Abstract: A method of making catheters is disclosed in which the wall of the catheter has a porous structure for carrying additional agents, such as therapeutic or diagnostic agents. The method includes providing a core, applying a base polymer material and an inert material over the outer surface of the core, and consolidating the base polymer material to form a catheter having a porous polymer layer with the inert material contained within the pores thereof. The inert material can be applied with the base polymer material, or it can be applied in a separate step after the base polymer material has been partially consolidated to form the porous polymer layer. Additional agents can be mixed with the inert material before it is applied to the catheter, or such agents can be applied to the porous polymer layer of the catheter in a separate step after the inert material is removed therefrom.

Abstract: A bumper assembly for attachment to a post has a hollow bumper member with an internal bore that fits over a post and allows the bumper member to rotate. A protective liner is provided between the bumper member and the post and has an internal bore that fits around the post and an external wear surface that fits within and rotatably supports the bumper member. A retaining ring can be secured to the post to hold the bumper assembly in place vertically. Alternatively, the hollow bumper member can be provided with end faces that interact with the upper and lower surfaces of a protective liner positioned within the hollow bumper member to hold the bumper assembly in place vertically. The components of the bumper assembly can be split along one side or provided as two separate halves attachable together to facilitate attachment to posts that are restrained on both ends.

Abstract: An apparatus and method for curving a catheter after deployment include a catheter having a primary lumen, a secondary lumen, and a resilient fiber contained within the secondary lumen. The resilient fiber and the secondary lumen have corresponding, preformed curve shapes when the catheter is in a straight, unstressed condition. The resilient fiber is slidable within the secondary lumen to create a desired curve shape in the catheter as the curved portion of the resilient fiber slides into an originally straight portion of the secondary lumen. In another embodiment, the preformed curve shape of the resilient fiber is held in a straight condition within a stiff, marker ring segment of the catheter until after the catheter is deployed. Once deployed, the resilient fiber is slid out of the marker ring segment, and the preformed curve shape of the resilient fiber creates a corresponding curve shape in the catheter.

Abstract: A catheter having a fibrous reinforcement is formed by anchoring a filament at a proximal end of a core member, and winding the filament onto the core member continuously from the proximal end to the distal end of the core member and then back to the proximal end to form a first fibrous layer. The filament is wound with a constant or variable pitch along the length of the core member. Additional fibrous layers can be applied by continuously winding a filament over the first fibrous layer from the proximal end to the distal end or to an intermediate position along the core member and then back to the proximal end. The additional layers can extend to different distal positions to form a catheter having a tapering profile. In alternative embodiments, catheters are formed by winding a group of filaments onto the core member simultaneously.

Abstract: An apparatus and method for curving a catheter include a resilient fiber core with a preformed curve shape and a catheter having a lumen. The resilient fiber core is inserted into the lumen to create a desired curve shape in the catheter. The lumen in which the fiber core is inserted can be the primary lumen of the catheter, a secondary lumen, or a channel in the wall of the catheter. The catheter can be formed of a soft polymer material. The fiber core can be inserted into the catheter before or after the catheter is introduced into a body. The method can be used with a catheter having a varying hardness over its length, including a soft portion that conforms to the curve shape of the fiber core. A positive or negative pressure can be applied to a channel in the catheter to selectively straighten or curve the catheter.

Abstract: An apparatus and method for filtering intravascular fluids and for delivering diagnostic and therapeutic agents intravascularly is disclosed in which the apparatus has a shape defined by a preset shape of a resilient fiber core. The resilient fiber core is covered by a soft polymer tubing or other polymer material to form a delivery apparatus that takes the shape of the resilient fiber core. Various shapes and structures are disclosed that infuse diagnostic and therapeutic agents through a lumen of the polymer tubing, that deliver the agents in the form of a soluble coating, that circulate or contain a preloaded charge of radioactive material for intravascular radiotherapy, and that deploy filtration devices intravascularly for removing particulate matter from body fluid. The resilient fiber core and soft polymer material permit the construction of a very small apparatus that can be removed easily following treatment.

Abstract: An apparatus and method for delivering diagnostic and therapeutic agents intravascularly in which the apparatus has a shape defined by a preset shape of a resilient fiber core. The resilient fiber core is covered by a soft polymer tubing or other polymer material to form a delivery apparatus that takes the shape of the resilient fiber core. Various shapes and structures are disclosed that infuse diagnostic and therapeutic agents through a lumen of the polymer tubing, that deliver the agents in the form of a soluble coating, and that circulate or contain a preloaded charge of radioactive material for intravascular radiotherapy. The resilient fiber core and soft polymer material permit the construction of a very small apparatus that can be removed easily following treatment. Various deployment systems are disclosed for deploying the delivery apparatuses into a vessel and for protecting against radiation exposure.

Abstract: An apparatus and method for nonextrusion manufacturing of catheters that can be used to produce catheters having a simple or complex configuration. A polymer material in a particulate preform is applied in a layer over an outer surface of a core member. By applying the polymer material in a particulate preform, a composition of the polymer material can be varied continuously as it is being applied to provide a variable hardness over the length of the catheter. A fibrous reinforcement can be used having a constant or variable pitch and a constant or variable number of fibers and fiber types. Sensors can be easily placed in a wall of the catheter as the catheter is being fabricated, thereby allowing more sensors to be used without placing conductors in the lumen of the catheter. Deflection passages can be provided in a wall of the catheter for inserting a wire to deflect the catheter.

Abstract: An infusion coil apparatus and method for delivering fluid-based diagnostic and therapeutic agents intravascularly in which an infusion coil is placed in an artery or other vessel at a diseased location, and then fluid-based agents are delivered through the infusion coil to that specific location. The infusion coil apparatus includes a resilient fiber core enclosed in a soft, hollow polymer tubing. The resilient fiber core has a preshaped coil at one end that overcomes the susceptibility of the infusion coil to become uncoiled, while permitting a construction of the infusion coil having a very small diameter. The polymer tubing is radiopaque and has a soft surface for engaging the inside of a vessel. The infusion coil is deployed by a deployment device at a specific site in a vessel to be treated. Once at the delivery site, the deployment device ejects the infusion coil out of a delivery sheath into the vessel.

Abstract: A method of manufacturing, extruding, milling and welding a high torque, thin monolithic walled guiding catheter having resilient reinforcement material (8, 23, 29, 70, 73) integrally spiralled or braided into monolithic walls (21) of flexible material. A solid lubricant, also referred to as dry lubricant, comprised of either special fluorine containing materials or polymeric organic silicon compounds is embedded into interior and exterior wall surfaces of the catheters. Smooth interior walls (11) are channeled (10) to decrease friction resistance, to trap resistance particles and to dissipate friction heat in the high ratio of surface area to cross-sectional area of small catheters. Number of spirals or braids of reinforcement strands per unit of length, number of layers of strands of the catheters, catheter diameter and progressiveness thereof are designedly different for separate portions of particular catheters.

Abstract: A high torque, thin walled guiding catheter has resilient reinforcement material (8, 23, 29, 70, 73) integrally spiraled or braided into monolithic walls (21) of flexible material. A solid lubricant, also referred to as dry lubricant, comprised of either special fluorine containing materials or polymeric organic silicon compounds is embedded into interior and exterior wall surfaces of the catheters. Smooth interior walls (11) are channeled (10) to decrease friction resistance, to trap resistance particles and to dissipate friction heat in the high ratio of surface area to cross-sectional area of small catheters. Number of spirals or braids of reinforcement strands per unit of length, number of layers of strands of the catheters, catheter diameter and progressiveness thereof are designedly different for separate portions of particular catheters. Catheter tips (6) are weldable immediately adjacent to select density of strands of reinforcement material. Perfusion ports are weldable where desired.

Abstract: A heat flux meter determines the heat transfer characteristics prior to processing or during steady-state autoclave heating conditions utilizing a monitoring element selected-thereof such that lumped heat transfer analysis is applicable thereto. During the curing process of a material, the heat flux meter calculates the instantaneous convection film coefficient for a particular location and determines the total present heat flux to an object.