Compressible Bioabsorbable Adjunct for Surgical Stapler Tissue Sealing
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Solution Overview
Problem
Surgical staplers face challenges in achieving consistent sealing and tissue integration due to inconsistent tissue thickness and the lack of natural flexibility in staples, leading to undesirable leakage and tissue tearing.
Innovation Solution
A compressible non-fibrous adjunct is developed, formed from a bioabsorbable polymer, which is attached to the surgical stapler cartridge and designed to deform under stress, providing a strain range of 0.1 to 0.9, allowing for consistent tissue compression and integration, and featuring various unit cell configurations such as triply periodic minimal surfaces and Schwarz-P structures to enhance tissue ingrowth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If staples are used to close tissue openings, then tissue sealing is achieved, but the staples lack natural flexibility and cannot withstand varying intra-tissue pressures, leading to tissue tearing and leakage
Solution Approach 1:
The patent replaces rigid staples with a flexible membrane-based closure device that can adapt to varying intra-tissue pressures. The membrane is configured to conform to the tissue surface and flexibly withstand pressure variations, preventing tissue tearing while maintaining sealing reliability.
Solution Approach 2:
The invention changes the physical state and properties of the closure material from rigid metal staples to a flexible membrane material with specific mechanical properties. The membrane's flexibility, elasticity, and pressure resistance are engineered to match physiological conditions, allowing it to adapt to varying pressures without causing tissue damage.
2Ease of manufacture
If staples with fixed heights are used, then manufacturing is simplified, but they cannot achieve desired fired configuration at each staple site due to inconsistent tissue thickness, resulting in leakage
Solution Approach 1:
The patent transitions from static, fixed-height staples to a dynamic membrane system that can adapt its configuration based on tissue thickness variations. The membrane's flexible structure allows it to conform to different tissue depths and profiles, achieving consistent sealing across varying tissue thicknesses while maintaining manufacturing simplicity through a single adaptable component design.
3Strength
If rigid objects are implanted in tissue, then structural support is provided, but they lack natural flexibility and cause undesirable tissue tearing at the implantation site
Solution Approach 1:
The patent replaces rigid implanted objects with a flexible membrane that provides structural support while maintaining tissue compatibility. The membrane's flexible nature allows it to move with tissue without causing tearing, while still providing the necessary structural support for wound closure and healing.
Solution Approach 2:
The invention employs composite material structures that combine strength and flexibility. The membrane may incorporate multiple layers or materials that work together to provide structural support while maintaining flexibility and biocompatibility, reducing the risk of tissue tearing while ensuring adequate mechanical support.
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 adjunct ensures consistent tissue compression and sealing across varying tissue thicknesses, reduces leakage and tearing, and promotes tissue ingrowth for improved healing and integration with the body.
Implementation Method 1
The adjunct has a plurality of repeating unit cells that are interconnected such that the adjunct, while under an applied stress in a range of 30 kPa to 90 kPa, undergoes a strain in a range of 0.1 to 0.9
Data Source
AI summary
Stapling assemblies for use with a surgical stapler are provided. In one exemplary embodiment, the stapling assembly includes a cartridge having a plurality of staples disposed therein and a non-fibrous adjunct formed of at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge. Adjunct systems for use with a surgical stapler are also provided. Surgical end effectors using the stapling assemblies are also provided. Methods for manufacturing stapling assemblies and using the same are also provided.