Bone Marrow Cryopreservation With Volume-Specific Cooling Rates
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Solution Overview
Problem
The mainstream use of cadaveric bone marrow in clinical applications is hindered by the lack of a streamlined process for controlled extraction and preservation, particularly concerning the quality of viable cells like hematopoietic stem cells (HSCs) during cryopreservation.
Innovation Solution
A method involving controlled cooling rates for bone marrow samples, with specific volume adjustments and temperature exposure to maintain consistent post-thaw cell proliferation and viability rates, utilizing static and controlled-rate freezers for cryopreservation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If multiple syringes are used to extract sufficient marrow from the bone, then the quantity of bone marrow obtained is improved, but the risk of contamination increases
Solution Approach 1:
The patent combines multiple syringe functions into a single collection system. Multiple syringes are connected in series to a single collection bag, allowing marrow to be transferred through a controlled interface rather than requiring multiple separate connections to the sterile field. This merging approach maintains the quantity benefit while reducing contamination risk by minimizing breaches of sterile technique.
Solution Approach 2:
The collection bag acts as an intermediary between the extraction syringes and the final storage. Marrow is first drawn into syringes, then transferred to the collection bag through a controlled process. This intermediary step allows for centralized handling and reduces the need for repeated sterile field breaches, thereby maintaining quantity while reducing contamination risk.
2Adaptability or versatility
If whole bone marrow is obtained from deceased donors, then the availability of graft sources is improved, but the complexity of extraction and preservation processes increases
Solution Approach 1:
The preservation process is segmented into distinct phases: extraction phase, initial processing phase, and cryopreservation phase. Each phase has specific protocols and requirements. This segmentation allows the system to handle the complexity of deceased donor marrow by breaking it into manageable steps, thereby enabling broader graft source availability without overwhelming operational complexity.
Solution Approach 2:
The patent employs specific parameter changes to simplify the overall process. Controlled cooling rates (e.g., -1°C/min) and specific cryoprotectant concentrations are used to standardize the preservation process. These parameter specifications transform a complex variable process into a more predictable and manageable procedure, enabling wider use of deceased donor marrow.
3Reliability
If different cooling rates are applied to different volumes of bone marrow, then the cryopreservation quality is improved, but the process complexity increases
Solution Approach 1:
The patent applies local quality by tailoring cooling rates to specific volumes and container types. Different cooling rates are specified for different volume ranges (e.g., smaller volumes may require faster cooling). This localized approach improves cryopreservation quality for each specific batch while managing overall process complexity through standardized protocols for each volume category.
Solution Approach 2:
The patent establishes specific parameter ranges for different scenarios. Instead of requiring continuous optimization, discrete cooling rate parameters are specified for different volume categories. This parameter standardization improves reliability across batches while reducing the operational complexity of determining optimal rates for each case.
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
Ensures high post-thaw viability and proliferation rates of hematopoietic stem cells, enabling effective cryopreservation and long-term storage of bone marrow derived from deceased donors.
Implementation Method 1
cooling the first volume at a first cooling rate and cooling the second volume at a second cooling rate
Implementation Method 2
utilizing static and controlled-rate freezers for cryopreservation
Data Source
AI summary
Methods, systems, and compositions are provided for extracting bone marrow cells from bone obtained from deceased donors, for preparing the bone marrow for cryopreservation, and for obtaining desired cells from cryopreserved and fresh bone marrow