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EP0318919A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Balloon catheter

Assignee: Boston Scientific Corp
•
Filing: 1988-11-29
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Granted: —
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Expires: 2008-11-29
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Abstract

Abstract An inflatable medical balloon is formed by fabricating a tubular preform having a tapered region at the end of the portion where the main body of the balloon will form to enable the corresponding transition section of the blown balloon to have a separately controllable thickness profile. The preferred method includes providing a tube of a selected resin of wall thickness and diameter suitable for being formed into a balloon, and selectively heating to drawing temperature a defined region of the tube at one or both ends of the portion of the tube from which the balloon is to be formed. Tension is applied in opposite directions to respective ends of the heated region to draw the region to a smaller diameter, thereby providing a preform having, at the end of the portion of the tube, a tapered, relatively small diameter region of material that has substantially no crystallization or molecular orientation. In preferred embodiments a tapered region is provided at both ends of the portion in which the main body of the balloon is to be formed. Thereafter the tubular preform is heated to blowing temperature and, while heated, a balloon is formed by drawing and blowing the preform including the tapered regions. The balloon is mounted to form a balloon catheter device. A dilatation balloon catheter, is also described having wall thickness in the transition region less than 0.001 inch.

Inventors

  • 👤 Richard A. Noddin
  • 👤 Ralph J. Barry, Jr.
  • 👤 Arthur R. Madenjian

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-25 06:02
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/1027; A61M25/1029; A61L; A61L29/00; A61L29/04; A61L29/06; A61M25/104

Claims Analysis

Total Claims: 20
Claim 1
Independent Claim 173 words
A method of forming an inflatable medical balloon comprising a) providing a tube of a selected resin of wall thickness and diameter suitable for being formed into a balloon for a balloon catheter drive, b) selectively heating to drawing temperature a defined region of said tube at an end of the portion of the tube from which the balloon is to be formed, c) applying tension in opposite directions to respective ends of said heated region to draw the region to a smaller diameter, thereby providing a preform having, at the end of said portion of tube, a tapered relatively small diameter region comprised of material that has substantially no crystallization or molecular orientation, d) thereafter heating said tubular preform to blowing temperature and, while heated, forming a balloon by drawing and blowing said preform including said tapered region and e) mounting said balloon to form a balloon catheter device, said step of preforming said tapered end region enabling the corresponding section of the blown balloon to have a separately controllable thickness profile.
Claim 2
Independent Claim 173 words
A method of forming an inflatable medical balloon comprising a) providing a tube of a selected resin of wall thickness and diameter suitable for being formed into a balloon for a balloon catheter drive, b) selectively heating to drawing temperature a defined region of said tube at an end of the portion of the tube from which the balloon is to be formed, c) applying tension in opposite directions to respective ends of said heated region to draw the region to a smaller diameter, thereby providing a preform having, at the end of said portion of tube, a tapered relatively small diameter region comprised of material that has substantially no crystallization or molecular orientation, d) thereafter heating said tubular preform to blowing temperature and, while heated, forming a balloon by drawing and blowing said preform including said tapered region and e) mounting said balloon to form a balloon catheter device, said step of preforming said tapered end region enabling the corresponding section of the blown balloon to have a separately controllable thickness profile.
Claim 3
Independent Claim 171 words
A method of forming an inflatable medical balloon comprising a) providing a tube of a selected resin of wall thickness and diameter suitable for being formed into a balloon for a balloon catheter drive, b) selectively heating to drawing temperature two defined regions of said tube at the ends of the portion of the tube from which the balloon is to be formed, c) applying tension in opposite directions to respective ends of said heated regions to draw the regions to smaller diameter, thereby providing a preform having, at the ends of said portion of tube, tapered, relatively small diameter regions comprised of material that has substantially no crystallization or molecular orientation, d) thereafter heating said tubular preform to blowing temperature and, while heated, forming a balloon by drawing and blowing said preform including said tapered regions and e) mounting said balloon to form a balloon catheter device, said step of preforming said tapered end regions enabling the corresponding sections of the blown balloon to have a separately controllable thickness profile.
Claim 4
Independent Claim 171 words
A method of forming an inflatable medical balloon comprising a) providing a tube of a selected resin of wall thickness and diameter suitable for being formed into a balloon for a balloon catheter drive, b) selectively heating to drawing temperature two defined regions of said tube at the ends of the portion of the tube from which the balloon is to be formed, c) applying tension in opposite directions to respective ends of said heated regions to draw the regions to smaller diameter, thereby providing a preform having, at the ends of said portion of tube, tapered, relatively small diameter regions comprised of material that has substantially no crystallization or molecular orientation, d) thereafter heating said tubular preform to blowing temperature and, while heated, forming a balloon by drawing and blowing said preform including said tapered regions and e) mounting said balloon to form a balloon catheter device, said step of preforming said tapered end regions enabling the corresponding sections of the blown balloon to have a separately controllable thickness profile.
Claim 5
Dependent Claim 30 words
The method of claim 1 or 2 wherein said drawing temperature is above the glass transition temperature and below crystallization temperature such that substantially no crystallization or molecular orientation occurs.
Claim 6
Dependent Claim 29 words
The method of claim 1 or 2 wherein said drawing temperature is near or above the melt temperature of said resin and after drawing, said preform is rapidly quenched.
Claim 7
Dependent Claim 28 words
The method of claim 1 or 2 wherein said blowing temperature is approximately the glass transition temperature or above, and substantially below the crystallization temperature of said resin.
Claim 8
Dependent Claim 30 words
The method of claim 5 wherein, for biaxially orienting the balloon, said blowing temperature is below the drawing temperature, in the region of the glass transition temperature of said resin.
Claim 9
Dependent Claim 37 words
The method of claim 1 or 2 wherein said resin is amorphous polyethylene terephthalate, said drawing temperature is between about 105 and 130 degrees centigrade and said blowing temperature is between about 85 and 115 degrees centigrade.
Claim 10
Dependent Claim 54 words
The method of claim 1 or 2 wherein said drawing to form said preform and said step of drawing and blowing said preform are so related that the wall thickness of the main body of the balloon and the wall thickness of a tapered end section of the balloon are of substantially equal value.
Claim 11
Dependent Claim 42 words
The method of claim 1 or 2 wherein said heating of said defined region is performed in such a manner that the portion of the tube from which the main body of the balloon is to be formed is not substantially heated.
Claim 12
Dependent Claim 13 words
A balloon product made according to the method of claim 1 or 2.
Claim 13
Dependent Claim 11 words
A balloon product made according to the method of claim 8.
Claim 14
Dependent Claim 136 words
In a dilatation balloon catheter for angioplasty comprising: a) an elongated, small diameter catheter adapted to be passed through the vascular system of the body to a point of stenotic occlusion of a blood vessel, b) an inflatable dilatation balloon secured about said catheter, adapted to be inflated at said point of occlusion to enlarge the blood vessel and relieve the restriction to blood flow, said balloon comprising a main body section of full diameter and at least one tapering transition section at one end of said main body section, c) and means to inflate and deflate said balloon said catheter characterized in that said balloon is the product of the process of blowing and drawing a preformed tubular member having a tapered contour in the region corresponding to the transition section of the blown balloon.
Claim 15
Dependent Claim 136 words
In a dilatation balloon catheter for angioplasty comprising: a) an elongated, small diameter catheter adapted to be passed through the vascular system of the body to a point of stenotic occlusion of a blood vessel, b) an inflatable dilatation balloon secured about said catheter, adapted to be inflated at said point of occlusion to enlarge the blood vessel and relieve the restriction to blood flow, said balloon comprising a main body section of full diameter and at least one tapering transition section at one end of said main body section, c) and means to inflate and deflate said balloon said catheter characterized in that said balloon is the product of the process of blowing and drawing a preformed tubular member having a tapered contour in the region corresponding to the transition section of the blown balloon.
Claim 16
Dependent Claim 33 words
The dilatation balloon catheter of claim 12 wherein the preformed tubular member is the product of heating and drawing a defined region of an extruded tube of originally constant diameter and wall thickness.
Claim 17
Dependent Claim 31 words
The dilatation balloon catheter of claim 12 wherein the wall thickness of said tapering transition section is about the same as the wall thickness of the main body of the balloon.
Claim 18
Dependent Claim 29 words
The dilatation balloon catheter of claim 12 wherein the wall thickness of said tapering transition section is less than the wall thickness of the main body of the balloon.
Claim 19
Dependent Claim 27 words
The dilatation balloon catheter of claim 12, 13, 14 or 15 wherein the main body of said balloon has an inflated diameter of 5 mm or larger.
Claim 20
Dependent Claim 23 words
The dilatation balloon catheter of claim 12, 13, 14 or 15 wherein the resin from which the balloon is formed is polyethylene terephthalate.

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