Abstract: An introducer sheath for a medical device is provided. The sheath includes a deformable, elongate body disposed about a longitudinal axis. The body has proximal and distal ends and defines a lumen extending between the proximal and distal ends and configured to allow passage of the medical device therethrough. The body is configured to allow an electric current to pass radially between a space outside of the body and the lumen such that the position of the medical device within a patient can be monitored and electrogram readings from body tissues can be measured while the device is in the sheath. In some embodiments of the invention, the body may include a one or more apertures extending from the radially outer surface of the body to the lumen or a portion of the body may be made from a conductive and/or fluid permeable material.

Abstract: A splittable cannula includes a radiopaque marker placed at or near the distal end of the cannula. The radiopaque marker may be a unitary piece, or may consist of several portions. The cannula may include a sheath or catheter body with a grooved score line running along a portion of the sheath body and a radiopaque marker located at a distal end of the body and abutting the body. The radiopaque marker may be located within the lumen of the sheath, may be embedded in the sheath wall, or may be affixed to the external sheath wall. The radiopaque marker may be scored, notched, grooved, or contain apertures longitudinally. The notches, grooves, apertures, and/or score lines in both the sheath or catheter body and the radiopaque marker serve to provide a weakened tear path. An electrode lead may be coupled with the radiopaque marker.

Abstract: The present invention is a splittable multi-piece hemostasis valve that is held together in an assembled condition via a binder formed about the assembled valve. The binder may be a sleeve of thin polymer material shrink-wrapped about the valve. When the valve needs to be split in order to clear a medical device such as a pacemaker lead, the sleeve is split and the valve is disassembled.

Abstract: A medical catheter includes a deflectable and compressible catheter shaft; a pull ring near a distal end of the catheter shaft; a distal tip that includes a tip element and a mounting shaft; and an attachment apparatus for securely attaching the distal tip to the catheter shaft, the attachment apparatus including a compression ring which compresses the catheter shaft and the mounting shaft together. The compression ring can be located around the catheter shaft to compress the catheter shaft against an outer surface of the mounting shaft, or within the catheter shaft to compress the catheter shaft outwardly against an inner surface of the mounting shaft. The catheter can be a non-irrigated ablation catheter, with the tip element being a tip electrode, and it can be an irrigated ablation catheter, with the distal tip including a fluid manifold.

Abstract: A catheter assembly comprises a deflectable catheter shaft comprising a distal end and a lumen extending therethrough. The catheter assembly further comprises least one pull wire comprising a distal portion comprising a side and a distal end, wherein the side comprises a first side portion and a second side portion. The catheter assembly further comprises a distal pull assembly operatively coupled to the at least one pull wire. The distal pull assembly comprises a longitudinal axis, a first surface, and a second surface. The first side portion of the at least one pull wire is adjacent to the first surface of the distal pull assembly, and the second side portion of the at least one pull wire is adjacent to the second surface of the distal pull assembly.

Abstract: A medical catheter includes a deflectable and compressible catheter shaft; a pull ring near a distal end of the catheter shaft; a distal tip that includes a tip element and a mounting shaft; and an attachment apparatus for securely attaching the distal tip to the catheter shaft, the attachment apparatus including a compression ring which compresses the catheter shaft and the mounting shaft together. The compression ring can be located around the catheter shaft to compress the catheter shaft against an outer surface of the mounting shaft, or within the catheter shaft to compress the catheter shaft outwardly against an inner surface of the mounting shaft. The medical catheter can be an ablation catheter, with the tip element being a tip electrode, and it can be an irrigated ablation catheter, with the distal tip including a fluid manifold.

Abstract: A medical catheter assembly includes a deflectable catheter shaft, a distal tip with tip element and a mounting shaft, and a pull ring assembly, the distal tip defining guide channels through which pull wires of the pull ring assembly pass such that the pull wires will initially extend from the pull ring toward the tip element and then loop back toward and through the catheter shaft and to a handle actuator. Pulling of the pull wires by the handle actuator to tilt the pull ring and deflect the catheter shaft will cause the pull ring to move toward tip element. The pull ring and tip element are thus interlocked. Stress forces on the connection joints between the pull wires and the pull ring will be dissipated, reducing the incidence of failure of the pull ring assembly. The medical catheter can be a non-irrigated ablation catheter wherein the tip element is a tip electrode, or an irrigated ablation catheter wherein the tip element is a tip electrode and a fluid manifold.

Abstract: A system for connecting a hemostasis valve to a splittable sheath includes an interface formed between a ledge on the proximal end of a cannula portion of the hemostasis valve and an engagement structure aligned with the handles of the splittable sheath. Pulling the handles to split the sheath likewise disengages the ledge from the engagement structure. A snap ring on the cannula portion engages a snap ring in the lumen of a sheath hub formed on the proximal end of the splittable sheath. An O-ring between the cannula portion and the sheath hub provides a fluid-tight seal.

Abstract: A splittable cannula includes a radiopaque marker placed at or near the distal end of the cannula. The radiopaque marker may be a unitary piece, or may consist of several portions. The cannula may include a sheath or catheter body with a grooved score line running along a portion of the sheath body and a radiopaque marker located at a distal end of the body and abutting the body. The radiopaque marker may be located within the lumen of the sheath, may be embedded in the sheath wall, or may be affixed to the external sheath wall. The radiopaque marker may be scored, notched, grooved, or contain apertures longitudinally. The notches, grooves, apertures, and/or score lines in both the sheath or catheter body and the radiopaque marker serve to provide a weakened tear path. An electrode lead may be coupled with the radiopaque marker.

Abstract: A splittable cannula includes a radiopaque marker placed at or near the distal end of the cannula. The radiopaque marker may be a unitary piece, or may consist of several portions. The cannula may include a sheath or catheter body with a grooved score line running along a portion of the sheath body and a radiopaque marker located at a distal end of the body and abutting the body. The radiopaque marker may be located within the lumen of the sheath, may be embedded in the sheath wall, or may be affixed to the external sheath wall. The radiopaque marker may be scored, notched, grooved, or contain apertures longitudinally. The notches, grooves, apertures, and/or score lines in both the sheath or catheter body and the radiopaque marker serve to provide a weakened tear path. An electrode lead may be coupled with the radiopaque marker.

Abstract: The invention relates to a steerable catheter having a distal section with reduced variation in deflection path during deflection. The distal section of the catheter includes stripes of different material hardness along the length of the distal section affecting the directionality of catheter deflection upon the application of a deflection force like that applied by pull wires. The stripes result in preferential bending in a desired path with greater reproducibility.

Abstract: The present invention is a tool coupled to a hemostasis valve and adapted to slit/split a tubular body of a catheter or sheath to facilitate the removal of the tubular body from about a medical device extending through the hemostasis valve and tubular body. The tool comprises a conical barrel portion supporting one or more radially outward extending blades. The tool also comprises a stabilizing component for preventing displacement between the tool and medical device when the tubular body is being removed from about the medical device.

Abstract: A medical catheter assembly includes a deflectable catheter shaft, a distal tip with tip element and a mounting shaft, and a pull ring assembly, the distal tip defining guide channels through which pull wires of the pull ring assembly pass such that the pull wires will initially extend from the pull ring toward the tip element and then loop back toward and through the catheter shaft and to a handle actuator. Pulling of the pull wires by the handle actuator to tilt the pull ring and deflect the catheter shaft will cause the pull ring to move toward tip element. The pull ring and tip element are thus interlocked. Stress forces on the connection joints between the pull wires and the pull ring will be dissipated, reducing the incidence of failure of the pull ring assembly. The medical catheter can be a non-irrigated ablation catheter wherein the tip element is a tip electrode, or an irrigated ablation catheter wherein the tip element is a tip electrode and a fluid manifold.

Abstract: A medical catheter includes a deflectable and compressible catheter shaft; a pull ring near a distal end of the catheter shaft; a distal tip that includes a tip element and a mounting shaft; and an attachment apparatus for securely attaching the distal tip to the catheter shaft, the attachment apparatus including a compression ring which compresses the catheter shaft and the mounting shaft together. The compression ring can be located around the catheter shaft to compress the catheter shaft against an outer surface of the mounting shaft, or within the catheter shaft to compress the catheter shaft outwardly against an inner surface of the mounting shaft. The medical catheter can be an ablation catheter, with the tip element being a tip electrode, and it can be an irrigated ablation catheter, with the distal tip including a fluid manifold.

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: The invention relates to a steerable catheter having a distal section with reduced variation in deflection path during deflection. The distal section of the catheter includes stripes of different material hardness along the length of the distal section affecting the directionality of catheter deflection upon the application of a deflection force like that applied by pull wires. The stripes result in preferential bending in a desired path with greater reproducibility.

Abstract: Lead placement apparatus to transmit electrical signals to stimulate selected body tissue includes an introducer handle supporting a tubular outer sheath of flexible resilient material including a rigid section and a deflectable section adjacent the distal end, enabling the deflectable section to deflect among a plurality of positions in orientations transverse of a longitudinal axis. An operative member on the introducer handle connected to the distal end of the outer sheath serves to move that distal end. An inner tubular sheath of flexible resilient material slidably received within the outer sheath includes a driving socket fixed to its distal end whereby, with a lead slidably received within the inner tubular sheath and including a driven socket fixed to its distal end for releasable mating engagement by the driving socket, an electrode at the distal tip of the lead can be advanced and directed to the selected body tissue for stimulation.

Abstract: A tearable hemostasis valve for use with a splittable sheath. The hemostasis valve may include grip tabs, which may be pulled in generally opposing directions. The opposing forces tear open the valve body open along a score line. The tearable hemostasis valve includes a snap fit arrangement for mounting to a neck-and-hub arrangement of a splittable sheath. When the valve is pressed down onto the neck-and-hub arrangement, the snap fit arrangement deforms outwardly to permit the hub to pass through and into the cavity. After the hub passes through, the annular sidewall seats snugly around the neck. When an operation is complete, the tearable hemostasis valve may be torn open and discarded. The splittable introducer sheath may be torn open along its longitudinal axis by grasping opposing sheath wings and pulling in opposite directions. As the sheath is split, it may be withdrawn from a body and discarded.

Abstract: A splittable cannula including a radiopaque marker. Generally, the marker is placed at or near the distal end of the cannula. The radiopaque marker may be a unitary piece, or may consist of several portions. The sheath may include a sheath body having at least one sheath score line running along a portion of the sheath body, a radiopaque marker located at a distal end of the sheath body and abutting the sheath body, and at least one score line running along a portion of the radiopaque marker. The radiopaque marker may be located within the lumen of the sheath, or may be embedded in the sheath wall. Alternative embodiments may replace the marker score line with a notch or groove running along the length of the radiopaque marker. The notches, grooves, and/or score lines in both the sheath body and radiopaque marker serve to provide a weakened tear path.

Abstract: A hemostasis cannula unit including a valve housing, a cap, and a hemostasis valve, wherein the hemostasis valve includes a proximal valve gasket and a distal valve gasket compressed against the valve gasket by the valve housing, wherein the proximal valve gasket is the same shape as the distal valve gasket.