Blood bags for collecting and reusing wound blood during surgery

Description

[0001] This invention relates to a blood container for collecting the patient's blood in the event of unexpected blood loss during an operation in an operating room and, after cleaning with m aschineller A car ttransfusion MAT, for example in a so-called cell saver, to be able to be used again straight away. Containers for collecting wound blood are known in the prior art. For example, US 4 898 572 A discloses a device with a filter chamber and an integrated bag made of flexible plastic material for collecting patient blood. For this purpose, a negative pressure is created in the bag via an air jacket surrounding the bag. US 2010 / 130957 A1, however, deals with a compressible liquid container with a rigid lid with inlets and outlets. The liquid container can also be used as a suction canister. Despite such known containers, the patient's own wound blood cannot still be made available for possible reuse when blood is lost during operations.

[0002] Blood loss occurs in all invasive surgeries. Currently, this blood, along with the sodium chloride used for continuous wound cleansing, is suctioned into a bag. Vacuum lines or negative pressure line connections are available in the operating room for this purpose. A tube leads from the vacuum connection into the bag, and another tube, a drainage tube with a suction port, leads from the operating table to the bag and then enters the bag near the vacuum line connection.

[0003] During surgery, if the patient bleeds, the wound is continuously washed with sodium chloride, and the resulting blood, along with the sodium chloride used, is continuously suctioned away by the airflow created in the suction line, similar to saliva at the dentist's office, and is collected via this tube into the collection bag. After the surgery, this blood bag is always discarded. The blood is lost.

[0004] Only if the operation is expected to result in significant blood loss of more than 500 ml from the outset is a blood purification device, known as a cell saver, placed in the operating room. These operations include cardiac and vascular surgery, abdominal and transplant surgery, orthopedic and trauma surgery, and, to a limited extent, tumor surgery and obstetric interventions. Mechanical autotransfusion (MAT) using a cell saver generally helps minimize the need for allogeneic blood and the associated risks. The cost of using a cell saver is between CHF 180 and CHF 250 per operation.

[0005] When a Cell Saver is used, the aspirated blood is directed via the drainage tube directly into the Cell Saver, where any solids present in the blood are filtered out and the blood is purified. All systems on the market operate on the centrifuge principle. After collecting the wound or drain blood, it must not simply be returned to the patient without processing. The reasons for this include the risk of coagulation activation and the risk of flooding the patient with cytokines, endotoxins, and other biologically active substances. The blood is therefore filtered and centrifuged in the processing device. This process removes, in particular, the following components: Activated and non-activated coagulation factors Complement factors Free hemoglobin Platelets Leukocytes (depending on the system up to 99% reduction) Heparin Antibiotics Fat (depending on the system up to 99.8%) Inflammatory mediators

[0006] In return, the red blood cells are enriched. The treated blood is fed via a dispensing tube into a hanging blood bag and from there into the patient via infusion. This blood then contains 25,000 IU of an anticoagulant, such as heparin or sodium citrate, per 500 ml volume. 25,000 IU is sufficient for up to 3 liters of blood.

[0007] If a patient unexpectedly suffers a large amount of blood during an operation, a cell saver is usually not available in the operating room. The blood is then aspirated into a conventional blood collection bag that holds up to 3 liters. This blood cannot be reused, however, as it may be contaminated with particles and may even have clotted. This blood is lost and must be disposed of. In such cases of unexpectedly large blood loss, donor blood has to be used, which is usually available within about 30 minutes. However, this donor blood must first be tested - it must belong to the correct blood group, and it must also be checked whether the patient has any antibodies in their blood that would make this donor blood incompatible.If the test is successful, the blood can be administered to the patient via an infusion. It takes approximately 30 minutes from the time the order is placed, and up to a maximum of three hours, for the blood to be available for infusion within the hospital. In cases where a patient's aorta is accidentally cut, mass infusions are required, approximately 20 to 40 standard blood bags.

[0008] The problems with current blood management can be illustrated by practical examples: During routine hip replacement surgery, blood losses of 200 to 700 ml have been observed. A person has approximately 70 ml of blood per kg of body weight. For example, if a lightweight person weighs 45 kg, they have approximately 3150 ml of blood, and if they then lose 1000 ml of blood, this becomes critical. With such a small amount of blood, the person can absorb correspondingly less oxygen. The risk of infection increases, and if this happens, a patient is kept in the hospital for an extra day, with corresponding cost consequences. Generally, dialysis is worthwhile starting with a blood loss of approximately 500 ml. It would be much simpler and more effective if wound blood could be used in such cases of unexpectedly high blood loss. However, operating rooms and their equipment are not yet equipped for this.Unfortunately, the unexpectedly leaking blood is regularly lost.

[0009] In view of the above-described circumstances, the object of the present invention is to make the use of donor blood as unnecessary as possible, especially in cases of unexpectedly high blood loss, i.e., when no blood purification device or cell saver is available in the operating room. Rather, in such a case, the invention is intended to allow the wound blood to be reused.

[0010] This object is achieved by a blood collection container according to the features of independent claim 1. Preferred embodiments of the blood collection container are recited in the dependent claims.

[0011] The container is shown as an example in the figures and described below.

[0012] It shows: Figure 1: A conventional blood collection container in the form of a bottle; Figure 2: The blood collection container according to the invention, sterilely packaged in a delivery bag; Figure 3: The blood collection container seen from above; Figure 4: The lower end of the unpacked blood collection container with the specially arranged pouring spout with hose clamp, for draining blood into a cell saver; Figure 5: The suspended blood collection container in use in an operating room, with a supply hose for the drainage blood at the top, an air suction hose to a vacuum connection and the drain hose at the bottom for feeding blood into a cell saver.

[0013] Figure 1shows a conventional blood collection container in the form of a plastic collection bottle 20. It has a tab 21 at the top and an associated plastic tie strip 22, so that it can be easily hung on a stand or hook next to the operating table. Two nozzles 23, 24 open outwards at the top. One nozzle 23 is used to connect a vacuum hose from a stationary vacuum connection in the operating room, the other nozzle 24 is used to connect a drainage hose, which has a drainage suction nozzle at the other end, for suctioning wound blood from bleeding areas of the patient, i.e. where the patient has a wound or where their body has been opened for surgical purposes. Here, a hose section 25 is slipped over this nozzle 24, which at its upper end again forms a nozzle 26 to which the drainage hose can be connected.The tube section 25 is equipped with a tube clamp 27 to temporarily prevent the flow of blood when the bottle is full and replaced. The wounds or openings are continuously cleaned with sodium chloride (NaCl), which is then mixed with the blood and collected in this collection bottle 20. In the example shown, a measuring scale 28 is attached to the outside of this bottle so that the volume of the contents can be read at any time. When such a bottle 20 is full, it is replaced by an empty bottle. However, the full bottle, and in particular the wound blood collected therein, must be disposed of and is definitely lost, even though it is valuable wound blood. In an emergency, if the patient requires additional blood due to significant blood loss, donor blood is normally used. This is available in a hospital within 30 minutes to a maximum of 3 hours. However, it must first be tested.The blood group must match, and the patient must not have any antibodies in their blood that could cause incompatibility with the intended donor blood.

[0014] The Figure 2shows a blood collection container 1, here in the form of a bellows-like bag according to the present invention, here sterile and sealed packaged in a plastic bag 2 with a hermetically sealable closure 3 on top, i.e. with an airtight and watertight closure 3. As a special feature, this blood collection bag 1 has an additional nozzle 4 at its lower end for connecting a blood drainage tube 30. Here you can see a section of an auxiliary tube 15, which is equipped with a hose clamp 16. This auxiliary tube 15 also has a cap 31 on a securing band 32. This cap 31 can also be molded onto the nozzle 4 with its securing band 32. The auxiliary tube 15 or the blood drainage tube 30 to be connected to the nozzle 4 instead of the auxiliary tube 15 can be sterilely closed at the end with this cap 31.The bag can also contain a few additional sterile reserve caps so that it can always be sealed sterilely in order to safely store a patient's wound blood for a while. On top of the blood collection container 1, here formed by a dimensionally stable, plate-shaped lid 5, two nozzles 6, 10 are attached or injection-molded in plastic as a single piece with this lid 5, which taper slightly towards their free end. On both sides of the lid 5, hanging brackets 14 are integrally formed at their two ends on its edge, whereby these two hanging brackets 14 can be pivoted upwards towards each other over the lid 5, after which the container 1 can be hung on these two hanging brackets 14 with the lid 5 lying horizontally on a hook or stand next to the operating table.One of the nozzles 6 on the lid 5 can optionally be equipped with an elbow 7, to the other end of which a hose can then be attached in order to suck out air via this nozzle 6 when the hose is connected to a stationary vacuum connection in the operating room. The attached elbow 7 ensures that when the container is suspended, the suction hose leading to the vacuum connection on a wall is not kinked, which would otherwise restrict or interrupt the air flow. The nozzle 6 or the attached elbow 7 can be sealed at the free end with a cap 9. To prevent the cap 9 from getting lost, it is attached directly to the lid 5 with a securing strap 8. The second nozzle 10 in the lid 5 is used to connect a drainage hose in order to suck out blood and sodium chloride from wounds or opened parts of a patient's body.This nozzle 10 is also attached to a retaining band 11 by means of a cap 12, which can be tightly closed. The plastic bag of the container, which seals against the lid 5 at the bottom, is designed as a bellows 13, allowing it to expand downwards with increasing blood volume, until it can hold, for example, a maximum of 3 liters of blood. Designed as a bellows 13, it requires less space than a rigid bottle when not in use and for transport and storage purposes.

[0015] According to the invention, this bellows 13 is—and this is very important—filled from the outset with a sufficient quantity of an anticoagulant. For example, per 500 ml of blood volume, the blood can contain at least 25,000 IU of an anticoagulant called heparin to reliably prevent blood coagulation. In the case of heparin, 25,000 IU is sufficient for up to 3 liters of blood. Even if less than 500 ml of blood enters the container 1, this does not result in any disadvantages, even if it contains 25,000 IU of this anticoagulant. Alternative anticoagulants, such as sodium citrate or others, are also suitable. This blood collection container 1 is therefore used in the manner shown here. Figure 2It is delivered from the factory in the condition shown and temporarily stored in the hospital until needed. Its important features are, firstly, that it has a connection piece 4 at its lower end for connecting a blood drainage tube 30 with a tube clamp 16. Secondly, it already contains a sufficient amount of anticoagulant for the full blood volume that the container 1 can hold, for example, up to 3 liters of blood. Thirdly, the entire container 1 is sterilized before being packaged in a hermetically sealable delivery bag 2 at the factory. It is then packed into the delivery bag 2 under sterile conditions and temporarily stored in this delivery bag 2 in the hospital. Whenever the blood collection container 1 is 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.Then the blood drainage tube 30 is connected to the lower nozzle 4 and this tube 30 is either closed with a tube clamp 16 or connected directly to a cell saver.

[0016] The Figure 3 shows a top view of the lid of the blood collection container. The two nozzles 6, 10, the connected tubes, and a cap 12 with a securing strap 11 are visible. On both sides of the circumference, brackets 14 are integrally molded onto the lid 5; they are shown here in their resting position. They can be pivoted upwards by 90° if necessary, forming two support brackets from which the blood collection container can be hung on a hook.

[0017] The Figure 4shows the lower end of the blood collection container 1 according to the invention. Here, the drainage nozzle 4 can be seen, as well as an auxiliary tube 15 connected to it with a tube clamp 16. Also present is a sterile cover cap 31, which hangs on a securing strap 32 so that it is always available to sterilely close the auxiliary tube 15 or a connected blood drainage tube 30. To connect the effective blood drainage tube 30, this small tube section 15 is removed, and the tube clamp 16 is pushed onto the effective blood drainage tube. The clamp 16 is then either closed or opened for a planned direct blood drainage.

[0018] The Figure 5shows this inventive blood collection container 1 in practical use. It is suspended from a hook 17 by its two suspension brackets 14. Connected to its intake port 6 at the top are the elbow 7 and a suction hose 18, which leads to a vacuum connection, as found in every operating room.

[0019] The blood drainage tube 19 is connected to the other nozzle 10. The blood drainage tube 30 is connected to the discharge nozzle 4 at the bottom of the bellows 13 of the blood collection container 1, as is the hose clamp 16. As indicated by arrows in the suction hose 18 and drainage hose 19, air is sucked out of the container 1 via the suction hose 18, and the induced air flow propagates into the drainage hose 19, so that with its free end and a suction piece attached there, blood can be conveniently sucked out of wounds or opened patient areas, according to the same principle as, for example, a dentist sucks saliva out of a patient's mouth.

[0020] If the tube clamp 16 in the blood drainage tube 30 is closed, blood will continuously flow into the container 1 during suction, along with sodium chloride, which is used for ongoing wound cleansing. The container 1 will gradually fill with blood. When the container 1 is full, the tubes 18, 19 at the top can be removed, and the nozzles 6, 10 can be closed with their caps 9, 12. The container 1 remains tightly closed at the bottom by the tube clamp 16. The collected patient blood is precious wound blood and is then available for transfusion. It does not clot and is stored sterile. Should complications arise during surgery—or even simply due to an unexpectedly high blood loss—this collected wound blood can be transfused directly, thanks to this container 1, as soon as a Cell Saver is placed in the operating room or is already present there.If such a blood purification device or a cell saver needs to be brought into the operating room, it must of course be done sterilely, meaning only a previously sterilized blood device may be brought into the operating room. In this case, the blood drainage tube 30 is connected to the lower nozzle 4 and its other end to the cell saver, so that the collected wound blood can be purified in the cell saver and then directed directly into an infusion bag, from which it can be administered to the patient via an infusion. The use of allogeneic blood and the associated logistical and medical measures can be omitted. This saves time and money, and infections are avoided. Furthermore, patients who have suffered relatively large blood losses can be discharged from the hospital earlier, usually one or even several days earlier than usual. This, in turn, saves considerable costs.

[0021] Wound blood is the most troublesome blood for the patient anyway, and thanks to this blood collection container 1, it is no longer lost as before, but is available to the patient at any time, either immediately or with interruptions of several hours or days. This means that no patient ever needs to bleed to death on the operating table again.

Claims

1. Blood collection container (1) with a suction nozzle (10) at the top for connecting a drainage hose (19) and a suction nozzle (6) for connecting the suction hose (18) of a vacuum connection, wherein the blood collection container (1) has a discharge nozzle (4) at the bottom for discharging collected wound blood via a blood discharge hose (30) to a blood purification device, and further in that the blood collection container (1) for wound blood contains an agent for inhibiting blood coagulation in sufficient quantity for a full volume of blood which the container (1) can hold, and is sterilised as a whole and is packed in a delivery bag (2) which is sterilely sealed by means of a hermetic closure (3), for opening in the operating theatre shortly before use.

2. Blood collection container (1) according to claim 1, wherein a hose section (15) is fitted to the lower discharge nozzle (4) as an auxiliary hose for connecting the blood discharge hose (30) to this discharge nozzle (4), wherein the hose section (15) can be closed with a hose clamp (16), so that by means of the hose clamp (16) the hose section (15) or the blood discharge hose (30) to be connected can be selectively opened or closed, and wherein a closure cap (31) can be fitted to the discharge nozzle (4) or to the hose section (15) via a securing means. the blood discharge hose (30) to be connected can be optionally opened or closed by means of the hose clamp (16), and wherein a sealing cap (31) is moulded onto the discharge nozzle (4) or the hose section (15) via a securing band (32).

3. Blood collection container (1) according to claim 1, wherein the container (1) is designed as a bellows (13), so that in the suspended state its volume can expand downwards with the amount of blood supplied and it can grow downwards to its full volume.

4. Blood collection container (1) according to one of the preceding claims, wherein the container (1) is sealed at the top with a disc-shaped lid (5), wherein the lid (5) is perforated by the two nozzles (6, 10) for connecting the suction hose (18) or the drainage hose (19).

5. Blood collection container (1) according to claim 4, wherein the nozzles (6, 10) can each be sealed by a cap (9, 12), which are each held on the lid (5) by a securing band (8, 11).

6. Blood collection container (1) according to one of the preceding claims, wherein an angle piece (7) can be placed on the connecting piece (10) to avoid kinks in the outgoing or incoming vacuum (18) or drainage hose (19).

7. Blood collection container (1) according to one of claims 4 to 6, wherein it has two suspension brackets (14) moulded onto its upper lid, which can be swivelled up towards each other, for suspending the blood collection container (1) from a hook.

8. Blood collection container (1) according to one of the preceding claims, wherein the volume of blood that the container (1) can hold corresponds to 3 litres of blood.