WO1998003218B1

WO1998003218B1 - High compliance, high strength catheter balloons useful for treatment of gastrointestinal lesions

Info

Publication number: WO1998003218B1
Application number: PCT/US1997/012074
Authority: WO
Filing date: 1997-07-11
Publication date: 1998-03-12
Anticipated expiration: 1999-01-23

Abstract

Balloon especially useful for dilatation of gastrointestinal lesions has a burst pressure of at least 9 atmospheres, a diameter at 3 atmospheres of about 5 mm or more, and an average compliance over the range of from 3 atmospheres to burst of at least 3 % per atmosphere. Such balloons and balloons having other combinations of burst strength, compliance and diameter may be prepared by a method wherein a tubing of a thermoplastic polymer material is radially expanded under a first elevated pressure at an elevated temperature to form the balloon at a first diameter and then annealing the balloon at a second elevated temperature and a second pressure less than the first elevated pressure for a time sufficient to shrink the formed balloon to a second diameter less than the first diameter. The thermoplastic polymer material may be a block copolymer material. Catheters bearing balloons prepared by this method have low withdrawal force requirements, especially catheters used in through-the-scope applications.

Claims

AMENDED CLAIMS

[received by the International Bureau on 28 January 1998 (28.01.98); original 12, 34 amended; new claims 35 and 36 added; remaining claims unchanged (2 pages)]

8. The method as in claim 4. wherein the hard segments are polyesters of an aromatic dicarboxvlic acid and a C--C₄ diol.

9. The method as in claim 4. wherein the hard segments are polyamides chosen from the group consisting of the combination of C₆ or higher carboxylic acids and C₆ or higher organic diamines and C₆ or higher, aliphatic ω-amino-α-acids.

10. The method as in claim 1. wherein the second pressure is within the range of 1 -l O psi.

1 1. Λ balloon for a medical device made by the method as in claim 1.

12. A balloon for a medical device, comprising a thermoplastic block copolymer material and having an operating pressure to which the balloon may be safeh inflated without bursting of at least 12 atmospheres, a diameter at 3 atmospheres of from about 1.5 to about 3.0 mm, a generally linear diameter growth rate over the range of 3-12 atmospheres, and a diameter growth of at least 0.25 mm over the range of 3-12 atm.

13. A balloon as in claim 12 wherein said diameter growth is at least 0.5 mm

14. A balloon as in claim 11 having an operating pressure to which the balloon may be safely inflated without bursting of at least 12 atmospheres, a diameter at 3 atmospheres of from about 3.25 to about 6.0 mm, a generally linear diameter growth rate over the range of 3-12 atmospheres, and a diameter growth of at least 1.0 mm over the range of 3-12 atm.

15. A balloon as in claim 11 having an operating pressure to which the balloon may be safely inflated without bursting of at least 10 atmospheres, a diameter at 3 atmospheres of from about 6 to about 12 mm, a generally linear diameter growth rate over the range of 3-10 atmospheres, and a diameter growth of at least 2 mm over the range of 3-10 atm. diameter, and then pressurizing the balloon in a fixed diameter form, said fixed diameter being greater than said second diameter but no more than 90% of said first diameter, at a pressure above the annealing pressure but no more than 50 psi and a temperature not less than said annealing temperature and not greater than said blowing temperature for a time to provide the balloon with a final diameter at 3 atm inflation pressure which is greater than said second diameter but not more than 90% of said first diameter.

30. A method as in claim 29 wherein said final diameter is 85% or less of said first diameter.

31. A method as in claim 29 wherein said final diameter is 65-75% of said first diameter.

32. A method as in claim 29 wherein the thermoplastic polymer material is a block copolymer, a thermoplastic elastomer, a polymer blend, a random copolymer of rigid and flexible monomers, polyurethanes which have rigid and flexible portions, polyketones, polysulfides or a polyamide homopolymer or copolymer.

33. In a method of treating a gastrointestinal lesion by inserting a catheter having a balloon thereon into the gastrointestinal tract, positioning the balloon at the lesion, inflating the balloon to accomplish treatment of the lesion, deflating the balloon and then withdrawing the catheter, the improvement wherein the balloon is a balloon as in claim 23.

34. A method as in claim 33 wherein the catheter is inserted into the gastrointestinal tract, and withdrawn therefrom, through an endoscope.

35. A balloon for a medical device characterized by an overall compliance from 3 atmospheres to burst pressure of at least about 27%.

36. A balloon as in claim 35, having a burst pressure of at least 9 atmospheres,