Blood examination apparatus

Abstract

To provide an improved blood examination apparatus.SOLUTION: The present invention relates to a blood examination apparatus for direct connection to a blood flow apparatus, particularly a through-flow apparatus of an extracorporeal blood circuit, and for detecting a blood parameter of blood flowing through the through-flow apparatus. The blood examination apparatus can be operated cordlessly.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a flow-through unit for blood, in particular to a blood testing device that can be directly connected to a flow-through unit for extracorporeal blood flow and can record blood parameters of the blood flowing through the flow-through unit.

[0002] Furthermore, the present invention relates to a flow-through unit designed and intended to be added to extracorporeal blood flow such that blood flows along a flow path through the flow-through unit and is designed to be directly connected to a blood testing device according to the present invention.

[0003] The present invention also relates to a system having a blood testing device of this type and a flow-through unit of this type.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] The problem of the present invention is to provide an improved blood testing device.

[0006] This problem is solved by a blood testing device characterized by being operable wirelessly.

[0007] The problem of the present invention is also to provide a flow-through unit that can easily and quickly determine various blood parameters in various ways by a blood testing device that can be connected to the flow-through unit.

[0008] This problem is solved by a flow-through unit, characterized in that the flow-through unit has at least one attachable transducer element and at least one flow-through device transducer.

Means for Solving the Problem

[0009] In particular, the blood testing device according to the present invention can be designed to be self-powered. The blood testing device according to the present invention is fast and is particularly advantageous in that it can be used without the need to be connected to a power source or accompanied by other devices. Since the blood testing device of the present invention is operated without cables, on the one hand, it is particularly easy to handle, and on the other hand, the staff treating the patient is not obstructed by the hanging cables and the cables are prevented from being disconnected by the moving staff. There is no need to attach the blood testing device to other devices for control, operation, power supply, or data display by visual display or alarm. Therefore, the blood testing device can be used anywhere where it is necessary to determine the measurement of one or all parameters in the blood-carrying blood vessels. Possible places of use are the fields of cardiopulmonary bypass devices, ECMO and ECLS (support of artificial lungs, artificial hearts, or heart circuits), organ perfusion, and other organ replacement or support systems.

[0010] The device can have a display for displaying the desired measurement parameters and one or more operating knobs that can select or change the display of the measurement parameters and alarms. Also, the device can be easily activated with an operating knob as needed for power saving.

[0011] Furthermore, the blood testing device is preferably designed as a portable device, is compact, and can be carried by one person and is easy to use. Therefore, the device can be lighter than 1 kg, particularly lighter than 0.5 kg, and has a housing smaller than 10×10×10 cm, particularly smaller than 10×6×6 cm. In particular, the device is made so that it can be easily attached to the blood-carrying blood vessels without the need for a support.

[0012] In an advantageous embodiment, the blood testing device has a housing, and arranged within or on the housing are an electrical energy storage device and a display device for displaying the recorded blood parameters, which can be supported or replaced by a cable such as a USB cable and are charged even during the operation of the internal current source. Data can also be transmitted or read out using an optional connection. Charging by energy transmission is also possible.

[0013] In a particular embodiment, the blood testing device has a device for wireless transmission of data for external monitoring, for example via a Bluetooth or RF link. When the patient enters the medical environment after transportation, the blood testing device can be directly connected to the medical monitoring system.

[0014] In a particular embodiment, the blood testing device has a transducer. In particular, the transducer is designed and specified such that the flow-through unit can be operably connected using a transducer connection element. The transducer connection element may be, for example, a window or a membrane as described in detail below. Basically, it is advantageously provided that an operable connection is formed between the transducer of the blood testing device and the transducer connection element of the flow-through unit in order to measure the blood value. In order to form an operable connection, preferably a positive locking connection is established between the blood testing device and the flow-through unit. Furthermore, it is preferred that the transducer is connected such that it is in close contact with or directly touches the transducer connection element.

[0015] In one embodiment, it is particularly advantageous for the transducer to have at least one light source for illuminating the blood flowing through the flow-through unit. By doing so, the transducer may cause specific light to penetrate into the blood, and the detected light emitted from the blood (e.g., reflected light, scattered light, or fluorescence) can be detected by the light sensor of the transducer and, if necessary, analyzed particularly with respect to the light power and / or wavelength.

[0016] Alternatively, or in addition, it can be advantageously provided that the transducer has at least one sound source for applying sound to the blood flowing through the flow-through unit. By this method, a specific sound can be input into the blood by the transducer. A sound sensor for receiving the sound reflected from or scattered by the blood may be provided. This type of transducer may particularly be an ultrasonic transducer that operates based on ultrasonic waves and functions as a flow meter.

[0017] In one embodiment, it is particularly advantageous for the transducer to have both a light source and a sound source. As a result, both blood parameters provided by the transducer having a light source and the transducer having a sound source can be recorded simultaneously.

[0018] In one embodiment, the blood testing device according to the present invention has a transducer interface designed and intended to be operably connected to a flow-through transducer incorporated in the flow-through unit, which facilitates handling. Thereby, the blood testing device can be used together with a flow-through unit including an integrated transducer, which enables a simple and rapid connection without the need for additional cable connections in particular.

[0019] In particular, the transducer interface can advantageously be designed such that the power from the electrical energy storage device of the blood testing device is transmitted to the flow-through device transducer incorporated in the flow-through unit, and / or is designed to transfer a measurement signal from the flow-through device transducer incorporated in the flow-through unit. In this way, by connecting to the blood testing device of the present invention without the need to connect an additional cable connection to the power or signal transmission facility, it becomes possible to immediately place the flow-through device transducer incorporated in the flow-through unit.

[0020] In particular, the transducer can preferably be a pressure transducer, a flow transducer, or an optical transducer. In particular, it is also particularly possible for there to be a plurality of different types of transducers. In this way, various technical investigation possibilities can be realized, especially in combination.

[0021] In a simple and easy-to-handle embodiment of the blood testing device, there is a holder, within or on which the flow-through unit can be attached, in particular non-destructively and / or without using tools. The holder enables quick and efficient, in particular non-destructive, connection or disconnection of the flow-through unit. Furthermore, by enabling the user to immediately recognize the possibility of connection, operator errors due to incorrect connection can be reduced. In particular, this ensures that the blood testing device and the flow-through unit are correctly and safely connected.

[0022] The holder can be advantageously designed such that when adding the through-flow unit, an operable connection of the transducer to the transducer connection element and / or an operable connection of the transducer interface to the through-flow device transducer is automatically formed. In an advantageous manner, this results in an efficient connection of the through-flow unit to the blood testing device. Alternatively, or in addition, the holder can be designed such that an operable connection of the transducer interface to the through-flow device transducer automatically occurs while the through-flow unit is being added, thereby advantageously enabling the transmission of data from a transducer disposed on or within the through-flow unit to the blood testing device as well.

[0023] In certain embodiments, the holder has at least one fastening element for fastening the through-flow unit. Thereby, the through-flow unit can be fastened to the blood testing device particularly securely. Alternatively, the through-flow unit can have a fastening element that creates a mechanical connection with the holder. In another design, the holder has a fastening element that cooperates with a pair of fastening elements of the through-flow unit, thereby enabling a particularly stable attachment.

[0024] In an advantageous embodiment, the blood testing device is designed to record at least one blood parameter. For this purpose, the blood testing device has a signal and data processing unit that processes signals received from a transducer, such as reflected sound from blood cells, and determines the corresponding blood parameters from the signals and transmits them to an output part on a display device.

[0025] In particular, the blood testing device is designed to record at least the following blood parameters, namely, the oxygen saturation of the blood, the CO 2 content of the blood, the temperature of the blood, the pressure of the blood, the change in blood flow rate over time, the blood flow velocity, and the proportion of hemoglobin in the blood. As a result, many blood parameters related to the patient's biological functions can be monitored, particularly in a permanently advantageous manner.

[0026] The flow-through unit according to the invention is designed and intended to be incorporated into an extracorporeal blood circuit, so that blood flows along the direction of flow through the flow-through unit and is suitable for direct connection to the blood testing device according to the invention. The flow-through unit has at least one transducer connection element and at least one flow-through device transducer.

[0027] Thus, with the flow-through unit, firstly, the blood testing device can be mechanically connected particularly easily, and secondly, the connection for transmitting energy and data is particularly easily carried out both from the flow-through unit to the blood testing device and from the blood testing device to the flow-through unit.

[0028] In a special embodiment, the flow-through device transducer has a pressure transducer for recording the pressure of the blood in the extracorporeal blood circuit.

[0029] In a further embodiment, the flow-through device transducer has a flow transducer. Thus, in an advantageous manner, the flow rate of the blood through the extracorporeal blood circuit per unit time can thereby be determined.

[0030] In another embodiment, the flow-through device transducer has an optical transducer. In this type of embodiment, for example, there is the advantage that the oxygen saturation, CO 2 content, or hemoglobin content of the blood can be determined.

[0031] Advantageously, the flow-through unit can also have a plurality of integrated transducers, in particular some of the above-mentioned transducers.

[0032] Alternatively, or in addition, the transducer mounting element can be designed to connect to the flow-through device transducer of the blood testing device, where in the blood testing device, the flow-through device transducer has a pressure transducer, a flow transducer, or an optical transducer. As a result, the various transducers of the blood testing device can be connected to the flow-through unit in various combinations in an advantageous manner.

[0033] In a particular embodiment, the flow-through device transducer can also have at least one light source for illuminating the blood flowing through the flow-through unit. Using this method, a specific amount of light enters the blood by the transducer, and the detected light is detected using the illuminometer of the transducer by the influence of the light emerging from the blood (e.g., reflected light, scattered light, or fluorescence), and if necessary, analyzed particularly with respect to the light intensity and / or wavelength.

[0034] Alternatively, or in addition, it can be advantageously provided that the flow-through device transducer has at least one sound source for influencing the blood flowing through the flow-through unit using sound. This is achieved by the transducer, particularly by directing an adjustable sound into the blood. Also provided is an acoustic sensor that receives the sound reflected or scattered by the blood. This type of transducer can particularly be an ultrasonic transducer, which operates based on ultrasonic waves and functions as a flow meter.

[0035] One embodiment where the transducer is both a light source and a sound source is particularly advantageous. As a result, in particular, a plurality of different blood parameters can be recorded simultaneously.

[0036] In particular, it can be advantageously provided that the transducer mounting element has a window. For example, before the blood testing device is connected to the through-flow unit, it is possible to visually confirm through the window that blood is flowing from the through-flow unit. Thus, in an advantageous manner, medical personnel can see, for example, a color change of the blood indicating a change in the hemoglobin content in the blood.

[0037] Furthermore, since the light from the light source of the optical transducer and / or the light received by the sensor of the optical transducer can be propagated through the window, an efficient connection of the optical transducer is possible.

[0038] Alternatively, or in addition, the transducer mounting element of the through-flow unit can have a flexible membrane. By means of the flexible membrane, it is possible to make operative contact with the blood flowing through the through-flow unit.

[0039] The mechanical flexibility of the membrane enables, for example, a quick and easy connection of a transducer designed as a pressure transducer of the blood testing device according to the invention. By means of this type of membrane, for example, an increase in the pressure of the blood within the through-flow unit or within an extracorporeal blood circuit causes the membrane to bulge outward in a dome shape and is directly transmitted to the pressure transducer.

[0040] In a particularly advantageous and particularly compactly designed embodiment, both the transducer connection element and the through-flow device transducer (and possibly also other elements of this type) surround the longitudinal axis of the through-flow unit in a tangential direction and / or are arranged axially spaced apart from each other. In particular, they can be arranged in a common plane perpendicular to the direction of flow. For this to occur, the through-flow unit is designed to be short and compact in an advantageous manner with respect to its longitudinal extension. Thus, the device can also be used in the curved region of the tube or does not prevent the tube from extending flexibly. Usually, the transducer is arranged in the direction of flow or longitudinally at various positions.

[0041] In a further embodiment, the through-flow unit has a plug-in connection for fluid connection to a tube or tubing section of an extracorporeal blood circuit. The tube can be plugged into the plug connection, is particularly non-slip, and interlocks with each other. In particular, this prevents leakage at the interface between the tube and the through-flow unit, so that blood does not leak from the extracorporeal blood circuit.

[0042] In particular, the plug-in connections each have a disk. Each of the disks can function as a stop element for the respective tube to be attached. Alternatively or additionally, the disks can be arranged to mechanically guide the through-flow unit and the blood testing device during the connection process to each other, and the blood testing device can be guided, in particular, between the disks to a part of the through-flow unit such that they interlock.

[0043] In a particularly advantageous embodiment, the through-flow unit is made of a flexible material, in particular plastic. This allows it to be deformed to a certain extent without damaging the structure due to its flexibility, thus reducing the risk of breakage or malfunction of the through-flow unit due to mechanical shock. In particular, the through-flow unit can have a flexible transparent tube or be designed in the form of a flexible transparent tube containing its technical device through which blood flows. The transparent tube can, in addition to the advantages already mentioned with regard to flexibility, also allow direct observation of the blood in an advantageous manner. The blood testing device can also advantageously be designed to be operably connected to a simple, in particular transparent, tubing as a through-flow unit (without an integrated transducer) for recording blood parameters.

[0044] Alternatively, the through-flow unit according to the invention may be designed as a cuvette made of polycarbonate or MABS.

[0045] Particularly advantageous is a system having a through-flow unit according to the invention and a blood testing device according to the invention. Thereby, medical personnel can quickly and easily measure and / or monitor the blood parameters in the extracorporeal blood circuit of a patient, particularly a patient connected to a heart-lung machine.

[0046] In the drawings, the subject matter of the invention is shown illustratively and schematically and is explained using the figures in the following text, in which most of the same elements and elements acting in the same way are given the same reference numerals even in different embodiments.

Brief Description of the Drawings

[0047]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Embodiments for Carrying Out the Invention

[0048] FIGS. 1 and 2 show a plan view of an embodiment of a system according to the invention comprising a blood testing device 1 and a through-flow unit 2. The blood testing device 1 is connected to the through-flow unit 2 of an extracorporeal blood circuit 3. The blood testing device 1 is designed to record the blood parameters of the blood flowing through the through-flow unit 2.

[0049] The through-flow unit 2 has two plug connectors 4 connected to the tube 5 of the extracorporeal blood circuit 3. The direction of flow 25 is indicated by the arrows in FIGS. 1 and 2.

[0050] The blood testing device 1 has a housing 6, and disposed within or on the housing are an electrical energy storage device 7 (not shown in FIGS. 1 and 2) and a display device 8 for displaying the recorded blood parameters.

[0051] The blood testing device 1 of this system can be used quickly without the need to connect to a power circuit or other devices. Since the blood testing device 1 is operated without cables, on the one hand, it is particularly easy to handle, and on the other hand, the staff treating the patient does not feel inconvenienced by the hanging cables or have the cables disconnected by the moving staff. Furthermore, the blood testing device 1, as a manual device, has a particularly compact design.

[0052] FIG. 2 shows an extracorporeal blood circuit 3 having a through-flow unit 2 to which the blood testing device 1 is connected. The extracorporeal blood circuit 3 also has a pump 9 for sucking up blood and an artificial lung 10. The devices are connected by tubes 5, and the connection to the patient's blood circuit is also made by tubes 5.

[0053] FIG. 3 shows a second embodiment of the system according to the invention, including a second embodiment of the blood testing device and a second embodiment of the through-flow unit, in cross-section. The blood testing device 1 is autonomously designed and can be operated without cable connection to other devices of the cardiopulmonary bypass device or an external energy source. In the illustrated embodiment, the blood testing device 1 has an electrical energy storage device 7 which is a battery 11 for supplying electrical energy to the remaining components of the blood testing device 1.

[0054] The blood testing device 1 has a holder 12 to which the through-flow unit 2 is fixed. The holder 12 has a flap 16 pivotally attached to the housing 6 rotatably, and this flap can be opened for inserting the through-flow unit 2 and can be closed again after the insertion of the through-flow unit 2 so that the through-flow unit 2 is operatively connected to the blood testing device 1. The upper part of the flap 16 is flexible and has a snap-in lug 26 at its end.

[0055] The through-flow unit 2 is non-destructively attached to the holder 12 without the need for tools. The holder 12 enables quick and efficient connection and disconnection of the through-flow unit 2. Also, by allowing the user to immediately recognize the fixing ability, the holder 12 can reduce the risk of operational errors due to misconnection. In particular, this ensures that the blood testing device 1 and the through-flow unit 2 are correctly and safely connected.

[0056] The through-flow unit 2 has a transducer mounting element 17, and the blood testing device 1 has a transducer 18. The transducer 18 is an optical transducer 19. The transducer mounting element 17 is formed by the transparent wall of the through-flow unit 2, and light for recording an optical measurement signal can pass through the transparent wall.

[0057] When the through-flow unit 2 is added, an operable connection of the transducer 18 of the blood testing device 1 to the transducer mounting element 17 of the through-flow unit 2 is automatically formed, and an operable connection of the transducer interface 23 to the through-flow device transducer 13 of the through-flow unit 2 is automatically formed. By doing so, advantageously, an effective connection of the through-flow unit 2 to the blood testing device 1 occurs. Advantageously, data can also be transmitted from the transducer 13 to the blood testing device 1 via the transducer interface 23.

[0058] The through-flow unit 2 has a through-flow device transducer 13 which is a pressure transducer 14 according to the embodiment shown in FIG. 3. The pressure transducer 14 is connected by a transducer connecting element 17 which has an interior 15 of the through-flow unit 2 through which blood flows, so that the blood pressure occurring in the interior space is transmitted to the pressure transducer 14. The transducer mounting element 17 has a membrane by means of which the blood pressure is transmitted to the pressure transducer 14.

[0059] Alternatively, the transducer mounting element 17 can also be designed, for example, by a compression die acting on the pressure transducer 14.

[0060] The blood testing device 1 also has an electrical device 20 such as a programmable logic controller (PLC), and a display device 8 for the display of the recorded blood parameters.

[0061] Furthermore, the blood testing device 1 has a transceiver device 21 for transmitting and receiving measurement signals, and the transceiver device 21 of this embodiment is designed for wireless transmission.

[0062] FIG. 4 is a sectional view of a third embodiment of the blood testing device 1 according to the invention. The blood testing device 1 has an optical transducer 19 as a transducer 18 arranged on the opposite side of the pressure transducer 14 of the through-flow unit 2.

[0063] The battery 11 of the blood testing device 1 supplies power to both the optical transducer 19 of the blood testing device 1 and the pressure transducer 14 of the through-flow unit 2. The battery 11 is connected to the transducer 19 by a cable and to the pressure transducer 14 by a transducer interface 23 shown schematically.

[0064] FIG. 5 shows a perspective view of a fourth embodiment of the through-flow unit 2 according to the invention.

[0065] The through-flow unit 2 has two plug-in connections 4 for fluid connection to a tube 5 (not shown) of an extracorporeal blood circuit 3 (not shown). Each of the plug-in connections 4 has a disk 22. The disk 22 functions as a stopper for the tube 5 to be connected. The disk 22 serves two functions simultaneously, that is, as soon as the blood test device 1 is inserted into and connected to the through-flow unit 2, it functions as a guide for connecting the blood test device 1 to the through-flow unit 2. Further, the disk 22 is arranged so as to enable the interlocking connection of the blood test device 1.

[0066] The disk is also arranged to guide the blood test device 1 for attachment to the through-flow unit 2. The blood test device 1 is guided between the disks 22, and the intermediate part of the through-flow unit 2 is pressed against the disks in an interlocking manner.

[0067] The through-flow unit 2 also has a pressure transducer 14 and a transducer mounting element 17 for the automatic connection of a transducer 18 (not shown) of the blood test device 1. The transducer mounting element 17 and the pressure transducer 14 are arranged on one common plane (schematically shown by a dotted line) perpendicular to the flow direction 25. By doing so, since it extends in the longitudinal direction, the through-flow unit 2 is designed to be short and compact.

[0068] FIG. 6 shows a cross-sectional view of a fifth embodiment of the through-flow unit 2 according to the present invention.

[0069] The through-flow unit 2 is defined as the blood test device 1 according to the present invention. For the sake of simplicity, only the transducer 18 of the blood test device 1 is shown. The blood test device 1 has a transducer 18 that measures the blood flow rate per unit time as an ultrasonic transducer 24. The ultrasonic transducer 24 has an ultrasonic transmitter and a reflector that reflects ultrasonic waves. Further, the blood test device 1 (not fully shown) measures the oxygen content and / or CO in the blood 2It has an optical transducer 19 for determining the content.

[0070] Since there are a plurality of transducers 18 of various types, they can also bring various technical possibilities in combination.

Explanation of symbols

[0071] 1 Blood testing device, 2 Through-flow unit, 3 Blood circuit, 4 Plug-in connection part, 5 Tube, 6 Housing, 7 Energy storage device, 8 Display device for display, 9 Pump, 10 Artificial lung, 11 Battery, 12 Holder, 13 Through-flow device transducer, 14 Pressure transducer, 15 Internal space, 16 Flap, 17 Transducer connection element, 18 Transducer, 19 Optical transducer, 20 Programmable logic controller, 21 Transceiver, 22 Disk, 23 Transducer interface, 24 Ultrasonic transducer, 25 Flow direction, 26 Snap-in lug.

Claims

1. 1. A blood testing device for direct connection to a flow-through unit for blood, in particular to a flow-through unit of an extracorporeal blood circuit, and for recording blood parameters of the blood flowing through the flow-through unit, characterized in that the blood testing device can be operated without cables.

2. 2. The blood testing device according to claim 1, wherein the blood testing device has a housing, and an electrical energy storage device and a display device for displaying the recorded blood parameters are disposed within or on the housing.

3. 3. A blood test apparatus, particularly as defined in claim 1 or 2, characterized in that it operates autonomously.

4. 4. The blood test apparatus according to claim 1, 2 or 3, comprising at least one transducer.

5. 5. The blood test apparatus according to claim 4, wherein the transducer comprises: a. having at least one light source for illuminating the blood flowing through the flow-through unit; and / or b. having an acoustic source for acoustically enveloping the blood flowing through the flow-through unit; and / or c. having a pressure transducer; and / or d. having a flow transducer; and / or e. Having an optical transducer A blood testing apparatus comprising:

6. 6. The blood test apparatus according to claim 1, further comprising at least one transducer interface.

7. 7. The blood test apparatus according to claim 6, wherein the transducer interface comprises: a. Transfer energy from an electrical energy storage device to a flow-through device transducer integrated into the flow-through unit; and / or b. Relaying the measurement signal from the flow-through device transducer built into the flow-through unit A blood test apparatus characterized by being designed as follows.

8. 8. The blood testing device of claim 6 or 7, wherein the transducer interface is designed to connect to a through-flow device transducer having a pressure transducer, a flow transducer, or an optical transducer.

9. 9. The blood test apparatus according to claim 1, characterized in that a holder can be fixed in or on the one flow-through unit.

10. In particular, the blood test apparatus according to any one of claims 1 to 9 is configured to measure the following blood parameters: a. the blood oxygen saturation; b. CO in the blood ２ content, c. the temperature of the blood; d. the pressure of the blood; e. the flow rate of said blood per unit time; f. the flow rate of the blood; g. The percentage of hemoglobin in said blood A blood testing device characterized in that it is designed to record at least one of the following:

11. A flow-through unit designed and intended to be introduced into an extracorporeal blood circuit, in particular designed to be directly connected to a blood testing device as described in any one of claims 1 to 8, characterized in that the flow-through unit comprises at least one transducer mounting element and at least one flow-through device transducer, such that blood flows along the direction of flow through the flow-through unit.

12. 12. The flow-through unit of claim 11, a. the through-flow device transducer comprises a pressure transducer, a flow transducer or an optical transducer; and / or b) the flow-through device transducer has at least one light and / or sound source to flood the blood flowing through the flow-through unit with light and / or sound; and / or c) the transducer mounting element is designed to connect to a transducer of a hematology testing device having a pressure, flow or optical transducer; and / or d. The transducer mounting element includes a window or a flexible membrane. A through-flow unit characterized by:

13. 13. A flow-through unit as described in claim 11 or 12, characterized in that both the transducer mounting element and the flow-through device transducer extend tangentially around the longitudinal axis of the flow-through unit and / or are spaced axially from each other.

14. A system comprising the flow-through unit according to any one of claims 11 to 13 and the blood testing apparatus according to any one of claims 1 to 10.

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