Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element that can be locked to a helix mount, is described. The fixation element includes a fastener that engages a keeper of the helix mount. When engaged with the keeper, the fastener locks the fixation element to the helix mount. Accordingly, the fixation element does not move relative to the helix mount when the biostimulator is delivered into a target tissue. Other embodiments are also described and claimed.

Abstract: A leadless biostimulator, such as a leadless pacemaker, includes a housing sized and configured to be implanted within a heart of a patient and includes both primary and secondary fixation features. The primary fixation feature is adapted to rotate to fix the leadless biostimulator to a wall of the heart during initial implantation. Once the leadless biostimulator is implanted, the secondary fixation feature is adapted to resist counter-rotation of the leadless biostimulator. The primary fixation feature may include a fixation helix configured to affix the housing to the heart by rotating in a screwing direction. The secondary fixation feature may include an apex to engage the heart to resist unscrewing of the primary fixation feature.

Abstract: A leafless biostimulator, such as a leadless pacemaker, includes a housing sized and configured to be implanted within a heart of a patient and includes both primary and secondary fixation features. The primary fixation feature is adapted to rotate to fix the leadless biostimulator to a wall of the heart during initial implantation. Once the leadless biostimulator is implanted, the secondary fixation feature is adapted to resist counter-rotation of the leadless biostimulator. The primary fixation feature may include a fixation helix configured to affix the housing to the heart by rotating in a screwing direction. The secondary fixation feature may include an apex to engage the heart to resist unscrewing of the primary fixation feature.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element that can be locked to a helix mount, is described. The fixation element includes a fastener that engages a keeper of the helix mount. When engaged with the keeper, the fastener locks the fixation element to the helix mount. Accordingly, the fixation element does not move relative to the helix mount when the biostimulator is delivered into a target tissue. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. 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: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. 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: A biostimulator, such as a leadless cardiac pacemaker, having a patch antenna integrated into a housing, is described. The housing includes an annular wall that contains electronic circuitry of the biostimulator and provides a ground plane of the antenna. The patch antenna includes a meandering trace embedded in a curved dielectric layer that is mounted on the annular wall. The trace provides a conductor of the antenna and the dielectric layer provides a dielectric substrate of the antenna between the conductor and the ground plane. The electronic circuitry contained within the annular wall is electrically connected to the trace via an electrical feedthrough that passes through the annular wall and the dielectric layer. The electrical feedthrough places the electronic circuitry in communication with the antenna to transmit or receive wireless communication signals from an external device. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element that can be locked to a helix mount, is described. The fixation element includes a fastener that engages a keeper of the helix mount. When engaged with the keeper, the fastener locks the fixation element to the helix mount. Accordingly, the fixation element does not move relative to the helix mount when the biostimulator is delivered into a target tissue. Other embodiments are also described and claimed.

Abstract: A leafless biostimulator, such as a leadless pacemaker, includes a housing sized and configured to be implanted within a heart of a patient and includes both primary and secondary fixation features. The primary fixation feature is adapted to rotate to fix the leadless biostimulator to a wall of the heart during initial implantation. Once the leadless biostimulator is implanted, the secondary fixation feature is adapted to resist counter-rotation of the leadless biostimulator. The primary fixation feature may include a fixation helix configured to affix the housing to the heart by rotating in a screwing direction. The secondary fixation feature may include an apex to engage the heart to resist unscrewing of the primary fixation feature.

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 biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. Other embodiments are also described and claimed.

Abstract: A method for electrically attaching electrode wire to a conductor in a defibrillation lead is disclosed. The method comprises melting the end of the wire with a hydrogen torch to form a ball of metal, then crimping or welding the ball to the conductor or to a joining piece attached to the conductor. Also, a hydrogen torch (water welder) may be used to join two or more electrode wires to each other.

Abstract: The present invention is directed toward providing a composite lead body design for pacing and defibrillation leads. This lead body design improves the lead crush resistance in the lead segment that is implanted in the patient's clavicular region, while maintaining good fatigue resistance in the lead segment implanted in the heart. The clavicular segment has a generally flat profile. By flattening the clavicular segment proximal to the venous entry site, the lead will have a lower profile. Also, by substantially co-aligning the conductors within the clavicular segment, the crush resistance of the lead is significantly improved.

Abstract: An implantable defibrillator lead comprises a flexible core onto which is wound helically wound coils to form an electrode. These electrode coils are partially encapsulated by a flexible matrix which holds them in their wrapped position around the core. Due to its coiled coil structure, this electrode provides improved flexibility, and can be used endocardially, intravascularly, epicardially, or subcutaneously. The electrode may function alternately as a defibrillation electrode and as a sensing electrode in a lead with a separate pacing electrode.

Abstract: A method for electrically attaching electrode wire to a conductor in a defibrillation lead is disclosed. The method comprises melting the end of the wire with a hydrogen torch to form a ball of metal, then crimping or welding the ball to the conductor or to a joining piece attached to the conductor. Also, a hydrogen torch (water welder) may be used to join two or more electrode wires to each other.