Nitinol Barbed Clip for Reversible Tissue Hole Closure
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Solution Overview
Problem
Existing methods for closing holes in tissue during minimally invasive surgery, such as those left by catheters, often fail to provide a reliable and reversible liquid and gas-tight seal, especially in thicker tissues, and require larger gripping areas to apply sufficient force, which can lead to marginal closure and difficulty in removing the closure device if needed.
Innovation Solution
A flexible clip made of Nitinol, temporarily attached to an insertion tool, which can be expanded to grip tissue over a larger area than the hole, providing a hemostatic seal and allowing for easy removal and re-use, with multiple sharp barbs for tissue gripping and a stem for attachment to the tool.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If plugs (expanding foam, metal, or barbed) are used to seal the hole, then immediate hemostatic seal is achieved, but the hole is forced to become larger rather than shrinking
Solution Approach 1:
Instead of forcing the hole to become larger to achieve sealing (as with plugs), the invention inverts the approach by using a device that shrinks the hole. The closure device is deployed inside the hole and contracts to reduce the hole diameter, pulling tissue inward to achieve closure while maintaining or reducing the original hole size.
Solution Approach 2:
The closure device utilizes changes in physical parameters (shape, volume, rigidity) to achieve its function. The device is delivered in a compressed or expanded state and transitions to a contracted state inside the hole, changing its dimensional parameters to effect tissue closure and hole reduction.
2Adaptability or versatility
If the Star Closure device is used for thin walled body lumens, then the device can rely on folding the tissue to close the hole, but it is not suitable for thicker tissue where gripping points must be spread over a larger area
Solution Approach 1:
The closure device incorporates dynamic elements that allow it to adapt its configuration based on tissue characteristics. The device can adjust its gripping point distribution and tissue engagement strategy depending on whether it encounters thin-walled or thick-walled lumens, transitioning between different operational states to optimize closure for varying tissue thicknesses.
Solution Approach 2:
The invention creates a universal closure device that can handle both thin-walled and thick-walled body lumens through a single platform. The device incorporates multiple functional capabilities including adjustable gripping mechanisms, variable deployment configurations, and adaptive tissue engagement that allow it to effectively close holes across a wide range of tissue types and thicknesses.
3Ease of operation
If the closure device is attached too close to the hole, then access is simplified, but insufficient forces can be applied resulting in marginal closure
Solution Approach 1:
The closure device utilizes dimensional strategies by extending gripping points radially outward from the hole in multiple directions. This spatial arrangement allows the device to engage tissue at optimal distances from the hole center, distributing closure forces across a larger area while maintaining effective mechanical leverage for achieving complete closure.
4Ease of manufacture
If traditional closure methods are used, then the operation is simple, but the closure cannot be removed if bleeding or additional procedure is required
Solution Approach 1:
The closure device incorporates dynamic, reversible attachment mechanisms that allow it to be securely deployed during the procedure and then easily removed if needed. The device uses reversible tissue engagement features such as removable anchors, detachable barbs, or reversible adhesive mechanisms that maintain closure integrity during surgery but allow for controlled removal afterward.
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
The clip achieves immediate and reliable hemostatic sealing without enlarging the hole, accommodating tissue changes with elastic compliance, and can be easily installed, removed, and re-used via a catheter, ensuring effective closure across various tissue thicknesses and hole sizes.
Implementation Method 1
A flexible clip made of Nitinol, temporarily attached to an insertion tool, which can be expanded to grip tissue over a larger area than the hole
Implementation Method 2
The clip has three different positions: a storage position, in which it is folded inside a delivery tube; an expanded position, in which it opens up to reach an area significantly larger than the hole, and a closed position in which elastic forces try to close the clip
Data Source
AI summary
A device for closing holes in tissue is delivered via a catheter to the inside of a body lumen such as a heart. An elastic barbed clip is expanded, pulled into the tissue and released, pulling the tissue with it. The operation is fully reversible.