Bioabsorbable Fastener for Tissue Wound Closure
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Solution Overview
Problem
Conventional suturing and stapling techniques for skin closure involve puncturing the epidermis and dermis, leading to patient discomfort, aesthetic issues, and the risk of infection, with non-absorbable fasteners requiring subsequent removal.
Innovation Solution
A mechanical system for rotatably securing tissue wounds using a fastener with a tissue manipulator and rotatable drive mechanism to insert cleats into the dermal layer, maintaining dermal layer contact for healing without exposed fasteners.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional suturing and stapling techniques are used to close tissue openings, then the opposing sides of the opening can be held in close proximity, but the epidermis and dermis must be punctured causing patient discomfort, aesthetic issues, and infection risk
Solution Approach 1:
The invention extracts the fastening function from the epidermis and places it solely in the dermal layer. The fastener is inserted through the dermis only, with the epidermis remaining intact and serving as a protective barrier. This separation eliminates the need to puncture the epidermis while maintaining effective wound closure through dermal fastening.
Solution Approach 2:
The dermal layer serves as an intermediary between the epidermis and subcutaneous tissue. The fastener engages with the dermis as an intermediate structure, allowing tissue approximation without directly penetrating the protective epidermal barrier. This intermediary approach enables closure while preserving epidermal integrity.
2Strength
If non-absorbable fasteners are used for tissue closure, then the fastener can provide durable wound approximation, but the fastener must be removed after healing is complete
Solution Approach 1:
The invention changes the material parameter of the fastener from non-absorbable to bioabsorbable. The fastener is constructed from materials that gradually degrade and are absorbed by the body over time, eliminating the need for removal after the fastening function is complete. This parameter change transforms a permanent implant into a temporary, self-resolving element.
Solution Approach 2:
The fastener is designed as a disposable, bioabsorbable element that performs its function during healing and then naturally degrades. This approach treats the fastener as a single-use medical consumable that eliminates the need for return visits or removal procedures, aligning with the principle of using temporary, self-resolving medical devices.
3Ease of operation
If exposed fasteners are used for skin closure, then the fastening mechanism is accessible for insertion, but the exposed fasteners create aesthetic issues and increase infection risk
Solution Approach 1:
The fastener is nested within the dermal layer, with the epidermis acting as an outer protective shell. The fastening mechanism is hidden beneath the intact epidermis, creating a nested structure where the functional elements are contained within the protective barrier. This nesting eliminates exposed fasteners while maintaining accessibility for insertion through the dermis.
Data Source
AI summary
A mechanical system for rotatably, sequentially securing opposing sides of a tissue wound with a fastener. An applicator apparatus is capable of imparting rotatable motion to a falcate tissue penetrator that sequentially pierces and carries a fastener into a first side and a second side of the tissue wound. The first side and second side of tissue can be simultaneously captured and positioned with respect to a tissue definition member or alternatively, the first tissue side and second tissue side can be individually, sequentially captured and positioned relative to the tissue definition member. The applicator apparatus can comprise a single fastener for small tissue wounds or resections or alternatively, the applicator can comprise a plurality of staged fasteners for use in closing a larger wounds or wounds with increased tension.