System and apparatus comprising a multisensor guidewire for use in interventional cardiology
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Publication Number
US-10722175-B2
Publication Date
2020-07-28
Expiration Date
Abstract
A system (1) and apparatus comprising a multisensor guidewire (100/200/300) for use in interventional cardiology, e.g., Transcatheter Valve Therapies (TVT), comprises a plurality of optical sensors (10/20) for direct measurement of cardiovascular parameters, e.g. transvalvular blood pressure gradients and flow. A conventional outer coil wire (35) contains a shaped core wire (31) having a cross-section defining a channel surface (132), e.g. grooves (32), extending along its length, to position optical fibers (11) and optical sensors (10/20) in a channel (33). Advantageously, the core wire has a diameter that provides sufficient stiffness to the guidewire for use as a support guidewire for TVT, e.g. Transcatheter Aortic Valve Implantation (TAVI), while accommodating multiple sensors and fibers within a guidewire of outside diameter ≤0.89 mm. An optical connector (112) couples the guidewire to a control system (150). Optionally, the guidewire includes a contact force sensor (60), a pre-formed tip (400-1/400-2) and a separable micro-connector (140).
Core Innovation
The multisensor guidewire assembly measures blood pressure concurrently at multiple locations during transcatheter heart valve therapies (TVT). It includes distal and proximal parts connected by a micro optical coupler that is separable to enable over the guidewire delivery of TVT components.
The distal part comprises a guidewire having a tubular covering layer with a flexible coil of a first stiffness and an inner member of a second stiffness extending within the coil along the length between the proximal and distal ends. The distal end portion carries a flexible distal tip and a plurality of optical sensors with a plurality of optical fibers, and the optical sensors are positioned at respective sensor locations spaced apart lengthwise within the distal end portion.
The proximal part includes a flexible optical cable with optical fibers and a female part of the optical coupler, and an optical input/output at the proximal end for connection to an optical controller. The male and female parts of the micro optical coupler mutually align and optically couple the plurality of optical fibers for operation of the optical pressure sensors.
Claims Coverage
The document includes one independent claim that sets a complete multisensor guidewire assembly architecture, with separable micro optical coupler enabling over-the-guidewire delivery of TVT components and concurrent blood pressure measurement at multiple locations using at least two optical pressure sensors.
Multisensor guidewire for concurrent blood pressure measurement during TVT
A multisensor guidewire assembly for measuring blood pressure concurrently at multiple locations during transcatheter heart valve therapies (TVT), comprising distal and proximal parts connected by a micro optical coupler that is separable to enable over the guidewire delivery of TVT components.
Distal guidewire structure with flexible coil and inner member
The distal part comprises a guidewire with a tubular covering layer including a flexible coil of a first stiffness and an inner member of a second stiffness extending within the coil from the proximal end to the distal end, with a flexible distal tip.
Optical pressure sensor arrangement with spaced sensor locations
A plurality of optical sensors and a plurality of optical fibers, with sensor ends of the optical fibers attached and optically coupled to respective optical sensors, where the optical sensors include at least two optical pressure sensors and the optical fibers form a sensor arrangement positioning the optical sensors at respective sensor locations spaced apart lengthwise within a distal end portion of the guidewire.
Separable micro optical coupler for optical coupling to an optical controller
The proximal part comprises a flexible optical cable containing the optical fibers, with a female part of the optical coupler at the distal end and an optical input/output at the proximal end for connection to an optical controller, where the male and female parts are configured to mutually align and optically couple the optical fibers for operation of the optical pressure sensors.
Coupler geometry enabling over-the-guidewire delivery of TVT components
The male and female parts of the optical coupler are separable, and the male part of the optical coupler has an outside diameter that accepts TVT components for over the guidewire delivery.
Across the independent claim, the key inventive structure is a multisensor guidewire with a distal sensor-bearing portion using optical fibers coupled to at least two optical pressure sensors spaced along the distal end portion, and a separable micro optical coupler that aligns and optically couples distal and proximal fiber bundles while allowing over-the-guidewire delivery of TVT components.
Stated Advantages
Enables over the guidewire delivery of TVT components using a separable micro optical coupler.
Measures blood pressure concurrently at multiple locations during transcatheter heart valve therapies (TVT).
Documented Applications
Real-time pre- and post-TVT hemodynamic assessment, including computation of valve area when flow is measured.
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