Balloon catheter device
First Claim
Patent Images
1. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the catheter balloon has a burst pressure of at least about 5 atmospheres.
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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.
124 Citations
69 Claims
- 1. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the catheter balloon has a burst pressure of at least about 5 atmospheres.
- 15. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the catheter balloon following inflation to 8 atmospheres and subsequent deflation has a compaction efficiency ratio of at least about 0.3.
- 25. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the balloon maintains a substantially circular cross section during inflation and deflation in the absence of external constraint.
- 39. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the catheter balloon has opposing ends affixed to a catheter, said balloon having a length measured between said opposing ends, and wherein the length varies less than about ten percent between when the balloon is in a deflated state and when the balloon is inflated to a pressure of 8 atmospheres.
- 47. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the porous material is polytetrafluoroethylene.
- 56. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the catheter balloon is configured for stent delivery.
- 59. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the catheter balloon is configured for graft delivery.
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62. A catheter balloon comprising a porous material and elastomeric material, the porous material being sealed to render it liquid-tight, wherein the catheter balloon following inflation to 8 atmospheres and subsequent deflation has a compaction ratio of at least about 0.5.
- 63. A catheter balloon comprising a balloon cover tubularly covering a balloon wherein the balloon cover comprises a porous material.
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67. A catheter balloon comprising a porous material and an inelastic material, wherein the porous material includes void spaces being sealed with the inelastic material to render the balloon liquid-tight.
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68. A catheter balloon comprising a porous material and an inelastic material, wherein the balloon during inflation exhibits a larger diameter at a first portion of its length than at a second portion of its length.
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69. A method of making a balloon catheter, comprising:
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a. providing a length of tubular catheter shaft having an inflation lumen connecting to an inflation port;
b. helically wrapping a length of porous polytetrafluoroethylene film about a first mandrel and removing the first mandrel, thereby creating a film tube having two opposing ends;
c. substantially sealing void spaces in the porous polytetrafluoroethylene film of the film tube with an elastomeric material; and
d. affixing the two opposing ends of the film tube to the tubular catheter shaft such that the inflation port is located between the two ends of the film tube, thereby creating an inflatable balloon from the film tube;
wherein after removing the film tube from the mandrel it is fitted over a second mandrel of smaller diameter than the first mandrel and tension is applied to the film tube in a longitudinal direction to cause it to conform to the second mandrel, after which the film tube and second mandrel are heated and allowed to cool, after which the film tube is compressed longitudinally, and then removed from the second mandrel.
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Specification
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Current AssigneeW. L. Gore & Associates (W.L. Gore & Associates)
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Original AssigneeGore Enterprise Holdings Incorporated
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InventorsLaguna, Alvaro J., Campbell, Carey V., Spencer, Mark S.
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current606/192
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CPC Class CodesA61F 2/958 Inflatable balloons for pla...A61F 2250/0039 differing in diameterA61L 29/041 obtained by reactions only ...A61L 29/085 Macromolecular materialsA61L 29/12 Composite materials, i.e. c...A61L 29/146 Porous materials, e.g. foam...A61M 2025/1075 having a balloon composed o...A61M 2025/1081 having sheaths or the like ...A61M 25/0014 Connecting a tube to a hubA61M 25/10 Balloon catheters A61M25/01...A61M 25/1029 Production methods of the b...A61M 25/1034 Joining of shaft and balloonC08L 27/12 containing fluorine atomsC08L 27/18 Homopolymers or copolymers ...C08L 75/04 PolyurethanesC08L 83/04 PolysiloxanesY10T 428/1334 Nonself-supporting tubular ...Y10T 428/1359 Three or more layers [conti...
