Abstract: A stent includes a continuous wave form having a plurality of struts and a plurality of crowns throughout the wave form. Each crown connects two adjacent struts. The wave form is wrapped around a longitudinal axis to define a central portion and two end portions located on opposite sides the central portion. The central portion includes a plurality of turns wrapped around the longitudinal axis and oriented at a first pitch angle relative to the longitudinal axis. The end portions each include a plurality of turns wrapped around the longitudinal axis and oriented at different pitch angles, and an end turn oriented at an angle relative to the longitudinal axis. The different pitch angles of the end portions are between the first pitch angle and the angle of the end turn relative to the longitudinal axis.

Abstract: Catheter apparatuses having expandable mesh structures and associated systems and methods for intravascular renal neuromodulation are disclosed herein. A catheter treatment device includes an expandable mesh structure configured to position an energy delivery element in contact with a renal artery via an intravascular path. The mesh structure can assume an expanded configuration 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. A collapsed configuration may facilitate insertion and/or removal of the catheter or repositioning of the energy delivery element within the renal artery.

Abstract: An implantable medical device, such as a sensor for monitoring a selected internally detectable physiological parameter of a patient, is attached to a fixation member that is deployable within the patient to position and orient the sensor to enable it to perform its function. The fixation member may be configured to lie in a single plane when deployed or may be tubular in shape. The attachment of the housing and fixation member includes providing the fixation member with a linear attachment strut that is non-circular in cross section and providing the housing with external members that define an elongate channel, non-circular in cross section and receptive to the attachment strut. The attachment strut can be inserted transversely into the channel and the external member can be crimped over the strut to secure the housing and fixation member together.

Abstract: A catheter system for delivery of a medical implant, the system including a cap removably covering an open distal end of a catheter. An elongate actuator wire is fixedly attached to the cap, extends through a lumen of the catheter, and has a distal region that can assume a pre-formed shape when unconstrained by the catheter lumen. The pre-formed shape of the wire distal region defines a bend adapted to laterally deflect the cap from the catheter distal end when assuming the pre-formed shape. At least a portion of the lumen adjacent the catheter distal end is sized and shaped to slidably receive the medical implant alongside the actuator wire. A push rod extends through the catheter lumen for ejecting the medical implant from the catheter distal end. Methods of using the invention are also disclosed.

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: Waveforms for forming helical stents with opposing and/or alternating pitch angles along their lengths are disclosed. A wire is bent to form a waveform having a series of sinusoidal segments between a first end and a second end thereof. Each sinusoidal segment is longitudinally offset from its adjacent segment(s). Each waveform includes at least one sinusoidal segment having a first portion in which the amplitude between consecutive turns of the wire gradually increases and a longitudinally offset second portion in which the amplitude between consecutive turns of the wire gradually decreases. The waveform is wrapped from one end to the other about a mandrel to form the stent and depending on the arrangement of sinusoidal segments along the waveform may have opposing and/or alternating pitch angles along a section or an entire length of the stent.

Abstract: A delivery device for implanting a medical device that includes an expandable fixation member adapted to fix the position of the medical device within a lumen of a human body. The delivery device has an inner shaft rotatably disposed in a tubular outer shaft. A retention member is secured to and rotatable with the inner shaft and has a free end and a retainer portion adapted to protrude outwardly through an exit aperture in the outer shaft to extend circumferentially about the exterior of the outer shaft. The fixation member of the medical device may be retained on the tubular shaft in a low profile configuration by the outwardly protruding retainer portion and may be released to expand upon retraction of the retainer portion in response to rotation of the inner shaft.

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 method for forming a wave form for a stent includes moving a first forming portion of a first forming member across an axis along which a formable material is provided in a first direction substantially perpendicular to the axis to engage and deform the formable material while engaging the formable material with a first forming portion of the second forming member. The method includes moving the first forming portion of the first forming member and the first forming portion of the second forming member across the axis in a second direction that is substantially opposite the first direction to draw and form the formable material over the first forming portion of the second forming member, disengaging the first forming member from the formable material, and moving the first forming member to position a second forming portion of the first forming member to face the formable material.

Abstract: A method for forming a wave form for a stent includes moving a first forming portion of a first forming member across an axis along which a formable material is provided in a first direction substantially perpendicular to the axis to engage and deform the formable material while engaging the formable material with a first forming portion of the second forming member. The method includes moving the first forming portion of the first forming member and the first forming portion of the second forming member across the axis in a second direction that is substantially opposite the first direction to draw and form the formable material over the first forming portion of the second forming member, disengaging the first forming member from the formable material, and rotating the first forming member to position a second forming portion of the first forming member to face the formable material.

Abstract: A fixation device for retaining a leadless medical implant to tissue includes an annular collar and an array of self-expanding tines extending from the collar. When deployed, the annular collar encircles the implant and the tines are preset to splay outwardly from the implant to grab body tissue and anchor the implant at a treatment site. The implant and fixation device are contained within a sheath for delivery to the treatment site and a pushing force is applied to a pusher of the delivery system to distally advance the fixation device relative to the implant and deploy the tines. A distal end of the implant having an electrode may form a distal tip of the delivery system, and a potential implantation site may be tested prior to deployment of the fixation device to allow for easy repositioning of the implant if the potential implantation site is determined to be unacceptable.

Abstract: This disclosure is directed to an implantable medical device having a communication dipole configured in accordance with the techniques described herein. In one example, the disclosure is directed to an implantable medical device comprising a housing that encloses at least a communication module, a first electrode of a communication dipole electrically coupled to the communication module and an electrically conductive fixation mechanism that is electrically coupled to a portion of the housing and wherein a portion of the fixation mechanism is configured to function as at least part of a second electrode of the communication dipole. The electrically conductive fixation mechanism includes a dielectric material that covers at least part of a surface of the fixation mechanism. The communication module is configured to transmit or receive a modulated signal between the first electrode and second electrode of the communication dipole.

Abstract: An implantable medical device, such as a sensor for monitoring a selected internally detectable physiological parameter of a patient, is attached to a fixation member that is deployable within the patient to position and orient the sensor to enable it to perform its function. The fixation member may be configured to lie in a single plane when deployed or may be tubular in shape. The attachment of the housing and fixation member includes providing the fixation member with a linear attachment strut that is non-circular in cross section and providing the housing with external members that define an elongate channel, non-circular in cross section and receptive to the attachment strut. The attachment strut can be inserted transversely into the channel and the external member can be crimped over the strut to secure the housing and fixation member together.

Abstract: A fixation device for retaining a leadless medical implant to tissue includes an array of elongate tines having self-expanding distal portions. The fixation tines may be advanced between an implant body and an outer jacket to deploy the tines from a delivery configuration in which the tines are constrained by the outer jacket to an expanded configuration in which the distal end portions of the tines are released from the outer jacket. The implant and fixation device are contained within a sheath for delivery to the treatment site and a pusher within the sheath advances the fixation device relative to the implant body and deploys the tines. A distal end of the implant having an electrode may form a distal tip of the delivery system, and a potential implantation site may be tested prior to deployment of the fixation device to allow for easy repositioning of the implant.

Abstract: An implant centering system includes a sensor connected to a hollow cylindrical anchor via at least two struts. The hollow cylindrical anchor is transformable between a radially compressed configuration for delivery and a radially expanded configuration for lodging against a vessel wall. The struts longitudinally relocate the sensor between a first position in which the sensor is longitudinally spaced apart from the radially compressed anchor, and a second position in which the sensor is at least partially within a lumen of the radially expanded anchor and radially centered within vessel. In one embodiment, the struts are heat-set into a curved configuration and an externally applied force longitudinally relocates the sensor until the struts lock over center into their heat-set configuration. In another embodiment, radial expansion of the anchor longitudinally relocates the sensor without an externally applied force.

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 medical device adapted to be implanted in a vessel of a human body includes a housing that contains a diagnostic or therapeutic module and an anchor for supporting the housing in an intended location and orientation within the vessel. The anchor is expandable from a low profile configuration adapted for delivery to an expanded configuration for engagement with the vessel wall. The anchor and a delivery catheter are adapted to enable the medical device to be retrieved and repositioned or removed from the vessel. The anchor is adapted to apply sufficient force against the vessel wall to maintain the anchor in place but less force than that required to provide scaffolding support for the vessel.

Abstract: A method for forming a wave form for a stent. The wave form includes a plurality of substantially straight portions and a plurality of curved portions. Each curved portion connects adjacent substantially straight portions. The method includes feeding a formable material between a first die and a second die, the first die having a protruding surface in the shape of the wave form, and the second die having a recessed surface in the shape of the wave form complementing the protruding surface of the first die, pressing the formable material with the protruding surface of the first die into contact with the recessed surface of the second die, and shearing the wave form from the formable material with shearing forces created by the pressing.

Abstract: A medical device adapted to be implanted in a vessel of a human body includes a housing that contains means for performing medical functions and an anchor for supporting the housing in an intended location and orientation within the vessel. The anchor is expandable from a low profile configuration adapted for delivery to an expanded configuration for engagement with the vessel wall. The anchor and delivery device are adapted to enable the medical device to be retrieved and repositioned or removed from the vessel. The anchor is adapted to apply sufficient force against the vessel wall to maintain the anchor in place but less force than that required to provide scaffolding support for the vessel.