Superelastic Tissue Closure Device Nested Delivery
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Solution Overview
Problem
Tissue defects or wounds resulting from endoscopic procedures, such as EMR or ESD, can be difficult to close and may take a long time to heal, increasing the risk of infection due to their size or prolonged exposure.
Innovation Solution
A tissue closure system comprising a delivery device with a tubular element and a tissue closure device made of superelastic material, such as Nitinol, which transitions between a constrained configuration for delivery and an expanded configuration to engage and draw target tissue portions together, using a suture to connect and hold the tissue in place.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If the tissue opening is left open to avoid complex closure procedures, then the closure procedure complexity is reduced, but the healing time is prolonged and infection risk increases
Solution Approach 1:
The tissue closure device is nested within the lumen of the delivery device during delivery, allowing for minimally invasive insertion. The device is delivered in a compact, constrained state through the lumen and then deployed at the target site, enabling complex closure functionality to be delivered through a simple catheter-based approach that reduces procedural complexity while maintaining effective closure capability
Solution Approach 2:
The tissue closure device utilizes self-expanding properties of superelastic material to automatically transition from a constrained delivery configuration to an expanded closure configuration upon deployment. The device's inherent elastic memory allows it to self-deploy and engage tissue portions without requiring complex actuation mechanisms, reducing procedural complexity while achieving effective tissue approximation and closure
2Ease of operation
If a tissue closure device is delivered through a lumen, then the ease of delivery is improved, but the device must be able to transition from a constrained to an expanded configuration
Solution Approach 1:
The device utilizes changes in physical parameters, specifically the elastic properties of superelastic material, to enable configuration transition. The material's superelasticity allows the device to be constrained during delivery and then spontaneously expand to its functional configuration upon deployment, achieving complex shape transformation through material property changes rather than mechanical actuation
Solution Approach 2:
The tissue closure device is constructed from superelastic materials that combine the properties of elasticity and shape memory. This composite material approach allows the device to maintain a constrained configuration during delivery through the lumen and then transition to an expanded configuration at the target site, achieving both ease of delivery and effective closure functionality through material science rather than complex mechanical mechanisms
3Reliability
If the first and second end portions are biased toward each other to draw tissue portions together, then the closure effectiveness is improved, but the force required to maintain the biased configuration increases
Solution Approach 1:
The tissue closure device utilizes self-expanding properties of superelastic material to automatically transition from a constrained delivery configuration to an expanded closure configuration upon deployment. The device's inherent elastic memory allows it to self-deploy and engage tissue portions without requiring complex actuation mechanisms, reducing procedural complexity while achieving effective tissue approximation and closure
Solution Approach 2:
The biased configuration of the tissue closure device creates an internal counteracting force system where the superelastic material's tendency to return to its original shape provides the closing force. This internal force generation eliminates the need for external actuation or continuous application of force to maintain the closure, as the device's inherent elastic properties sustain the tissue-apposing force throughout the healing process
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 system effectively closes tissue openings by drawing target tissue portions together, promoting healing and reducing the risk of infection through efficient and secure closure.
Implementation Method 1
a tissue closure device made of superelastic material, such as Nitinol, which transitions between a constrained configuration for delivery and an expanded configuration to engage and draw target tissue portions together
Data Source
AI summary
The present disclosure relates to the field of tissue closures including medical devices that close openings in tissue during a surgical procedure. In particular, the present disclosure relates to devices that transition from a constrained to an unconstrained configuration to engage tissue on opposing sides of a tissue opening, and hold opposing tissue portions together to maintain the opening in a closed configuration.