Topical Polymer Gel for Gastrointestinal Bleeding
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Solution Overview
Problem
Current treatments for upper gastrointestinal bleeding are inadequate, with systemic medications posing serious side effects and limited efficacy in reducing mortality and re-bleeding rates, and there is a need for a reliable and safe therapeutic option that can be administered effectively to stop bleeding in the GI tract.
Innovation Solution
Topical formulations containing polymers that transition from a liquid to a gel at physiological temperatures, promoting blood clotting and reducing bleeding, either alone or in combination with antihemorrhagic agents, which can be delivered via drinking, nasogastric tube, or endoscopically, avoiding systemic side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If systemic medications (tranexamic acid) are administered intravenously to treat upper GI bleeding, then the risk of death and surgical intervention is reduced, but serious side effects occur and thrombosis risk increases
Solution Approach 1:
The patent applies local quality by transitioning from systemic administration to localized topical delivery of hemostatic agents directly to the GI bleeding site. This is achieved through formulations that can be administered via nasogastric tube, endoscope, or oral route, ensuring the medication acts locally at the bleeding site without systemic circulation, thereby maintaining efficacy while eliminating thrombosis risk and systemic side effects
Solution Approach 2:
The patent uses an intermediary delivery system (topical formulations including gels, foams, powders, or liquid solutions) that mediates between the hemostatic agent and the bleeding site. These formulations serve as carriers that deliver the active ingredient locally, allowing the medication to reach the target site without requiring systemic circulation, thus resolving the contradiction between effective delivery and avoidance of systemic side effects
2Object-generated harmful factors
If proton pump inhibitors are administered to treat upper GI bleeding, then gastric acid secretion is reduced, but evidence of decreased death rates, re-bleeding events, or surgical interventions is conflicting
Solution Approach 1:
The patent extracts the hemostatic function from adjunctive therapies like proton pump inhibitors and focuses on direct topical hemostatic agents. Rather than relying on acid reduction as a secondary benefit, the invention directly addresses bleeding through localized application of hemostatic substances that promote clot formation and vessel constriction at the bleeding site, providing reliable efficacy without the conflicting outcomes associated with PPIs
3Object-affected harmful factors
If topical formulations are used to treat GI bleeding, then systemic side effects are avoided, but the formulations must be delivered effectively to the bleeding site
Solution Approach 1:
The patent applies universality by designing topical formulations that can be delivered through multiple routes (oral, nasogastric tube, endoscopic) to treat bleeding at various locations in the GI tract. This multi-functional delivery system ensures that the same formulation can reach different bleeding sites through different administration pathways, maintaining the advantage of avoiding systemic side effects while ensuring effective delivery regardless of bleeding location or patient condition
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 polymer-based formulations effectively stop GI bleeding by forming a gel at body temperature, providing superior efficacy and safety by local delivery, reducing bleeding time and risk of thrombosis, and can be used in combination with systemic therapies for enhanced treatment outcomes.
Implementation Method 1
polymers that trigger the formulations to undergo a conditional, e.g., temperature-dependent, phase transition. In temperature-dependent formulations, the polymers exist dispersed in a liquid, such as in solution, colloid, suspension, or emulsion, at sub-physiological temperatures, which allows the formulations to be provided to patients in liquid form. At physiological temperatures (i.e., at or near 37° C.), however, the polymers aggregate to form a gel that coats the mucosa of the GI tract and promotes blood clotting
Data Source
AI summary
The invention provides compositions and methods for treatment of gastrointestinal bleeding, such as upper GI bleeding. In certain aspects, the invention provides topical formulations that stop bleeding in the GI tract by forming a gel when a polymer in the formulation exceeds a threshold level (optionally a pre-determined threshold level) for a property of the polymer of the formulation, which threshold level may be for example, a physical (e.g., temperature), chemical (e.g., pH), or temporal threshold level following contact with the affected tissue. In certain aspects, a combination of properties, such as a combination of physical (e.g., temperature), chemical (e.g., pH), or temporal threshold levels determines when the polymer in the formulation transitions from a liquid to a gel. Methods of using such compositions are also provided.