WO1997017098B1 - Method of balloon formation by cold drawing/necking - Google Patents
Method of balloon formation by cold drawing/neckingInfo
- Publication number
- WO1997017098B1 WO1997017098B1 PCT/US1996/015958 US9615958W WO9717098B1 WO 1997017098 B1 WO1997017098 B1 WO 1997017098B1 US 9615958 W US9615958 W US 9615958W WO 9717098 B1 WO9717098 B1 WO 9717098B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- segment
- center portion
- balloon
- mold
- tension
- Prior art date
Links
- 230000015572 biosynthetic process Effects 0.000 title 1
- 238000010622 cold drawing Methods 0.000 title 1
- 238000005755 formation reaction Methods 0.000 title 1
- 239000000463 material Substances 0.000 claims abstract 18
- 229920001169 thermoplastic Polymers 0.000 claims abstract 12
- 239000004416 thermosoftening plastic Substances 0.000 claims abstract 12
- 239000011521 glass Substances 0.000 claims abstract 9
- 210000001624 Hip Anatomy 0.000 claims 14
- 238000004519 manufacturing process Methods 0.000 claims 6
- 238000007598 dipping method Methods 0.000 claims 5
- 238000001816 cooling Methods 0.000 claims 3
- -1 polyethylenes Polymers 0.000 claims 3
- 239000004952 Polyamide Substances 0.000 claims 2
- 239000004698 Polyethylene (PE) Substances 0.000 claims 2
- 229920001400 block copolymer Polymers 0.000 claims 2
- 238000007664 blowing Methods 0.000 claims 2
- 229920001971 elastomer Polymers 0.000 claims 2
- 239000000806 elastomer Substances 0.000 claims 2
- 229920002647 polyamide Polymers 0.000 claims 2
- 229920000728 polyester Polymers 0.000 claims 2
- 229920000573 polyethylene Polymers 0.000 claims 2
- 230000000875 corresponding Effects 0.000 claims 1
- HDERJYVLTPVNRI-UHFFFAOYSA-N ethene;ethenyl acetate Chemical class C=C.CC(=O)OC=C HDERJYVLTPVNRI-UHFFFAOYSA-N 0.000 claims 1
- 230000003100 immobilizing Effects 0.000 claims 1
- 229920000554 ionomer Polymers 0.000 claims 1
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 claims 1
- 239000011528 polyamide (building material) Substances 0.000 claims 1
- 229920000139 polyethylene terephthalate Polymers 0.000 claims 1
- 239000005020 polyethylene terephthalate Substances 0.000 claims 1
- 229920002635 polyurethane Polymers 0.000 claims 1
- 239000004814 polyurethane Substances 0.000 claims 1
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.
Claims
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 center portion 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.
2. The method as in claim 1 , wherein the thermoplastic material is chosen from the group consisting of polyamide elastomers, polyester elastomers, polyamides, polyesters, polyethylenes, polyurethanes, polyethylene ionomers, and ethylene vinyl acetates.
3. The method as in claim 2, wherein the thermoplastic material is polyethylene terephthalate.
4. The method as in claim 2, wherein during the drawing step the center portion is maintained at a temperature of no more than approximately room temperature.
5. The method as in claim 4, wherein the center portion is cooled just prior to drawing, such that the center portion remains cool during the drawing step.
6. The method as in claim 4, wherein the segment is cooled just prior to drawing.
7. The method as in claim 5, wherein the stretch rate is between 25 % to 75 % per second.
8. The method as in claim 5, wherein the stretch rate is approximately 75 % per second.
AMENDED SHEET (ARTICLE 11)
9. The method as in claim 5, wherein the cooling is accomplished by clamping the center portion with cold clamps, such that the center portion remains cool during the drawing step.
10. The method as in claim 7, wherein the segment is allowed to reach approximate room temperature before the expanding step.
11. The method as in claim 10, the expanding step comprising placing the segment of a thermoplastic material in the mold and blowing the balloon by pressurizing and tensioning the segment and gradually dipping the mold into a heated heat transfer media so as to sequentially blow the proximal end, the center portion and the distal end of the balloon, the segment being subjected to a relatively lower pressure than while the first waist and second waist portions are blown.
12. The method as in claim 11, wherein the segment is also subjected to a relatively a lower tension while the body portion is blown than while the first waist and second waist portions are blown.
13. The method as in claim 10, wherein the expanding step comprises the steps of placing the stretched segment in a mold having an internal form corresponding to the desired outer configuration of the balloon, and blowing the balloon by applying axial tension and internal pressure to the preform upon dipping of the mold into a heated heat transfer media, the expanding step further comprising: pressurizing the stretched segment to a first pressure in the range of 150-320 psi and applying a first tension in the range of 5-150 g; dipping the mold to a first depth in the range of from the transition (C) from the first waist to the first cone to the transition (D) from the first cone to the body portion of the balloon; reducing the pressure to a second pressure between 80 and 170 psi and setting a second tension in the range of the first tension; dipping the mold to a second depth in the range of from the transition (E) from the body portion to the second cone portion to the transition (F) from the second cone to the second waist; increasing the pressure to a third pressure higher than the second pressure and between 150 and 320 psi and increasing the tension to a third tension, higher than the first tension, and then, 25
dipping the mold to a third depth (H) beyond the depth of the second waist.
14. The method as in claim 13 wherein the third tension is in the range of 50 to 700 g.
15. The method as in claim 13 wherein: the mold is held at the first depth for a predetermined first time interval while maintaining said first tension and first pressure before said pressure reducing step; the mold is held at the second depth while maintaining the second tension and the second pressure for a predetermined second time interval before said pressure increasing step; and, the mold is held at the third depth for a predetermined third time interval while maintaining said third tension and third pressure.
16. The method of claim 15, wherein said heat transfer media is heated to a temperature of 90° C to 100° C.
17. The method of claim 13, wherein the second tension is the same as the first tension.
18. The method of claim 13, wherein the second tension is less than the first tension.
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: 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; immobilizing the center portion so that it becomes dimensionally stable and cannot be appreciably drawn; drawing the proximal end to a predetermined length while maintaining the immobilization of the center portion, 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. 26
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: 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 center portion 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.
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: 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 center portion 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 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 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. 27
22. A method of making a tubular parison for use in manufacturing catheter balloons comprising the steps: 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 center portion having a temperature; and drawing the segment to a predetermined length while maintaining the temperature of the center portion 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.
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE69611378T DE69611378T2 (en) | 1995-11-08 | 1996-10-04 | METHOD FOR BALLOON PRODUCTION BY COLD DRAWING / NECKING |
| EP96934058A EP0861104B1 (en) | 1995-11-08 | 1996-10-04 | Method of balloon formation by cold drawing/necking |
| AT96934058T ATE198280T1 (en) | 1995-11-08 | 1996-10-04 | METHOD FOR MAKING BALLOONS BY COLD DRAWING/NECKING |
| CA 2236879 CA2236879C (en) | 1995-11-08 | 1996-10-04 | Method of balloon formation by cold drawing/necking |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US55521995A | 1995-11-08 | 1995-11-08 | |
| US08/555,219 | 1995-11-08 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO1997017098A1 WO1997017098A1 (en) | 1997-05-15 |
| WO1997017098B1 true WO1997017098B1 (en) | 1997-07-10 |
Family
ID=24216449
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1996/015958 WO1997017098A1 (en) | 1995-11-08 | 1996-10-04 | Method of balloon formation by cold drawing/necking |
Country Status (6)
| Country | Link |
|---|---|
| US (2) | US5807520A (en) |
| EP (1) | EP0861104B1 (en) |
| AT (1) | ATE198280T1 (en) |
| DE (1) | DE69611378T2 (en) |
| ES (1) | ES2153984T3 (en) |
| WO (1) | WO1997017098A1 (en) |
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-
1996
- 1996-10-04 DE DE69611378T patent/DE69611378T2/en not_active Expired - Lifetime
- 1996-10-04 ES ES96934058T patent/ES2153984T3/en not_active Expired - Lifetime
- 1996-10-04 WO PCT/US1996/015958 patent/WO1997017098A1/en active IP Right Grant
- 1996-10-04 EP EP96934058A patent/EP0861104B1/en not_active Expired - Lifetime
- 1996-10-04 AT AT96934058T patent/ATE198280T1/en not_active IP Right Cessation
-
1997
- 1997-10-20 US US08/954,453 patent/US5807520A/en not_active Expired - Lifetime
-
1998
- 1998-09-14 US US09/152,413 patent/US6168748B1/en not_active Expired - Lifetime
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