Inflatable balloon catheter seal and method
OwnerBoris Shkolnikinventor
Life of this patent
Estimating the term…
Abstract
An improved balloon catheter seal which may be used for attaching an inflatable balloon to a catheter body, especially when the balloon and catheter body are formed from dissimilar materials. The seal is formed by applying a layer of adhesive material between the inflatable balloon and the catheter body, and crimping a retaining ring over each seal junction. The invention is especially useful when joining a compliant balloon made from silicone to a catheter body made from polyurethane.
Claims20
A balloon catheter having a balloon and a catheter body formed of dissimilar polymeric materials, said balloon catheter comprising:
- a catheter body including an outer tubular member having proximal and distal ends and a lumen extending therethrough, said outer tubular member formed from a first polymeric material;
- said catheter body further including an inner tubular member having proximal and distal ends and a lumen extending therethough, said inner tubular member being coaxial with said outer tubular member, said inner tubular member running longitudinally through said outer tubular member and extending distally beyond the distal end of said outer tubular member, said inner tubular member formed from said first polymeric material;
- an inflatable balloon having a main body portion and proximal and distal portions extending from said main body portion, said proximal and distal portions each having an inner and outer surface, said inflatable balloon formed from a second polymeric material different from said first polymeric material;
- a first layer of adhesive material interposed between said inner surface of the proximal portion of the balloon and said distal end of the outer tubular member to bond said inner surface of the proximal portion of the balloon to said distal end of the outer tubular member;
- a first retaining ring positioned over and crimped tightly around said proximal portion of the balloon to reinforce the bond formed with said first layer of adhesive material and said distal end of the outer tubular member;
- a second layer of adhesive material interposed between said inner surface of the distal portion of the balloon and said distal end of the inner tubular member to bond said inner surface of the distal portion of the balloon to said distal end of the inner tubular member;
- a second retaining ring positioned over and crimped tightly around said distal portion of the balloon to reinforce the bond formed with the second layer of adhesive material and said distal end of the inner tubular member;
- and,
- a coupling member having a lumen extending therethrough, said coupling member being mounted on the proximal end of the outer tubular member and the lumen of the coupling member communicating with the lumen between the outer tubular member and the inner tubular member so that fluid may be injected into the lumen of the coupling member to inflate the balloon.
A balloon catheter comprising:
- an outer tubular member having proximal and distal ends and a lumen extending therethrough;
- an inner tubular member having proximal and distal ends and a lumen extending therethough, said inner tubular member being coaxial with said outer tubular member, said inner tubular member running longitudinally through said outer tubular member and extending distally beyond the distal end of said outer tubular member;
- an inflatable balloon having a main body portion and proximal and distal portions extending from said main body portion, said proximal and distal portions each having an inner and outer surface;
- a first layer of adhesive material interposed between said inner surface of the proximal portion of the balloon and said distal end of the outer tubular member to bond said inner surface of the proximal portion of the balloon to said distal end of the outer tubular member;
- a first retaining ring positioned over and crimped tightly around said proximal portion of the balloon to reinforce the bond formed with said first layer of adhesive material and said distal end of the outer tubular member;
- a second layer of adhesive material interposed between said inner surface of the distal portion of the balloon and said distal end of the inner tubular member to bond said inner surface of the distal portion of the balloon to said distal end of the inner tubular member;
- a second retaining ring positioned over and crimped tightly around said distal portion of the balloon to reinforce the bond formed with the second layer of adhesive material and said distal end of the inner tubular member;
- and,
- a coupling member having a lumen extending therethrough, said coupling member being mounted on the proximal end of the outer tubular member and the lumen of the coupling member communicating with the lumen between the outer tubular member and the inner tubular member so that fluid may be injected into the lumen of the coupling member to inflate the balloon.
A method of manufacturing a balloon catheter which includes an outer tubular member having proximal and distal ends;
- an inner tubular member having proximal and distal ends, said inner tubular member being coaxial with said outer tubular member, said inner tubular member running longitudinally through said outer tubular member and extending distally beyond the distal end of said outer tubular member;
- an inflatable balloon having a main body portion and proximal and distal portions extending from said main body portion, said proximal and distal portions each having an inner and outer surface;
- wherein the method includes the steps of:
- applying a first layer of adhesive material to the distal end of the outer tubular member;
- inserting the proximal portion of the balloon over the section of the outer tubular member covered by the first layer of adhesive material such that the balloon and the outer tubular member are coaxially oriented;
- positioning a first retaining ring over the proximal portion of the balloon;
- crimping a first retaining ring onto the proximal portion of the balloon;
- inserting the inner tubular member inside the balloon;
- positioning a second retaining ring over the balloon;
- applying a second layer of adhesive material onto the distal end of the inner tubular member at a location beneath the distal portion of the balloon;
- and,
- crimping the second retaining ring onto the distal portion of the balloon.
A method of manufacturing a balloon catheter which includes an outer tubular member having proximal and distal ends;
- an inner tubular member having proximal and distal ends, said inner tubular member being coaxial with said outer tubular member, said inner tubular member running longitudinally through said outer tubular member and extending distally beyond the distal end of said outer tubular member;
- an inflatable balloon having a main body portion and proximal and distal portions extending from said main body portion, said proximal and distal portions each having an inner and outer surface;
- wherein the method includes the steps of:
- applying a first layer of adhesive material to the distal end of the outer tubular member;
- inserting the proximal portion of the balloon over a portion of the outer tubular member covered by the first layer of adhesive material such that the balloon and outer tubular member are coaxially oriented;
- positioning a first retaining ring over the proximal portion of the balloon;
- crimping the first retaining ring onto the proximal portion of the balloon;
- positioning a proximal retaining ring sleeve over at least a half of the first retaining ring and extending over a proximal portion of the first retaining ring;
- heat fusing the proximal retaining ring sleeve to the outer tubular member and the first retaining ring;
- inserting the inner tubular member inside the balloon;
- positioning a second retaining ring over the balloon;
- applying a second layer of adhesive material onto the distal end of the inner tubular member at a location beneath the distal portion of the balloon;
- crimping the second retaining ring onto the distal portion of the balloon;
- positioning a distal retaining ring sleeve distally adjacent to the second retaining ring;
- and, heat fusing the distal retaining ring sleeve to the inner tubular member.
Dependencies are inferred from the claim text.