Serial Tissue Fastener Deployment via Shape Memory Alloy
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Solution Overview
Problem
Existing methods for securing tissue layers often require removal and reloading of delivery devices for multiple fasteners, which is inefficient and complex.
Innovation Solution
One-piece tissue fasteners made from shape memory materials, such as Nitinol alloy, are designed to be loaded in a tubular delivery device, where they self-expand radially upon release to secure tissue layers, allowing for sequential deployment without device reconfiguration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If multiple fasteners are delivered using existing methods, then tissue layers can be secured, but the delivery device requires removal and reloading for each fastener which reduces efficiency
Solution Approach 1:
Multiple fasteners are pre-loaded into the delivery needle in a tandem array before the procedure begins. The fasteners are prepared in advance with their legs in a folded low-profile configuration, allowing them to be staged for sequential deployment without requiring device reconfiguration during the procedure.
Solution Approach 2:
Multiple fasteners are nested within the lumen of the delivery needle in a tandem arrangement. Each fastener is contained within the needle, with the distal fastener positioned for first deployment, followed by proximal fasteners in sequence. This nesting allows multiple fasteners to be transported and deployed from a single delivery device.
2Productivity
If multiple fasteners are pre-loaded in a tandem array, then sequential deployment is enabled, but the fasteners must be compressed to a low profile for containment
Solution Approach 1:
The fasteners are made from shape memory material that can change its physical state between two configurations: a compressed low-profile state for containment within the needle lumen, and an expanded deployed state for tissue fixation. The material properties are specifically selected to allow reversible transformation between these states upon release from the delivery device.
3Ease of operation
If shape memory material is used for fasteners, then self-expansion is achieved, but the material complexity increases
Solution Approach 1:
The shape memory material enables the fastener to automatically transform from its compressed containment configuration to its expanded deployed configuration without requiring external actuation mechanisms. Upon release from the delivery needle, the material's inherent shape memory properties drive the self-expansion of the legs to the radially extended position, eliminating the need for complex deployment mechanisms.
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 simplified fixation of tissue layers with multiple fasteners deployed in sequence, eliminating the need for device reloading and enhancing procedural efficiency.
Implementation Method 1
The fasteners may be formed from a shape memory material so that the legs can be folded to a low profile in which they can be contained in the lumen of the delivery needle. When released from the containment of the delivery needle the legs self-expand to a deployed configuration in which they extend radially outward of the axis of the tubular body.
Data Source
AI summary
One-piece tissue fasteners are provided for securing two or more tissue layers to each other. Delivery devices are described by which a tandem array of such fasteners can be delivered and deployed to secure tissue layers in a number of locations without requiring removal or reloading of the removal tool.