WO2004032999A1

WO2004032999A1 - A liquid component separator

Info

Publication number: WO2004032999A1
Application number: PCT/TR2002/000063
Authority: WO
Inventors: Osman Murat İVEGEN
Original assignee: Eczacibaşi - Baxter Hastane Ürünleri̇ A.Ş
Priority date: 2002-10-09
Filing date: 2002-10-09
Publication date: 2004-04-22
Also published as: AU2002348570A1; EP1556100A1

Abstract

The present invention relates to an apparatus that is used to transfer the components of the liquid in a flexible bag, various components of which are stacked on one another in layers after being subjected to centrifugation, to separate bags. The apparatus subject to the invention makes use of a bladder in order to exert pressure onto the parent bag containing said liquid. The movement created by the inflation of said bladder is transmitted to the parent bag my means of a plate. Furthermore, all child bags are hung to a single weighing unit and all of the tubes connected to said child bags are sealed simultaneously with a single seal.

Description

A LIQUID COMPONENT SEPARATOR

The present invention relates to an apparatus that is used to transfer the components of the liquid in a flexible bag, various components of which are stacked on one another in layers after being subjected to centrifugation, to separate bags.

Human blood collected from donors is filled in specific, elastic bags and then is centrifugally separated in three layers. The whole centrifuged blood, consists of a yellow plasma layer with the least density, an intermediary layer consisting of leukocytes and platelets, which is denser and has a pink colour (buffy-coat layer) and a lower layer consisting mostly of erythrocytes (red blood corpuscles), which is quite dense and heavy.

However separating said layers in a rapid and correct way is a procedure that has to be realized with accuracy, which takes quite a long time. In the state of art, various solutions are suggested with respect to this subject. In the course of time, automatic means, as well as the manual means, have been developed.

In the automatic devices of the state of art, the force obtained from the electric motor or pumps is applied on the parent blood bag and the blood component leaking out of the perforations provided on the bag as the result of the force applied, is transferred to the child bags by means of tubes.

In order to see which layer is in turn to be transferred, one had to either use an optical reader or depend on the skill ofthe operator.

In the US Patent No. 4,655,742, an arrangement wherein the blood components contained in the blood bag are transferred to various bags by applying a pressure by using a balloon inflated and deflated by a compressor, is disclosed. In European Patent No. 0 432 146, a blood component separator wherein a balloon is inflated by compressed gas to exert a direct force on the blood bag, is disclosed.

In US Patent No. 3,640,277, an arrangement comprising a balloon and a blood bag arranged side-by side, is described.

In the arrangement disclosed in the International Patent No. WO 96/29081 two inflatable pads are provided to exert pressure onto the blood bag.

In the EU Patent No. 329,786 a device that transfers the components to the bags according to the weight information obtained from a measuring unit, is described.

In the US Patent No. 4,663,032, a row of optical readers arranged on the parent bag, in order to determine which blood layer has been reached, is described.

The arrangements disclosed in these applications are quite expensive and complex devices. During the inflation of a balloon or an elastic bag (bladder), the pressure applied onto the blood bag is not distributed homogeneously. A separate tube, a separate balance and a separate seal has to be used for each child bag. Furthermore, arrangement of one or more optical readers directly on the parent bag, also increases the cost.

In the devices used in the state of art, the whole blood bag is placed from above, between the movable and stationary surfaces. If a large amount of blood is contained in said blood bag, it will be difficult to place it in its housing. Moreover in these arrangements, the face of the bag which is without the label has to be placed in the device, as the optical readers are provided at the stationary section. In case the label comes in front ofthe optical reader, or if the bag is wet, dirty etc. the product cannot be separated or if it is separated it will not be of the desired quality. In the previous arrangements, tubes are provided both on top and bottom of the blood bag so that the plasma, being the upper layer and the erythrocytes, being the lower layer, are transferred to the child bags. However, when they are too dense with very low viscosities, the transfer of the erythrocytes will take a long time.

The object of the present invention is to exert homogeneously a pressure onto the centrifuged parent bag by means of a plate pulled and/or pushed by a balloon that can be inflated and/or deflated by a compressor.

Another object of the present invention is to realize a device wherein the amount ofthe compounds contained in the blood bag is calculated automatically.

One other object of the present invention is to provide a device comprising only one balance from which child bags are suspended together.

Yet another object ofthe present invention is to seal the tubes opening to the ₍ child bags, simultaneously using only one sealer.

A final object of the present invention is to provide an economical device that realizes the separation ofthe liquid components in a rapid way.

The device realized to attain the above mentioned objects of the present invention has been illustrated in the attached drawings, wherein :

Figure 1, is the schematic view ofthe device;

Figure 2, is the detail view showing the flap and the sealer ofthe device, Figure 3, is the front perspective view of the section of the device wherein the parent bag is placed, Figure 4, is the cross-section view of another embodiment of the section wherein the parent bag is placed, Figure 5, is the cross-section view of another embodiment of the section wherein the parent bag is placed.

The components shown in the drawings have been enumerated separately as shown below :

1. Liquid component separating device

2. Compressor

3. Three-way valve

4. Balloon

5. Balloon plate

6. Shaft

7. Fixed plate

8. Bladder plate

9. Cover, lid

10. Balloon housing

11. Control Unit

12. Balance

13. Optical reader

14. Printer

15. Sealer

16. Guide

17. Parent bag

18. Valve outlet

19. Negative valve inlet

20. Positive valve inlet

21. Tube

22. Negative compressor outlet

23. Positive compressor outlet

24. Journal bearing

Kl : First flap K2 : Second flap TI : First child bag T2 : Second child bag

The device (1) according to the invention, which is used for separating the centrifuged liquids that contain more than one compound with different densities, particularly the blood compounds, comprises a compressed gas producing part (2); a balloon (4) inflated by said part (2); a housing (10) in the form of a box with one open face, in which said balloon is placed; a component (5, 6, 7, 24 and 8) that transmits the movement created by the inflation of said balloon (4) linearly and homogeneously, to the parent bag; a cover (9) located at the other side of the parent bag; an optical reader (13) that detects the type of the compound passing through the tube (21) leaving the parent bag; tubes (21) connecting the parent bag with the child bags (TI and T2); the flaps (Kl and K2) on which said tubes (21) are located; two guides (16) assembling the arms of the tube; a sealer (15) providing impermeability by heating and binding the ends of the tubes; a balance (12) from which the child bags are suspended together and a control unit (11) that operates/stops and/or opens/closes the components in line with data obtained from various components and data/command inputs entered by the user (Fig. 1).

The compressor (2) being an essential component that provides the compressed gas required to inflate the balloon in order to apply pressure onto the parent bag, is preferably of the 14 watt type. Said compressor, in addition to creating pressure to inflate said balloon, can also apply vacuum in order to deflate it and comprises two outlets (22 and 23) one of which generates negative pressure and the other, positive pressure. By virtue of the vacuum established, the balloon is deflated more rapidly and linearly, and consequently the device can be prepared more rapidly for a new operation.

The three-way valve (3) connected to said compressor, has three openings, namely one vacuum inlet (19), one pressure inlet (20) and one outlet (18). The vacuum outlet (22) ofthe compressor is connected to the vacuum inlet (19) ofthe said valve and the pressure outlet (23) of the compressor is connected to the pressure inlet (20) of the valve, whereas the outlet (18) of the valve is connected to the balloon.

Said balloon, made of a thick and elastic material, preferably of rubber, is inflated in a housing (10) with one open face which is made of a rigid and strong material, preferably of metal. Said housing provides the inflation of said balloon in the direction of its open face and allows it to transmit the thrusting force towards this direction.

The movement created by the inflation of the balloon, is transferred to the parent bag in various ways : First, it is transferred to the blood bag by means of a plate (7) fixed to the balloon at the open face side of the recess, of a shaft (6) movably placed in the journal bearing (24) of said plate (7) fixed in said balloon housing (10), and of a second plate (8) connected to said shaft (Fig. 3). The two plates are parallel to each other.

Secondly, only a shaft (6) fixed directly to the balloon (4) and a bag plate (8) connected to said shaft, are used.

In order to ensure the linear movement of the shaft, it is moved in one or more guide rails located next to the bag plate (8) (Fig. 5). Said rails may be formed as the extension of said balloon housing or can be incorporated later. Finally, the shaft may be deleted completely and the pressure is transferred to the parent bag only by means of a plate that moves in a linear way (Fig. 4).

A cover (9) is provided in front of the bag plate (8). The parent bag (17) placed inside the cover after it is opened, is left between the plate (8) and the cover (9) when it is closed. The tube (21) from said blood bag remains within the detection range of the optical reader (13). Said reader detects the type ofthe compound passing through the tube at the moment of reading, by making use of the fact that different compounds ofthe blood have different light reflection coefficients.

The tube passing through the reader, is divided into two branches in the form 'Y'. Each branch is provided with one flap (Kl and K2). Said flaps (K1,K2) control the flow of blood by opening/closing according to the commands sent by the control unit (11). After these flaps, the tubes are brought together by a guide (16a) and pass between the metal caps of a sealer (15). The tubes then pass through the second guide (16b) and are distributed to the child bags (TI and T2). When the sealer (15) is closed, it binds the plastic tubes by heating. When the head of said sealer (15) is opened, the branches of the tube are in a closed and sealed state in such a manner that the above remained liquid does not flow down. The guides (16a and 16b) being preferably metallic, enable said two tube branches first to come side-by-side, then to pass smoothly between the sealer caps and after passing, to be sealed as a single tube by following a single line again (Fig. 2).

The child bags (TI and T2) are suspended together from the balance (12). By using a single balance, the weights of both bags are monitored.

Said balance (12), flaps (Kl and K2), sealer (15) and compressor (2) are controlled by a control unit (11). Said control unit (11) comprises, input and output units, preferably a display, a key-set and various control buttons. In a preferred embodiment of the present invention, a printer (14) connected to the control unit, is also provided.

The liquid separator device, subject to the present invention is operated by a certain method. When the device (1) is first opened, the control unit checks the balloon (8) by the compressor (2) and if the user desires, checks the optical reader

(13), balance (12), printer (14), flaps (Kl, K2) key-set and the display, to see if a problem exists. It applies a certain pressure to the balloon and checks the pressure valves of the balloon, before, just after and a certain time after the application, in order to see if there is a leakage.

It also checks the compressor by detecting whether the balloon pressure rises to a certain value at a certain time period and whether it falls below a certain value at a certain time when vacuum is applied. These checking procedures are realized in a very short time, when the device is first opened.

After the opening, the device asks the user to enter certain data. These data can be entered by the user, by means of the key-set located at the control unit or by choosing one of the programs previously loaded. The authorized users can load, by using their passwords new programs to the memory ofthe device.

The main criterion to be taken as the base for the operation of the device, is the inhibition ofthe mixing ofthe intermediary layer into the other two layers. For this reason, information about the quantity of said layer is required.

This information can be entered by the user, but this method which depends on the skill and experience of the user, may lead to certain faults. Therefore, it is preferred that more accurate information such as the data related to the donor's blood and the weight of the blood bag should be input to the device and let the control unit (1) calculate the quantity/volume of the intermediary layer. In case said liquid is blood, the hematocrit, WBC (White Blood Cell; leukocytes), PLT (Platelet; thrombocytes), HGB (hemoglobin) counts and the quantity of the blood collected must be known.

Following said procedures, the device is brought to operational mode.

The centrifuged liquid (whole blood) is suspended without agitating to the hanger in the cover and the cover is closed slowly. The only tube leaving the parent bag (17) is placed in the recess of the optical reader (13) and the tube leaving said optical reader is divided into two branches by a connection in the form of a Υ and is connected to the child bags (TI and T2). Both tubes are provided with a flap (Kl and K2) each. After these flaps, said tubes pass together through a guide (16a), and between the caps of one sealer (15) and of a second guide (16b). The child bags to which said tubes are connected, are suspended together to a single balance (12).

Upon a command given to the device for the control unit to start the separation process, the flaps (Kl and K2) are closed but the metal caps of the sealer (15) are still open. The compressor generates a certain amount of pressure and stops, thus fills in the gap between the parent bag placed between the plate (8) and the cover and the plate. Meanwhile the balance (12) resets itself by taking the deadweight (tare) ofthe child bags (TI and T2). After a short while, the flap Kl is opened and the compressor is started; the yellow plasma liquid passing through this flap (Kl) starts to be transferred to the first child bag (TI). The control unit compares the weight information from the balance (12) and the information obtained from the optical reader (13), and makes an evaluation on whether there is a flow or whether the flow is excessive/insufficient or not. These evaluations provide the data necessary for the operation or stopping of the compressor and/or flaps. If the optical reader informs that the intermediate layer is reached or if the balance shows a value that is more than possible, said flap (Kl) is closed. In case the liquid to be separated is human blood, generally it contains 40 % dark red eryfhrocyte portion and 60 % yellow plasma portion and if the balance shows a calculation that the amount of plasma collected is more than 65 %, the control unit shuts the flap and warns the user. Usually a blood bag contains 450 ml of whole blood. 63 ml of ACD-A or another anticoagulant solution is previously put into said bag in order to prevent the spoiling (decomposition) of the blood taken from the donor. If the total volume is considered to be approximately 500 ml, it is not possible, theoretically to collect more than 325 ml of plasma. Thus, since the quantity of plasma has been calculated in advance, numerous errors can be avoided in case the optical reader (13) or the balance is defective. For instance, the balance checks the weight if the optical reader erroneously sends the command for closing the flap because of a red blood cell passing accidentally through the tube, although an adequate quantity of plasma has not yet been collected.

However, if the reader sequentially generates the red blood cell signal, it should be understood that the blood layers have been mixed and the system is stopped. If the reader does not send any other red blood cell signal and the balance still detects a deficient weight, it should be understood that the blood layers have been mixed instantaneously and the procedure is carried on.

After the collection of plasma and closing of the flap, the balance transfers the value it has taken when the child bags were empty, and the value it has taken after the plasma is collected, to the control unit. In this way, the volume of the plasma collected in the first child bag (TI) is calculated clearly. Then the flap K2 is opened while keeping the flap Kl closed, and the compressor is operated now, the pink colored intermediate layer is flowing through the tube.

The compressor is operated in line with the information sent by the balance to the control unit. When the weight value calculated for the intermediate layer or entered by the user is attained, or when the optical reader starts to send the information that the lowest red layer has been reached, the flap (K2) is closed and the compressor (2) is stopped.

If the user has chosen the option "Automatic Shut-off upon the opening of the device for the first time, the control unit switches on the sealer (15) and seals both child bags.

If another option has been selected, the control unit asks the confirmation of the user to close the bags and it seals the bags when confirmation is given. Upon the completion of sealing, the printer is enabled to print a product weight label and/or optionally a bar code immediately if the automatic labeling option has been chosen, or after receiving the confirmation of the user, if this option has not been chosen. Said labels are taken from the printer and are pasted on corresponding bags. In case no information is available about the bag, wliich usually is the case, the device prints only the weights of the plasma layer and of the intermediate layer on the labels. If the weight of the bag suspended to the cover is known and if this information has been entered to the device, said device also calculates the weight ofthe erythrocytes and prints three labels.

After the completion of blood transfer to the bags, the balloon is rapidly and linearly deflated by means of the vacuum applied by the compressor, which in turn leads to the return ofthe bag plate connected to the balloon.

Thus the device is prepared for a new separation process. It is also possible to provide more than two branchings of the tube by making more connections to the tube passing through the optical reader, if desired, and one child bag each can be attached to each branch. This method can be used for separating liquids comprising more than three components.

In the devices used in prior art, the whole blood bag is placed from above, between the movable and fixed surfaces. In these devices, if excessive blood is collected in the blood bag, it will be difficult to place said bag in its partition; whereas since the device according to the present invention comprises a cover, it is more flexible. Again, in the devices ofthe prior art, the face ofthe blood bag on which no label is pasted, has to be placed in the device, as the optical readers are placed at the fixed section. If the labeled face is brought, by mistake, in front of the optical reader or if the bag is wet, dirty, etc. the product cannot be separated or even if it is separated the quality of separation will not be satisfactory. In the device disclosed herein, it is not important to consider the face of the bag to be placed in the device, or whether the bag is wet, dirty, etc., as the product is monitored by the optical reader located at the downstream (outlet) of the bag, while it is flowing through the tube.

In the prior art devices, the uppermost layer, i.e. plasma and the lowest layer, i.e. erythrocytes are transferred to the child bags, by placing tubes both on the top and the bottom ofthe blood bag. However, the transfer ofthe erythrocytes may take a long time as they are quite dense with low viscosity. Whereas in the device of the present invention, the process that usually took 7-10 minutes previously, can be completed in a few minutes, as the erythrocytes are left in the parent bag while transferring the plasma and the intermediate layers to the child bags. Again in the prior art systems, two sealers had to be used as one more tube is present at the bottom of the parent bag in addition to the one at the top. This also increases the cost of the device. In the new device, the fact that all the tubes pass through a single sealer, reduces the production cost of the device as well as the cost ofthe blood separation process.

In the device according to the present invention, only a single balance is used while two separate balances for two products are used in the available systems.

In brief, the device according to the present invention is economical; it also provides saving of time by achieving the separation process in a very short time.

Claims

1. A device used for separating the compounds of centrifuged liquids comprising more than one compound of diffent densities, and for transferring them from a parent bag to the child bags, which comprises the child bags (TI and T2) connected to said parent bag, a balance (12), means for generating pressurized gas (2), a balloon (4) connected to said means, and an arrangement that transmits the movement created by the inflation of said balloon (4) to the parent bag, linearly and homogeneously.

2. A device as defined in Claim 1, characterized with a housing (10) in the form of a box with one open face, that causes the inflation of the balloon towards one direction.

3. A device as defined in Claim 1 and 2 characterized with a transmission system to transmit the movement of the balloon to the parent bag, consisting of one or more rails fixed to the lateral surfaces of the balloon housing and a plate (7) fixed onto the balloon at the open face side of the housing (10) in such a manner that it moves along said rails.

4. A device as defined in Claim 3, characterized with a transmission system which also comprises a shaft (6) secured between the balloon (4) and the plate (7).

5. A device as defined in Claim 4, characterized with a transmission system which also comprises a plate (5) secured between the balloon (4) and the shaft (6), in parallel to said bag plate (7).

6. A device as defined in Claim 1, characterized with a transmission system which also comprises, a plate (7) fixed onto the balloon at the open face side of the housing, a shaft (6) connected to said plate, which is movably placed in the journal bearing (24) in the said plate (7) fixed to the balloon housing (10) and a second plate (8) connected to said shaft. . A device as defined in any one of the above Claims, characterized with a single tube extending from the parent bag. . A device as defined in Claim 7, characterized with an optical reader (13) mounted on the tube (21) leaving the parent bag and which detects the type ofthe compound passing through said tube. . A device as defined in any one of the above Claims, characterized with a connection dividing the tube leaving the parent bag into more than one branch, flaps (Kl and K2) located on said branches, two guides (16a and 16b) assembling the branches and a single sealer (15) providing the sealing of all branches by heating and binding them simultaneously.

10. A device as defined in any one of the above Claims, characterized with a single balance (12) from which all child bags are suspended together.

11. A device as defined in any one of the above Claims, characterized with a compressed gas generating system which is a compressor that generates pressure to inflate the balloon linearly and applies vacuum to deflate it, provided with two outlets (22 and 23) one of which generates negative and the other, positive pressure.

12. A device as defined in Claim 11, characterized with a three-way valve, two inlets of which is connected to the compressor and one outlet, to the balloon.

13. A device as defined in any one of the above Claims, characterized with a control unit (11) that checks the components in line with the data from various parts and information/commands entered by the user, and operates/stops and/or opens/closes the device, and which comprises data input-output units, one display screen, a set of keys and various control buttons.

14. A device as defined in Claim 13 characterized in that it also comprises a printer (14) connected to the control unit/and which prints the product information labels to be pasted on the bags.

15. A device as defined in Claim 13 and 14, characterized with a control unit that realizes the steps of : closing the flaps (Kl and K2) upon the command for starting the separation process; filling in the gap between the plate and the parent bag placed between the plate (8) and the cover (9) when the compressor stops after generating a certain amount of pressure; self-resetting of the balance (12) by taking the deadweight (tare) of the child bags (TI and T2); opening of the flap (Kl) and starting of the compressor; start of the transfer of the first fluid compound passing through said flap to the first child bag (TI); comparison of the weight information from the balance (12) and the information obtained from the optical reader (13) to be made by the control unit which then makes an evaluation on whether there is a flow or whether the flow is excessive/insufficient or not; if the optical reader informs that the intermediate layer is reached or if the balance shows a value that is more than possible; closing said flap (Kl); opening the flap (K2) to collect the intermediate layer in the other child bag (T2); stopping the compressor when the collection of said layer is completed; leaving the last compound in the parent bag and printing the product information labels by the printer.

16. A device as defined in Claim 13 to 15, characterized with a control unit that checks the balance weight if the optical reader erroneously sends the command for closing the flap because of a piece of another compound passing accidentally tlirough the tube, although an adequate quantity of plasma has not yet been collected.; closes the flap connected to the bag in case the weight is more than that has been calculated; however if the weight is less than that has been calculated and if the reader sequentially generates a signal concerning the other compound, understands that the compounds have mixed with each other and stops the device: if the reader does not send any other a signal concerning the other compound, and the balance still detects a deficient weight, understands that the compounds have mixed with each other instantaneously and carries out the procedure.