Multisensor Guidewire with Grooved Core for Cardiac Support
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Solution Overview
Problem
Current guidewires for transcatheter heart valve therapies face challenges in providing accurate diagnostic measurements of cardiovascular parameters like transvalvular pressure gradients while minimizing interference with heart valve operation and reducing the risk of tissue trauma during procedures.
Innovation Solution
A multisensor guidewire with a grooved core wire design that accommodates multiple optical sensors and fibers within a small diameter, maintaining sufficient stiffness for procedural support while allowing for precise measurements and minimizing tissue trauma through a contact force sensor and flexible tip.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a fine diameter guidewire is used to minimize interference with heart valve operation and reduce tissue trauma, then the risk of tissue trauma and valve interference is reduced, but the guidewire stiffness and ability to provide procedural support deteriorates
Solution Approach 1:
The guidewire employs a composite structure combining a flexible coil outer layer with a stiffer core wire, creating a composite material system that achieves both flexibility for minimal tissue trauma and sufficient stiffness for procedural support. The core wire provides structural integrity while the flexible coil reduces trauma, resolving the contradiction between these opposing requirements.
Solution Approach 2:
The guidewire is segmented into distinct functional zones: a flexible distal tip for atraumatic navigation and valve crossing, a sensor-containing midsection for diagnostic measurements, and a stiffer proximal section for operator control and support. This segmentation allows each section to optimize its mechanical properties for its specific function, balancing flexibility and stiffness throughout the device.
2Measurement precision
If multiple optical sensors are incorporated into the guidewire for accurate diagnostic measurements, then measurement capability and diagnostic precision are improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
Multiple optical sensors are merged into a single integrated guidewire structure, with all sensors and their optical fibers embedded within the flexible coil and core wire assembly. This consolidation allows simultaneous measurement of multiple parameters (pressure, flow, temperature) at different locations without requiring multiple separate devices, achieving diagnostic precision while managing complexity through integration.
Solution Approach 2:
The guidewire is designed as a multi-functional device that combines diagnostic measurement capabilities (multiple optical sensors for pressure, flow, and temperature) with therapeutic guidance functions (structural support for valve implantation). This universality allows a single device to perform both diagnostic and therapeutic roles, improving measurement precision while avoiding the need for separate specialized devices.
3Ease of operation
If the guidewire maintains sufficient stiffness to provide procedural support, then the ability to guide and support valve delivery deteriorates, but the guidewire can cause more tissue trauma and valve interference
Solution Approach 1:
The guidewire exhibits dynamic mechanical properties where the flexible coil and core wire structure allows the device to adapt its stiffness characteristics during different procedural phases. The flexible distal tip dynamically conforms to vascular anatomy and valve structures during navigation, while the stiffer proximal section maintains operational stiffness for device delivery, enabling ease of operation without excessive tissue trauma.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables accurate and minimally invasive diagnostic and therapeutic procedures by providing real-time data on cardiovascular parameters and reducing the risk of tissue damage during transcatheter valve interventions.
Implementation Method 1
The sensor guidewire comprises a distal end portion containing multiple optical sensors arranged for measuring blood pressure at several sensor locations simultaneously in real-time, and optionally also blood flow
Data Source
AI summary
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).