Barbell-Shaped Anchoring Structure for Minimally Invasive Valve Replacement
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Solution Overview
Problem
Existing surgical methods for replacing or repairing diseased cardiac valves, such as the mitral and tricuspid valves, are invasive and risky, particularly for elderly patients, necessitating a minimally invasive approach that can be performed under local anesthesia in a cardiac catheterization lab.
Innovation Solution
A self-expandable apparatus comprising a barbell-shaped anchoring member and an expandable support member with a prosthetic cardiac valve, delivered via a catheter, that secures to the native cardiac valve annulus using end portions that contact its superior and inferior aspects, allowing for minimally invasive replacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical valve replacement is performed using traditional open-heart surgery, then the valve can be reliably replaced with a prosthetic valve, but the procedure requires heart-lung machine, complete anesthesia, and carries high risk especially for elderly patients
Solution Approach 1:
The procedure is segmented into percutaneous delivery and intracardiac deployment phases. The prosthetic valve and anchoring member are delivered separately through catheters, allowing the procedure to be performed in stages under local anesthesia rather than requiring complete surgical intervention with heart-lung machine
Solution Approach 2:
A delivery catheter serves as an intermediary device to transport the prosthetic valve and anchoring member to the target site. This intermediary approach enables minimally invasive delivery through peripheral vessels, avoiding the need for open surgical access and heart-lung machine support
2Manufacturing precision
If open-heart surgery is performed for valve replacement, then direct vision and precise sewing can be achieved, but the procedure becomes highly invasive requiring sternotomy and cardiopulmonary bypass
Solution Approach 1:
The anchoring member is designed to self-expand and self-secure within the annulus upon deployment. The barbell-shaped structure with expandable ends automatically engages the annular tissue, eliminating the need for manual sewing or complex attachment procedures that would require open surgical access
Solution Approach 2:
The anchoring member transitions from a compressed delivery state to an expanded deployed state, changing its physical parameters in situ. This parameter change allows the device to achieve its final secure configuration within the annulus after delivery through minimally invasive catheter access
3Reliability
If traditional surgical approaches are used for valve replacement, then the prosthetic valve can be securely implanted, but the procedure cannot be performed under local anesthesia in a catheterization lab
Solution Approach 1:
The prosthetic valve is nested within the anchoring member structure, which itself is delivered through the catheter. This nested configuration allows both components to be transported through the same minimally invasive access route and deployed in sequence, enabling the entire procedure to be performed in a catheterization lab under local anesthesia
Data Source
AI summary
An apparatus is provided for replacing a native cardiac valve. The native cardiac valve has at least one leaflet and is surrounded by a native cardiac valve annulus having superior and inferior aspects. The apparatus comprises a barbell-shaped, expandable anchoring member including first, second, and main body portions extending between the end portions. The main body portion includes a channel defined by inner and outer surfaces. Each of the first and second end portions has a diameter greater than the diameter of the main body portion. The first and second end portions are sized to respectively contact the superior and inferior aspects of the native cardiac valve annulus when the expandable anchoring member is in an expanded configuration. The apparatus also includes an expandable support member operably disposed within the main body portion of the expandable anchoring member, and a prosthetic cardiac valve secured within the expandable support member.