Surgical Adjunct Material with Clearance Fit Mating Features
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Solution Overview
Problem
Surgical staplers often cause leaks and inflammation due to the trauma of stapling, and the staples lack the natural flexibility and characteristics of the tissue they are implanted in, leading to issues like tissue tearing and inadequate sealing.
Innovation Solution
An end effector with a jaw configuration that includes a cartridge with staple cavities and an anvil, along with an adjunct material that is releasably retained on the jaws, featuring male and female components for a clearance fit, allowing movement in one plane while preventing displacement, and an adhesive for secure attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If staples are used to close tissue openings, then tissue sealing is achieved, but leaks occur through staple holes and inflammation results from stapling trauma
Solution Approach 1:
An adjunct material is introduced as an intermediary component between the staples and the tissue. This adjunct material seals around the staple shafts to prevent fluid leakage through the staple holes and provides a barrier that reduces tissue inflammation and trauma from the stapling process.
Solution Approach 2:
The adjunct material is formed from expandable particles that create a composite structure when expanded. This composite material combines the rigidity needed for structural support with the flexibility to conform to tissue contours, providing both leak prevention and inflammation reduction.
2Reliability
If staples are implanted in tissue, then tissue closure is achieved, but the staples lack natural tissue flexibility causing tissue tearing
Solution Approach 1:
The adjunct material undergoes a parameter change from a compressed state during stapling to an expanded state afterward. When expanded, the material becomes flexible and compliant, matching the mechanical properties of surrounding tissue and allowing natural tissue movement without causing tearing or stress concentration.
Solution Approach 2:
The expanded adjunct material forms a flexible shell or film structure around the staples and tissue. This flexible structure conforms to tissue contours and movements, providing reinforcement while maintaining tissue flexibility and preventing tearing at the staple line.
3Adaptability or versatility
If an adjunct material is releasably retained on the jaw with male and female features, then the adjunct material can move with respect to the jaw in a first plane, but displacement in other directions must be prevented
Solution Approach 1:
The retention system is segmented into male features on the jaw and corresponding female features on the adjunct material. This segmentation allows independent optimization of each component: the male features provide stable anchoring points while the oversized female features permit controlled movement in the first plane parallel to the tissue-facing surface.
Solution Approach 2:
The female features are locally designed with oversized dimensions specifically to allow movement in the first plane while maintaining engagement with the male features. This local quality change enables the adjunct material to accommodate tissue contours and movements without compromising overall retention stability.
Data Source
AI summary
An adjunct material for use with an end effector for a surgical instrument is provided that has different types of features for mating with the end effector. The adjunct is configured to be releasably retained on a jaw, such as a cartridge or anvil, using a plurality of female features formed thereon. Each female feature is configured to encompass a corresponding at least one of male features formed on the jaw in a clearance fit such that the adjunct is able to move with respect to the jaw at least in a first plane parallel to the tissue-facing surface. The male and female features mate such that the adjunct is not retained in a second plane that is perpendicular to the first plane. The adjunct also includes at least one attachment feature configured to releasably retain the adjunct on the jaw.