Biodegradable Bone Hemostatic Paste for Stable Sealing and Healing
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Solution Overview
Problem
Existing bone waxes used for hemostasis, such as beeswax and polyethers, have issues with cytotoxicity, abrasiveness, non-biodegradability, and adverse effects on bone healing, particularly when used near joint endoprostheses, and they can cause secondary bleeding due to solubility in aqueous environments.
Innovation Solution
A paste-like hemostatic agent composed of particulate sugar alcohols, saturated glycerol trifatty acid esters with varying melting points, and optional pharmaceutical active ingredients, which are biocompatible, non-cytotoxic, and biodegradable, providing mechanical stability and adhesion to bone and metallic surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If beeswax-based bone wax is used for hemostasis, then good adhesion to bone tissue and high viscosity are achieved, but the material is non-biodegradable and acts as a barrier to bone ingrowth
Solution Approach 1:
The patent changes the chemical composition parameters by replacing beeswax with glycerol monostearate and adjusting the ratio of solid to liquid fat esters. This transforms the material from non-biodegradable to biodegradable while maintaining the necessary viscosity and adhesion properties for hemostasis, eliminating the barrier effect on bone healing
Solution Approach 2:
The invention creates a composite material system combining glycerol monostearate (solid fat ester) with glycerol trioctanoate (liquid fat ester) and optional fillers like calcium sulfate or calcium carbonate. This composite approach achieves both hemostatic effectiveness and biodegradability, resolving the contradiction between reliability and harmful effects
2Object-generated harmful factors
If polyether compositions are used for hemostasis, then complete renal excretion and no barrier function are achieved, but high solubility in aqueous environments causes dissolution and secondary bleeding
Solution Approach 1:
The patent changes the solubility parameter by selecting fat esters with specific hydrophobic characteristics. Glycerol monostearate and glycerol trioctanoate have low water solubility compared to polyethers, ensuring the material remains stable in aqueous environments while maintaining biodegradability and lack of barrier function
3Object-generated harmful factors
If wax-like compositions with oligoesters are used for hemostasis, then biodegradability is achieved, but acidic degradation products cause local pH decrease and impair bone tissue
Solution Approach 1:
The patent changes the chemical structure parameter by selecting saturated fat esters with even-numbered carbon chains (C8, C10, C12, C14, C16, C18). These esters degrade into neutral fatty acids and glycerol rather than producing acidic oligoester degradation products, thus achieving biodegradability without local pH decrease
Solution Approach 2:
The invention converts the potential harmful acidic degradation into beneficial neutral degradation products. The fat esters are designed to break down into fatty acids that can be further metabolized by the body into neutral substances, turning a potentially harmful process into a beneficial one
4Strength
If inorganic calcium salts are used as fillers in hemostatic agents, then mechanical stability is improved, but abrasive properties damage joint endoprostheses
Solution Approach 1:
The patent replaces permanent inorganic calcium salts with organic fat esters that provide temporary mechanical stability during the hemostasis process. The organic components are biodegradable and do not exhibit abrasive properties, eliminating damage to joint endoprostheses while maintaining necessary mechanical properties
Solution Approach 2:
The invention creates a composite system where organic fat esters work synergistically with optional non-abrasive fillers. This composite approach achieves mechanical stability without the abrasive harmful effects of inorganic calcium salts, protecting joint endoprostheses
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 agent effectively seals bleeding bone tissue, is resistant to aqueous environments, supports bone healing without adverse effects, and can serve as a local drug release system, maintaining stability and adhesion without causing cytotoxicity or abrasion.
Implementation Method 1
The hemostatic effect of bone waxes is due to their good adhesion to moist and even fatty bone tissue and their high viscosity
Implementation Method 2
the high solubility of these polyethers in aqueous environments is a disadvantage. This can make adhesion of these compositions difficult in the case of heavily bleeding bone tissue due to the dissolution of the wax-like composition
Implementation Method 3
It has been shown that the use of these wax-like compositions during hydrolytic degradation produces acidic degradation products that can impair bone tissue due to a local decrease in pH
Data Source
Figure 1~2
AI summary
A paste-like hemostatic agent is proposed. The hemostatic agent comprises a) at least one particulate sugar alcohol; b) at least one saturated glycerol trifatty acid ester with a melting point greater than or equal to 40°C; and c) at least one saturated glycerol trifatty acid ester with a melting point less than 0°C. Furthermore, the uses of the paste-like hemostatic agent and a method for its preparation are described.