Pacing guidewire

Inventors

Daniels, David • Kugler, Chad • Bridgeman, John • Stratton, Derek • Peterson, Dean • Brenizer, Joshua

Assignees

Cardiac Interventions And Aviation LLC • Teleflex Life Sciences LLC

Abstract

Guidewires and methods for transmitting electrical stimuli to a heart and for guiding and supporting the delivery of elongate treatment devices within the heart are disclosed. A guidewire can comprise an elongate body, including first and second elongate conductors, and at least first and second electrodes. A distal end portion of the elongate body can include a preformed bias shape, such as a pigtail-shaped region, on which the first and second electrodes can be located. The preformed bias shape can optionally be non-coplanar relative to an intermediate portion of the elongate body. The first and second elongate conductors can be formed of a single structure or two or more electrically connected structures. The conductors can extend from proximal end portions to distal end portions that electrically connect to the first and second electrodes. A corewire can extend the length of the elongate body, can at least partially form the first conductor, and can be at least partially surrounded by the second conductor.

Core Innovation

The invention provides a pacing guidewire-based system for percutaneous heart valve procedures, where an elongated guidewire supports over-the-wire delivery and accurate positioning placement of a treatment device to the heart while a pulse generator maintains rapid pacing. The guidewire includes an electrode positioned on or spaced from a ventricular wall and provides electrical stimulation delivery and conduction-based detection of a heart response through the electrode.

An electrical pulse generator detects an electrophysiological response from the heart based on conduction through the electrode in response to delivery of electrical stimulation. Based on the detected electrophysiological response, the pulse generator adjusts a characteristic of the electrical stimulation to achieve or maintain rapid pacing of the heart, such that the proximal and intermediate portions of the guidewire support delivery and accurate positioning of the treatment device.

The disclosure further includes adjusting electrical stimulation using physiological measurements derived from the electrophysiological response, including heart rate, and hemodynamic signals such as pulse pressure and systolic blood pressure detected using a pressure monitor positioned in a central artery. In some implementations, the stimulation is adjusted to drop blood pressure or cardiac output below a threshold amount, with the threshold amount selected to facilitate safe balloon deployment of the heart.

Claims Coverage

The document contains three independent claims covering a system, an apparatus, and a method. Across these independent claims, the core inventive features are a guidewire with a distal ventricular electrode supporting treatment device delivery and positioning, a pulse generator delivering stimulation and detecting an electrophysiological response via the electrode, and closed-loop adjustment of a stimulation characteristic to achieve or maintain rapid pacing while maintaining accurate placement for the treatment device.

The independent claims collectively focus on a ventricular pacing guidewire system where a pulse generator performs sensing of an electrophysiological response through a ventricular electrode during stimulation and then adjusts a stimulation characteristic to achieve or maintain rapid pacing. The guidewire is also configured for delivery and accurate positioning of a treatment device to the heart during pacing.

Stated Advantages

Documented Applications