Interchangeable Plate Wound Simulator for Bleeding Severity Assessment
Solution Overview
Problem
Current methods lack a reliable and repeatable protocol for assessing the severity of surface bleeding, particularly in surgical procedures, which hinders the evaluation of hemostatic agents and leads to inconsistent assessments across investigators.
Innovation Solution
A device and method are proposed to simulate surface bleeding using a controlled blood flow system with interchangeable plates of varying hole patterns, allowing for the simulation of different bleeding severities and the development of a standardized Surface Bleeding Severity Scale (SBSS) for consistent assessment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a standardized bleeding severity assessment scale is implemented, then measurement precision and reliability are improved, but device complexity and protocol complexity increase
Solution Approach 1:
The simulation device is divided into modular components: a base platform, interchangeable wound models with different geometries and vessel configurations, and standardized blood delivery systems. Each module can be independently selected and combined to create specific bleeding scenarios, enabling precise assessment without requiring a completely complex custom-built device for each scenario.
Solution Approach 2:
The device enables systematic variation of key parameters including blood flow rate (controlled via pump), wound surface area (different plate sizes), vessel diameter (interchangeable inserts), and bleeding duration. These parameter changes allow the same base device to simulate multiple bleeding severities and types, achieving measurement precision without proportionally increasing device complexity.
2Adaptability or versatility
If multiple interchangeable plates with different hole patterns are used to simulate various bleeding scenarios, then adaptability and versatility are improved, but device complexity and manufacturing complexity increase
Solution Approach 1:
A single base platform design supports multiple wound models and interchangeable plates, creating a universal simulation system. The standardized mounting interface and blood delivery system allow different plate configurations to be used with the same core apparatus, achieving versatility without requiring multiple complete devices.
Solution Approach 2:
The interchangeable plates incorporate porous structures with controlled pore sizes and distributions to simulate different tissue types and bleeding characteristics. These porous plates can be manufactured using standardized casting or 3D printing processes, reducing manufacturing complexity compared to creating entirely unique structures for each bleeding scenario.
3Reliability
If a controlled blood flow system with pump is implemented, then measurement precision and reliability are improved, but device complexity and cost increase
Solution Approach 1:
The system incorporates flow sensors and pressure monitors that provide real-time feedback to a control system, which automatically adjusts pump speed to maintain desired flow rates. This closed-loop control ensures reliable and repeatable bleeding simulations while reducing the complexity of manual flow regulation.
Solution Approach 2:
The blood reservoir is designed with an integrated heating element and temperature sensor that automatically maintains physiological temperature (37°C) without external intervention. This self-regulating temperature control ensures consistent blood viscosity and flow characteristics, improving reliability while simplifying the overall system by eliminating the need for separate temperature control equipment.
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 enables consistent and reliable assessment of bleeding severity, facilitating the evaluation of hemostatic agents and ensuring that only eligible bleeding severities are enrolled in clinical trials, thereby improving the safety and efficacy of hemostatic product testing.
Implementation Method 1
A pump system connected to the source of blood liquid and configured to provide a controlled flow of said blood liquid
Data Source
Figure 1
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AI summary
The invention relates to a device to simulate a surface bleeding, comprising: - A source (1) of a blood liquid, in particular a synthetic blood liquid or a blood liquid having been removed from a human body; - A pump system (2) connected to the source (1) of blood liquid and configured to provide a controlled flow of said blood liquid; - A wound simulator (3) having an open chamber (31) connected to the pump system (2) to receive the controlled flow of blood liquid, wherein the wound simulator (3) comprises a set of interchangeable plates (32), o each plate (32) having a plurality of holes (321) arranged through said plate (32) according to a specific pattern, wherein the specific pattern is different for each plate (32) of the set of interchangeable plates (32), and o each plate (32) being adapted to be removably mounted on the wound simulator (3) to close the open chamber (31), so that blood liquid flows out of the chamber (31) through the holes (321) of the plate (32) mounted on the wound simulator (3). The invention also relates to a method for simulating a plurality of different surface bleedings with such device.