Device for separating blood into its components as well as a method for doing so and use of such a device

Abstract

The invention relates to a device for separating blood into its components and a method for the same and use of such a device. The device comprises a magnetic drive device, which causes a container to rotate about its own axis, wherein the container has at least one open end and at least one inlet therein and is suspended in a magnetically floating manner.

Claims

1. A device for separating blood into its components, comprising a magnetic bearing and drive device, a container having a cylindrical shape suspended during operation in the bearing and drive device in a magnetically floating manner, having an axis, about which axis the container is rotated by the bearing and drive device during operation, and having at least one open end, at least one tube-shaped inlet and at least one outlet provided, independently, in the at least one open end of the container, at least one magnet connected to, or integrated into, the container, and a control device configured to control the at least one magnet and the magnetic bearing and drive device for securing and accurately positioning the container in the bearing and drive device during operation.

2. The device according to claim 1, further comprising a module accommodated by the at least one open end of the container, which module integrates therein the at least one inlet, the at least one outlet, or the at least one inlet and the at least one outlet and has means for removing the blood components that have been separated.

3. The device according to claim 1, characterized in that the container is made of a dimensionally stable material that is compatible with blood.

4. The device according to claim 1, characterized in that the container has a diameter of at least 10 mm and max. 100 mm and a height of at least 20 mm and max. 900 mm.

5. The device according to claim 1, characterized in that the at least one magnet is connected to the container, either releasably or fixedly, and is situated outside the container or inside the container.

6. The device according to claim 1, characterized in that the container is surrounded by a housing.

7. The device according to claim 1, characterized in that all blood-carrying parts are designed as disposable articles.

8. A method for separating blood into its components, comprising a container according to claim 1, wherein the method comprises the following steps: introducing blood into the container driving the container to rotate about its own axis removing the blood components characterized in that the container is suspended in a magnetically floating manner during the separation process.

9. The method according to claim 8, characterized in that the position of the container is detected by at least one sensor and is stabilized or corrected by an evaluation unit with the help of a control device.

10. The method according to claim 8, characterized in that the rotational speed in rotation is between 1000 and 50,000 revolutions per minute.

11. The method according to claim 10, characterized in that a plasma flow rate of 1 mL/min to 300 mL/min is achieved.

12. A medical technical treatment unit having the device according to claim 1, which is designed as a disposable unit.

13. The device according to claim 1 for separation of blood into its components as part of a medical technical treatment device.

14. The device according to claim 1, characterized in that the container is made of dimensionally stable plastic compatible with blood.

15. The device according to claim 1, characterized in that the container is made of polycarbonate.

16. The device according to claim 1, characterized in that the container has a diameter of at least 10 mm and max. 100 mm and a height of at least 20 mm and max. 500 mm.

17. The device according to claim 1, characterized in that the container has a diameter of at least 10 mm and max. 100 mm and a height of at least 20 mm and max. 500 mm, wherein the container has a minimum volume of 2 mL and a maximum volume of 600 mL.

18. The device according to claim 1, characterized in that the container has a diameter of at least 10 mm and max. 100 mm and a height of at least 20 mm and max. 900 mm, wherein the container has a minimum volume of 2 mL and a maximum volume of 600 mL.

19. The device according to claim 1, characterized in that the at least one magnet is integrated into the container forming a single piece.

Description

(1) The invention is explained in greater detail below with reference to the drawings, in which:

(2) FIG. 1: shows a simplified schematic diagram of the device according to the invention for separation of blood;

(3) FIG. 2: shows a simplified schematic diagram of the device according to the invention for separation of blood with a housing surrounding the container;

(4) FIGS. 3a-d: show various embodiments of the device according to the invention in a simplified schematic diagram.

(5) FIG. 1 shows an device according to the invention for separation of blood in a simplified schematic diagram.

(6) The device for separation of blood 1 has a container 2 and at least one bearing and drive device 11. The bearing and drive device 11 serves as a bearing for the container 2 and, at the same time, as a magnetic drive which is capable of inducing rotation of container 2 about its own axis.

(7) The container 2 may be positioned vertically or horizontally or even obliquely, i.e., in stages between these two orientations.

(8) With very tall containers, a counter-bearing may be mounted on the other end of the container 2 with respect to the bearing and drive device 11 to stabilize the container to prevent it from tilting.

(9) The counter-bearing may be designed purely mechanically as a guide aid.

(10) A magnetic embodiment of the counter-bearing in approximation to the bearing and drive device 11 is also conceivable, so that here again, a magnetically levitated and thus non-contact mount and, if necessary, an additional drive may also be provided here.

(11) The container 2 has at least one inlet 5, which is situated on the at least one open end 3 of the container 2.

(12) The open end 3 of the container 2 may be opened completely over the entire diameter of the container 2 or even to a lesser extent. The protrusion 15 formed with a less wide opening of the container 2 may serve as an overflow weir 10 for the outflowing blood plasma or blood serum 13, while the separated blood components 14 with a higher density are retained by it in the container 2.

(13) At least one outlet 6 may also be provided on an open end 3 of the container 2.

(14) The container 2 is made of a dimensionally stable material which is compatible with blood, for example, glass, metal or plastic. Of the plastics, polycarbonates have proven especially suitable. Use of thermoplastics or other dimensionally stable plastics that are compatible with blood is also conceivable.

(15) The container 2 preferably has a cylindrical, shape, wherein the diameter 2a is min. 10 mm and max. 100 mm and the height to 2b is min. 20 mm and max. 900 mm, preferably 500 mm. The diameter 2a and height 2b can be varied and also influence one another mutually. Thus, if the diameter 2a is reduced, the height 2b must increase and vice versa, so that these two parameters are in a ratio to one another that is appropriate for the result of the separation, and the volume of the container 2 is not less than a minimum of 2 mL and does not exceed a maximum of 600 mL.

(16) The container 2 is in contact with at least one magnet 9. The magnet 9 may be releasably or fixedly connected to the container 2 and/or may be a one-piece component with the same.

(17) If the magnet 9 in one embodiment is releasably connected to the container 2, then it may be removed and reused before disposing of the container 2.

(18) The magnet 9 may be situated in the interior of the container 2 or may also be on the outside of the container 2. If the magnet is mounted in the interior of the container, then it is a type of overflow weir 10 at the same time, so that the plasma is already separated at this location. This simplifies the separation process.

(19) If the magnet is mounted on the outside of the container 2, it may advantageously be stored and reused when the container 2 is discarded.

(20) The use of various types of magnets such as a shell magnet or a disk magnet or a ring magnet which completely or partially surrounds the container 2 is also conceivable. Use of multiple small magnets which are grouped at a defined distance in or on the container 2 is also possible.

(21) The parts of the device which come in contact with blood may be designed as reusable parts, but then they must be cleaned after each use. Therefore all blood-carrying parts are advantageously designed as disposable items. These can be discarded after use.

(22) The device according to the invention has a bearing and drive device 11, which builds up a magnetic field and at the same serves as the bearing for the container 2 so that the container is held in a magnetically levitated position. The drive device may be operated electromagnetically. A drive by means of rotating permanent magnets, compressed air or fluid is also conceivable.

(23) In the operating state, the container 2 rotates about its own axis, driven and held in suspension by the interaction between the magnetic field created electromagnetically by the bearing and drive device 11 and the magnet 9, which is either connected to the container 2 or integrated into it.

(24) The rotational speed during operation is between 1000 and 50,000 revolutions per minute.

(25) The centrifugal force occurring due to the rotation leads to the separation of the blood which is introduced into the container 2 through the inlet 5 at the first open end 3 or at the second open end 3 and is distributed on the inside of the wall of the rotating container 2. The blood components 14 that are separated are distributed according their density at different radial distances from the wall of the container 2, while the blood plasma and/or serum 13 is collected centrally in a container 2. The blood components and the blood plasma and/or serum 13 are forced in the direction of the open end of the container 2 by the blood being continuously resupplied.

(26) A plasma flow of 1 mL/min to 300 mL/min is achieved, depending on the rotational speed.

(27) A bearing and drive device 11 of the type described here is used, for example, by the company Levitronix for the drive for centrifugal pumps which are used to pump a fluid.

(28) With the magnetically levitated mount, the position of the container 2 can be corrected by means of a control device 18, which controls the magnets to ensure a secure and accurately positioned mounting of the container 2 in the bearing and drive device for the duration of operation.

(29) The functioning with respect to magnetic bearing and drive is described in detail in the documents EP 0 900 572 and EP 0 819 330, in particular, the contents of which are familiar to those skilled in the art and are herewith incorporated into the present description.

(30) Due to the magnetic interaction and/or the resulting reluctance forces the container is stabilized to a certain extent even to prevent tipping.

(31) In a particularly preferred embodiment, at least one sensor 16 is integrated into the device; by means of the sensor together with an evaluation unit 17, it is possible to obtain information about the position of the container.

(32) An embodiment of the blood-separating device according to the invention in the form oil a disposable cassette as a medical technical treatment unit is also conceivable.

(33) The device according to the invention may be part of a medical treatment device.

(34) The device according to the invention may be used for separation of blood.

(35) FIG. 2 shows a simplified schematic diagram of the device according to the invention for separation of blood with a housing 12 which surrounds the container 2.

(36) The container 2 may advantageously be surrounded by a housing 12. The housing 12 spatially separates blood and blood components 14 from the bearing and drive device 11. If unforeseen contaminants from the surroundings around the container 2 occur in introducing or removing blood components 14 or even if the container 2 itself has a defect, the user is protected from contact with possible infectious material. All cost-intensive parts such as the bearing and drive device 11 of the container 2 are not contaminated and may continue being used.

(37) Conversely, the blood to be treated and its components are protected from contaminants, thereby ensuring sterility.

(38) If the device is operated in the manner of an overflow centrifuge, the housing 12 may also serve as a collecting vessel for overflow of blood plasma and/or serum 13. It is conceivable to flood the space around the container 2 completely with blood plasma or serum 13.

(39) If the housing 12 has an outlet 12a, then blood plasma or serum 13 can be removed. The blood components 14 remaining in the container 2 are removed separately.

(40) FIG. 3a shows an embodiment of the device 1 according to the invention in a simplified schematic diagram in which the magnets 9 are located on the closed end 4 of the container 2.

(41) FIG. 3b shows an embodiment of the device 1 according to the invention in a simplified schematic diagram in which the magnets 9 are on the closed end 4 of the container 2 and a module 7 having means for removing the blood components 8 from the at least one open end 3 of the container 2 is accommodated.

(42) It is also conceivable that the module 7 is designed so that individual blood components 14 may themselves be removed with it, for example, in that the blood components 14 are released from the wall of the container and conveyed outward, while the edge of the module 7 is in contact with the inside edge of the container 2.

(43) Inlet 5 and/or outlet 6 may also be integrated into the module 7.

(44) FIG. 3c shows an embodiment of the device 1 according to the invention in a simplified schematic diagram in which the magnets 7 are mounted at half height within the container 2. In this embodiment, the container 2 has a first open end 3 and a second open end 3.

(45) The blood is introduced through the lower end 3 while the blood components having a higher density collect beneath the magnets 9 in the lower section 2 of the container 2 during rotation while the blood plasma or blood serum 13 having a lower density overcomes the magnets 19 and moves into the upper section 2 of the container 2. The magnets 9 then serve as an overflow weir 10.

(46) FIG. 3d shows an embodiment of the device 1 according to the invention in a simplified schematic diagram, in which the magnets 9 are mounted on the exterior of the container 2.

(47) In addition to the embodiments describe above, additional embodiments with variations of the aforementioned features are of course also conceivable.

LIST OF REFERENCE NUMERALS

(48) Device for separation of blood 1 Container 2 Upper section of the container 2 Lower section of the container 2 Diameter of the container 2a Height of the container 2b Open end 3 First open end 3 Second open end 3 Closed end 4 Inlet 5 Outlet 6 Module 7 Means for removing the blood components 8 Magnet 9 Overflow weir 10 Bearing and drive device 11 Housing 12 Outlet of the housing 12a Blood plasma/serum 13 Separated blood components 14 Protrusion 15 Sensor 16 Evaluation unit 17 Control device 18 Axis of rotation 19