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 medical device, such as, for example, a catheter, includes a tubular member having a first portion having a shape memory polymer.

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: A medical device includes a balloon catheter having an expandable member, e.g., an inflatable balloon, at its distal end and a stent or other endoprosthesis. The stent is, for example, an apertured tubular member formed of a polymer and is assembled about the balloon. The stent has an initial diameter for delivery into the body and can be expanded to a larger diameter by inflating the balloon.

Abstract: A catheter comprises a catheter shaft, at least a portion of which defines a medical device receiving region, and at least one sleeve. The at least one sleeve comprises a tubular member constructed and arranged to transition between an extended state and a retracted state. The tubular member has a first portion being engaged to a portion of the catheter shaft adjacent to the medical device receiving region. In the extended state a second portion is constructed and arranged to at least partially overlay the medical device receiving region. In the retraced state the second portion is removed from about the medical device receiving region. At least one of the first portion and the second portion of the tubular member are at least partially constructed from a shape memory material.

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 includes a body, a member in the body, and a contrast agent in the member. The device can be visible by magnetic resonance imaging.

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: Multilayer medical devices, apparatuses for making such devices, and methods of making such devices are disclosed.

Abstract: A three dimensional cell scaffold is provided including a biocompatible polymer formed from a plurality of fibers configured so as to form a non-woven three dimensional open celled matrix having a predetermined shape, a predetermined pore volume fraction, a predetermined pore shape, and a predetermined pore size, with the matrix having a plurality of connections between the fibers.

Abstract: Multilayer medical devices, apparatuses for making such devices, and methods of making such devices are disclosed.

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: A catheter comprises a catheter shaft, at least a portion of which defines a medical device receiving region, and at least one sleeve. The at least one sleeve comprises a tubular member constructed and arranged to transition between an extended state and a retracted state. The tubular member has a first portion being engaged to a portion of the catheter shaft adjacent to the medical device receiving region. In the extended state a second portion is constructed and arranged to at least partially overlay the medical device receiving region. In the retraced state the second portion is removed from about the medical device receiving region. At least one of the first portion and the second portion of the tubular member are at least partially constructed from a shape memory material.

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: A system for delivering a flowable substance capable of changing from liquid to solid for use as implants and surgical sealants includes a first reservoir containing a first flowable substance including a bulking agent, a second reservoir containing a second flowable substance including a reacting agent, and a cannula. A method of delivering flowable substance that changes from liquid to solid for use as implants and surgical sealants includes introducing a cannula having first and second lumens into the body, passing a flowable substance including a bulking agent through the first lumen, passing a second flowable substance including a reacting agent through the second lumen, mixing the first and second flowable substances in the cannula so that the bulking agent reacts with the reacting agent to form a flexible elongated fiber in the cannula, and moving the fiber through the opening in the cannula and into the body to form at least one of an implant and surgical seal.

Abstract: A medical device includes an inflatable balloon formed having portions of different materials, and a cutting element carried by the balloon. The materials can have different distensibility and/or compliancy.

Abstract: Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device.

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.