Twister Device for Beating-Heart Mitral Valve Repair
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Solution Overview
Problem
Conventional cardiac valve repair procedures are invasive, require cardiac arrest, and involve significant morbidity and mortality risks due to the need for cardiopulmonary bypass and sternotomy, particularly in cases of mitral valve regurgitation, where existing methods like annuloplasty rings and valve replacement come with complications such as infection and long-term anticoagulation requirements.
Innovation Solution
A method and apparatus for remotely securing two or more sutures together using a twister device that allows for minimally invasive, beating-heart cardiac valve repairs by approximating tissue strands outside the heart, reducing the need for foreign objects within the heart and enabling adjustable, reversible approximation of valve leaflets without cardiopulmonary bypass.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional open-heart surgery is performed for mitral valve repair, then complete access to the heart is achieved, but patient morbidity and mortality increase significantly
Solution Approach 1:
The patent extracts the surgical procedure from the traditional open-heart setting by removing the need for sternotomy and cardiopulmonary bypass. The delivery device is introduced through a peripheral vascular access site, extracting the invasive elements while maintaining the ability to perform mitral valve repair.
Solution Approach 2:
The patent introduces a delivery device as an intermediary between the operator and the mitral valve. This device serves as a mediator that enables tissue manipulation and suture delivery without requiring direct surgical exposure of the heart, thus reducing patient trauma while maintaining procedural capability.
2Ease of operation
If cardiopulmonary bypass is used during mitral valve repair, then the heart can be stopped for surgery, but patient risk of complications increases
Solution Approach 1:
The patent removes the requirement for cardiopulmonary bypass by performing the procedure on a beating heart. The delivery device is designed to function in the dynamic environment of a contracting heart, extracting the harmful element of mechanical circulatory support while maintaining surgical capability.
Solution Approach 2:
The patent employs preliminary actions by pre-positioning the delivery device and pre-loading the sutures before engaging the mitral valve tissue. This allows the procedure to be completed quickly on a beating heart without requiring cardiac arrest, thereby eliminating bypass-related complications.
3Ease of operation
If sternotomy is performed for open-heart surgery, then direct access to the heart is obtained, but patient recovery time extends significantly
Solution Approach 1:
The patent extracts the sternotomy step entirely by introducing the delivery device through peripheral vascular access. This eliminates the need for chest bone cutting and soft tissue dissection, dramatically reducing both procedural time and recovery duration while maintaining access to the mitral valve.
4Manufacturing precision
If annuloplasty rings are implanted for mitral valve repair, then valve geometry is corrected, but risk of infection and other complications increases
Solution Approach 1:
The patent extracts the annuloplasty ring implantation step by using an alternative approach: delivering sutures that directly approximate the mitral valve leaflets. This eliminates the foreign body (annuloplasty ring) that poses infection risk, while still achieving valve geometry correction through suture-based leaflet approximation.
5Reliability
If mechanical valve replacement is performed, then stenosis is treated effectively, but lifelong anticoagulation is required
Solution Approach 1:
The patent employs absorbable sutures that degrade over time after performing their function of approximating the valve leaflets. This temporary intervention achieves the therapeutic goal (treating regurgitation) without requiring permanent foreign bodies like mechanical valves, thereby avoiding lifelong anticoagulation while maintaining effective stenosis treatment.
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 approach enables less invasive, less labor-intensive, and technically less challenging cardiac valve repairs that reduce the risk of complications associated with traditional open-heart surgery, allowing for real-time adjustment and improved coaptation of valve leaflets to prevent regurgitation, thereby enhancing patient outcomes and reducing recovery time.
Implementation Method 1
a twister device that allows for minimally invasive, beating-heart cardiac valve repairs by approximating tissue strands outside the heart
Data Source
Figure 1A~1C
Figure 1D
Figure 2
AI summary
Described herein are methods and apparatus for approximating targeted tissue by intertwining two or more sutures together. The sutures are attached to the targeted tissue and routed to a twister device. The twister device secures end portions of the sutures and twists them to intertwine the sutures. Controlling the number of twists provides control over the forces applied to the targeted tissue. In conjunction with visualization feedback, real-time adjustments can be made to achieved targeted results, such as elimination of mitral regurgitation when the disclosed methods and apparatus are applied to mitral valve repair.