Inflatable medical devices

Abstract

Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application Nos. 61 / 057,986, filed 2 Jun. 2008; 61 / 086,739, filed 6 Aug. 2008; 61 / 105,385, filed 14 Oct. 2008; and 61 / 205,866, filed 22 Jan. 2009 which are incorporated by reference herein in their entireties.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]This invention relates to inflatable structures for use in medicine and other applications, and methods of manufacture and use of the same.[0004]2. Description of the Related Art[0005]Inflatable structures, such as balloons, are widely used in medical procedures. A balloon is inserted, typically on the end of a catheter, until the balloon reaches the area of interest. Adding pressure to the balloon causes the balloon to inflate. In one variation of use, the balloon creates a space inside the body when the balloon inflates.[0006]Balloons may be used to move plaque away from the center of a vascular lumen toward the vasc...

AI Technical Summary

Benefits of technology

[0074]A method for making the device is disclosed that can include applying fibers to a mandrel, applying an elastomeric resin to the fibers and bonding the fibers to the mandrel. Applying the fibers can include rotating the mandrel while feeding the length of the fibers from a location off the mandrel. The fibers or layer containing the fibers can be bonded to the mandrel or to an adjacent layer to prevent the fibers from slipping against the mandrel or adjacent layer. The mandrel can have an ovaloid shape.

Problems solved by technology

Sometimes the vasculature has a narrowing that is calcified, which can create a particularly difficult obstruction for dilation.

CTOs can be difficult to pass through with a device such as a guidewire or catheter and can be difficult to dilate or open.

Stenting of the carotids may release a stream of debris that can travel to the brain, causing strokes.

Traditional high-compliance medical balloons can be inadequate for many reasons.

High-compliance, or highly elastic medical balloons typically cannot reach high pressures because their walls have a low tensile strength and their walls thin out as the balloon expands.

In some instances, high-compliance medical balloons provide insufficient force to complete a procedure.

Exceeding the rated pressure of a high-compliance medical balloon creates an excessive risk of balloon failure which can lead to serious complications for the patient.

High-compliance medical balloons also have poor shape control.

In some cases, this can be contrary to what the medical practitioner desires.

High-compliance medical balloons often suffer from poor puncture resistance.

Therefore, many high-compliance medical balloons are not compatible with the introduction of aspects of the procedure that the high-compliance medical balloon is meant to support.

Balloons made from PET walls are fragile and prone to tears.

When pressed against a hard or sharp surface in the body, such as bone, PET balloons have poor puncture resistance.

PET is very stiff so balloons made from PET may be difficult to pack or fold into a small diameter or with good trackability (i.e., the ability to slide and bend over a guidewire deployed through a tortuous vessel).

In some applications, PET's chemical resistance can lead to unwanted adhesion, degradation or destruction of a PET balloon during a procedure.

Balloons made from PET, while stronger than most other balloons made from homogenous polymers, may still not be strong enough to hold pressures sufficient to complete certain medical procedures.

However, the oriented PET may not have strength in all directions exactly proportionate to the expected load.

The blow molding process makes it difficult or impossible to create certain shapes.

Blow molding can result in wall thicknesses in the balloon that do not match the material thicknesses to the expected load.

Nylon readily absorbs water, which can have an adverse affect on Nylon's material properties in some circumstances.

Low compliance fiber reinforced medical balloons may suffer from several problems.

Commercially available low compliance fiber reinforced medical balloons and the processes that produce them may only allow limited flexibility in the placement of the high strength inelastic fibers.

This limited choice of fiber orientation is not always the optimum way to orient the fibers for maximum strength.

This limited choice of fiber orientation is not always the optimum way to orient fibers to resist puncture or ripping.

Commercially available low compliance fiber reinforced medical balloons and the processes that produce them may not allow for a large variety of different balloon shapes to be manufactured.

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