Fluid processing device

Abstract

The present invention relates to a system, apparatus, and method for separating components of a fluid, e.g. blood, which eliminates the need for expensive hardware and produces a stabilized waste product. The system comprises an apparatus or device (V) for separating components of a fluid (15) comprising a container (5) having at least one separation or filtration member (10) capable of selectively separating or filtering at least one component from the fluid, and a superabsorbent material (20) capable of absorbing the at least one component separated from the fluid, and thereby providing a processed fluid free or substantially free of said at least one component; and agitation means.

Claims

1. An apparatus for processing blood into a blood cell concentrate, the apparatus comprising: a permeable membrane defining, within it, an inner compartment, wherein the permeable membrane has an effective pore size of 0.2-8 m and is capable of allowing water, salts, and proteins to pass through the permeable membrane; a container comprising a substantially transparent portion, the container surrounding the permeable membrane and the inner compartment, the container defining an outer compartment between the permeable membrane and the container into which blood is initially received; an inlet in the container for introducing blood into the outer compartment of the container; an outlet in the outer compartment of the container distant from the inlet; and a valve or seal on the inlet and the outlet which permits and prevents selective entry and discharge of material to and from the outer compartment of the container and has a flow control system to prevent blood flow from escaping from the container; and a superabsorbent material surrounded by the permeable membrane, wherein the superabsorbent material expands as the superabsorbent material absorbs water, salts, and proteins removed from the blood which have passed through the permeable membrane, thereby leaving a blood cell concentrate in the outer compartment.

2. The apparatus of claim 1, wherein the apparatus is capable of reducing the volume of the blood by at least 20%.

3. The apparatus of claim 1, wherein the superabsorbent material is impregnated in a support material.

4. The apparatus of claim 3, wherein the support material impregnated with the superabsorbent material comprises a cellulosic material or a polyester material.

5. The apparatus of claim 1, wherein the container is in the form of a flexible pouch.

6. The apparatus of claim 1, wherein the permeable membrane is made from a polymeric material.

7. The apparatus of claim 1, wherein the superabsorbent material is made from a superabsorbent polymer.

8. A system for processing blood into a blood cell concentrate comprising: the apparatus of claim 1 and an agitation means.

9. The system of claim 8, wherein the agitation means comprises an orbital shaker.

10. A method for processing blood into a blood cell concentrate comprising: providing the apparatus of claim 1; introducing blood, containing water, salts, and proteins, via the inlet, into the container; passing the water, salts, and proteins through the permeable membrane into the inner compartment and leaving a blood cell concentrate in the outer compartment; absorbing the water, salts, and proteins in the superabsorbent material; and recovering the blood cell concentrate from the outer compartment via the outlet.

11. The method of claim 10 further comprising: agitating the apparatus.

12. The apparatus of claim 1, wherein the superabsorbent material precludes the requirement of external force to separate the water, salts, and proteins to be moved from the blood.

13. The apparatus of claim 1, wherein the inlet comprises a means for feeding fluid into the container.

14. The apparatus of claim 1, wherein the permeable membrane defines the shape and size of the container.

15. The apparatus of claim 1, wherein the transparent portion comprises a vertical strip.

16. The apparatus of claim 1, wherein the transparent portion comprises a means to measure the volume of blood in the apparatus.

17. The apparatus of claim 1, wherein the superabsorbent material forms a stable gel upon absorption of the water, salts, and proteins removed from the blood.

18. The apparatus of claim 1 further comprising: a covering portion.

19. The apparatus of claim 1 further comprising: a further processing means.

20. The apparatus of claim 19, wherein the further processing means is a filter.

21. The method of claim 10, wherein the flow control system provides a controlled rate at which the blood escapes from the container.

Description

BRIEF DESCRIPTION OF DRAWINGS

(1) Embodiments of the invention will now be given by way of example only, and with reference to the accompanying drawings, which are:

(2) FIG. 1(a) a cross-sectional view of a separation device according to a first embodiment of the present invention;

(3) FIG. 1(b) a cross-sectional view of the separation device of FIG. 1(a), the receiving portion of which is filled with a fluid to be processed;

(4) FIG. 1(c) a cross-sectional view of the separation device of FIG. 1(a) at or near the final stage of the separation process;

(5) FIG. 2(a) a cross-sectional front view of a separation device according to a second embodiment of the present invention;

(6) FIG. 2(b) a cross-sectional side view of the separation device of FIG. 2(a), the receiving portion of which is filled with a fluid to be processed;

(7) FIG. 2(c) a cross-sectional side view of the separation device of FIG. 2(a); at or near the final stage of the separation process; and

(8) FIG. 3 a graph representing the effect of agitation (using an orbital shaker) on the efficiency of the separation device of FIG. 2(a), when the processed fluid is blood.

DETAILED DESCRIPTION OF DRAWINGS

(9) Referring to FIGS. 1(a), 1(b) and 1(c) there is shown an apparatus or device for separating components of a fluid, generally designated 1, according to a first embodiment of the present invention. The separation device 1 comprises a container 5 which contains at least one separation or filtration member 10 capable of separating or filtering at least one component from the fluid 15, and a superabsorbent material 20 capable of removing the at least one component filtered through or separated by the member 10 disposed therein.

(10) Conveniently, the separation device is capable of reducing the volume of the fluid-to-be-processed by at least 20%, preferably at least 30%, more preferably at least 40%, and typically approximately 50-80%.

(11) In this embodiment, the filtration member 10 and the superabsorbent material 20 form two separate components.

(12) The container 5 comprises an inlet, first opening or first aperture 25, typically near a top portion thereof for introducing the fluid 15 into the container 5.

(13) The inlet, first opening or first aperture 25 is in communication with a receiving portion, compartment or cavity 30 located inside the device 1 and into which the fluid 15 to be processed is initially received, prior to the separation/filtration step.

(14) In use, the fluid 15 is provided into the receiving portion, compartment or cavity 30 of the device 1 through the inlet, first opening or first aperture 25.

(15) The volume and shape of the receiving portion, compartment or cavity 30 is at least partially defined by a first separation or filtration member 11.

(16) In this embodiment, the first member 11 is a rigid and/or self-supported member.

(17) The member 11 comprises a first side 12 facing toward the receiving portion, compartment or cavity 30 and a second side 13 facing in the opposite direction.

(18) In use, a fluid 15 fed into the receiving portion, compartment or cavity 30 of the device 1 comes into contact with a first side 12 of the member 11.

(19) The superabsorbent material 20 is in contact with a second side 13 of the member 11.

(20) In this embodiment, the second side 13 of the member 11 is in contact with a support material 21 impregnated with the superabsorbent material 20.

(21) In this embodiment, the superabsorbent material 20 is located between the second side 13 of the member 11 and an inside wall 6 of the container 5. By such provision, in use, the at least one component selectively separated or filtered from the fluid 15 migrates outwardly, with respect to the wall of the container 5, from the receiving portion, compartment or cavity 30 towards the superabsorbent material 20.

(22) In this embodiment, the device 1 comprises a substantially hollow portion 35 between the superabsorbent material 20 and the inside wall 6 of the container 5. By such provision the impregnated material 21 is allowed to expand or swell upon absorption of fluid comprising the at least one filtered component.

(23) In use, absorption by the superabsorbent material 20 draws a portion of fluid 15 comprising the at least one component through the separation or filtration member 10 whilst other components are retained in the receiving portion, compartment or cavity 30. By such provision the apparatus 1 does not require application of any external force to separate the at least one component from the fluid 15.

(24) The receiving portion, compartment or cavity 30 is in communication with an outlet, second opening or second aperture 40, typically near a bottom portion of the container 5, for removal of the processed fluid.

(25) The outlet, bottom opening or bottom aperture 40 is further equipped with a flow control system 45, e.g. a valve or a seal.

(26) In use, a processed fluid 16 may be retrieved or recovered from the receiving portion, compartment or cavity 30 of the device through the outlet, second opening or second aperture 40.

(27) Alternatively, the processed fluid 16 may be retrieved or recovered from the receiving portion, compartment or cavity 30 of the device 1 through the inlet, first opening or first aperture 25, e.g. by inverting the device.

(28) In this embodiment, the container 5 is in the form of a rigid cylinder.

(29) The container 5 is made from a polymeric material, e.g. medical grade polyvinyl chloride (PVC).

(30) The container 5 comprises a substantially transparent portion (not shown), e.g. a transparent vertical strip. By such provision the inside of the receiving portion, compartment or cavity 30 of the device 1 is visible by a user during use.

(31) The substantially transparent portion of the container 5 is provided with measuring means to indicate the level or volume of fluid present inside the receiving portion, compartment or cavity 30. By such provision, after filling the device 1 with a desired quantity of fluid 15, a user may be able to determine when a sufficient amount of the component-to-be-removed has been absorbed by the superabsorbent material 20.

(32) The at least one separation or filtration member 10 is a membrane 14, e.g. a semi-permeable porous filtration membrane.

(33) The membrane 14 is made from a polyolefin material, e.g. Celgard 2500 microporous polypropylene flat sheet membrane (0.2 m pore size) from Celgard LLC, 13800 South Lakes Dr, Charlotte, N.C. 28273, U.S., or another polymeric material such as nylon or a MicroPES polyethersulfone hydrophilic flat membrane (Type 4F toa, 5F M, or 6F) from Membrana GmbH, Oehder Strae 28, D-42289 Wuppertal, Germany.

(34) The permeability of the membrane 14 is chosen according to the type of fluid 15 to be processed and/or the specific components to be separated or removed from the fluid 15.

(35) For example, when using a Celgard 2500 membrane, an effective membrane pore size of 0.2 m will allow water, small salts and proteins to pass through the membrane.

(36) The superabsorbent material 20 is made from a superabsorbent polymer, e.g. Super Absorber (99%+ Cellulose Sodium Polyacrylate superabsorber) from Brightwake Ltd, Lowmoor Business Park, Kirkby-in-Ashfield, Nottinghamshire NG17 7JZ, UK.

(37) In this embodiment, the superabsorbent material 20 is in powder form.

(38) In use, the superabsorbent material 20 forms a stable gel upon absorption of a fluid, e.g. water.

(39) The at least one component separated from a fluid 15 is permanently removed from the fluid 15 and/or retained by the superabsorbent 20.

(40) The support material 21 impregnated with the superabsorbent material 20 comprises a cellulosic material or a polyester material, e.g. a cellulose tissue material or a polyester fibre material.

(41) In this embodiment, the polyacrylate superabsorbent material impregnated in a cellulosic fibrous material is in the form of a Brightwake wound dressing.

(42) The superabsorbent material 20 and/or the support material 21 may further comprise additives.

(43) Conveniently, the superabsorbent material 20 and/or the support material 21 are impregnated with stabilising agents, e.g. anti-microbial agents, to further stabilise the waste product for safe disposal.

(44) In this embodiment, the device 1 is a bodily fluid separation device, e.g. a blood separation device.

(45) Referring now to FIGS. 2(a), 2(b) and 2(c) there is shown an apparatus or device for separating components of a fluid, generally designated 1, according to a second embodiment of the present invention. In this embodiment the container 5 is in the form of a flexible bag or pouch.

(46) The separation device 1 comprises a container 5 which contains at least one separation or filtration member 10 capable of separating or filtering at least one component from a fluid 15, and a superabsorbent material 20 capable of removing the at least one component filtered through or separated by the member 10 disposed therein.

(47) Conveniently, the separation device is capable of reducing the volume of the fluid-to-be-processed by at least 20%, preferably at least 30%, more preferably at least 40%, and typically approximately 50-80%.

(48) In this embodiment, the filtration member 10 and the superabsorbent material 20 form two separate components.

(49) The container 5 comprises an inlet, first opening or first aperture 25, typically near a top portion thereof for introducing the fluid 15 into the container 5.

(50) The inlet, first opening or first aperture 25 is in communication with a receiving portion, compartment or cavity 30 located inside the device 1 and into which the fluid 15 to be processed is initially received, prior to the separation/filtration step.

(51) In use, the fluid 15 is provided into the receiving portion, compartment or cavity 30 of the device 1 through the inlet, first opening or first aperture 25.

(52) The volume and shape of the receiving portion, compartment or cavity 30 is at least partially defined by a first separation or filtration member 11.

(53) In this embodiment, the first member 11 is a self-supported member.

(54) The member 11 comprises a first side 12 facing toward the receiving portion, compartment or cavity 30 and a second side 13 facing in the opposite direction.

(55) In use, a fluid 15 fed into the receiving portion, compartment or cavity 30 of the device 1 comes into contact with a first side 12 of the member 11.

(56) The superabsorbent material 20 is in contact with or adjacent the second side 13 of the member 11.

(57) In this embodiment, the second side 13 of the member 11 is in contact with a support material 21 impregnated with the superabsorbent material 20.

(58) In this embodiment, the receiving portion, compartment or cavity 30 is provided between an inside wall 6 of the container 5 and a first side face of the at least one separation or filtration member 11. In such an arrangement, in use, the at least one component selectively separated or filtered from the fluid 15 migrates inwardly, with respect to the wall of the container 5, from the receiving portion, compartment or cavity 30 towards the superabsorbent material 20.

(59) The superabsorbent material 20 is provided or enclosed within a volume defined by the second side face 13 of the at least one separation or filtration member 11. By such provision the at least one separation or filtration member 11 and the superabsorbent material 20 define a pad-like assembly provided inside the container 5.

(60) In this embodiment, the member 11 comprises a substantially hollow portion 36 inside the volume defined by the second side face 13 of the member 11. By such provision the impregnated material 21 is allowed to expand or swell upon absorption of the at least one filtered component.

(61) Advantageously, the separation or filtration member 11 is attached to e.g., an inside wall 6 of the container.

(62) In use, absorption by the superabsorbent material 20 draws a portion of fluid 15 comprising the at least one component through the separation or filtration member 10 whilst other components are retained in the receiving portion, compartment or cavity 30. By such provision the apparatus 1 does not require application of any external force to separate the at least one component from the fluid 15.

(63) The receiving portion, compartment or cavity 30 is in communication with an outlet, second opening or second aperture 40, typically near a bottom portion of the container 5, for removal of the processed fluid.

(64) The outlet, bottom opening or bottom aperture 40 is further equipped with a flow control system 45, e.g. a valve or a seal.

(65) In use, a processed fluid 16 may be retrieved or recovered from the receiving portion, compartment or cavity 30 of the device through the outlet, second opening or second aperture 40.

(66) Alternatively, the processed fluid 16 may be retrieved or recovered from the receiving portion, compartment or cavity 30 of the device 1 through the inlet, first opening or first aperture 25, e.g. by inverting the device.

(67) In this embodiment, the container 5 is in the form of a flexible bag or pouch. By such provision the device is suitable for flat pack storage.

(68) The container 5 is made from a polymeric material, e.g. medical grade polyvinyl chloride (PVC).

(69) The container 5 comprises a substantially transparent portion (not shown), e.g. a transparent vertical strip. By such provision the inside of the receiving portion, compartment or cavity 30 of the device 1 is visible by a user during use.

(70) The substantially transparent portion of the container 5 is provided with measuring means to indicate the level or volume of fluid present inside the receiving portion, compartment or cavity 30. By such provision, after filling the device 1 with a desired quantity of fluid 15, a user may be able to determine when a sufficient amount of the component-to-be-removed has been absorbed by the superabsorbent material 20.

(71) The at least one separation or filtration member 10 is a membrane 14, e.g. a semi-permeable porous filtration membrane.

(72) The membrane 14 is made from a polyolefin material, e.g. Celgard 2500 microporous polypropylene flat sheet membrane (0.2 m pore size) from Celgard LLC, 13800 South Lakes Dr, Charlotte, N.C. 28273, U.S., or another polymeric material such as nylon or a MicroPES polyethersulfone hydrophilic flat membrane (Type 4F toa, 5F M, or 6F) from Membrana GmbH, Oehder Strae 28, D-42289 Wuppertal, Germany.

(73) The permeability of the membrane 14 is chosen according to the type of fluid 15 to be processed and/or the specific components to be separated or removed from the fluid 15.

(74) For example, when using a Celgard 2500 membrane, an effective membrane pore size of 0.2 m will allow water, small salts and proteins to pass through the membrane.

(75) The superabsorbent material 20 is made from a superabsorbent polymer, e.g. Super Absorber (99%+ Cellulose Sodium Polyacrylate superabsorber) from Brightwake Ltd, Lowmoor Business Park, Kirkby-in-Ashfield, Nottinghamshire NG17 7JZ, UK.

(76) In this embodiment, the superabsorbent material 20 is in powder form.

(77) In use, the superabsorbent material 20 forms a stable gel upon absorption of a fluid, e.g. water.

(78) The at least one component separated from a fluid 15 is permanently removed from the fluid 15 and/or retained by the superabsorbent 20.

(79) The support material 21 impregnated with the superabsorbent material 20 comprises a cellulosic material or a polyester material, e.g. a cellulose tissue material or a polyester fibre material.

(80) In this embodiment, the polyacrylate superabsorbent material impregnated in a cellulosic fibrous material is in the form of a Brightwake wound dressing.

(81) The superabsorbent material 20 and/or the support material 21 may further comprise additives.

(82) Conveniently, the superabsorbent material 20 and/or the support material 21 are impregnated with stabilising agents, e.g. anti-microbial agents, to further stabilise the waste product for safe disposal.

(83) The device 1 is provided with attaching means or holes 50 for attaching the device 1 to a static piece of surgical equipment, e.g. a stand or a bed, or to agitation means.

(84) In this embodiment, the device 1 is a bodily fluid separation device, e.g. a blood separation device.

(85) In use, a subject's bodily fluid may provided into the receiving portion 30 of the separation device 1, while the device 1 is provided on or attached to a static piece of surgical equipment such as a stand or a bed. When a desired amount of bodily fluid 15 is provided in the separation device 1, the inlet 25 is closed or sealed to prevent leakage, and the device 1 is transferred to agitation means to improve separation efficiency.

(86) Alternatively, the separation device 1 may be provided on or in said agitation means prior to its receiving portion 30 being filled with a subject's bodily fluid 15. By such provision agitation may be applied either simultaneous or subsequent to a subject's bodily fluid 15 being provided into the receiving portion 30 of the device 1.

(87) FIG. 3 shows the effect of agitation on the efficiency of a separation device according to the second embodiment of the present invention, when the processed fluid is blood. FIG. 3 illustrates the significant enhancement of the efficiency of the separation device when an orbital shaker is used in combination with the separation device. For example, FIG. 3 shows approximately a 2-fold increase in packed cell volume concentration after 30 minutes when an orbital shaker is used. It is believed that agitation prevents the larger blood particles from covering or aggregating on the surface of the filtration member, e.g. a semi-permeable membrane. Such effect can occur as the filtered component is drawn from the fluid and absorbed by or into the superabsorbent material through the filtration member. Agitation ensures, in use, homogeneous mixing of the fluid to-be-processed, e.g. blood, thus maintaining the efficiency of the filtering member by preventing covering of its surface by larger particles.

(88) It will be appreciated that the embodiments of the invention hereinbefore described are given by way of example only and are not meant to limit the scope thereof in any way.

(89) It will particularly be appreciated that while the fluid processed by the separation device of the disclosed embodiments consists of blood, the invention may be applied to process other fluids, e.g. other types of bodily fluids.