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Non-compliant medical balloon having a longitudinal fiber layer

Inactive Publication Date: 2005-06-09
CR BARD INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0005] The present invention is directed to a non-compliant medical balloon suitable for angioplasty and other medical procedures and which integrally includes very thin inelastic fibers having high tensile strength, and methods for manufacturing the balloon. The fiber reinforced balloons of the present invention meet the requirements of medical balloons by providing superior burst strength; superior abrasion-, cut- and puncture-resistence; and superior structural integrity.

Problems solved by technology

Balloons are exposed to large amounts of pressure.
Unfortunately, PET and other materials with high strength-to-film thickness ratios tend to be scratch- and puncture-sensitive.
Polymers that tend to be less sensitive, such as polyethylene, nylon and urethane are compliant and, at the same film thickness as the non-compliant PET, do not provide the strength required to withstand the pressure used for transit in a blood vessel and expansion to open an occluded vessel.
Further difficulties often arise in guiding a balloon catheter into a desired location in a patient due to the friction between the apparatus and the vessel through which the apparatus passes.
The result of this friction is failure of the balloon due to abrasion and puncture during handling and use and also from over-inflation.

Method used

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  • Non-compliant medical balloon having a longitudinal fiber layer
  • Non-compliant medical balloon having a longitudinal fiber layer
  • Non-compliant medical balloon having a longitudinal fiber layer

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0027] An angioplasty balloon, as shown in FIG. 1, having a wall thickness of 0.0008 inch is inflated to about 100 psi, and the two open ends of the balloon are closed off. The inflation pressure maintains the shape (geometry) of the balloon in an inflated profile during the construction of the composite balloon. The balloon is a blow-molded balloon of highly oriented polyethylene terephthalate (PET). To the inflated balloon is applied a very thin coat of 3M-75 adhesive to hold the fibers sufficiently to prevent them from slipping out of position after placement on the balloon.

[0028] Kevlar® fibers are placed, by hand, along the length of the balloon as shown in FIG. 2 to provide the primary wind. Each of the fibers is substantially equal in length to the length of the long axis of the balloon. Twenty-four fibers are used, substantially equally spaced from each other. The fiber used for the primary wind has a thickness of 0.0006 inch.

[0029] Next, a hoop wind of Kevlar® fiber is ap...

example 2

[0032] The procedure of Example 1 was repeated with the exception that Vectran® fiber, having a thickness of 0.0005 inch is used in place of the Kevlar® fiber. The resulting composite balloon is axially and radially non-compliant at very high working pressures. The balloon has very high tensile strength and abrasion and puncture resistance.

[0033] Vectran® is a high strength fiber available from Hoechst-Celanese, Charlotte, N.C.

example 3

[0034] A mandrel in the shape of a balloon as shown in FIG. 1 is made of a water-soluble wax. The wax mandrel is coated with a very thin layer (0.0002 inch) of Texin® 5265 polyurethane. After curing, adhesive and Vectran® fibers are applied, following the procedure of Example 1. Next, several coats of Texin® 5265 polyurethane as applied in Example 1. The wax is then exhausted by dissolving in hot water to give a non-compliant, very high strength, abrasion-resistant, composite fiber-reinforced balloon.

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Abstract

A non-compliant medical balloon is formed with a first fiber layer including a first fiber and a second fiber layer over said first fiber layer. The first fiber is substantially parallel to a longitudinal axis of the non-compliant medical balloon.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 10 / 726,960, filed Dec. 3, 2003 and U.S. patent application Ser. No. 10 / 726,464, filed Dec. 3, 2003. [0002] This application is related to U.S. Pat. No. 6,746,425, issued Jun. 8, 2004, which is a continuation-in-part of U.S. patent application Ser. No. 08,873,413, filed Jun. 12, 1997, which claims benefit of U.S. provisional application 60 / 019,931, filed Jun. 14, 1996. FIELD OF THE INVENTION [0003] This invention relates to the field of balloons that are useful in angioplasty and other medical uses. BACKGROUND OF THE INVENTION [0004] Catheters having inflatable balloon attachments have been used for reaching small areas of the body for medical treatments, such as in coronary angioplasty and the like. Balloons are exposed to large amounts of pressure. Additionally, the profile of balloons must be small in order to be introduced into blood vessels and other small areas ...

Claims

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Application Information

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IPC IPC(8): A61M29/02
CPCA61M25/104A61M2025/1086Y10T156/1062Y10T428/1369Y10T156/1075A61M2025/1084
Inventor BECKHAM, JIM
Owner CR BARD INC
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