Mucosal-Adhesive Hemostatic Foam for Endoscopic GI Bleeding
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Solution Overview
Problem
Current endoscopic hemostatic devices for gastrointestinal bleeding, such as hemoclips and Hemospray, face challenges including limited applicability, high re-bleed rates, and complications, particularly in patients with large ulcers or antithrombotic use, necessitating a need for a biocompatible, easily administered, and rapid clotting technology.
Innovation Solution
Development of in situ hemostatic foams composed of components like chitosan, kaolin, and surfactants, delivered via a syringe system, which form stable, uniform foams that adhere to mucosal tissue and promote clotting, overcoming delivery hurdles posed by mucus secretion in the GI tract.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If hemoclips are used for endoscopic hemostasis, then mechanical compression is provided, but they cannot be placed on lesions located high on the gastric wall or on portions of the duodenal bulb
Solution Approach 1:
The invention uses a pressurized delivery system to喷射 hemostatic powder onto bleeding lesions. The pneumatic delivery mechanism allows the powder to reach difficult-to-access locations in the GI tract, including high gastric wall lesions and duodenal bulb portions where mechanical clips cannot be placed.
2Reliability
If cautery is repeatedly applied to control bleeding, then hemostasis is achieved, but perforation may occur in thin bowel tissue
Solution Approach 1:
The invention uses a disposable hemostatic powder that provides immediate hemostasis without requiring repeated applications. The powder forms a protective layer that stops bleeding in a single application, eliminating the cumulative thermal damage risk associated with repeated cautery applications.
3Speed
If Hemospray is used for hemostasis, then rapid clotting is promoted, but the powder may clot in the catheter when water or blood enters it
Solution Approach 1:
The invention design allows for flushing the catheter with saline before and after powder delivery to prevent clotting. The preliminary flushing action clears the catheter of blood and water that could cause the powder to clot, ensuring the device remains usable for subsequent applications.
4Productivity
If compressed gas is used to deliver Hemospray, then powder delivery is achieved, but gas embolism risk increases in patients with varices
Solution Approach 1:
The invention uses a controlled pneumatic delivery system that can be adjusted to deliver powder without excessive pressure. The system allows for precise control of gas flow to minimize the risk of gas embolism while maintaining effective powder delivery to the bleeding site.
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 hemostatic foams provide effective, prolonged hemostasis, reducing re-bleeding risks and surgical interventions, while being biocompatible and easy to use, with potential for extended clotting duration and tailored drug delivery.
Implementation Method 1
form stable, uniform foams that adhere to mucosal tissue
Implementation Method 2
promote clotting
Implementation Method 3
overcoming delivery hurdles posed by mucus secretion in the GI tract
Data Source
AI summary
A hemostatic formulation may include a gas component; a liquid vehicle; a surfactant; at least one of a mucosoadhesive or a thickening agent; and a coagulant. The at least one of the mucosoadhesive or the thickening agent may be Carbopol. The coagulant may include at least one of chitosan, kaolin, chitin. The surfactant may include at least one of polysorbate and glycerol. The hemostatic formulation may further include a viscosity-enhancing agent, which, in some implementations, may be a poly-N-isopropylacrylamide (pNIPAM).