Multi-Lumen Aspiration Device for Higher Stem Cell Yield
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Solution Overview
Problem
Current bone marrow aspiration methods yield low numbers of mesenchymal stem cells, are plagued by hemodilution, and cause significant patient pain, limiting the effectiveness of stem cell therapies and increasing procedural costs.
Innovation Solution
An aspiration device with a unique design featuring multiple lumens and lateral openings that allows for concurrent infusion and aspiration, modulating pressure to enhance stem cell harvest and reduce pain, using pharmacological mobilization agents to increase cell yield.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If conventional single-lumen aspiration devices are used, then the device structure is simple, but stem cell yield is low and hemodilution occurs
Solution Approach 1:
The device is divided into multiple lumens (first lumen for infusion, second lumen for aspiration) that operate independently. This segmentation allows simultaneous infusion of pharmacological agents and aspiration of bone marrow, enabling pharmacological mobilization to increase stem cell yield while preventing hemodilution by separating the two functions into distinct pathways.
Solution Approach 2:
The first elongate member (infusion needle) is positioned within the lumen of the second elongate member (aspiration needle). This nested configuration allows both lumens to be delivered through a single access point into the bone marrow, achieving complex functionality while maintaining a compact delivery system.
2Productivity
If high vacuum suction is applied during aspiration, then aspiration speed is fast, but patient pain increases
Solution Approach 1:
Pharmacological mobilization agents are infused into the bone marrow before aspiration begins. This preliminary action mobilizes stem cells from the bone marrow niche into the vascular space, increasing their concentration in the aspirate and reducing the need for high-volume, high-vacuum aspiration, thereby reducing patient pain.
Solution Approach 2:
The device enables continuous infusion of pharmacological agents during the aspiration process. This continuous action maintains pharmacological mobilization throughout the procedure, ensuring steady stem cell release and allowing for lower vacuum settings to achieve adequate yield, thus reducing pain while maintaining productivity.
3Quantity of substance
If large volume aspiration is performed from a single position, then more cells are obtained, but hemodilution increases
Solution Approach 1:
By separating infusion and aspiration into different lumens, the device enables pharmacological agents to be delivered directly to the aspiration site. This segmentation allows for targeted mobilization of stem cells at the biopsy site, increasing local cell concentration and enabling smaller, more concentrated aspirates that reduce hemodilution.
Solution Approach 2:
Pharmacological mobilization agents serve as intermediaries that facilitate stem cell release from the bone marrow niche. These agents increase the proportion of stem cells in the aspirate by mobilizing them into the vascular space, thereby reducing the relative amount of peripheral blood contamination even when larger volumes are aspirated.
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 device significantly increases stem cell yield, reduces blood contamination, and decreases patient pain, improving the efficiency and safety of bone marrow and adipose tissue aspirations.
Implementation Method 1
administering a solution through a first elongate member having a lumen extending between a proximal opening and a distal opening to a first region of the biopsy site
Implementation Method 2
extracting an aspirate through a second elongate member having a lumen extending between a proximal opening and a distal opening from a second region adjacent to the first region of the biopsy site
Implementation Method 3
the distal tip of the at least one first elongate member forms a sealing engagement with the second elongate member between the distal tip opening and the at least one lateral opening of the second elongate member
Data Source
AI summary
The present invention provides improved devices for biopsy, aspiration, stem cell acquisition, and methods of using the same. The devices balance aspiration with concurrent infusion to manage changes in pressure at the site of biopsy. The present invention can be adapted for any biopsy, aspiration, or cell harvest procedure, including adipose tissue aspiration and bone marrow aspiration (BMA). In particular, the present invention limits patient pain, prevents blood contamination, and increases cell mobilization, such as improved stem cell yields with intraosseous (10) pharmacological mobilization of stem cells during a BMA procedure, and with improved stem cell yields using pharmacological mobilization of stem cells from fat. The pharmacological mobilization of cells allows the harvest of cells from a biopsy many fold larger than existing methods.