Multilayer medical balloon

Patent metadata

Field	Value
Publication number	US-10286115-B2
Application number	US-201615000650-A
Country	US
Kind code	B2
Filing date	Jan 19, 2016
Priority date	Sep 3, 2008
Publication date	May 14, 2019
Grant date	May 14, 2019

Abstract

An expandable medical balloon including an inner layer formed of a poly (ether-block-amide) copolymer and an outer layer formed of a polyamide, the expandable medical balloon having a burst strength of greater than 50,000 psi, and to methods of making and using the same.

First claim

The invention claimed is:

1. A method of making an expandable medical balloon, the expandable medical balloon having an inner layer formed of a poly(ether block amide) copolymer; and an outer layer formed of a polyamide; the method comprising:
forming a tubular parison, the tubular parison comprising the inner layer formed of a poly(ether-block-amide) copolymer and the outer layer formed from a polyamide;
longitudinally stretching the tubular parison at a stretch ratio of less than 4.0; and
radially expanding the tubular parison in a balloon mold to form the expandable medical balloon.

2. The method of claim 1 further comprising heat setting said balloon at a temperature of less than about 150° C.

3. The method of claim 2 wherein said heat set temperature is about 120° C.

4. The method of claim 1 wherein said stretch ratio is about 3.5 or less.

5. The method of claim 1 wherein said polyamide is formed from laurolactam.

6. The method of claim 1 wherein said balloon mold is at a pressure of about 500 psi to about 600 psi.

7. The method of claim 1 wherein a radial cross-section of said tubular parison comprises a material ratio of about 70% to about 30% based on the outer layer to the inner layer.

8. The method of claim 1 wherein the resultant expandable medical balloon has a burst strength of 45,000 psi or more.

9. The method of claim 1 wherein the inner layer has a Shore D hardness of about 50D to about 70D.

10. The method of claim 1 wherein the outer layer has a Rockwell hardness of about 80 to about 115.

11. The method of claim 1 further comprising the step of applying a lubricious coating to at least a portion of said outer layer.

12. The method of claim 11 wherein said lubricious coating is applied by a method selected from the group consisting of dipping, spraying, brushing, sponge coating, and pad printing.

13. A method of making an expandable medical balloon, the expandable medical balloon having an inner layer formed of an elastomer; and an outer layer formed of a non-elastomer; the method comprising:
forming a tubular parison, the tubular parison comprising the inner layer from an elastomer and the outer layer formed from a non-elastomer;
longitudinally stretching the tubular parison at a stretch ratio of less than 4.0; and
radially expanding the tubular parison in a balloon mold to form the expandable medical balloon.

14. The method of claim 13 further comprising heat setting said balloon at a temperature of less than about 150° C.

15. The method of claim 13 wherein said heat set temperature was about 120° C.

16. The method of claim 13 wherein said stretch ratio is about 3.5 or less.

17. The method of claim 15 wherein the outer layer has a Rockwell hardness between about 70 and about 115 and the inner layer has a Shore D hardness of about 50D to about 75D.

18. The method of claim 13 wherein the outer layer has a Shore D harness of 80D or greater or a Rockwell hardness of greater than about 95.

19. The method of claim 13 wherein a radial cross-section of said tubular parison comprises a material ratio of about 70% to about 30% based on the outer layer to the inner layer.

20. The method of claim 13 wherein the resultant expandable medical balloon has a burst strength of 45,000 psi or more.

Assignees

• Boston Scient Scimed Inc

Inventors

• Chen John J
• Horn Daniel J

Classifications

• A61L29/08

  Materials for coatings · CPC title

• A61L2400/10

  Materials for lubricating medical devices · CPC title

• A61M25/10

  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 title

• A61L29/049 Primary

  Mixtures of macromolecular compounds · CPC title

• A61L29/14

  Materials characterised by their function or physical properties {, e.g. lubricating compositions} · CPC title