Aspiration device
Inventors
Brown, James Elliott • THOMSON, Blake • Xavier-Ferrucio, Juliana • Krause, Diane • Halene, Stephanie
Assignees
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Publication Number
US-12419619-B2
Publication Date
2025-09-23
Expiration Date
Abstract
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.
Core Innovation
The disclosed invention provides an intraosseous method for delivering a pharmacologic composition to mobilize and collect a concentration of stem cells. An aspiration device is inserted into bone marrow tissue, where at least one elongate member includes a lumen extending between a proximal opening and a distal opening. A stem cell mobilizing composition is administered through the distal opening of the at least one elongate member into a first location of the bone marrow tissue.
The method further relies on diffusing the administered stem cell mobilizing composition into a second location of the bone marrow tissue that is remote from the first location. This diffusion mobilizes stem cells such that the stem cells have an increased concentration at the second location compared to prior to the administration of the stem cell mobilizing composition. After a delay of between 30 seconds and 120 minutes from administration, a bone marrow tissue sample is collected from the second location containing mobilized stem cells.
A multi-lumen aspiration device configuration is also described, including an elongate member having a first lumen and a second lumen with separate distal end openings, enabling administration at one spatial location and collection at a remote location. The disclosed approach includes a defined performance expectation for the collected sample, in which the number of stem cells collected is at least 50% greater than compared to a theoretical number of stem cells collected without administering the stem cell mobilizing composition into the first location.
Claims Coverage
The provided excerpt contains three independent claims. Across these independent claims, the inventive features are organized around intraosseous delivery with remote diffusion-driven mobilization, time-delayed collection, device lumen configurations, and quantitative collection outcomes versus a theoretical baseline.
Intraosseous diffusion-based mobilizing delivery and remote collection
An intraosseous method inserting an aspiration device into bone marrow tissue, administering a stem cell mobilizing composition through a distal opening into a first location, diffusing the composition into a second remote location to mobilize stem cells with increased concentration at the second location, and collecting a bone marrow tissue sample at the second location after a delay of between 30 seconds and 120 minutes.
Quantified stem cell concentration increase versus a theoretical baseline
The collected bone marrow tissue sample is obtained after the delay of between 30 seconds and 120 minutes, wherein a number of stem cells collected is at least 50% greater compared to a theoretical number of stem cells collected without the administration of the stem cell mobilizing composition into the first location.
Remote collection with separate distal openings in a multi-lumen aspiration device
An intraosseous method using an aspiration device with an elongate member having a first lumen and a second lumen, where the second lumen has a distal end opening separate from the distal end opening of the first lumen; administering the stem cell mobilizing composition through the distal opening of the first or second lumen into a first location, diffusing into a second remote location surrounding the distal opening not used for administration, and collecting the sample through the distal opening of the lumen not used for the administration.
The independent claims collectively cover intraosseous administration of a stem cell mobilizing composition into a first bone marrow location, diffusion to a remote second location for increased stem cell concentration, time-delayed collection from the remote location, and, in at least one independent claim, a multi-lumen device structure with spatially separate distal openings, together with a quantitative stem-cell improvement threshold versus a theoretical no-administration baseline.
Stated Advantages
Increased concentration of mobilized stem cells at the second location compared to prior to administration.
A number of stem cells collected at least 50% greater compared to a theoretical number without administering the stem cell mobilizing composition into the first location.
Documented Applications
Mobilizing and collecting a concentration of stem cells from bone marrow using an intraosseous method with diffusion to a remote location and time-delayed sample collection.
Intraosseous delivery and collection workflows for bone marrow tissue using aspiration device configurations that include lumen structures enabling administration at one location and collection at a remote location.
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