Cortical Bone Aperture and Cancellous Plug Flushing for MSC Harvesting
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Solution Overview
Problem
Conventional methods for harvesting and processing mesenchymal stem cells (MSCs) from bone marrow are inefficient, resulting in a less than desirable amount, type, or quality of cells or physiological fluid, and do not effectively address the need for minimally manipulated autologous cell treatments as per FDA guidelines.
Innovation Solution
A method and apparatus involving a Jamshidi-type needle and cannula with external threads for creating an aperture in the cortical bone, aspirating bone marrow material, and using a filtering apparatus to enhance MSC concentration, which includes lysing red blood cells and centrifuging the aspirated solution to separate and concentrate MSCs, ensuring compliance with FDA regulations for autologous treatments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional aspiration methods are used to harvest bone marrow, then the procedure is simple and quick, but the harvested MSC cell count and concentration are insufficient
Solution Approach 1:
The harvesting procedure is segmented into distinct phases: initial cortical bone penetration, cancellous bone plug extraction, and systematic flushing through multiple syringes. This segmentation allows each phase to be optimized independently, resulting in higher MSC yield without proportionally increasing overall complexity
Solution Approach 2:
The cortical bone is penetrated and a cancellous bone plug is extracted beforehand, creating a prepared pathway and reservoir before the main aspiration phase. This preliminary action facilitates more efficient MSC harvest during the subsequent flushing steps
2Quantity of substance
If multiple aspirations are performed to increase MSC yield, then the cell count improves, but the procedure time and patient discomfort increase
Solution Approach 1:
Instead of discontinuous multiple aspirations, the method employs continuous flushing action through sequential syringes, maintaining constant flow and pressure on the cancellous bone plug. This continuous action extracts MSC more efficiently in a single sustained procedure rather than multiple intermittent attempts
Solution Approach 2:
The approach shifts from repeated linear aspirations to a multi-dimensional flushing strategy using multiple syringes in sequence, applying pressure from different directions and angles to comprehensively extract MSC from the cancellous bone plug
3Quantity of substance
If extensive processing is applied to separate and concentrate MSC, then cell concentration improves, but the manipulation level increases beyond FDA minimal manipulation guidelines
Solution Approach 1:
The cancellous bone plug acts as an intermediary medium that naturally concentrates MSC during extraction. By flushing through this plug rather than directly aspirating marrow, the system achieves concentration without requiring complex external separation devices or procedures
Solution Approach 2:
The cancellous bone plug self-concentrates MSC through its structural properties during the flushing process. The plug's matrix naturally filters and concentrates the stem cells, eliminating the need for additional complex processing steps while maintaining minimal manipulation status
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 method significantly increases the harvested MSC cell count and concentration, maintaining their non-inflammatory phenotype, and allows for efficient reinjection or therapeutic use while adhering to FDA guidelines for minimally manipulated autologous cell treatments.
Implementation Method 1
inserting a Jamshidi-type needle and cannula with external threads for creating an aperture in the cortical bone
Implementation Method 2
centrifuging the aspirated solution to separate and concentrate MSCs
Implementation Method 3
lysing red blood cells
Data Source
AI summary
A mesenchymal stem cell harvesting system and method for increasing the efficiency of collecting and processing physiological fluids containing mesenchymal stem cells from a cavity within a patient's skeletal system. Microenvironments risk in MSC production and concentration within a cavity, for example the patient's ilium, are penetrated with a pointed instrument used to create an aperture in the hard cortical bone forming the cavity followed by the insertion of an aspiration device which extracts one or more samples of cancellous bone, bone marrow, bone marrow blood and other aspirated material. The aspirate is rinsed and may be filtered to remove unwanted material and to increase the concentration and purity of the mesenchymal stem cells in the aspirant far beyond levels formerly obtainable for use in autologous treatment of the patient.