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.

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 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: 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 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: An ablation catheter is provided for ablating internal tissue of a patient. The catheter includes a distal end that is adapted to be inserted into a body cavity relative to a desired location therein (e.g., within the heart). An ablation electrode is connected relative to the distal end of the catheter for providing ablation energy to patient tissue. A heat sink is provided that is in thermal contact with the ablation electrode. The heat sink, in addition to being in thermal contact with the ablation electrode, is electrically isolated from the ablation electrode. This allows the heat sink to conduct heat away from the ablation electrode without dissipating electrical energy from the electrode. In this regard, the heat sink may prevent build-up of excess heat within the electrode that may result in blood coagulation and/or tissue charring.

Abstract: The present invention is a splitable/peelable reinforced flexible tubular body (10) for a catheter or sheath (12). The body (10) comprises a proximal end (14), a distal end (16), a wall structure (18), and a lumen (20) defined by the wall structure (18). The wall structure (18) extends between the ends and includes a reinforcement layer (22) within the wall structure (18) and a separation line (26) extending longitudinally along the wall structure (18). The separation line (26) is adapted to facilitate the splitting/peeling of the wall structure (18) to allow a medical device such as a pacemaker lead to be removed from within the tubular body (10).

Abstract: A splittable/peelable tubular body (2) of a catheter or sheath wherein the tubular body (2) has a splittable/peelable atraumatic tip (14) is disclosed. The atraumatic tip (4) is generally softer than the tubular body (2). The tubular body (2) and atraumatic tip (4) each comprise a peel mechanism longitudinally extending along their respective lengths. The peel mechanisms are formed by longitudinally extending regions of interfacial bonding (11) between first and second longitudinally extending strips (8, 10) of polymer material. Each strip (8, 10) forms at least a portion of an outer circumferential surface of the tubular body (2) and atraumatic tip (4). A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the tubular body (2) and atraumatic tip (4) along their respective peel mechanisms.

Abstract: A catheter shaft includes an inner layer of a first polymeric material, an intermediate layer of a second polymeric material, an outer layer of a third polymeric material, a first wire reinforcing layer encapsulated between the inner and intermediate layers, and a second wire reinforcing layer encapsulated between the outer and intermediate layers. Typically, the first wire reinforcing layer includes one or more metallic wires helically wound in one direction and the second wire reinforcing layer includes one or more metallic wires helically wound in the opposite direction. The intermediate layer is bonded to the inner and outer layers, as by extruding layers over one another or by thermal lamination or reflow bonding. Typically, the intermediate layer has a larger yield strain and/or a lower flexural modulus and/or a lower durometer than at least one of the inner layer and the outer layer.

Abstract: An ablation catheter is provided for ablating internal tissue of a patient. The catheter includes a distal end that is adapted to be inserted into a body cavity relative to a desired location therein (e.g., within the heart). An ablation electrode is connected relative to the distal end of the catheter for providing ablation energy to patient tissue. A heat sink is provided that is in thermal contact with the ablation electrode. The heat sink, in addition to being in thermal contact with the ablation electrode, is electrically isolated from the ablation electrode. This allows the heat sink to conduct heat away from the ablation electrode without dissipating electrical energy from the electrode. In this regard, the heat sink may prevent build-up of excess heat within the electrode that may result in blood coagulation and/or tissue charring.

Abstract: The present invention is a method of manufacturing a flexible tubular body for catheter, sheath or similar medical device. The method comprises pre-extruding an inner layer of the body from a thermoplastic polymer and then pulling the inner layer over a mandrel and tightening the layer down. If wire lumens were not integrally formed in the inner layer when pre-extruded, then two polymer spaghetti tubes, each with wire lumens, are laid 180 degrees apart axially along the outer surface of the inner layer. Deflection wires are then fed into the wire lumens. A cylindrical wire braid is woven or pulled over the inner layer (and the spaghetti tubes, as the case may be) and tightened down. The aforementioned components are then encased in an outer polymer layer. A heat-shrinkable tube is then placed over the outer layer.

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: An ablation catheter is provided for ablating internal tissue of a patient. The catheter includes a distal end that is adapted to be inserted into a body cavity relative to a desired location therein (e.g., within the heart). An ablation electrode is connected relative to the distal end of the catheter for providing ablation energy to patient tissue. A heat sink is provided that is in thermal contact with the ablation electrode. The heat sink, in addition to being in thermal contact with the ablation electrode, is electrically isolated from the ablation electrode. This allows the heat sink to conduct heat away from the ablation electrode without dissipating electrical energy from the electrode. In this regard, the heat sink may prevent build-up of excess heat within the electrode that may result in blood coagulation and/or tissue charring.

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 present invention is a method of manufacturing a flexible tubular body for catheter, sheath or similar medical device. The method comprises pre-extruding an inner layer of the body from a thermoplastic polymer and then pulling the inner layer over a mandrel and tightening the layer down. If wire lumens were not integrally formed in the inner layer when pre-extruded, then two polymer spaghetti tubes, each with wire lumens, are laid 180 degrees apart axially along the outer surface of the inner layer. Deflection wires are then fed into the wire lumens. A cylindrical wire braid is woven or pulled over the inner layer (and the spaghetti tubes, as the case may be) and tightened down. The aforementioned components are then encased in an outer polymer layer. A heat-shrinkable tube is then placed over the outer layer.

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 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. Upon actuation of pull wires, the distal deflectable segment may be deflected to move/sweep the distal catheter tip through a sweeping plane. The anisotropic bending stiffness of the distal deflectable segment permits in-plane movement of the distal catheter tip in the sweeping plane while resisting any out-of-plane movements. In one arrangement, stiffening elements are selectively disposed within the distal deflectable segment such that the out-of-plane bending stiffness is largely increased and greater than the in-plane bending stiffness for deflection in the sweeping plane.