Polysaccharide Coated Hemostatic Composition for Bleeding Control
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Solution Overview
Problem
Existing hemostatic agents face challenges such as thrombin denaturation during mixing, difficulty in applying to bleeding sites without flowing, instability at room temperature, and risks of infection from animal-derived polymers.
Innovation Solution
A hemostatic composition comprising a polysaccharide coated with a mixture of a stabilizer, a binder, and thrombin, along with an antibiotic, which can be stored at room temperature and applied as either a powder or hydrogel to effectively control bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thrombin is stored as liquid or powder, then it can be applied to bleeding sites, but it easily runs off and fails to show sufficient hemostatic effect
Solution Approach 1:
The patent uses a biodegradable polymer matrix as an intermediary carrier to immobilize thrombin. This matrix acts as a mediator that prevents thrombin from running off the bleeding site while maintaining its hemostatic activity. The polymer matrix serves as a temporary scaffold that delivers thrombin locally and then degrades, solving the problem of thrombin loss during application.
Solution Approach 2:
The patent employs a gelatin-based hydrogel matrix that forms a flexible, conformable layer over the bleeding site. This thin film structure adheres to the irregular surface of the bleeding area, ensuring thrombin remains in place during application. The hydrogel matrix provides a three-dimensional structure that traps thrombin and facilitates contact with blood vessels while maintaining flexibility for easy application.
2Reliability
If animal-derived polymers like gelatin or collagen are used as hemostatic agents, then they provide good hemostatic effects, but they carry risks of infectious diseases such as BSE
Solution Approach 1:
The patent changes the material parameter from animal-derived polymers to synthetic biodegradable polymers. This parameter change maintains the desirable properties of hemostatic agents (biocompatibility, degradability) while eliminating the harmful infectious risks associated with animal products. The synthetic polymers can be produced without biological contaminants, achieving safety while preserving functional performance.
Solution Approach 2:
The patent creates a composite material system combining synthetic biodegradable polymer with thrombin. This composite structure integrates the safety advantages of synthetic materials with the superior hemostatic properties of thrombin. The composite formulation allows for controlled degradation and sustained release of thrombin, achieving both safety and effectiveness without relying on animal-derived components.
3Strength
If oxidized regenerated cellulose is mixed with thrombin, then it provides structural support, but acidic residues denature thrombin and render it ineffective
Solution Approach 1:
The patent converts the potential harm of acidic residues in cellulose derivatives into a benefit by carefully selecting and modifying the polymer material. The synthetic biodegradable polymer is designed to provide structural support without generating acidic residues that would denature thrombin. The material is engineered to maintain neutral or basic pH conditions, transforming a potentially harmful property into a beneficial one for thrombin stability.
Solution Approach 2:
The patent employs a biodegradable polymer that serves its structural support function temporarily and then degrades harmlessly. This disposable-like approach allows the polymer to provide mechanical strength during the critical hemostasis process without long-term persistence that could cause inflammation or interfere with thrombin activity. The temporary nature of the polymer ensures it fulfills its support role and then disappears, preventing long-term interference with biological processes.
4Duration of action of stationary object
If thrombin is lyophilized and frozen for long-term storage, then it maintains stability, but its activity rapidly decreases in solution and requires removal from storage just before use
Solution Approach 1:
The patent incorporates stabilizing agents and appropriate polymer matrices into the thrombin formulation during manufacturing. This preliminary action prepares the thrombin for enhanced stability during storage and use. The stabilizers are pre-added to protect thrombin from degradation, and the polymer matrix is pre-formed to maintain thrombin activity, eliminating the need for complex storage and preparation procedures just before use.
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 composition provides a long shelf-life at room temperature, effective fixation and application of thrombin, reduced risk of infection, and excellent hemostatic efficacy without toxicity.
Implementation Method 1
a polysaccharide coated with a mixture of a stabilizer, a binder, and thrombin
Implementation Method 2
a polysaccharide coated with a mixture of a stabilizer, a binder, and thrombin
Implementation Method 3
an antibiotic
Implementation Method 4
thrombin acts on fibrinogen to cleave fibrinogen peptides to produce fibrins
Implementation Method 5
a fibrin network is formed by electrostatic attraction between the fibrins
Data Source
Figure 1~3
Figure 4
AI summary
The present disclosure relates to a hemostatic composition and a hemostasis kit including the same. More particularly, the present disclosure relates to a rapidly applicable hemostatic composition and a hemostasis kit including the same. The hemostatic composition according to the present disclosure includes a polysaccharide, a stabilizer, a binder, thrombin and an antibiotic, in which the polysaccharides is coated with the stabilizer, binder and thrombin, and the antibiotic is mixed with the coated polysaccharide. Since the hemostatic composition according to the present disclosure is provided in the form of a polysaccharide powder coated with a stabilizer, a binder, and thrombin, the hemostatic composition can be stored for a long period of time even at room temperature due to a large interaction area between the stabilizer and the thrombin, can be well fixed to the application site due to the binder, and has good hemostatic efficacy due to the high surface area of thrombin. In addition, the hemostatic composition can prevent infection at the bleeding site due to the presence of the antibiotic. In addition, the hemostatic composition may be mixed with a cationic solution that is separately stored, so that the hemostatic composition may be used as a hydrogel hemostatic agent if necessary. In addition, the powdered hemostatic composition can be housed in an endoscopic dispensing instrument to control bleeding during endoscopic procedures as needed, and thus can be used in a variety of bleeding situations.