Embolic Protection Filter With Tactile Feedback Bumper
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Solution Overview
Problem
Current medical devices for embolic protection face challenges in precise delivery without fluoroscopy, particularly in surgical suites lacking imaging equipment, and there is a need for alternative designs and methods to effectively contain embolic material during procedures like transcatheter aortic valve replacement.
Innovation Solution
The development of embolic protection devices featuring a filter anchor, a permeable filter membrane, and sensors such as impedance, flow, or pressure sensors to provide location indication and tactile feedback, allowing for precise placement within the aorta without fluoroscopic guidance, along with radiopaque or ultrasound-visible coatings for imaging compatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy is used for device placement guidance, then placement precision is improved, but device complexity and procedural cost increase
Solution Approach 1:
The embolic protection device incorporates self-contained sensors (impedance, flow, or pressure sensors) that autonomously provide location indication and placement verification without requiring external fluoroscopy equipment. The device serves its own guidance needs through integrated sensing capabilities, eliminating dependence on complex external imaging systems.
Solution Approach 2:
The patent replaces the mechanical/optical fluoroscopy system with electronic sensing mechanisms. Instead of using X-ray imaging equipment to visualize device position, the invention uses electrical impedance sensors, flow sensors, or pressure sensors to detect and report device location and placement status through electrical and physiological signals.
2Measurement precision
If fluoroscopy equipment is available, then device placement accuracy is improved, but ease of operation deteriorates in surgical suites without imaging equipment
Solution Approach 1:
The device provides its own placement verification through integrated sensors that autonomously monitor and report device position and embolic material containment status. This self-service capability ensures the device can be accurately placed and verified in any surgical setting regardless of external imaging equipment availability.
Solution Approach 2:
The sensors act as intermediaries between the device and the clinician, translating physical device position and embolic material presence into detectable electrical signals (impedance changes, flow patterns, or pressure variations) that provide real-time feedback without requiring direct visual imaging.
3Measurement precision
If sensors are added to provide location indication, then placement precision is improved, but device complexity increases
Solution Approach 1:
The sensors serve multiple functions: they detect device location, verify proper placement, monitor embolic material containment, and provide real-time feedback to the clinician. This multi-functionality justifies the added complexity by consolidating multiple measurement and monitoring tasks into single integrated sensing elements.
Solution Approach 2:
The device detects placement status by monitoring changes in physiological parameters (electrical impedance, blood flow characteristics, or pressure differentials) that naturally occur when the device is correctly positioned and functioning. These parameter changes provide inherent placement verification without requiring additional active sensing mechanisms.
4Ease of operation
If tactile feedback is provided during delivery, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The bumper provides automatic tactile feedback when the device reaches the correct position or encounters resistance from embolic material. This self-service feedback mechanism guides the operator without requiring external imaging or complex control systems, using simple mechanical interaction to communicate device status.
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 precise and effective containment of embolic material during medical procedures in environments without fluoroscopy, ensuring accurate device placement and shielding sensitive vasculature from embolic material, even in surgical suites.
Implementation Method 1
the sensor includes an impedance sensor
Implementation Method 2
the sensor includes a flow sensor
Implementation Method 3
the sensor includes a pressure sensor
Implementation Method 4
further comprising an ultrasound-visible coating disposed along at least a portion of the filter wire, the filter anchor, the filter membrane, the bumper, or combinations thereof
Implementation Method 5
further comprising an ultrasound-visible coating disposed along at least a portion of the filter wire, the filter anchor, the filter membrane, the bumper, or combinations thereof
Data Source
AI summary
Embolic protection devices and methods for making and using embolic protection devices are disclosed. An embolic protection device may include an elongate filter wire having a distal end region, a filter anchor coupled to the distal end region, a filter membrane coupled to the filter anchor, and a bumper coupled to the filter anchor. The bumper may be designed to provide a tactile feedback to a clinician during delivery of the embolic protection device.