Method of balloon formation by cold drawing/necking
First Claim
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1. A method of making a balloon for a catheter device, the catheter device having a distal portion to be inserted into a body and the balloon being situated on the distal portion of the catheter device, comprising the steps:
- extruding a segment of thermoplastic material having a predetermined wall thickness and length, the segment having a proximal end, a distal end and a center portion, the center portion having a temperature;
drawing the segment to a predetermined length while maintaining the temperature of the segment below the glass transition temperature of the thermoplastic material, or below the highest glass transition temperature if the material is a block copolymer, wherein, during the drawing, the wall thickness of the center portion does not substantially change, and the proximal and distal ends form a first and second waist, respectively; and
expanding the segment in a mold to produce the balloon, the balloon having a body portion, wherein the center portion of said segment becomes the balloon body portion.
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Abstract
A method for forming a balloon for a dilatation catheter involving the steps of extruding a segment of thermoplastic material, maintaining the center portion at a temperature below the glass transition of the thermoplastic material, drawing the segment to a predetermined length, wherein after the drawing the wall thickness of the center portion does not appreciably change, and expanding the segment in a mold to produce the balloon.
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Citations
26 Claims
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1. A method of making a balloon for a catheter device, the catheter device having a distal portion to be inserted into a body and the balloon being situated on the distal portion of the catheter device, comprising the steps:
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extruding a segment of thermoplastic material having a predetermined wall thickness and length, the segment having a proximal end, a distal end and a center portion, the center portion having a temperature; drawing the segment to a predetermined length while maintaining the temperature of the segment below the glass transition temperature of the thermoplastic material, or below the highest glass transition temperature if the material is a block copolymer, wherein, during the drawing, the wall thickness of the center portion does not substantially change, and the proximal and distal ends form a first and second waist, respectively; and expanding the segment in a mold to produce the balloon, the balloon having a body portion, wherein the center portion of said segment becomes the balloon body portion. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 26)
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19. A method of making a balloon for a catheter device, the catheter device having a distal portion to be inserted into a body and the balloon being situated on the distal portion of the catheter device, comprising the steps:
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extruding a segment of thermoplastic material having a predetermined wall thickness and length, the segment having a proximal end, a distal end and a center portion; maintaining the segment at a temperature below the glass transition temperature of the thermoplastic material or below the highest glass transition temperature if the material is a block copolymer while immobilizing the center portion so that it becomes dimensionally stable and cannot be appreciably drawn relative to the proximal end; drawing the proximal end to a predetermined length while maintaining the relative immobilization of the center portion and maintaining the segment below said glass transition temperature, wherein, during the drawing, the wall thickness of the center portion does not appreciably change, and the proximal end forms a first waist; and expanding the segment in a mold to produce the balloon, the balloon having a body portion, wherein the center portion of said segment becomes the balloon body portion, and the distal end, due to expansion in the mold, stretching longitudinally to form a second waist.
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20. A method of making a balloon for a catheter device, the catheter device having a distal portion to be inserted into a body and the balloon being situated on the distal portion of the catheter device, comprising the steps:
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extruding a segment of thermoplastic material having a predetermined wall thickness and length, the segment having a proximal end, a distal end and a center portion; cooling the segment to a temperature below the glass transition temperature of the material; drawing the segment to a predetermined length while maintaining the temperature of the center portion below the glass transition temperature of the material, wherein, during the drawing, the wall thickness of the center portion does not appreciably change, and the proximal and distal ends form a first and second waist, respectively; and expanding the segment in a mold to produce the balloon, the balloon having a body portion, wherein the center portion of said segment becomes the balloon body portion. - View Dependent Claims (23)
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21. A method of making a balloon for a catheter device, the catheter device having a distal portion to be inserted into a body and the balloon being situated on the distal portion of the catheter device, comprising the steps:
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extruding a segment of thermoplastic material having a predetermined wall thickness and length, the segment having a proximal end, a distal end and a center portion; cooling the segment to a temperature below the glass transition temperature of the material; drawing the proximal end to a predetermined length while maintaining the temperature of the segment below the glass transition temperature of the material, wherein, during the drawing, the wall thickness of the center portion does not appreciably change, and the proximal end forms a first waist; and expanding the segment in a mold to produce the balloon, the balloon having a body portion, wherein the center portion of said segment becomes the balloon body portion, and the distal end, due to expansion in the mold, stretching longitudinally to form a second waist. - View Dependent Claims (24)
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22. A method of making a tubular parison for use in manufacturing catheter balloons comprising the steps:
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extruding a segment of thermoplastic material having a predetermined wall thickness and length, the segment having a first end, a second end and a center portion, the segment having a temperature and the center portion having a temperature; and drawing the segment to a predetermined length while maintaining the temperature of the segment below the glass transition temperature of the thermoplastic material, or below the highest glass transition temperature if the material is a block copolymer, wherein, during the drawing, the wall thickness of the center portion does not substantially change, and the first and second ends form a first and second waist, respectively. - View Dependent Claims (25)
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Specification