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, 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 includes a body having a longitudinal axis and an electronics compartment containing pacing circuitry. The biostimulator includes a header assembly mounted on the body along the longitudinal axis. The header assembly includes a header housing having a lateral surface facing laterally outward from the longitudinal axis. The header assembly includes an electrode channel in the lateral surface. A pacing electrode extends through the electrode channel along an electrode axis. The electrode axis is substantially orthogonal to the longitudinal axis. 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 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: An implantable medical device includes an electrode and an insulative material secured to the electrode. The electrode includes a metal substrate and a metal coating. The metal coating is disposed on an outer surface of the metal substrate. The insulative material is secured to the electrode via an adhesive that adheres to the metal coating.

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 includes a housing having a longitudinal axis and containing an electronics compartment. The biostimulator includes a fixation element coupled to the housing. The fixation element extends about the longitudinal axis. The biostimulator includes a pacing element coupled to the housing. The pacing element includes a strain relief surrounding a flexible conductor distal to the fixation element. A stiffness of the strain relief decreases in a distal direction. Other embodiments are also described and claimed.

Abstract: Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curvate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Abstract: A pacing device, such as a pacing lead or a biostimulator, includes a tip electrode electrically connected to an electrical conductor. The electrical conductor conveys pacing impulses from pacing circuitry to the tip electrode. The tip electrode extends along a spiral axis and has a surface that, at a position along the spiral axis, includes an insulative portion and a conductive portion. 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: Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curvate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Abstract: An implantable lead includes an inner lead subassembly contained within and movable relative to an outer lead subassembly. The inner lead subassembly has a helical electrode to pace a target anatomy. The outer lead subassembly includes a ring electrode to sense or pace the target anatomy. A threaded interface interconnects the inner lead subassembly and the outer lead subassembly such that relative rotation of the lead subassemblies causes relative axial movement between the helical electrode and the ring electrode. 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 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.