Granted Patent
B2
US 12,440,835 · App. 17/424,871 · Granted Oct 14, 2025
Methods, systems and apparatus for separating components of a biological sample
Inventors:
Sanjay Batra (Doylestown, PA); Elizabeth G. Cellucci (Doylestown, PA); Justin Joseph Batra (Doylestown, PA); Jaya Krishna Rose Batra (Doylestown, PA)
B01L3/50215A61K35/16A61K35/19B01D17/0217B04B5/0414C12N5/0644B01L2200/026B01L2200/0652B01L2300/042B01L2300/046B01L2300/0832B01L2400/0409
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Abstract
Described herein are methods, systems and apparatus for separating components of a biological sample; as well as methods of using compositions prepared by same. In some embodiments, the present invention provides a method for separating components of a biological sample, the method comprising: introducing a biological sample having a plurality of components to a tube comprising: a lumen; a proximal end; a distal end; an interior wall; and an exterior wall; applying a force to said tube for a time sufficient to separate said plurality of components; and agitating said tube at an angle of from about 5° to about 60°.
Claims (23)
1. A method for:
increasing a number of platelets available for administration, in a post-centrifuged sample, to a patient, comprising:
centrifuging a collection tube containing a biological sample and a separation barrier; and
maintaining the collection tube at an angle of from about (−)15° to about 90°; and
agitating the collection tube at said angle and at a rate effective to create a thin layer of foam on top of said biological sample;
wherein the collection tube is agitated for at least five seconds; and
wherein the number of platelets available for administration to a patient is increased by at least 10% versus the number of platelets available for administration to a patient provided by a control system.
2. The method according to claim 1 , wherein the collection tube further comprises an anticoagulant selected from: a citrate salt; an EDTA salt; citrate-theophylline-adenosine-dipyridamole (CTAD); hirudin, benzylsulfonyl-d-Arg-Pro-4-amidinobenzylamide (BAPA); citric/citrate dextrose (ACD); heparin; an iodoacetate salt; an oxalate salt; a fluoride salt; and a combination of two or more thereof.
3. The method according to claim 1 , wherein the biological sample comprises a plurality of components.
4. The method according to claim 3 , wherein the centrifugation is performed at a force of from 500 g up to 4000 g for a time sufficient to separate the plurality of components in the biological sample.
5. The method according to claim 3 , wherein the separation barrier comprises a thixotropic gel and wherein the thixotropic gel forms a barrier between the plurality of components of the biological sample.
6. The method according to claim 5 , wherein the biological sample comprises a first component comprising a plasma fraction; and a second component comprising lymphocytes, monocytes and erythrocytes.
7. The method according to claim 6 , wherein the collection tube is agitated for a time sufficient to provide a plasma fraction having a hue angle, h, in the CIELAB system of from 310 to 350 degrees.
8. The method according to claim 6 , wherein, the centrifuging creates a plasma-gel interface between a surface of the thixotropic gel and a surface of the plasma fraction.
9. The method according to claim 8 , wherein the plasma-gel interface comprises platelets.
10. The method according to claim 9 , wherein the platelets in the plasma-gel interface are releasably bound to the thixotropic gel.
11. The method according to claim 10 , wherein the agitation releases platelets from the plasma-gel interface.
12. The method according to claim 1 , wherein the biological sample comprises whole blood.
13. The method according to claim 1 , wherein the foam layer has a thickness of from about one millimeter to about five millimeters.
14. The method according to claim 1 , wherein the agitation comprises a plurality of five second intervals of agitation.
15. The method according to claim 14 , wherein the agitation further comprises a break between five second intervals.
16. The method according to claim 1 , wherein the collection tube is agitated for from about ten seconds to about sixty seconds.
17. The method according to claim 1 , wherein the number of platelets available for administration to a patient are greater than 400,000 platelets/microliter.
Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED AT REEL: 058394 FRAME: 0269. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT .
Recorded Mar 31, 2022
From: ECLIPSE MEDCORP, LLC
To: VIAS PARTNERS, LLC
Reel/Frame 060351/0621 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Dec 15, 2021
From: ECLIPSE MEDCORP, LLC.
To: VIAS PARTNERS LLC
Reel/Frame 058394/0269 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 11, 2021
From: BATRA, JAYA KRISHNA ROSE; CELLUCCI, ELIZABETH G.; BATRA, SANJAY, PHD; BATRA, JUSTIN JOSEPH
To: ECLIPSE MEDCORP, LLC
Reel/Frame 058085/0581 →
Continuity (2)
Provisional Application
62794961
· Jan 21, 2019
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