Tissue Reinforcement Material for Staple Line Sealing
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Solution Overview
Problem
Surgical staplers often cause tissue tears and inflammation due to the lack of natural tissue characteristics in staples, leading to leaks and deformation, which complicates the healing process.
Innovation Solution
A method and system for reinforcing a staple line using a tissue reinforcement material with a central region for sealing staple penetration sites and an outer region to distribute strain, combined with a sealant that transitions from a liquid to a solid state to enhance the seal and reduce tissue movement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If surgical staplers are used to seal and divide tissue, then the tissue can be closed and divided efficiently, but tissue tears and inflammation can occur due to lack of natural tissue characteristics in staples
Solution Approach 1:
A tissue reinforcement material is introduced as an intermediary between the staples and the tissue. This material has natural tissue characteristics that reduce inflammation and prevent tears while allowing staples to effectively seal and divide the tissue. The reinforcement material absorbs and distributes the mechanical stress, protecting the tissue from direct staple-induced damage.
Solution Approach 2:
The solution uses a composite structure combining staples with a tissue reinforcement material that has both synthetic and natural tissue-like properties. The reinforcement material is composed of biocompatible substances that mimic natural tissue characteristics, providing both mechanical support and biological compatibility to prevent inflammation and tearing while maintaining sealing efficiency.
2Reliability
If staples are used to close tissue openings, then the tissue can be sealed, but leaks can occur due to staples forming tears in the tissue
Solution Approach 1:
The tissue reinforcement material is applied to the tissue before stapling to provide cushioning and protection. This pre-positioned reinforcement material prevents staples from directly tearing the tissue, absorbing the mechanical stress and distributing it evenly across the sealed area, thereby maintaining seal integrity and preventing leak formation.
Solution Approach 2:
The reinforcement material is strategically positioned at critical areas where staples will be placed, providing localized protection against tear formation. The material's properties are optimized for the specific regional requirements, enhancing seal integrity at staple penetration points while maintaining overall tissue flexibility.
3Strength
If traditional staples are implanted in tissue, then the tissue can be held together, but the tissue lacks natural flexibility and characteristics after stapling
Solution Approach 1:
The reinforcement material's physical and mechanical parameters are designed to match natural tissue properties, including flexibility, elasticity, and compliance. By adjusting these parameters, the material provides adequate holding strength for tissue approximation while maintaining the tissue's natural flexibility and adaptability for physiological movements and healing processes.
Solution Approach 2:
The reinforcement material is designed to be homogeneous with natural tissue in terms of mechanical properties and biological response. This homogeneity ensures that the stapled tissue maintains natural characteristics and flexibility, as the reinforcement material integrates seamlessly with the surrounding tissue rather than creating a rigid, non-compliant structure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution effectively reduces leaks and inflammation by maintaining tissue integrity and promoting healing through improved sealing and strain distribution, ensuring a more stable and secure staple line.
Implementation Method 1
sealant can be delivered to the tissue reinforcement material when the sealant is in a first, liquid state such that the sealant solidifies thereon
Data Source
AI summary
Adjunct material and methods of using adjunct material to reinforce a staple line are provided herein. In general, adjunct material can be used to maintain a seal in tissue and prevent stapled tissue from tearing. This adjunct material can be coupled to a jaw of a surgical stapler, and can be deployed into tissue along with the staples. In some embodiments, the adjunct material can be sized and shaped so that a portion of the material extends laterally outside of the staple line and distributes strain to tissue outside of the staple line. In certain aspects, sealant can be applied to the staple line and to the adjunct material in various ways to further seal the tissue and/or prevent leaks from forming in the tissue.