Nested Tissue Closure Delivery System with Winding Mechanism
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Solution Overview
Problem
Existing medical devices for closing tissue openings, such as patent foramen ovale or septal defects, are often large and require additional tools for insertion, lacking maneuverability and flexibility.
Innovation Solution
A device comprising a handle with a gripping portion, a sleeve, and a sheath with a winding mechanism that applies tension to a filament for inserting and anchoring a closure device through a hemostatic valve, allowing for precise placement and closure of tissue openings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If existing medical devices for closing tissue openings are used, then closure function is achieved, but device size is large and maneuverability is reduced
Solution Approach 1:
The delivery system employs a nested configuration where the sheath portion is inserted through the sleeve, which is inserted through the hemostatic valve. The closure device is delivered through the sheath, creating a nested structure that minimizes the overall profile of the system while maintaining the functionality of each component. This nesting approach allows the system to pass through narrow vascular pathways without requiring large access points.
Solution Approach 2:
The delivery system is divided into distinct functional segments: the handle portion for operator control, the sleeve for vascular access and positioning, the sheath portion for closure device delivery, and the closure device itself. Each segment can be independently optimized and manipulated, allowing the operator to navigate the system through complex anatomical pathways with precision and control.
2Adaptability or versatility
If existing delivery systems are used, then closure placement is achieved, but flexibility and maneuverability are insufficient
Solution Approach 1:
The delivery system incorporates dynamic elements including the slidable relationship between the sleeve and sheath portion, which allows the operator to adjust the position of the closure device relative to the access site. The winding mechanism provides dynamic tension control on the filament, enabling precise positioning and anchoring of the closure device in various anatomical configurations.
Solution Approach 2:
The filament acts as an intermediary element connecting the handle portion to the closure device, allowing force transmission and positioning control without direct mechanical connection. This intermediary filament-based system provides flexibility in maneuvering the closure device through complex vascular anatomy while maintaining control from the operator's perspective.
3Reliability
If larger devices are used for insertion, then closure function is achieved, but hemostasis maintenance is compromised
Solution Approach 1:
The nested structure of the delivery system allows the sheath and closure device to be delivered through the sleeve, which is inserted through the hemostatic valve. This nested configuration enables the system to maintain a small profile at the access site, preserving hemostasis, while still delivering the necessary closure device to the target location.
Solution Approach 2:
The delivery system utilizes flexible tubular structures (sleeve and sheath) that can be inserted through narrow vascular openings without compromising the integrity of the access site. These flexible components allow the system to navigate through the hemostatic valve and into the target area while maintaining a small footprint that preserves hemostasis.
Data Source
AI summary
Among other things, methods and apparatus for inserting devices for closing tissue openings are disclosed. Examples may include a handle, sheath and/or sleeve for insertion into a patient and through or adjacent a tissue defect, fistula, or other tissue opening to be closed. Winding mechanisms for operation in or with such inserting devices are also described.