Abstract: Aspects of the present disclosure are directed to intravascular electrophysiology catheters including a catheter handle with a steering-wire locking mechanism.

Abstract: The present disclosure provides a medical device comprising a restraining assembly configured to assist in restraining a catheter shaft in a deflected configuration. The resistance assembly may include an inner restraining assembly and an outer restraining assembly configured to engage one another and create normal and frictional resistances therebetween sufficient to prevent unintentional and/or undesired proximal, retracting movement of an actuator, and thus, to prevent changes in a desired deflected configuration of the catheter shaft. In one embodiment, the restraining assembly is configured to allow for temporary, i.e., reversible, restraining of the catheter shaft in the deflected configuration.

Abstract: A method of manufacturing a flexible tubular body for a medical device includes extruding an inner layer from a thermoplastic polymer, pulling it over a mandrel, and tightening it down. If wire lumens were not formed in the inner layer when extruded, polymer spaghetti tubes with wire lumens are laid along the outer surface of the inner layer. Deflection wires are fed into the wire lumens. A wire braid is placed over the inner layer (and spaghetti tubes, if present) and tightened down. The components are encased in an outer polymer layer and a heat shrinkable tube. Pressurized fluid is injected into each wire lumen to maintain the internal diameter thereof greater than the diameter of the deflection wire received therein. Heat is applied to the assembled components, causing the layers to laminate. Once the laminated body has cooled, the heat-shrinkable tube is removed.

Abstract: Disclosed herein is a collapsible and self-expanding cannula for a percutaneous heart pump. The collapsible and self-expanding cannula comprises an open proximal end, an open distal end, and an elongate fluid-impermissible wall structure that includes a first balloon film, a cannula strut, and a second balloon film. The first balloon film is disposed on an interior surface of the cannula, the second balloon film is disposed on the exterior surface of the cannula, and the cannula strut is between the two balloon films. Together they form an integrated hybrid structure upon thermal fusion bonding. Also disclosed herein is a method of manufacturing the collapsible and self-expanding cannula.

Abstract: The invention relates to biocompatible polycarbonate/polyamide polymer compositions for use in medical and surgical devices. Additional additives, crosslinking agents, phosphites, and optionally a radiopaque filler or fillers can be used to produce the high performance compositions desired. The polymer compositions have improved melt processability along with balanced or enhanced physical and mechanical properties, especially when combined or over-extruded onto or covering other polymer layers, such as soft and/or flexible layers commonly used in medical device applications and catheter tips, for example. The ability to incorporate radiopaque compounds into these polymer compositions during melt processing offers improved methods for monitoring and visualizing medical devices when used inside the body and as well as improving the operating characteristics of the medical device components.

Abstract: In various embodiments, a surgical catheter is provided. The catheter may comprise one or more hydrophobic barrier layers made from an ethylene-pertfluoroethylenepropylene (“EFEP”) copolymer. Additionally, the catheter may comprise another polymer layer made from a reactive polar polymer. In at least one embodiment, the reactive polar polymer may be a modified-poly(ether block amide) (“PEBA”) copolymer, such as an amine-terminated PEBA. Moreover, in various embodiments, a composition is provided that may comprise a reactive polar polymer bonded to an EFEP copolymer.

Abstract: A body (2) for a catheter or sheath is disclosed. The body (2) includes strips (8, 10) formed longitudinally from the proximal (6) portion of the body (2) to the distal (4) portion of the body (2). The strips are formed of different materials. The strips can have different radiopacities, or can be splittable/peelable. The splittable/peelable body comprises a peel mechanism longitudinally extending along its respective length. The peel mechanism can be formed by longitudinally extending regions of interfacial bonding between first and second longitudinally extending strips of polymer material. A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the body (2) along its peel mechanism. The polymer material of the first strip (8) can have a greater amount of radiopaque filler than the polymer material of the second strip (10). Each strip forms at least a portion of an outer circumferential surface of the body (2).

Abstract: In various embodiments of the present disclosure, a surgical catheter is provided. The present disclosure provides a catheter shaft that includes a distal portion and a proximal portion. The proximal portion comprises a handle operably connected to the distal portion of the elongated structure. The distal portion three radially positioned polymeric layers. At least two of the layers include chemically dissimilar polymers and at least one of the three layers includes functionalized polyvinylidene fluoride (PVDF).

Abstract: A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

Abstract: A medical device can include an elongate shaft extending along a shaft longitudinal axis, which can include a shaft proximal end and a shaft distal end. A force sensor can be disposed on the shaft distal end and can include a sensor proximal end and a sensor distal end. A tip can be disposed on the sensor distal end. A tubular moisture barrier can define a barrier lumen, wherein the tubular moisture barrier extends along the shaft longitudinal axis between the shaft distal end and the tip, and wherein the force sensor is disposed within the barrier lumen.

Abstract: The invention comprises self-lubricating polymer compositions that are especially useful in medical devices and valves and gaskets of medical devices. In a preferred embodiment, the polymer compositions comprise a thermosetting or thermoplastic silicone elastomer in combination with a lubricity enhancing polyfluoropolyether fluid or hydrocarbon-based synthetic oil. In other preferred embodiments, the polymer compositions contain only biocompatible components. The improved anti-friction properties of the self-lubricating polymers can be demonstrated over a course of insertion and withdrawal cycles, where conventional polymers have changing and mostly increasing force required for each insertion and withdrawal, while the polymer compositions of the invention remain stable.

Abstract: A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

Abstract: The invention comprises self-lubricating polymer compositions that are especially useful in medical devices and valves and gaskets of medical devices. In a preferred embodiment, the polymer compositions comprise a thermosetting or thermoplastic silicone elastomer in combination with a lubricity enhancing polyfluoropolyether fluid or hydrocarbon-based synthetic oil. In other preferred embodiments, the polymer compositions contain only biocompatible components. The improved anti-friction properties of the self-lubricating polymers can be demonstrated over a course of insertion and withdrawal cycles, where conventional polymers have changing and mostly increasing force required for each insertion and withdrawal, while the polymer compositions of the invention remain stable.

Abstract: In various embodiments of the present disclosure, a surgical catheter is provided. The present disclosure provides a catheter shaft that includes a distal portion and a proximal portion. The proximal portion comprises a handle operably connected to the distal portion of the elongated structure. The distal portion three radially positioned polymeric layers. At least two of the layers include chemically dissimilar polymers and at least one of the three layers includes functionalized polyvinylidene fluoride (PVDF).

Abstract: The invention relates to biocompatible polycarbonate/polyamide polymer compositions for use in medical and surgical devices. Additional additives, crosslinking agents, phosphites, and optionally a radiopaque filler or fillers can be used to produce the high performance compositions desired. The polymer compositions have improved melt processability along with balanced or enhanced physical and mechanical properties, especially when combined or over-extruded onto or covering other polymer layers, such as soft and/or flexible layers commonly used in medical device applications and catheter tips, for example.

Abstract: The invention comprises self-lubricating polymer compositions that are especially useful in medical devices and valves and gaskets of medical devices. In a preferred embodiment, the polymer compositions comprise a thermosetting or thermoplastic silicone elastomer in combination with a lubricity enhancing polyfluoropolyether fluid or hydrocarbon-based synthetic oil. In other preferred embodiments, the polymer compositions contain only biocompatible components. The improved anti-friction properties of the self-lubricating polymers can be demonstrated over a course of insertion and withdrawal cycles, where conventional polymers have changing and mostly increasing force required for each insertion and withdrawal, while the polymer compositions of the invention remain stable.

Abstract: A method of manufacturing a splittable/peelable tubular body of a catheter or sheath wherein the tubular body has a splittable/peelable atraumatic tip is disclosed. The atraumatic tip is generally softer than the tubular body. The tubular body and atraumatic tip each comprise a peel mechanism longitudinally extending along their respective lengths. The peel mechanisms are formed by longitudinally extending regions of interfacial bonding between first and second longitudinally extending strips of polymer material. Each strip forms at least a portion of an outer circumferential surface of the tubular body and atraumatic tip. A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the tubular body and atraumatic tip along their respective peel mechanisms.

Abstract: A guidable, or steerable, or deflectable catheter is provided that includes a proximal portion and a distal portion for insertion into a body cavity. A selectively deflectable segment having an anisotropic bending stiffness for deflection in individual planes is incorporated into the distal portion of the catheter shaft. The deflectable segment comprises a corrugate structure that provides smooth curvatures of desirable configurations, deflection planarity, and easiness.

Abstract: A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

Abstract: A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.