Fluid separation devices, systems and/or methods using a fluid pressure driven and/or balanced approach

• US 6,736,768 B2
• Filed: 11/02/2001
• Issued: 05/18/2004
• Est. Priority Date: 11/02/2000
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Gambro, Inc. (DaVita Incorporated)
• Inventors: Hlavinka, Dennis J., Felt, Thomas J.
• Primary Examiner(s): Cooley, Charles E.
• Assistant Examiner(s): SORKIN, DAVID L
• Application Number:
  US10/008,989
• Publication Number:
  US 20020068675A1
• Time in Patent Office: 928 Days
• Field of Search: 494/37, 494/41, 494/42, 494/45, 494/60, 494/63, 494/67, 494/81, 494/84, 422/72, 210/781, 210/782, 210/787, 604/6-1-
• US Class Current: 494/60
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 1/38 Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: B04B 2005/045 having annular separation channels
• CPC Class Codes: B04B 2005/0464 with hollow or massive core in centrifuge bowl
• CPC Class Codes: B04B 2009/143 by weight compensation with liquids
• CPC Class Codes: B04B 5/0428 with flexible receptacles
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: B04B 7/08 Rotary bowls centrifugal casting machines B22D
• CPC Class Codes: B04B 9/08 Arrangement or disposition of transmission gearing for solid bowl screw centrifuges B04B1/2016; Couplings; Brakes

Abstract

A centrifugal separation device separates a composite fluid, such as blood, into the components thereof. The fluid is delivered to a fluid receiving area in a rotor from which area the fluid travels through a radial inlet channel having an inlet channel height to a proximal end of a circumferential fluid separation channel. Near a distal end of the separation channel, fluid components travel into distinct first and second outlet channels. The height of the first channel is greater than the height of the more distal second channel. The inlet channel height is greater than the height of the first channel. The rotor may be balanced by axially symmetrical sets of inlet channels, separation channels and outlet channels or by a balance channel connected to the separation channel but displaced from the outlet channels.

Claims

1. A centrifugation configuration for centrifugally separating a composite fluid into at least two of the component fluid parts thereof, said configuration being adapted to receive a composite fluid from a fluid source and adapted to provide for the delivery of at least one separated fluid component to a separated component fluid receiver, said configuration having an axis of rotation and comprising:

a separation layer having a fluid receiving area adjacent said axis of rotation, said fluid receiving area being adapted to be disposed in fluid communication with a composite fluid source, said separation layer also having;

a fluid inlet channel having an inlet channel height;

a circumferential fluid separation channel, said separation channel having a proximal end and a distal end; and

,

a first separated fluid outlet channel having a first height;

a second separated fluid outlet channel having a second height, said second outlet channel being adjacent said distal end of said separation channel and said first outlet channel being proximal from said second channel;

wherein said inlet channel is disposed in fluid communication with said fluid receiving area; and

wherein said circumferential separation channel is disposed in fluid communication with said fluid inlet channel adjacent said proximal end of said separation channel and with each of said separated fluid outlet channels; and

wherein at least one separated fluid outlet channels is also adapted to be disposed in fluid communication with a corresponding separated component fluid receiver; and

wherein said second height is less than said first height and said first height is less than said inlet channel height.

2. A centrifugal configuration according to claim 1 in which the relationship of the respective inlet and outlet positions of said inlet and said at least one separated fluid outlet channels to each other provides a fluid pressure imbalance.

3. A centrifugal configuration according to claim 1 in which the relationship of the respective inlet and outlet positions of said inlet and said at least one separated fluid outlet channels to each other provides a fluid pressure imbalance which provides fluid flow control by driving the flow of a composite fluid and at least one component thereof forward from the receiving area, respectively through the inlet, circumferential and at least one outlet channels.

4. A centrifugal configuration according to claim 1 in which the relationship of the respective inlet and outlet positions of said inlet and said at least one separated fluid outlet channels to each other provides a fluid pressure imbalance for respective fluids flowing through the respective inlet and at least one outlet channels, and is defined as:

5. A centrifugal configuration according to claim 1 wherein the inlet position of the inlet channel is designated as h₁ and,

wherein the outlet position of the first outlet channel is h₂, and the outlet position of the second outlet channel is h₃, and,

wherein g₁, g₂ and g₃ are centrifugal values, and,

ρ

₁ represents the density of the fluid in the fluid inlet channel, ρ

₂ represents the density of the fluid in the first outlet channel, and ρ

₃ represents the density of the fluid in the second outlet channel, and,

whereby these structural values are related to each other such that the inlet channel fluid dynamic pressure, ρ

₁g₁h₁, is greater than either of the two outlet fluid dynamic pressures, ρ

₂g₂h₂ and ρ

₃g₃h₃, as in;

6. A centrifugal configuration according to claim 5 wherein the ρ

gh values may be incrementally summed such that;

Σ

(ρ

gh)₁>

Σ

(ρ

gh)₂, or, Σ

(ρ

gh)₁>

Σ

(ρ

gh)₃.

7. A centrifugal configuration according to claim 5 wherein the ρ

values are different for each term in the relationship such that the first ρ

value, in ρ

₁g₁h₁, is the density of the inlet composite fluid to be separated, whereas, the second and third ρ

values, appearing in ρ

₂g₂h₂ and ρ

₃g₃h₃, represent the densities of respective first and second separated fluid components.

8. A centrifugal configuration according to claim 5 wherein the ρ

values are different for each term in the relationship such that

the first ρ

value, in ρ

₁g₁h₁, is the density of the inlet composite fluid to be separated,

whereas, the second and third ρ

values, appearing in ρ

₂g₂h₂ and ρ

₃g₃h₃, represent the densities of respective first and second separated fluid components, and

whereby ρ

₂g₂h₂ and ρ

₃g₃h₃ equalize with each other.

9. A centrifugal configuration according to claim 5 wherein the composite fluid to be separated is blood and the ρ

values are different for each term in the relationship such that the first ρ

value, in ρ

₁g₁h₁, is the density of a whale blood composite fluid, whereas, the second and third ρ

values, appearing in ρ

₂g₂h₂ and ρ

₃g₃h₃, represent the densities of respective separated blood components.

10. A centrifugal configuration according to claim 5 wherein the ρ

values are different for each term in the relationship such that the first ρ

value, in ρ

₁g₁h₁, is the density of the inlet composite fluid to be separated, whereas, the second and third ρ

values, appearing in ρ

₂g₂h₂ and ρ

₃g₃h₃, represent the densities of respective first and second separated fluid components; and

wherein the second ρ

value, in ρ

₂g₂h₂, includes first and second elements from the respective first and second separated fluid components, such that ρ

₂g₂h₂ is the sum of ρ

_1stcomponentg_1stcomponent(h₂-h_i) and ρ

_2ndcomponentg_2ndcomponenth_i;

wherein h_i is the height of the interface between the first and second separated fluid components.

11. A centrifugal configuration according to claim 10 wherein the composite fluid to be separated is blood and the ρ

values are different for each term in the relationship such that the first ρ

value, in ρ

₁g₁h₁, is the density of whole blood, whereas, the respective first and second separated fluid ρ

values, appearing in ρ

_1stcomponentg_1stcomponent(h₂-h_i) and ρ

_2ndcomponentg_2ndcomponenth_i;

represent the densities of the separated components, plasma and red blood cells (RBCs), respectively.

12. A centrifugal configuration according to claim 1

wherein the relationship of the respective first and second lengths of said first and second separated fluid outlet channels to each other provides a substantial fluid pressure balance for respective fluids flowing therethrough.

13. A centrifugal configuration according to claim 1

wherein the relationship of the respective first and second lengths of said first and second separated fluid outlet channels to each other provides a substantial fluid pressure balance for respective fluids flowing through the respective first and second outlet channels, and is defined such that it provides fluid flow control of the interface of separated fluid components within the circumferential separation channel.

14. A centrifugal configuration according to claim 1

wherein the relationship of the respective first and second lengths of said first and second separated fluid outlet channels to each other provides a substantial fluid pressure balance for respective fluids flowing through the respective first and second outlet channels, and is defined as:

15. A centrifugal configuration according to claim 14 wherein the ρ

gh values may be incrementally summed such that;

Σ

(ρ

gh)₂=Σ

(ρ

gh)₃.

16. A centrifugal configuration according to claim 14 in which the composite fluid to be separated is blood and the first and second separated components are plasma and red blood cells (RBCs), respectively.

17. A centrifugal configuration according to claim 14 in which the ρ

₂ value in the ρ

₂g₂h₂ term has two distinct components derived from a combination of separated fluid component terms such that ρ

₂g₂h₂ is the sum of ρ

_1stcomponentg_1stcomponent(h₂-h_i) and a ρ

_2ndcomponentg_2ndcomponenth₁;

whereby h₁ is the height of the interface between the first and second separated fluids, and,

18. A centrifugal configuration according to claim 14 in which the composite fluid to be separated is blood and the first and second separated components are plasma and red blood cells (RBCs);

and,

wherein the ρ

₂ value in the ρ

₃gh₂ term has two distinct components derived from a combination of separated fluid component terms, thus having a plasma and an RBC component such that ρ

₂g₂h₂ is the sum of ρ

_plasmag_plasma(h₂-h_i) and a ρ

_RBCg_RBCh_i portion;

wherein h_i is the height of the interface between the RBCs and the plasma, and,

19. A centrifugal configuration according to claim 14 wherein the inlet position of the inlet channel is designated as h₁ and wherein the first outlet position of the first outlet channel is h₂, and the second outlet position of the second outlet channel is h₃, wherein g₁, g₂ and g₃ are centrifugal values and ρ

₁ represents the density of the fluid in the fluid inlet channel, ρ

₂ represents the density of the fluid in the first outlet channel, and ρ

₃ represents the density of the fluid in the second outlet channel and these values are related to each other such that the inlet fluid dynamic pressure, ρ

₁g₁h₁, is greater than the either of the two outlet fluid dynamic pressures, ρ

₂g₂h₂ and ρ

₃g₃h₃, as in;

20. A centrifugal configuration according to claim 19 wherein the ρ

values are different for each term in the relationship such that the first ρ

value, in ρ

₁g₁h₁, is the density of the inlet composite fluid to be separated, whereas, the second and third ρ

values, appearing in ρ

₂g₂h₂ and ρ

₃g₃h₃, represent the densities of the respective first and second separated fluid components.

21. A centrifugal configuration according to claim 18 wherein the composite fluid to be separated is blood and the ρ

values are different for each term in the relationship such that the first ρ

value, in ρ

₁g₁h₁, is the density of whole blood, whereas, the second and third ρ

values, appearing in ρ

₂g₂h₂ and ρ

₃g₃h₃, represent the densities of the first and second separated components, plasma and red blood cells (RBCs).

22. A centrifugal configuration according to claim 1 in which the configuration further includes an outlet layer which is disposed in fluid communication with said outlet channels.

23. A centrifugal configuration according to claim 22 in which the outlet layer is disposed below the separation layer.

24. A centrifugal configuration according to claim 22 in which the outlet layer is disposed above the separation layer.

25. A centrifugal configuration according to claim 22 in which each of said first and a second outlet channels is disposed in discrete fluid communication with the outlet layer from the separation layer.

26. A centrifugal configuration according to claim 22 in which the outlet layer is a first outlet layer and in which the configuration further includes a second outlet layer;

and in which the first outlet channel is disposed in fluid communication with said first outlet layer and said second outlet channel is disposed in fluid communication with said second outlet layer.

27. A centrifugal configuration according to claim 26 in which the first outlet layer is disposed below the separation layer and the second outlet layer is disposed above the separation layer.

28. A centrifugal configuration according to claim 26 in which the first and second outlet layers are disposed below the separation layer.

29. A centrifugal configuration according to claim 26 in which the first and second outlet layers are disposed above the separation layer.

30. A centrifugal configuration according to claim 22 in which the outlet layer is disposed in fluid communication with at least one outlet conduit member which is adapted to be disposed in fluid communication with a storage container.

31. A centrifugal configuration according to claim 30 in which the at least one outlet channel includes a first and a second outlet channel and each of said first and a second outlet channels is disposed in discrete fluid communication with the outlet layer;

and wherein said at least one outlet conduit member includes first and second outlet conduit members each of which being in discrete fluid communication with the respective first and second outlet channels, and adapted to be disposed in fluid communication with respective first and second storage containers.

32. A centrifugal configuration according to claim 22 whereby said at least one separated fluid outlet channel is also adapted to be disposed in fluid communication with a corresponding separated component fluid receiver.

33. A centrifugal configuration according to claim 32 in which the configuration delivers the separated fluid component to said at least one separated fluid outlet channel such that the separated fluid component retains kinetic energy to flow to the corresponding separated component fluid receiver.

34. A centrifugal configuration according to claim 33 in which the configuration has a vortex pump configuration such that the kinetic energy is retained by action of the vortex pump configuration.

35. A centrifugal configuration according to claim 32 in which the configuration delivers the separated fluid component to said at least one separated fluid outlet channel by gravity drainage of the separated fluid component to the corresponding separated component fluid receiver.

36. A centrifugal configuration according to claim 1 in which the configuration further includes a second inlet channel having a second inlet channel height;

a second circumferential channel, said second circumferential channel having a proximal end and a distal end, a third outlet channel having a third height and a fourth outlet channel having a fourth height;

whereby said second inlet channel is disposed in fluid communication with said fluid receiving area; and

wherein said second circumferential channel is disposed in fluid communication with said second fluid inlet channel adjacent said proximal end of said circumferential channel and with said fourth outlet channel adjacent said distal end of said circumferential channel and with said third outlet channel proximal from said fourth outlet channel; and

wherein at least one of said third and fourth separated fluid outlet channels is also adapted to be disposed in fluid communication with a corresponding separated component fluid receiver; and

wherein said fourth height is less than said third height and said third height is less than said second inlet channel height.

37. A centrifugal configuration according to claim 36 in which the receiving area of said configuration further includes a septum which divides said receiving area into first and second parts, said first part being in fluid communication with the first inlet channel and the second part being in fluid communication with the second inlet channel.

38. A centrifugal configuration according to claim 36 in which the second inlet channel;

the second circumferential channel and the third and fourth outlet channels are disposed in said configuration so as to provide a weight balance to said configuration relative to said first inlet channel and the first circumferential channel and the first and second outlet channels.

39. A centrifugal configuration according to claim 38 in which the second inlet channel;

the second circumferential channel and the third and fourth outlet channels are disposed diametrically opposite said first inlet channel;

the first circumferential channel and the first and second outlet channels.

40. A centrifugal configuration according to claim 1 in which said configuration further includes a balance channel which is disposed in fluid communication with the circumferential channel, said balance channel being between said proximal end of said circumferential channel and said first channel and having a geometry that counterbalances said first and second outlet channels;

whereby said balance channel may provide a weight balance to said configuration relative to said inlet channel and the at least one outlet channel.

41. A centrifugal configuration according to claim 40 in which said balance channel is disposed in fluid communication with an outlet layer.

42. A centrifugal configuration according to claim 41 in which said balance channel is an outlet channel which provides for flow of a separated component fluid therethrough.

43. A centrifugal configuration according to claim 42 in which said circumferential channel is of a first width adjacent the inlet channel and is of a second wider width adjacent the balance channel.

44. A centrifugal configuration according to claim 42 in which said circumferential channel is of a first width adjacent the inlet channel and is of a second wider width at a substantially diametrically opposed portion of said circumferential channel.

45. A centrifugal configuration according to claim 1 in which the configuration further includes an interface wall extending radially outwardly into said circumferential channel between said first and second outlet channels.

46. A centrifugal configuration according to claim 1 in which the configuration is comprised within a rotor.

47. A centrifugal configuration according to claim 46 in which the rotor is comprised within a housing, said rotor and housing being a centrifuge unit.

48. A centrifugal configuration according to claim 46 in which the rotor is comprised within a housing, said rotor and housing being a disposable centrifuge unit.

49. A centrifugal configuration according to claim 46 in which the rotor is comprised within a housing, said rotor and housing being a centrifuge unit;

whereby said centrifuge unit has connected thereto at least one tubing line.

50. A centrifugal configuration according to claim 49 in which said centrifuge unit has connected thereto at least one outlet tubing line.

51. A centrifugal configuration according to claim 50 in which said outlet tubing line has connected thereto at least one storage container.

52. A centrifugal configuration according to claim 49 in which said centrifuge unit has connected thereto at least first and second outlet tubing line.

53. A centrifugal configuration according to claim 52 in which each said first and second outlet tubing lines has connected thereto respective first and second storage containers.

54. A centrifugal configuration according to claim 49 in which said centrifuge unit has connected thereto at least one inlet tubing line.

55. A centrifugal configuration according to claim 54 in which said inlet tubing line has connected thereto at least one access device.

56. A centrifugal separation system for use in a fluid separation system to centrifugally separate a composite fluid into composite components thereof, said centrifugal separation device comprising:

a centrifugal drive motor base;

a centrifugal rotor housing which is adapted to be disposed in an operable rotor-driving position on said centrifugal drive motor base, said housing having a fluid inlet port and at least one fluid outlet port; and

,

a rotor disposed in a freely rotatable position within said housing, said rotor having a fluid receiving area which is disposed in fluid communication with the fluid inlet port of said rotor housing, said rotor also having a fluid inlet channel, said fluid inlet channel having a fluid inlet height, a circumferential fluid separation channel having a proximal end and a distal end and first and second separated fluid outlet channels, said first outlet channel having a first height and said second outlet channel having a second height, said second outlet channel being adjacent said distal end of said separation channel and said first channel being proximal from said second channel, wherein said inlet channel is disposed in fluid communication with said fluid receiving area and wherein said circumferential separation channel is disposed in fluid communication with said fluid inlet channel adjacent said proximal end of said fluid separation channel and with said first and second separated fluid outlet channels, at least one of said first and second separated fluid outlet channels also being disposed in fluid communication with said at least one fluid outlet port of said housing;

wherein said second height is less than said first height and said first height is less than said inlet channel height.

57. A centrifugal separation system according to claim 56 in which the centrifugal drive motor base produces a rotating magnetic field, and wherein said rotor contains a magnetically reactive material which is adapted to rotate with the rotating magnetic field produced by said motor base, whereby said rotor is caused to rotate by the co-action of said magnetically reactive material and said rotating magnetic field.

58. A centrifugal separation device according to claim 56 in which the centrifugal drive motor base has a flat top surface, and the rotor housing has a flat bottomed surface, whereby the flat top surface of the drive motor base and the flat bottomed surface of the rotor housing co-act to provide the adaptation of the rotor housing to be disposed in operable rotor-driving position on said centrifugal drive motor base.

59. A centrifugation configuration for centrifugally separating a composite fluid into at least one of the component fluid parts thereof, said configuration being adapted to receive a composite fluid from a fluid source and adapted to provide for the delivery of at least one separated fluid component to a separated component fluid receiver, said configuration comprising:

a separation layer having a fluid receiving area which is adapted to be disposed in fluid communication with a composite fluid source, said separation layer also having;

a fluid inlet channel;

a circumferential fluid separation channel; and

at least one separated fluid outlet channel

wherein said inlet channel is disposed in fluid communication with said fluid receiving area; and

wherein said circumferential separation channel is disposed in fluid communication with said fluid inlet channel and with each of said at least one separated fluid outlet channel channels; and

wherein each of said at least one separated fluid outlet channels is also adapted to be disposed in fluid communication with a corresponding separated component fluid receiver;

whereby said fluid inlet and each of said at least one fluid outlet channels also have respective inlet and outlet positions such that said positions are related to each other so as to provide fluid flow control in said separation layer; and

a first outlet layer which is disposed in fluid communication with said at least one outlet channel and a second outlet layer; and

in which the least one outlet channel includes first and a second outlet channels;

whereby the first outlet channel is disposed in fluid communication with said first outlet layer and said second outlet channel is disposed in fluid communication with said second outlet layer, and in which the first outlet layer is disposed below the separation layer and the second outlet layer is disposed above the separation layer.