Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: Aspects of the disclosure include bodily lumen reshaping and reduction systems, devices and methods. Such implants can include a plurality of anchors serially interconnected with a cinching member. Delivery devices of the disclosure are configured to deploy a first anchor into tissue. The delivery device can then deploy a second anchor and wind the cinching member around the second anchor to reduce a distance between the first and second anchors, placating the tissue between the anchors. Additional anchors can be similarly deployed and the cinching member can be similarly adjusted to reshape the lumen. Methods of deploying and reshaping a bodily lumen are also disclosed. In various examples, the bodily lumen is a heart valve, atrial appendage, portion of a gastrointestinal tract or urethra. Various embodiments include one or more anchors having a ratchet assembly or the like to substantially prevent the cinching member from unwinding.

Abstract: Aspects of the disclosure include systems and devices for delivering an annuloplasty implant and anchor delivery apparatus to a valve annulus. The systems and devices of the disclosure are configured to dispense and secure or anchor the implant to the valve annulus. Various implants of the disclosure include one or more cinching members that can be tensioned to reshape the valve annulus. Methods of deploying the implant, securing the implant to the valve annulus and reshaping the valve annulus are also disclosed.

Abstract: The disclosure describes an annuloplasty device that includes a wire configured to extend around at least part of an annulus of a cardiac or vascular valve, such as at least partially around a circumference of the annulus, and a plurality of anchors. The anchors of the plurality of anchors are configured to engage the wire and anchor the wire to the annulus. The wire is configured to urge at least some anchors of the plurality of anchors toward each other in a radially inward direction to decrease a distance between valve leaflets that extend from the annulus.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: Balloon catheters for delivery of prosthetic hear valves is provided. The balloon catheters are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein are configured with substantially incompressible retention bumpers that promote longitudinal inflation fluid flow.

Abstract: A catheter includes a handle with torquing and steering mechanisms. The torquing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter and is configured to transmit a torque from the nosecone to the shaft when the nosecone is rotated. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: The disclosure describes a medical device comprising a frame configured to substantially conform to a curvature of a coaptation zone of at least two valve leaflets of a cardiac or vascular valve, and a curtain configured to be attached to the frame and extend into the coaptation zone to support coaptation of the at least two valve leaflets.

Abstract: The disclosure describes an annuloplasty device that includes a wire configured to extend around at least part of an annulus of a cardiac or vascular valve, such as at least partially around a circumference of the annulus, and a plurality of anchors. The anchors of the plurality of anchors are configured to engage the wire and anchor the wire to the annulus. The wire is configured to urge at least some anchors of the plurality of anchors toward each other in a radially inward direction to decrease a distance between valve leaflets that extend from the annulus.

Abstract: A guide catheter assembly includes a dilator and a guide catheter. The dilator includes a dilator lumen extending from a distal opening at a distal end to a proximal opening at a proximal end, and a side exit port proximal of the distal opening and in communication with the dilator lumen. The guide catheter includes a proximal end, a distal end, and a guide lumen extending therebetween. The dilator and the guide lumen are sized such that the dilator can pass through the guide lumen. The dilator and the guide catheter are sized such that with the proximal end of the dilator generally aligned along an axis with the proximal end of the guide catheter, the distal end of the dilator extends distally past the distal end of the guide catheter and the side exit port is disposed distal of the distal end of the guide catheter.

Abstract: A guide catheter assembly includes a dilator and a guide catheter. The dilator includes a dilator lumen extending from a distal opening at a distal end to a proximal opening at a proximal end, and a side exit port proximal of the distal opening and in communication with the dilator lumen. The guide catheter includes a proximal end, a distal end, and a guide lumen extending therebetween. The dilator and the guide lumen are sized such that the dilator can pass through the guide lumen. The dilator and the guide catheter are sized such that with the proximal end of the dilator generally aligned along an axis with the proximal end of the guide catheter, the distal end of the dilator extends distally past the distal end of the guide catheter and the side exit port is disposed distal of the distal end of the guide catheter.

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 tether subassembly, which may be employed by a tool that deploys an implantable medical device, includes a test segment for verification of adequate fixation of the device at an implant site. When the device is located in proximity to a distal opening of the tube, a tether first length extends through an attachment structure of the device and within an elongate tube of the tool, a tether second length extends alongside the tether first length within the tube, and the test segment is located in proximity to the distal opening. The test segment is configured so that only a tug force, applied to the tether first length, and greater than or equal to a predetermined force, can pull the test segment through an aperture, either of the delivery tool or of the device. The predetermined force corresponds to a minimum adequate fixation force for the device.

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: 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: A guide catheter assembly includes a dilator and a guide catheter. The dilator includes a dilator lumen extending from a distal opening at a distal end to a proximal opening at a proximal end, and a side exit port proximal of the distal opening and in communication with the dilator lumen. The guide catheter includes a proximal end, a distal end, and a guide lumen extending therebetween. The dilator and the guide lumen are sized such that the dilator can pass through the guide lumen. The dilator and the guide catheter are sized such that with the proximal end of the dilator generally aligned along an axis with the proximal end of the guide catheter, the distal end of the dilator extends distally past the distal end of the guide catheter and the side exit port is disposed distal of the distal end of the guide catheter.

Abstract: A neuromodulation catheter in accordance with a particular embodiment includes an elongate shaft and a neuromodulation element operably connected to the shaft. The shaft includes a proximal hypotube segment at its proximal end portion and a jacket disposed around at least a portion of an outer surface of the hypotube segment. The jacket may be made at least partially of a polymer blend including polyether block amide and polysiloxane. The neuromodulation element includes a distal hypotube segment and a tubular jacket disposed around at least a portion of an outer surface of the distal hypotube segment. The jacket has reduced-diameter segments spaced apart along its longitudinal axis. The neuromodulation element further includes band electrodes respectively seated in the reduced-diameter segments and respectively forming closed loops extending circumferentially around the jacket.

Abstract: A catheter includes a proximal portion and a distal portion, the distal portion including an arcuate portion. The catheter further includes a rotating portion, the rotating portion connecting the proximal portion and distal portion, the rotating portion including a first piece and a second piece, wherein the first piece and second piece create a snap fit. Methods of using the catheter include threading the inserted catheter through the vasculature and allowing the distal portion to freely rotate about an axis defined by the rotating portion responsive to any tortuosity in the vasculature.