Temporary electrode connection for wireless pacing systems
Inventors
Moore, David F. • Cowan, Mark W. • Willis, Nathaniel Parker
Assignees
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Publication Number
US-11752352-B2
Publication Date
2023-09-12
Expiration Date
Abstract
Delivery of an implantable wireless receiver-stimulator (R-S) into the heart using delivery catheter is described. R-S comprises a cathode and an anode and wirelessly receives and converts energy, such as acoustic ultrasound energy, to electrical energy to stimulate the heart. Conductive wires routed through the delivery system temporarily connect R-S electrodes to external monitor and pacing controller. R-S comprises a first temporary electrical connection from the catheter to the cathode, and a second temporary electrical connection from the catheter to the anode. Temporary electrical connections allow external monitoring of heart's electrical activity as sensed by R-S electrodes to determine tissue viability for excitation as well as to assess energy conversion efficiency.
Core Innovation
The invention relates to implanting a wireless receiver-stimulator at a location of a heart of a patient. The receiver-stimulator is advanced while connected to a delivery system, and electrical energy is delivered to the heart via first and/or second electrodes. The delivery system is electrically connected between a contact of the receiver-stimulator electrically connected to a first electrode and an external electrical system configured to generate the electrical energy.
After implantation, the receiver-stimulator wirelessly delivers energy, converts the energy to electrical energy, and delivers electrical energy to the location of the heart via the first and/or second electrodes. Temporary electrical connections are used while the receiver-stimulator is connected to the delivery system for external monitoring, including electrogram (EGM) monitoring and pacing threshold assessment, and for assessing energy conversion efficiency.
A disconnect mechanism electrically isolates a temporary connection to prevent alternate current paths through the patient. The disconnect mechanism disconnects the receiver-stimulator electrical contact from the first electrode to block a current path through the patient from the electrical contact to the second electrode while maintaining a current path through the patient from the first electrode to the second electrode. Multiple disconnect mechanism options are described, including sealed contact with an insulating seal, magnetically operated switch, reed switch, bellows, conductive dome, and alternative fuse or electronic switch.
Claims Coverage
The relevant material includes three independent claims. Across these, each claim centers on wireless receiver-stimulator implantation with temporary delivery-system electrical connection and a disconnect mechanism that blocks a specific current path after release while maintaining the intended electrode-to-electrode current path.
Catheter-connected wireless receiver-stimulator implantation with timed energy delivery
Advancing an implantable receiver-stimulator to a heart location while connected to a delivery system, delivering electrical energy via a first electrode and/or a second electrode, and delivering energy after disconnect by wireless delivery where the receiver-stimulator converts the energy to electrical energy and delivers it to the heart via the first electrode and/or the second electrode.
Disconnect mechanism that blocks a current path while maintaining an electrode-to-electrode path
Disconnecting the receiver-stimulator from the delivery system such that disconnecting includes blocking a current path through the patient from a contact to the second electrode while maintaining a current path through the patient from the first electrode to the second electrode.
Releasable receiver-stimulator device with electrical contact disconnect upon release
An implantable receiver-stimulator configured to be releasably connected to a delivery system, including a first electrode, a second electrode, and an electrical contact electrically connected to the first electrode when connected to the delivery system, and a disconnect mechanism configured to electrically disconnect the electrical contact from the first electrode upon release to block a current path through the patient from the electrical contact to the second electrode while maintaining a current path through the patient from the first electrode to the second electrode.
Wireless energy receiver-stimulator delivering to heart electrodes
Configuring the receiver-stimulator to wirelessly receive energy from a controller-transmitter and convert the energy to electrical energy, with the first and second electrodes configured to deliver the electrical energy to the heart.
Seal-based electrical insulation of contact after release
A disconnect mechanism including a seal configured to electrically insulate the electrical contact from the patient to block a current path through the patient between the electrical contact and the second electrode while maintaining a current path through the patient between the first electrode and the second electrode when the receiver-stimulator is released from the delivery system.
The claim set coverage centers on an implantable wireless receiver-stimulator that is temporarily connected to a delivery system for advancing and energy delivery, followed by disconnect that blocks a current path from an electrical contact to a second electrode while maintaining the intended current path between first and second electrodes. The device embodiments require a disconnect mechanism, including seal-based electrical insulation, and dependent variations specify disconnect implementations such as magnetic switch, reed switch, bellows, conductive dome, and fuse/electronic switch.
Stated Advantages
Prevents alternate current paths that would shunt stimulation or reduce effectiveness by electrically isolating the temporary connection.
Allows external monitoring of EGM and pacing threshold and assessment of energy conversion efficiency during the temporary connection phase.
Documented Applications
Monitoring electrogram (EGM) and pacing threshold during implantation using temporary electrical connections with an external monitor/pacing controller.
Assessing energy conversion efficiency during implantation while the receiver-stimulator is connected to the delivery system.
Implanting a wireless receiver-stimulator at a location of a patient’s heart using a delivery catheter/system and a disconnect mechanism after permanent attachment.
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