WO2013022491A1 - Procédé et système pour éliminer l'oxygène et le dioxyde de carbone pendant le traitement d'érythrocytes en utilisant un gaz vecteur inerte et ensemble de collecteur - Google Patents

Procédé et système pour éliminer l'oxygène et le dioxyde de carbone pendant le traitement d'érythrocytes en utilisant un gaz vecteur inerte et ensemble de collecteur Download PDF

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Publication number
WO2013022491A1
WO2013022491A1 PCT/US2012/030930 US2012030930W WO2013022491A1 WO 2013022491 A1 WO2013022491 A1 WO 2013022491A1 US 2012030930 W US2012030930 W US 2012030930W WO 2013022491 A1 WO2013022491 A1 WO 2013022491A1
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WO
WIPO (PCT)
Prior art keywords
oxygen
rbcs
portable system
gas
carbon dioxide
Prior art date
Application number
PCT/US2012/030930
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English (en)
Inventor
Paul Vernucci
Tatsuro Yoshida
Original Assignee
New Health Sciences, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by New Health Sciences, Inc. filed Critical New Health Sciences, Inc.
Priority to CN201280020712.9A priority Critical patent/CN103492041B/zh
Priority to EP12821624.9A priority patent/EP2691160A4/fr
Priority to CA2831465A priority patent/CA2831465C/fr
Priority to AU2012294890A priority patent/AU2012294890B2/en
Priority to JP2014502746A priority patent/JP6034362B2/ja
Publication of WO2013022491A1 publication Critical patent/WO2013022491A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A61M1/0218—Multiple bag systems for separating or storing blood components with filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0429—Red blood cells; Erythrocytes

Definitions

  • the present disclosure relates to a portable blood treatment manifold assembly.
  • the present disclosure relates to a portable blood treatment manifold assembly for leukoreduction and oxygen and/or carbon dioxide depletion of blood in preparation for blood storage and/or transfusion to a recipient.
  • Sasakawa et al. are directed to additive solutions for blood preservation and activation.
  • U.S. Patent No. 5,624,794 to Bitensky et al. U.S. Patent No. 6, 162,396 to Bitensky et al.
  • U.S. Patent No. 5,476,764 are directed to the storage of red blood cells under oxygen-depleted conditions.
  • U.S. Patent No. 5,789,151 to Bitensky et al is directed to blood storage additive solutions.
  • Additive solutions for blood preservation and activation are known in the art.
  • Rejuvesol available from enCyte Corp., Braintree, MA
  • enCyte Corp. a commercially available product
  • freezing i.e., at -80°C with glycerol
  • U.S. Patent No. 6,447,987 to Hess et al. is directed to additive solutions for the refrigerated storage of human red blood cells.
  • the present disclosure provides a system that is capable of removing oxygen and/or carbon dioxide and/or leukocytes from RBCs in advance of transfusion or for further storage in an anaerobic environment.
  • the present disclosure also provides for a system and methodology for the preparation of RBCs in advance of transfusion or for further storage in an anaerobic environment. It is a further object of the present disclosure to provide a stand-alone portable system that has an oxygen or an oxygen/carbon dioxide depletion (OCDD) device that removes oxygen or oxygen and or carbon dioxide from RBCs passing through the device.
  • OCDD device operates with a gas exchange system that pumps gas into the device through which RBCs that first passes through an oxygen or oxygen/carbon dioxide (OCDD) device to remove oxygen or oxygen/carbon dioxide from such RBCs.
  • the RBCs are thereby depleted of oxygen or oxygen/carbon dioxide and deposited in a blood storage bag for extended storage or storage in advance of transfusion.
  • the RBCs are thereby free of leukocytes and depleted of oxygen or oxygen/carbon dioxide and deposited in a blood storage bag for extended storage or storage in advance of transfusion.
  • Such system contains oxygen, carbon dioxide and/or partial pressure sensors between an inlet manifold that receives oxygen and/or carbon dioxide rich air or inert gas from an OCDD device and an outlet manifold. The sensors monitor and regulate oxygen and or carbon dioxide levels in air or inert gas mixtures received in the outlet manifold and monitor oxygen and carbon dioxide partial pressure of filtered gas that is pumped pumped back to OCDD device.
  • Such system contains oxygen, carbon dioxide and/or partial pressure sensors between an inlet manifold that receives oxygen and/or carbon dioxide rich air or inert gas mixtures from an OCDD device and an outlet manifold that feeds oxygen and carbon dioxide depleted air or inert gas mixtures back to the OCDD device.
  • the sensors monitor and regulate oxygen and or carbon dioxide levels in gas received in the outlet manifold and monitor oxygen and carbon dioxide partial pressure of gas that is pumped back to OCDD device.
  • a portable assembly for processing red blood cells RBCs including a disposable blood collection set including a blood bag, an anaerobic storage bag and an oxygen and/or oxygen and carbon dioxide depletion device disposed between the blood collection bag and anaerobic storage bag.
  • the portable assembly further provides for a gas circulation device in fluid communication with the oxygen or oxygen and carbon dioxide depletion device,
  • the gas circulation device includes a pressure source that is able circulate flushing gas through the depletion device as RBCs pass from the blood collection bag, through the depletion device and into the anaerobic storage bag.
  • a portable assembly for processing red blood cells (RBCs) including an oxygen or oxygen and carbon dioxide depletion (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 RBCs 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 is able to circulate a flushing gas through the continuous space and remove oxygen and/or carbon dioxide from RBCs passing through the OCDD device.
  • Fig. 1 a illustrates a portable blood processing system according to the present disclosure
  • Fig 1 b illustrates an alternative embodiment of the present disclosure in which red blood cells are processed using a load cell
  • Figure 1 c illustrates the OCDD device of the embodiment of Fig. 1 b directly connected to the processing system
  • Fig. 1d illustrates a collection system that incorporates a flow regulator according to the embodiment of Fig. 1 b;
  • Fig. 1e illustrates a collection system that incorporates a leukoreduction filter with an OCDD device
  • Figs. 2a through 2c illustrate a leukoreduction filter incorporated into an OCDD device according to the embodiment of Fig. 1 e;
  • Fig. 2d illustrates an OCDD device of the embodiment of Fig. 1 a;
  • Fig. 3 illustrates an OCDD device according to a further embodiment of the present disclosure having OCCD device, leukoreduction filter and plasma separation device in a unitary structure.
  • System 10 includes a housing 15 and supports a blood collection and depletion system 100 (hereinafter "collection system 100").
  • Collection system 100 includes a blood bag 200, a leukoreduction filter 300, an oxygen and/or carbon dioxide depletion (OCDD) device 400 and an anaerobic storage bag 600.
  • Device 400 is able to deplete oxygen or alternatively, oxygen and carbon dioxide from gas from RBCs.
  • Collection system 100 is suspended within system 10 to enable convenient movement and transport of blood preparation processes in locations that may be remote from a standard hospital or clinical setting. The orientation of system 100, permits RBCs in blood bag 200 to flow under the force of gravity to anaerobic storage bag 600.
  • stand 12 of housing 15 could carry as many as ten or more such systems for processing.
  • Housing 15 includes a gas circulation device including a pressure source such as a pump 30 or a vacuum or a pressurized container, a valve/pressure regulator 40 and further
  • Collection system 100 includes a blood bag 200 that contains RBCs that have been collected from whole blood. Generally, whole blood is collected from a donor using traditional methods and processed using centrifugation to separate plasma and RBCs. Blood bag 200 is a standard blood collection bag. RBCs are collected in a blood bag 200 that may contain an additive.
  • An additive solution such as, for example, OFAS3, includes adenine, dextrose, mannitol, NaH 2 P0 4 , and optionally NaCI and/or NH 4 CI.
  • Additive solution OFAS3 preferably comprises ingredients having the following ranges: about 0.5-4.0 mmole/liter of adenine, about 50-150 mmole/liter of dextrose, about 20-70 mmole/liter of mannitol, about 0-100 mmole/liter of NaCI, about 2-20 mmole/liter of NaH 2 P0 4 , and about 0-30 mmole/liter NH 4 CI.
  • OFAS3 has an adjusted pH from about 5.5-7.5 and includes about 2 mmole/liter adenine, about 1 10 mmole/liter dextrose, about 55 mmole/liter NaCI, and about 12 mmole/liter NaH 2 P0 4 and an adjusted pH of 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 may also be used in this system.
  • RBCs contained in blood bag 200 flow under the force of gravity to
  • Leukoreduction filter 300 and through OCDD device 400 Leukoreduction is the process of removing white blood cells from the whole blood or RBCs. Leukocytes in blood products can cause immunosuppressive effects and can pre-dispose patients to an increased risk of viruses, fevers, and have deleterious effects on RBCs.
  • Leukoreduction reduces RBC storage lesions, reduces primary alloimunization and reduces total number of transfusion reactions.
  • leukoreducing RBCs preferably occurs after the RBCs have been separated from the plasma and can occur before or after removal of oxygen and carbon dioxide have been removed from the RBCs. In either case, leukoreduction should occur before storage of RBCs and anaerobic storage bag 600.
  • OCDD device 500 includes a cartridge 505, an inlet 510, a leukoreduction filter 520, a plurality of hollow fibers 530, and a fiber support 540 to hold the plurality of hollow fibers 530.
  • OCDD device 500 also includes an outlet 515 for passage of RBCs.
  • Leukoreduction filter 520 is preferably a fibrous or a felt-like filtering material that captures leukocytes, prior to such leukocytes travelling through plurality of hollow fibers 530.
  • Fiber support 540 supports the plurality of hollow fibers 530 in a vertical configuration and may be made from a material such as polyurethane or a similar material. Either whole blood or pRBC flow through filter 520 during
  • OCDD device 500 is in communication with gas from pump 30 via an inlet 524 and an outlet 528.
  • OCDD cartridge 500 contains approximately 5000 fibers for the passage of RBCs. More or fewer fibers may be used to generate a sufficient surface area for gas exchange to reduce the oxygen and/or carbon dioxide concentrations to the desired levels.
  • Plurality of hollow fibers 530 are for the purpose of removing oxygen or oxygen and carbon dioxide from RBC and will be discussed further below.
  • Gas permeable material or porous materials of plurality of hollow fibers 530 enable oxygen and carbon dioxide to pass from RBCs to carrier gas when such gas is circulated through OCDD device 500.
  • OCDD device 500 depletes, 0 2 and C0 2 , or 0 2 , or C0 2 alone, or 0 2 with specific levels of C0 2 by supplying an appropriate composition of flushing gas.
  • Gases appropriate for depletion for use in OCDD devices are any inert gasses that will not cause harm to the RBCs or blood recipient, for example, Ar, He, N 2 , Ar/C0 2 , He/C0 2 or N 2 /C0 2 .
  • OCDD device 500 RBCs flow into OCDD device 500 to be depleted of oxygen or oxygen and carbon dioxide.
  • OCDD device 500 reduces the degree of RBC hemoglobin oxygen saturation levels to less than 3 % and the carbon dioxide partial pressure to less than 50 Torr at 37 °C.
  • OCDD device 500 is a combination oxygen and carbon dioxide filter that removes oxygen and carbon dioxide from RBCs to enhance the storage life of such RBCs and promotes optimal transfusion.
  • OCDD device 500 is used with housing 115 and stand 12 of Fig. 1e and contains same components as embodiment of Fig. 1 a.
  • an OCDD device 400 does not contain the leukoreduction capability and is only capable of depleting oxygen or oxygen and carbon dioxide from RBCs passing there through.
  • Fig. 2d illustrates an OCDD device 400 that has an inlet 410 for the entry of RBCs, an outlet 415 for the passage of RBCs, and a plurality of fibers 430 through which such RBCs pass to be deleted of oxygen and/Oor carbon dioxide gas.
  • OCDD device 400 also contains an entry port 424 for flushing gas and an exit port 428 for the egress of flushing gas and a plurality of spaces 450 that surround plurality of fibers 430 that are inside of cartridge 405 and where gas exchange from RBCs to flushing gas occurs.
  • the circulation of gas through OCDD device 400 via entry port 424, exit port 428 and plurality of spacees 450 ensures that the partial pressure of oxygen and carbon dioxide in RBCs stored in bags 600 is at acceptable levels for optimal storage of RBCs.
  • housing 15 includes an inlet manifold 20, a pump 30, an outlet manifold 60 and an inlet valve/pressure regulator 40.
  • OCDD cartridge 400 is connected to inlet manifold 20 and outlet manifold 60 by tubing 27 and 13 or direct connections 128 and 124 (Fig. 1 c) respectively.
  • a first oxygen/carbon dioxide sensor 50 and a second oxygen/carbon dioxide sensor 90 are disposed between inlet manifold 20 and outlet manifold 60.
  • System 10 is connectable to an AC outlet or other supply of power for operation of pump 30. Alternatively, system 10 can connect to a battery for remote operation of system 10.
  • Housing 15 contains a disposable or re-usable sorbent cartridge 75 that is disposed between inlet manifold 20 and outlet manifold 60 to purify and air or inert gas mixture that has passed through OCDD device 400.
  • Sorbent cartridge 75 is a large cartridge that is preferably iron based or other inorganic and/or organic compound that can physically or chemically absorb oxygen or oxygen/carbon dioxide.
  • Sorbent cartridge 75 contains an oxygen and/or a carbon dioxide sorbent 76.
  • oxygen and carbon dioxide can also be depleted from oxygen and carbon dioxide rich air or inert gas mixture by using membrane filters designed for gas separation, such as those found in nitrogen generator systems.
  • sorbent cartridge 75 also includes activated charcoal filter 78 to absorb volatiles produced by oxygen or oxygen/carbon dioxide sorbent.
  • Charcoal filter 78 also includes a HEPA filter to remove any particulates.
  • System 10 also includes various sterilization filter sensor assemblies 70, 80 and 85.
  • Sterilization filter sensor assembly 70 are dispose between tubing 23 and inlet manifold 20.
  • Sterilization filter sensor assembly 80 is disposed between outlet manifold 60 and tubing 27.
  • Filters 70 and 80 capture any pathogens and/or particulates that could enter gas flow between respective tubing and manifold and compromise filtration and or purification of RBCs.
  • Filters in 70 and 80 filter sensor assemblies monitor levels partial pressures of oxygen and carbon dioxide for an individual OCDD 400 (or 500).
  • Sterilization filter 85 is disposed between external portion of housing 15 and inlet valve pressure regulator 40. Sterlization filter filter sensor assembly 85 monitors gas entering pump 30.
  • Filter in filter sensor assembly 85 capture pathogens and particulates between system 10 and ambient air or inert gas mixture and are also able to sense levels of oxygen, carbon dioxide, temperature and pressure and humidity.
  • Filter sensor assemblies 70, 80 and 85 also function as sensors and are in communication with controller 35.
  • Controller 35 is programmed with predetermined set points to monitor and control concentration and flow ratre of oxygen and carbon dioxide, temperature, humidity and total pressure of the gas mixtures. Should levels not be appropriate, a warning signal, such as a light or alarm, informs an operator that sorbent cartridge, sterilization filter or HEPA filter should be replaced.
  • Housing 15 includes casters 25 to permit movement and positioning of system
  • System 10 also includes a large sorbent cartridge 75 or hollow fiber gas separation module.
  • RBCs flow from collection bag 200 into OCDD cartridge directly or via leukoreduction filter. Flushing gas is simultaneously circulated through OCDD cartridge 400.
  • the flow of oxygen or oxygen/carbon dioxide adjusted gas and oxygen/carbon dioxide rich gas to and from OCDD cartridge 400 is carried by tube 27 and tube 23, respectively.
  • Tube 23 is connected to inlet manifold 20 and tube 27 is connected to outlet manifold 60.
  • Tube 23 is connected to inlet manifold by a sterilization filter sensor assembly 70.
  • outlet manifold 60 is connected to tube 27 by sterilization filter 80.
  • Pump 30 operates to maintain gas flow through system 10.
  • Pump 30 is preferably an electrically driven pump that regulates pressures and flows.
  • Pump 30 is connected to a valve 40, preferably a one way valve and pressure regulator that accepts ambient air or inert gas mixture at ambient pressure or insert gasses at elevated pressures.
  • Sensor 50 and sensor 90 measure partial pressure of oxygen and carbon dioxide, in addition to gas partial pressure, temperature, flowrate total pressure and humidity of the entire portable assembly. Air or inert gas is purified in cartridge 75 and returned to OCDD 400 to continue to depletion RBCs before such RBCs flow into anaerobic storage bag 600.
  • housing 1 15 contains similar gas exchange components as housing 15. Namely, housing 1 15 also contains an inlet manifold 20, a pump 30, an outlet manifold 60 and an inlet valve/pressure regulator 40 contained within housing 115. Housing 1 15 also contains a load cell 6 that is connected to bag 200 and a flow regulator valve 470. Load cell 6 measures the unit weight in bag 200 and communicates change in mass in bag to a controller 35 that communicates with flow regulator valve 470 to monitor flow of RBCs through OCDD device 400. By monitoring change of mass of RBCs in bag 200, valve 470 can be adjusted to ensure that RBCs remain in OCDD device 400 for adequate oxygen or oxygen and carbon dioxide removal. Controller 35 is in electrical
  • Oxygen saturation sensor 475 measures oxygen saturation levels in RBCs.
  • Controller 35 receives signals indicative of oxygen saturation levels and in turn sends signal to adjust flow regulator valve 470 o assure adequate oxygen depletion levels in RBCs.
  • the several bags 200 (Fig. 1 b) can be connected to housing 1 15 and be similarly equipped with a flow regulator valve 470 although only one flow regulator 470 is shown.
  • Housing 1 15 has an outside surface to which OCCD devices 400 can be directly connected via couplings. By configuring OCDD devices 400, as shown in Figs. 1 b through 1 d, so that they are directly connected to housing 1 15 via couplings 124 and 128, the need for tubing of the embodiment of Fig. 1 a is eliminated.
  • the configuration of housing 1 15 can also be used with devices 500 that include leukoreduction capability. Referring to Fig.
  • a multifunction OCDD device 700 is a combination leukoreduction filter 710, OCDD device 720, in combination with a plasma separator 730.
  • Multifunction OCDD device 700 eliminates the need for separation of the whole blood, received from donor, which is currently a separated by using a centrifuge. By combining these three devices into a single device, the need for a separate centrifuge, a highly costly and cumbersome device, is eliminated.
  • This embodiment contains a leukreduction portion 710, a OCDD device 720 and a plasma separator 730. Plasma flows through port 740 to a further collection bag for further processing.
  • whole blood can be collected from a donor, leukocytes can be removed, oxygen, or oxygen and carbon dioxide can be removed and plasma and platelets can be removed to pass RBCs through device.
  • the RBCs are then deposited into collection bag 600 for storage or transfusion to a recipient.
  • Multifunction OCDD 700 as part of collection system 100 and system 10 permit rapid transformation of whole blood to stored RBCs for immediate storage or transfusion to a recipient.

Abstract

La présente invention concerne un ensemble portable pour traiter des érythrocytes RBC comprenant un ensemble de collecte de sang jetable comprenant une poche de sang, une poche de stockage anaérobie et un dispositif de déplétion d'oxygène et/ou d'oxygène et dioxyde de carbone disposé entre la poche de collecte de sang et la poche de stockage anaérobie. L'ensemble portable comprend en outre un dispositif de circulation de gaz en communication fluidique avec le dispositif de déplétion d'oxygène ou d'oxygène et de dioxyde de carbone. Le dispositif de circulation de gaz comprend une source de pression qui est capable de faire circuler du gaz de purge à travers le dispositif de déplétion tandis que les RBC passent de la poche de collecte de sang, à travers le dispositif de déplétion et dans la poche de stockage anaérobie.
PCT/US2012/030930 2011-03-28 2012-03-28 Procédé et système pour éliminer l'oxygène et le dioxyde de carbone pendant le traitement d'érythrocytes en utilisant un gaz vecteur inerte et ensemble de collecteur WO2013022491A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN201280020712.9A CN103492041B (zh) 2011-03-28 2012-03-28 用于在红细胞血液处理过程中使用惰性载气和歧管组件去除氧和二氧化碳的方法和系统
EP12821624.9A EP2691160A4 (fr) 2011-03-28 2012-03-28 Procédé et système pour éliminer l'oxygène et le dioxyde de carbone pendant le traitement d'érythrocytes en utilisant un gaz vecteur inerte et ensemble de collecteur
CA2831465A CA2831465C (fr) 2011-03-28 2012-03-28 Procede et systeme pour eliminer l'oxygene et le dioxyde de carbone pendant le traitement d'erythrocytes en utilisant un gaz vecteur inerte et ensemble de collecteur
AU2012294890A AU2012294890B2 (en) 2011-03-28 2012-03-28 Method and system for removing oxygen and carbon dioxide during red cell blood processing using an inert carrier gas and manifold assembly
JP2014502746A JP6034362B2 (ja) 2011-03-28 2012-03-28 不活性キャリアガス及びマニホルド組立体を用いて酸素及び二酸化炭素を赤血球血液処理中に除去するための方法及びシステム

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161468377P 2011-03-28 2011-03-28
US61/468,377 2011-03-28

Publications (1)

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WO2013022491A1 true WO2013022491A1 (fr) 2013-02-14

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EP (1) EP2691160A4 (fr)
JP (2) JP6034362B2 (fr)
CN (2) CN103492041B (fr)
AU (1) AU2012294890B2 (fr)
CA (1) CA2831465C (fr)
WO (1) WO2013022491A1 (fr)

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CN107096081A (zh) 2017-08-29
CA2831465C (fr) 2018-02-27
AU2012294890A1 (en) 2013-10-31
CN103492041B (zh) 2017-02-08
EP2691160A1 (fr) 2014-02-05
AU2012294890B2 (en) 2017-05-18
JP2014516285A (ja) 2014-07-10
JP6034362B2 (ja) 2016-11-30
EP2691160A4 (fr) 2015-04-08
JP2017074381A (ja) 2017-04-20
CN103492041A (zh) 2014-01-01
CN107096081B (zh) 2019-09-06
CA2831465A1 (fr) 2013-02-14

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