Fabric-Like SMA Hernia Plug for Low-Trauma Fixation
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Solution Overview
Problem
Conventional hernia meshes result in poor tissue regrowth, tearing, bleeding, and nerve entrapment, leading to discomfort and pain, and are not tension-free, complicating surgical procedures.
Innovation Solution
A hernia plug made of a smart memory alloy (SMA), such as nitinol, transforms from a compressed state for insertion to an expanded state for secure fixation, featuring a mesh portion with open cells and struts, optionally covered by PTFE, to minimize tissue damage and enhance integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional hernia meshes are used for repair, then hernia defect can be covered, but poor tissue regrowth, tearing, bleeding, and nerve entrapment occur leading to discomfort and pain
Solution Approach 1:
The hernia plug employs a porous PTFE fabric material that allows tissue ingrowth through its porous structure. The open-cell foam structure provides channels for tissue penetration and integration, eliminating the harmful effects of conventional meshes while maintaining structural integrity for reliable hernia repair
Solution Approach 2:
The device combines multiple materials with complementary properties: PTFE fabric for biocompatibility and tissue integration, open-cell foam for structural support and tissue ingrowth, and shape memory alloy for deployability. This composite approach resolves the contradiction by integrating materials that simultaneously provide structural strength and tissue-friendly characteristics
2Ease of operation
If conventional hernia meshes are used, then hernia defect is covered, but the procedure is not tension-free and complicates surgical procedures
Solution Approach 1:
The hernia plug utilizes shape memory alloy technology that allows the device to dynamically change shape in response to temperature changes. The plug transitions from a compressed delivery configuration to an expanded deployed configuration automatically upon insertion, eliminating the need for complex surgical manipulation and tension-free fixation procedures
Solution Approach 2:
The shape memory alloy structure enables the hernia plug to self-deploy and self-fixate automatically after insertion. The thermal response to body temperature triggers the expansion and anchoring mechanism without requiring additional surgical steps, simplifying the overall procedure while maintaining device functionality
3Strength
If a hernia plug is designed for secure fixation, then stable anchoring is achieved, but tissue damage and complications may occur
Solution Approach 1:
The porous PTFE fabric and open-cell foam structure enable tissue to grow through and anchor the device securely. This biological fixation mechanism achieves strong anchoring without mechanical penetration or suturing, eliminating tissue damage while maintaining fixation stability
Solution Approach 2:
The shape memory alloy changes its physical parameters (shape, rigidity) in response to temperature changes. This allows the device to be soft and flexible during insertion to avoid tissue damage, then become rigid and stable for secure fixation after deployment, resolving the contradiction between anchoring strength and tissue protection
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 SMA hernia plug provides a secure, minimally invasive solution that reduces complications, promotes tissue integration, and simplifies surgical procedures by adapting to the body's temperature or applied force for expansion, ensuring stable fixation without causing significant harm.
Implementation Method 1
the mesh portion comprises a plurality of open cells surrounded by struts formed of a smart memory alloy (SMA)
Data Source
Figure 1A
Figure 1B
Figure 2A~2C
AI summary
Disclosed examples generally relate to a fabric-like smart hernia plug (202) and method of manufacturing thereof. In some examples, the hernia plug comprises an expandable mesh portion (206) formed of a smart memory alloy (SMA), wherein the mesh portion is transformable between a compressed pre-activated state and an expanded post-activated state, the mesh portion comprising a plurality of open cells surrounded by struts formed of the SMA.