Systems and methods for autologous biological therapeutics

• US 9,840,690 B2
• Filed: 09/08/2015
• Issued: 12/12/2017
• 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:
  US14/848,073
• Publication Number:
  US 20150376564A1
• Time in Patent Office: 826 Days
• 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

An autologous cell concentrating system and method are disclosed. The system has a blood separation component, a first vessel, a second vessel, a first valve, a second valve, and a concentration and flow logic and control component. The concentration and flow logic and control component is configured to: determine a first volume of a target cell-poor fraction in the first vessel to mix with a target cell-rich fraction in the second vessel in order to form a target cell-rich concentrate having a concentration of target cells that is within a target concentration range; and control the second valve to transfer the first volume of the target cell-rich fraction from the first vessel to the second vessel to form the target cell-rich concentrate. The target concentration range is between 1.0 and 1.5×106 target cells/μL.

Claims

1. A 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, the plasma fraction comprising a target cell-rich fraction and a target cell-poor fraction, the blood sample having a volume of between 60 mL and no more than 250 mL;

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

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

a first valve upstream of the first vessel and the second vessel, and downstream of the blood separation component;

a second valve for providing selective fluid communication between the first vessel and the second vessel;

a concentration and flow logic and control component comprising a concentration measurement component, a partial separation component, and a controller, the concentration measurement component comprising at least one of a fluorescent activated cell sorting component and an optical sensor, the partial separation component comprising a microfluidic channel device for separating particles within the blood sample and a light scattering device for measuring a number of particles in the blood sample, and the controller comprising a processor and memory configured to;

control the first valve to remove the target cell-poor fraction to the first vessel and to remove the target cell-rich fraction to the second vessel;

determine, via the controller, a first volume of the target cell-poor fraction in the first vessel to mix with the target cell-rich fraction in the second vessel 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, wherein the first volume is determined by the controller via information from a flow meter or from a calculation based upon a known concentration of the blood sample and a known volume of the blood sample that is in the memory of the controller;

determine, via the concentration measurement component, whether the target cell-rich concentrate has a concentration of target cells within the target concentration ranges wherein the concentration is determined by the controller via information from the flow meter and a hematology analyzer;

control, via the controller, the second valve to transfer the first volume of the target cell-poor cell rich fraction from the first vessel to the second vessel to form the target cell-rich concentrate; and

wherein the target concentration range is between 1.0 and 1.5×

10⁶ target cells/uL.

2. The cell concentrating system of claim 1, wherein the blood sample is a whole blood sample or a bone marrow sample.

3. The cell concentrating system of claim 1,

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

4. The cell concentrating system of claim 3, wherein the concentration measurement component measures a concentration of target cells in the target cell-rich fraction and the second volume is that of the target cell-rich fraction.

5. The cell concentrating system of claim 3, wherein the concentration measurement component is configured to perform a function selected from the group consisting of optical microscopy, optical light scattering, and electrical impedance.

6. The cell concentrating system of claim 1, wherein the target cells are selected from the group consisting of:

pluripotent cells, white blood cells, platelets, Neutrophils, Monocytes, Lymphoctyes, Eosinophils, and Basophils.