JPH01500012A - Antipathogenic blood collection device and method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Background of the invention The present invention relates to human T-lymphotropic tendency (Lymphotropic)-retroviral virus/viral virus (HTLV), especially type III, can be transmitted to people receiving blood by transfusion. The present invention relates to an apparatus and method for preventing blood contamination, particularly for collecting blood components. and the human T-lymphotropic retrovirus that is present at the same time as the infusion. closed (sterile) systems and techniques for neutralizing viruses without compromising their integrity. Concerning maintaining.

In recent years, the dreaded acquired immunodeficiency syndrome (AIDS) and its causative agents, Human T-lymphotropic virus type III (HTLV-II)/lymphadenopathy As the occurrence of a related virus (LAV) increases in the human population, the number of reported cases increases. Is-related infusions are increasing (Peterman et al., JAMA Vol. 254, 2 No. 0, pages 2913-2917, November 22-29, 1985).

AIDS has infected 17,000 Americans.

Caused by a virus known as HTLV-I or LAV AIDS is spread primarily through sexual contact, shared hypodermic injections, and infusions. united states of america The people most likely to get AIDS in the country are homosexuals and people who use intravenous drugs. I am a user. However, blood transfusions, plasma, platelets, red blood cells, and hemophiliacs use caused by the use of blood products such as coagulation aid factors such as factor VIII. There are some cases where To ensure the security of the blood supply, the United States government has established Screening blood for antibodies against LV-II and LAV viruses We proceeded with the development of a test to

The first generation of these tests were enzyme-linked immunosorbent assays. (Enzyme-Linked Immunosorbent As5ay:E The LISA test is contracted for use in screening blood donations. ing. However, these tests only detect antibodies against the virus; It is less sensitive than screening tests that can detect lupus.

It is difficult to estimate how much blood screening can prevent AIDS. of blood People infected with HTLV-II through infusion primarily infect their sexual partners, It gets even more complicated when you consider infecting the next person. Therefore, Multiple secondary infections combined in a single infusion, with each infection directly attributable to the infusion. This will cause staining.

There will be many false negative tests (Pear 1 in Massachusetts). Public policy implications of HTLV-II antibody screening, Masa (Revised 6/18/85) Chusetts State Department of Health and Welfare).

First, testing blood from a group of people who are seropositive is an ELISA test. Not served.

Second, blood tests from a group of people who are truly antibody negative may be positive for the virus. Ru. These people are truly negative in the sense that they have no antibodies in the ELISA. Even if there is, it is a “false negative” because it has the HTLV-II virus. It is also important in this sense.

Some studies show that 4% of people who are positive for the virus are not positive for antibodies (Salahud) din S, Groupman J, et al. HTL in asymptomatic seropositive people. V-III Lancet 1984 December 22/29 1418-1420 (page), and preliminary studies suggest a figure of 5% to 10%.

Recent studies indicate that in the United States, between 1 and 2 million people have HTLV- The probability of being seropositive for the II virus and being a carrier who can transmit the virus is The high HTLV-II virus is spreading throughout humanity, and Long wet period (7 years or less) (Peterman et al. JAMA Vol. 254 No. 20) Pages 2913-2917 November 22-29, 1985), AIDS-related transfusions are likely to become more common. According to the aforementioned data, blood donation screening Recent tests used in clinical trials have shown fewer AIDS-related infusions, but none. It didn't happen.

Research by the Centers for Disease Control shows that the epidemic pattern of AIDS transmission is due to sexual contact, for example. It is very similar to hepatitis B, which is passed from person to person through blood and its products (D, Peter Drotman JAMA August 23-30, 1985 254 Vol. 8, Q&A, p. 1085), Technical Manual of the American Association of Blood Banks, No. 9 According to the 1985 edition, p. 346, ``Blood banks' main focus is on voluntary donors of blood. Hepatitis B surface antigen (HB) was administered to all blood donors. Infusion-related hepatitis B cases have decreased since the adoption of outsourced sAg) screening.

However, despite highly sensitive tests for the detection of HBsAg, type B Hepatitis often persists, even more so than screening tests. Effective techniques can help prevent life-threatening infections such as HTLV-I II caused by transfusion of blood. Necessary to prevent the spread of pathogens.

According to recent transfusion practices, blood consists of plasma, packed red blood cells, platelets, white blood cells, aggregated Whole blood containing all blood components is collected using various centrifugation protocols. Using it, whole blood is separated into its components.

Two or more blood components from a single blood unit may be infused into different patients.

Whole blood generally contains 40% red blood cells and 60% plasma. When packed red blood cells are separated , the blood becomes extremely thick and is usually diluted before transfusion.

According to the Blood and Drug Administration (FDA) regulations, once a whole blood unit is collected, it is considered a closed (sterile) system and can be stored for several weeks with blood thinners and insurance drugs. Wear.

Whole blood can be processed in a different bag in the original unit, but if the bag is not refilled or After connecting the main blood bag or taking a sample from the main blood bag, The stem is considered open and blood must be infused within 24 hours or discarded. Must be.

Therefore, 1. the present invention provides a method that is permanently attached to the original blood collection unit and closed (permanently). pathogens in the collected blood, especially HTLV-I, without compromising the integrity of the system. II Contains a catherite container containing a suitable agent suitable for neutralizing I.

prior art 3--azido-3-1-deoxythymidine, HT for patients with AIDS-related complexes Administration of LV-II I/LAV replication inhibitors, Yarchoan et al., Lan cet.

pp. 575-580, Sarcoma, Kaposi, March 15, 1986. Sarcoma) or HTLV-I indicated as AIDS-related complex Effect of Suramine on I/LAV infection, Viv Clinical pharmacology and inhibition of viral replication in o), Broder et al., Lance t, pp. 627-630, September 21, 1985. Ribavirin suppression of replication in lymphadenopathy-associated viruses, McCormick et al., Lancet, pp. 1367-1369, 1984.12 15th of the month Vitr on infection and cytopathological effects of HTLV-I o) Suramin protection of T-cells in Mitsuya et al., 5science 226 Volume 172-174, October 12, 1984 Prospects for the treatment of infections caused by human T-lymphotropic virus type III, Hirsch et al., Annals of Internal Medicine, vol. 103, 7. pp. 50-755, November 1985 Cyclic Nucleotide Phosbodiesterase against the calcium-dependent activator of Phospodiesterase) Selective binding of antipsychotic and psychoactive agents, Levin et al., J.

of Pharmacology and Experimental Ther peutics, vol. 209, pp. 454-459, 1979, vol. 3 Disassembly of retroviruses by chelating agents, Wunderlich et al., Archi ves of Virol.

g3/, vol. 73, pp. 173-183, 1982 and retroviruses in Toro. Cytolytic action of neurotropic drugs, Wunderlich et al., Europ JC ancer 16 1127-1132 (1980) Phosphonoformate (Phosphonof.

According to Rmate), suppression of T-lymphotropic virus type III in humans, Sandstrom et al., The Lancet, 148C)-82, 1985 June 29th Prospects for treatment of infection with human T-lymphotropic virus type III Hir sch et al., Annals.

f Internal Medicine, 1985; 103.750-755 Phosphonoformate (PFA, Foscarnet) ) antiviral effect of sodium), Oberg G,, Pharmacolog yand Therapeutics, 1983; 19; 387-415 antimoniotungstate (A) in 3 AIDS patients and 1 prodromal patient. nt imoniotungstate) (HPA23>processing, Rozenba um et al., Lancet, 1985; 1; 450-451 HTLV-I I /LAW)7'/AnSamycin inhibitor replication and inftavi Tay (Infootivity) (abstract) Anand et al. International Conference on AIDS: Abstract Translation Philadelphia; Physical Society; 198 Vitro and Vivo Anti-Effect Various initial results of anti-inflammatory agents Riesenberg et al., J.A.M.A., November 8, 1985, 254. Volume No. 18, Page 2521, U.S. Patent No. 4,223,675 discloses that The present invention relates to a sterile container for solutions particularly suitable for blood bags for disinfecting liquids.

U.S. Patent No. 4,259,952 includes a diluent to dilute red blood cells in an infusion bag. Packed red blood cells in an infusion bag consisting of a flexible, squeezable diluent bag This invention relates to a diluting device.

U.S. Pat. No. 4,432,750 is a non-toxic, physiologically compromising sterol Contains additive solutions used to maintain normal red blood cell morphology during storage. .

U.S. Pat. No. 4,435,179 discloses a blood bag and its interior connected to a second bag. a blood bag assembly comprising: means for connecting the connecting portion and the disconnection point; The coupling is connected directly to the top of the bag. It ends virtually flat.

U.S. Pat. No. 4,445,889 prevents patient infection from indwelling catheters Regarding the method, connecting a patient to a catheter, connecting the catheter to a fluid receiving container, Place a biocide dispenser device in the container to inhibit the growth of infectious bacteria within the container. Place biocide into the fluid in the container to prevent the fluid from entering the catheter and patient. It will be done.

U.S. Pat. No. 4,484,920 combines a liquid and a solid that are initially placed in separate compartments. For containers containing solids, the compartment containing the solids has two access holes and the liquid contains solids. Since it passes through compartments, it can be mixed well.

U.S. Patent No. 4,467,588 cleans sterile powder ingredients and sterile liquid ingredients. It relates to sterile containers that are kept separately in a safe condition.

Brief description of the drawing FIG. 1 shows a standard blood collection system.

FIG. 2 shows the system of the present invention.

FIG. 3 shows another container of the invention for neutralization.

FIG. 4 shows the sterilization container of FIG. 2 in detail.

FIG. 5 shows another example of the container of FIG. 3.

FIG. 6 shows another example of the container of FIG. 4.

FIG. 7 shows another example of the container of FIG. 3.

Description of the claimed invention FIELD OF THE INVENTION The present invention relates to an apparatus and method for preventing disease-related infusions, particularly AIDS. subordinate In recent years, nine hospitals have been screening blood donors to prevent the spread of disease. In the claimed invention, blood from blood donors was collected at a temperature of 1 to 37°C, preferably at room temperature. After, infected blood units are neutralized by neutralizing the virus before being injected into the patient. Disease-related infusions can be prevented, even if they are from.

The present invention provides a novel method for collecting blood using a suitable neutralizing agent in a closed system. Regarding systems that can be used as is. Depending on the neutralizing agent used, blood may One or more standard washes after introduction of the neutralizing agent or to dilute or remove the neutralizing agent After going through the process it can be used for infusion.

In one embodiment, the present invention provides, in addition to commercially available blood collection units, Use of novel destructible semi-rigid or rigid containers to hold suitable neutralizing agents. Ru.

Neutralizing agents are supplied in standard 450ml bags in various devices used in standard blood collection units. can be separated from the inside. Neutralizing agent is introduced after blood collection and incubated for a certain period of time (temperature) I can do it.

The standard 450ml blood container collects blood into a pre-installed 63ml anticoagulant. Defined as a container that holds between 405ml and 495ml (average 450ml) of blood. be done.

The neutralizer in the container is a solution or powder that is separated from the reducing solution and both are in the container. ing. The neutralizing agent can be reduced and mixed with whole blood in a 450ml bag. Alternatively, you can place the neutralizing agent as a powder directly into the blood collection bag before adding it to the transfused blood or It may be reduced by mixing with a liquid anticoagulant.

The neutralizing agent must buffer the collected blood to a pH of 6.5 to 7.4. increases cell permeability of neutralizing agents such as dimethyl sulfoxide and glycerol It is better to include a substance in the neutralizing agent.

A standard blood transfusion device consists of several satellites connected to a 450ml main blood collection bag. These satellite bags are less than or equal to the size of the main bag; components such as platelets, white blood cells, plasma, blood thinners, blood preservatives, or whole blood. Can be retained. The neutralizing agent of the present invention can be installed in a small container and used in these satellite batteries. attached to any of the bags and connected to the collection unit as described above. It may be placed in advance in a bag or in a 450ml bag.

Therefore, although the present invention may be a commercially available unit, the HTLV-II new, ready-to-use blood with suitable neutralizing agents against pathogens such as Provide collection units.

Depending on the neutralizing agent used, a culture period may be required for the neutralizing agent to take effect; Continuous mixing of blood may be necessary to strengthen and speed up the process. For dilution and cleaning of neutralization One or more washing steps may be necessary. Depending on the application, neutralizing agent may be added to whole blood after collection. or into blood components such as packed red blood cells or plasma, respectively.

Examples of suitable neutralizing agents for pathogens such as HTLV-I II according to the present invention are shown below. The following is shown.

1. Suramin Use a total input volume of 0.02 to 900 cm for a 450 ml bag.

2. Ribavirin 0.02■~ for 450ml bag Use with a total input of 900 ■.

3. Neurotropic drugs including the following groups: 80 Neuroleptic drugs such as; 1. The following phenothiazines and their derivatives; Butaperazine, Methofenazine phenazine), fluphenazine hydrochloride (Fluphena zine Hydrochloride), fluphenazine decanoate (F l　uphenazine　Decanoate),) riflubromazine (T ri　f　upromazineL　) rifluoverazine (Tri　f　1u Rauwolfia alkaloids such as 2, reserpine, etc. 3. Butyrophenones such as haloperidol and trifluperidol 4. Dibenzodiazepines (Dibe) such as clozapine (C1ozapine) antiemetics such as nzodiazepine) 1. Chlorphenetazine (Chlorphenetazine) 2. Promethacin C. Beta-blockers such as propranolol These neuroactive drugs After concentration, the maximum amount in the range of 0.001 mmol to 100 mmol per 450 m bag is It is used at a concentration that gives the final molar concentration.

4. Trisodium phosphonoformate (Trisodium Pho) sphonoformate): This is for 450ml bag after blood collection. and a final molar concentration in the range of 0.003 mmol to 2.0 mmol. used in

5. Ansamycin: A derivative of rifamycin S , after collection of blood, between 0.01 mmol and 900 mmol per 450 ml bag. It is used at a concentration such that the final molar concentration is within the range.

6. Antimoniotungstate :HPA-23): 0.01 mmol to 500 mmol per 450ml bag It is used at a concentration that gives a final molar concentration in the range of .

Formerly known as 7,3-monoacyto-3-deoxythymidine compound S, it is a compound that is present in the blood. After collection, the maximum concentration ranges from 0.01 mmol to 900 mmol per 450 m bag. It is used at a concentration that gives the final molar concentration.

8. Ethylenediaminetetraacetate (EDTA) and ethylene glycol Bis(2-amino ethyl ether)-N,N,N-1N-1-tetraacetic acid ( EGTA): Final moles of EDTA or EGTA range from 0.01 mmol to 900 mmol. It is used in such a concentration that These are all Food and Drugs Administration or Investigational Approved for human use by New Drugs.

One or more neutralizing agents may be used alone or in combination. mixed continuously If not, an incubation period at 1-37°C, preferably room temperature, may be necessary for blood cells. Add dimethyl sulfoxide or glycerol to blood cells to increase permeability of cell components. The anticoagulant itself is added to the neutralizer bag.

If the neutralizer is toxic, clean or dilute it to avoid toxicity. One or more washing steps may be required to clean the area. Randomly infused patients (mostly ), the patient is exposed to the neutralizing agent due to the limited number of blood component units required. The amount is much lower than its toxic level.

Brief description of the drawing In FIG. 1, a standard blood collection device of the prior art is shown, with a 450ml blood collection chamber. Tug 2 has a 16 gauge needle 1 with a fixed length to transfer blood from its source to bag 2. Connected to the flexible tube. Furthermore, the flexible tube 5 is pulled out from the bag 2, and at 8 It is divided into tubes 6 and 7. Tube 6 leads to a small satellite bag 3 and tube 7 a special 63 ml of anticoagulant is placed in bag 2, 9, through the platelet bag 4.

An existing standard closure device 25 that can be opened by operation prevents the contents of bag 2 from entering tube 5. It's starting to look ugly.

FIG. 2 shows a modification of the system of FIG. 1 in accordance with an embodiment of the present invention. bag 2 ．． 3.4, connecting tube 5.6.7 and anticoagulant are as described above. But small There is a container 10, which may be a flexible bag or a rigid container such as glass. Good, the container contains an appropriate amount of neutralizing agent 12 against pathogens such as HTLV-II It is possible to hold the Parts 13.14 are standard fixtures for removing vehicle fluid during infusion. It is. 25 and 26 are standard closure devices that connect the contents of the bag that can be opened by operation. It is a place.

FIG. 3 shows another embodiment in which the container 10 is divided into upper and lower compartments 15, 16. Ru. Powdered neutralizer 17 is placed in the lower compartment 16 and added to water or 0.9% sodium chloride. A lysate, such as lysate, is placed in the upper compartment 15. The two compartments are inside the container 10 It is divided in the center by a restricting part 18 and a thin membrane 19, and one membrane is used as an example. For example, it breaks down under pressure, and the neutralizing agent and liquid are mixed together before being placed in a blood bag.

FIG. 4 shows details of the container of FIG. 2, containing neutralizing agent 20. FIG.

FIG. 5 shows a modification of the container of FIG. 3; in this example, container 10 contains a reducing solution. and a lower compartment containing a solid, liquid, or powder neutralizing agent 24. It is being A stopper 22 connects the upper and lower compartments and maintains the appropriate pressure in the container. can be applied to remove the stopper 22. Therefore, the stopper 22 is Basically, it acts in the same way as the membrane 19.

directly into the blood bag if suitable dilution is possible, or anticoagulated before blood collection. It is reduced by binder.

FIG. 7 shows a modification of the container of FIG. 3; in this example, the container holds the reducing solution. and a lower compartment containing a solid, liquid, or powder neutralizing agent 24. ing.

The standard closure device 32, like closure devices 25, 26, is adapted to connect with the contents of the bag. It can be opened by operation.

Submission of translation of amendment (Article 184-7, Paragraph 1 of the Patent Law) December 7, 1988 1. Indication of patent application: PCT/US 871007532, title of invention: Antipathogenic Vehicle fluid collection device and method 3, patent applicant Address: Massachusetts, USA 02146 Burzklein, P. , O, Box 654 Name Arushioufui, Habika Nationality Syria 4. Agent Address: 3rd floor, 2nd Onogi Building, 151, 2-20-12 Yoyogi, Shibuya-ku, Tokyo September 21, 1987 The scope of the claims 1. A blood collection device that prevents the transmission of pathogens in the blood, consisting of the following elements:

an occlusive blood collection container having means for introducing and withdrawing blood, connected to said blood collection container; controllably introduces an effective amount of neutralizing agent into a blood collection container to neutralize pathogens in the blood. A second container to hold the contents.

2. To prevent the transmission of pathogens from the transfused blood, the following elements should be used: Available blood collection devices.

a first closed blood collection container connected to a means for introducing blood from its source; 1 connected to a first container to receive and hold blood or blood components from the first container; one or more additional containers connected to the first container containing an effective amount of blood pathogen-neutralizing material; an additional container for holding a compensating agent for controllable introduction into the first container;

3. The device of claim 1, wherein the container is a sealed flexible blood bag.

4. The device of claim 1, wherein the blood collection container contains an anticoagulant.

5. The neutralizing agent is made from the following substances, buffered to pH 6.5 to PH 7.4 of the collected blood. The apparatus of claim 1 selected from the group consisting of:

suramin, ribavirin, phenothiazine, chlorpromazine, promacin, porcine Perazine, metophenazine, fluphenazine, hydrochloride, fluphenazi Tenka Eight, Triflupromacine, Trifluoperazine, Reserpine, loperidol, trifluperidol, dienzodiazepines, chlorpromazine, promethacin, beta blockers, trisodium phosphonoformates, samycin, antimoniotungstate, 3--azido-3-deoxythymidine ethylenediaminetetraacetate (EDTA) and ethylene glycol. Bis(2-amino ethyl ether)-N,N.

N-1N-1-tetraacetic acid (EGTA).

6. The apparatus of claim 1, wherein the neutralizing agent is contained in liquid form in the second container.

7. The second container is divided into two compartments, and the compartments contain the contents of one compartment for mixing. one compartment contains the neutralizing agent in powder form. and the other compartment contains a liquid solubilizing agent for the container agent. Device.

8. An effective amount of dimethyl sulfoxide for the neutralizing agent to increase the penetration of blood cell components. 6. The device of claim 5, comprising glycerol and glycerol.

9. The device according to claim 1, wherein the pathogen is a virus.

10. Claims that the virus belongs to the family of human T-lymphotropic leukemia viruses Apparatus according to paragraph 9.

11. The device according to claim 10, wherein the virus is HTLV-I type II.

12. Additional containers containing blood thinners and preservatives may be used to introduce diluents and preservatives. 2. The device of claim 1, wherein the device is attached to a blood collection container for the purpose of providing blood collection.

13. The first container and the additional container for blood or blood components are flexible blood bags. The device according to claim 2.

14. The device of claim 2, wherein the first container contains an anticoagulant.

15. The device according to claim 2, wherein the neutralizing agent is selected from the group consisting of the following substances:

suramin, ribavirin, phenothiazine, chlorpromazine, promacin, porcine Perazine, metophenazine, fluphenazine, hydrochloride, fluphenazi Ndecanoate, Triflupromacine, Triflureoperazine, Reserpine, Ha loperidol, trifluperidol, dienzodiazebin, chlorphenetadine , promethacin, beta blockers, trisodium phosphonoformates, nsamycin, antimoniotungstate, 3'-azido-3-deoxythymine gin, ethylenediaminetetraacetate) (EDTA) and ethylene glycol bis(2-amino ethyl ether)-N,N.

N-1N-1-tetraacetic acid (EGTA).

16. The apparatus of claim 2, wherein the neutralizing agent is a liquid.

17. The additional container containing the neutralizing agent is divided into two compartments, one compartment being one compartment is separated by means of controllingly conveying the contents of the compartment to the other compartment for mixing. The neutralizing agent is contained in powder form, and the other compartment is designed to contain a liquid solubilizing agent for the container. Apparatus according to item 2 of the scope of request.

18. The neutralizing agent contains dimethyl sulfate in an amount effective to increase the penetration of cellular components of the blood. 16. The device of claim 15, comprising phoxide and glycerol.

19. The device according to claim 2, wherein the pathogen is a virus.

20. Claims that the virus belongs to the family of human T-lymphotropic leukemia viruses Apparatus according to paragraph 19.

21. The device according to claim 20, wherein the virus is HTLV-I type II.

22. A container containing a blood thinner or blood preservative is attached to the blood collection container. The apparatus according to claim 2.

23. To prevent the transmission of HTLV-I type II virus in transfused blood, which consists of the following elements: Blood collection device to prevent.

Containing an effective amount of anticoagulant and connected to a means by which blood can be drawn from its source and introduced. a first closed, flexible blood bag; connects to a first blood bag and receives blood or blood components from the first blood bag; one or more additional blood bags for holding; Connected to the first blood bag and effective to neutralize HTLV-I type I virus A container for holding a quantity of neutralizing agent for controllable introduction into the first bag.

24. The device of claim 23, wherein the neutralizing agent is selected from the group consisting of the following substances:

suramin, ribavirin, phenothiazine, chlorpromazine, promacin, porcine Perazine, metophenazine, fluphenazine, hydrochloride, fluphenazi Ndecanoate, Triflupromacin, Trifluoberazine, Reserpine, Halo peridol, trifluperidol, dienzodiazepines, chlorphenetadine, promethacin, beta blockers, trisodium phosphonoformates, samycin, antimoniogustite, 3--azido-3-deoxythymidine ethylenediaminetetraacetate (EDTA) and ethylene glycol. Bis(2-amine ethyl ether)N,N.

N-1N-1-tetraacetic acid (EGTA).

25. The neutralizing agent contains an effective amount of dimethyl sulfate to increase the penetration of cellular components of the blood. Contains phoxide (DMSO) and glycerol, dimethyl sulfoxide (DMSO) ) or glycerol is pre-filled in the bag of the blood collection unit. Apparatus according to paragraph 24.

26. The apparatus of claim 24, wherein the neutralizing agent is a liquid.

27. The container containing the neutralizing agent is divided into two compartments, and the compartment contains the contents of one compartment. separated by means of controlled transfer of substances to another compartment for mixing, one compartment being neutralized The container contains the agent in powder form and the other compartment contains a liquid solubilizing agent for the container agent. Apparatus according to Scope No. 24.

28. A method for neutralizing pathogens in transfused blood, which consists of the following steps:

collecting the blood or blood components from its source in one or more closed containers; introducing a pathogen-effective amount of a neutralizing agent into the container during or after the introduction of the blood; 29. The method according to claim 28, wherein the pathogen is a virus.

30. Claim 2 in which the viral pathogen is the HTLV-II virus Method of Section 9.

31. The method of claim 28, wherein the neutralizing agent is selected from the group consisting of the following substances:

suramin, ribavirin, phenothiazine, chlorpromazine, 10 machines, pig Perazine, metophenazine, fluphenazine, hydrochloride, fluphenazi Ndecanoate, Triflushi Promacin, Trifluleoverazine, Reserpine, Haloperidol, trifluperidol, dienzodiazepines, chlorphenetage promethacin, beta blockers, trisodium phosphonoformates, Ansamycin, antimoniotungstate, 3--azido-3″deoxythi Midine, ethylenediaminetetraacetate (EDTA) and ethylene glycol bis(2-amino ethyl ether)-N,N.

N-5N-1-tetra vinegar M (EGTA).

32. The method of claim 28, wherein the content of the closed container is an anticoagulant.

33. The method of claim 28, wherein the anticoagulant is added to the blood simultaneously with the neutralizing agent.

34. The collected blood is subsequently washed to dilute and remove the neutralizing agent, and then continuously mixed. The incubation period at temperatures between 1°C and 37°C, preferably at room temperature, with or without continuous mixing. The method of claim 28, as may be included.

35. The method of claim 28, wherein the neutralizing agent is a liquid.

36. Claim 28, wherein the neutralizing agent is a solid that is dissolved before being introduced into the container. the method of.

37. Claim 2, wherein the neutralizing agent is pre-filled in one or more containers prior to blood collection. Method of Section 8.

38. The apparatus of claim 1, wherein the neutralizing agent is contained in powder form in the second container.

39. The device of claim 2, wherein the neutralizing agent is in powder form.

40. The device of claim 1, wherein the second container is made of a flexible or rigid material. Place.

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Claims (40)

[Claims] 1. A blood collection device that prevents the transmission of pathogens in the blood, consisting of the following elements: an occlusive blood collection container having means for introducing and withdrawing blood, connected to said blood collection container; controllably introduces an effective amount of neutralizing agent into a blood collection container to neutralize pathogens in the blood. A second container to hold the contents. 2. Used directly to prevent the transmission of pathogens in transfused blood, consisting of the following elements: Available blood collection devices. a first closed blood collection container connected to a means for introducing blood from its source; 1 connected to a first container to receive and hold blood or blood components from the first container; one or more additional containers connected to the first container containing an effective amount of blood pathogen-neutralizing material; an additional container for holding a compensating agent for controllable introduction into the first container; 3. 2. The device of claim 1, wherein the container is a sealed flexible blood bag. 4. 7. The device of claim 1, wherein the blood collection container includes an anticoagulant. 5. The neutralizing agent is buffered to pH 6.5-7.4 of the collected blood from the following substances: The apparatus of claim 1 selected from the group consisting of: suramin, ribavirin, phenothiazine, chlorpromazine, promazine, porcine perazine, metophenazine, fluphenazine hydrochloride, fluphenazine Decanoate, triflupromazine, trifluoperazine, reserpine, halope Ridol, trifluperidol, dienzodiazepines, chlorphenetazine, Lomethazine, Beta Blockers, Trisodium Phosphofluormate, Ansa Mycin, antimoniotungstate, 3'-azido-3'deoxythymidine , ethylenediaminetetraacetate (EDTA) and ethylene glycol vinyl (2-amino ethyl ether)-N,N,N',N',-tetraacetic acid (E GTA). 6. 2. The apparatus of claim 1, wherein the neutralizing agent is contained in liquid form in the second container. 7. The second container is divided into two compartments, the compartments allowing the contents of one compartment to be mixed. one compartment contains the neutralizing agent in powder form. and the other compartment contains a liquid solubilizing agent for the container agent. Device. 8. an amount of dimethyl sulfoxide effective for the neutralizing agent to increase the penetration of blood cell components; 6. The device of claim 5, comprising glycerol and glycerol. 9. The device according to claim 1, wherein the pathogen is a virus. 10. Claims that the virus belongs to the family of human T-lymphotropic leukemia viruses Apparatus according to paragraph 9. 11. 11. The apparatus of claim 10, wherein the virus is HTLV-III type. 12. Additional containers containing blood thinners and preservatives may be used to introduce diluents and preservatives. 2. The device of claim 1, wherein the device is attached to a blood collection container for the purpose of providing blood collection. 13. The first container and the additional container for blood or blood components are flexible blood bags. The device according to claim 2. 14. 3. The device of claim 2, wherein the first container contains an anticoagulant. 15. 3. The device of claim 2, wherein the neutralizing agent is selected from the group consisting of: suramin, ribavirin, phenothiazine, chlorpromazine, promazine, porcine perazine, metophenazine, fluphenazine hydrochloride, fluphenazine Decanoate, triflupromazine, trifluoperazine, reserpine, halope Ridol, trifluperidol, dienzodiazepines, chlorphenetazine, Lomethazine, Beta Blockers, Trisodium Phosphofluormate, Ansa Mycin, antimoniotungstate, 3'-azido-3'deoxythymidine , ethylenediaminetetraacetate (EDTA) and ethylene glycol vinyl (2-amino ethyl ether)-N,N,N',N',-tetraacetic acid (E GTA). 16. 3. The apparatus of claim 2, wherein the neutralizing agent is a liquid. 17. An additional container containing the neutralizing agent is divided into two compartments, one compartment being separated by means of controlling the contents of the other compartment for mixing; contains the neutralizing agent in powder form, and the other compartment contains the liquid solubilizing agent for the container agent. The apparatus according to claim 2. 18. the neutralizing agent in an amount effective to increase the penetration of cellular components of the blood; 16. The device of claim 15, comprising phoxide and glycerol. 19. 3. The device according to claim 2, wherein the pathogen is a virus. 20. Claims that the virus belongs to the family of human T-lymphotropic leukemia viruses Apparatus according to paragraph 19. 21. 21. The apparatus of claim 20, wherein the virus is HTLV-III type. 22. A container containing a blood thinner or blood preservative is attached to the blood collection container The apparatus according to claim 2. 23. Preventing the transmission of HTLV-III virus in transfused blood, consisting of the following elements: Blood collection device that stops. Containing an effective amount of anticoagulant and connected to a means by which blood can be drawn from its source and introduced. a first closed, flexible blood bag; connects to a first blood bag and receives blood or blood components from the first blood bag; one or more additional blood bags for holding; connected to the first blood bag and containing an effective amount of blood to neutralize HTLV-III virus. A container that holds a neutralizing agent for controllable introduction into the first bag. 24. 24. The device of claim 23, wherein the neutralizing agent is selected from the group consisting of: suramin, ribavirin, phenothiazine, chlorpromazine, promazine, porcine perazine, metophenazine, fluphenazine hydrochloride, fluphenazine Decanoate, triflupromazine, trifluoperazine, reserpine, halope Ridol, trifluperidol, dienzodiazepines, chlorphenetazine, lomethazine, beta blockers, trisodium phosphonoformates, ansa Mycin, antimoniotungstate, 3'-azido-3'deoxythymidine , ethylenediaminetetraacetate (EDTA) and ethylene glycol vinyl (2-amino ethyl ether)-N,N,N',N',-tetraacetic acid (E GTA). 25. the neutralizing agent in an amount effective to increase the penetration of cellular components of the blood; Contains phoxide (DMSO) and glycerol, dimethyl sulfoxide (DMSO) ) or glycerol is pre-filled in the bag of the blood collection unit. Apparatus according to paragraph 24. 26. 25. The apparatus of claim 24, wherein the neutralizing agent is a liquid. 27. The container containing the neutralizing agent is divided into two compartments, the compartments containing the contents of one compartment separated by means of controlled transfer of the substances to the other compartment for mixing, and one compartment for neutralization. The container contains the agent in powder form and the other compartment contains a liquid solubilizing agent for the container agent. Apparatus according to Scope No. 24. 28. A method for neutralizing pathogens in transfused blood, which consists of the following steps: collecting the blood or blood components from its source in one or more closed containers; introducing a pathogen-effective amount of a neutralizing agent into the container during or after the introduction of the blood; 29. 29. The method of claim 28, wherein the pathogen is a virus. 30. Claim 29, wherein the viral pathogen is the HTLV-III virus the method of. 31. 29. The method of claim 28, wherein the neutralizing agent is selected from the group consisting of: suramin, ribavirin, phenothiazine, chlorpromazine, promazine, porcine perazine, metophenazine, fluphenazine hydrochloride, fluphenazine Decanoate, triflupromazine, trifluoperazine, reserpine, halope Ridol, trifluperidol, dienzodiazepines, chlorfenetadine, lomethazine, beta blockers, trisodium phosphonoformates, ansa Mycin, antimoniotungstate, 3'-azido-3'deoxythymidine , ethylenediaminetetraacetate (EDTA) and ethylene glycol vinyl (2-amino ethyl ether)-N,N,N',N',-tetraacetic acid (E GTA). 32. 29. The method of claim 28, wherein the contents of the closed container are an anticoagulant. 33. 29. The method of claim 28, wherein the anticoagulant is added to the blood simultaneously with the neutralizing agent. 34. The collected blood is subsequently washed to dilute and remove the neutralizing agent, and then continuously mixed. The incubation period at temperatures between 1°C and 37°C, preferably at room temperature, with or without continuous mixing. The method of claim 28, as may be included. 35. 29. The method of claim 28, wherein the neutralizing agent is a liquid. 36. Claim 28, wherein the neutralizing agent is a solid that is dissolved before being introduced into the container. the method of. 37. Claim 2, wherein the neutralizing agent is pre-filled in one or more containers prior to blood collection. Method of Section 8. 38. 2. The apparatus of claim 1, wherein the neutralizing agent is contained in powder form in the second container. 39. 3. The device of claim 2, wherein the neutralizing agent is in powder form. 40. The device of claim 1, wherein the second container is made of a flexible or rigid material. Place.