Synthetic Polymer Hemostatic Delivery via Pneumatic Spray
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Solution Overview
Problem
Current methods for delivering synthetic polymers to address internal bleeding, such as in the abdominal cavity, are inadequate for rapid deployment by non-surgeon personnel in out-of-hospital settings, often resulting in delayed treatment and increased mortality due to the complexity and risk of injury from existing needle-based systems.
Innovation Solution
A system for delivering synthetic polymer formulations as an aqueous solution, gel, or foam through a probe and needle mechanism that automatically stops upon insertion, using a canister with a propellant to expand within the body cavity, providing controlled pressure and bioactive substances to stop bleeding, and being resorbable to minimize complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If needle-based systems are used to deliver synthetic polymers into the abdominal cavity, then the polymer can be delivered to stop bleeding, but the risk of injury to internal organs increases and deployment complexity increases
Solution Approach 1:
The patent introduces a Veress needle as an intermediary device that enables safe percutaneous access to the abdominal cavity. This intermediary tool allows non-surgeon personnel to deliver the synthetic polymer formulation without directly inserting large needles that could injure internal organs, thus resolving the contradiction between deliverability and safety
Solution Approach 2:
The patent replaces the mechanical needle-based injection system with a spray-based delivery system. Instead of injecting polymer through a needle, the system sprays the synthetic polymer formulation (e.g., gelatin foam) onto the bleeding site, eliminating the need for deep needle insertion and reducing the risk of organ injury while maintaining hemostatic effectiveness
2Productivity
If complex needle-based systems are used for polymer delivery, then polymer delivery is achieved, but the ease of operation decreases and requires specialized training
Solution Approach 1:
The patent employs self-expanding foam technology where the synthetic polymer formulation automatically expands upon contact with body fluids or air after being sprayed. This self-service mechanism eliminates the need for complex manual manipulation or specialized surgical skills to deploy the hemostatic agent, allowing non-surgeon personnel to effectively stop bleeding by simply spraying the formulation onto the wound
Solution Approach 2:
The patent utilizes pneumatic spray delivery where compressed gas propels the synthetic polymer formulation through a nozzle onto the bleeding site. This pneumatic mechanism simplifies the delivery process, enabling rapid and controlled application of the hemostatic agent without requiring manual injection techniques or specialized surgical training
3Loss of time
If rapid hemostasis is achieved in out-of-hospital settings, then mortality is reduced, but the complexity of the delivery system increases
Solution Approach 1:
The patent segments the hemostatic treatment into simple, discrete steps: spray the synthetic polymer formulation onto the bleeding site, allow it to expand and adhere, and achieve hemostasis. This segmentation simplifies the overall treatment process into manageable actions that can be performed rapidly by non-surgeon personnel in out-of-hospital settings, reducing time to stop bleeding without requiring complex delivery systems
Solution Approach 2:
The patent changes the physical state of the synthetic polymer formulation from a compressed sprayable form to an expanded foam form upon delivery. This parameter change enables the polymer to rapidly fill and conform to irregular wound cavities, achieving effective hemostasis quickly. The simple spray-to-foam transformation eliminates the need for complex delivery mechanisms while enabling rapid deployment in pre-hospital environments
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
Enables rapid, safe, and effective hemostasis in out-of-hospital settings by allowing non-surgeon personnel to deploy the system, reducing the risk of injury and enabling controlled pressure to manage bleeding, while being resorbable and non-toxic, thus improving patient outcomes.
Implementation Method 1
the synthetic polymer formulation expands once reaching the body cavity or space (e.g. abdominal cavity) to reduce and/or stop bleeding
Implementation Method 2
the propellent gas is kept separate from the polymer to be delivered by a membrane and/or bag, so that it can transmit pressure but does not directly mix with the agent to be delivered to the body
Implementation Method 3
synthetic polymer formulations... being resorbable to minimize complications
Data Source
AI summary
Systems, methods and compositions relating to delivering synthetic polymer formulations to the body are described, which can be used by a range of medical personnel including those with minimal experience and training. Under some embodiments, the present invention relates to systems and devices for delivering polymer formulations to a body cavity (e.g. peritoneal cavity) to reduce or stop bleeding. Under some embodiments, an initial percutaneous access pathway is first formed using a delivery device with a probe and needle mechanism that automatically stops the advance of the device upon insertion into a body cavity or space, thus minimizing user error and improving patient safety. The hollow probe then allows transmission of polymer, mixed with gas and/or additional substances, from a holding chamber or canister to flow through the device and hollow probe into the patient's anatomic cavity or space of interest, stopping expansion when the device senses the appropriate pressure. Once reaching the body cavity, the polymer formulation functions to reduce and/or stop bleeding.