Non-compliant multilayered balloon for a catheter

• US 20070142771A1
• Filed: 12/20/2005
• Published: 06/21/2007
• Est. Priority Date: 12/20/2005
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Durcan, Jonathan
• Granted Patent: US 7,828,766 B2
• Time in Patent Office: Days
• US Class Current: 604/103.60
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• 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: A61M 25/104 used for angioplasty
• CPC Class Codes: B29C 67/0014 for shaping tubes or blown tubular films
• CPC Class Codes: C08L 77/00 Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08L79/06; of polyamideimides or polyamide acids C08L79/08; Compositions of derivatives of such polymers

Abstract

A balloon catheter having a multi-layered balloon which has a first layer and at least a second layer, and which has noncompliant limited radial expansion beyond the nominal diameter of the balloon. By selecting the polymeric materials forming the balloon layers, and arranging and radially expanding the multiple layers of the balloon in accordance with the invention, a balloon is provided having an improved low compliance, preferably in combination with high flexibility and softness.

Claims

1. A balloon catheter, comprising:

a) an elongated catheter shaft having a proximal end, a distal end, and an inflation lumen; and

b) a multilayered balloon on a distal section of the shaft having an interior in fluid communication with the inflation lumen, and having a first layer of a first elastomeric polymeric material, and a second layer of a second elastomeric polymeric material having a lower Shore durometer hardness than the first material and being an inner layer relative to the first layer, the balloon being formed by blow-molding such that the balloon inflates to a nominal working diameter, and the multilayered balloon has a compliance above the nominal diameter that is less than or equal to a balloon which consists of the first elastomeric polymeric material and which has a wall thickness which is the same or greater than the multilayered balloon.

2. The balloon catheter of claim 1 wherein the multilayered balloon first layer is a polyether block amide having a Shore durometer hardness of about 70D to about 72D.

3. The balloon catheter of claim 2 wherein the multilayered balloon second layer is a polyether block amide having a Shore durometer hardness of about 60D to about 70D.

4. The balloon catheter of claim 1 wherein the first layer is directly bonded to the second layer.

5. The balloon catheter of claim 1 including a third layer of a third polymeric material between the first and second layers, having a Shore durometer hardness between the Shore durometer hardnesses of the first and second elastomeric polymeric materials.

6. The balloon catheter of claim 5 wherein the first, second, and third polymeric materials are polyamides.

7. The balloon catheter of claim 5 wherein the multilayered balloon includes one or more additional polymeric layers.

8. The balloon catheter of claim 5 wherein the multilayered balloon includes an outer-most layer of a relatively low Shore durometer hardness elastomeric polymeric material having a Shore durometer hardness less than the first layer of the multilayered balloon.

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

10. The balloon catheter of claim 1 wherein the multilayered balloon has a modulus higher than a modulus of the balloon consisting of the first elastomeric polymeric material.

11. The balloon catheter of claim 1 wherein the multilayered balloon has a rupture pressure greater than, equal to, or not substantially lower than the balloon consisting of the first elastomeric polymeric material

12. The balloon catheter of claim 1 wherein the multilayered balloon compliance from nominal to a rated burst pressure is less than about 0.03 mm/atm, so that the multilayered balloon is noncompliant.

13. The balloon catheter of claim 1 wherein the multilayered balloon wall thickness is about equal to the balloon consisting of the first elastomeric polymeric material.

14. The balloon catheter of claim 13 wherein the multilayered balloon compliance from nominal to a rated burst pressure is less than the compliance of the balloon consisting of the first elastomeric polymeric material, and is less than about 0.02 mm/atm, so that the multilayered balloon is noncompliant.

15. A balloon catheter, comprising:

a) an elongated catheter shaft having a proximal end, a distal end, and an inflation lumen; and

b) a multilayered balloon on a distal section of the shaft having an interior in fluid communication with the inflation lumen, and having a first layer of a first polyether block amide elastomeric polymeric material having a Shore durometer hardness of about 72D, and a second layer of a second polyether block amide elastomeric polymeric material having a Shore durometer hardness of about 63D and being an inner layer relative to the first layer, and a mid layer of a third polyether block amide elastomeric polymeric material having a Shore durometer hardness of about 70D, the multilayered balloon being formed by blow-molding such that the balloon inflates to a nominal working diameter, and the multilayered balloon has a compliance above the nominal diameter that is less than or equal to a balloon which consists of the first elastomeric polymeric material and which has a wall thickness which is the same or greater than the multilayered balloon.

16. The balloon catheter of claim 15 wherein the multilayered balloon compliance from nominal to a rated burst pressure is less than about 0.02 mm/atm.

17. The balloon catheter of claim 15 wherein the multilayered balloon compliance from nominal to a rated burst pressure is not greater than about 0.018 mm/atm.

18. The balloon catheter of claim 15 wherein the multilayered balloon includes a fourth elastomeric polymeric layer.

19. A method of making a multilayered balloon for a catheter, having a blow-molded nominal working diameter and a noncompliant radial expansion above the nominal working diameter, comprising:

a) selecting a first and a second polymeric material, the second polymeric material having a maximum blow-up-ratio higher than the first polymeric material, and forming a multilayered tube having an inner diameter, an outer diameter, a first layer of the first polymeric material having an inner diameter, and a second layer of the second polymeric material having an inner diameter and being an inner layer relative to the first layer;

b) forming the blow-molded multilayered balloon by radially expanding the multilayered tube in a balloon mold having an inner diameter selected so that the ratio of the inner diameter of the mold and the inner diameter of each layer of the multilayered tube before being radially expanded in the mold is substantially at the maximum blow-up-ratio of polymeric material forming the layer, so that radially expanding the tube to the mold inner diameter radially expands each layer substantially to the maximum blow-up-ratio of the polymeric material forming the layer, such that the multilayered balloon has a compliance above the nominal diameter that is less than or equal to a balloon which consists of the first polymeric material and which has a wall thickness which is the same or greater than the multilayered balloon.

20. The method of claim 19 wherein the second polymeric material has a lower Shore durometer hardness than the first material, and wherein radially expanding the multilayered tube comprises radially expanding the first layer to a BUR of about 6 to 7, and radially expanding the second layer to a BUR of about 7 to 8.

21. The method of claim 20 wherein the first and second polymeric materials are elastomers and the multilayered tube is formed by coextrusion.