Hemostatic Microbead Buttress for Surgical Stapling
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Solution Overview
Problem
Current surgical stapling instruments face challenges in effectively sealing and reinforcing fragile tissues, such as lung, esophageal, intestinal, and vascular tissues, due to issues with air or fluid leakage and staple pull-through, particularly when using biocompatible fabric buttresses with hemostatic agents that are not efficiently targeted to the wound site upon stapling.
Innovation Solution
A surgical buttress incorporating microbeads with a polymeric casing containing a hemostatic agent, which is designed to release upon actuation of the stapling apparatus, providing targeted delivery and enhanced sealing, with the option of a multilayered configuration including non-porous and porous layers for improved tissue interaction and reinforcement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a hemostatic agent is incorporated into the buttress material, then bleeding control is improved, but the hemostatic agent may be released prematurely before reaching the wound site
Solution Approach 1:
The hemostatic agent is pre-loaded into microbeads that are embedded within the buttress material before surgery. The microbeads remain intact during handling and application, but are designed to release their contents only when subjected to the specific mechanical conditions of stapling, ensuring the hemostatic agent is delivered at the precise moment and location needed.
Solution Approach 2:
The microbead structure serves as an intermediary carrier between the hemostatic agent and the wound site. The microbead shell protects the hemostatic agent during transport and application, while being designed to rupture under stapling forces, thereby controlling the release timing and location of the hemostatic agent.
2Measurement precision
If the hemostatic agent is released upon actuation, then targeted delivery to the wound site is improved, but the complexity of the buttress structure increases
Solution Approach 1:
The buttress material is segmented to contain multiple discrete microbeads distributed throughout its structure. Each microbead is a separate functional unit that can be independently controlled for release. This segmentation allows the complex release function to be achieved through simple, identical repeating units rather than a complex centralized mechanism.
Solution Approach 2:
The release mechanism is based on changing the physical state of the microbead shell from intact to ruptured under mechanical stress. By designing the microbead material and structure to have specific mechanical properties, the complex function of targeted release is achieved through a simple parameter change (integrity to rupture) rather than an active control system.
3Reliability
If microbeads are used to contain the hemostatic agent, then controlled release upon stapling is improved, but the manufacturing process becomes more complex
Solution Approach 1:
The manufacturing process merges the incorporation of microbeads into the buttress material with the standard fabrication processes for surgical materials. The microbeads are integrated during the material formation process rather than being added as a separate post-processing step, thereby combining multiple functions into a unified manufacturing flow.
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 achieves effective sealing and reinforcement of staple lines by releasing a significant percentage of the hemostatic agent directly at the wound site, reducing bleeding and tissue ingrowth, while maintaining tissue integrity and preventing staple pull-through.
Implementation Method 1
The surgical buttress is configured to release the hemostatic agent in response to compression by the jaw assembly
Implementation Method 2
The surgical buttress may include a porous and non-porous layer
Implementation Method 3
The adhesive is releasable by virtue of its hydrophilic properties
Implementation Method 4
The adhesive is releasable by virtue of its hydrophilic properties
Data Source
Figure 1
Figure 2~3D
Figure 4~5
AI summary
A surgical stapling apparatus includes a jaw assembly including a pair of jaw members and a surgical buttress positioned adjacent a tissue contacting surface of at least one of the pair of jaw members. The surgical buttress includes a hemostatic agent and is configured to release the hemostatic agent therefrom upon actuation of the surgical stapling apparatus to approximate the pair of jaw members and exert a pressure on the surgical buttress.