Blood bags for collecting and reusing blood lost during surgery

Abstract

The present invention relates to a blood collection container fitted at its top with a suction connector 10 for connecting a drainage tube 19 and also fitted with a suction connector 6 for connecting said suction tube 18 of a vacuum connection. The present invention is characterized in that, firstly, the blood collection container 1 has a discharge port 4 at its bottom for draining the collected blood via a tube 30 to a blood washing device, secondly, the blood collection container 1 contains an anticoagulant, and thirdly, the blood collection container 1 is entirely sterile and is packaged in a delivery bag 2 sterile-sealed by a hermetic seal 5 to be opened in the operating room immediately before use. A tubing section is advantageously placed in the lower drain port 4, which tubing section can be closed by a tubing clamp 16 for connecting a drainage tube 30 to this drainage port 4 and for optionally opening or closing the tubing section or the drainage tube 30 by means of the tubing clamp 16.

Description

[Technical Field]

[0001] The present invention provides a method for preventing unexpected blood loss during surgery in the operating room, for example in the so-called Cell Saver. Automated This invention relates to a blood container for collecting a patient's blood for immediate reuse after purification using machine autotransfusion (MAT). Containers for collecting wound blood are known in the prior art. For example, U.S. Patent No. 4,898,572 discloses a device for collecting a patient's blood, comprising a filter chamber and an integrated bag made of a flexible plastic material. For this purpose, negative pressure is generated via an air jacket surrounding the bag. Meanwhile, U.S. Patent Application Publication No. 2010 / 130957 relates to a compressible liquid container with a fixed lid, an inlet, and an outlet. This liquid container can also be used as a suction canister. Despite the existence of such containers, it is still not possible to provide a patient's own wound blood for reuse as needed in the event of blood loss during surgery. [Background technology]

[0002] During all invasive surgery, blood loss occurs. Heretofore, such blood has been drawn into a bag connected to a vacuum line or operating room vacuum line, along with sodium chloride, which is used for continuous wound irrigation. hose But the vacuum connection leads to the bag and another hose Drainage with suction opening hose leads from the operating table to the bag and enters near the nozzle for the vacuum line to the bag.

[0003] During surgery, if the patient is bleeding, the wound is continuously washed with sodium chloride, and the exiting blood, together with the sodium chloride used, is continuously sucked out in the suction line by a generated air flow, similar to saliva in dentistry, and this hose The blood reaches the collection bag via the blood bag. After surgery, the blood bag is discarded and the blood is lost.

[0004] Only when a surgery indicates that a significant blood loss of more than 500 ml is anticipated from the outset, a blood purification device such as the Cell Saver is installed in the operating room. These procedures include cardiac and vascular surgery, abdominal surgery, transplant surgery, orthopedic and trauma surgery, and, with restrictions, oncology surgery and obstetrics and gynecology. Automated Autologous transfusion MAT helps minimize the need for donor blood and the associated risks. The cost per use of Cell Saver is between 180 and 250 CHF per surgery.

[0005] When Cell Saver is used, the aspirated blood is directly transferred to the drainage system. hose The blood is then sent to the Cell Saver via the centrifugation device, where any solids present in the blood are filtered and the blood is purified. All commercially available systems work on the principle of centrifugation. When wound or drainage blood is collected, it cannot simply be returned to the patient without being treated. Reasons for this include the risk of coagulation activation, exposing the patient to large amounts of cytokines, endotoxins, and other physiologically active substances. The blood is then filtered and centrifuged in the treatment device. In particular, the following components are removed: ·Activated and inactivated clotting factors Complement factors Free hemoglobin ·platelet White blood cells (by the system maximum 99% cut decrease) Heparin ·Antibiotics Fat (up to 99.8% depending on the system) Inflammatory mediators

[0006] Instead, the red blood cells are concentrated. The processed blood is delivered hose The blood is then pumped through a hose into a hanging blood bag, from which it is infused into the patient. The blood then contains 25,000 IU of an anticoagulant, such as Heparin or sodium citrate, per 500 ml volume. For up to 3 liters of blood, 25,000 IU is sufficient.

[0007] When a patient suffers unexpected massive blood loss during surgery, there is usually no Cell Saver available in the operating room. As a result, blood is drawn into a conventional blood collection bag, which can hold up to 3 liters. However, this blood cannot be reused because it may be contaminated with particles and some of it has already clotted. This blood is lost and must be discarded. Therefore, in the event of unexpected massive blood loss, it has traditionally been necessary to use donor blood, which is typically usable within about 30 minutes. However, this donor blood must first be tested to ensure it is of the correct blood type and that the patient does not have any antibodies in their blood that would make the donor blood incompatible with the patient. If the test is successful, the donor blood can be administered to the patient via infusion. From the time it is ordered in the hospital until it is actually available for infusion takes about 30 minutes, and up to 3 hours. If a patient's aorta is suddenly severed, a large infusion of approximately 20 to 40 standard blood bags is required.

[0008] A practical example can illustrate the current challenges of blood management. During the insertion of a typical hip prosthesis, blood loss of 200 to 700 ml has been observed. A person has approximately 70 ml of blood per kilogram of body weight. For example, a lighter person weighing 45 kg has approximately 3150 ml of blood, and a blood loss of 1000 ml would be fatal. With such a small amount of blood, a person can absorb correspondingly less oxygen. The risk of infection increases, and if an infection occurs, the patient must remain hospitalized for several more days, resulting in corresponding costs. Generally, blood irrigation is effective from approximately 500 ml of blood loss. It would be much simpler and more effective to use wound blood in such cases of unexpected massive blood loss. However, operating rooms and their facilities are not yet equipped for this. Unfortunately, unexpected blood leaks are regularly lost. Summary of the Invention [Problem to be solved by the invention]

[0009] In view of the above, the object of the present invention is to make the use of other blood as unnecessary as possible, especially in cases of unexpected massive blood loss, i.e., when no blood purification device is present or when Cell Saver is not available in the operating room. Rather, according to the present invention, wound blood can still be reused in such cases. [Means for solving the problem]

[0010] This problem is solved by a blood collection container having a suction nozzle at the top for connecting a drainage hose and a suction nozzle for connecting a vacuum-connected suction hose, the blood collection container having a discharge nozzle at the bottom for discharging the collected blood via the hose into a blood purification device, and further characterized in that the blood collection container contains a drug for inhibiting blood coagulation, is sterilized throughout, and is packaged in a delivery bag that is sterile-sealed with a hermetic closure for opening in the operating room immediately before use.

[0011] The container is shown in the drawings and described below as an exemplary embodiment. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 shows a conventional blood collection container in the form of a bottle. [Figure 2] FIG. 1 shows a blood collection container according to the present invention packaged in a shipping bag. [Figure 3] FIG. 1 is a top view of a blood collection container. [Figure 4] Figure 1 shows the bottom end of an opened blood collection container with a hose clamp and a specially positioned outlet for draining blood into a Cell Saver. [Figure 5]FIG. 1 shows a hanging blood collection container in use in an operating room, with a supply hose at the top for drainage blood, an air suction hose to a vacuum connection, and a drain hose at the bottom to supply blood to a Cell Saver. DETAILED DESCRIPTION OF THE INVENTION

[0013] Referring first to FIG. 1, a conventional blood collection container in the form of a plastic collection bottle 20 is shown. It has a tab 21 and associated plastic connecting strip 22 at the top for easy hanging on a stand or hook next to the operating table. Two nozzles 23, 24 open outward at the top. One nozzle 23 is used to connect a vacuum hose from a fixed vacuum connection in the operating room, and the other nozzle 24 is used to connect a drainage hose, which at its other end has a drainage suction nozzle for aspirating wound blood from a bleeding area of ​​the patient, i.e., where the patient has a wound or where the patient's body has been incised for a surgical procedure. A hose portion 25 fits over this nozzle 24 and again forms a nozzle 26 at its upper end, to which a drainage hose can be connected. The hose portion 25 is equipped with a hose clamp 27 to temporarily prevent the inflow of blood if the bottle becomes full and needs to be replaced. The wound or incision is continuously washed with sodium chloride (NaCl), which is then mixed with the blood and sent to this collection bottle 20. In the example shown, the bottle is equipped with a measuring scale 28 so that the volume of the contents can be read at any time. When such a bottle 20 becomes full, it is replaced with an empty bottle, and the full bottle, and in particular the wound blood collected therein, must be discarded and completely lost, even if it is valuable wound blood. In an emergency, if a patient requires additional blood due to severe blood loss, it is standard practice to use blood from another source. This can be used within the hospital within 30 minutes or up to three hours. However, this must first be confirmed. The blood type must match, and the other person's blood must not have any antibodies that would cause it to be incompatible with the patient's blood.

[0014] 2 shows a blood collection container 1 according to the invention, here in the form of a bellows bag, sterilized and sealed in a plastic bag 2 having a hermetically sealable closure 3 on top, i.e. an airtight and watertight closure 3. As a special feature, this blood collection bag 1 is suitable for blood drainage. hose At the lower end there is a further nozzle 4 for connecting hose Auxiliary clamp 16 hose You can see part of 15. hose 15 also subsidized hose 15 or subsidy hose Blood outlet connected to nozzle 4 instead of 15 hoseThe blood collection container 1 includes a cap 31 on a fixing band 32 so that the bag can be sterile-sealed at the end with the cap 31. This cap 31 with the fixing band may be formed into a nozzle 4. Typically, the bag can further include several sterile storage caps so that the bag can always be sterile-sealed to allow the patient's wound blood to be safely stored for a certain period of time. Two slightly conical nozzles 6, 10 are attached to the upper side of the blood collection container 1, here formed by a dimensionally stable plate-like lid 5, toward the free end or formed integrally with the molded plastic lid 5. On both sides of the lid 5, hanging arms 14 are integrally molded at both ends, allowing the two hanging arms 14 to be flipped up toward each other, after which the container 1 can be hung on a stand or hook near the operating table with the lid 5 oriented horizontally. One nozzle 6 on the lid can optionally be fitted with an elbow 7, and a hose can be attached to the opposite side to draw air through the nozzle 6 when the hose is connected to a fixed vacuum connection in the operating room. The attached elbow 7 ensures that the suction hose does not kink so as to restrict or block airflow when the container is suspended and the suction hose is connected to the wall vacuum connection. The connecting piece 6 or the attached angle piece 7 can be sealed by a cap 9. To prevent loss of the cap 9, a safety strap is attached at its free end directly to the cover 5. A second connecting piece 10 of the cover 5 is used as a drainage tube for aspirating blood and sodium chloride 8 from a wound or incision area on the patient's body. hose The nozzle 10 is held in place by a safety strap 11 via an associated cap 12, which can be tightly closed. The plastic bag of the container is securely connected at the bottom and designed as a bellows 13, which allows it to expand downwards as the amount of blood increases, until it can hold up to 3 liters of blood. The bellows 13 design allows it to take up less space than a rigid bottle when not in use or for transport or storage.

[0015] According to the present invention, and this is very important, the bellows 13 is initially filled with a sufficient amount of a drug to inhibit blood clotting. To ensure reliable prevention of blood clotting, for example, at least 25,000 IU of an anticoagulant called Heparin can be contained for every 500 ml of blood. In the case of Heparin, 25,000 IU is sufficient for up to 3 liters of blood. Even if 25,000 IU of this anticoagulant is contained, there are no associated disadvantages, even if less than 500 ml of blood ends up in the container 1. Other anticoagulants, such as sodium citrate, are also suitable. The blood collection container 1 is delivered from the factory in the condition shown in Figure 2 and temporarily stored in the hospital until needed. Its important features are, first, its ability to facilitate blood drainage. hose of hose - It has a connecting piece at its lower end 4 for connection with a clamp 16. Secondly, it already contains a sufficient amount of anticoagulant for the total volume of blood that the container 1 can hold, for example up to 3 liters of blood. Thirdly, the entire container 1 is sterilized at the factory before being hermetically packed in the delivery bag 2. It is then packed in the delivery bag 2 under sterile conditions and temporarily stored in this delivery bag 2 in the hospital. When the blood collection container 1 is to be used, it is removed from the delivery bag 2 by opening the hermetically sealed closure 3 and hung on a stand in the operating room. Thereafter, the blood removal hose is connected to the bottom nozzle 4, hose teeth, hose It is either closed by a clamp 16 or connected directly to the Cell Saver.

[0016] Figure 3 shows a top view of the lid of the blood collection container. Two nozzles 6, 10 and the connected hose, as well as a cap 12 with a safety strap 11. The lid 5 has integrally formed arms 14 on either side of its circumference, shown in the parked position. If necessary, these can be rotated upwards by 90° to form two support arms for hanging the blood collection container on a hook.

[0017] In Figure 4, the lower end of the blood collection container according to the present invention 1 is shown, where the discharge nozzle 4 and the auxiliary hose 15 with the hose clamp 16 attached can be seen. hose 15 or connected blood drainage hose There is a sterile cover cap 31 attached to a safety strap 32 so that it is always available to cover and sterilely close the catheter 30. hose To connect this small hose The part 15 is removed, hose Clamp 16 ensures effective blood drainage hose , and then the clamp 16 is closed or opened for planned direct blood drainage.

[0018] Figure 5 shows this blood collection container 1 according to the invention in use. It is suspended from a hook 17 by two hanging arms 14. At the top, an elbow 7 and a suction hose 18 are connected to a suction nozzle 6, leading to a vacuum connection like those found in any operating room.

[0019] The other nozzle 10 is for blood drainage. hose At the bottom of the bellows 13 of the blood collection container 1, a blood drainage hose 30 is connected to the drainage nozzle 4 as well as to the hose clamp 16. In the suction hose indicated by the arrow hose 19, air is sucked out of the container via the suction hose 18, the sucked air flows into the drainage hose 18 and the drainage continues to 19, by means of which the free end can be conveniently sucked out of a wound or incision on a patient to which a suction element is attached, for example, by the same principle as when saliva is sucked out of a patient's mouth in dentistry.

[0020] Blood drainage hose of hose When the clamp 16 is closed, blood continuously enters the container 1 by suction, together with sodium chloride, which is used for continuous wound cleansing. The container 1 gradually fills. When the container 1 is full, at the top hose 18, 19 can be removed and the nozzles 6, 10 can be closed by the caps 9, 12. At the bottom, the container 1 is still sealed by the hose clamp 16. The blood collected from the patient is precious wound blood and is now available for transfusion. It is not coagulated and is kept sterile. In case of complications during surgery or unexpected massive blood loss, this collected wound blood can be directly transfused by this container 1 as soon as the Cell Saver is placed in the operating room or as soon as the Cell Saver is already there. When such a blood purification device or Cell Saver has to be brought into the operating room, this must of course be done under sterile conditions, i.e. only previously sterilized blood devices can be brought into the operating room. In this case, blood drainage hose 30 is connected to the lower nozzle 4, and its other end is connected to the Cell Saver, where the collected wound blood can be washed and then sent directly to an infusion bag, from which it can be administered to the patient via infusion. The use of someone else's blood and the associated logistics and medical procedures can be avoided, thereby saving time and money and preventing infection. Furthermore, patients who have suffered a relatively large amount of blood loss can be discharged from the hospital earlier than usual, one or even several days earlier than usual. This in turn saves significant costs.

[0021] Wound blood, which is anyway the least problematic blood for the patient, is no longer lost as before, but is available to the patient immediately or at any time with an interruption of a few hours or days, thanks to this blood collection container 1. This means that patients will no longer bleed to death on the operating table.

Claims

1. A blood collection container (1) having at its top a suction nozzle (10) for connecting a drainage tube (19) and a suction nozzle (6) for connecting a suction tube (18) for vacuum connection, The blood collection container (1) has a discharge nozzle (4) at the bottom for discharging the collected wound blood to a blood purification device via a tube (20); The blood collection container (1) for wound blood contains a drug that inhibits blood clotting, is entirely sterile, and is packaged in a shipping bag (2) sterile-sealed with a hermetic closure (3) for opening in the operating room immediately before use. A blood collection container (1) characterized by:

2. A hose portion (15) is fitted to the lower discharge nozzle (4), said hose section (15) can be closed by a hose clamp (16) for connecting a discharge hose (30) to said discharge nozzle (4) and for opening or closing said hose section (15) or said discharge hose (30) at will by means of said hose clamp (16); A sealing cap (31) is formed on the discharge nozzle (4) or the auxiliary hose (15) of the discharge nozzle (4) via a fixing band (32). A blood collection container (1) according to claim 1, characterized in that

3. 2. The blood collection container (1) according to claim 1, characterized in that the container (1) is designed as a bellows (13) so that, in a suspended state, the volume can expand downwards according to the amount of blood supplied, and can increase downwards to the total volume.

4. The container (1) is sealed at the top by a plate-shaped lid (5), The cover (5) is pierced by two connection pieces (6, 10) for connecting a suction hose (18) and a drainage hose (19). A blood collection container (1) according to any one of claims 1 to 3, characterized in that

5. The container (1) is sealed at the top by a plate-shaped lid (5), said cover (5) is pierced by two nozzles (6, 10) for connecting a suction tube (18) and a drainage tube (19); The nozzles (6, 10) are each sealingly closable by caps (9, 12) that are each held on the lid (5) via fixing bands (8, 11). A blood collection container (1) according to any one of claims 1 to 4, characterized in that it

6. A blood collection container (1) according to any one of claims 1 to 5, characterized in that a free angle part (7) belonging to the collection container (1) can be installed on the nozzle (6) or the nozzle (10) in order to avoid kinking of the outgoing or incoming vacuum hose (18) or drainage hose (19).

7. 7. A blood collection container (1) according to any one of claims 1 to 6, characterized in that the container (1) is designed as a bellows (13) so that, in a suspended state, its volume can expand downwards according to the amount of blood supplied, and can increase downwards to its total volume.

8. The container (1) has two hanging arms (14) integrally formed on the top cover, The hanging arms (14) can be flipped up towards each other to hang the blood collection container (1) on the hook. A blood collection container (1) according to any one of claims 4 to 7, characterized in that

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