Inverted Prosthetic Valve Anchors for Secure Subannular Fixation
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Solution Overview
Problem
Challenges exist in developing prosthetic heart valves that can be delivered minimally invasively and securely anchored to the native heart valve annulus, particularly in ensuring adequate anchoring without puncturing the surrounding tissue.
Innovation Solution
The design of prosthetic heart valves with anchoring elements, such as feet, that are configured to contact the fibrous annular region with a geometry and surface area to avoid puncturing, and a method of inverting the implant anchors to facilitate secure deployment and repositioning, using a delivery system with inner and outer catheters to control the anchor configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If anchors are extended to secure anchoring of prosthetic valve, then anchoring strength is improved, but risk of puncturing native heart tissue increases
Solution Approach 1:
The foot geometry is specifically designed with optimized contact surface area and angle to distribute pressure locally on the fibrous annular region. The foot contact surface area is designed such that the pressure exerted by the foot is below the pressure required to puncture the heart tissue, while still providing adequate anchoring force to the fibrous annulus which has higher puncture resistance.
Solution Approach 2:
The delivery system inverts the implant anchors to point downward toward the ventricle while crossing the native mitral valve annulus. The anchors are deployed once the tips are a sufficient distance past the annulus, allowing the inverted configuration to reduce imaging intensity and facilitate secure deployment without puncturing tissue.
2Object-affected harmful factors
If minimally invasive delivery method is used, then patient trauma is reduced, but ability to securely anchor prosthetic valve is compromised
Solution Approach 1:
The prosthetic valve with expandable frame and anchors is delivered through a minimally invasive delivery instrument in a collapsed configuration. The delivery system includes an outer catheter member and an inner catheter member that work together to contain and control the prosthetic valve during delivery through the vascular system to the heart.
Solution Approach 2:
The prosthetic valve transitions from a collapsed deliverable configuration to an expanded deployed configuration once positioned at the native valve annulus. The expandable frame allows the valve to assume its functional shape, and the anchors transition from an inverted delivered state to an expanded anchored state that engages the subannular location for secure fixation.
3Stability of the object's composition
If anchors are deployed for secure anchoring, then prosthetic valve stability is improved, but ability to reposition or remove valve is reduced
Solution Approach 1:
The inverted delivery technique allows the anchors to be contained in an inverted configuration within the delivery system. If repositioning or removal is needed, the frame can be retracted using delivery mechanisms to return the feet to the inverted state, which facilitates removal or reattempting deployment of the valve by disengaging the anchors from the subannular tissue.
Data Source
Figure 1A~1B
Figure 2
Figure 3A~3B
AI summary
A method of delivering a valve prosthesis to be deployed within a native heart valve at a native heart valve annulus. The method including collapsing a prosthetic valve having an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough inside of a delivery instrument, such that a plurality of spaced anchors extending from the distal end of the expandable frame towards the proximal end are collapsed to an inverted position in a collapsed anchor configuration. The method further including advancing the delivery instrument a first distance such that the plurality of spaced anchors extend below the valve annulus, and releasing each of the plurality of spaced anchors such that each of the plurality of spaced anchors is repositioned from the inverted position to an expanded anchor configuration to contact a subannular location.