Automatic Annulus Downsizing for Heart Valve Replacement
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Solution Overview
Problem
Current heart valve repair and replacement procedures, such as the Parachute procedure, are highly dependent on the surgeon's skill and experience, requiring manual downsizing and fixation of an annuloplasty ring, which can be time-consuming and prone to errors, especially since the heart is frequently arrested during surgery.
Innovation Solution
A medical device with a downsizing element that automatically reshapes the heart valve annulus by inserting a loop-shaped element to circumflex and reposition the chordae, separating the downsizing process from the fixation of the annuloplasty ring, allowing for a more efficient and less complex procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual downsizing and fixation of annuloplasty ring are performed using traditional Parachute procedure, then the surgeon can restore valve function, but the procedure becomes time-consuming and highly dependent on surgeon skill
Solution Approach 1:
The patent divides the traditional combined downsizing and fixation procedure into two separate sequential steps: first performing automatic downsizing using a downsizing device, then performing fixation of the annuloplasty ring. This segmentation allows each step to be optimized independently, reducing overall procedure time and complexity while maintaining reliability of valve function restoration.
Solution Approach 2:
The downsizing device performs automatic downsizing of the valve annulus without requiring manual suturing or complex surgeon manipulation. The device self-adjusts to reduce the annulus size to appropriate dimensions, eliminating the time-consuming manual downsizing process and reducing dependence on surgeon skill while maintaining consistent results.
2Reliability
If manual downsizing is performed to achieve correct geometrical arrangement, then valve function can be restored, but the procedure becomes complex and surgeon-dependent
Solution Approach 1:
The downsizing device automatically performs the downsizing function through its own mechanical action, eliminating the need for complex manual suturing techniques. The device self-adjusts to achieve the correct geometrical arrangement of the annulus, reducing procedure complexity and surgeon dependency while maintaining reliable valve function restoration.
Solution Approach 2:
The downsizing device acts as an intermediary tool between the surgeon and the valve annulus, performing the complex downsizing function automatically. This intermediary device simplifies the surgeon's task from performing complex manual downsizing to simply deploying the device, thereby reducing procedure complexity while ensuring reliable geometric correction.
3Adaptability or versatility
If simultaneous downsizing and fixation are performed, then both functions are achieved in one procedure, but the procedure becomes tedious and highly integrated
Solution Approach 1:
The patent separates the simultaneous downsizing and fixation into sequential steps: first automatic downsizing, then fixation. This segmentation improves ease of operation by allowing the surgeon to perform simpler, more focused tasks in sequence rather than managing complex simultaneous operations, while still achieving both functions in one overall procedure.
Solution Approach 2:
The downsizing device performs automatic downsizing without requiring complex surgeon manipulation or coordination with fixation steps. This self-service capability simplifies the overall procedure by automating the downsizing function, making the combined procedure easier to perform while maintaining adaptability to achieve both downsizing and fixation.
Data Source
AI summary
A method for replacement of a defective heart valve involves introducing a distal loop-shaped element of a medical device between the heart muscle wall and chordae of the heart, positioning a first loop-shaped element of the medical device on a first side of the heart valve, arranging the first loop-shaped element to reposition the chordae towards a center of the heart valve, and moving a prosthetic valve along the medical device into position for attachment.