Hook Catheter Leaflet Cutting for Valve Replacement
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Solution Overview
Problem
Current methods for treating mitral valve regurgitation, particularly those involving fixation devices, often require invasive surgeries and may not effectively address persistent or recurring issues, limiting options for patients who are frail or have existing devices that obstruct transcatheter valve replacement.
Innovation Solution
A system comprising a guide catheter, a hook catheter with shape-memory properties, and a cutting mechanism that can be steered to a cardiac valve to cut leaflet tissue, allowing for the removal or disablement of existing fixation devices, facilitating the installation of an artificial valve without the need for open-heart surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a fixation device is installed into the heart using minimally invasive techniques, then the treatment of mitral valve regurgitation is improved, but the device obstructs subsequent transcatheter mitral valve replacement
Solution Approach 1:
The fixation device is divided into two separate components: a first fixation element and a second fixation element that can be independently deployed and removed. This segmentation allows the first element to remain in place providing continuous support while the second element can be removed to clear the obstruction path for subsequent valve replacement procedures.
Solution Approach 2:
The invention provides a mechanism to extract or remove the obstructing fixation element from the heart valve structure. The removal system includes catheters and cutting tools that can access and remove the second fixation element without requiring open-heart surgery, thus clearing the path for transcatheter valve replacement while maintaining the first fixation element.
2Reliability
If open heart surgery is performed for mitral valve repair, then effective treatment is achieved, but the procedure has high mortality and morbidity rate
Solution Approach 1:
The invention replaces the mechanical open-heart surgery approach with a transcatheter-based system. Instead of requiring chest opening and cardiopulmonary bypass, the fixation device is deployed and removed using catheters introduced through peripheral vessels, substituting major surgical mechanics with minimally invasive catheter-based mechanics.
Solution Approach 2:
The fixation device utilizes flexible catheter structures that can navigate through the vascular system and heart chambers. The catheters and delivery systems employ flexible materials and thin-film constructions that allow minimally invasive access to the mitral valve, avoiding the need for sternotomy and reducing surgical trauma.
3Adaptability or versatility
If a cutting mechanism is used to remove fixation devices, then the obstruction is cleared, but the procedure requires precise positioning and control
Solution Approach 1:
The invention introduces a stabilizing catheter as an intermediary component that provides a stable platform and reference frame for positioning the cutting mechanism. The stabilizing catheter engages with anatomical landmarks or the remaining fixation structure to establish a stable base, simplifying the positioning and control of the cutting tool relative to the target fixation element.
Solution Approach 2:
The cutting mechanism replaces complex mechanical positioning systems with a catheter-based delivery system that utilizes the natural anatomy and the stabilizing catheter for alignment. Instead of requiring complex external guidance systems, the cutting tool is delivered through the catheter lumen and positioned using the catheter's inherent flexibility and the stabilizing catheter's anchoring capability.
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 minimally invasive cutting of cardiac valve leaflet tissue, allowing for the removal of fixation devices and preparation for artificial valve installation, reducing the need for invasive surgeries and improving treatment options for patients with persistent mitral valve regurgitation.
Implementation Method 1
The hook catheter has a pre-defined shape-memory hook shape and is configured to return to the pre-defined shape-memory hook shape when extended beyond the distal end of the guide catheter
Data Source
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AI summary
A system configured to cut leaflet tissue at a cardiac valve may comprise a guide catheter having a proximal end and a distal end, wherein the distal end of the guide catheter is steerable to a position above a cardiac valve. The system may also include a hook catheter having a proximal end and a distal end, the hook catheter configured to extend from the distal end of the guide catheter through a first orifice of the cardiac valve. Further, the system may comprise a cutting mechanism extending from the hook catheter, the cutting mechanism configured to cut a portion of leaflet tissue of the cardiac valve. Finally, the system may include a handle coupled to the proximal end of the guide catheter, the handle comprising at least one control operatively connected to the cutting mechanism.