Surgical Staple With Integral Pledget for Tissue Sealing
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Solution Overview
Problem
Existing surgical staplers lack an effective mechanism to ensure secure and hemostatic sealing of tissue layers during anastomotic procedures, often resulting in incomplete closure and potential tissue tearing due to the thin pressure line applied by conventional staples.
Innovation Solution
The development of a surgical stapling instrument with an integral pledget that tilts and deflects, increasing the staple's footprint and pressure area, thereby distributing force more evenly across the tissue and enhancing structural integrity and hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional staples are used to seal tissue layers, then the stapling process is simple and quick, but the sealing is incomplete and tissue tearing occurs due to thin pressure line
Solution Approach 1:
The patent combines the staple with an integrated pledget into a single unit. The pledget is formed as one piece with the staple body, creating a unified structure that delivers both the staple and the reinforcing pledget simultaneously during deployment, eliminating the need for separate components while achieving enhanced sealing reliability
Solution Approach 2:
The pledget extends the pressure distribution from a one-dimensional line contact (staple only) to a two-dimensional area contact by adding lateral extensions. This dimensional expansion creates a broader pressure zone that distributes force across a larger tissue area, preventing tissue tearing while maintaining sealing effectiveness
2Object-affected harmful factors
If conventional staples are used, then the device is simple, but the pressure distribution is concentrated causing tissue damage
Solution Approach 1:
The pledget features lateral extensions that create localized pressure distribution zones at the edges of the staple. These extensions concentrate pressure in specific lateral areas to reinforce sealing at the tissue margins while the central portion maintains adequate pressure, achieving non-uniform pressure distribution that prevents tissue damage without compromising seal integrity
Solution Approach 2:
The pledget transforms the pressure application from a linear one-dimensional contact to a two-dimensional area contact by extending laterally beyond the staple body. This dimensional expansion distributes the clamping force across a broader tissue area, reducing pressure concentration and preventing tissue damage while maintaining effective sealing
3Reliability
If conventional staples are used, then the procedure is fast, but hemostasis is insufficient due to inadequate pressure area
Solution Approach 1:
The staple and pledget are merged into a single integrated component that is deployed together in one action. This combination ensures that the hemostatic pledget is always present with its corresponding staple, providing reliable hemostasis without requiring separate deployment steps, thus maintaining procedural efficiency while improving hemostatic effectiveness
Solution Approach 2:
The pledget's lateral extensions expand the pressure application area from a narrow linear contact to a broader two-dimensional surface. This increased pressure area improves blood vessel compression and sealing effectiveness, achieving reliable hemostasis while the integrated design maintains deployment speed
Data Source
AI summary
A circular stapler apparatus for stapling tissue includes a staple and pledget assembly and a circular staple head operable to drive staples toward an anvil. A staple of the staple and pledget assembly has a pair of legs disposed substantially perpendicular to a crown of the staple in a first position. The pair of legs is operable to advance against a pocket in the anvil to form a staple with bent legs. The staple and pledget assembly includes the staple and a pledget configured to receive the pair of legs of the staple. The pledget comprises a bioabsorbable material. The pledget is configured to advance distal ends of the pair of legs to a position in which the distal ends are laterally offset from a plane in which the crown of the staple is disposed.