Heart Valve Ligation Clip Removal Apparatus
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Solution Overview
Problem
Patients with implanted ligation clips for heart valve repair become ineligible for future transcatheter mitral prosthetic valve replacement due to incorrect clip placement, clip failure, or re-occurrence of mitral regurgitation, necessitating a method to safely remove these clips without damaging native leaflets.
Innovation Solution
A clip removal apparatus featuring pivotably coupled arms and a wedge assembly to dislodge and remove tissue ligation clips from heart valve leaflets non-destructively, preserving native leaflet tissue and preventing further ventricle dilatation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a ligation clip is implanted to repair heart valve regurgitation, then the valve regurgitation is reduced, but the patient becomes ineligible for future transcatheter mitral prosthetic valve replacement
Solution Approach 1:
The patent describes a removal apparatus that extracts the ligation clip from the heart valve leaflets. The apparatus includes a delivery catheter that navigates to the clip, engages it, and retrieves it through the vasculature, thereby restoring future valve replacement eligibility while maintaining the initial repair benefit
2Reliability
If a ligation clip is used to join heart valve leaflets, then the leaflets are held together to reduce regurgitation, but the clip may need to be removed if placement is incorrect or treatment fails
Solution Approach 1:
The patent employs a delivery catheter as an intermediary device that engages the ligation clip and facilitates its removal. The catheter navigates through the vasculature to reach the clip, engages it with retrieval elements, and extracts it through the same access path, making the removal process minimally invasive and comparable in complexity to the initial implantation
3Ease of operation
If a ligation clip is implanted with minimally invasive transcatheter techniques, then the procedure is less invasive, but the clip becomes permanently fixed and cannot be removed for future prosthetic valve replacement
Solution Approach 1:
The patent transforms the static, permanent nature of the implanted clip into a dynamic, removable state by introducing a retrieval system. The clip remains in place during the initial repair phase but can be dynamically removed through the same minimally invasive transcatheter approach when future valve replacement becomes necessary
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 the safe and effective removal of ligation clips, allowing for potential prosthetic valve replacement while minimizing damage to the heart valve leaflets and reducing the progression of ventricle dilatation.
Implementation Method 1
The wedge member is configured to be advanced between the arms to pivot open the arms of the tissue ligation clip to be removed
Implementation Method 2
The backstop member is configured to surround at least a portion of the tissue ligation clip to be removed while the wedge member is advanced between the arms of the tissue ligation clip
Data Source
AI summary
Aspects of the disclosure include apparatuses for and methods of removing a ligation clip interconnecting two mitral valve leaflets. Methods can include providing a mitral valve having first and second valve leaflets interconnected with a ligation clip. The ligation clip includes a base supporting a first and second retaining arms each having an end opposite the base. The first and second valve leaflets are compressed between the first and second retaining arms. The methods further include physically separating the ligation clip from both of the first and second leaflets with the apparatus, which is configured to dislodge the first and second leaflets from the ligation clip. The apparatuses are further configured to withdraw the ligation clip from the patient along with the apparatus.