Percutaneous Suturing Catheter for Damaged Mitral Flaps
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Solution Overview
Problem
Existing percutaneous mitral valve repair techniques face challenges such as the inability to position clips on severely damaged flaps, limited ability to apply multiple suturing points, and the inability to remove incorrectly positioned suturing points, which are common drawbacks in current clip-based treatments for mitral insufficiency.
Innovation Solution
A suturing catheter system comprising a suturing catheter, knotting catheter, and cutting catheter, which allows for the percutaneous application of multiple suturing points, even on deteriorated mitral flaps, and enables the removal of badly positioned suturing points, utilizing a 'edge to edge' technique.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If clip-based percutaneous repair is used, then the procedure is minimally invasive, but it cannot be applied to severely damaged flaps and allows only single suturing point
Solution Approach 1:
The catheter is divided into multiple independent functional modules: a delivery catheter for positioning, a knotting catheter for creating suturing points, and a cutting catheter for trimming excess material. This segmentation allows each module to be optimized for its specific function while working together as an integrated system, enabling multiple suturing points to be created percutaneously on damaged flaps that would be unsuitable for traditional clip-based approaches
Solution Approach 2:
The patent introduces a flexible suture material as an intermediary between the catheter system and the mitral valve tissue. This suture material can adapt to various flap conditions and configurations, allowing the system to create effective suturing points on severely damaged flaps where rigid clips would fail. The suture acts as a mediator that can conform to irregular tissue surfaces and provide secure anchoring in challenging anatomical conditions
2Reliability
If traditional open heart surgery is used, then complete repair control is achieved, but it requires chest opening, cardiac arrest, and extracorporeal circulation
Solution Approach 1:
The patent replaces the complex mechanical system of open heart surgery (chest opening, cardiac arrest, extracorporeal circulation) with a minimally invasive catheter-based system. The suturing function is achieved through a controlled mechanical action of the knotting catheter that can be deployed through a simple percutaneous puncture, eliminating the need for major surgical infrastructure while maintaining reliable repair control through direct operator manipulation of the catheter and suture material
Solution Approach 2:
The system performs preliminary positioning and preparation actions through the delivery catheter before the actual suturing takes place. The catheter is first positioned accurately at the target site on the mitral valve, and the suture material is pre-positioned and prepared within the catheter system. This preliminary action ensures that when the knotting catheter is deployed, the suturing can be performed immediately with precise control, achieving reliable repair without the need for complex surgical setup
3Reliability
If multiple suturing points are required, then better repair efficacy is achieved, but traditional methods allow only single clip placement
Solution Approach 1:
The catheter system is designed with universal multi-functionality, where the same knotting catheter mechanism can be used to create multiple suturing points at different locations on the mitral valve. The system is not limited to a single application but can address multiple repair needs through repeated deployment or positioning at different sites, enabling comprehensive repair with multiple suturing points using a single versatile device platform rather than requiring multiple different devices
4Ease of operation
If clip positioning is attempted, then percutaneous repair is achieved, but incorrect positioning cannot be corrected
Solution Approach 1:
The system incorporates dynamic reversibility, allowing the operator to correct positioning errors at any stage before final knotting. The suture material remains mobile and adjustable within the catheter system until the knot is fully secured, enabling dynamic adjustment of the suturing point position. If positioning is found to be incorrect, the catheter can be repositioned and the suture re-routed to create a new suturing point at the correct location, providing the flexibility to correct errors without requiring device removal or complex manipulation
Data Source
AI summary
A suturing catheter for reducing mitral insufficiency by applying suturing points percutaneously is provided. The suturing catheter has a catheter body provided with a distal end and at least one internal lumen, at least one U-folded suture filament with two free ends, each provided with a suture needle, a pair of stylets, each provided with a catch needle, the suture and catch needles being provided with a connecting portion that allows a catch needle to mechanically engage with a suture needle, and a lever having a stapling arm, from which the suture needles protrude. The stapling arm, together with the catheter body, from which the catch needles protrude, defines a catch zone for a flap of a mitral valve. An opposite operating arm, together with the catheter body, defines an operating zone of the lever.