Radiopaque TAVR Delivery Markers for Commissure Alignment
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Solution Overview
Problem
Existing methods for implanting prosthetic valves face challenges in accurately determining the location and orientation of the valve assembly relative to anatomical landmarks during procedures like TAVR, leading to potential improper fit and complications such as perivalvular leakage.
Innovation Solution
A delivery system with radioscopically conspicuous markers integrated into the catheter assembly, allowing for precise alignment of the prosthetic valve with native valve commissures through radioscopic imaging, ensuring correct rotational positioning and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If radiologic imaging techniques are used to guide valve placement, then the procedure can be performed with standard imaging equipment, but the location of valve components cannot be directly determined because valve materials are not radiopaque
Solution Approach 1:
The patent introduces radiopaque markers as intermediary elements that bridge the gap between the non-radiopaque valve materials and the radiologic imaging system. These markers are attached to specific components of the valve assembly (such as the stent frame and valve leaflets) and serve as visible proxies that indicate the location and orientation of the otherwise invisible valve components during fluoroscopic imaging.
Solution Approach 2:
The patent applies the principle of visual contrast by using radiopaque markers that appear distinct and conspicuous under radiologic imaging. The markers have different radiopacity characteristics compared to the surrounding tissues and catheter components, creating visual contrast that enables clear identification of valve component locations and orientations during the implantation procedure.
2Ease of operation
If the catheter assembly is rotated to achieve proper alignment, then the prosthetic valve can be positioned relative to native valve commissures, but it becomes difficult to determine the rotational position and orientation under radioscopic imaging
Solution Approach 1:
The patent employs asymmetric marker configurations that create unique radioscopic signatures for different rotational positions of the catheter assembly. By placing markers at specific asymmetric locations on the catheter and valve components, the system enables differentiation between various rotational orientations under fluoroscopic imaging, allowing the operator to achieve and verify precise angular alignment with native valve commissures.
Solution Approach 2:
The radiopaque markers serve as intermediary reference points that mediate between the operator's rotational manipulation of the catheter and the imaging system's ability to visualize orientation. These markers provide visible indicators that allow the operator to determine the rotational position of the catheter assembly relative to anatomical landmarks during the alignment process.
3Measurement precision
If multiple markers are added to the catheter assembly to improve alignment accuracy, then the visual references for alignment become more numerous and precise, but the device complexity increases
Solution Approach 1:
The patent divides the marker system into multiple discrete, functionally distinct marker elements positioned at different locations on the catheter assembly and valve components. Each marker serves a specific function in indicating different aspects of positioning and orientation. This segmentation allows for precise alignment verification while maintaining modularity and simplifying the overall design compared to a single complex marking system.
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
Enhances the accuracy of prosthetic valve placement by providing clear visual references for alignment, reducing the risk of improper fit and complications.
Implementation Method 1
A prosthetic valve delivery system includes a catheter assembly having a central axis and being adapted to retain a prosthetic valve in a collapsed state, and a marker integrated with the catheter assembly at a marker location radially offset from the central axis. The marker may have a contrasting radiopacity to the radiopacity of a material of the catheter assembly on both sides of the marker location in the circumferential direction.
Data Source
AI summary
A catheter assembly for retaining a prosthetic valve as the prosthetic valve is guided to a point of delivery within a patient is provided with radioscopic markers. The markers are distributed within the catheter assembly such that an observer may discern a rotational orientation of the assembly from a radioscopic image of the assembly within the patient. Delivery of the prosthetic valve may include aligning the markers with the commissures of the prosthetic valve and radioscopic observation of the location or movement of the markers to rotationally align the prosthetic valve with a native valve within the patient, such as by aligning the commissures of the prosthetic valve with the commissures of the native valve.