Systems for autologous biological therapeutics

• US 9,164,079 B2
• Filed: 03/15/2012
• Issued: 10/20/2015
• Est. Priority Date: 03/17/2011
• Status: Active Grant

• Current Assignee: David Karli
• Original Assignee: Greyledge Technologies, LLC
• Inventors: Karli, David, Bombard, David L.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): WHATLEY, BENJAMIN R
• Application Number:
  US13/421,728
• Publication Number:
  US 20120237490A1
• Time in Patent Office: 1,314 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 35/16 Blood plasma; Blood serum umbilical cord blood A61K35/51
• CPC Class Codes: A61K 35/19 Platelets; Megacaryocytes
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61M 1/382 Optimisation of blood component yield
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C12M 33/10 by centrifugation centrifuges in general B04B; Cyclones cyclones in general B04C
• CPC Class Codes: C12M 41/36 of biomass, e.g. colony counters or by turbidity measurements electrooptical investigation of individual particles G01N15/14, flow cytometers G01N15/1404
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

This disclosure describes systems, methods, and apparatuses for forming concentrates of platelet-rich plasma or bone marrow cells having user-defined concentrations, concentration ranges, and/or volumes. Whole blood or bone marrow samples can be passed through one or two separation operations in which platelets or bone marrow cells are separated from red blood cells and concentrated in a plasma. During this separation and concentrating, a total number of platelets or bone marrow cells or a concentration of either is determined and then used to ascertain what volumes and concentrations need be mixed in order to produce a platelet-rich plasma concentrate or a bone marrow-rich plasma concentrate having a target concentration and/or volume.

Claims

1. An autologous cell concentrating system comprising:

a blood separation component having a blood sample input and having a centrifuge to separate the blood sample into a red blood cell fraction, and a plasma fraction, where the plasma fraction comprises a target cell-rich fraction and a target cell-poor fraction, the blood separation component having a volume of between 60 mL and no more than 250 mL, the blood sample being a whole blood sample or a bone marrow sample;

a first vessel for storing the target cell-poor fraction separated from the blood sample, the first vessel comprising a syringe opening;

a second vessel for storing the target cell-rich fraction separated from the blood sample, the second vessel comprising a syringe opening;

a measurement system that measures a total number of target cells in the cell concentrating system;

a processor comprising a concentration and flow logic and control component configured to determine a first volume of the target cell-poor fraction to mix with the target cell-rich fraction in order to form a target cell-rich concentrate having a concentration of target cells that is within a target concentration range for studying or defining a dose-response relationship in a patient, the concentration and flow logic and control component further configured to determine whether the target cell-rich concentrate has a concentration of target cells within the target concentration range;

a first valve controlled by the processor to remove the target cell-poor fraction to the first vessel and to remove the target cell-rich fraction to the second vessel; and

a mix component configured to form the target cell-rich concentrate by mixing the first volume of the target cell-poor fraction with the target cell-rich fraction, the mix component comprising a second valve controlled by the processor to transfer the first volume of the target cell-poor fraction from the first vessel to the second vessel containing the target cell-rich fraction;

wherein

the processor is configured to control the cell concentrating system to achieve a target concentration range of 1.0-1.5×

10⁶ target cells/μ

L.

2. The cell concentrating system of claim 1, wherein the measurement system comprises:

a concentration measurement component that measures a concentration of target cells in the cell concentrating system; and

a flow meter component that measures a second volume in which the concentration was measured.