Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes a joint to allow an electrode to pivot relative to a housing. The housing contains electrical circuitry that is electrically connected to the pacing electrode. The joint allows the pacing electrode to affix to target tissue of an interventricular septal wall of a heart when the housing is pivoted toward an apex of the heart. Other embodiments are also described and claimed.

Abstract: A biostimulator transport system for transporting a biostimulator includes a sleeve having a sleeve lumen. A support member extends through the sleeve lumen, and a belt extends longitudinally through the sleeve lumen between the sleeve and the support member. The belt has a loop distal to a distal member end of the support member. A portion of a biostimulator can extend through the loop such that the belt retains the biostimulator against the support member. A method of using the biostimulator transport system includes delivering the biostimulator to a target tissue, driving the belt to rotate a pacing electrode of the biostimulator into the target tissue, and cutting the belt to release the implanted biostimulator. Other embodiments are also described and claimed.

Abstract: A pacing lead conversion tool and a method of using the pacing lead conversion tool to reversibly convert an extendable cardiac pacing lead into a fixed cardiac pacing lead. The pacing lead conversion tool includes a locking lumen configured to receive a pacing lead. The locking lumen includes a connector body segment to receive a connector body of the pacing lead in a first friction fit and a pin segment to receive a connector pin of the pacing lead in a second friction fit. The friction fits allow for relative rotation between a lead body of the pacing lead and the connector pin when the pacing lead conversion tool is twisted, and prevents relative rotation between the lead body and the connector pin when the cardiac pacing lead is burrowed through a target tissue. Other embodiments are also described and claimed.

Abstract: A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes a burrowing nose to allow the biostimulator to embed within a target tissue. The embedded biostimulator has a reduced exposed length within a heart chamber, and is less likely to interfere with adjacent heart structures. Embodiments include burrowing ridges on a nose or a housing of the biostimulator to affix the embedded biostimulator to the target tissue. Other embodiments are also described and claimed.

Abstract: A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes an articulation to allow an electrode axis of a pacing electrode to be directed differently than a housing axis of a housing. The housing contains electrical circuitry that is electrically connected to the pacing electrode. The differently directed axes allow the pacing electrode to affix to target tissue of an interventricular septal wall of a heart when the housing of the biostimulator is located near an apex of the heart. The articulation can include a flexible portion of an extension, a hinge, or a tether. Other embodiments are also described and claimed.

Abstract: A biostimulator and a pace mapping system for deep septal pacing. The biostimulator includes a pacing element that extends distally beyond a fixation element. The pacing element is insulated between a distal tip of the fixation element and a distal portion of the pacing element. The pace mapping system can be used to determine a distance between a septal wall of a heart septum and a bundle branch within the septum. The pacing element can be selected based on the distance, and delivered into the septum to pace the bundle branch. Other embodiments are also described and claimed.

Abstract: A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly is described. The header assembly includes a helix mount mounted on a flange. An inner surface of the helix mount conforms to an outer surface of the flange, and the outer surface has a non-circular profile such that the conforming surfaces interfere with rotation of the helix mount relative to the flange. The non-circular profile includes a linear segment, such as a radial segment, that resists rotational movement of the helix mount. The helix mount has a protrusion that extends into a recess of the flange to interfere with longitudinal movement between the helix mount and the flange. The protrusion is formed before or after mounting the helix mount on the flange. The interfering surfaces threadlessly interconnect the header assembly components. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless pacemaker, has electrode(s) coated with low-polarization coating(s). A low-polarization coating including titanium nitride can be disposed on an anode, and a low-polarization coating including a first layer of titanium nitride and a second layer of platinum black can be disposed on a cathode. The anode can be an attachment feature used to transmit torque to the biostimulator. The cathode can be a fixation element used to affix the biostimulator to a target tissue. The low-polarization coating(s) impart low-polarization to the electrode(s) to enable an atrial evoked response to be detected and used to effect automatic output regulation of the biostimulator. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue, is described. The coaxial fixation elements include an outer fixation element extending along a longitudinal axis and an inner fixation element radially inward from the outer fixation element. One or more of the fixation elements are helical fixation elements that can be screwed into tissue. The outer fixation element has a distal tip that is distal to a distal tip of the inner fixation element, and an axial stiffness of the outer fixation element is lower than an axial stiffness of the inner fixation element. The relative stiffnesses are based on one or more of material or geometric characteristics of the respective fixation elements. Other embodiments are also described and claimed.

Abstract: A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly is described. The header assembly includes a helix mount mounted on a flange. An inner surface of the helix mount conforms to an outer surface of the flange, and the outer surface has a non-circular profile such that the conforming surfaces interfere with rotation of the helix mount relative to the flange. The non-circular profile includes a linear segment, such as a radial segment, that resists rotational movement of the helix mount. The helix mount has a protrusion that extends into a recess of the flange to interfere with longitudinal movement between the helix mount and the flange. The protrusion is formed before or after mounting the helix mount on the flange. The interfering surfaces threadlessly interconnect the header assembly components. Other embodiments are also described and claimed.

Abstract: An implantable medical device includes an electrode and an insulative material secured to the electrode via an adhesive. The electrode includes a metal substrate and a metal coating. The metal substrate includes a connection segment and an active segment along a length of the metal substrate. The metal coating is disposed on an outer surface of the metal substrate along the connection segment and the active segment. The insulative material surrounds the connection segment of the metal substrate without surrounding the active segment, and the adhesive adheres to the metal coating on the connection segment.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue, is described. The coaxial fixation elements include an outer fixation element extending along a longitudinal axis and an inner fixation element radially inward from the outer fixation element. One or more of the fixation elements are helical fixation elements that can be screwed into tissue. The outer fixation element has a distal tip that is distal to a distal tip of the inner fixation element, and an axial stiffness of the outer fixation element is lower than an axial stiffness of the inner fixation element. The relative stiffnesses are based on one or more of material or geometric characteristics of the respective fixation elements. Other embodiments are also described and claimed.

Abstract: A biostimulator delivery system having a tether cable, is described. A connector can be mounted on the tether cable to connect to a biostimulator. The connector can be a protuberance that lodges within the biostimulator, or a threaded connector that screws into the biostimulator. The tether cable has a stranded cable configuration, including several strands extending about a core strand in a helical direction. The stranded cable structure resists breaking under bending stresses typically seen during a tether mode used during delivery of the biostimulator. The tether cable reliably secures the biostimulator to the delivery system in the tether mode. Other embodiments are also described and claimed.

Abstract: A leadless biostimulator, such as a leadless pacemaker, including a header assembly having a monolithic controlled release device (MCRD) for therapeutic agent elution, is described. The MCRD is in fluid communication with a space between an insulator and an electrode of the header assembly to elute therapeutic agent into the space when the leadless biostimulator is implanted. The therapeutic agent can elute through the space around the electrode to provide controlled elution of the therapeutic agent to a surrounding environment. The electrode can extend longitudinally through the insulator cavity to a distal tip that provides a stable surface area and controlled impedance for pacing a target tissue. Other embodiments are also described and claimed.

Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly is described. The header assembly includes a helix mount mounted on a flange. An inner surface of the helix mount conforms to an outer surface of the flange, and the outer surface has a non-circular profile such that the conforming surfaces interfere with rotation of the helix mount relative to the flange. The non-circular profile includes a linear segment, such as a radial segment, that resists rotational movement of the helix mount. The helix mount has a protrusion that extends into a recess of the flange to interfere with longitudinal movement between the helix mount and the flange. The protrusion is formed before or after mounting the helix mount on the flange. The interfering surfaces threadlessly interconnect the header assembly components. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless pacemaker, having electrode(s) coated with low-polarization coating(s), is described. A low-polarization coating including titanium nitride can be disposed on an anode, and a low-polarization coating including a first layer of titanium nitride and a second layer of platinum black can be disposed on a cathode. The anode can be an attachment feature used to transmit torque to the biostimulator. The cathode can be a fixation element used to affix the biostimulator to a target tissue. The low-polarization coating(s) impart low-polarization to the electrode(s) to enable an atrial evoked response to be detected and used to effect automatic output regulation of the biostimulator. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless pacemaker, having electrode(s) coated with low-polarization coating(s), is described. A low-polarization coating including titanium nitride can be disposed on an anode, and a low-polarization coating including a first layer of titanium nitride and a second layer of platinum black can be disposed on a cathode. The anode can be an attachment feature used to transmit torque to the biostimulator. The cathode can be a fixation element used to affix the biostimulator to a target tissue. The low-polarization coating(s) impart low-polarization to the electrode(s) to enable an atrial evoked response to be detected and used to effect automatic output regulation of the biostimulator. Other embodiments are also described and claimed.