Abstract:
A dimensionally stable and growth controlled inflatable member formed by adding a multifunctional agent to a soft polymer to form a compound, extruding an inflatable member from the compound, and crosslinking the compound. The inflatable member is configured to be formed-in-place with a body lumen. Preferably, the inflatable member is blown to a working diameter prior to use and then heated to the glass transition temperature of the polymer to shrink the diameter of the blown inflatable member back to about the nominal diameter of the tubing. In another embodiment, the invention is a dimensionally stable and growth controlled inflatable member comprising longitudinal zones of crosslinked material symmetrically spaced about the circumference of the inflatable member and a uniform working diameter. Preferably, there are three or more longitudinal zones that run the working length of the inflatable member. The selectively irradiated inflatable members are formed in a mold having symmetrically spaced longitudinal windows.
Abstract:
A balloon for a balloon catheter and a method of manufacture The method entails providing a polymeric tubular member having an inner lumen and a longitudinal axis. An incompressible fluid is introduced into the inner lumen at a predetermined volumetric flow rate, expanding the polymeric tubular member to a desired outer diameter. The volumetric flow rate of fluid may be predetermined to not over-inflate the balloon. The balloon is blown slower because no initial pressure need be exceeded, so higher blow up ratios may be achieved without sacrificing any strength of the balloon. The balloons embodying features of the invention have thinner walls, yet maintain the same physical and mechanical properties of a thicker walled balloon manufactured in today's methods. Therefore, the process of the invention will lead to lower profile balloon catheters for balloon catheters with the same outer diameter balloon on them. Alternatively, a balloon with the same wall thickness as a balloon made from standard techniques will yield a much stronger balloon.
Abstract:
A method of treating vulnerable plaque comprising intentionally damaging or rupturing the vulnerable plaque using a wingless balloon which is inflated from a wingless unexpanded diameter to a limited expanded diameter. This process produces significant increase in ECM synthesis at the site of the damage or rupture. As a result, the method strengthens the vulnerable plaque while minimizing or avoiding damage to the surrounding wall of the body lumen or damaging a stable plaque mistakenly believed to be a vulnerable plaque. The method of the invention is particularly useful in treating a fibroatheroma type of vulnerable plaque. In one embodiment, the balloon is self-limiting such that it expands compliantly at initial inflation pressures, and above nominal pressure it expands noncompliantly. In an alternative embodiment, the balloon is inflated using a diameter-limiting device, such as a device which limits the inflation pressure or the volume of inflation fluid in the balloon.
Abstract:
Medical devices having at least a component, such as a catheter balloon, stent cover and vascular graft, formed of ultrahigh molecular weight polyolefin, such as ultrahigh molecular weight polyethylene. The device component is formed from ultrahigh molecular weight polyethylene that has been processed so that it is microporous and has an oriented node and fibril structure. The device component expands compliantly at low strains and are substantially less compliant at higher strains. The invention also comprises methods for making such medical devices, including the steps of compacting a polyethylene powder and deforming it to impart the oriented structure.
Abstract:
Medical devices such as catheter balloons, stent covers and vascular grafts formed of ultrahigh molecular weight polyethylene. The devices are formed from polyethylene that has been processed so that it is microporous and has an oriented node and fibril structure. The balloons expand compliantly at low strains and are substantially less compliant at higher strains. The invention also comprises methods for making such balloons, including the steps of compacting a polyethylene powder and deforming it to impart the oriented structure.
Abstract:
A catheter system for removably securing a stent which generally includes an inner tubular member and an outer tubular member with an expandable member disposed about the inner tubular member. A foamed cover is disposed between the expandable member and the inner tubular member. An expandable stent is crimped onto the expandable member and is retained in place by compressing the foamed cover. Used with a stent delivery system, the catheter system is inserted into a body lumen such as an artery. The stent is secured in place while advancing the system through tortuous body lumen passages. The stent is advanced to the desired location in the body lumen and implanted by inflating the expandable member and thereby expanding the stent into the body lumen. The stent is released from the system by deflating the expandable member and withdrawing the catheter system from the body.
Abstract:
Medical devices such as catheter balloons, stent covers and vascular grafts formed of ultrahigh molecular weight polyethylene. The devices are formed from polyethylene that has been processed so that it is microporous and has an oriented node and fibril structure. The balloons expand compliantly at low strains and are substantially less compliant at higher strains. The invention also comprises methods for making such balloons, including the steps of compacting a polyethylene powder and deforming it to impart the oriented structure.
Abstract:
A balloon formed of a single layer of polybutylene terephthalate and polytetramethylene ether glycol terephthalate copolymer in a substantially unblended form. The copolymer has a flexural modulus of greater than about 150,000 psi. The presently preferred copolymer is Hytrel® 8238 by DuPont. The balloon would be substantially unblended, defined as greater than about 60% by weight to about 100% by weight of the copolymer. The balloon is formed in a series of molds. The balloon exhibits high rupture pressure and low compliance coupled with good lesion cross and recross ability.