Biocompatible Adjunct Material for Colon Tissue Sealing
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Solution Overview
Problem
Current surgical staplers often cause leaks and inflammation due to staple holes, and biologic materials used to mitigate these issues are difficult to maintain and manufacture effectively for surgical applications.
Innovation Solution
A staple cartridge assembly with a biocompatible adjunct material formed of a fiber matrix, releasably retained on the cartridge body, which includes a medicant to encourage desired effects like angiogenesis or vasodilation, and is designed to minimize leaks and inflammation by being delivered with staples to colon tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical staplers are used to close openings in tissue, then tissue sealing and closure are achieved, but leaks occur through staple holes and inflammation results from tissue trauma
Solution Approach 1:
A biocompatible adjunct material is introduced as an intermediary between the staples and the tissue. This adjunct material fills the holes created by staple penetration, preventing leaks of blood and gastrointestinal fluids while reducing tissue inflammation. The adjunct material serves as a mediator that addresses the harmful effects of staple insertion without compromising the primary sealing function.
Solution Approach 2:
The adjunct material is configured with a porous structure that allows it to be delivered through the stapler device and integrate with the tissue. The porous nature enables the material to fill irregular spaces around staples while maintaining flexibility and biocompatibility, effectively sealing leaks through physical obstruction of fluid pathways.
2Object-affected harmful factors
If biologic materials are used to address leaks and inflammation, then tissue healing is promoted, but the materials are difficult to maintain at desired location and lack structural support
Solution Approach 1:
The adjunct material is formed as a composite structure combining biocompatible biologic materials with a supportive matrix. This composite construction provides both the therapeutic benefits of biologic materials for tissue healing and the structural integrity needed for easy positioning and retention during and after stapling. The composite nature allows the material to maintain its shape and location while delivering therapeutic effects.
Solution Approach 2:
The adjunct material is configured with a curved or conformable shape that adapts to the tissue surface and staple arrangement. This geometric design enables the material to be easily positioned at the surgical site and maintain contact with the tissue, improving ease of operation while ensuring the biologic components remain at the desired location for effective healing.
3Object-affected harmful factors
If biologic materials are used for tissue stapling, then tissue compatibility is improved, but manufacturing to desired shape and thickness is difficult
Solution Approach 1:
The manufacturing process utilizes controlled parameter changes, particularly temperature and pressure variations, to form the biologic material into precise shapes and thicknesses. By adjusting these parameters during processing, the material can be manufactured with consistent geometric specifications while maintaining its biocompatible properties. This approach enables mass production of adjunct materials with uniform characteristics.
Solution Approach 2:
The use of composite materials allows combination of biologic components with manufacturing-friendly matrices that can be precisely formed using conventional techniques. The biologic material provides tissue compatibility while the matrix structure enables accurate shaping and thickness control during manufacturing, resolving the contradiction between biocompatibility and manufacturability.
4Object-affected harmful factors
If fragile biologic materials are used, then tissue biocompatibility is enhanced, but the materials lack structural support for surgical stapler application
Solution Approach 1:
The adjunct material is constructed as a composite where fragile biologic materials are embedded within or coated onto a structurally supportive matrix. This composite structure provides the strength and rigidity needed for surgical stapler application while preserving the biocompatible properties of the biologic materials. The supportive matrix acts as a scaffold that protects the fragile biologic components until they are deployed at the surgical site.
Solution Approach 2:
The biologic material is configured as a flexible thin film or coating that can be applied to the stapler components or directly to the tissue. This thin film configuration provides sufficient structural support for handling and deployment while maintaining close contact with the tissue surface, ensuring both structural integrity and biocompatibility.
Data Source
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AI summary
Adjunct materials for delivery to colon tissue are provided. In general, the adjunct materials can be configured to be delivered to colon tissue by deployment of staples from a cartridge body of a surgical stapler to form at least one line of deployed staples. The adjunct material can be formed of a fiber matrix and include an effective amount of one or more medicants for delivery to the colon tissue. The medicant is disposed within and releasable from the adjunct material, and effective to encourage a desired effect on blood vessels, such as angiogenesis and/or vasodilation, along the at least one line of deployed staples. Methods of using a staple cartridge assembly or an end effector to apply such adjunct materials to colon tissue are also provided.