Optical Pressure Sensor Guidewire with Distal Offset
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Solution Overview
Problem
Existing medical devices, such as guidewires, face challenges in effectively measuring and monitoring blood pressure within blood vessels, particularly in navigating through tortuous anatomy and maintaining flexibility while accurately determining fractional flow reserve (FFR).
Innovation Solution
A pressure-sensing guidewire design featuring an elongated shaft with a proximal and distal region, an optical fiber, and a tubular member with a pressure sensor positioned at least 30 centimeters from the distal end, allowing for fluid communication and flexibility, along with slots and a non-circular cross-sectional shape to enhance navigation and accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the pressure sensor is positioned close to the distal end of the guidewire, then the measurement location is optimal for FFR determination, but the sensor is susceptible to deformation from external forces and tortuous anatomy navigation
Solution Approach 1:
A pressure transfer tube serves as an intermediary element, physically separating the pressure sensor from the distal tip environment. The tube transmits pressure from the distal region to the sensor location, allowing accurate pressure measurement while protecting the sensor from deformation forces at the distal end.
Solution Approach 2:
The guidewire is segmented into distinct functional zones: a distal region for pressure sensing, a pressure transfer tube for pressure transmission, and a proximal region housing the sensor. This segmentation allows each component to optimize its function while isolating the sensor from harmful distal environment factors.
2Ease of operation
If the guidewire shaft is made more flexible to navigate tortuous anatomy, then navigation ease is improved, but structural support for the pressure sensor may be compromised
Solution Approach 1:
The guidewire exhibits different mechanical properties at different locations: the distal portion and pressure transfer tube are designed for flexibility to navigate tortuous anatomy, while the proximal sensor housing region provides structural support and stability for the pressure sensor. This local differentiation of mechanical properties resolves the contradiction between flexibility and strength.
3Measurement precision
If the pressure sensor is positioned in the distal region, then FFR measurement accuracy is improved, but the guidewire complexity increases due to additional components
Solution Approach 1:
The pressure transfer tube serves multiple functions: it transmits pressure from the distal tip to the sensor, provides structural support for the distal portion, and acts as a protective conduit. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in overall device complexity while achieving accurate distal pressure measurement.
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
The guidewire effectively measures blood pressure and calculates FFR with increased flexibility and accuracy, enabling easier navigation through vasculature and reducing the likelihood of pressure sensor deformation.
Implementation Method 1
an optical fiber extending along the proximal region, an optical pressure sensor coupled to the optical fiber
Data Source
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AI summary
Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a medical device for measuring blood pressure. The medical device may include an elongated shaft having a proximal region and a distal region. An optical fiber may extend along the proximal region. An optical pressure sensor may be coupled to the optical fiber. The medical device may also include a tubular member having a proximal end disposed adjacent to the optical pressure sensor and a distal portion extending along the distal region of the shaft.