Distensible pet balloon and method of manufacture

• US 5,645,789 A
• Filed: 07/20/1995
• Issued: 07/08/1997
• Est. Priority Date: 07/20/1995
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Vascular Enterprises Limited (Abbott Laboratories)
• Original Assignee: Navius Corp. (JOMED NV)
• Inventors: Roucher, Leo R. Jr.
• Primary Examiner(s): Timm, Catherine
• Application Number:
  US08/504,537
• Time in Patent Office: 719 Days
• Field of Search: 264/523, 264/529, 264/530, 264/532, 264/573, 264/905, 604/96, 606/194
• US Class Current: 264/529
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: B29C 2949/08 Preforms made of several individual parts, e.g. by welding or gluing parts together
• CPC Class Codes: B29C 49/0042 without using a mould B29C49/1602 takes precedence
• CPC Class Codes: B29C 49/08 Biaxial stretching during blow-moulding
• CPC Class Codes: B29C 49/18 using several blowing steps B29C49/16 takes precedence
• CPC Class Codes: B29K 2067/00 Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2105/258 Tubular
• CPC Class Codes: Y10S 264/905 having plural, distinct differential fluid pressure shaping steps

Abstract

A semi-compliant PET balloon and a method for manufacturing the balloon are disclosed. The method for manufacturing the semi-compliant PET balloon includes the steps of varying the temperature and inflation pressure on a tube of PET material in an ordered sequence to i) form the balloon, ii) thin the walls of the balloon, ii) size the balloon and then, iv) crystallize the PET material of the balloon. First, to form the balloon, the tube of PET material is preheated, and simultaneously pressurized and stretched. The pressure in the tube is then increased to conform the balloon to the shape of a mold. Next the balloon walls are thinned by decreasing pressure and providing additional stretch on the PET tube. A subsequent increase in pressure sizes the balloon. The sized balloon is next subjected to an increase in temperature and a decrease in pressure to crystallize the PET material. A cooling step completes the method for manufacture.

Claims

1. A method for manufacturing a semi-compliant polyethylene terephthalate (PET) balloon which comprises the steps of:

positioning a tube of PET material across a mold cavity, said tube having a lumen extending therethrough;

preheating said tube in said cavity to a first temperature to soften said PET material;

pressurizing said lumen to a first pressure;

stretching said tube a first predetermined distance to lengthen said tube;

forming said balloon by raising said first pressure to a second pressure;

thinning said balloon by decreasing said second pressure to a third pressure and additionally stretching said tube a second predetermined distance;

sizing said balloon by increasing said third pressure to a fourth pressure;

crystallizing said PET material of said balloon by decreasing said fourth pressure to a fifth pressure and increasing said first temperature to a second temperature; and

cooling said PET material of said balloon by decreasing said second temperature to a third temperature.

2. A method as recited in claim 1 wherein said stretching step is accomplished simultaneously with said pressurizing step.

3. A method as recited in claim 1 wherein said forming step is accomplished over a time interval of approximately ten seconds.

4. A method as recited in claim 1 wherein said thinning step is accomplished over a time interval of approximately five seconds.

5. A method as recited in claim 1 wherein said sizing step is accomplished over a time interval of approximately ten seconds.

6. A method as recited in claim 1 wherein said crystallizing step is accomplished over a time interval of approximately sixty seconds.

7. A method as recited in claim 1 wherein said cooling step is accomplished over a time interval of approximately forty seconds.

8. A method as recited in claim 1 wherein said tube is approximately twelve inches in length and said first predetermined distance in said stretching step is in a range between thirty millimeters and eighty millimeters (30-80 mm).

9. A method as recited in claim 8 wherein said second predetermined distance is in a range between three millimeters and ten millimeters (3-10 mm).

10. A method as recited in claim 1 wherein said first temperature is approximately one hundred and eighty six degrees Fahrenheit (186°

F.).

11. A method as recited in claim 1 wherein said second temperature is approximately two hundred and seventy five degrees Fahrenheit (275°

F.).

12. A method as recited in claim 1 wherein said third temperature is approximately eighty five degrees Fahrenheit (85°

F.).

13. A method as recited in claim 1 wherein said first pressure is approximately one hundred pounds per square inch (100 psi).

14. A method as recited in claim 1 wherein said second pressure is approximately three hundred and twenty pounds per square inch (320 psi).

15. A method as recited in claim 1 wherein said third pressure is approximately thirty five pounds per square inch (35 psi).

16. A method as recited in claim 1 wherein said fourth pressure is approximately three hundred and twenty pounds per square inch (320 psi).

17. A method as recited in claim 1 wherein said fifth pressure is approximately one hundred pounds per square inch (100 psi).

18. A method as recited in claim 1 wherein said PET material for said balloon has an intrinsic viscosity in the range of from 0.66 to 0.78.