Fluid Path System for Hyperpolarized Material Dissolution
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Solution Overview
Problem
Current methodologies for dissolving frozen hyperpolarized materials in MRI and NMR spectroscopy face challenges such as incomplete dissolution, contamination risks, and the need for sterile handling, which complicates the transfer and injection of pharmaceutical products.
Innovation Solution
A fluid path system comprising a vial, a dissolution fluid path, and a delivery fluid path with integrated valves and a filter cartridge, along with a sliding seal unit, ensures rapid and complete dissolution of frozen hyperpolarized materials while maintaining sterility and controlling pH levels, using a heated dissolution medium and a cryogenic cooling system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the dissolution medium is pressurized and heated to dissolve the frozen sample, then the dissolution speed and completeness are improved, but the risk of contamination and loss of sterility increases
Solution Approach 1:
The system divides the dissolution process into separate functional zones: a first region for dissolving the frozen sample and a second region for sterile filtration and collection. This segmentation allows the dissolution medium to be heated and pressurized in the first region for rapid dissolution while maintaining sterility through controlled transitions and filtration in the second region, thereby resolving the contradiction between dissolution speed and contamination risk.
Solution Approach 2:
A sterile filter acts as an intermediary component between the dissolution region and the collection region. The filter allows the dissolved sample to pass through while blocking contaminants, enabling the system to achieve rapid dissolution through heating and pressurization while preventing contamination in the final injectable solution.
2Loss of time
If the dissolution medium flow rate is increased to improve dissolution completeness, then the dissolution time is reduced, but the risk of freezing before complete dissolution increases
Solution Approach 1:
The system employs dynamic control of the dissolution medium flow rate and temperature. The medium is heated to a controlled temperature and flow rate is adjusted to ensure complete dissolution of the frozen sample before transition to the collection region. This dynamic adjustment prevents freezing by maintaining sufficient thermal energy while optimizing dissolution speed, resolving the contradiction between time loss and reliability.
3Manufacturing precision
If the dissolution medium is heated to high temperature to ensure complete dissolution, then the dissolution completeness is improved, but the pH control precision deteriorates
Solution Approach 1:
The system applies different thermal conditions to different regions: the first region experiences high temperature for complete dissolution, while the second region maintains controlled temperature for sterile filtration and pH control. This local differentiation of thermal quality allows complete dissolution without compromising pH control precision in the final injectable solution.
4Object-affected harmful factors
If a sterile filter is integrated into the delivery path, then the sterility is maintained, but the device complexity increases
Solution Approach 1:
The sterile filter is merged with the delivery fluid path, combining the filtration function with the existing delivery structure. This integration minimizes additional components while maintaining sterility, resolving the contradiction between sterility maintenance and device complexity by incorporating the filter as an inherent part of the delivery system rather than a separate add-on.
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 effectively dissolves and transports hyperpolarized solutions, ensuring complete dissolution, maintaining sterility, and achieving the desired pH and concentration for injection, thereby improving the efficiency and safety of the pharmaceutical product delivery.
Implementation Method 1
a defined volume of dissolution medium containing sodium hydroxide, TRIS-buffer, and EDTA is pressurized with helium gas to a defined pressure in a titanium cylinder and heated to a defined temperature
Implementation Method 2
the cryogenically frozenhyperpolarized material is dissolved into a dissolution medium for injection into the patient
Implementation Method 3
a cryogenic cooling system to cool a material to behyperpolarized to a cryogenic temperature
Implementation Method 4
a superconducting magnet positioned about the cryogenic cooling system to create a magnetic field andhyperpolarize the material
Implementation Method 5
a filter cartridge integrated within the delivery fluid path to remove at least one of an electron paramagnetic agent (EPA) and a processing agent from thehyperpolarized solution
Data Source
AI summary
A fluid path system includes a vial containing a pharmaceutical product therein. A dissolution fluid path is also included in the fluid path system, the dissolution fluid path having an output end in fluid communication with the vial and an input end attached to a pressure vessel containing a dissolution medium. A delivery fluid path is also included in the system having a first end hermetically attached to the vial to transport therefrom a mixture of dissolved pharmaceutical product and dissolution medium and a second end connected to a receiving vessel to receive the mixture. A dissolution fluid path valve is positioned between the pressure vessel and the dissolution fluid path to control flow of the dissolution medium, and a delivery fluid path valve is also included in the fluid path system to control flow of the mixture from the delivery fluid path to the receiving vessel.