Multiple layer high strength balloon for dilatation catheter

• US 5,755,690 A
• Filed: 10/21/1994
• Issued: 05/26/1998
• Est. Priority Date: 01/09/1987
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C. R. Bard
• Inventors: Saab, Mark A.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/327,300
• Time in Patent Office: 1,313 Days
• Field of Search: 604/96-103, 606/192-195, 428/35.2, 128/207.15
• US Class Current: 604/103.06
• 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 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 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]

Abstract

A multilayer high strength balloon for a dilation catheter is provided. The balloon comprises a plurality of balloon layers, including an inner layer which has a cylindrical midportion, a cone at each end, and necks at the ends of the cones, and at least one additional layers which have the cylindrical midportions and cones. Each layer is formed from an inelastic, polymeric material, and perhaps an inelastic, biaxially oriented, thermoplastic material. Preferably, one or more of the balloon layers is blow molded and stretched to biaxially orient the material to form a very high strength layer. The multilayer balloon resulting from the plurality of balloon layers, of which one or more has been biaxially oriented, is stronger than a single layer balloon of the same finished diameter which has been made from the same material with comparable thickness. The composite high strength balloon may be formed to eliminate undesirable thickening of the cone regions of conventional blow molded balloon designs by stepping the cone regions so that they are not substantially greater than the wall thickness in the midportion of the balloon. The resulting balloon is better adapted to collapse to a low profile about the catheter shaft on which it is mounted.

Claims

1. A balloon dilatation catheter having a balloon, at least a portion of said balloon comprising at least two layers of the same inelastic, biaxially oriented, polymeric material composition, the catheter having an inflation lumen therein and the interior of the balloon being in fluid communication with the inflation lumen.

2. The balloon dilatation catheter as in claim 1 wherein the balloon has longitudinal and hoop strengths, said inelastic, biaxially oriented, thermoplastic material being oriented such that the longitudinal strength exceeds one half the hoop strength.

3. The balloon dilatation catheter as in claim 1, wherein at least one of said layers has a wall thickness to diameter ratio of less than 5.0×

10^-3.

4. The balloon dilatation catheter as in claim 3, wherein said balloon has a burst strength of at least 25 bars.

5. The balloon dilatation catheter as in claim 1, wherein said balloon has a radial tensile strength greater than about 35,000 psi.

6. The balloon dilatation catheter as in claim 1, wherein at least one of said layers of said balloon is heat set.

7. The balloon dilatation catheter as in claim 1, wherein said balloon has an F5 radial tensile strength greater than 30,000 psi.

8. The balloon dilatation catheter as in claim 1, wherein at least one of said layers of said balloon is a semicrystalline polymer.

9. The balloon dilatation catheter as in claim 1, wherein at least one of said layers of said balloon is polyethylene terephthalate.

10. The balloon dilatation catheter as in claim 1 wherein each said layer of said balloon is stable during storage and under inflation pressure.

11. The balloon dilatation catheter as in claim 1, wherein each of said at least two layers is formed from an extruded parison, each of the at least two layers including a cylindrical midportion, a cone extending from each end of said midportion, and a neck extending from each cone of one of said layers, the layers being coaxially and sequentially layered with the first layer forming the outermost layer, wherein said portion of said balloon comprises said midportion.

12. The balloon dilatation catheter as in claim 1, wherein at least one of said layers is stretched radially, close to the maximum achievable radial expansion for the material under the process conditions used.

13. The balloon dilatation catheter as in claim 12, wherein said stretched layer has an inner surface and an outer surface, said layer being stretched radially at said inner surface to within 10% of the maximum achievable radial expansion of said material under the process conditions used.

14. The balloon dilatation catheter as in claim 12, wherein each of said layers is stretched radially, close to the maximum achievable radial expansion for the material under the process conditions used.

15. The balloon dilatation catheter as in claim 1, wherein each of said layers of said balloon has a tensile strength greater than 35,000 p.s.i.

16. The balloon dilatation catheter as in claim 1, wherein the polymeric material of each of said layers is thermoplastic.

17. A multilayer balloon for use in a balloon dilatation catheter, at least a portion of said balloon comprising at least two layers, each layer being formed from an inelastic orientable polymeric material composition, each said layer being stretched radially, close to the maximum achievable radial expansion for the material under the process conditions used, to result in a highly oriented layer, wherein each of said layers is formed from the same polymeric material composition.

18. A multilayer balloon for use in a balloon dilatation catheter, at least a portion of said balloon comprising at least two layers formed from the same inelastic, orientable polymeric material composition, at least one of said layers being stretched radially, close to the maximum achievable radial expansion for the material under the process conditions used, to result in a highly oriented layer.

19. The multilayer balloon as in claim 18, wherein at least said stretched layer is formed from a thin walled parison having an inner surface and an outer surface, said parison being stretched at said inner surface to within 10% of the maximum achievable radial expansion of said material at said inner surface.

20. The multilayer balloon as in claim 19, wherein said parison has a wall thickness and an inside diameter measured from the center of said parison to said inner surface, the ratio of the wall thickness to the inside diameter being at most approximately 0.45.

21. The multilayer balloon as in claim 18, wherein each of said layers is formed from a thin walled parison having an inner surface and an outer surface, each said parison being stretched radially, close to the maximum achievable radial expansion for the material under the process conditions used, to result in a highly oriented polymeric material.

22. The multilayer balloon as in claim 21, wherein each of said parisons is stretched at said inner surface to within 10% of the maximum achievable radial expansion of said material at said inner surface under the process conditions used.

23. The multilayer balloon as in claim 22, wherein each of said parisons has a wall thickness and an inside diameter measured from the center of said parison to said inner surface, the ratio of the wall thickness to the inside diameter being at most approximately 0.45.

24. The multilayer balloon as in claim 18, wherein each of said layers is formed from a thermoplastic material.

25. The multilayer balloon as in claim 18, wherein each of said layers is formed from a semicrystalline material.

26. The multilayer balloon as in claim 18, wherein each of said layers is stretched to result in a highly oriented polymeric material.

27. The multilayer balloon as in claim 26, wherein each of said layers is stretched to result in a biaxially oriented polymeric material.