Method and apparatus for separating a material

• US 8,591,391 B2
• Filed: 04/12/2010
• Issued: 11/26/2013
• 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): Griffin, Walter D
• Assistant Examiner(s): CLEVELAND, TIMOTHY C
• Application Number:
  US12/758,127
• Publication Number:
  US 20110251041A1
• Time in Patent Office: 1,324 Days
• Field of Search: 494 1- 4, 494 16- 18, 494/36, 210/516, 210/518, 210/782, 210/789
• US Class Current: 494/4
• 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 apparatus for dental treatment A61C17/065
• 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 separation system for separating a multiple component material into at least two fractions comprising:

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; and

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,

wherein the valve includes a screen, a valve activation member, and a seal, 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.

2. The separation system of claim 1, further comprising a sump base having angled walls at the second end of the separation device, the valve is between the first end of the separation device and the sump base.

3. The separation system of claim 1, wherein the valve includes an insert having a conical surface that extends between the sidewall and a longitudinal axis of the separation chamber, the conical surface is angled downward toward the second end of the separation chamber.

4. The separation system of claim 1, wherein the screen defines openings that are one of circular and pie-shaped.

5. The separation system of claim 1, wherein the seal that is one of the following:

fastened to the activation member, integral with the activation member, and separate from the activation member.

6. The separation system of claim 5, wherein the valve activation member is movable between a closed position and an open position, in the closed position the valve activation member and the seal extend along a plane that is perpendicular to a longitudinal axis of the separation chamber and the seal contacts a grated portion of the valve to prevent the passage of material through the screen, in the open position the valve activation member and the seal are flexed toward the second end and the seal is spaced apart from the grated portion of the screen to permit the passage of material through the valve.

7. The separation system of claim 1, further comprising a disruptor and a vacuum pump in communication with the separation chamber.

8. The separation system of claim 1, wherein the multiple component material includes adipose tissue;

wherein the first fraction is isolated between the valve and the second end, the first fraction includes cellular material;

wherein the second fraction is isolated between the valve and the first end, the second fraction includes fat; and

wherein a third fraction is isolated between the valve and the first fraction and between the valve and the second fraction, the third fraction includes tumescent fluid.

9. A separation system for separating a multiple component material into at least two fractions comprising:

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; and

a valve mounted at a fixed positioned 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 includes;

a screen;

a flexible valve actuation member that is movable in response to gravitational forces applied to the separation device; and

a sealing member supported by the flexible valve actuation member;

wherein each of the screen, the flexible valve actuation member, and the sealing member 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;

wherein the flexible valve actuation member and the sealing member extend in a plane perpendicular to a longitudinal axis of the separation chamber and the sealing member contacts the screen to prevent the passage of materials through the screen when the valve is in a closed position; and

wherein the flexible valve actuation member and the sealing member bend toward the second end when the valve is in an open position in response to gravitational forces exerted upon the separation device such that the sealing member is spaced apart from the screen to permit the passage of material through the screen.

10. The separation system of claim 9, wherein 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, and the valve is operable to isolate a third fraction including tumescent fluid between the valve and the first fraction and between the valve and the second fraction.

11. The separation system of claim 9, further comprising a second extraction tube extending from a position that is proximate to a side of the valve facing the first end to a second extraction port of the separation chamber.

12. The separation system of claim 9, further comprising a disruptor and a vacuum pump in fluid communication with the separation chamber.

13. The separation system of claim 9, wherein, with adipose tissue present in the separation chamber, the valve moves to the open position when the device is spun to permit cellular material to pass through the valve;

and

wherein after the device is spun the valve moves to the closed position to isolate the cellular material between the valve and the second end, the cellular material can be withdrawn from the separation device for further use.

14. The separation system of claim 9, wherein the screen, the flexible valve, and the sealing member are aligned along a longitudinal axis of the separation chamber.

15. 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 each of the screen, the flexible valve actuation member, and the sealing member 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.

16. The method of claim 15, further comprising loading 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

centrifuging the device at a speed of about 3,200 revolutions/minute for about fifteen minutes.

17. The method of claim 15, further comprising extracting the multiple component material from a patient and simultaneously loading the material directly into the separation device using a vacuum pump.

18. The method of claim 15, further comprising subjecting the multiple component material to disruption prior to loading the multiple component material into the separation chamber.