balloon having an interior chamber in fluid communication with the inflation lumen, wherein said balloon is formed of polymeric material;

wherein said balloon has a preinflated shape, said shape having a substantially circular cross-section;

wherein said balloon has opposing ends affixed to the catheter shaft, said balloon having a length measured between said opposing ends, wherein the length varies less than ten percent between when the balloon is in a deflated state and when the balloon is inflated to a pressure of 8 atmospheres; and

iii) an expandable stent disposed about and mounted onto the balloon;

b) inserting the catheter system into the patient'"'"'s body;

c) inflating the balloon to produce radial expansion of the balloon and the stent mounted thereon; and

d) deflating the balloon to its preinflated shape.

4. The method of claim 3, wherein the balloon length varies less than five percent between when the balloon is in a deflated state and when the balloon is inflated to a pressure of 8 atmospheres.