Mitral Valve Annulus Reshaping via Temporary Coronary Sinus Displacement
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Solution Overview
Problem
Existing medical devices for treating defective mitral valves via the coronary sinus are less effective in retaining the desired annulus geometry, require complex and difficult-to-operate procedures, and can cause traumatic effects on the coronary sinus, leading to long-term complications and increased patient risk.
Innovation Solution
A medical system comprising a removable and flexible elongate displacement unit that temporarily inserts into the coronary sinus, reversibly expanding to modify the annulus shape, followed by a permanent annuloplasty device for fixation, allowing for efficient downsizing and reshaping of the mitral valve annulus with reduced anatomical trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If permanent implants are introduced into the coronary sinus to replace annuloplasty rings, then the valve function can be affected, but the implants cause traumatic effects on the coronary sinus and require long-term implantation which leads to complications
Solution Approach 1:
The device is divided into two separate components: a temporary displacement unit implanted in the coronary sinus for a limited period (6-12 months) to achieve annulus reshaping, and a permanent annuloplasty device implanted at the mitral valve for long-term support. This segmentation allows the coronary sinus implant to be removed after serving its purpose, eliminating long-term traumatic effects while maintaining valve function reliability.
Solution Approach 2:
The temporary displacement unit performs the preliminary action of reshaping the annulus to the desired geometry before the permanent annuloplasty device is implanted. By achieving the geometric transformation first, the permanent device can then be positioned optimally to maintain the corrected shape without requiring long-term presence in the coronary sinus.
2Reliability
If complex devices are deployed in the coronary sinus to ensure correct function over time, then valve function can be maintained, but the devices are difficult to operate and require frequent adjustment and repositioning
Solution Approach 1:
The complex adjustment and repositioning requirements are extracted from the permanent implant and transferred to the temporary displacement unit, which is designed to be simple to operate and remove. The temporary unit achieves the necessary geometric transformation through a straightforward implantation and activation process, eliminating the need for frequent adjustments while maintaining reliable valve function.
3Stability of the object's composition
If fixation structures are used to ensure correct position of the device in the coronary sinus over time, then the device position can be maintained, but traumatic effects on the coronary sinus are caused
Solution Approach 1:
The fixation approach is made dynamic through time: the temporary displacement unit employs fixation structures that are adequate for the short-term implantation period (6-12 months), providing sufficient positional stability during the reshaping phase. After this limited period, the unit is removed, eliminating long-term traumatic effects. The permanent annuloplasty device provides ongoing stability through its anchoring to the mitral valve annulus rather than the coronary sinus.
4Reliability
If a significant part of the annulus is reshaped, then valve function is improved, but the engagement with the anatomy must be atraumatic
Solution Approach 1:
The reshaping action is concentrated locally at the target annulus region through the temporary displacement unit, which applies force only where needed to achieve the desired geometric transformation. The unit's design allows for localized engagement with the annulus tissue, achieving significant reshaping of the affected area while minimizing engagement with and potential damage to surrounding anatomy. The permanent annuloplasty device then maintains this locally corrected geometry.
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 system enables long-term functioning of the mitral valve with less complex procedures, reduced risk of anatomical damage, and improved patient safety by providing secure downsizing and reshaping of the annulus while minimizing long-term negative effects.
Implementation Method 1
The displacement unit comprises an expandable body that is deliverable in a first configuration and expandable to a second configuration
Implementation Method 2
at least a portion of the displacement unit is temporarily movable in a radial direction of the CS towards the valve in such a manner that the shape of the annulus is modified
Data Source
Figure 1
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Figure 2b
AI summary
A medical system (300) is disclosed for treating a defective mitral valve (MV) having an annulus (A). The system (300) comprises in combination a removable and flexible elongate displacement unit (301) for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into said CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from the delivery state. The displacement unit comprises a proximal reversibly expandable portion (302), a distal anchoring portion (303) being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to the activated state in which the shape of the annulus is modified to a modified shape (A'); and an annuloplasty device (102) for permanent fixation at the mitral valve annulus by annuloplasty of the valve when the modified shape is obtained. The annuloplasty device (102) comprises a fixation structure that is adapted to retain the modified shape.