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

VSEngineering 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

Engineering Contradiction:
Improveclosure operationVSAvoidaccess requirement
Core Design Contradiction:
Ease of operationVSDevice complexity

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

Inventive Principle:
Principle #13The other way round (Inversion)

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

Inventive Principle:
Principle #7Nested doll (Nesting)

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

Engineering Contradiction:
Improveclosure capabilityVSAvoidincision dimension
Core Design Contradiction:
Ease of manufactureVSLength of moving object

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

Inventive Principle:
Principle #1Segmentation

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

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If shape memory material is used to enable automatic configuration change, then external closure is facilitated, but the material complexity increases

Engineering Contradiction:
Improveclosure operationVSAvoidmaterial composition
Core Design Contradiction:
Ease of operationVSDevice complexity

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

Inventive Principle:
Principle #36Phase transitions

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

Inventive Principle:
Principle #40Composite materials

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.

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Polymer

Implementation Method 2

The fastener may change from the first position to the second position upon the application of heat.

Methodology Applied
Scientific EffectThermal activation: Heating

Data Source

PatentUS9295463B2Shape memory fasteners and method of use
Publication Date: 2016.03.29 COVIDIEN LP
  • US9295463B2 patent drawing
  • US9295463B2 patent drawing
  • US9295463B2 patent drawing

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.