Deformable Annuloplasty Ring for Minimally Invasive Mitral Valve Repair
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Solution Overview
Problem
Current minimally-invasive mitral valve reconstruction methods require open-heart surgery and involve complex implantation processes with rigid annuloplasty rings, which are not suitable for beating hearts and often result in undesirable tissue stress and incomplete valve closure.
Innovation Solution
A minimally-invasive mitral valve implant system using a deformable annuloplasty ring that can be compressed for insertion through a trocar and expanded within the heart, anchored to tissue anchors, allowing for simple and efficient attachment to the mitral valve annulus without the need for open-heart surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If rigid annuloplasty rings are used for minimally-invasive mitral valve reconstruction, then the valve can be reconstructed with structural support, but the device cannot be implanted in beating hearts and causes undesirable tissue stress
Solution Approach 1:
The annuloplasty ring is designed with dynamic characteristics, allowing it to adapt to the beating heart environment. The ring can deform elastically to accommodate cardiac motion while maintaining its structural support function, enabling implantation in beating hearts without causing tissue stress.
Solution Approach 2:
The physical parameters of the annuloplasty ring are changed from rigid to flexible/elastic, allowing it to maintain structural support while adapting to the dynamic environment of the beating heart. This parameter change enables the ring to be implanted minimally-invasively without requiring open-heart surgery.
2Shape
If rigid annuloplasty rings are used, then the valve geometry can be maintained, but the implantation process becomes complex and requires open-heart surgery
Solution Approach 1:
The flexible annuloplasty ring can be dynamically compressed into a compact form for minimally-invasive delivery through catheters, then expanded to its functional shape once positioned in the heart. This dynamic transformation simplifies the implantation process while maintaining the required valve geometry.
Solution Approach 2:
The annuloplasty ring is designed to be nested within a delivery catheter in a compressed state, allowing it to be delivered through minimally-invasive access. Once positioned, the ring is deployed and expanded to its functional configuration, eliminating the need for complex open-heart surgical procedures.
3Reliability
If traditional annuloplasty rings are used, then valve reconstruction can be achieved, but surgical trauma is increased and recovery time is extended
Solution Approach 1:
The traditional mechanical open-heart surgical approach is replaced with a minimally-invasive catheter-based delivery system. The flexible annuloplasty ring is delivered through a catheter and deployed within the heart, substituting the need for sternotomy and cardiopulmonary bypass, thereby reducing surgical trauma while maintaining valve reconstruction effectiveness.
Solution Approach 2:
The annuloplasty ring is constructed as a flexible shell that can be compressed for delivery and then expanded to its functional form. This flexible shell design enables minimally-invasive implantation through catheters, reducing surgical trauma compared to rigid ring implantation that requires open-heart surgery.
4Object-affected harmful factors
If the annuloplasty ring is designed for minimally-invasive delivery, then surgical trauma is reduced, but the ring must be deformable which may compromise structural support
Solution Approach 1:
The material parameters of the annuloplasty ring are specifically engineered to exhibit elastic flexibility during delivery and deployment, then maintain adequate structural support in its expanded functional state. This parameter optimization allows the ring to be deformable for minimally-invasive delivery while still providing necessary structural support for valve reconstruction.
Solution Approach 2:
The annuloplasty ring is constructed from composite materials that combine flexibility for delivery with sufficient structural strength for valve support. The composite structure allows the ring to be compressed for catheter delivery while maintaining the mechanical properties needed to provide structural support once deployed in the heart.
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
Enables minimally-invasive surgery on beating hearts, reducing surgical trauma, shortening recovery time, and effectively eliminating mitral valve regurgitation by restoring normal valve geometry and function without the need for cardiopulmonary bypass or chest wall incision.
Implementation Method 1
the annuloplasty ring can be deformed from an initial configuration into a guiding configuration and subsequently into an expanded configuration
Implementation Method 2
the annuloplasty ring can be deformed from an initial configuration into a guiding configuration and subsequently into an expanded configuration
Implementation Method 3
Multiple fastening means are to connect an annuloplasty ring to the threads of multiple implanted tissue anchors
Data Source
AI summary
The invention relates in general to the field of heart surgery. In the surgical field, instruments are used in order to examine the interior of living organisms and/or to use for operative interventions. These also include implants for the production of the functionality of a heart. The invention relates to such an implantable device and a method for eliminating regurgitation in the area of the heart. The implantable device is an annuloplasty ring with a large number of tissue anchors. An unfolded annuloplasty ring is positioned in the cavity of a body element in order to constrict a bodily opening. Using the minimally-invasive technique, each tissue anchor of the annuloplasty ring is intravascularly inserted in advance into a precise position on the edge of the mitral valve annulus. The annuloplasty ring that is configured in the shape of an arc or circle is mounted and fastened to the thus anchored fastening means in order to influence in size and shape the septal and lateral annulus of the mitral valve and to close the gap between the anterior and posterior cusps in the valve.