Polymer Fastening Device for ADM Tissue Fixation
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Solution Overview
Problem
Current surgical fastening devices are inadequate for efficiently joining soft tissues to synthetic or biological meshes, particularly acellular dermal matrix (ADM), as they require time-consuming suturing and can cause tissue damage due to the use of metal fasteners or require unsuitable staplers.
Innovation Solution
A fastening device with a shaft and needle featuring a slot, capable of deploying a fastener with a bar connector system that minimizes insertion force and trauma, allowing for quick and secure fixation of ADM or other meshes to soft tissues using polymeric or resorbable fasteners.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple sutures are used to fix ADM to tissue, then secure fixation is achieved, but procedure time increases significantly
Solution Approach 1:
The suture is segmented into multiple discrete fasteners (staples or tacks) that can be deployed simultaneously or in rapid succession by the fastening device, replacing the time-consuming sequential hand-suturing process while maintaining secure fixation through multiple attachment points
Solution Approach 2:
The manual mechanical suture tying process is replaced with an automated fastening device that uses mechanical force to drive fasteners through the ADM and underlying tissue, achieving secure fixation through the deformation and locking mechanism of the fasteners rather than manual knot-tying
2Loss of time
If staplers or tackers are used for fastening, then procedure time is reduced, but tissue damage occurs due to metal or rigid fasteners
Solution Approach 1:
The material properties of the fasteners are changed from traditional metal or rigid materials to softer, more compliant materials that can still achieve mechanical fixation while being gentler on surrounding tissues, reducing the harmful effects of rigid structures on soft tissue and organs
Solution Approach 2:
The fastening device applies force locally at the fastener deployment site rather than requiring broad tissue compression, and the fasteners themselves are designed with localized sharp tips for penetration while maintaining overall softer construction that minimizes damage to surrounding tissues during and after deployment
3Strength
If forceful pushing is applied to ensure good connection, then fixation strength is improved, but underlying tissues or organs are damaged
Solution Approach 1:
The fastening device is designed to pre-position the fasteners accurately before deployment, ensuring optimal placement and engagement with the ADM and underlying tissue, which allows for effective fixation with reduced forcing compared to traditional staplers that require significant pushing to ensure proper connection
Solution Approach 2:
The fastening device acts as an intermediary that translates operator input into controlled, precise fastener deployment, mediating between the need for strong fixation and the risk of tissue damage by providing a mechanical advantage system that delivers adequate force without requiring excessive pushing that would damage underlying structures
Data Source
AI summary
A medical device for joining materials is provided. The device comprises a piercing element configured to penetrate materials to be joined. The piercing element is sufficiently sharp to penetrate materials to be joined and comprises a hollow interior along at least a portion of its length configured to distal advancement of a fastener therethrough; and an open tip through which the fastener can be pushed. The device can be used for fastening materials including tissue, synthetic mesh, and biologic mesh (e.g., ADM).