WO2012122154A2 - Systèmes et dispositifs pour le stockage de globules rouges - Google Patents

Systèmes et dispositifs pour le stockage de globules rouges Download PDF

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Publication number
WO2012122154A2
WO2012122154A2 PCT/US2012/027840 US2012027840W WO2012122154A2 WO 2012122154 A2 WO2012122154 A2 WO 2012122154A2 US 2012027840 W US2012027840 W US 2012027840W WO 2012122154 A2 WO2012122154 A2 WO 2012122154A2
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WO
WIPO (PCT)
Prior art keywords
compartment
blood
solution
storage
structured
Prior art date
Application number
PCT/US2012/027840
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English (en)
Other versions
WO2012122154A3 (fr
Inventor
James C. Zimring
Original Assignee
Emory University
Children's Heatlhcare Of Atlanta, 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 Emory University, Children's Heatlhcare Of Atlanta, Inc. filed Critical Emory University
Publication of WO2012122154A2 publication Critical patent/WO2012122154A2/fr
Publication of WO2012122154A3 publication Critical patent/WO2012122154A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0236—Mechanical aspects
    • A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
    • 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
    • A61M1/0272—Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
    • 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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes

Definitions

  • RBCs red blood cells
  • All units of RBCs are stored prior to transfusion so as to allow screening for a variety of pathogens prior to infusion into recipients.
  • storage allows for planned procedures with large inventories and the ability to match RBCs to recipients so as to provide a safe and compatible transfusion.
  • the disclosure relates to a Nutrient-Waste-Dialysis (NWD) storage system.
  • the system is configured to allow ongoing introduction of nutrition and removal of waste from stored blood.
  • a system for red blood cell storage may include a blood compartment structured for collection and/or storage of donated blood, a solution compartment for storing a storage solution, and a dialysis membrane disposed between the blood compartment and the solution compartment.
  • the dialysis membrane may be structured to allow introduction of nutrition and removal of waste from stored blood.
  • the system may be structured to store a volume for the storage solution greater than a volume for the donated blood.
  • the storage solution compartment may be larger than the blood compartment.
  • the storage solution may be a nutrient storage solution.
  • the system may include a container divided into the blood compartment and the storage solution compartment.
  • the system may include a container for each of the compartments.
  • the system may include a plurality of containers, wherein one of the containers includes a storage solution compartment and a blood compartment.
  • the blood compartment and the solution compartment may be disposed within a single container.
  • the container may be a self-contained bag.
  • the system may further include a dialysis membrane disposed between the blood compartment and the solution compartment.
  • the dialysis membrane may have about a 3500 molecular weight cut-off.
  • the system may include a container having a plurality of blood compartments and storage solution compartments.
  • the system may include a container including plurality of blood compartments and a plurality of solution compartments.
  • the system may be a container having a blood compartment and a plurality of solution compartments.
  • the plurality of blood compartments may be for a single or multiple blood units.
  • the system may include at least three compartments, a first compartment being structured to store donated blood, a second compartment being structured to store and/or collect a storage solution, and a third compartment being structured to store one of a storage solution or donated blood; and at least one dialysis membrane disposed between the compartments.
  • the system may include a container for each compartment.
  • the system may include a container having a blood compartment connected to a container having a storage solution compartment.
  • the system may include a removable protective device that is structured to shield the dialysis membrane while the blood is collected from a donor.
  • the system may include at least one port structured to be in communication with one of the compartments.
  • the port may be a one-way valve.
  • the port may be a two-way valve.
  • the at least one port may be structured to be in fluid communication with the blood compartment.
  • the at least one port may be structured to receive the donated blood for storage in the blood compartment.
  • the at least one port may be structured to be in fluid communication with the solution compartment.
  • the system may include a plurality of ports, each port being structured to be in communication with each compartment.
  • the solution compartment may include the storage solution.
  • the solution compartment may be prepackaged with the storage solution.
  • the blood compartment may include a blood preservative.
  • the blood compartment may be disposed adjacent to the solution compartment. In other embodiments, the blood compartment may at least partially surround the solution compartment. In other embodiments, the solution compartment may at least partially surround the blood compartment.
  • each component of the system may be sterilized.
  • the system may be a single-use unit.
  • the system may be disposable.
  • the solution compartment may be prepackaged with a nutrient storage solution.
  • the blood compartment may be prepackaged with any known blood preservative.
  • the storage solution may include phosphate buffered saline, glucose and adenine.
  • the storage solution may further include amino acids, nucleic acids, vitamins, lipids, carbohydrates and others.
  • the storage solution may also include chemical anti-oxidants, metal chelators, and preservative chemicals may be added to the storage solution.
  • the storage solution may also include pathogen inactivation chemicals and any additional small molecule that may be beneficial for any issue regarding RBC storage.
  • the storage solution may also consist of lowering glucose to physiological concentrations as opposed to the superphysiological concentrations used in current solutions. Doing so would decrease damage to RBCs from hyperglycemic storage, in particular, advanced glycation endproducts (AGEs).
  • AGEs advanced glycation endproducts
  • Figure 1 illustrates an example of a system according to an embodiment.
  • Figure 2 show the system used to demonstrate the principles behind the operation of a system according to an embodiment.
  • Figure 3 shows the assessment of GFP + RBCs, of post-transfusion survival of blood used in the system of Figure 2, that were enumerated post-transfusion into wild-type mice.
  • Figures 4 show the results of the monitoring of post-transfusion survival of blood used in the system of Figure 2 at 4 hours.
  • Figure 5 show the results of the monitoring of post-transfusion survival of blood used in the system of Figure 2 over a 48 hour time course.
  • Figure 6 shows the microparticle analysis of RBCs, stored in the system of Figure 2, that were subject to flow cytometry prior to transfusion. GFP+ events were gated on to distinguish intact cells. TER119 + events were then plotted against FSC to distinguish intact RBCs from RBCs with decreased size, including erythroid microparticles.
  • the disclosed storage devices and systems are based upon the principles that the storage lesion is not the result of storing RBCs under the unnatural conditions of cold, citrate, dextrose and pH at an unphysiological pH.
  • the principles are based on the idea that RBC storage lesion is a natural result of simple starvation and failure to eliminate natural waste.
  • the RBCs When stored according to the current standard, in a bag of blood, the RBCs are given a limited supply of food (in this case glucose) and there is no mechanism at all to eliminate waste (in this case mostly lactate but also other waste products). Moreover, the storage solutions lack the necessary chemicals for the RBC to maintain internal molecules of essential function (i.e., the amino acids required for glutathione generation are absent). In the natural state, the liver and GI system will maintain equilibrium of nutrients in the blood, and the kidneys will efficiently eliminate waste. In a blood bag, nutrients are not supplied and waste is not removed. Although cold, stored RBCs are nevertheless living, and undergo active albeit slowed metabolism.
  • food in this case glucose
  • waste in this case mostly lactate but also other waste products.
  • the storage solutions lack the necessary chemicals for the RBC to maintain internal molecules of essential function (i.e., the amino acids required for glutathione generation are absent).
  • the liver and GI system will maintain equilibrium of nutrients in the blood, and the kidneys will efficiently eliminate waste.
  • the disclosed storage devices and systems are designed to mitigate or eliminate the storage lesion by providing ongoing nutrition and efficient waste removal.
  • the storage of RBC may be significantly improved because the systems and devices according to the disclosure expose the stored blood to additional fluid volume to allow additional nutrients and the removal of toxic waste products.
  • the systems and devices according to the disclosure use nutrient waste dialysis (NWD) storage to achieve these benefits.
  • NWD nutrient waste dialysis
  • the RBC storage devices and systems according to the disclosure may be structured to allow ongoing introduction of nutrition and removal of waste from stored blood.
  • the system may be structured so as not to alter the volume of blood that would be transfused from the current standard of care.
  • a device may include at least one compartment structured to collect and/or store the donated blood (hereinafter “blood compartment”) and at least one compartment structured to store a storage solution (hereinafter “solution compartment”).
  • the storage solution may be a nutrient storage solution.
  • the nutrient storage solution may be according to embodiments or may be a different nutrient storage solution.
  • the devices and systems may include more than two compartments. In some embodiments, the devices and systems may include three compartments, four compartments, five compartments, six compartments, etc. In some embodiments, there may be the same number of blood compartments and solution compartments. In other embodiments, there may be a different number of blood compartments and solution compartments. There may be more blood compartments than solution compartments. In other embodiments, there may be more solution compartments than blood compartments.
  • the solution compartment may the same size as the blood compartment. In other embodiments, the solution compartment and the blood compartment may be of different sizes. In some embodiments, the solution compartment may be larger than the blood compartment. In other embodiments, the solution compartment may be smaller than the blood compartment.
  • each compartment may be structured to directly receive donated blood or storage solution.
  • one, some, or all compartments may be structured to receive a cartridge of the blood and/or nutrient storage solution.
  • the cartridge may be a bag.
  • the systems and devices may include a single container that includes the at least two compartments. At least one (a first compartment) of the compartments may be structured to store a storage solution and at least one (a second compartment) of the compartments may be structured to store donated blood.
  • the blood compartment may further include a blood preservative.
  • the blood compartment may be prepackaged with the blood preservative.
  • the blood preservative may be any known blood preservative.
  • the preservative may include but is not limited to, sodium fluoride, sodium acetate, and sodium bicarbonate.
  • the solution compartment may include the storage solution.
  • the solution compartment may be prepackaged with the storage solution.
  • the solution compartment and the blood component may be disposed adjacent to each other.
  • the blood compartment may partially or completely surround the solution compartment.
  • the solution compartment may partially or completely surround the blood compartment.
  • the system may include a container having a plurality of blood and/or solution compartments.
  • the container may include additional compartment(s) (for example, a third compartment) that is structured to store one of the storage solution and donated blood.
  • the system may include a container having a blood compartment and at least two solution compartments.
  • the system may include a container having a solution compartment and at least two blood compartments.
  • the blood compartments may be for a single or multiple blood units.
  • the system may be structured to store a volume for the storage solution greater than a volume for the donated blood.
  • the system may include more storage compartments than the blood compartment(s), a larger storage compartment than the blood compartment, or any combination thereof.
  • the system may include a single container. In other embodiments, the system may include a plurality of containers. In some embodiments, the systems and devices may include a container for each compartment. In some embodiments, the systems and devices may include two containers. In other embodiments, the systems and devices may include more than two containers, for example, three containers, four containers, five containers, etc. In some embodiments, the system may include a plurality of containers having the same compartment configuration, containers having different compartment configurations, or a combination thereof.
  • each compartment and/or container may be self-contained and pliable.
  • each container may be similar to existing RBC bags.
  • the container may have any shape. In some embodiments, the container may have a circular, oval, or an asymmetric shape. In some embodiments, the container may have a shape to correspond to the blood collection and/or transfer system.
  • each container and/or compartment may be made of a medical grade plastic material.
  • the material may include but is not limited to polyvinyl chloride plasticized with di-2-ethylhexyl-phthalate (PVC-DEHP), citrate ester, polypropylene, or other suitable plastic materials.
  • the systems and devices may further include at least one dialysis membrane.
  • the dialysis membrane may be between the blood and solution compartments.
  • the dialysis membrane may be structured to segregate the RBCs from the larger volume of the RBCs. This configuration allows the benefits of large volume nutrient and waste exchange while maintains the RBCs in a small volume so as to allow transfusion of packed RBCs without volume overload.
  • the dialysis membrane may be structured to allow introduction of nutrition and removal of waste from stored blood.
  • a dialysis membrane may be disposed between the blood and solution compartments within a container.
  • a dialysis membrane may be provided within a container that is in fluid communication with containers that each include a blood or solution compartment.
  • the dialysis membrane may be constructed from porous membrane materials or fibers.
  • the dialysis membrane may be a small molecular weight cut-off, such as a 3500 MWCO. In some embodiments, the dialysis membrane may have a molecular weight cutoff of about 3500 MWCO. In other embodiments, the dialysis membrane may have a smaller or larger molecular weight cut-off.
  • the systems and devices may include at least one port.
  • each compartment may communicate with a port.
  • one of the compartments may communicate with a port.
  • each container may include a port.
  • each container may include more than one port.
  • the ports may be of the same type, different type, or a combination thereof.
  • the port may be one-way valve or may be a two- way valve.
  • each blood compartment may include at least one port. In some embodiment, each blood compartment may include at least two ports.
  • each container may be in fluid connection with each other.
  • the containers may communicate by a port.
  • the systems and devices may include tubing so that each container is in fluid connection with each other.
  • Figure 1 illustrates an example of a system according to embodiments. As shown in
  • a system may include a container 100 divided into two compartments 110 and 120 for the blood compartment and the solution compartment, respectively.
  • the blood compartment may be structured to collect and/or store donated blood and a solution compartment may be structured to store a nutrient storage solution.
  • the system may further include a dialysis membrane 130 disposed between the two compartments.
  • the system may also include at least one port 140 that is in fluid communication with the blood compartment.
  • This configuration may help maintain the pliability of the system. Due to the dialysis membrane separation, the volume of solution compartment may exceed the blood compartment as much as desired without diluting the RBCs in the blood compartment.
  • the system may include a removable protective device that is structured to shield the dialysis membrane while the blood is collected from a donor.
  • the devices and systems are not limited to one blood compartment, one solution compartment, and one dialysis membrane, as shown in Figure 1.
  • the devices and systems may have any number and configuration of blood compartment(s), solution compartment(s), and dialysis membrane(s) that allow the blood compartment to have a dialysis communication with a solution compartment.
  • multiple blood compartments connected to the solution compartment.
  • Multiple blood compartments may be of a single unit or of multiple units of blood.
  • the components of the devices and systems may be sterilized.
  • the devices and systems may be disposable.
  • the compartments of the devices and systems may be prepackaged for single use as part of a kit.
  • the systems may be configured so that the solution compartment may be structured to receive a solution bag that may be changed periodically.
  • the solution compartment may be prepackaged with a nutrient storage solution.
  • the blood compartment may be prepackaged with any known blood preservative.
  • the system may be designed so as not to alter the volume of blood that would be transfused from the current standard of care.
  • the blood compartment, as well as the entire system, may also be designed so as to collect and store blood according to FDA and other healthcare guidelines.
  • the system may include a nutrient storage solution.
  • the nutrient storage solution may include phosphate buffered saline, glucose and adenine.
  • additional nutrients may be added to the storage solution including, but not limited to, amino acids, nucleic acids, vitamins, lipids, carbohydrates and others.
  • chemical anti-oxidants, metal chelators, and preservative chemicals may be added to the storage solution.
  • the storage solution may further include pathogen inactivation chemicals and any additional small molecule that may be beneficial for any issue regarding RBC storage.
  • the storage solution may also include compositions configured to lower glucose to physiological concentrations as opposed to the superphysiological concentrations used in current solutions. Doing so would decrease damage to RBCs from hyperglycemic storage, in particular, advanced glycation endproducts (AGEs). The enhanced volume of the NWD system would allow the same overall glucose nutrition but with a decreased concentration.
  • compositions configured to lower glucose to physiological concentrations as opposed to the superphysiological concentrations used in current solutions. Doing so would decrease damage to RBCs from hyperglycemic storage, in particular, advanced glycation endproducts (AGEs).
  • AGEs advanced glycation endproducts
  • the enhanced volume of the NWD system would allow the same overall glucose nutrition but with a decreased concentration.
  • the system used in the example is not intended to approximate a product per se or to reflect a potential system for clinical use. Rather, this system was designed to specifically test the principle of operation of the disclosed systems and devices. This system tests the principle that exposing stored RBCs to extra volume of solution will both supplement nutrition and also allow the diffusion away of toxic waste products. Accordingly, this example establishes how the systems and devices according to the embodiments operate to increase the viability of the stored blood.
  • a system was developed according to the disclosure and tested using a murine model, which was developed to be used to model storage of human blood.
  • RBCs were harvested from mice under conditions that mimic how human RBCs are stored. Donors that are transgenic for green fluorescent protein (GFP) were utilized. This allowed transfusion of stored blood into wild-type recipients, providing an easy method for assessing post-transfusion survival and biology of stored RBCs without otherwise altering them. This has been shown to be a powerful in vivo pre -clinical model, and mouse RBCs stored under these conditions show similar changes in surface markers and storage characteristics of stored human RBCs.
  • GFP green fluorescent protein
  • the system developed according to the system principles of the disclosure and tested had a small dialysis compartment (in this case, a slidalyzer purchased from Pierce Co). A 3500 molecular weight cut-off was chosen, as this will allow free diffusion of small molecules, but keeps small proteins (including hemoglobin) in the compartment with the stored blood. Blood was collected in standard CPDA-1 storage solution (as is used in humans) and was then placed into the dialysis compartment. The dialysis compartment was then submerged in 1 Liter of solution containing PBS, 4.5g/L glucose, and 0.25 mM adenine (see Figures 2a and 2b).
  • This amount of glucose and adenine was chosen as it approximates the final levels found in routine blood bag storage solutions currently used in humans; however in the example, a much greater overall molar amount of glucose and adenine are available to the stored RBCs than in standard human blood bags.
  • No citrate was added to the beaker solution as Calcium free saline was used and thus the citrate in the collection fluid was sufficient to prevent coagulation.
  • the enclosure of RBCs in the dialysis tubing maintains the small volume of concentrated RBCs, which is an absolute necessity for transfusing without exposing the patient to excess volume.
  • RBCs stored under standard human conditions were likewise transfused, as were freshly isolated RBCs.
  • the 21 day time point was specifically chosen, as murine blood stored under standard human blood storage conditions reaches its capacity for storage (as per the established FDA guideline for human blood) after 16 days. Thus, 21 days represent outdated blood that has very poor posttransfusion survival.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Urology & Nephrology (AREA)
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Abstract

La présente invention concerne un système de stockage de globules rouges qui est configuré pour permettre l'introduction de nutrition et l'élimination des déchets de sang donné stocké. Le système comprend au moins un compartiment sanguin structuré pour contenir du sang donné ; au moins un compartiment de solution structuré pour contenir une solution de stockage ; et une membrane de dialyse disposée entre le compartiment sanguin et le compartiment de solution.
PCT/US2012/027840 2011-03-08 2012-03-06 Systèmes et dispositifs pour le stockage de globules rouges WO2012122154A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161450172P 2011-03-08 2011-03-08
US61/450,172 2011-03-08

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WO2012122154A2 true WO2012122154A2 (fr) 2012-09-13
WO2012122154A3 WO2012122154A3 (fr) 2012-12-06

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10557861B2 (en) 2014-05-23 2020-02-11 University Of Iceland, Center For Systems Biology Systems, methods, and biomarkers for determining the metabolic state of red blood cells and platelets

Citations (6)

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Publication number Priority date Publication date Assignee Title
US4304672A (en) * 1978-04-04 1981-12-08 Sbr Lab, Inc. Stored blood and liquid system pH control method and apparatus
US4432750A (en) * 1981-12-02 1984-02-21 Baxter Travenol Laboratories, Inc. Additive sterol solution and method for preserving normal red cell morphology in whole blood during storage
US5037419A (en) * 1989-09-21 1991-08-06 Eastman Kodak Company Blood bag system containing vitamin E
WO1999037340A2 (fr) * 1998-01-23 1999-07-29 Pall Corporation Systeme de traitement de fluide biologique
US6726671B2 (en) * 1998-08-19 2004-04-27 Gambro, Inc. Cell storage maintenance and monitoring system
US20060054557A1 (en) * 2002-12-12 2006-03-16 Takahiro Hori Virus-removing bag and virus-removing method using the same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4304672A (en) * 1978-04-04 1981-12-08 Sbr Lab, Inc. Stored blood and liquid system pH control method and apparatus
US4432750A (en) * 1981-12-02 1984-02-21 Baxter Travenol Laboratories, Inc. Additive sterol solution and method for preserving normal red cell morphology in whole blood during storage
US5037419A (en) * 1989-09-21 1991-08-06 Eastman Kodak Company Blood bag system containing vitamin E
WO1999037340A2 (fr) * 1998-01-23 1999-07-29 Pall Corporation Systeme de traitement de fluide biologique
US6726671B2 (en) * 1998-08-19 2004-04-27 Gambro, Inc. Cell storage maintenance and monitoring system
US20060054557A1 (en) * 2002-12-12 2006-03-16 Takahiro Hori Virus-removing bag and virus-removing method using the same

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10557861B2 (en) 2014-05-23 2020-02-11 University Of Iceland, Center For Systems Biology Systems, methods, and biomarkers for determining the metabolic state of red blood cells and platelets

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