Abstract: A delivery system assembly includes an elongate inner member that extends distally through a lumen of an elongate outer tube of the assembly; the outer tube is moveable relative to the inner member between first and second positions to deploy an implantable medical device that is held within the outer tube lumen. The inner member may include a flared distal end that abuts, and preferably conforms to, the proximal end of the device, when the device is held within the outer tube lumen. The assembly further includes a stability sheath that surrounds a limited length of the outer tube, in proximity to the handle, to provide an interface for both an operator, who handles the assembly, and for an introducer sheath that provides passage for the assembly into the venous system, so that movement of the outer tube is not hindered by either during device deployment.

Abstract: A delivery system assembly includes an outer tube, an inner member, extending within a lumen of the outer tube, and a deflectable shaft, extending within the outer tube lumen and around the inner member; the tube and inner member are longitudinally moveable with respect to the shaft, and a distal end of the inner member is located distal to the shaft within the tube lumen. A medical device can be loaded into the tube lumen, along a distal-most portion of the tube, and contained between the inner member and a distal opening of the tube lumen. Deflecting the shaft orients the distal-most portion for navigation of the assembly, and, when the distal end of the inner member is engaged within the tube lumen, distal movement of the tube, with respect to the shaft, causes similar distal movement of the inner member and the loaded medical device toward an implant site.

Abstract: Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a multi-electrode array configured to be delivered to a renal blood vessel. The array is selectively transformable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally spiral/helical shape). The multi-electrode array is sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the renal blood vessel when the array is in the deployed (e.g., spiral/helical) state. The electrodes or energy delivery elements are configured for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function.

Abstract: Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a multi-electrode array configured to be delivered to a renal blood vessel. The array is selectively transformable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally spiral/helical shape). The multi-electrode array is sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the renal blood vessel when the array is in the deployed (e.g., spiral/helical) state. The electrodes or energy delivery elements are configured for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function.

Abstract: A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.

Abstract: A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.

Abstract: Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a multi-electrode array configured to be delivered to a renal blood vessel. The array is selectively transformable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally spiral/helical shape). The multi-electrode array is sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the renal blood vessel when the array is in the deployed (e.g., spiral/helical) state. The electrodes or energy delivery elements are configured for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device, the kit comprising an outer sheath, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with a tapered distal end. The inner sheath is slidable within the inner lumen of the outer sheath and is selectably removable from the inner lumen of the outer sheath by sliding the inner sheath out of the proximal opening of the outer sheath. The kit includes an elongated deployment receptacle including a deployment bay slidable within the inner lumen of the outer sheath when the inner sheath is not within the inner lumen of the outer sheath. The deployment bay carries an implantable medical device through the inner lumen of the outer sheath and facilitates deployment of the implantable medical device from the distal end of the outer sheath.

Abstract: In one example, this disclosure is directed to a method for intravascular implantation of an implantable medical device comprising positioning a distal end of an elongated outer sheath forming an inner lumen adjacent a target site within a vasculature of a patient, and partially deploying an implantable medical device from the distal opening, wherein the implantable medical device includes an expandable fixation element. A portion of the expandable fixation element assumes an expanded position when the implantable medical device is partially deployed from the distal opening. The method including advancing the distal end of the outer sheath within the vasculature with the implantable medical device partially deployed from the distal opening, and monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection to determine when the size of the portion of the expandable fixation element corresponds to the size of the vasculature.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an enlarged distal portion, wherein the enlarged distal portion is configured to substantially fill the inner lumen and close-off the distal opening of the outer sheath. The enlarged distal portion is slidable relative to the outer sheath. The inner sheath further includes a tether with a helical element that is remotely controllable from a proximal end of the inner sheath to release the implantable medical device from a distal portion of the outer sheath.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated inner sheath with a distal end, a first coupling module slidably connected to the inner sheath, an elongated outer sheath forming an inner lumen with a distal opening and a proximal opening. The outer sheath sized to traverse a vasculature of the patient. The proximal opening is configured to receive the distal end of the inner sheath. The inner lumen is sized to receive the inner sheath and to contain the implantable medical device. The kit further includes a mating coupling module that connects to the first coupling module such that the inner sheath is axially aligned with the outer sheath. The inner sheath is slidable within the outer sheath while the first coupling module is connected to the mating coupling module.

Abstract: An inner subassembly of a delivery system assembly extends within a lumen of an elongate outer tube of the assembly, and includes a flared distal end, which is preferably configured to conform to a proximal end of an implantable medical device; a distal-most portion of the outer tube is sized to contain both the flared distal end and an entirety of the medical device. The inner subassembly includes a core, an elongate pull-wire, extending along the core, and a sheath surrounding the pull-wire and the core; the sheath includes a slot opening that allows the pull-wire to pass laterally therethrough. The assembly preferably has a pre-formed curvature along a length of the sheath, and the slot opening extends along the pre-formed curvature. The outer tube is longitudinally moveable relative to the inner subassembly, for example, to deploy the medical device.

Abstract: A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.

Abstract: A delivery system assembly includes an outer tube, an inner member, extending within a lumen of the outer tube, and a deflectable shaft, extending within the outer tube lumen and around the inner member; the tube and inner member are longitudinally moveable with respect to the shaft, and a distal end of the inner member is located distal to the shaft within the tube lumen. A medical device can be loaded into the tube lumen, along a distal-most portion of the tube, and contained between the inner member and a distal opening of the tube lumen. Deflecting the shaft orients the distal-most portion for navigation of the assembly, and, when the distal end of the inner member is engaged within the tube lumen, distal movement of the tube, with respect to the shaft, causes similar distal movement of the inner member and the loaded medical device toward an implant site.

Abstract: A delivery system assembly includes an elongate inner member that extends distally through a lumen of an elongate outer tube of the assembly; the outer tube is moveable relative to the inner member between first and second positions to deploy an implantable medical device that is held within the outer tube lumen. The inner member may include a flared distal end that abuts, and preferably conforms to, the proximal end of the device, when the device is held within the outer tube lumen. The assembly further includes a stability sheath that surrounds a limited length of the outer tube, in proximity to the handle, to provide an interface for both an operator, who handles the assembly, and for an introducer sheath that provides passage for the assembly into the venous system, so that movement of the outer tube is not hindered by either during device deployment.

Abstract: A spiral balloon perfusion catheter assembly having a retaining wire and method of making the balloon. Also, a retaining wire for such a catheter and method of forming the retaining wire. A typical spiral catheter balloon has a spiral configuration of lobes and channels mounted on a catheter extending beyond the balloon ends. A retaining wire formed from a shape memory alloy is configured to have a central region having a spaced spiral configuration conforming to the spiral balloon channel and end regions configured to have a contiguous spiral configuration conforming to the catheter diameter. When placed over a spiral balloon, the central spiral region prevents expansion of the channel when the balloon is inflated, while the end regions secure the retaining wire to the catheter. Preferred shape memory alloys comprise nickel and titanium.

Abstract: A method and apparatus for forming perfusion balloons from thermoplastic materials. A helical member having a cross section corresponding to a desired perfusion channel cross section is placed in a tubular mold in contact with the mold wall. A thermoplastic tube is inserted into the helical member in the mold. The assembly is heated to the glass transition temperature of the tube and the tube is pressurized to expand into contact with the helical member and mold wall. After cooling, the formed balloon is removed from the mold. The helical member has a "T" shaped, or rectangular, or square, or triangular cross section. Limited pre-pressure and pre-stretch are preferably applied prior to the tube expansion and post forming tube conditioning may be used. Axial stretching of the tube in a mold, with our without the helical member, by microprocessor controlled air actuators provides highest quality balloons having selected wall thicknesses.

Abstract: A sheath arrangement for spiral balloon catheters which permits improved perfusion during dilation of a body vessel. Methods of making the sheath and assembling the sheath onto a balloon and the resulting sheathed balloon catheter are included. A tube sized to fit over a spiral balloon is cut, preferably by laser cutting, to form ribs extending from the tube ends with collars at the distal ends of the ribs. Preferably, the tube ends are trimmed to match the balloon spiral lobes. The sheath is placed over the spiral balloon, bonded to the balloon lobes. The collars are secured to the catheter adjacent to the balloon. When the balloon is expanded to dilate a body vessel, blood can freely pass through the interlobe channels while the sheath prevents entry of arterial intima from entering into the channels. The rib and collar arrangement securely maintains the sheath in place on the balloon.

Abstract: A spiral balloon perfusion catheter assembly having a retaining wire and method of making the balloon. Also, a retaining wire for such a catheter and method of forming the retaining wire. A typical spiral catheter balloon has a spiral configuration of lobes and channels mounted on a catheter extending beyond the balloon ends. A retaining wire formed from a shape memory alloy is configured to have a central region having a spaced spiral configuration conforming to the spiral balloon channel and end regions configured to have a contiguous spiral configuration conforming to the catheter diameter. When placed over a spiral balloon, the central spiral region prevents expansion of the channel when the balloon is inflated, while the end regions secure the retaining wire to the catheter. Preferred shape memory alloys comprise nickel and titanium.

Abstract: A method apparatus for a radially expandable stent for implantation within a body vessel, comprising a first wire formed winding and a second wire formed winding. The first wire formed winding has a hollow cylindrical shape including a preformed pattern such as a sinusoidal wave form and being wound into a continuous helix the length of the stent. The second wire formed winding has a hollow cylindrical shape including a preformed pattern such as a sinusoidal wave form and being wound into a continuous helix the length of the stent. The second winding helix is opposite that of the first winding helix. The second winding has a greater inner diameter than the outer diameter of the first winding. The second winding is coaxial with the first winding, the pattern of the first winding symmetrically intersects with the pattern of the second winding to form a uniform series of crossings thereby permitting even expansion of the first and second windings.