Cardiac Valve Positioning via ICE Catheter and Navigation
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Solution Overview
Problem
Current catheter-based prosthetic cardiac valve implantation methods face challenges with imprecise positioning of prosthetic valves, leading to paravalvular leaks and potential complications such as impaired left-ventricular function and hemolysis, which existing sealing methods attempt to address but require additional occluding elements and risk stability issues.
Innovation Solution
A prosthetic cardiac valve implantation arrangement that includes a prosthesis catheter with an ICE catheter for ultrasound imaging and a navigation system to determine absolute and relative positions and orientations, enabling precise positioning and control of the prosthetic valve using control commands for the ICE catheter and navigation system, potentially reducing the need for additional corrective interventions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If catheter-based prosthetic cardiac valve implantation is performed without navigation guidance, then the procedure is simpler and faster, but positioning precision deteriorates leading to paravalvular leaks
Solution Approach 1:
An ICE catheter with ultrasound transceiver system acts as an intermediary tool between the operator and the prosthetic valve, providing real-time imaging feedback during positioning. The navigation system serves as another intermediary that processes position data and provides guidance signals, enabling precise valve placement without direct visual inspection of the valve position.
Solution Approach 2:
The patent replaces manual mechanical positioning with a navigation-guided system that uses ultrasound imaging and computational algorithms to determine optimal valve placement. The navigation system substitutes the need for complex mechanical manipulation by providing electronic guidance based on real-time anatomical imaging.
2Reliability
If additional occluding elements are used to seal paravalvular leaks, then leak sealing is improved, but device complexity and stability risks increase
Solution Approach 1:
The navigation system performs preliminary assessment of the annulus geometry and valve positioning before the actual implantation. By predicting potential leak sites in advance and guiding initial valve placement, the system prevents paravalvular leaks from occurring in the first place, eliminating the need for subsequent sealing interventions.
Solution Approach 2:
The ICE catheter provides real-time ultrasound feedback during valve deployment, allowing the operator to monitor valve positioning and annulus engagement continuously. This feedback mechanism enables immediate adjustments to prevent leak formation, rather than requiring additional occluding elements after leaks have developed.
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
This method enhances the reliability and precision of minimally invasive prosthetic cardiac valve insertion, reducing the risk of paravalvular leaks and avoiding the need for subsequent adjustments, thereby ensuring optimal patient outcomes and minimizing complications.
Implementation Method 1
an ICE catheter with an ultrasonic transceiver system at its tip, which is able to create ultrasound images within the heart
Data Source
AI summary
A prosthetic cardiac valve implantation arrangement is described. The prosthetic cardiac valve implantation arrangement includes a prosthesis catheter with a prosthetic cardiac valve to be implanted; and an ICE catheter for introduction into area surrounding a cardiac valve to detect a relative position and/or relative direction of orientation of the cardiac valve with respect to the ICE catheter with the aid of an ultrasound image of the cardiac valve recorded by the ICE catheter. In addition, a navigation system is for determining an absolute position and an absolute direction of orientation of the ICE catheter; and a control facility is for controlling the insertion of the prosthetic cardiac valve into the annulus of the cardiac valve on the basis of the ultrasound image recordings of the ICE catheter and positional and/or orientation-direction information from the navigation system. Also described is a method for monitoring a catheter-based prosthetic cardiac valve implantation.