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 system for delivering electrical stimulation to a heart, where the guidewire has an elongate body with a first elongate conductor extending from a proximal end portion to at least one first electrode along a distal end portion, and a second elongate conductor extending from the proximal end portion to at least one second electrode along the distal end portion. A connector member is removably coupled to the proximal end portion and includes a set of separate electrical conductors extending between a guidewire connection portion and a pulse generator connection portion to provide electrical connections between the first and second elongate conductors and an electrical pulse generator.

The disclosed guidewire system is configured for bipolar electrical stimulation using spaced electrodes coupled to respective conductors to induce and maintain tachycardia in the patient’s heart. The electrical stimulation is intended to provide ventricular tachycardia to lower blood pressure during valve deployment, including balloon deployment for transcatheter valve procedures such as TAVI/TAVR, BV, and TMVR.

In some implementations, the distal end portion includes a preformed bias shape such as a pigtail-shaped region, and the electrodes are provided along a non-coplanar distal end portion. The disclosure also describes conductor and electrode structures for the bipolar configuration, including a corewire and a surrounding conductor such as a braid, a hypotube, or helical coils, as well as electrically-conductive polymer layers.

The patent further describes connector and safety features such as an entrance seal member that electrically isolates conductors from fluids in a patient treatment area, and a connector member configured to couple to an external pulse generator. The disclosure also describes lubricious and/or hydrophilic coatings and optional implementations that integrate the pacing guidewire with valve delivery systems, with examples of maintaining ventricular tachycardia during delivery of a treatment device over the guidewire.

Claims Coverage

Independent claim set covers 3 main inventive feature areas: a bipolar pacing guidewire with first and second conductors and removable pulse-generator connector, a connector member providing electrical stimulation to a bipolar pacing guidewire through first and second conductors, and an integrated method delivering treatment while the heart is maintained in tachycardia.

The independent claims collectively cover bipolar pacing delivery using a guidewire with first and second conductors and electrodes coupled through a removable connector to an electrical pulse generator, and an integrated method in which electrical stimulation induces and maintains tachycardia so that a treatment device is delivered over the guidewire while the heart is maintained in that tachycardia state.

Stated Advantages

Documented Applications