Bioabsorbable Tissue Fastener Deployment for Low-Trauma Closure
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Solution Overview
Problem
Current surgical staplers using bioabsorbable fasteners face issues such as bulkiness, tissue trauma, bleeding, and require multiple operators, making them unsuitable for short incisions and minimally invasive surgeries.
Innovation Solution
A single-user, hand-held device that deploys bioabsorbable fasteners with minimal tissue trauma, using a novel mechanism that includes a housing with a handle and barrel, tissue holders, and a fastener delivery system, allowing for precise insertion of fasteners entirely below the tissue surface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If bioabsorbable fasteners are made thicker to maintain strength during healing, then the fastener strength is improved, but the device complexity and tissue trauma increase
Solution Approach 1:
The patent changes the geometric parameters of the fastener by reducing thickness while increasing length, transforming it from a traditional thick staple to a thin wire-like configuration. This parameter change allows the fastener to maintain strength through extended length rather than cross-sectional thickness, thereby reducing tissue trauma during insertion.
Solution Approach 2:
The invention transitions from a two-dimensional thick staple profile to a three-dimensional wire configuration by extending the fastener length significantly. This dimensional change allows the fastener to achieve structural integrity through its extended geometry rather than relying on thickness, enabling minimal invasive insertion.
2Reliability
If a driving head is inserted into the incision to compress tissue for fastener deployment, then the fastener deployment is improved, but the device complexity increases and the device may get trapped in short incisions
Solution Approach 1:
The patent extracts the driving head from the incision site by deploying fasteners from the external surface downward. This eliminates the need for internal driving head insertion and tissue compression, simplifying the device configuration and preventing entrapment in short incisions while maintaining reliable fastener deployment.
Solution Approach 2:
The invention inverts the traditional deployment approach by inserting fasteners from the outside in rather than from the inside out. This reversal eliminates the need for internal driving mechanisms and tissue compression, reducing device complexity and avoiding the trap of driving heads becoming lodged in closed incisions.
3Strength
If traditional metal staples are used to close incisions, then the closure strength is improved, but the need for exposed portions and follow-up removal increases
Solution Approach 1:
The patent employs bioabsorbable fasteners that are designed to perform their closure function and then naturally absorb and disappear. This eliminates the need for permanent metal staples requiring removal, aligning with the disposable concept where the fastener completes its mission and is biologically degraded, simplifying the overall surgical process.
Solution Approach 2:
The invention utilizes the biological recovery process by deploying fasteners that are subsequently absorbed and discarded by the body's natural metabolic processes. This eliminates the manual removal step required for metal staples, as the fasteners are recovered through biological absorption rather than mechanical removal.
4Reliability
If piercing members cut holes in tissue to insert fasteners, then the fastener insertion is improved, but the bleeding and trauma increase
Solution Approach 1:
The patent employs a high-velocity delivery mechanism that launches the fastener through tissue at high speed, skipping the traditional cutting step. This rapid penetration minimizes tissue damage and bleeding by creating a clean passage through the fastener's kinetic energy rather than mechanical cutting.
Solution Approach 2:
The invention replaces the mechanical cutting system with a kinetic penetration system. Instead of using piercing members to cut holes, the fastener is delivered at high velocity to punch through tissue, substituting mechanical cutting with kinetic penetration to reduce trauma and bleeding.
Data Source
AI summary
The present invention is directed to a hand-held surgical device, operable by a single user, for deploying fasteners to close a wound or incision in tissue. The device includes tissue pinching and folding members operably controlled by the user during actuation of a trigger of the device, which can temporarily secure and expose inner surfaces of two edges of an incision or wound, where one of a plurality of fasteners can be inserted upon further actuation of the trigger, without crushing or causing undue trauma to the tissue.