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 biostimulator, such as a leadless cardiac pacemaker, having a header assembly that includes an antenna, is described. The antenna can be integrated into an insulator that separates an electrode of the header assembly from a flange of the header assembly. The antenna includes an antenna loop embedded in a ceramic material of the insulator. The antenna loop is located distal to the flange to reduce the likelihood of signal interference and increase communication range of the antenna. The header assembly is mounted on a housing have an electronics compartment, and an antenna lead extends from the antenna loop to electronic circuitry contained within the electronics compartment. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless pacemaker, including a header assembly having an electrical feedthrough assembly incorporating a helix mount, is described. The header assembly includes a fixation element mounted on the helix mount. The helix mount is mounted on a flange of the electrical feedthrough assembly, and thus, the fixation element can attach the leadless biostimulator to a target tissue. An electrode of the electrical feedthrough assembly is mounted within the flange to deliver a pacing impulse to the target tissue. A ceramic portion of the helix mount is disposed between the flange and the electrode to block an electrical path between the electrode and the flange. Accordingly, the helix mount both retains the fixation element on the leadless biostimulator and electrically isolates the flange and electrode components of the electrical feedthrough. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, having a header assembly that includes an antenna, is described. The antenna can be integrated into an insulator that separates an electrode of the header assembly from a flange of the header assembly. The antenna includes an antenna loop embedded in a ceramic material of the insulator. The antenna loop is located distal to the flange to reduce the likelihood of signal interference and increase communication range of the antenna. The header assembly is mounted on a housing have an electronics compartment, and an antenna lead extends from the antenna loop to electronic circuitry contained within the electronics compartment. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, having a header assembly that includes an antenna, is described. The antenna can be integrated into an insulator that separates an electrode of the header assembly from a flange of the header assembly. The antenna includes an antenna loop embedded in a ceramic material of the insulator. The antenna loop is located distal to the flange to reduce the likelihood of signal interference and increase communication range of the antenna. The header assembly is mounted on a housing have an electronics compartment, and an antenna lead extends from the antenna loop to electronic circuitry contained within the electronics compartment. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless pacemaker, including a header assembly having an electrical feedthrough assembly incorporating a helix mount, is described. The header assembly includes a fixation element mounted on the helix mount. The helix mount is mounted on a flange of the electrical feedthrough assembly, and thus, the fixation element can attach the leadless biostimulator to a target tissue. An electrode of the electrical feedthrough assembly is mounted within the flange to deliver a pacing impulse to the target tissue. A ceramic portion of the helix mount is disposed between the flange and the electrode to block an electrical path between the electrode and the flange. Accordingly, the helix mount both retains the fixation element on the leadless biostimulator and electrically isolates the flange and electrode components of the electrical feedthrough. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, having a header assembly that includes an antenna, is described. The antenna can be integrated into an insulator that separates an electrode of the header assembly from a flange of the header assembly. The antenna includes an antenna loop embedded in a ceramic material of the insulator. The antenna loop is located distal to the flange to reduce the likelihood of signal interference and increase communication range of the antenna. The header assembly is mounted on a housing have an electronics compartment, and an antenna lead extends from the antenna loop to electronic circuitry contained within the electronics compartment. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless pacemaker, including a header assembly having an electrical feedthrough assembly incorporating a helix mount, is described. The header assembly includes a fixation element mounted on the helix mount. The helix mount is mounted on a flange of the electrical feedthrough assembly, and thus, the fixation element can attach the leadless biostimulator to a target tissue. An electrode of the electrical feedthrough assembly is mounted within the flange to deliver a pacing impulse to the target tissue. A ceramic portion of the helix mount is disposed between the flange and the electrode to block an electrical path between the electrode and the flange. Accordingly, the helix mount both retains the fixation element on the leadless biostimulator and electrically isolates the flange and electrode components of the electrical feedthrough. Other embodiments are also described and claimed.

Abstract: An implant delivery instrument includes a housing with a main body section that defines a passage therethrough from a front end of the main body section to a back end of the main body section. The passage receives an obturator through an opening at the back end, and also receives an implant device. Movement of the obturator through the passage pushes the implant device through a discharge opening at the front end and through an incision into a subdermal pocket of a patient. The housing includes a tab connected to and projecting from the front end of the main body section. The tab has a blunt dissection tip for maintaining the incision in an open state without creating or enlarging the incision, and the tab is configured to surround the implant device moving through the discharge opening along only one side of the implant device.

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 biostimulator, such as a leadless pacemaker, including a header assembly having an electrical feedthrough assembly incorporating a helix mount, is described. The header assembly includes a fixation element mounted on the helix mount. The helix mount is mounted on a flange of the electrical feedthrough assembly, and thus, the fixation element can attach the leadless biostimulator to a target tissue. An electrode of the electrical feedthrough assembly is mounted within the flange to deliver a pacing impulse to the target tissue. A ceramic portion of the helix mount is disposed between the flange and the electrode to block an electrical path between the electrode and the flange. Accordingly, the helix mount both retains the fixation element on the leadless biostimulator and electrically isolates the flange and electrode components of the electrical feedthrough. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, having a header assembly that includes an antenna, is described. The antenna can be integrated into an insulator that separates an electrode of the header assembly from a flange of the header assembly. The antenna includes an antenna loop embedded in a ceramic material of the insulator. The antenna loop is located distal to the flange to reduce the likelihood of signal interference and increase communication range of the antenna. The header assembly is mounted on a housing have an electronics compartment, and an antenna lead extends from the antenna loop to electronic circuitry contained within the electronics compartment. Other embodiments are also described and claimed.