Dual-Reservoir Alginate Gel Dispensing System
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Solution Overview
Problem
Existing alginate gel-forming systems for medical applications often lack homogeneity, strength, and flexibility, leading to uneven drug release and potential leakage when used as sealants, due to non-uniform in situ formation during surgery or wound dressing.
Innovation Solution
A dual reservoir system that simultaneously expels an aqueous alginate solution and a polyol-containing composition, with a cross-linking agent, to form a homogeneous, ionically cross-linked alginate gel in situ, allowing for controlled gelation and enhanced properties such as strength and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional alginate gel-forming systems are used for in situ formation, then the gel can be formed at the application site, but the gel lacks homogeneity and uniformity leading to uneven drug release and potential leakage
Solution Approach 1:
The invention divides the gel-forming composition into two separate components stored in different reservoirs: Component A (aqueous sodium alginate solution) and Component B (cross-linking agents including calcium chloride, glucono-delta-lactone, and acid). These components are expelled simultaneously through separate outlets and mix at the application site, ensuring uniform distribution and homogeneous gel formation while preventing premature reaction.
Solution Approach 2:
The patent prepares the alginate solution and cross-linking agents separately in advance and stores them in ready-to-use reservoirs with delivery systems. The components are pre-formulated with specific concentrations and ratios, allowing for controlled and uniform gelation when mixed at the application site, thereby ensuring consistent drug release and seal integrity.
2Reliability
If alginate gel is formed for sealant application, then sealing function is provided, but the gel may sweat or leak due to non-uniform structure
Solution Approach 1:
By separating the alginate solution and cross-linking agents into distinct components that mix only at the application site, the invention ensures uniform gel structure formation. This segmentation prevents premature gelation and ensures consistent cross-linking throughout the gel matrix, eliminating weak points that would cause sweating or leakage.
Solution Approach 2:
The patent controls the concentration ratios of sodium alginate (2-10% w/v), calcium chloride (0.1-5% w/v), and glucono-delta-lactone (0.1-5% w/v) to optimize gel properties. By adjusting these parameters, the gel achieves appropriate viscosity, strength, and structural uniformity to prevent sweating and leakage while maintaining effective sealing function.
3Manufacturing precision
If multi-component system is used for in situ gel formation, then homogeneity is achieved, but the device complexity increases
Solution Approach 1:
The invention uses a dual-reservoir system with separate outlets for Component A and Component B, allowing independent control and storage of each component. This segmentation enables homogeneous gel formation through controlled mixing at the application site while maintaining a relatively simple overall device structure that can be manufactured and sterilized efficiently.
Solution Approach 2:
The dual-reservoir delivery system is designed to be versatile, accommodating various concentrations and formulations of alginate and cross-linking agents. The system can deliver different gel types for various applications (drug delivery, sealant, wound dressing) using the same basic device architecture, reducing the need for multiple specialized devices.
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 system produces homogeneous, dry, and flexible alginate gels that provide a watertight seal, enabling effective drug delivery and tissue adhesion, while minimizing leakage and swelling, suitable for various medical and veterinary uses.
Implementation Method 1
wherein (i) the first and/or second flowable composition contains 0.1-5 wt.% of an inactive cross-linking agent and the second flowable composition contains 0.01-5 wt.% of an activator or (ii) the second flowable composition contains 0.5-50 wt.% of an active cross-linking agent; and wherein upon admixture of the first flowable composition with the second flowable composition the cross-linking agent initiates the formation of a solid or semi-solid ionically cross-linked alginate gel
Implementation Method 2
The inventors have unexpectedly discovered that the presence of a substantial amount of polyol in the second flowable composition favourably affects the cross-linking reaction between the cross-linking agent and the alginate. More particularly, it was found that the polyol acts as a temporary sequestrant of the multivalent cation delaying gelation until after the mixed composition has been expelled from the device
Data Source
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AI summary
The present invention relates to a dispensing system that can be used to introduce a gel-forming fluid into or onto the body that will produce a homogeneous gel in situ. The system according to the present invention comprises: a first reservoir comprising a first flowable composition in the form of an aqueous solution of ionically cross-linkable alginate; a second reservoir comprising a second flowable composition, said second flowable composition containing one or more polyols; a first outlet from the first reservoir; a second outlet from the second reservoir, said first outlet and said second outlet being arranged in such a way that the first flowable composition is mixed with the second flowable composition when both compositions are simultaneously expelled from the respective reservoirs thereby forming the gel- forming fluid; wherein the first and/or second flowabel composition contains a cross- linking agent and upon admixture of the first flowable composition with the second flowable composition said cross-linking agent initiates the formation of a solid or semi-solid ionically cross- linked alginate gel. The presence of a substantial amount of polyol in the second flowable composition favourably affects the cross-linking reaction between the cross-linking agent and the alginate.