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Curable silicone with calcium hydroxide for blood storage

Info

Publication number
CA1084414A
CA1084414A CA 282880 CA282880A CA1084414A CA 1084414 A CA1084414 A CA 1084414A CA 282880 CA282880 CA 282880 CA 282880 A CA282880 A CA 282880A CA 1084414 A CA1084414 A CA 1084414A
Authority
CA
Grant status
Grant
Patent type
Prior art keywords
blood
storage
rubber
silicone
bag
Prior art date
Legal status (The legal status 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 status listed.)
Expired
Application number
CA 282880
Other languages
French (fr)
Inventor
Thomas D. Talcott
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dow Corning Corp
Original Assignee
Dow Corning Corp
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
Grant date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14Blood; Artificial blood
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES, AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02Preservation of living parts
    • A01N1/0205Chemical aspects
    • A01N1/021Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES, AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02Preservation of living parts
    • A01N1/0236Mechanical aspects
    • A01N1/0263Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L33/00Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/06Use of macromolecular materials
    • A61L33/068Use of macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers

Abstract

ABSTRACT OF THE DISCLOSURE

A method of storing blood is disclosed in which a plastic blood collection bag is further supplied with silicone rubber into which pure Ca(OH)2 has been compounded.
The method is an efficient way to prolong the useful life of blood, especially the erythrocytes, since their viability can be enhanced by removal of CO2 from the blood. Such removal can be a method of maintaining an adequate pH balance in the complex blood system which appears to be essential to maintaining the blood in storage for prolonged periods of time.

Description

The anatomy and physiology of blood has been of great interest to the human race for a long time because the blood system is the fluid pipeline that maintains the complex chemical balance of the h~man body. The blood system carries nutrients to the other living tissues of the body and at the same time carries away the waste by-products of the multitudinous complex chemical reactions that are going on inside the body and which are essential to life itself.
Severe intrusions on body tissues and/or the blood system itself often requires the supplementation of blood to the blood system. Generally, if the intrusion is not too severe or the loss of blood is not too copious, the body has a unique system for supplementing or replacing lost blood.
In those instances when the body cannot replace or supplement the needed blood because of sheer volume loss or because the body has a physiological malfunction, the replacement or supplementation can come from an external source, such as stored blood.
The storage of blood outside the body is a relatively recent development. With the onset of the Second World War, the need for large volumes of replacement blood brought on a flurry of activity in researching the best methods of storing blood.
Since the end of the Second World War and up to -approximately the beginning of the present decade, the systems for storing blood that were developed were those used during the war period. At the very best, however, the duration of storage of whole blood in its liquid form was 21 days.

10~4414 ;~ :

Such storage systems usually involved the storage of blood in an Acid Citrate-Dextrose solution.
Recently, Dr. Lee Wood and Dr. Ernest Beutler in a publication, Transfusion, Vol. 11, No. 3, May-June, 1971, pp. 123-133, reported that blood could be stored for 35 days by the co-use of adenine with Acid Citrate-Dextrose solutions and that such a practice was the primary storage system in Sweden.
They further set forth a method they had developed for the storage of erythrocytes. They remove the plasma from whole blood and store the erythrocytes in an artificial media. Their work shows that they can get equivalent storage to the ACD-adenine storage system.
One of the ma~or problems in the storage of whole blood is that the erythrocytes produce large quantities of lactic acid from glucose. This phenomena proceeds even when the blood is stored at low temperatues. The presence of the lactic acid, among other things, contributes to the continued decrease in the pH of the stored whole blood.
The lowering of the blood pH has a dramatic effect on the viability of the erythrocytes when the blood is transfused.
The mechanisms involved in the effect are described by Wood and Beutler in an article entitled l'Preservation of Red Cell 2, 3-DPG and Viability in Bicarbonate-Containing Medium: The Effect of Blood Bag -Permeability " , Journal of Lab and Clinical Medicine, -Vol. 80, No. 5, pp. 723-728, "The fall in the pH of the stored cells results initially in the loss of their 2,3-diphosphoglycerate (2,3-DPG), so necessary for efficient

-2-~084414 delivery of oxygen to the tissues. Eventually, glycolysis is choked off at the pH-sensitive hexokinase and phosphofructokinase steps, so that the erythrocyte loses its capacity to live and circulate when transfused. Thus, regulation of pH plays a key role in liquid preservation " .
Wood and Beutler go on to state the essential problem, " the use of very alkaline blood preservative solutions is unsatisfactory, however. Very high pH levels result in reduction of NAD to NADH in the ]actate-pyrovate system, and thus impede glycolysis at the glyceraldehyde phosphate dehydrogenose step. Although alkaline preservatives result in good 2,3-DPG maintenance, adenosinetriphosphate (ATP) 1s rapidly depleted under these conditions, and viability is poor. To some extent, this effect may be counteracted by the addition of pyrovate to reoxidize NADH, but even very alkaline preservatives cannot absorb enough hydrogen ions to maintain the pH level above the critical values required to prevent the decomposition of 2,3-DPG.
Clearly, it would be helpful to have a highly efficient buffer system which would maintain the pH of preserved cells above 7.4 in the face of the production of large amounts of lactic acid. Yet, no buffer ion which can absorb this large amount of acid and yet be reinfused is known~
Prior art attempts at preventing degeneration of whole blood suffering from the disadvantages described above, that is, generally the buffer solutions of sufficient strength required to maintain the high pH level have the disadvantage of not being compatible enough to reinfuse in the human without deleterious side effects. Further, 4~14 attempts nave been made to include small pouches, containing ~ ~
a CO2 absorbent, inside the larger storage bag but this method ~ ~ -is highly dependent on the ability of C02 to penetrate the small bag to reach the absorbent and further, these small bags are readily susceptible to a mucous-like build-up on their surface which further cuts down on the transmission of C02 to the contained absorbent.
Moreover, the small bags containing the CO
absorbent have the possibility of highly contaminating the whole blood if they leak or are ruptured in some manner.
Further, such a bag-within-a-bag design causes complicated fabricatlon problems for the bag manufacturer.
The present invention is directed to overcoming some of the problems associated with blood storage.
It ls an object of the present invention to provide a method of prolonging the period of storage of blood.
It is another object of the present invention to prolong the storage of blood yet provide for wholesome blood that can be reinfused.
It is yet another object of this invention to provide a composition which can be used in a whole blood storage bag to prolong the life of the whole blood stored therein.
It is still another object of this invention to provide a method of easier fabrication of a blood storage bag containing compositions which will prolong the life of the blood stored therein.
It is a further object of this invention to provide a blood storage bag which can prolong the life of _4-.. . . .

1084gl4 whole blood and which can contribute little or no whole blood contamination from the inventive composition.
There is, therefore, provided by this invention a composition of matter to be used in blood storage bags to inhibit the degeneration of the blood stored therein.
Such a composition consists of a curable silicone rubber contalning compounded therein essentially pure Ca(OH)2 as a CO2 absorbent. ~
Thus, in accordance with the present teachings, a method is provided of storing blood which comprises compounding a curable silicone rubber with 5 to 30 parts by weight of Ca(OH)2, based on 100 parts by weight of curable silicone rubber, inserting the compounded silicone rubber into a blood storage bag, subsequently infusing the bag with whole blood whereupon there is obtained a storage stable blood.
For the purposes of this invention, "essentially pure"
- means that the Ca(OH)2 useful in the invention contains at least 95% of Ca(OH)2 as opposed to CaO. Further, "essentially pure"
also preferably refers to the highest grade of Ca(OH)2 commercially available wherein the other impurities present are non-calcium materials and are present in very minute quantities, i.e., on the order of parts per million.
There is also provided a method of storing blood and a blood storage system aimed at retarding degeneration of blood which consists of equipping a blood storage bag with the above mentioned compounded rubber in the form of sheets, ribbons, kernals, granules, lumps or small blocks. By equipping is meant that the compounded silicone rubber is added to a blood storage bag along with the normal artificial medias. Such com-~ _5_ C~

-~ 1084414 ~ :
. ,.
pounded silicone rubber thus acts as a CO2 sink and thereby facilitates the inhibition of the degeneration of the whole :
blood stored therein.
The present invention comtemplates contacting blood ~ .
with cured silicone rubber containing essentially pure Ca(OH)2 :
while the blood is stored. It should be understood for purposes of this invention, that because the ,,,,"

-5a- ~ :

cl - ~0~4i4 ~

compounded rubber acts as a C02 sink, the surface area of the silicone rubber is an important factor in the selection of the physlcal form of the rubber to be used. To provide the necessary surface area the rubber is in the form of sheets, ribbons, kernels, granules, lumps or small blocks, but some degree of care is necessary in choice of configurations. For example, if granules are used to provide a large surface area for absorption of large quantities of COz, care must be taken that the granules are not so small as to clog the infusion tubes and etc., of the storage bag.
On the other hand, very large blocks or spheres of such rubber do not allow the requisite surface area for enough CO2 absorption. Thus, design of the silicone pieces actually used is dependent. on the amount of CO2 absorption that is actually desired and this has to be balanced against possible mechanical malfunctions such as the clogging described above.
The silicone rubbers useful in this invention are those silicone rubbers which are easily curable. Such methods of curing are preferably peroxide cures or platinum catalyzed curing of -SiH containing siloxanes with -Si alkenyl containing siloxanes.
Such silicone rubbers are well known in the art and further elaboration is not required herein.
The Ca(OH)2 useful in this invention is Ca(OH)2 that is essentially pure. For obvious reasons, poorer grades of Ca(OH) 2 should not be used because of the possible contamination problems. Preferably, Ca(OH)2 is used that has greater than 95~ Ca(OH) 2 as opposed to CaO. Further, preferably there should be used a Ca(OH) 2 that is the ~ 34414 purest that can be reasonably obtained and which has impurities other thar calcium in the parts per million range.
The Ca(OH) 2 iS compounded into the uncured silicone rubber by any means normally used in the art such as a two-roll mill.
The largest amount of Ca(OH) 2 that can be used is limited by the amount that can be milled into silicone rubber without detracting from the cure or the physical properties of the silicone rubber. The smallest amount is determined by the practical effects of absorbing power and quantlties of CO2 that are required to be absorbed. Usually, the amount ranges from 5 to 30 parts by weight based on 100 parts by weight of the silicone rubber. The compounded ;-rubber is then cured by any convenient means which is conventional in the art and which is dependent on the cure system used and the catalyst required.
The uncured rubber can be molded to the proper shape or can be molded in blocks or sheets and cut or carved to the proper physical form.
At the present time, the preferred form both from a functional surface area and from a physical malfunctions aspect, is a 3 cm x 3 cm piece that is 1 cm thick and which has the corners slightly rounded.
The pieces are simply inserted into a blood -storage bag during the fabrication of the bag and are allowed to float free within the bag.
The silicone rubber pieces adapt very nicely to ~ ~
sterilization tec~niques. ~ -Now so that those skilled in the art can more fully understand the invention, the following example is submitted.

lV~4~4 Example ~ -Silicone rubber into which 17~ by weigh~ of pure Ca(OH) 2 had been compounded and which had been cured were fashioned into 3.0 cm by 3.0 cm x 1 cm blocks.
One block was inserted into each blood collection bag for this example by opening the bottom of an empty 600 ml B transfer pack (Fenwal PL 130 plastic), inserting the block and then resealing the pack with a hot iron and au~oclaving for 20 minutes at 121C.
Four hundred and fifty ml of blood were collected from healthy adult donors into 67.5 ml of ACD (NI~ formula A).
The blood was allowed to stand for 15 to 30 minutes at room temperature, and then was centrifuged at 4C at 4500 x g for five to ten minutes in a Sorvall RC-3 centrifuge with a swinging bucket rotor. The plasma and buffy coat were both pressed off, and 200 ml of preservative solution (BAGPM) containing 101.4 m~ of sodium bicarbonate (NaHCO3), 14.3 mM
sodium carbonate (Na2CO~), 1 mM bisodium phosphate (Na2HPO4), 1 m~ adenine, 55 mM glucose and 0.5% mannitol was added for each volume of plasma expressed. After gentle but thorough mixing, the red cell suspension was aseptically transferred into the bag containing the blocks. The red cells were then stored at 4C. for 42 days, and agitated for one minute either once at the time of sampling, or fi~e times weekly to ensure thorough mixing.
Erythrocyte ATP was quantitated by the hexokinase method (set out in Beutler,-E., "Red Cell Metabolism " , A Manual of Biochemical Methods, Second Edition, New York, 1975, Greene and Stratton), and the concentration of 2,3-DPG was measured by a modification of the technique of Krimsky. (See r,~ ~ ~ Arl~ --8--10~4~1~
Beutler, E. immediately above.) The pH was determined by a technique whish allowed anaerob-c measurements at 0 to 4C.
(Bensinger, T. A., Metro, J. and Beutl2r, E., redesigned ~ -apparatus for anaerobic measurement of blood pH at low temperatures, Amer., J. Clin. Path., 63, 264-268, 1975.) ;
Four units of blood were stored in BAGPM with the blocks and agitated one time per week. The pH ranged from a high of 7.82 + .02 on day 7 to 7.41 + .03 on day 42. -Seven units containing the BAGPM and blocks were agitated five times weekly and these units maintained their pH at 7.86 + .03 on day zero to 7.55 + . o8 on day 42.
Intracellular 2,3-DPG which was 13.16 + .88 ~Mole/g Hgb on day zero was 10.22 + 2.35 ~Mole/g Hgb on day 42 in the units stored with BAGPM and blocks that were agitated five times weekly. 2,3-DPG, which was originally 15.3 + 1.6 ~Mole/g at the time of drawing, was 10.13 + 1.20 ~Mole/g Hgb on day 42 if the system was agitated once weekly. In the units agitated once weekly, the day 42 ATP was 2.40 + o.64 ~Mole/g Hgb. The blood agitated five times weekly was 2.40 T 0. 64 ~Mole/g Hgb. The blood agitated five times weekly had ATP
levels of 1.88 + 0.26 ~Mole/g Hgb after 42 days of storage.

' ' '';

.. .

3o .

Claims (2)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A method of storing blood which comprises compounding a curable silicone rubber with 5-30 parts by weight of Ca(OH)2, based on 100 parts by weight of curable silicone rubber;
inserting the compounded silicone rubber into a blood storage bag;
subsequently infusing the bag with whole blood;
whereupon there is obtained a storage stable blood.
2. A method of storing blood which comprises compounding a curable silicone rubber with 5-30 parts by weight of Ca(OH)2, based on 100 parts by weight of curable silicone rubber;
inserting the compounded silicone rubber into a blood storage bag containing an artificial blood storage media;
subsequently infusing the bag with blood;
whereupon there is obtained a storage stable blood.
CA 282880 1976-08-05 1977-07-15 Curable silicone with calcium hydroxide for blood storage Expired CA1084414A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US05712106 US4082509A (en) 1976-08-05 1976-08-05 Method of storing blood and a blood storage bag therefor
US712,106 1976-08-05

Publications (1)

Publication Number Publication Date
CA1084414A true CA1084414A (en) 1980-08-26

Family

ID=24860776

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 282880 Expired CA1084414A (en) 1976-08-05 1977-07-15 Curable silicone with calcium hydroxide for blood storage

Country Status (6)

Country Link
US (2) US4082509A (en)
JP (1) JPS5930684B2 (en)
CA (1) CA1084414A (en)
DE (1) DE2735453C3 (en)
FR (1) FR2360248B1 (en)
GB (1) GB1538378A (en)

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JPS6350017B2 (en) * 1978-10-26 1988-10-06 Baxter Travenol Lab
US4267269A (en) * 1980-02-05 1981-05-12 Baxter Travenol Laboratories, Inc. Red cell storage solution
US4455299A (en) * 1981-11-20 1984-06-19 Baxter Travenol Laboratories, Inc. Storage of blood platelets
WO1984001292A1 (en) * 1982-09-27 1984-04-12 Baxter Travenol Lab Method and container for storing platelets
EP0168755B1 (en) * 1984-07-16 1991-04-17 Sumitomo Bakelite Company Limited Container and method for storing blood
JPS61112564A (en) * 1984-11-07 1986-05-30 Brother Ind Ltd Reciprocatingly moving device
JPS6241374U (en) * 1985-08-30 1987-03-12
US4902287A (en) * 1987-09-24 1990-02-20 Miles Inc. Sterilizable system for blood storage
US5147776A (en) * 1990-02-26 1992-09-15 University Of Iowa Research Foundation Use of 2,5-anhydromannitol for control of pH during blood storage
JP3185108B2 (en) * 1990-11-07 2001-07-09 バクスター、インターナショナル、インコーポレイテッド Erythrocyte storage solution
US6565802B1 (en) * 1999-06-03 2003-05-20 Baxter International Inc. Apparatus, systems and methods for processing and treating a biological fluid with light
US7445756B2 (en) * 1999-06-03 2008-11-04 Fenwal, Inc. Fluid processing sets and organizers for the same
US6364864B1 (en) 1999-06-03 2002-04-02 Baxter International Inc. Plastic containers having inner pouches and methods for making such containers
US7068361B2 (en) * 1999-06-03 2006-06-27 Baxter International Apparatus, systems and methods for processing and treating a biological fluid with light
US7025877B1 (en) 1999-06-03 2006-04-11 Baxter International Inc. Processing set for processing and treating a biological fluid
WO2011049709A1 (en) 2009-10-23 2011-04-28 Fenwal, Inc. Methods and systems for providing red blood cell products with reduced plasma
US8375730B2 (en) * 2011-01-28 2013-02-19 Tcp Reliable, Inc. Selecting packaging and coolant systems for shipment of biological products
EP2741605A4 (en) * 2011-08-12 2015-06-10 Cytosorbents Corp Polymeric sorbent for removal of impurities from whole blood and blood products
US20160219870A1 (en) * 2013-09-17 2016-08-04 Becton, Dickinson And Company Stabilization of Blood pH During Sample Storage
WO2017044856A1 (en) * 2015-09-10 2017-03-16 New Health Sciences, Inc Reinforced gas permeable blood storage bags, and methods of preparation thereof

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GB459951A (en) * 1935-06-18 1937-01-18 John Stoddart Wilson An improved process for the treatment and preservation of blood for medicinal purposes
US2301710A (en) * 1939-04-01 1942-11-10 Charles R Drew Apparatus for preserving blood
GB901675A (en) * 1957-05-03 1962-07-25 Gerhard Dauelsberg Process for improving the storage qualities of conserved whole-blood
US3221741A (en) * 1962-06-18 1965-12-07 Veen Harry H Le Container for collecting and storing blood having anticoagulant means therein
US3279996A (en) * 1962-08-28 1966-10-18 Jr David M Long Polysiloxane carrier for controlled release of drugs and other agents
US3291612A (en) * 1963-12-02 1966-12-13 Schneider Packing Company Method for collecting and preserving blood
US3418209A (en) * 1964-06-16 1968-12-24 Cordis Corp Red cell preservation
US3942529A (en) * 1967-02-01 1976-03-09 Investrop A.G. Package and method for storing blood
US3579999A (en) * 1968-08-08 1971-05-25 Redeco Method and apparatus for the preservation of biological substances
US3677022A (en) * 1969-07-24 1972-07-18 Redeco Method for extending the useful storage period of biological substances such as blood
US3729947A (en) * 1970-12-04 1973-05-01 Alza Corp Process for storing blood platelets
US3925153A (en) * 1971-05-14 1975-12-09 Experimentales Et Cliniques De Composition for conservation of blood
US3846236A (en) * 1971-10-22 1974-11-05 Wisconsin Alumni Res Found Method and apparatus for dialysis
US3874384A (en) * 1971-11-01 1975-04-01 American Hospital Supply Corp Improved blood storage unit and method of storing blood

Also Published As

Publication number Publication date Type
JP1254073C (en) grant
DE2735453B2 (en) 1979-08-09 application
US4082509A (en) 1978-04-04 grant
GB1538378A (en) 1979-01-17 application
DE2735453A1 (en) 1978-02-09 application
DE2735453C3 (en) 1980-04-10 grant
CA1084414A1 (en) grant
JPS5930684B2 (en) 1984-07-28 grant
FR2360248A1 (en) 1978-03-03 application
JPS5320683A (en) 1978-02-25 application
US4162676A (en) 1979-07-31 grant
FR2360248B1 (en) 1980-12-05 grant

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