Abstract:
A method including forming a pseudo-gel of a semi-crystalline polymer material and a solvent. The pseudo-gel is shaped into a first form and stretched. A portion of the solvent is removed to create a second form. The second form is stretched into a microstructure including nodes interconnected by fibrils. A method including forming a first form of a pseudo-gel including an ultra-high molecular weight polyethylene material and a solvent; stretching the first form; removing the solvent to form a second form; stretching the second form into a microstructure including nodes interconnected by fibrils; and annealing the stretched second form. An apparatus including a body portion formed of a dimension suitable for a medical device application and including a polyolefin polymer including a node and a fibril microstructure. An apparatus including a body portion including an ultra-high molecular weight polyolefin material including a node and a fibril microstructure.
Abstract:
A method including forming a semi-crystalline polymer material into a lamella; and stretching the lamella into a polymer including a node of folded lamella and a fibril orientation. A method including extruding a pseudo-gel including an ultrahigh molecular weight polyethylene material into a lamella; stretching the lamella into a polymer including a node of folded lamella and a fibril orientation; and annealing the polymer at a temperature sufficient to define the node and fibril orientation. An apparatus including a body portion formed of a dimension suitable for a medical device application and including a semi-crystalline polymer arrayed in a node of folded lamella and a fibril orientation. An apparatus including a body portion including an ultra-high molecular polyethylene material arrayed in a node of folded lamella and a fibril orientation.
Abstract:
A method including positioning a catheter at a location in a blood vessel; imaging a thickness of a portion of a wall of the blood vessel at the location; identifying a treatment site; advancing a needle a distance into the wall of the blood vessel to the treatment site; and introducing a treatment agent through the needle to the treatment site. A composition including an inflammation-inducing agent and a carrier in the form of microspheres having a particle size suitable for transvascular delivery. A composition including a therapeutic angiogenesis promoter in a carrier and an opsonin-inhibitor coupled to the carrier. An apparatus for delivery of a therapeutic angiogenesis promoter.
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:
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 of the invention 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 of the invention exhibits high rupture pressure and low compliance coupled with good lesion cross and recross ability.
Abstract:
The present invention relates to an implantable medical device comprising therapeutic agents coated on the device using polyesters for the drug reservoir layer that exhibit surface-eroding characteristics.
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:
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:
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.