Biocompatible Adjunct Material for Staple Cartridge Sealing
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Solution Overview
Problem
Current surgical staplers often result in leaks and tissue inflammation due to staple holes, and biologic materials used for reinforcement face challenges in maintaining position and manufacturing complexity, lacking natural tissue flexibility.
Innovation Solution
A staple cartridge assembly with a biocompatible adjunct material, such as a film or foam, releasably retained on the cartridge body, which includes a medicant to encourage a desired reaction in stomach tissue, such as faster healing, and is configured to be stapled to the external surface of the stomach tissue, allowing it to erode into the stomach cavity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical staplers are used to close openings in tissue, then the openings are sealed, but leaks occur due to staple holes and tissue inflammation occurs
Solution Approach 1:
A biocompatible adjunct material is introduced as an intermediary between the staples and the tissue. This material fills the holes created by staples, preventing leaks of blood, air, and gastrointestinal fluids, while also reducing tissue inflammation. The adjunct material acts as a mediator that resolves the harmful effects of staple penetration without compromising the sealing function.
Solution Approach 2:
The invention uses composite materials comprising biocompatible adjunct materials with specific physical and chemical properties. These composite materials are designed to be flexible like natural tissue while providing structural support to prevent leaks. The composite nature allows simultaneous achievement of leak prevention and inflammation reduction.
2Reliability
If biologic materials are used for tissue reinforcement, then healing is promoted, but positioning and manufacturing become difficult
Solution Approach 1:
The biocompatible adjunct material is manufactured with controlled physical parameters including specific thickness ranges and density values. These parameter controls enable the material to be produced with consistent properties that facilitate both manufacturing processes and subsequent surgical positioning, while maintaining the healing-promoting biological properties.
3Reliability
If biologic materials are used for tissue reinforcement, then healing is encouraged, but the materials lack structural support and are difficult to use with surgical staplers
Solution Approach 1:
The biocompatible adjunct material is engineered as a composite with enhanced structural properties. The material combines biological components with structural elements to provide the necessary strength and rigidity for use with surgical staplers, while preserving the healing-encouraging characteristics of biologic materials.
4Strength
If staples are used to close openings, then tissue is joined, but the natural characteristics of the tissue are compromised
Solution Approach 1:
The biocompatible adjunct material serves as an intermediary that preserves the natural characteristics of tissue. It maintains tissue flexibility and compliance while providing the structural reinforcement needed for effective joining. The material allows tissue to retain its natural behavior patterns despite the presence of staples.
Data Source
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AI summary
Adjunct materials for delivery to stomach tissue are provided. In general, the adjunct materials can be configured to be delivered to tissue by deployment of staples from a cartridge body of a surgical stapler. The adjunct material can have a structure effective to cause a desired reaction in the stomach tissue. The adjunct material can include an effective amount of one or more medicants disposed within and releasable from the adjunct material for delivery to the stomach tissue to encourage the desired reaction. The adjunct material can be in the form of at least one of a film and a foam that is releasably retained on the cartridge body. Methods of using a staple cartridge assembly or an end effector to apply such adjunct materials to stomach tissue are also provided.