Catheter-Delivered Annulus Implant With Adjustable Struts
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Solution Overview
Problem
Existing surgical procedures for reshaping heart valve annuli are invasive and time-consuming, posing risks and extended recovery times, while current minimally invasive solutions lack efficiency and reliability in reshaping the mitral valve annulus.
Innovation Solution
A minimally invasive implant system featuring a tubular frame with moveable struts and anchors that can be adjusted percutaneously to reshape the mitral valve annulus, using a threaded shaft to adjust the angle between struts and anchors for precise annulus remodeling, and a delivery system with imaging and positioning capabilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery with annuloplasty ring implantation is performed, then the valve annulus can be restored to native configuration, but the procedure is invasive and time-consuming with extended recovery time
Solution Approach 1:
The annuloplasty device is divided into multiple independent struts (first pair and second pair) that can be adjusted separately. Each strut pair can be independently reconfigured from an initial configuration to a contracted configuration, allowing localized annulus remodeling without requiring complete surgical exposure of the entire annulus.
Solution Approach 2:
The device incorporates moveable collars that can translate along the struts to dynamically change the angle between adjacent struts. This dynamic adjustment capability allows the annulus to be gradually remodeled from its dilated state to a restored native configuration, and provides post-implantation adjustability without requiring re-surgery.
2Reliability
If traditional annuloplasty procedure is used, then valve leaflet coaptation is restored, but the procedure requires cardiopulmonary bypass with associated risks
Solution Approach 1:
The invention replaces the mechanical surgical system (sutures, rings, and manual manipulation requiring open chest) with a percutaneous delivery system. The device is delivered through a catheter via venous access, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the annulus, thereby removing associated surgical risks.
Solution Approach 2:
The adjustable annuloplasty device is nested within a delivery catheter in a compressed delivery configuration. The struts and collars are contained within the catheter lumen during delivery, allowing percutaneous insertion through peripheral veins without surgical exposure. After deployment, the device expands to its functional configuration to perform annulus remodeling.
3Device complexity
If the implant is designed with fixed struts, then the structure is simpler, but the ability to dynamically adjust annulus size is limited
Solution Approach 1:
The device incorporates moveable collars that can translate along the struts to dynamically change the angle between adjacent struts. This dynamic adjustment capability allows the annulus to be gradually remodeled from its dilated state to a restored native configuration, and provides post-implantation adjustability without requiring re-surgery.
Solution Approach 2:
The device is delivered in a pre-compressed delivery configuration within the catheter, with the struts and collars arranged to minimize profile for percutaneous insertion. After deployment at the target site, the collars are released to allow translation along the struts, enabling subsequent adjustment of the annulus configuration without requiring additional delivery maneuvers.
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 effectively reduces the size of the dilated mitral valve annulus, minimizing regurgitation and blood backflow, while reducing procedure duration and risks, and allowing for dynamic post-implantation constriction for further annulus reduction.
Implementation Method 1
The shaft is carried by the proximal apex and has an outer thread. The collar has an inner thread engaged with the outer thread of the shaft. Rotation of the shaft about the rotation axis causes the collar to advance along the first pair of adjacent struts
Data Source
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AI summary
Systems, devices and methods related to various heart valve implants and for delivery of those implants are described. The implants may be used to re-size a native valve annulus or to replace a native heart valve. The implants include a re-sizable frame having angled struts. The implant is secured to tissue with anchors that can rotate without axial advancement to engage tissue while drawing the implant closer to the tissue. Collars are used to decrease the angle between struts of a frame to contract the implant. The implants can include a rotatable shaft, such as a threaded shaft, located internally to an axially translatable collar. Rotation of the shaft transmits force to the collar to cause the collar to translate axially, closing the angle of adjacent struts and decreasing the width of the implant and thus of the annulus. The implants can be delivered, secured and contracted via a catheter. The implants are repositionable and retrievable via catheter.