Method for forming catheter balloon

Patent metadata

Field	Value
Publication number	US-9579492-B2
Application number	US-201615145620-A
Country	US
Kind code	B2
Filing date	May 3, 2016
Priority date	Sep 14, 2010
Publication date	Feb 28, 2017
Grant date	Feb 28, 2017

Abstract

Multilayer balloon for a catheter comprises a first layer of a first elastomeric polymeric material, and a second layer of a second elastomeric polymeric material having a lower maximum blow up ratio (BUR) than the first elastomeric polymeric material and being an outer layer relative to the first layer. The multilayer balloon is formed by blow-molding such that the multilayer balloon is blown, in at least a first stage, to a final working radial dimension, wherein an area draw-down ratio (ADDR) of 2.0 for the multilayer balloon is targeted.

First claim

What is claimed:

1. A multilayer balloon for a catheter, comprising:
a first layer of a first elastomeric polymeric material, and a second layer of a second elastomeric polymeric material having a lower maximum blow up ratio (BUR) than the first elastomeric polymeric material and being an outer layer relative to the first layer, the multilayer balloon being formed by blow-molding such that the multilayer balloon is blown, in at least a first stage, to a final working radial dimension, wherein an area draw-down ratio (ADDR) of 2.0 for the multilayer balloon is targeted.

2. The multilayer balloon of claim 1 , wherein the multilayer balloon is blown in the first stage to a first radial dimension, and further wherein the multilayer balloon is blown in a subsequent stage to the final working radial dimension.

3. The multilayer balloon of claim 1 , wherein second layer has a Shore durometer hardness greater than a Shore durometer hardness of the first layer.

4. The multilayer balloon of claim 1 , wherein the first layer is bonded to the second layer with a tie layer.

5. The multilayer balloon of claim 1 , wherein the multilayer balloon is for a stent delivery catheter, and further wherein an expandable stent is mounted on the multilayer balloon for delivery and deployment within a patient's body lumen.

6. The multilayer balloon of claim 1 , wherein the multilayer balloon is blown in the first stage to the final working radial dimension and further wherein the multilayer balloon is heat set at a temperature above 100° C. after blow molding.

7. The multilayer balloon of claim 6 , wherein the multilayer balloon is heat set for about 15 to about 60 minutes.

8. The multilayer balloon of claim 6 , wherein the second layer has a Shore durometer hardness greater than a Shore durometer hardness of the first layer.

9. The multilayer balloon of claim 6 , wherein the first layer is bonded to the second layer with a tie layer.

10. The multilayer balloon of claim 6 , wherein the multilayer balloon is for a stent delivery catheter, and further wherein an expandable stent is mounted on the multilayer balloon for delivery and deployment within a patient's body lumen.

11. The multilayer balloon of claim 1 , wherein the multilayer balloon is formed by coextruding an extruded tube before the blow-molding.

12. The multilayer balloon of claim 1 , wherein the multilayer balloon has an average blow up ratio (BUR) greater than that of a comparative multilayer balloon having a first layer of the first elastomeric polymeric material and a second outer layer of the second elastomeric polymeric material and wherein an area draw-down ratio (ADDR) of 3.0 for the comparative multilayer balloon is targeted.

13. The multilayer balloon of claim 12 , wherein the average blow up ratio is an integrated average blow up ratio.

14. The multilayer balloon of claim 1 , wherein the multilayer balloon has a circumferential orientation throughout a balloon wall greater than that of a comparative multilayer balloon having a first layer of the first elastomeric polymeric material and a second outer layer of the second elastomeric polymeric material and wherein an area draw-down ratio (ADDR) of 3.0 for the comparative multilayer balloon is targeted.

15. The multilayer balloon of claim 1 , wherein the multilayer balloon has a compliance less than that of a comparative multilayer balloon having a first layer of the first elastomeric polymeric material and a second outer layer of the second elastomeric polymeric material and wherein an area draw-down ratio (ADDR) of 3.0 for the comparative multilayer balloon is targeted.

16. The multilayer balloon of claim 1 , wherein the multilayer balloon has a rupture strength greater than that of a comparative multilayer balloon having a first layer of the first elastomeric polymeric material and a second outer layer of the second elastomeric polymeric material and wherein an area draw-down ratio (ADDR) of 3.0 for the comparative multilayer balloon is targeted.

17. The multilayer balloon of claim 1 , wherein the multilayer balloon is formed by blow molding an extruded tube, the extruded tube having an elongation to failure between about 125% and about 150%.

Assignees

• Abbott Cardiovascular Systems Inc

Inventors

• Simpson John A
• Nelson Sarah A
• Durcan Jonathan P

Classifications

• B29C49/0411

  Means for defining the wall or layer thickness · CPC title

• B29C49/18

  using several blowing steps (B29C49/16 takes precedence) · CPC title

• B29C49/22

  using multilayered preforms or parisons · 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

• A61M25/0009

  Making of catheters or other medical or surgical tubes · CPC title