Malleable Biodegradable Hemostatic Agent for Bone Sealing
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Solution Overview
Problem
Current hemostatic agents for bleeding bone tissue, such as bone wax, are non-degradable, difficult to knead, and can cause adverse reactions due to acidic degradation products or solubility issues, leading to ineffective sealing and potential tissue damage.
Innovation Solution
A malleable, biodegradable hemostatic agent composed of saturated glycerol-1,2,3-tri-fatty acid esters, particulate filling agents, and a compound with low solubility in water, which forms a stable matrix to maintain mechanical stability and adhere to surfaces without dissolving in blood, ensuring effective sealing and biocompatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional bone wax is used to achieve hemostasis, then effective sealing of bleeding bone tissue is attained, but the material is non-degradable and causes adverse reactions in the human body
Solution Approach 1:
The patent changes the chemical composition parameters by using saturated glycerol-1,2,3-tri-fatty acid esters with melting temperatures above 37°C instead of conventional beeswax. This parameter change enables the material to be biodegradable while maintaining hemostatic effectiveness, resolving the contradiction between reliability and harmful effects.
Solution Approach 2:
The patent creates a composite material system combining saturated glycerol-1,2,3-tri-fatty acid esters with particulate filling agents and compounds having low water solubility. This composite approach maintains the mechanical stability and adhesive properties needed for effective hemostasis while introducing biodegradability, thus eliminating adverse reactions.
2Ease of operation
If beeswax with plasticizer is used to improve malleability, then the wax becomes easier to knead, but the material remains non-degradable in the human body
Solution Approach 1:
The patent selects saturated glycerol-1,2,3-tri-fatty acid esters with specific melting temperatures above 37°C, which provides optimal malleability at body temperature without requiring plasticizers. This parameter selection enables both ease of operation during surgery and biodegradability in the human body, resolving the contradiction between malleability and degradation time.
3Ease of operation
If polyether compositions are used to achieve kneadability, then the material is spreadable at body temperature, but the composition dissolves in aqueous media and loses barrier function
Solution Approach 1:
The patent changes the chemical composition to saturated glycerol-1,2,3-tri-fatty acid esters with melting temperatures above 37°C, which provides kneadability at body temperature while maintaining low water solubility. This parameter change resolves the contradiction by enabling ease of operation without compromising composition stability in aqueous media.
Solution Approach 2:
The patent combines saturated glycerol-1,2,3-tri-fatty acid esters with particulate filling agents and compounds having low water solubility to create a composite material that maintains structural integrity in aqueous environments while remaining kneadable, thus resolving the contradiction between kneadability and solubility stability.
4Duration of action of stationary object
If oligoesters of hydroxycarbonic acids are used to create biodegradable wax-like compositions, then the material is degradable, but acidic degradation products lower pH and damage bone tissue
Solution Approach 1:
The patent changes the chemical structure from oligoesters of hydroxycarbonic acids to saturated glycerol-1,2,3-tri-fatty acid esters. This parameter change in chemical composition enables biodegradability through different metabolic pathways that do not produce harmful acidic degradation products, thus resolving the contradiction between biodegradability and harmful factors.
5Reliability
If conventional bone wax is used to achieve adhesive effect on moist and fatty bone tissue, then good hemostatic sealing is attained, but the material is difficult to knead at room temperature
Solution Approach 1:
The patent changes the melting temperature parameter of the base material to above 37°C, which provides optimal adhesive effect on bone tissue while ensuring the material becomes sufficiently soft and kneadable at body temperature during surgical application, resolving the contradiction between adhesive effect and kneadability.
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 arrests bleeding, maintains mechanical stability, and is biodegradable, preventing tissue damage and promoting bone healing without sticking to gloves or causing pH imbalances.
Implementation Method 1
forms a stable matrix to maintain mechanical stability
Implementation Method 2
adhere to surfaces without dissolving in blood, ensuring effective sealing
Implementation Method 3
biodegradable hemostatic agent
Implementation Method 4
biodegradable, preventing tissue damage and promoting bone healing
Implementation Method 5
compound with low solubility in water, which forms a stable matrix
Data Source
AI summary
A malleable, biodegradable hemostatic agent is provided that can be used for mechanical sealing of bleeding bone tissue, as well as a method for forming a malleable, biodegradable hemostatic agent of this type, and a medical implant having a coating that includes a malleable, biodegradable hemostatic agent of this type. The malleable, biodegradable hemostatic agent contains (a) at least one saturated glycerol-1,2,3-tri-fatty acid ester having a melting temperature above 37° C., (b) at least one filling agent present in particulate form, at least in part, and having a melting temperature above 37° C., and (c) at least one compound having a melting temperature not above 37° C. and a solubility at a temperature of 25° C. of less than 50 grams per liter of water.