Shape Memory Surgical Fastener for External Tissue Closure
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Solution Overview
Problem
Conventional methods for closing puncture wounds or incisions in surgical procedures require internal access or enlarging the incision, which is not feasible when accessing a body cavity, necessitating a more efficient and accessible closure mechanism.
Innovation Solution
A surgical fastener made from shape memory materials like Polydioxanone and Poly(L-lactide) or Trimethylene Carbonate and Poly(L-lactide) that changes configuration from an open to a closed position upon activation, such as by heat, allowing for external closure of tissue openings without internal access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional methods (staples or sutures) are used to close the incision, then the incision can be closed, but internal access is required or the incision dimension must be increased to permit manipulation of closure devices
Solution Approach 1:
The fastener is designed to be inserted through the cannula in a compressed state and then expands within the body cavity to engage tissue on the internal surface, reversing the conventional approach of applying closure devices from the external surface. This allows closure without requiring internal surgical access while maintaining simplicity of operation
Solution Approach 2:
The fastener legs are configured to nest within each other during insertion, allowing the device to pass through the cannula in a compact form and then deploy outward to engage tissue. This nesting mechanism enables the closure device to be delivered through a small incision without requiring enlargement of the access site
2Ease of manufacture
If the incision dimension is increased to permit manipulation of suture or stapling device, then closure can be achieved, but the size of the incision increases
Solution Approach 1:
The fastener is divided into multiple legs that can be independently configured to engage tissue. Each leg includes a tissue-engaging portion with barbs that can be inserted through the small incision and then deployed to secure the closure, eliminating the need for a large incision while maintaining effective closure capability
Solution Approach 2:
The fastener utilizes shape memory material that changes its physical properties in response to temperature changes. The material transitions from a flexible state during insertion to a rigid state after deployment, enabling the device to be delivered through a small incision in a compact form and then expand to its functional configuration within the body cavity
3Ease of operation
If shape memory material is used to enable automatic configuration change, then external closure is facilitated, but the material complexity increases
Solution Approach 1:
The shape memory material undergoes a phase transition in response to temperature changes, transforming from a flexible, insertable state to a rigid, tissue-engaging state. This phase transition is triggered by the temperature difference between the cooler external environment and the warmer body cavity, automatically enabling the fastener to deploy and engage tissue without requiring additional actuation mechanisms
Solution Approach 2:
The fastener is constructed from composite shape memory materials that combine polymers with shape memory properties and tissue-compatible characteristics. This composite material approach enables the device to exhibit both the flexibility needed for insertion through a small incision and the structural integrity required for secure tissue engagement after deployment
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 efficient and external closure of tissue openings by using shape memory materials that change configuration in response to temperature, facilitating secure closure of incisions without the need for internal access or enlarging the wound.
Implementation Method 1
The surgical fastener is at least partially formed from a shape memory material including a combination of Polydioxanone and Poly(L-lactide) or a combination of Trimethylene Carbonate and Poly(L-lactide). The pair of legs are configured to move from the first position to the second position upon activation of the shape memory material.
Implementation Method 2
The fastener may change from the first position to the second position upon the application of heat.
Data Source
AI summary
A surgical fastener configured to close an opening in tissue is provided. The surgical fastener includes a base defining a central axis at least one pair of legs extending from the base. Each of the legs includes a base portion and a tissue engaging portion. When in a first position, each of the tissue engaging portions is arranged to define an insertion direction and when in a second position, each of the tissue engaging portions extends inward towards the central axis. The surgical fastener is at least partially formed from a shape memory material including a combination of Polydioxanone and Poly(L-lactide) or a combination of Trimethylene Carbonate and Poly(L-lactide). The pair of legs are configured to move from the first position to the second position upon activation of the shape memory material.


