Abstract: In accordance with the invention, there are provided medical devices with incorporated shape memory systems that allow a polymeric medical device to be inserted in a first conformation or configuration and revert to a second conformation or configuration. The invention is useful in allowing the easy insertion or implantation of a device followed by expansion of the device in order to be retained without expulsion from a body cavity, for example. In another aspect of the invention there is provided a medical device, such as a ureteral stent, that includes comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion. The elongated member has an initial outer diameter. A retention construction serves for retaining the member within a bodily cavity. The member is formulated of a physiologically acceptable polymer capable of hydrating and expanding from the initial member outer diameter to form a final member outer diameter.

Abstract: A synthesis method is set forth for forming a physiologically acceptable composition comprising a plurality of physiologically acceptable hydrogel particles which have been swollen in a water solution containing a low molecular weight water soluble organic compound, the solution having the ability to swell the particles. The concentration of the organic compound is such that the resulting particles can be inserted, without use of a carrier liquid utilizing a hand driven hypodermic syringe. The swollen hydrogel particles are substantially insoluble in body fluids. The method comprises contacting not fully swollen hydrogel particles with the organic compound and with water.

Abstract: A composition for injecting into tissues surrounding the urethra or ureter. It comprises a plurality of physiologically acceptable solid polymer particles dispersed in a physiologically acceptable biodissipatable liquid carrier. The polymer comprises a hydrophilic component. The solid polymer particles are a glycerine insoluble poly(ethylene oxide) (PEO) polymer or copolymer or a mineral oil insoluble polyvinylpyrrolidone polymer or copolymer. The plurality of solid polymer particles are capable of hydrating and upon hydration of absorbing at least about 30% water and of swelling to a predetermined volume. The solid particles are substantially insoluble in body fluids and substantially insoluble in and non-swellable by the liquid carrier. The composition is especially suitable in treating patients with urinary incontinence and patients with vesicoureteral reflux via injection into the tissues around the urethra or ureter.

Abstract: A method of treating urinary disorders utilizing a physiologically acceptable composition including a plurality of physiologically acceptable hydrogel particles which have been swollen in a water solution containing a low molecular weight water soluble organic compound, the solution having the ability to swell the particles. The concentration of the organic compound is such that the resulting particles can be inserted, without use of a carrier liquid utilizing a hand driven hypodermic syringe. The swollen hydrogel particles are substantially insoluble in body fluids.

Abstract: A package for a medical device made of an expandable or shape memory material is disclosed. The package is a sheath which surrounds and contains the medical device, and is of sufficient strength that upon exposure to conditions which would cause the medical device to expand or change its shape it is restrained from such shape change or expansion. The package has a tear-away or peel-away feature which provides easy access to the medical device when needed.

Abstract: An apparatus is provided for facilitating substantially bloodless insertion into and withdrawal from a patient's body of a longitudinal member having a proximal end portion and having a distal end portion which is adapted to extend into the patient's body. The apparatus comprises a longitudinally extending sleeve having proximal and distal end portions and defining a lumen extending there along. The longitudinal member is positioned along the lumen. The sleeve has a line extending longitudinally along it which is either split or splittable so that the sleeve can be separated along the line for removal from about the longitudinal member while the distal end portion of the longitudinal member remains extended into the patient. A valve structure serves for preventing blood flow through the lumen. An access is present for allowing substantially bloodless insertion and withdrawal of the longitudinal member through the lumen.

Abstract: The present invention is a medical device such as a stent in the form of an expandable mesh with an expandable polymer layer thereon. The mesh is metal or plastic. The polymer may be any of a variety of expandable polymers, which either expand upon hydration, or expand without significant resistance. The invention may be used, for example, as an expandable biliary, vascular, endotracheal, esophageal, or prostatic device.

Abstract: A ureteral stent comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion. The elongated member has an initial outer diameter. A retention construction serves for retaining the member within the ureter. The member is formulated of a physiologically acceptable polymer capable of hydrating and expanding from the initial member outer diameter to form a final member outer diameter. The stent can assume differing shapes and can exhibit different degrees of softening at different places along its length.

Abstract: An apparatus is provided for facilitating substantially bloodless insertion into and withdrawal from a patient's body of a longitudinal member having a proximal end portion and having a distal end portion which is adapted to extend into the patient's body. The apparatus comprises a longitudinally extending sleeve having proximal and distal end portions and defining a lumen extending there along. The longitudinal member is positioned along the lumen. The sleeve has a line extending longitudinally along it which is either split or splittable so that the sleeve can be separated along the line for removal from about the longitudinal member while the distal end portion of the longitudinal member remains extended into the patient. A valve structure serves for preventing blood flow through the lumen. An access is present for allowing substantially bloodless insertion and withdrawal of the longitudinal member through the lumen.

Abstract: An improved catheter assembly is set forth having a cannula having a proximal and distal end portions and longitudinal duct therethrough from said proximal to said distal end portion. A longitudinal piercing member having a distal end having a sharp insertion tip is positioned within the longitudinal duct of the cannula with the insertion tip extending beyond the distal end portion of the cannula. A hub having a passageway therethrough from its proximal to its distal end thereof has its distal end attached to the proximal end portion of the cannula with the passageway in flow communication with the duct in the cannula. A longitudinal piercing member extractor construction extends longitudinally from the longitudinal piercing member. The extractor construction extends through the duct of the cannula and through the passageway of the hub to a proximal end of the extractor construction.

Abstract: A catheter assembly is provided. An attachment structure has a proximal end portion of an outer cannula attached to it. A needle is insertable through the outer cannula and the attachment structure. An inner cannula is attached to an inner cannula attachment region of the attachment structure. The inner cannula is insertable axially through the attachment structure. The attachment structure can comprise two hubs, one for the outer cannula and the other for the inner cannula, the two hubs being attachable to one another to form the overall attachment structure. A valve structure is associated with the attachment structure, suitably with the outer cannula hub. The valve structure normally closes communication between an access passage in the attachment structure, e.g., in the outer cannula hub, and the outer cannula lumen.

Abstract: A swellable cannula is formed of concentric inner and outer hydrophilic and substantially non-hydrophilic layer structures. The hydrophilic layer structure comprises at least 2/3rds of the cross-sectional area of the wall of the cannula. The substantially non-hydrophilic layer structure is either substantially water impermeable or allows water to pass through at a controlled rate. The substantially non-hydrophilic layer structure may also control the diffusion of medicaments. The cannula has controlled softenability and swellability characteristics.

Abstract: The invention relates to a catheter assembly comprising a cannula, needle and catheter inserter wherein the inserter is in slidable relationship to the cannula and wherein the inserter or other device also serves to selectively restrict the cannula and needle from sliding relative to the inserter. The cannula comprises a material which, when inserted into the body of a living subject, softens and/or swells and has a tensile energy to break of at least about 700 N-cm/cm.sup.3 and a 2.5% Secant modulus of less than about 7,000 N/cm.sup.2. The invention also relates to a method of inserting a cannula into a living subject using an inserter which is positioned such that the desired length of cannula for initial insertion extends beyond the inserter. The method also relates to further inserting the cannula into the living subject after initial insertion of the cannula.

Abstract: An article, suitable for use as a body implant, is made from a novel composition comprising a multiple phase polymer composition comprising:(a) a first phase which comprises a substantially nonhydrophilic polymeric component; and(b) a second phase which comprises a hydrophilic polymeric component;said composition (i) being capable of absorbing water to an extent that it softens with a softening ratio of at least about 2:1 and/or swells with a swelling ratio of at least about 1.3:1; and (ii) when substantially completely hydrated has an energy to break of at least about 700 N-cm/cm.sup.3 and a 2.5% Secant modulus of less than about 7,000 N/cm.sup.2.

Abstract: An article, suitable for use as a body implant, is made from a novel composition comprising a multiple phase polymer composition comprising:(a) a first phase which comprises a substantially non-hydrophilic polymeric component; and(b) a second phase which comprises a hydrophilic polymeric component;said composition (i) being capable of absorbing water to an extent that it softens with a softening ratio of at least about 2:1 and/or swells with a swelling ratio of at least about 1.3:1; and (ii) when substantially completely hydrated has an energy to break of at least about 700 N-cm/cm.sup.3 and a 2.5% Secant modulus of less than about 7,000 N/cm.sup.2.

Abstract: A tubular cannula has distal and proximal end portions, a central passageway from the distal end portion of the proximal portion and a transition section connecting the distal and proximal end portions. The proximal end portion has larger inner and outer diamters and has thicker walls than does the distal end portion. The diameter difference and thickness are effectuated in a gradual manner in a transition section. The cannula is constructed of a material that softens on being inserted into a living body and/or contacted with an aqueous medium. The cannula combines kink resistance external of the living body with the advantages of a softening and generally swellable catheter.

Abstract: An improvement is set forth in a cannula having a proximal end portion adapted to be connected to a hub, a distal end portion and a longitudinal duct therethrough from the distal end portion to the proximal end portion. The improvement is wherein the cannula has a larger outer cross-section and the duct has a larger inner cross-section starting from the proximal end portion and continuing to a position along the cannula then have the cannula and duct starting at the distal end portion and continuing to the position. The position is located distally from the hub. A reinforcing tube is provided having an outer surface matingly held within the duct and an inner passageway, the tube extending from the proximal end portion distally beyond the hub towards the position. That portion of the cannula which is reinforced by the reinforcing tube is prevented from kinking and/or deforming.

Abstract: An improvement in a catheter assembly including a cannula, an inserter having a guide channel therethrough in which the cannula slidably fits and a hub structure with the cannula proximal end portion attached to the hub structure. The improvement includes a sheath having a longitudinal slit or weakened portion and being about the cannula between the inserter and the hub structure. A sheath stripping construction carried by the inserter strips the sheath from about the cannula as the cannula slides distally through the guide channel. A first lock member is carried by the inserter and an interlocking second lock member is located about the cannula between the inserter and the hub structure. The cannula is protected from contamination and from kinking and a positive lock serves to prevent its accidental withdrawal. A method of inserting a cannula using such an assembly is likewise set forth.

Abstract: A catheter assembly comprises a cannula having proximal and distal end portions and a longitudinal duct having an initial inner cross-section. The duct increases in cross-section when at least a part of the distal end portion of the cannula is inserted into a body of a living subject and maintained in contact with the body, and/or when the duct is contacted by an aqueous liquid, for a period of time sufficient for an enlarged duct cross-section to form. A hub has a passageway from a first to a second end thereof. The passageway has a cross-sectional area throughout at least substantially equal to 125% of the initial inner cross-section of the duct. A proximal end portion of the cannula is attached to the first end of the hub with a passageway through the hub in flow communication with the duct in the proximal end portion of the cannula.

Abstract: An improvement is set forth in a peripheral IV catheter assembly which comprises a needle hub having proximal and distal ends and a central bore having a flashback chamber, blood in said chamber being observable through said needle hub. A needle extends from the distal end of the bore. A catheter hub fits about the needle and has its proximal end held by the distal end of the needle hub. A cannula fits about the needle with its proximal end engaged with the distal end of the catheter hub. A flashback plug has proximal and distal ends. Its distal end can engage with the proximal end of the needle hub in blocking relation to the needle hub bore. A protector has a proximal end engagable with the distal end of the needle hub with the passage about the catheter hub, the needle and the cannula. The improvement comprises wherein the distal end of the protector is engageable with the proximal end of the needle hub with the central passage in the protector in flow communication with the central bore in the needle hub.