System and apparatus comprising a multisensor guidewire for use in interventional cardiology

Abstract

A system and apparatus comprising a multisensor guidewire for use in interventional cardiology, e.g. for Transcatheter Valve Therapies (TVT), comprises a plurality of optical sensors for direct measurement of cardiovascular parameters, e.g. transvalvular blood pressure gradients and flow. A conventional outer coil contains a shaped core wire having a cross-section defining helical grooves extending along its length, which accommodate optical fibers and optical sensors within a diameter Dcore of the core wire. Advantageously, the diameter and material of the core wire provides the guidewire with sufficient stiffness for use as a support guidewire for valve replacement, e.g. Transcatheter Aortic Valve Implantation (TAVI), while accommodating multiple sensors and optical fibers within a guidewire of outside diameter ≦0.89 mm. An optical connector couples the guidewire to a control system. Optionally, the guidewire includes a contact force sensor; a pre-formed tip; and / or a separable micro-connector for proximal mounting of over-the-guidewire components.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Continuation-in-Part of PCT International Application No. PCT / IB2015 / 055240, entitled “System and Apparatus Comprising a Multisensor Guidewire for Use in Interventional Cardiology”, filed Jul. 10, 2015, designating the United States, and claiming priority from U.S. Provisional patent application No. 62 / 023,891, entitled “System And Apparatus Comprising a Multisensor Support Guidewire for Use in Trans-Catheter Heart Valve Therapies”, filed Jul. 13, 2014 and from U.S. Provisional patent application No. 62 / 039,952, entitled “System And Apparatus Comprising a Multisensor Support Guidewire for Use in Trans-Catheter Heart Valve Therapies”, filed Aug. 21, 2014; all said applications are incorporated herein by reference in their entirety.[0002]This application is related to U.S. patent application Ser. No. 14 / 354,624 which is a national stage entry of PCT International Application No. PCT / IB2012 / 055893, entitled “Apparatus, ...

AI Technical Summary

Benefits of technology

The present invention aims to improve the accuracy and minimize the risks associated with measuring cardiovascular parameters and performing interventional cardiac procedures, specifically transcatheter valve therapy (TVT) for heart valve repair or replacement. The invention offers a multisensor guidewire with high stiffness that can directly measure various hemodynamic parameters before and after the valve replacement, and also provide feedback to the interventional cardiologist to avoid tissue trauma or perforation. The guidewire has a grooved core wire with high stiffness, which can provide better support during the procedure. Additionally, the invention provides a fabrication method for improving stiffness and torque characteristics of the guidewire. Overall, the invention offers an improved solution for minimizing risks and improving the efficacy of TVT procedures.

Problems solved by technology

Since the stiffness of a wire varies as the fourth power of its diameter, the small diameter core wire significantly reduces the stiffness of the multisensor guidewire.

Thus, during measurement of a transvalvular pressure gradient, movement of the guidewire may create difficulty in positioning the sensors and the cardiologist may need to readjust the positioning of the guidewire to maintain the pressure sensors each side of the heart valve.

While a larger gauge, stiffer guidewire would be less easily displaced during measurements, for measurement of transvalvular pressure gradients, it would tend to interfere more with normal heart valve operation, and may increase the risk of tissue damage.

When a stiff support guidewire is introduced into the left ventricle of the heart through the aortic valve, if too much force is applied to the guidewire or it is pushed too far, there is some risk that the guidewire could cause damage or trauma to the heart tissues, e.g. damage to the aortic wall or ventricular perforation and pericardial effusion resulting in pericardial tamponade.

Moreover, there is increased risk of trauma or damage to the heart wall in a diseased, weakened or calcified heart.

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