Biocompatible Adjunct Material for Colon Tissue Sealing
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Solution Overview
Problem
Current surgical staplers face issues with leaks and inflammation due to staple holes, and biologic materials used to address these problems are difficult to maintain and manufacture effectively, lacking natural tissue characteristics.
Innovation Solution
A staple cartridge assembly with a biocompatible adjunct material in the form of a fiber lattice, including distinct heterogeneous sections and medicants, is used to promote organized tissue remodeling and growth, which is delivered along with staples to minimize leaks and inflammation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If biologic materials are used to promote tissue growth and seal leaks, then tissue healing and leak prevention are improved, but the materials are difficult to manufacture to desired shape and thickness, and lack structural support
Solution Approach 1:
The patent uses a composite structure combining a synthetic porous scaffold (polymethylpentene or polyethylene) with a biologic coating layer. The synthetic scaffold provides structural support and manufacturability, while the biologic coating promotes tissue growth and healing. This composite approach resolves the contradiction by integrating the advantages of both material types.
Solution Approach 2:
The patent employs a porous synthetic scaffold as the base material, which allows for controlled manufacturing of precise shapes and thicknesses while providing structural integrity. The porosity enables tissue ingrowth and maintains mechanical strength, solving both the manufacturing difficulty and structural support issues while promoting reliable tissue healing.
2Reliability
If biologic materials are used to promote tissue growth, then tissue remodeling is improved, but the materials lack flexibility and natural characteristics of the tissue
Solution Approach 1:
The porous structure of the synthetic scaffold mimics the natural extracellular matrix architecture, providing flexibility and allowing tissue to grow through and around the structure. This porous architecture enables the implant to adapt to the natural tissue environment while maintaining structural integrity for reliable tissue remodeling.
3Productivity
If staples are used to close tissue openings, then tissue closure is achieved, but leaks occur through staple holes and tissue inflammation increases
Solution Approach 1:
The patent places the porous synthetic scaffold with biologic coating as an intermediary layer between the staples and the tissue. This intermediary sealant fills and seals the staple holes, preventing leaks of blood and gastrointestinal fluids. The biologic coating on the scaffold also reduces tissue inflammation, addressing both harmful effects while maintaining efficient tissue closure.
4Reliability
If adjunct material is used to seal staple holes, then leak prevention is improved, but the material is difficult to maintain at desired location during and after stapling
Solution Approach 1:
The patent uses a thin, flexible porous scaffold that can conform to the tissue surface and maintain its position during stapling. The flexibility of the thin film structure allows it to adapt to tissue movement and stapler compression while remaining securely in place, solving the location maintenance issue while providing effective leak prevention.
Data Source
AI summary
Adjunct material to promote tissue growth is provided. In general, an implantable adjunct can be configured to be applied to tissue by a surgical stapler in conjunction with staples. The adjunct can have one or more medicants releasably retained therein that are effective to provide a desired effect on tissue in-growth in a predetermined manner. One or more characteristics associated with the adjunct can be altered between various implementations to promote organized tissue remodeling in a desired manner during wound healing, such as by encouraging tissue growth to be in a certain direction and/or by discouraging tissue growth in a certain area and/or on a certain structure.