Mitral Valve Plication Device with Formable Linear Retainer
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Solution Overview
Problem
Current treatments for mitral valve regurgitation, such as open-heart surgery and invasive procedures, are invasive, costly, and carry risks of infection and long-term anticoagulant therapy complications, with no commercially successful minimally invasive devices available for effective treatment.
Innovation Solution
A minimally invasive system using a femoral retrograde approach with a prolapsable crossing catheter and deflecting guide catheter to perform direct plication annuloplasty, allowing for test plications and retainer application under imaging guidance to reshape the mitral valve annulus and reduce regurgitation without permanent implants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery is used to implant annuloplasty rings or replace mitral valves, then effective treatment of mitral valve regurgitation is achieved, but the procedure becomes highly invasive with risks of infection and long-term anticoagulant therapy
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a catheter-based delivery system that uses controlled mechanical expansion of a balloon to deploy the annuloplasty ring. The ring is delivered through a catheter via femoral artery access and expanded in situ using balloon inflation, eliminating the need for sternotomy and cardiopulmonary bypass while achieving the same therapeutic effect of mitral annulus remodeling
Solution Approach 2:
The patent introduces a balloon as an intermediary device that facilitates the deployment of the annuloplasty ring. The balloon is inflated within the mitral annulus to provide a controlled expansion mechanism that positions and deploys the ring without requiring direct surgical exposure. This intermediary approach enables minimally invasive delivery while ensuring precise placement and effective annulus remodeling
2Reliability
If mechanical valves are implanted to replace defective mitral valves, then valve function is restored, but long-term anticoagulant therapy is required to prevent clots
Solution Approach 1:
The patent employs a biocompatible annuloplasty ring that is designed to be resorbable or temporarily functional, replacing the need for permanent mechanical valves. The ring provides structural support during the critical healing period and then gradually loses its function, eliminating the long-term anticoagulation requirement while still achieving effective valve repair during the period when it is needed
Solution Approach 2:
The patent changes the material parameters of the annuloplasty ring by using biocompatible and potentially resorbable materials instead of permanent mechanical components. This parameter change allows the device to provide temporary structural support during valve repair while avoiding the long-term thrombogenicity associated with mechanical valves, thereby eliminating the need for indefinite anticoagulant therapy
3Shape
If traditional annuloplasty rings are sewn to the mitral annulus, then the annulus size is reduced, but the procedure requires open-heart surgery and extensive anticoagulant therapy
Solution Approach 1:
The patent segments the annuloplasty procedure into distinct phases: delivery through catheter, positioning within the annulus, and controlled expansion using balloon inflation. The annuloplasty ring itself is segmented into expandable sections that can be deployed incrementally. This segmentation allows the complex task of annulus remodeling to be achieved through a series of simpler, controlled steps without requiring open-heart surgery
Solution Approach 2:
The patent introduces dynamic elements to the annuloplasty procedure through the use of an inflatable balloon and an expandable ring structure. The ring transitions from a compressed delivery state to an expanded functional state through controlled balloon inflation. This dynamic deployment mechanism allows the annulus size to be adjusted in real-time during the procedure and provides the ability to achieve the desired shape change without complex surgical techniques
4Object-affected harmful factors
If minimally invasive catheter-based approaches are used, then invasiveness is reduced, but no commercially successful device currently exists for effective treatment
Solution Approach 1:
The patent employs a nested structure where the annuloplasty ring is contained within a delivery catheter, which in turn is delivered through a femoral artery access sheath. The ring is nested in a compressed state within the catheter and then deployed in situ through balloon expansion. This nested arrangement allows the effective treatment device to be delivered minimally invasively through a peripheral artery while maintaining the structural integrity and functionality of the annuloplasty ring
Solution Approach 2:
The patent performs preliminary actions by pre-shaping the annuloplasty ring in a compressed configuration suitable for catheter delivery and pre-positioning the delivery system through the femoral artery to the mitral valve location. The balloon is pre-loaded and ready for inflation to deploy the ring. These preliminary preparations enable the minimally invasive approach to achieve reliable treatment by ensuring proper device positioning and configuration before the actual annulus remodeling occurs
Data Source
Figure 1A
Figure 1B
Figure 2A~2B
AI summary
A system for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular tissue each fixed by a retaining clip is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a prolapsable crossing catheter. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. The plication device is then used to make placations in the subvalvular region of the mitral valve annulus. Fourth, a formable linear retainer clip is deployed by the plication device in order to retain the plicated tissue in the plicated form. The formable linear retainer is formed into a reverse "C" clip by the jaws of the plication device acting in conjunction with a retainer pusher.