Abstract: A biostimulator transport system includes a catheter shaft extending to a distal shaft end. The biostimulator transport system includes a biostimulator coupling mounted on the distal shaft end to receive a biostimulator having a fixation element. The biostimulator transport system includes a protective sleeve movable relative to the biostimulator coupling between a protective state and an unprotective state. The protective sleeve covers the fixation element in the protective state. The protective sleeve does not cover the fixation element in the unprotective state. The protective sleeve has a distal section including one or more folds that open when the protective sleeve moves from the protective state to the unprotective state.

Abstract: A delivery system and method are described that include an access introducer sheath and a delivery catheter. The access introducer sheath defines a channel through a body thereof from a proximal end to a distal end. The delivery catheter is disposed within the channel of the access introducer sheath, and defines a lumen that extends along a central axis of the delivery catheter. A distal end segment of the delivery catheter projects beyond the distal end of the access introducer sheath. The lumen is configured to receive a dilator therein that projects beyond the distal end of the delivery catheter so that the distal end segment of the delivery catheter is disposed between a tip segment of the dilator and the distal end of the access introducer sheath along the central axis.

Abstract: A biostimulator transport system includes a biostimulator coupling along a central axis, and one or more location guides. The location guides are deployable radially outward from the central axis. When deployed, the location guides engage anatomical landmarks. Other embodiments are also described and claimed.

Abstract: A biostimulator transport system includes a locking tube having a central lumen. The biostimulator transport system includes a tether extending through the central lumen. The tether includes a locking end coupled to a tether body. The locking end is wider than the tether body. Other embodiments are also described and claimed.

Abstract: Embodiments are disclosed of a loading tool for a biostimulator transport system. The loading tool includes a plunger having a free end and a tether end. A tether is coupled to the tether end of the plunger and coupled to a biostimulator. The plunger is stored in a storage container and can exit the storage container through an outlet.

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 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 delivery device for an implantable medical device may include an inner shaft configured to retain the implantable medical device at its distal end, an outer shaft slidably disposed about the inner shaft, and a locking hub affixed to the outer shaft. The locking hub may include a housing, a piston element in the housing, an actuator operatively coupled to the piston element, and a clamping gasket made of a compressible material and disposed in the housing. The actuator may be movable relative to the housing between unlocked and locked conditions. The clamping gasket may have a lumen defining a first diameter with the actuator in the unlocked condition and a second diameter with the actuator in the locked condition, the second diameter being less than the first diameter. The outer shaft and the locking hub may be fixed to the inner shaft with the actuator in the locked condition.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: A biostimulator includes a housing, an electrode extension, and an expandable frame. The housing has a longitudinal axis and an electronics compartment containing pacing circuitry. The electrode extension extends distally between the housing and an electrode. The biostimulator includes an expandable frame including several struts disposed about the longitudinal axis. Other embodiments are also described and claimed.

Abstract: A biostimulator transport system includes an input shaft and an output shaft. The input shaft extends distally to an input gear. The output shaft extends proximally from an output gear to a biostimulator coupling. The output gear is rotationally coupled to the input gear such that rotation of the input shaft drives rotation of the biostimulator coupling. Other embodiments are also described and claimed.

Abstract: A biostimulator includes a body having an electronics compartment containing pacing circuitry. The biostimulator includes an electrode arm pivotably coupled to the body. The electrode arm is pivotable from an undeployed state to a deployed state. A pivot angle between the electrode arm and the body is greater in the deployed state than in the undeployed state. Other embodiments are also described and claimed.

Abstract: A biostimulator system includes a biostimulator having a header module and a housing module. The header module includes a fixation element, a pacing electrode, and an electrical pin. The housing module includes pacing circuitry that is electrically connected to a power source, and an electrical socket to receive and electrically connect the electrical pin to the pacing circuitry. The biostimulator system includes a biostimulator transport system to deliver the header module to an interventricular septal wall and to deliver the housing module to a ventricular chamber. The modules are then electrically connected within the ventricular chamber. Other embodiments are also described and claimed.

Abstract: A biostimulator and a biostimulator system for septal pacing are described. The biostimulator includes a housing having an electronics compartment containing pacing circuitry and an electrical extension having an elongated electrical conductor, wherein the electrical extension extends from a proximal extension end at the housing to a distal extension end. The biostimulator further includes a pacing extension body mounted on the distal extension end of the electrical extension. The pacing extension body includes a pacing electrode electrically coupled to the pacing circuitry through the elongated electrical conductor, a fixation mechanism, and a drive mechanism to transmit torque to the fixation mechanism. Other embodiments are also described and claimed.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: A biostimulator includes a housing having an electronics compartment containing pacing circuitry. A fixation guide is mounted on the housing and includes a guide passage. A fixation element is movable through the guide passage from an undeployed state to a deployed state. In the undeployed state, a fixation tip of the fixation element is within the guide passage. In the deployed state, the fixation tip extends out of the guide passage. A biostimulator system includes the biostimulator mounted on a biostimulator transport system to deliver the biostimulator to, and extend the fixation tip into, a target anatomy. Other embodiments are also described and claimed.

Abstract: A valve bypass tool for an implantable medical device (IMD) delivery system includes a back panel and a tube connected to the back panel and extending from the back panel to a distal end of the tube. The back panel defines an inlet opening. The tube is cylindrical and the distal end of the tube is configured to dilate a seal of an access introducer. The tube defines a channel therethrough that aligns with and is open to the inlet opening in the back panel. The inlet opening and the channel of the tube are sized to receive an IMD therethrough.

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 loading tool for loading a biostimulator onto a biostimulator delivery system is described. The loading tool includes a first body portion and a second body portion connected by a hinge. A latch is mounted on the first body portion, and the latch can be locked to fasten the first body portion to the second body portion. A biostimulator can be mounted in the loading tool, and a tether of a biostimulator delivery system can be inserted through a funnel in the loading tool to engage the biostimulator. An operator can use only one hand to unlock the latch, open the loading tool, and remove the loading tool from the biostimulator prior to delivering the biostimulator into a patient. Other embodiments are also described and claimed.

Abstract: A loading tool for loading a biostimulator onto a biostimulator delivery system is described. The loading tool includes a first body portion and a second body portion connected by a hinge. A latch is mounted on the first body portion, and the latch can be locked to fasten the first body portion to the second body portion. A biostimulator can be mounted in the loading tool, and a tether of a biostimulator delivery system can be inserted through a funnel in the loading tool to engage the biostimulator. An operator can use only one hand to unlock the latch, open the loading tool, and remove the loading tool from the biostimulator prior to delivering the biostimulator into a patient. Other embodiments are also described and claimed.