Abstract: A biostimulator, such as a leadless cardiac pacemaker, has a header assembly that includes an antenna. A header assembly includes an antenna cap having an antenna loop embedded in a cap body. The cap body includes a dielectric material, and the antenna loop extends about a central channel of the cap body. The central channel extends along a longitudinal axis over a cap length, and the cap body has a cap width transverse to the longitudinal axis. The cap body has an aspect ratio of the cap width to the cap length greater than 1. A header assembly includes an antenna loop of the antenna encased in a header body of the header assembly. The header assembly includes a fixation element. A proximal end of the fixation element is encased in the header body. Other embodiments are also described and claimed.

Abstract: Disclosed herein is an implantable electronic device. The device includes a housing and a header connector assembly coupled to the housing. The header connector assembly includes a DF4/IS4 assembly and a header including a bore. The DF4/IS4 assembly is locked within the bore via a locking datum arrangement that exists between the DF4/IS4 assembly and the header.

Abstract: A leadless biostimulator has a housing including an electronics compartment, an electronics assembly mounted in the electronics compartment, a proximal electrode that disposed on and/or integrated into the housing, and an electrical feedthrough assembly. The electrical feedthrough assembly includes a distal electrode and a flange. The flange is mounted on the housing. The distal electrode is electrically isolated from the flange by an insulator and configured to be placed in contact with target tissue to which a pacing impulse is to be transmitted by the leadless biostimulator. A mount is mounted on the flange and thereby mounted on the electrical feedthrough assembly. A fixation element is mounted on the mount and configured to facilitate fixation of the leadless biostimulator to tissue of a patient.

Abstract: An electrical feedthrough assembly, which is configured to be mounted on a housing of a leadless biostimulator, comprises an electrode body including a cup having an electrode wall extending distally from an electrode base around an electrode cavity, an electrode tip mounted on a distal end of the electrode body, and a filler in the electrode cavity between the electrode base and the electrode tip, wherein the filler includes a therapeutic agent. The electrode tip is configured to be placed in contact with target tissue to which a pacing impulse is to be transmitted by the leadless biostimulator. A pin extends proximally from the electrode base, wherein the pin is configured to be into contact with an electrical connector of an electronics assembly within the housing of the leadless biostimulator.

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: An implantable medical device includes a header configured to be mounted to an end of a device housing that contains an electronics module therein. The header includes an antenna, a sensing electrode, and a header body that at least partially surrounds the antenna and the sensing electrode. The sensing electrode includes a first body portion, a second body portion, and a bridge portion that mechanically and electrically connects the first and second body portions. The first body portion is at least partially exposed to an external environment along a first side of the header, and the second body portion is at least partially exposed to the external environment along a second side of the header that is different from the first side.

Abstract: A leadless biostimulator, and an electrical feedthrough assembly for use therewith, are described herein. The leadless biostimulator comprises an electrode body including a cup having an electrode wall extending distally from an electrode base around an electrode cavity, an electrode tip mounted on a distal end of the electrode body, and a filler in the electrode cavity between the electrode base and the electrode tip, wherein the filler includes a therapeutic agent. The electrode tip is configured to be placed in contact with target tissue to which a pacing impulse is to be transmitted by the leadless biostimulator. A pin extends proximally from the electrode base, wherein the pin is configured to be into contact with an electrical connector of an electronics assembly within a housing of the leadless biostimulator, and wherein the electrical feedthrough assembly is configured to be mounted on the housing of the leadless biostimulator.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including an electrical feedthrough assembly mounted on a housing, is described. An electronics compartment of the housing can contain an electronics assembly to generate a pacing impulse, and the electrical feedthrough assembly can include an electrode tip to deliver the pacing impulse to a target tissue. A monolithically formed electrode body can have a pin integrated with a cup. The pin can be electrically connected to the electronics assembly, and the cup can be electrically connected to the electrode tip. Accordingly, the biostimulator can transmit the pacing impulse through the monolithic pin and cup to the target tissue. The cup can hold a filler having a therapeutic agent for delivery to the target tissue and may include retention elements for maintaining the filler at a predetermined location within the cup.

Abstract: A leadless biostimulator including an attachment feature to facilitate precise manipulation during delivery or retrieval is described. The attachment feature can be monolithically formed from a rigid material, and includes a base, a button, and a stem interconnecting the base to the button. The stem is a single post having a transverse profile extending around a central axis. The transverse profile can be annular and can surround the central axis. The leadless biostimulator includes a battery assembly having a cell can that includes an end boss. A tether recess in the end boss is axially aligned with a face port in the button to receive tethers of a delivery or retrieval system through an inner lumen of the stem. The attachment feature can be mounted on and welded to the cell can at a thickened transition region around the end boss. Other embodiments are also described and claimed.

Abstract: A leadless biostimulator including an attachment feature to facilitate precise manipulation during delivery or retrieval is described. The attachment feature can be monolithically formed from a rigid material, and includes a base, a button, and a stem interconnecting the base to the button. The stem is a single post having a transverse profile extending around a central axis. The transverse profile can be annular and can surround the central axis. The leadless biostimulator includes a battery assembly having a cell can that includes an end boss. A tether recess in the end boss is axially aligned with a face port in the button to receive tethers of a delivery or retrieval system through an inner lumen of the stem. The attachment feature can be mounted on and welded to the cell can at a thickened transition region around the end boss. Other embodiments are also described and claimed.

Abstract: Setscrews for implantable medical devices include multiple drive features. The drive features may include a first or primary drive feature (such as a hex socket) and a second drive feature that can be engaged independently from the first drive feature such that the second drive feature may be used to extract the setscrew in the event the first drive feature is damaged or obstructed. The second drive feature may extend laterally and/or longitudinally beyond the first drive feature. Examples of second drive features include, without limitation, slots, sockets, extensions/protrusions, and counter-threaded bores. Spacers for use with implantable devices including elastomeric septums are further provided to prevent damage to the septum and obstruction of the primary drive feature during backing out of the setscrew.

Abstract: Disclosed herein is an implantable electronic device. The device includes a housing and a header connector assembly coupled to the housing. The header connector assembly includes a DF4/IS4 assembly and a header including a bore. The DF4/IS4 assembly is locked within the bore via a locking datum arrangement that exists between the DF4/IS4 assembly and the header.

Abstract: Disclosed herein is an implantable electronic device. The device includes a housing and a header connector assembly coupled to the housing. The header connector assembly includes a DF4/IS4 assembly and a header including a bore. The DF4/IS4 assembly is locked within the bore via a locking datum arrangement that exists between the DF4/IS4 assembly and the header.

Abstract: A pulse generator comprises a header connector assembly coupled with a housing. The header connector assembly includes a connector assembly and a header enclosing the connector assembly. The connector assembly includes an electrically insulative segment, a first electrically conductive segment, and a second electrically conductive segment axially spaced apart from the first electrically conductive segment by the electrically insulative segment. Each electrically conductive segment includes a connector ring, a spring housing and a spring supported by the spring housing. The connector ring and spring housing are in electrical communication with each other. The electrically insulative segment includes an insulator ring that is positioned between the first and second electrically conductive segments. The insulator ring includes a first end and a second end axially opposite the first end.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including an electrical feedthrough assembly mounted on a housing, is described. An electronics compartment of the housing can contain an electronics assembly to generate a pacing impulse, and the electrical feedthrough assembly can include an electrode tip to deliver the pacing impulse to a target tissue. A monolithically formed electrode body can have a pin integrated with a cup. The pin can be electrically connected to the electronics assembly, and the cup can be electrically connected to the electrode tip. Accordingly, the biostimulator can transmit the pacing impulse through the monolithic pin and cup to the target tissue. The cup can hold a filler having a therapeutic agent for delivery to the target tissue and may include retention elements for maintaining the filler at a predetermined location within the cup.

Abstract: A leadless biostimulator including an attachment feature to facilitate precise manipulation during delivery or retrieval is described. The attachment feature can be monolithically formed from a rigid material, and includes a base, a button, and a stem interconnecting the base to the button. The stem is a single post having a transverse profile extending around a central axis. The transverse profile can be annular and can surround the central axis. The leadless biostimulator includes a battery assembly having a cell can that includes an end boss. A tether recess in the end boss is axially aligned with a face port in the button to receive tethers of a delivery or retrieval system through an inner lumen of the stem. The attachment feature can be mounted on and welded to the cell can at a thickened transition region around the end boss. Other embodiments are also described and claimed.

Abstract: Disclosed herein is an implantable electronic device. The device includes a housing and a header connector assembly coupled to the housing. The header connector assembly includes a DF4/IS4 assembly and a header including a bore. The DF4/IS4 assembly is locked within the bore via a locking datum arrangement that exists between the DF4/IS4 assembly and the header.

Abstract: The present disclosure provides leadless pacemaker systems and methods. A leadless pacemaker includes a battery subassembly, a feedthrough subassembly, and an electronics subassembly coupled between the battery subassembly and the feedthrough subassembly, the electronics subassembly including an electronics package, and a housing configured to provide a hermetic seal and comprising a first retaining feature and a second retaining feature configured to secure the electronics package within the housing.

Abstract: A pulse generator comprises a header connector assembly coupled with a housing. The header connector assembly includes a connector assembly and a header enclosing the connector assembly. The connector assembly includes an electrically insulative segment, a first electrically conductive segment, and a second electrically conductive segment axially spaced apart from the first electrically conductive segment by the electrically insulative segment. Each electrically conductive segment includes a connector ring, a spring housing and a spring supported by the spring housing. The connector ring and spring housing are in electrical communication with each other. The electrically insulative segment includes an insulator ring that is positioned between the first and second electrically conductive segments. The insulator ring includes a first end and a second end axially opposite the first end.

Abstract: In accordance with one embodiment, a leadless implantable medical device (LIMD), compromises a hermetic housing that has a distal portion and proximal portion. An electrode is proximate to the distal portion. An electronics package is disposed in the housing, in which the electronics package is configured to generate and deliver stimulation signals to the electrode. A fixation mechanism is disposed on the distal portion of the housing. A torque mechanism is disposed on the proximal portion of the housing. The torque mechanism has a tool engagement element movably coupled to the housing. The tool engagement element has a rotational force applied thereto during implant. The torque mechanism includes a torque limiter that maintains a fixed relation between the tool engagement element and the housing when in an engaged state. The torque limiter changes from the engaged state to a disengaged state when the rotational force exceeds a predetermined torque limit.