Abstract: A method including forming a semi-crystalline polymer material into a lamella; and stretching the lamella into a polymer comprising a node of folded lamella and a fibril orientation. A method including extruding a pseudo-gel comprising an ultrahigh molecular weight polyethylene material into a lamella; stretching the lamella into a polymer comprising 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 comprising a semi-crystalline polymer arrayed in a node of folded lamella and a fibril orientation. An apparatus including a body portion comprising an ultra-high molecular weight polyethylene material arrayed in a node of folded lamella and a fibril orientation.

Abstract: A medical device, and particularly an intracorporeal device for therapeutic or diagnostic use, comprising a silicone polyurethane. One embodiment of the invention is a medical device having a body formed of melt process extruded, porous silicone polyurethane material. In a method of the invention, the silicone polyurethane is combined with a porogen and then melt process extruded into a desired shape such as a tubular body. The porogen is then extracted from the extrudate, to form the extruded, melt processed, porous silicone polyurethane tubular body. The medical device, such as a stent cover, vascular graft, or catheter balloon, formed of the silicone polyurethane has excellent biostability, strength, and flexibility.

Abstract: A method of forming an expandable member for a medical device, and particularly a balloon for a catheter, in which extruded tubing is first expanded in a continuous or a semi-continuous process to form expanded tubing, and then the expanded tubing is further expanded in a balloon mold to form the catheter balloon. The method generally includes expanding a long length of tubing from a first inner and outer diameter to a second larger inner and outer diameter, to form expanded tubing having an expanded intermediate diameter, and processing the expanded tubing to form a plurality of expanded intermediate diameter tube segments, each segment having a length significantly shorter than the length of the expanded tubing. One of the segments is then placed in an inner chamber of a balloon mold, and expanded in the balloon mold to form a balloon for a catheter.

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 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: 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: 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.