Method and apparatus for separating a material

• US 9,533,090 B2
• Filed: 11/21/2013
• Issued: 01/03/2017
• Est. Priority Date: 04/12/2010
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Chavarria, Jason, Leach, Michael D.
• Primary Examiner(s): CLEVELAND, TIMOTHY C
• Application Number:
  US14/086,482
• Publication Number:
  US 20140088492A1
• Time in Patent Office: 1,139 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3695 with sedimentation by gravity
• CPC Class Codes: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 21/262 by using a centrifuge
• CPC Class Codes: B01D 21/307 Passive control mechanisms without external energy, e.g. using a float
• CPC Class Codes: B01D 2221/10 Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues
• CPC Class Codes: B01L 3/5021 Test tubes specially adapted for centrifugation purposes centrifuges B04B5/04

Abstract

A separation system for separating a multiple component material into at least two fractions. The separation system includes a separation device having a first end, a second end opposite to the first end, and a sidewall that extends between the first end and the second end to define a separation chamber having an interior volume. The system also includes a valve moveable between an open position and a closed position, the valve is mounted at a fixed location within the separation chamber at a position that is closer to the second end than to the first end and is spaced apart from the second end, the valve is operable to isolate a first fraction of the multiple component material having a first density on a first side of the valve from a second fraction having a second density on a second side of the valve that is opposite to the first side.

Claims

1. A method for isolating at least two fractions of a multiple component material comprising:

loading the multiple component material into a separation chamber of a separation device between a valve mounted at a fixed position in the separation chamber and a first end of the device, the first end is opposite to a second end and a sidewall extends between the first end and the second end to define the separation chamber having an interior volume wherein the valve includes a screen, a valve activation member, and a seal, and wherein each of the screen, the valve activation member, and the seal define a through hole at an axial center thereof;

wherein the through hole is in fluid communication with apertures at an end of the valve activation member proximate to the second end; and

wherein an extraction tube is seated in the through hole and is connected to an extraction port of the separation device;

centrifuging the separation device such that the valve moves to an open position in response to gravitational forces exerted on the device to permit a first fraction of the multiple component material of a first density to pass through the valve toward the second end;

ceasing centrifugation of the separation device to permit the valve to move to a closed position, thus isolating the first fraction of the first density between the valve and the second end and isolating a second fraction of a second density that is less dense than the first density between the valve and the first end; and

withdrawing at least one of the first fraction and the second fraction from the separation chamber for use in a subsequent procedure.

2. The method of claim 1, further comprising wherein the multiple component material is adipose tissue, and loading the adipose tissue into the separation chamber to isolate the first fraction including cellular material, the second fraction including purified fat, and a third fraction including tumescent fluid;

incubating the separation device with the adipose tissue loaded therein for about five minutes at about 37°

C.; and

wherein the step of centrifuging the separation device is carried out at a speed of about 3,200 revolutions/minute for about fifteen minutes.

3. The method of claim 1, further comprising extracting the multiple component material from a patient and simultaneously loading the material directly into the separation device using a vacuum pump.

4. The method of claim 3, wherein extracting comprises inserting multiple cannulas into an area of the patient, wherein each cannula is fluidly connected to a suction tube, and the suction tubes are fluidly connected to the separation device with a branch connector, and activating the vacuum pump to draw the multiple component material form the patient, through each cannula, and into the separation chamber.

5. The method of claim 1, further comprising subjecting the multiple component material to disruption prior to loading the multiple component material into the separation chamber.

6. The method of claim 1, further comprising using a vacuum pump to load the multiple component material from a patient into a disruptor comprising a plunger and a screen and depressing the plunger to drive the multiple component material through the screen and into the separation chamber.

7. The method of claim 1, wherein centrifuging comprises spinning at a force of about 100×

g to about 1500×

g for about 5 minutes and increasing the force to about 1500×

g to about 3000×

g for about an additional 12-15 minutes.

8. The method of claim of claim 1, further comprising adding an anticoagulant to the multiple component material within the separation chamber.

9. The method of claim 1, further comprising wherein the second fraction of the multiple component material includes cells and wherein a cell yield can be increased by withdrawing the second fraction from the separation chamber, passing the second fraction through a disruptor, injecting the second fraction back into the separation device and repeating the steps of centrifuging, ceasing, and withdrawing.

10. The method of claim 1, wherein the method is performed in a sterile field.

11. A method for isolating at least two fractions from adipose tissue comprising:

loading the adipose tissue into a separation chamber of a separation device between a valve mounted at a fixed position in the separation chamber and a first end of the device, the first end is opposite to a second end and a sidewall extends between the first end and the second end to define the separation chamber having an interior volume, wherein the valve includes a screen, a valve activation member, and a seal, and wherein each of the screen, the valve activation member, and the seal define a through hole at an axial center thereof, wherein the through hole is in fluid communication with apertures at an end of the valve activation member proximate to the second end, and wherein an extraction tube is seated in the through hole and is connected to an extraction portion of the separation device;

centrifuging the separation device at about 1500×

g to about 3000×

g for about 15 minutes such that the valve moves to an open position in response to gravitational forces exerted on the device to permit a first dense fraction of the adipose tissue comprising cellular material to pass through the valve toward the second end;

ceasing centrifugation of the separation device to permit the valve to move to a closed position, thus isolating the first dense fraction between the valve and the second end and isolating a second less dense fraction comprising purified fat between the valve and the first end, wherein a tumescent fluid layer is isolated on both sides of the valve; and

withdrawing at least one of the cellular material and the purified fat from the separation chamber for use in a subsequent procedure.

12. The method of claim 11, further comprising adding citrate phosphate dextrose to the adipose tissue within the separation chamber and incubating at 37°

C. for about 5 minutes prior to centrifuging.

13. The method of claim 11, further comprising performing an initial centrifugation at about 100×

g to about 1500×

g for about 5 minutes to allow for initial separation of fat layers prior to increasing the g force to about 1500×

g to about 3000×

g.

14. The method of claim 11, further comprising loosening the interaction between materials of the adipose tissue by passing the adipose tissue through a disruptor prior to loading the adipose tissue into the separation chamber.

15. The method of claim 14, wherein the adipose tissue is drawn directly from the patient through a tube and into the disruptor by using a vacuum pump.

16. The method of claim 11, further comprising extracting the adipose tissue from a patient and simultaneously loading the adipose tissue directly into the separation device using a vacuum pump.

17. A method for isolating at least two fractions from adipose tissue comprising:

extracting adipose tissue from the patient and simultaneously loading the tissue directly into a separation device using a vacuum pump, wherein the adipose tissue is loaded into a separation chamber of the separation device between a valve mounted at a fixed position in the separation chamber and a first end of the device, the first end is opposite to a second end and a sidewall extends between the first end and the second end to define the separation chamber having an interior volume wherein the valve includes a screen, a valve activation member, and a seal, and wherein each of the screen, the valve activation member, and the seal define a through hole at an axial center thereof;

wherein the through hole is in fluid communication with apertures at an end of the valve activation member proximate to the second end; and

wherein an extraction tube is seated in the through hole and is connected to an extraction port of the separation device;

centrifuging the separation device such that the valve moves to an open position in response to gravitational forces exerted on the device to permit a first dense fraction of the adipose tissue comprising cellular material to pass through the valve toward the second end;

ceasing centrifugation of the separation device to permit the valve to move to a closed position, thus isolating the first dense fraction between the valve and the second end and isolating a second less dense fraction comprising purified fat between the valve and the first end, wherein a tumescent fluid layer is isolated on both sides of the valve;

withdrawing at least one of the cellular material and the purified fat from the separation chamber; and

administering the cellular material or the purified fat to the patient.

18. The method of claim 17, wherein centrifuging comprises spinning the separation device at about 1500×

g to about 3000×

g for about 15 minutes.

19. The method of claim 17, wherein the cellular material is administered to the patient to facilitate wound healing.

20. The method of claim 17, wherein the purified fat is administered to the patient during reconstructive or cosmetic surgery.