Granted Patent B2

US 12,636,661 · App. 18/333,852 · Granted May 26, 2026

Inventors: Michael Masters (Broomfield, CO); Christopher Centeno (Broomfield, CO); Matthew Murphy (Broomfield, CO); Matthew Cooksey (Broomfield, CO); Dustin Berger (Broomfield, CO); Neven Steinmetz (Broomfield, CO)

Assignee: REGENEXX, LLC

B04B5/0442A61M1/3693B01D21/262B04B7/04B04B11/06B04B2005/0485

Abstract

Claims (85)

1 . A fractionation device comprising:

a sidewall, the sidewall having a generally cylindrical profile;

a top wall connected to an upper portion of the sidewall;

a bottom wall connected to a lower portion of the sidewall;

an interior partition comprising:

a sloped portion contacting the sidewall; and

a vertical portion contacting the top wall;

an upper chamber defined within the fractionation device by the interior partition, the top wall, and the upper portion of the sidewall;

a lower chamber defined within the fractionation device by the interior partition, an upper plunger surface of a captive plunger engaged with the sidewall, and the lower portion of the sidewall;

a lower region of the upper chamber defined by the sloped portion of the interior partition adjacent to the sidewall;

a sloped indentation formed in the sidewall, the sloped indentation defining a side of the sloped portion and causing the sloped portion to become narrower toward the lower region; and

a threaded opening formed in and through the bottom wall.

2 . The fractionation device of claim 1 further comprising:

an input channel extending from the top wall to the lower chamber; and

an overflow window at least partially formed in the vertical portion of the interior partition and providing a fluid pathway between the input channel and the upper chamber, wherein the top wall defines an upper boundary of the overflow window.

3 . The fractionation device of claim 2 , wherein the input channel is defined in part by the vertical portion of the interior partition and the upper portion of the sidewall.

4 . The fractionation device of claim 3 further comprising:

one or more input channel indentations in the sidewall at the input channel to restrict a horizontal cross section of the input channel, wherein the one or more input channel indentations curve inward into the input channel toward the vertical portion.

5 . The fractionation device of claim 3 further comprising:

a plurality of ports extending through the top wall.

6 . The fractionation device of claim 5 further comprising:

a first port of the plurality of ports opening into the input channel; and

an indentation in the sidewall causing a portion of the sidewall to extend toward the vertical portion of the interior partition within the input channel and under the first port.

7 . The fractionation device of claim 6 further comprising:

a lipid layer collection tube extending from the first port toward the lower chamber and having a length configured to extract at least a portion of the lipid layer.

8 . The fractionation device of claim 7 further comprising:

a second port of the plurality of ports opening into the upper chamber adjacent to the vertical portion of the interior partition; and

a plasma layer collection tube extending from the second port to a position within the upper chamber and having a length configured to extract at least a portion of the plasma layer.

9 . The fractionation device of claim 8 further comprising:

a third port of the plurality of ports opening into the upper chamber adjacent to the sidewall and above the lower region of the upper chamber; and

a leukocyte and platelet layer collection tube extending from the third port to a position above the lower region of the upper chamber and having a length configured to extract at least a portion of the leukocyte and platelet layer.

10 . The fractionation device of claim 1 , wherein the lower region of the upper chamber defined by the sloped portion of the interior partition adjacent to the sidewall comprises a flat portion configured to collect a platelet rich pellet layer or a leukocyte and platelet rich pellet layer, wherein the flat portion is a narrowest region of the sloped portion.

11 . The fractionation device of claim 1 , wherein the sidewall is fabricated from an optically transparent material.

12 . The fractionation device of claim 1 further comprising:

a threaded rod having threads sized to engage with the threaded opening.

13 . A method of collecting a blood or bone marrow aspirate (BMA) fraction, the method comprising:

providing a fractionation device comprising:

a sidewall, the sidewall having a generally cylindrical profile;

a top wall connected to an upper portion of the sidewall;

a bottom wall connected to a lower portion of the sidewall;

an interior partition comprising:

a sloped portion contacting the sidewall; and

a vertical portion contacting the top wall;

an upper chamber defined within the fractionation device by the interior partition, the top wall, and the upper portion of the sidewall;

a lower chamber defined within the fractionation device by the interior partition, an upper plunger surface of a captive plunger engaged with the sidewall, and the lower portion of the sidewall;

a lower region of the upper chamber defined by the sloped portion of the interior partition adjacent to the sidewall;

a sloped indentation formed in the sidewall, the sloped indentation defining a side of the sloped portion and causing the sloped portion to become narrower toward the lower region; and

a threaded opening formed in and through the bottom wall;

obtaining blood or bone marrow aspirate (BMA) from a patient;

pretreating the blood or the BMA from the patient;

inserting the blood or the BMA into the lower chamber of the fractionation device;

centrifuging the fractionation device in a first centrifuge cycle to separate the blood or the BMA into different layers;

engaging a threaded rod with the threaded opening;

rotating the threaded rod within the threaded opening to cause the captive plunger to rise within the lower chamber of the fractionation device until a plasma layer overflows into the upper chamber of the fractionation device via an overflow window formed in the vertical portion of the interior partition and providing a fluid pathway between an input channel and the upper chamber; and

removing at least a portion of the plasma layer from the upper chamber of the fractionation device.

14 . The method of claim 13 , wherein the blood or the BMA is inserted into the fractionation device via the input channel extending from the top wall to the lower chamber.

15 . The method of claim 13 , wherein, when BMA is used, the threaded rod is first rotated to cause a lipid layer to rise to a lipid layer collection tube extending from a first port toward the lower chamber, wherein the first port opens into the input channel, the method further comprising:

removing at least a portion of the lipid layer via the lipid layer collection tube from the fractionation device.

16 . The method of claim 13 , further comprising:

after rotating the threaded rod within the threaded opening to cause the captive plunger to rise within the lower chamber of the fractionation device until the plasma layer overflows into the upper chamber of the fractionation device via the overflow window, further rotating the threaded rod so that a leukocyte and platelet rich amount of red blood cells enter the upper chamber;

after rotating the threaded rod so that a leukocyte and platelet rich amount of red blood cells enter the upper chamber, removing the threaded rod from the fractionation device and centrifuging the fractionation device in a second centrifuge cycle to separate the plasma layer and the leukocyte and platelet rich amount of red blood cells into one or more layers including a leukocyte and platelet rich pellet;

removing at least the portion of the plasma layer from the upper chamber; and

removing at least a portion of the leukocyte and platelet rich pellet from the upper chamber.

17 . The method of claim 16 , wherein at least the portion of the plasma layer is removed from the upper chamber of the fractionation device via a second port opening into the upper chamber adjacent to the vertical portion of the interior partition and via a plasma layer collection tube extending from the second port to a position within the upper chamber.

18 . The method of claim 17 , wherein at least the portion of the leukocyte and platelet rich pellet is removed via a third port opening into the upper chamber adjacent to the sidewall and above the lower region of the upper chamber via a leukocyte and platelet layer collection tube extending from the third port to a position above the lower region of the upper chamber.

19 . The method of claim 18 , wherein at least the portion of the leukocyte and platelet rich pellet is collected in the lower region of the upper chamber.

20 . The method of claim 19 , wherein the lower region of the upper chamber defined by the sloped portion of the interior partition adjacent to the sidewall comprises a flat portion configured to collect the leukocyte and platelet rich pellet, and wherein at least the portion of the leukocyte and platelet rich pellet that is collected in the lower region of the upper chamber is disposed over the flat portion of the sloped portion of the interior partition.

21 . The method of claim 16 , further comprising:

providing a counterweight configured to counterbalance the fractionation device and having a first center of gravity in a first orientation and a second center of gravity in a second orientation;

wherein, during the first centrifuge cycle, the counterweight is in the first orientation and, during the second centrifuge cycle, the counterweight is in the second orientation.

22 . A system comprising:

a fractionation device comprising:

a sidewall, the sidewall having a generally cylindrical profile;

a top wall connected to an upper portion of the sidewall;

a bottom wall connected to a lower portion of the sidewall;

an interior partition comprising:

a sloped portion contacting the sidewall; and

a vertical portion contacting the top wall;

an upper chamber defined within the fractionation device by the interior partition, the top wall, and the upper portion of the sidewall;

a lower chamber defined within the fractionation device by the interior partition, an upper plunger surface of a captive plunger engaged with the sidewall, and the lower portion of the sidewall;

a lower region of the upper chamber defined by the sloped portion of the interior partition adjacent to the sidewall;

a sloped indentation formed in the sidewall, the sloped indentation defining a side of the sloped portion and causing the sloped portion to become narrower toward the lower region; and

a threaded opening formed in and through the bottom wall;

a centrifuge configured to receive the fractionation device; and

a counterweight configured to be placed in the centrifuge opposite the fractionation device to counterbalance the fractionation device and having a first center of gravity in a first orientation and a second center of gravity in a second orientation.

Assignments (1)

Continuity (1)

References Cited (125)