JP6034362B2 - Method and system for removing oxygen and carbon dioxide during erythrocyte blood processing using an inert carrier gas and manifold assembly - Google Patents

Description

  The present disclosure relates to a portable blood processing manifold assembly. More specifically, the present disclosure relates to portable blood processing for blood leukoreduction and oxygen and / or carbon dioxide depletion in preparation for blood storage and / or transfusion to a recipient. The present invention relates to a manifold assembly.

The supply of liquid blood is currently limited by storage systems used in conventional blood storage operations. Using current systems, the stored blood expires after being refrigerated for about 42 days at a temperature above the freezing point (ie, 1 ° C.-6 ° C.) as a packed blood cell product. Red blood cells (RBC) can separate and concentrate liquid blood components (plasma) from whole blood. Expired blood cannot be used and is discarded.
Blood is sometimes deficient due to blood donation fluctuations, emergencies and other factors. Blood supply and distribution logistics, especially in the army during battle, and remote hospitals or medical facilities, make blood processing or transfusion very difficult. Therefore, there is a need to be able to quickly prepare an RBC for storage or for remote blood transfusions.

Although storage of frozen blood is known in the art, such frozen blood has its limitations. Over the years, frozen blood has been used in blood banks and the military for specific high demand blood and rare blood group blood. However, frozen blood is difficult to handle. Frozen blood must be thawed and is not practical in an emergency. Once blood is thawed, it must be used within 24 hours. U.S. Patent No. 6,053,097 to Serebrennikov is directed to a method of storing blood at temperatures below 0 ° C.
U.S. Pat. Nos. 5,099,086 and Hamazaki et al. And U.S. Pat. Bitensky et al., US Pat. No. 6,057,049, Bitensky et al., US Pat. Bitensky et al., US Pat. No. 5,677,097 is directed to an additive solution for blood storage.
Additive solutions for blood storage and activation are known in the art. For example, Rejuvesol (available from enCyte Corp., Braintree, Mass.) Can be stored after cryopreservation (ie, 4 ° C.) immediately prior to transfusion or before freezing (ie, at −80 ° C. with glycerol) for long-term storage. Added to the blood. Hess et al., U.S. Patent No. 5,677,097 is directed to an additive solution for refrigerated storage of human erythrocytes.

US Pat. No. 6,413,713 U.S. Pat. No. 4,769,318 U.S. Pat. No. 4,880,786 US Pat. No. 5,624,794 US Pat. No. 6,162,396 US Pat. No. 5,476,764 US Pat. No. 5,789,151 US Pat. No. 6,447,987

  In view of current technology, there is a need for portable and cost-effective devices and methods for the preparation of RBCs that remove white blood cells and oxygen and / or carbon dioxide prior to transfusion or in preparation for anaerobic storage. The

Thus, the present disclosure provides a system that can remove oxygen and / or carbon dioxide and / or white blood cells from RBCs prior to transfusion or for further storage in an anaerobic environment.
The present disclosure also provides systems and methods for the preparation of RBCs for further storage prior to transfusion or in an anaerobic environment.

  A further object of the present disclosure is a stand-alone portable system that has an oxygen or oxygen / carbon dioxide removal (OCDD) device that removes oxygen or oxygen and / or carbon dioxide from an RBC that passes through the device. Is to provide. The OCDD device operates with a gas exchange system that pumps gas into the device through which the RCB first passes the oxygen or oxygen / carbon dioxide (OCDD) device, Remove oxygen or oxygen / carbon dioxide from RBC. The RBC is thereby freed of oxygen or oxygen / carbon dioxide and stored in a blood storage bag for long term storage or storage prior to transfusion.

  Yet another object of the present disclosure is to pump gas into a device through which an RBC passes a leukocyte reduction filter and an oxygen and / or carbon dioxide (OCDD) device, from which white blood cells and oxygen or oxygen. / To provide a stand-alone portable system that removes each carbon dioxide. The RBC is thereby free of leukocytes, oxygen or oxygen / carbon dioxide is removed and stored in a blood storage bag for long-term storage or storage prior to transfusion.

  Yet another object of the present disclosure is to circulate an oxygen or oxygen-conditioned air or inert gas mixture through the OCDD device and flow through this filter in preparation for anaerobic storage or transfusion. To provide a stand-alone portable system that removes such gases from the RBC. Such systems include oxygen, carbon dioxide and / or partial pressure sensors between an inlet manifold which receives oxygen and / or carbon dioxide rich air or inert gas from the OCDD device and an outlet manifold. The sensor monitors and adjusts the oxygen and / or carbon dioxide levels in the air or inert gas mixture received at the outlet manifold and monitors the oxygen and carbon dioxide partial pressures of the filtered gas that is pumped back to the OCDD device. To do.

  Yet another object of the present disclosure is to circulate an air or inert gas mixture that reduces leukocytes and regulates oxygen and / or carbon dioxide through an OCDD device in preparation for anaerobic storage or transfusion from the RBC. To provide a stand-alone portable system that removes such gases. Such a system includes an inlet manifold that receives an oxygen and / or carbon dioxide rich air or inert gas mixture from the OCDD device, and an outlet that provides the oxygen or carbon dioxide removed air or inert gas mixture back to the OCDD device. Between the manifold, oxygen, carbon dioxide and / or partial pressure sensors are included. The sensor monitors and adjusts the oxygen and / or carbon dioxide levels in the gas received at the outlet manifold and monitors the partial pressure of oxygen and carbon dioxide in the gas that is pumped back to the OCDD device.

  Treat red blood cell RBCs including a disposable blood collection set including a blood bag, an anaerobic storage bag, and oxygen and / or oxygen and carbon dioxide removal devices disposed between the blood collection bag and the anaerobic storage bag Portable assembly for doing. The portable assembly further comprises a gas circulation device in fluid communication with the oxygen or oxygen and carbon dioxide removal device. The gas circulation device includes a pressure source that can circulate flushing gas through the removal device as the RBC enters the anaerobic storage bag from the blood collection bag through the removal device.

  A portable assembly for processing red blood cells (RBCs) comprising an oxygen or oxygen and carbon dioxide removal (OCDD) device. The OCDD device includes a cartridge having an inlet and an outlet, and a plurality of hollow fibers disposed between the inlet and the outlet for transporting the RBC through the OCDD device. The plurality of hollow fibers are surrounded by a continuous space. The portable assembly includes a gas exchange device in fluid communication with the OCDD device. The gas exchange device includes a pressure source that can circulate flushing gas through the continuous space to remove oxygen and / or carbon dioxide from the RBC passing through the OCDD device.

  These and other objects and advantages of the present invention and equivalents thereof are achieved by the methods and configurations of the present invention as described herein and as set forth in the appended claims.

1 illustrates a portable blood processing system according to the present disclosure. Fig. 4 illustrates an alternative embodiment of the present disclosure in which red blood cells are processed using a load cell. Fig. 2 shows the OCDD device of the embodiment of Fig. Ib directly connected to the processing system. Fig. 2 shows a collection system incorporating a flow regulator according to the embodiment of Fig. Ib. Fig. 3 shows a collection system incorporating a leukocyte reduction filter in an OCDD device. FIG. 2 shows a leukocyte reduction filter incorporated into the OCDD device according to the embodiment of FIG. FIG. 2 shows a leukocyte reduction filter incorporated into the OCDD device according to the embodiment of FIG. FIG. 2 shows a leukocyte reduction filter incorporated into the OCDD device according to the embodiment of FIG. 2 shows the OCDD device of the embodiment of FIG. FIG. 6 illustrates an OCDD device according to a further embodiment of the present disclosure having an OCDD device, a leukocyte reduction filter, and a plasma separator in an integrated structure.

  Referring to FIG. 1, a stand-alone blood processing system is shown, which is referenced using reference numeral 10. The system 10 includes a housing 15 and supports a collection and removal system 100 (hereinafter “collection system 100”). The collection system 100 includes a blood bag 200, a leukocyte reduction filter 300, an oxygen and / or carbon dioxide removal (OCDD) device 400, and an anaerobic storage bag 600. The apparatus 400 can remove oxygen or oxygen and carbon dioxide from the RBS-derived gas. The collection system 100 is suspended within the system 10 so that the blood preparation process can be conveniently moved and transported to a location that may be remote from a normal hospital or clinical environment. The orientation of the system 100 allows the RBC in the blood bag 200 to flow to the anaerobic storage bag 600 under gravity. Although a single collection system 100 is illustrated, the stand 12 of the housing 15 can support as many as ten or more such systems for processing. The housing 15 includes a gas circulator, which is a pump 30 or a pressure source such as a vacuum or pressurized container, a valve / pressure regulator 40, and a gas circulates through the OCDD device 400. And further components to be described later. The inlet 410 and the outlet 415 (FIG. 2d) are connected to pipes 427 and 426, respectively.

Collection system 100 includes a blood bag 200 that contains RBCs collected from whole blood. In general, whole blood is collected from donors using conventional methods and processed using centrifugation to separate plasma and RBC. Blood bag 200 is a standard blood collection bag. The RBC is collected in a blood bag 200 that may contain additives. The additive solution, such as OFAS3, contains adenine, dextrose, mannitol, NaH ₂ PO ₄ , and optionally contains NaCl and / or NH ₄ Cl. The added solution OFAS3 is about 0.5-4.0 mmol / liter adenine, about 50-150 mmol / liter dextrose, about 20-70 mmol / liter mannitol, about 0-100 mmol / liter NaCl, about 2-20 mmol / l NaH ₂ PO _4, it is preferred to include components having of NH ₄ Cl range of about 0-30 mmol / l. Preferably, OFAS3 has a pH adjusted to about 5.5-7.5, about 2 mmol / L adenine, about 110 mmol / L dextrose, about 55 mmol / L NaCl, and about 12 Contains mmol / L NaH ₂ PO ₄ and a pH adjusted to about 6.5. Additives such as SAGM, PAGG-SM, AS-1, AS-3, AS-5, SOLX, MAPS, PAGG-GM, or any additive approved for blood storage should also be used in this system Can do.

  The RBC housed in the blood bag 200 reaches the leukocyte reduction filter 330 and flows through the OCDD device 400 under gravity. Leukocyte reduction is the process of removing white blood cells from whole blood or RBCs. Leukocytes in blood products can cause immunosuppressive effects, increase the risk of patients suffering from viruses, fever, and may have deleterious effects on RBCs. Leukocyte reduction reduces RBC storage damage, reduces primary allogeneic immunity, and reduces the total number of transfusion reactions.

  The RBC leukocyte reduction process is preferably performed after the RBC has been separated from the plasma and can be performed before or after removal of the oxygen and carbon dioxide removed from the RBC. In any case, the white blood cell reduction should be done before storing the RBC in the anaerobic storage bag 600.

  With reference to FIGS. 2 a, 2 b, and 2 c, the leukocyte reduction filter 300 is incorporated into the OCDD device 500. The OCDD device 500 includes a cartridge 505, an inlet 510, a leukocyte reduction filter 520, a plurality of hollow fibers 530, and a fiber support 540 for holding the plurality of hollow fibers 530. OCDD device 500 also includes an outlet 515 for RBC traffic. The leukocyte reduction filter 520 is preferably a fibrous or felt filter material that captures leukocytes before the leukocytes move through the plurality of hollow fibers 530. The fiber support 540 supports the plurality of hollow fibers 530 in a vertical configuration, and can be made of a material such as polyurethane or a similar material. Either whole blood or pRBC flows through filter 520 during the leukocyte reduction process. OCDD device 500 communicates with gas from pump 30 via inlet 524 and outlet 528.

The OCDD cartridge 500 contains approximately 5000 fibers for RBC traffic. A surface area sufficient to gas exchange to reduce the oxygen and / or carbon dioxide concentration to a desired level can be produced with more or fewer fibers. The plurality of hollow fibers 530 are for removing oxygen or oxygen and carbon dioxide from the RBC, which will be described later. A gas space 550 outside the hollow fiber and inside the cartridge 505 surrounds the plurality of hollow fibers 530 and is filled with a carrier gas. The gas permeable or porous material of the plurality of hollow fibers 530 allows oxygen and carbon dioxide to pass from the RBC to the carrier gas as the carrier gas circulates through the OCDD device 500. The OCDD apparatus 500 removes O ₂ and CO ₂ , or O ₂ , or CO ₂ alone, or O ₂ with a certain level of CO ₂ by supplying a flushing gas of an appropriate composition. Gases suitable for removal for use in an OCDD device are RBC or any inert gas that does not harm the recipient, such as Ar, He, N ₂ , Ar / CO ₂ , He / CO ₂ or N ₂ / CO ₂ .

  The RBC flows into the OCDD device 500 for removal of oxygen or oxygen and carbon dioxide. The OCDD device 500 reduces the RBC hemoglobin oxygen saturation level to less than 3% and reduces the carbon dioxide partial pressure to less than 50 torr at 37 ° C. The OCDD device 500 is a combined oxygen and carbon dioxide filter that removes oxygen and carbon dioxide from the RBC, extends the shelf life of the RBC, and facilitates optimal transfusion. The OCDD device 500 is used with the housing 115 and the stand 12 of FIG. 1e and includes the same components as the embodiment of FIG. 1a.

  Alternatively, as shown in FIG. 2d, the OCDD device 400 does not include a leukocyte reduction capability and is only capable of removing oxygen or oxygen and carbon dioxide from the passing RBC. FIG. 2d shows an OCDD device 400 having an inlet 410 for RBC entry, an outlet 415 for RBC traffic, and a plurality of fibers 430 through which the RBC passes to remove oxygen and / or carbon dioxide gas. Indicates. The OCDD device 400 also surrounds the inlet port 424 for the flushing gas, the outlet port 428 for the flushing gas to exit, and the plurality of fibers 430, inside the cartridge 405, and exchanges gas from the RBC to the flushing gas. And a plurality of spaces 450 in which. Gas circulation through the OCDD device 400 via the inlet port 424, outlet port 428, and the plurality of spaces 450 ensures that the partial pressure of oxygen and carbon dioxide in the RBC stored in the bag 600 is optimal for RBC storage. To ensure that it is at an acceptable level.

  Referring again to FIG. 1 a, the housing 15 includes an inlet manifold 20, a pump 30, an outlet manifold 60, and an inlet valve / pressure regulator 40. The OCDD cartridge 400 is connected to the inlet manifold 20 and the outlet manifold 60 by piping 27 and 13 or direct connections 128 and 124 (FIG. 1c), respectively. A first oxygen / carbon dioxide sensor 50 and a second oxygen / carbon dioxide sensor 90 are disposed between the inlet manifold 20 and the outlet manifold 60. System 10 can be connected to an AC outlet or other power source for operation of pump 30. Alternatively, the system 10 can be connected to a battery for remote operation of the system 10.

  The housing 15 includes a disposable or reusable sorbent cartridge 75 disposed between the inlet manifold 20 and the outlet manifold 60 for purifying air or inert gas that has passed through the OCDD device 400. The sorbent cartridge 75 is a large cartridge and is preferably an iron-based or other inorganic and / or organic compound that can physically or chemically absorb oxygen or oxygen / carbon dioxide. The sorbent cartridge 75 contains oxygen and / or carbon dioxide sorbent 76. As an alternative to large sorbent packs or organic and inorganic compounds, the use of membrane filters designed for gas separation, such as those found in nitrogen generation systems, can be used for air or oxygen rich in oxygen and carbon dioxide. Oxygen and carbon dioxide can also be removed from the active gas mixture. In addition to the oxygen or oxygen / carbon dioxide sorbent 76, the sorbent cartridge 75 also includes an activated carbon filter 78 that absorbs volatiles generated by the oxygen or oxygen / carbon dioxide sorbent. The activated carbon filter 78 also includes a HEPA filter for removing any particulates.

  System 10 also includes various sterilization filter and sensor assemblies 70, 80 and 85. The sterilizing filter and sensor assembly 70 is disposed between the piping 23 and the inlet manifold 20. The sterilizing filter and sensor assembly 80 is disposed between the outlet manifold 60 and the piping 27. Filters 70 and 80 capture any pathogens and / or particulates that may enter the gas flow between the respective piping and manifold and impair RBC filtration and / or purification. The filters in the 70 and 80 filter and sensor assemblies monitor the partial pressure levels of oxygen and carbon dioxide for each OCDD 400 (or 500). The sterilization filter and sensor assembly 85 is disposed between the outer portion of the housing 15 and the inlet valve pressure regulator 40. A sterile filter in the filter and sensor assembly 85 monitors the gas entering the pump 30. Filters in the filter and sensor assembly 85 capture pathogens and particulates between the system 10 and the ambient air or inert gas mixture and also sense oxygen, carbon dioxide levels, temperature and pressure, and humidity. It is also possible to do. Filter and sensor assemblies 70, 80 and 85 also function as sensors and communicate with controller 35. The controller 35 is programmed with predetermined setpoints and monitors and controls oxygen and carbon dioxide concentrations and flow rates, gas mixture temperature, humidity, and total pressure. If the level is not appropriate, a warning signal such as a light or alarm informs the operator that the sorbent cartridge, sterilization filter, or HEPA filter should be replaced.

  The housing 15 includes casters 25 that allow movement and positioning of the system 10. The system 10 also includes a large sorbent cartridge 75 or a hollow fiber gas separation module.

  In operation, as shown in FIG. 1, the RBC flows from the collection bag 200 into the OCDD cartridge, either directly or via a leukocyte reduction filter. Flushing gas is circulated through the OCDD cartridge 400 simultaneously. The oxygen or oxygen / carbon dioxide conditioned gas toward the OCDD cartridge 400 and the oxygen / carbon dioxide rich gas stream exiting the OCDD cartridge 400 are carried by tube 27 and tube 23, respectively. Tube 23 connects to inlet manifold 20 and tube 27 connects to outlet manifold 60. Tube 23 is connected to the inlet manifold by a sterilizing filter and sensor assembly 70. Similarly, the outlet manifold 60 is connected to the tube 27 by a sterilization filter 80.

  After the oxygen-enriched air or inert gas mixture exits OCDD device 400 via line 23, the air or inert gas mixture is received at inlet manifold 20 and pumped through pump 30. Pass through the sensor 50. Pump 30 operates to maintain gas flow through system 10. The pump 30 is preferably an electric pump that regulates pressure and flow. The pump 30 is connected to a valve 40, preferably a one-way valve, and a pressure regulator that accepts ambient air or an inert gas mixture at ambient pressure or an inert gas at high pressure. Sensors 50 and 90 measure the partial pressure of oxygen and carbon dioxide in addition to the partial pressure, temperature, flow rate, total pressure and humidity of the gas throughout the portable assembly. Air or inert gas is purified in the cartridge 75 and returned to the OCDD 400 to continue removing the RBC before the RBC enters the anaerobic storage bag 600.

  FIGS. 1 b to 1 d show an alternative embodiment of the housing 115. The housing 115 includes gas exchange components similar to the housing 15. That is, the housing 115 also includes an inlet manifold 20, a pump 30, an outlet manifold 60, and an inlet valve / pressure regulator 40 housed within the housing 115. The housing 115 also includes a load cell 6 connected to the bag 200 and a flow regulating valve 470. The load cell 6 measures the unit weight in the bag 200 and communicates the change in mass in the bag to the controller 35. The controller 35 communicates with the flow rate adjustment valve 470 to monitor the flow of the RBC passing through the OCDD device 400. To do. By monitoring the mass change of the RBC in the bag 200, the valve 470 can be adjusted to ensure that the RBC stays in the OCDD device 400 for proper oxygen or oxygen and carbon dioxide removal. . The controller 35 is in electrical communication with the load cell 6, the flow rate adjustment valve 470 and the oxygen saturation sensor 475. The oxygen saturation sensor 475 measures the oxygen saturation level in the RBC. The controller 35 receives a signal indicative of the oxygen saturation level and then transmits a signal to adjust the flow regulating valve 470 to ensure an appropriate oxygen removal level in the RBC. Several bags 200 (FIG. 1b) can be connected to the housing 115, which can likewise include a flow regulating valve 470, but only one flow regulator 470 is shown. The housing 115 has an outer surface to which the OCDD device 400 can be directly connected via a joint. By configuring the OCDD device 400 as shown in FIGS. 1b to 1d so that they are directly connected to the housing 115 via fittings 124 and 128, the piping of the embodiment of FIG. 1a is not necessary. . The configuration of the housing 115 can also be used with a device 500 that includes a leukocyte reduction capability.

  Referring to FIG. 3, the multi-function OCDD device 700 is a combination of a leukocyte reduction filter 710 and an OCDD device 720 combined with a plasma separator 730. The multi-function OCDD device 700 does not need to separate whole blood received from a donor, which is currently separated by using centrifugation. Combining these three devices into a single device eliminates the need for independent centrifugation, an expensive and cumbersome device. This embodiment includes a leukocyte reduction unit 710, an OCDD device 720, and a plasma separator 730. The plasma flows through port 740 to another collection bag for further processing. Thus, in this embodiment, whole blood can be collected from the donor, white blood cells can be removed, oxygen or oxygen and carbon dioxide can be removed, plasma and platelets can be removed and RBCs can be removed. The device can be passed through. The RBC is then stored in the collection bag 600 for storage or transfusion to the recipient. The collection system 100 and the multi-function OCDD 700 as part of the system 10 allows for rapid conversion of whole blood into stored RBCs for immediate storage or transfusion to the recipient.

While the invention will be described in detail with reference to specific embodiments, it will be understood that there are variations and modifications that fall within the scope of the disclosure and are known to those skilled in the art. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variations that fall within the scope of the disclosure as set forth in this disclosure.
Moreover, as a preferable configuration aspect, the present invention can also be configured as follows.
1. A portable system for processing red blood cells (RBC),
A disposable blood collection set comprising a blood bag, an anaerobic storage bag, and an oxygen and / or oxygen and carbon dioxide removal device disposed between the blood collection bag and the anaerobic storage bag;
A gas circulation device in fluid communication with the oxygen / oxygen and carbon dioxide removal device;
The gas circulation device includes a pressure source that can circulate flushing gas through the removal device when an RBC enters the anaerobic storage bag from the blood collection bag through the removal device. A portable system characterized by that.
2. The removing device includes a cartridge, a plurality of hollow fibers extending from an inlet to an outlet of the cartridge in the cartridge, and a continuous space surrounding the plurality of hollow fibers for passage of the flushing gas. The portable system according to 1 above.
3. The portable system of claim 2, wherein the plurality of hollow fibers comprise a gas permeable material or a porous material and are adapted to receive and transport red blood cells.
4). A housing that houses the gas circulation device, the housing including an inlet manifold for receiving flushing gas from the removal device; an outlet manifold for supplying flushing gas to the removal device; the pressure source; The portable system according to claim 1, further comprising a sorbent disposed between an outlet manifold and for removing oxygen and / or oxygen and carbon dioxide from the flushing gas.
5. A sensor disposed between the pressure source and the sorbent to detect the level of oxygen and / or carbon dioxide in the flushing gas in the OCDD, the sorbent and the outlet manifold; The portable system according to claim 4, further comprising a second sensor disposed between the two.
6). 2. The portable system according to 1 above, wherein the removing device further includes a leukocyte reduction filter.
7). The portable system according to claim 1, wherein the removing device further includes a leukocyte reduction filter and a plasma separator.
8). The portable system according to claim 1, further comprising a load cell connected to the collection bag, a flow control valve disposed between the removal device and the anaerobic storage bag, and a controller. .
9. The load cell measures the weight of the RBC in the collection bag, and the controller receives a signal indicating the weight of the RBC, transmits a signal to the flow control valve, and adjusts the flow control valve. 9. The portable system of claim 8, wherein the portable system restricts or facilitates the flow of RBC, thereby controlling exposure of the RBC to flushing gas in the removal device.
10. An oxygen saturation sensor disposed between the removal device and the flow control valve, wherein the controller receives a signal indicating an oxygen saturation level in the RBC and sends a signal to the flow control valve; 9. The portable system of claim 8, wherein the flow control valve is adjusted to limit or facilitate RBC flow, thereby controlling exposure of the RBC to flushing gas in the removal device.
11. The flushing gas comprises Ar, He, N ₂ , Ar / CO ₂ , He / CO ₂ or N ₂ / CO ₂ , or any combination of an inert gas and / or CO ₂ , The portable system according to 1.
12 The portable system of claim 1, further comprising a plurality of disposable blood collection sets connected to the housing and in fluid communication with the gas circulation device.
13. The portable system according to claim 1, wherein the pressure source is selected from the group consisting of a pump, a vacuum or a pressurized container.
14 A portable system for processing red blood cells (RBC),
The plurality of cartridges including a cartridge having an inlet and an outlet, and a plurality of hollow fibers disposed between the inlet and the outlet and for transporting RBC through an oxygen or oxygen and carbon dioxide removal (OCDD) device. An OCDD device in which hollow fibers are surrounded by a continuous space;
A gas circulation device in fluid communication with the OCDD device;
The gas circulation device includes a pressure source that can circulate a flushing gas through the continuous space to remove oxygen and / or carbon dioxide from the RBC passing through the OCDD device. system.
15. 15. The portable system of claim 14, further comprising a blood bag and an anaerobic storage bag, wherein the blood bag is connected to the inlet and the anaerobic storage bag is connected to the outlet.
16. 15. The portable system of claim 14, further comprising a housing having an outer surface, wherein the housing houses the gas circulation device and the removal device is directly coupled to the outer surface of the housing.
17. 14. The housing according to claim 14, further comprising a housing having an outer surface, wherein the housing houses the gas exchange device and a plurality of removing devices, and the plurality of removing devices are directly coupled to the outer surface of the housing. A portable assembly according to claim 1.
18. The load cell further includes a load cell, a flow regulating valve, and a controller, wherein the load cell measures a weight of the RBC in the blood bag, the controller receives a signal indicating the weight of the RBC, and sends a signal to the flow regulating valve. 15. The portable device of claim 14, wherein said flow regulating valve is adjusted to restrict or facilitate RBC flow, thereby reducing or increasing exposure of said RBC to flushing gas in said removal device System.
19. An oxygen saturation sensor disposed between the removal device and the flow control valve, wherein the controller receives a signal indicating an oxygen saturation level in the RBC and sends a signal to the flow control valve; 19. The portable system of claim 18, wherein the flow control valve is adjusted to limit or facilitate RBC flow to reduce or increase exposure of the RBC to flushing gas in the removal device.
20. The housing is disposed between an inlet manifold for receiving flushing gas from the removal device, an outlet manifold for supplying flushing gas to the removal device, the pressure source and the outlet manifold, and the flushing gas 18. The portable system according to claim 17, further comprising a sorbent for removing oxygen or oxygen and carbon dioxide from the water.
21. 21. The system of claim 20, further comprising system sensors on both sides of the sorbent for detecting levels of oxygen or oxygen and carbon dioxide in the flushing gas received and filtered in the sorbent. Portable system.
22. 15. The portable system as described in 14 above, wherein the removing device further includes a leukocyte reduction filter.
23. 15. The portable system as set forth in claim 14, wherein the removal device further includes a leukocyte reduction filter and a plasma separator.
24. A filter and sensor assembly disposed between the removal device and the inlet manifold, and the removal device and the outlet manifold for monitoring the level of gas parameters of gas flowing through the inlet and the outlet; 21. The portable system of claim 20, further comprising a filter and sensor assembly disposed between the two.
25. The filter and sensor assembly disposed between the removal device, the inlet manifold and the removal device, the filter and sensor assembly disposed between the removal device and the outlet manifold, and the system sensor 25. The portable system as described in 24 above, wherein the system measures oxygen partial pressure, carbon dioxide partial pressure, temperature, pressure, humidity, and gas flow rate of gas flowing through the system.
26. The flushing gas comprises Ar, He, N ₂ , Ar / CO ₂ , He / CO ₂ or N ₂ / CO ₂ , or any combination of an inert gas and / or CO ₂ , 14. The portable system according to 14.
27. 15. The portable system of claim 14, wherein the pressure source is selected from the group consisting of a pump, a vacuum or a pressurized container.

6: load cell 10: blood treatment system 12: stand 15, 115: housing 20: inlet manifold 23, 27: piping 25: caster 30: pump 35: controller 40: inlet valve / pressure regulator 50, 90: oxygen / carbon dioxide Sensor 60: Outlet manifold 70, 80, 85: Sterilization filter and sensor assembly 75: Sorbent cartridge 76: Sorptive material 78: Activated carbon filter 100: Blood collection and removal system 124, 128: Direct connection 200: Blood bag 300, 520, 710: Leukocyte reduction filter 400, 500, 720, 700: Oxygen or oxygen / carbon dioxide removal (OCDD) device 405, 505: Cartridge 410, 510: OCDD device inlet 415, 515: OCDD device outlet 424 524: Gas inlet port 428, 5 8: outlet port of the gas 430, 530: hollow fibers 450, 550: gas space 470: flow rate adjusting valve 475: the oxygen saturation sensor 540: fiber support 600: anaerobic storage bag 730: plasma separator

Claims (8)

A portable system for processing red blood cells (RBC),
A gas circulation device comprising a sterilizing flushing gas and arranged in fluid communication with one or more oxygen removal devices or oxygen and carbon dioxide removal devices;
The gas circulation device comprises a flushing gas source comprising flushing gases in fluid communication with each other;
A gas outlet manifold,
A first gas sterilization filter;
A second gas sterilization filter;
One or more sensor assemblies;
A gas inlet manifold,
A controller, and
The portable system wherein the at least one or more sensor assemblies are selected from the group consisting of an oxygen sensor, a carbon dioxide sensor, and combinations thereof , the sensor assembly comprising a partial pressure sensor .   A housing that houses the gas circulation device, the housing being disposed between the flushing gas source and the outlet manifold, for removing oxygen or oxygen and carbon dioxide from the flushing gas; The portable system according to claim 1, further comprising:   The one or more gas sensor assemblies include a first gas sensor assembly including a first partial pressure sensor disposed between the flushing gas source and the sorbent, the sorbent and the gas A second gas sensor assembly with a second partial pressure sensor disposed between the outlet manifold and the gas sensor assembly for detecting a level of oxygen or carbon dioxide in the flushing gas. Item 3. The portable system according to Item 2.   And further comprising one or more load cells and one or more flow regulating valves in communication with the controller, wherein the one or more flow regulating valves are the one or more oxygen removing devices or oxygen and carbon dioxide removing devices. The load cell is configured to control the flow of RBCs passing through the anaerobic storage bag, wherein the one or more load cells are configured to measure RBC loads collected in an anaerobic storage bag. Portable system.   The portable device according to claim 4, wherein the controller is responsive to signals from the one or more load cells to transmit a signal to the flow control valve to limit or facilitate RBC flow. system.   And further comprising an oxygen saturation sensor capable of measuring an oxygen saturation level in the RBC flowing through the one or more oxygen scavengers or oxygen and carbon dioxide scavengers and in communication with the controller, 5. A portable system according to claim 4, wherein a signal is sent to the flow regulating valve to limit or facilitate the flow of RBC. The flushing gas is Ar, He, N ₂ , CO ₂ , Ar / CO ₂ , He / CO ₂ , N ₂ / CO ₂ , any combination of inert gases, or any combination of inert gases and CO _2. The portable system according to claim 1, comprising:   The portable system of claim 1, wherein the flushing gas source is selected from the group consisting of a pump, a vacuum, and a pressurized container.

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