Bioprosthetic Valve Device with Contiguous Wall Portion
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current implantable venous valve devices are inadequate in addressing venous valve insufficiency, as they often fail to effectively prevent retrograde flow due to damaged or stretched natural valves, leading to discomfort and potential ulcers in the legs and ankles, and existing treatments are invasive or inefficient.
Innovation Solution
A bioprosthetic valve device comprising a single leaflet harvested from a natural valve with a contiguous wall portion, attached to an expandable support frame that creates a sinus region in the recipient vessel, allowing the leaflet to close against the vessel wall, thereby preventing retrograde flow, and is delivered minimally invasively using a percutaneous system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If natural valves are used in venous vessels, then valve function is maintained for extended time, but the valves become insufficient due to vessel wall stretching and leaflet damage
Solution Approach 1:
The natural valve is segmented into two functional components: the leaflet (for flow regulation) and the contiguous wall portion (for structural support and anchoring). This segmentation allows the leaflet to be harvested and reimplanted while retaining its natural functionality, addressing the reliability issue without sacrificing duration of action
Solution Approach 2:
The contiguous wall portion is prepared in advance by harvesting it with the leaflet still attached. This preliminary preparation ensures that when the valve is reimplanted, the leaflet has immediate structural support and proper anchoring, preventing the reliability degradation that occurs with vessel wall stretching over time
2Ease of operation
If compression stockings are used to treat venous valve insufficiency, then vessel walls are forced radially inward to restore valve function, but the treatment does not address underlying valve damage
Solution Approach 1:
The contiguous wall portion acts as an intermediary structure that provides immediate structural support and anchoring for the harvested leaflet. This mediator ensures proper valve function is restored by preventing leaflet displacement and ensuring adequate coaptation, addressing the reliability issue that compression stockings fail to resolve
3Reliability
If drastic ablation procedures are employed to treat venous insufficiency, then vein patency is restored, but the procedures are invasive and carry significant risks
Solution Approach 1:
Instead of discarding the damaged natural valve entirely through ablation, the invention recovers the functional leaflet component while discarding only the insufficient structural support. The harvested leaflet with its contiguous wall portion is then reimplanted to restore valve function, achieving vein patency reliability without the harmful effects of drastic ablation procedures
4Reliability
If prosthetic valves with multiple components are used, then valve function is restored, but the device complexity increases
Solution Approach 1:
The leaflet and contiguous wall portion are merged into a single integrated graft member that functions as one cohesive unit. This merging simplifies the implantation procedure and reduces device complexity compared to traditional prosthetic valves with multiple separate components, while maintaining reliable valve function through the combined structural and functional elements
Data Source
AI summary
Valve devices, methods of making valve devices, and methods of treating various venous-related conditions, disorders and/or diseases are described. In one embodiment, a valve device includes an expandable support frame and a bioprosthetic valve attached to the support frame. The bioprosthetic valve comprises a leaflet and a contiguous wall portion harvested from a multi-leaflet xenogeneic valve. The contiguous wall portion includes the attachment region where the leaflets attaches to the vessel wall and, in some embodiments, includes the natural margins of attachment between the leaflet and vessel wall.