NON-COMPLIANT MEDICAL BALLOON HAVING AN INTEGRAL WOVEN FABRIC LAYER

• US 20070213760A1
• Filed: 05/21/2007
• Published: 09/13/2007
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Futuremed Interventional, Inc. (Biomerics LLC)
• Inventors: HAYES, KELLI, DAVIES, WILLIAM, PEPPER, LANNY
• Granted Patent: US 8,002,741 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 29/04 Macromolecular materials
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: B32B 2255/02 on fibrous or filamentary layer
• CPC Class Codes: B32B 2255/26 Polymeric coating
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 37/1284 Application of adhesive
• CPC Class Codes: B32B 37/16 with all layers existing as coherent layers before laminating
• CPC Class Codes: B32B 5/024 : Woven fabric
• CPC Class Codes: B32B 5/26 : another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12

Abstract

A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a woven fabric layer composed of at least two woven fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Claims

1. A method of making a non-compliant balloon comprising:

forming a base balloon from a polymer material to form a flexible and substantially inelastic base balloon having a generally cylindrical barrel with a substantially fixed first circumference, first and second cylindrical end portions each having a proximate and distal end and a substantially fixed second circumference smaller than the first circumference and first and second transition portions each having a proximate end and a distal end, each transition portion extending from an end of the barrel to a proximate end of one of the cylindrical end portions;

applying a woven layer of substantially inelastic first fibers over the base balloon, the first fibers comprising warp and weft fibers woven in a pattern with each first fiber sequentially passing over and then under other of the first fibers in the woven layer and defining an intersect angle with the other first fibers;

applying at least one outer coating over the warp and weft fibers, the coating comprising a polymeric solution;

curing the outer coating to form an outer layer;

folding the balloon with balloon folds on the outer surface such that the balloon may be pressurized to an inflated state having an unfolded configuration with a substantially smooth outer surface by increasing the pressure within the base balloon; and

wherein the warp and weft fibers are fixed in position relative to the base balloon such that the angle at which each warp fiber intersects each weft fiber remains constant when the balloon is inflated and deflated.

2. The method of claim 1 wherein the step of applying a woven layer of substantially inelastic first fibers over the base balloon comprises applying substantially ribbon shaped fibers over the base balloon.

3. The method of claim 1 wherein the step of applying a woven layer of substantially inelastic first fibers over the base balloon comprises weaving the fibers in place over the base balloon.

4. The method of claim 1 wherein the step of applying a woven layer of substantially inelastic first fibers over the base balloon comprises applying pre-woven fibers over the base balloon.

5. The method of claim 4 further comprising applying an adhesive to the pre-woven fibers.

6. The method of claim 1 further comprising applying a second, substantially inelastic fiber over the warp and weft fibers, the second fiber extending around the balloon in a series of substantially parallel circumferential continuous loops from the distal end of the first transition section to the distal end of the second transition section.

7. The method of claim 1 wherein the base balloon is formed by one of blow molding a polymer material and applying a polymer layer to a mandrel.

8. A non-compliant medical balloon having a folded configuration and an inflated configuration, the balloon comprising:

a base balloon formed from a substantially inelastic polymer, the base balloon having a generally cylindrical barrel with a substantially fixed first circumference, first and second cylindrical end portions each having a proximate and distal end and a substantially fixed second circumference smaller than the first circumference and first and second transition portions each having a proximate end and a distal end, each transition portion extending from an end of the barrel to a proximate end of one of the cylindrical end portions, the circumference of the transition sections decreasing from the cylindrical barrel to cylindrical end portions;

a woven layer of substantially inelastic first fibers positioned on the base balloon, the first fibers comprising warp and weft fibers woven in a pattern with each first fiber sequentially passing over and then under other of the first fibers in the woven layer and defining an intersect angle with the other first fibers, the woven layer extending over the cylindrical barrel and transition portions of the balloon;

an adhesive for attaching the woven layer of first fibers to at least the cylindrical barrel and the transition sections;

an outer polymeric coating;

wherein the length and circumference of the balloon do not undergo a substantial change upon inflation of the balloon from the folded state to the inflated state; and

wherein the warp and weft fibers are fixed in position on the base balloon such that the angle at which each warp fiber intersects each weft fiber remains constant when the balloon is inflated and deflated.

9. The non-compliant medical balloon of claim 8 wherein the first fibers extend from the distal end of the first cylindrical end portion to the distal end of the second cylindrical end portion.

10. The non-compliant medical balloon of claim 8 further comprising a second fiber layer comprising a substantially inelastic hoop fiber wound over the warp and weft fibers, the hoop fiber extending around the circumference of the balloon between the ends of the cylindrical barrel in a series of substantially parallel circumferential continuous loops.

11. The non-compliant medical balloon of claim 10 wherein the substantially inelastic hoop fiber extends around the circumference of the balloon from the distal end of the first cylindrical end portion to the distal end of the second cylindrical end portion.

12. The non-compliant medical balloon of claim 8 wherein the cylindrical barrel has a diameter of from about five millimeters to about twenty millimeters.

13. The non-compliant medical balloon of claim 8 wherein the balloon has a length of from 2 to about 10 centimeters.

14. The non-compliant medical balloon of claim 8 wherein the transition sections are generally conical in shape with an angle of inclination of from about twelve degrees to about twenty degrees.

15. A non-compliant medical balloon that is expandable from a deflated state wherein the balloon is folded to an inflated state where the exterior of the balloon comprises a substantially smooth surface, the balloon comprising:

a base balloon formed from a substantially inelastic oriented polymer, the base balloon having a generally cylindrical barrel with a substantially fixed first circumference, first and second cylindrical end portions each having a proximate and distal end and a substantially fixed second circumference smaller than the first circumference and first and second transition portions each having a proximate end and a distal end, each transition portion extending from an end of the barrel to a proximate end of one of the cylindrical end portions, the circumference of the transition sections decreasing from the cylindrical barrel to cylindrical end portions, the cylindrical barrel having a wall thickness of less than 0.001 inch;

a plurality of substantially inelastic first fibers positioned on the base balloon, the first fibers comprising warp and weft fibers woven in a pattern with each fiber sequentially passing over and then under individual fibers in a series of transversely positioned fibers, the first fibers extending over the cylindrical barrel and transition portions of the balloon;

a second, substantially inelastic fiber discrete from the interwoven warp and weft fibers, the second fiber extending over the balloon between the ends of the cylindrical barrel;

an adhesive for attaching the plurality of first fibers to at least the cylindrical barrel and the transition sections;

an outer polymeric coating;

wherein the length and circumference of the balloon do not undergo a substantial change upon inflation of the balloon from the folded state to the inflated state; and

wherein the warp and weft fibers are fixed in position on the base balloon such that the angle at which each warp fiber intersects each weft fiber remains constant when the balloon is inflated and deflated.

16. The non-compliant medical balloon of claim 15 wherein the outer polymeric coating comprises a cured urethane polymer.

17. The non-compliant medical balloon of claim 15 wherein the first and second fibers are ribbon shaped, the fibers having a width greater than the thickness of the fiber.

18. The non-compliant medical balloon of claim 15 wherein the second fiber is wound over the warp and weft fibers in a series of continuous loops over the circumference of the barrel between the transition portions.

19. The non-compliant medical balloon of claim 15 wherein the second fiber is wound over the warp and weft fibers in a series of continuous loops over the circumference of the barrel between the distal ends of the transition sections.

20. The non-compliant medical balloon of claim 15 wherein the second fiber extends longitudinally along the length of the balloon from the distal end of the first cylindrical end portion to the distal end of the second cylindrical end portion.