Abstract: A balloon for a medical device has a structural layer of a highly crystallized PEN polymer material. The PEN polymer material a polyethylene naphthalate homopolymer or a crystallizable copolyester made up of residues of ethylene glycol, naphthalene dicarboxylic acid (NDC) and at least one member of the group (PA) consisting of terephthalic acid and isophthalic acid. The NDC groups make up about 5% or more of the sum of NDC and PA groups in the copolymer. The balloon is characterized by an ability to withstand a hoop stress of at least 35,000 psi without bursting.

Abstract: A guidewire having a super elastic core surrounded by a shape memory polymer jacket. The super elastic core wire permits the guidewire to be navigated through tortuous vasculature without undergoing plastic deformation, and the shape memory polymer jacket permits the guidewire to be shaped by the physician.

Abstract: The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Abstract: The present invention relates to an elongated medical device for intralumenal manipulation during a process of magnetic resonance imaging. The device includes an elongated body. An extrusion material is integrated with the elongated body and includes a hydrophilic polymer that incorporates a substance having a plurality of paramagnetic ions. The extrusion material is configured to enhance magnetic resonance visibility during said process of magnetic resonance imaging.

Abstract: Disclosed is an implantable or insertable medical device comprising (a) a substrate and (b) a hydrogel polymer coating at a least a portion of the surface of the substrate, wherein the hydrogel polymer is adapted to render the medical device visible under magnetic resonance imaging (MRI) upon insertion or implantation of the medical device into a patient. Also disclosed is the use of such a hydrogel coated implantable or insertable medical device in a medical procedure, wherein during or after insertion or implantation of the medical device in a patient, the position of the medical device is viewed under MRI. The use of a hydrogel polymer for coating a medical device wherein the hydrogel polymer is adapted to render a medical device coated with the hydrogel polymer visible under MRI and a hydrogel polymer adapted to render a medical device coated therewith visible under MRI are also disclosed.

Abstract: Stabilizing an object in the body of a patient involves the injection of a lower critical solution temperature (LCST) material in a flowable form into the body of the patient so that the material contacts the object. The LCST material then forms a gel in the body due to a temperature inside the body such that the object is contained at least partially within the gel and thereby stabilized by the gel such that the object can then be easily fragmented within the body and/or retrieved from the body.

Abstract: Catheter lesion diagnostics are disclosed.

Abstract: Stabilizing an object in the body of a patient involves the injection of a lower critical solution temperature (LCST) material or other flowable material into the body of the patient so that the material contacts the object. The LCST material or other flowable material then forms a gel in the body such that the object is contained at least partially within the gel and thereby stabilized by the gel such that the object can then be easily fragmented within the body and/or retrieved from the body.

Abstract: The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Abstract: An elongate polymer member having molecular helical orientation formed by rotation immediately after passing through the extrusion head. The elongate polymer member is rotated downstream of the extrusion head in the molten state prior to solidification in order to impart the molecular helical orientation. Rotating the polymer member in the molten state allows the helical orientation to be imparted at the molecular level, and allows for more rotations per lineal foot of extrusion.

Abstract: A medical device such as a tube or a balloon including wall structure with multiple layers. The wall structure can distribute stress, resulting in reduced defect propagation and failure.

Abstract: A balloon for a medical device has a structural layer of a highly crystallized PEN polymer material. The PEN polymer material a polyethylene naphthalate homopolymer or a crystallizable copolyester made up of residues of ethylene glycol, naphthalene dicarboxylic acid (NDC) and at least one member of the group (PA) consisting of terephthalic acid and isophthalic acid. The NDC groups make up about 5% or more of the sum of NDC and PA groups in the copolymer. The balloon is characterized by an ability to withstand a hoop stress of at least 35,000 psi without bursting.

Abstract: Stabilizing an object in the body of a patient involves the injection of a lower critical solution temperature (LCST) material or other flowable material into the body of the patient so that the material contacts the object. The LCST material or other flowable material then forms a gel in the body such that the object is contained at least partially within the gel and thereby stabilized by the gel such that the object can then be easily fragmented within the body and/or retrieved from the body.

Abstract: Stabilizing an object in the body of a patient involves the injection of a lower critical solution temperature (LCST) material in a flowable form into the body of the patient so that the material contacts the object. The LCST material then forms a gel in the body due to a temperature inside the body such that the object is contained at least partially within the gel and thereby stabilized by the gel such that the object can then be easily fragmented within the body and/or retrieved from the body.

Abstract: The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.

Abstract: A device and method for providing radiation to selected radial portions of a segment of the interior wall of a body lumen. In a preferred embodiment, an intravascular catheter is positioned within a desired blood vessel adjacent to a lesion. A radioactive fluid is then injected into the catheter, and the catheter directs the radioactive fluid about the central axis of the vessel in the area of the lesion. This allows selected radial portions of a vessel to have a higher radiation exposure than other portions, which is particularly useful when a lesion does not uniformly extend around the entire circumference of a vessel.

Abstract: The invention features a catheter and methods for delivering drug to tissue at a desired location of the wall of a body lumen. The catheter is constructed for insertion in a body lumen and has a catheter shaft and an expandable portion mounted on the catheter shaft. The expandable portion is expandable to a controlled pressure to fill the cross-section of the body lumen and press against the wall of the body lumen. In one embodiment, at least a portion of the exterior surface of the expandable portion is defined by a coating of a tenaciously adhered swellable hydrogel polymer. Incorporated in the hydrogel polymer is an aqueous solution of a preselected drug to be delivered to the tissue or plaque. The hydrogel polymer and drug are selected to allow rapid release of a desired dosage of the drug from the hydrogel polymer coating during compression of the hydrogel polymer coating against the wall of the lumen when the expandable portion is expanded.

Abstract: The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.

Abstract: A balloon for a medical device has a structural layer of a highly crystallized PEN polymer material. The PEN polymer material being a polyethylene naphthalate homopolymer or a crystallizable copolyester made up of residues of ethylene glycol, naphthalene dicarboxylic acid (NDC) and at least one member of the group (PA) consisting of terephthalic acid and isophthalic acid. The NDC groups make up about 5% or more of the sum of NDC and PA groups in the copolymer. The balloon is characterized by an ability to withstand a hoop stress of at least 35,000 psi without bursting.

Abstract: Systems and methods are disclosed for implanting and forming both a polysaccharide fiber and an implant formed of the fiber. In one system, a liquid including polysaccharide and a liquid including a cross linking agent are mixed in a cannula to form a cross linked polysaccharide fiber in the cannula. In another system, a carrier fluid delivers a previously manufactured fiber through a cannula. A cutter is optionally provided on the cannula to sever the fiber after a sufficient length of fiber is implanted. The disclosed methods include a method of forming a polysaccharide fiber in the cannula while the cannula is inserted in a body, and a method of making a cross linked polysaccharide fiber for loading in a delivery system.