EP2411070A1

EP2411070A1 - Blood treatment device

Info

Publication number: EP2411070A1
Application number: EP10701871A
Authority: EP
Inventors: Hans-Peter Klose; Bernd Huber
Original assignee: Robert Bosch GmbH
Current assignee: Robert Bosch GmbH
Priority date: 2009-03-26
Filing date: 2010-01-29
Publication date: 2012-02-01
Also published as: WO2010108714A1; DE102009001901A1; CN102361659A; CA2749076A1; US20120095351A1

Abstract

The invention relates to a device for treating blood in an extracorporeal circuit, at least one blood pump (4) and at least one filtering device (2) being provided to perform the blood treatment. The device comprises at least one pressure measuring element (10, 11, 12) for detecting the blood pressure, which pressure measuring element is characterized in that the pressure measuring element (10, 11, 12) comprises a sensor unit and an RFID transponder unit.

Description

description

Title blood treatment device

The present invention relates to a device for treating blood in an extracorporeal circulation with at least one blood pump, at least one filter device and at least one pressure measuring element for detecting the blood pressure.

State of the art

In the case of renal failure or impaired renal function, blood treatment, especially blood purification, is required to compensate for the limited or absent function of the kidney. Here, a filtering of the blood is carried out via a semipermeable membrane, wherein substances from the patient's blood reach the so-called dialysis fluid by dialysis from the blood. As a rule, the exchange takes place in an extracorporeal circuit. Here, the dialysis fluid and the blood of the patient in countercurrent principle in a filter device with a semi-permeable membrane led past each other, wherein the mass transfer takes place. This is called hemodialysis.

For the extracorporeal blood circulation during dialysis, blood is first taken from the patient via an arterial access. The blood is transported via a blood pump and fed to a filter device in which the actual dialysis takes place via the semipermeable membrane. Between the blood pump arranged in front of the filter device and the actual filter device, an access point for medicaments is generally provided, for example for the addition of heparin to reduce blood coagulation. Downstream of the filter device, any air bubbles in a so-called air bubble removed before the purified blood is returned to the patient via a venous access.

In addition to hemodialysis, hemofiltration is also known, in which water is squeezed out of the blood via a membrane and replaced by an electrolyte fluid. Hemodialysis and hemofiltration can also be used in combination. Another blood treatment procedure is hemoperfusion, which can be used especially in cases of acute poisoning. Here, the blood is pumped through adsorbents (e.g., activated carbon) to remove certain substances, e.g. Overdosed drugs to be removed from the blood.

Because dialysis and other blood treatment procedures can cause complications, the devices must have adequate monitoring capabilities to minimize the risk to the patient and, if necessary, initiate countermeasures. Of particular importance in this case is a drop in blood pressure, which in many cases requires a termination of or at least an intervention in the dialysis treatment. Conventionally, blood pressure measurement devices are therefore provided at various points of the extracorporeal blood circulation. Typically, arterial blood pressure is measured before the blood pump. After the filter device, the venous blood pressure is measured. In addition, the blood pressure upstream of the filter device, for example, downstream of a medication access point, may be detected.

Conventionally, the pressure measuring cells for detecting the blood pressure in the actual dialysis machine are permanently installed. To record the blood pressure, the corresponding points of the blood-carrying tubes are coupled to the pressure sensors in the dialysis machine. This is done, for example, hydrostatically with a so-called Anpress coupling with air buffer or via a stub of the hoses. This coupling of the hose systems to the permanently installed pressure sensors involves various problems. The connections may be faulty, resulting in leaks, for example. This can falsify the measurement result and, above all, also the penetration of air into the bloodstream with the known considerable risks for the patient. Furthermore, the sterility of the connections must be guaranteed. The branching of the lines also increases the risk of coagulation in the blood. This will require higher levels of anticoagulants. The branches of the lines require a higher extracorporeal blood volume. Furthermore, the risk of incorrect operation, especially in home dialysis, and the risk of false positives. In addition, such a blood pressure measurement associated with considerable manual effort in the device.

Especially in the case of chronic kidney disease dialysis in the home environment is sought as so-called home dialysis. Here, a simple handling for the patient or possibly not fully trained medically nursing persons is required. The disadvantages mentioned, which also occur in the application by medically trained personnel, therefore come especially in a home dialysis to fruition.

Disclosure of the invention

Advantages of the invention

The blood treatment device according to the invention and a use of an RFID-T ranpondereinheit and a sensor unit, as described in the independent claims, eliminate the disadvantages of the prior art and provide a dialysis device or a blood treatment device that provides a blood pressure measurement and / or Detecting other medical parameters during the treatment in a particularly advantageous manner. Preferred embodiments of this device and the use are set forth in the dependent claims.

The device according to the invention serves to treat blood in an extracorporeal circulation, for example for hemodialysis, for hemofiltration or for hemoperfusion. In this case, the blood is guided in an extracorporeal circulation with at least one blood pump and passes through a filter device, within which the actual blood treatment, in particular the osmotic mass transfer through a semipermeable membrane, takes place. For example, the filter device is a conventional fibril filter conventionally used for hemodialysis. Furthermore, the device is provided with at least one pressure measuring element for detecting the blood pressure. to detect changes in blood pressure that may indicate complications in performing dialysis treatment. The device according to the invention is characterized in that the pressure measuring element has a sensor unit for detecting the blood pressure and an RFID transponder unit which enables a wireless transmission of the measured values to an external device as a receiving device or as a reading device. This receiving device is preferably part of the device, for example the dialysis machine. In other embodiments, the receiving device may be located externally, for example on or in a separate monitoring computer.

The invention uses the known RFID technology. The abbreviation RFID stands for the English term "Radio Frequency Identification." Traditionally, this technique is used to automatically identify objects and living things, particularly humans or animals, and in the meantime, this technique also allows automatic collection and storage of data The RFI D system comprises a transponder unit and an external device, in particular a reader The reader generates a radio-frequency electromagnetic field via which data is transmitted from the transponder to the reader Typically, radio frequencies in the radio frequency range from 100 MHz to 100 kHz are used. In the meantime, frequencies are also already being used as far as the microwave range, so that the data is transferred in a contactless manner. <br/><br/><br/> In addition to the data transmission between the transponder and the external receiving device, the RFID system may also permit the Bes writing the transponder with data. The use of an RFID transponder unit as a component of a pressure measuring element in a device according to the invention has, inter alia, the advantage that no physical connection of the measuring element to, for example, the dialysis machine is required, as is necessary in conventional blood pressure measurement. Rather, the blood pressure measurement can be wireless, so that the handling for the medical or nursing staff or for the patient itself is much easier, since no separate connections for the pressure measuring sensors are required. The coupling of the pressure measuring sensors to the actual dialysis machine is very advantageous due to wireless and contactless data exchange. A mechanical or hydraulic Rostatische coupling is omitted, so that the handling is simplified and corresponding coupling elements are not required.

A particular advantage of the device according to the invention is that the sensors used can be detected via a unique sensor identification. This is particularly advantageous in cases in which several RFID-capable dialysis machines are set up in a close environment, for example in dialysis centers, whereby the correct measurement data can be received and evaluated by the reader by means of suitable collision-affected RFID transmission protocols, without causing confusion, for example can come from patient data.

Advantageously, as the sensor unit for the blood pressure measurement, a sensor can be used which detects mechanical stresses in a vessel wall, for example the tube wall, by detecting a change of wall properties of the tube wall by changing the wall tension. Suitable blood pressure sensors are known, for example, from German Patent Application DE 10 2007 038 402 A1, which describes an implantable RFID blood pressure sensor. However, these pressure measuring sensors have the disadvantage that the blood pressure is detected indirectly by measuring pressure-dependent material or design parameters in the pressure-carrying line, whereby the pressure measurement of material parameters of the wall material, e.g. Elasticity, pressure modulus, etc., is dependent. In a particularly preferred embodiment of the invention, therefore, a sensor unit is used, which makes a pressure measurement directly in the blood, so as to be able to exclude other sources of error. Here, the placement of the sensor unit is not limited to blood-carrying leads or tubes, but may be at any point, e.g. directly into a fibril filter.

Preferably, the one or more pressure measuring elements are integrated in a hose, in a hose connection, in the filter device and / or in a filter connection. The sensor unit and the RFID transponder unit can be kept very small in terms of their dimensions, so that integration at various points in the extracorporeal blood circulation is readily possible without significantly affecting the blood flow. This advantage comes in particular when using passive transponders in the RFID transponder unit to carry. The power supply of passive transponders via the external receiving device, so that passive transponders can be built very compact and small and in particular need not have their own power supply. As a result, a freedom from maintenance of the transponder is given.

Preferably, the pressure sensing elements according to the invention can be used at the usual locations for blood pressure measurement in the extracorporeal circuit of a device, for arterial pressure measurement, preferably upstream of the blood pump and for venous pressure measurement, preferably downstream of the filter device and upstream of an air bubble trap. Furthermore, for example, additionally or alternatively a pressure measuring element can be provided directly in front of the filter device. Since the pressure measuring elements according to the invention cause no further installation requirements, it is a great advantage of the invention that multiple pressure measuring elements can be used without any special effort for the operating personnel or the patient.

In a particularly preferred embodiment of the invention, the RFID transponder unit and preferably the entire pressure measuring element is a disposable unit. Here, the pressure measuring element, which comprises the sensor unit and the RFID transponder unit, intended for single use. Suitable disposable RFID transponder units are already known. They have the advantage that they can be used together with other disposable components in blood treatment. For example, tubing sets and filter units that are provided in a sterile manner and disposed of after use are commonplace. Cleaning, reprocessing and sterilization of such units is often not useful for cost reasons. For such units, therefore, the pressure measuring element is also provided as a disposable component, so that, for example, the correspondingly equipped hose set is connected in a known manner to the connections of the filter device and to the corresponding access points on the patient, without requiring further installation for blood pressure measurement. Furthermore, it may be provided that only the transponder unit is intended for single use, whereas the sensor unit is reusable. With particular advantage, it is provided that the device according to the invention comprises further measuring elements each having a sensor unit and an RFID transponder unit, wherein the further measuring elements are provided for detecting further medical parameters. These further measuring elements can be provided, for example, for detecting the blood flow rate, the temperature and / or for detecting gas inclusions, in particular air bubbles. Hemodialysis or other extracorporeal blood treatment methods require detailed monitoring of various parameters in order to avoid complications or be aware of them in a timely manner. The wireless coupling of corresponding sensors within the meaning of the invention therefore also offers particular advantages for these further parameters, since the conventional measurement of these further parameters, in particular in connection with home dialysis, for example through additional hose connections, has potential sources of error.

The invention further includes the use of an RFID transponder unit and a sensor unit as a measuring element for detecting medical parameters, in particular blood pressure, blood flow rate, temperature and / or gas inclusions, in a device for treating blood in an extracorporeal circuit. Other medical parameters in this context are, for example, blood sugar levels or certain gas concentrations in the blood. The device comprises at least one blood pump and at least one filter device and can be provided, for example, for hemodialysis or hemofiltration. In particular, it is a hemodialysis device which is equipped with a receiving device for reading data from one and in particular a plurality of RFID-T ranspondereinheiten. The RFID transponder units are integrated together with corresponding sensor units, for example as pressure measuring elements in the system of extracorporeal blood circulation, for example in the corresponding tubing sets or in the filter device. With regard to further features and advantages of this use according to the invention, reference is made to the above description.

A particular advantage of the device according to the invention and the use according to the invention is that the RFID transponder unit of the pressure measuring element or of another measuring element offers further possibilities in connection with the data storage on the RFID transponder. The use of an RFID transponder unit in the described pressure measuring element can be used particularly advantageously for the documentation of measured values and / or patient data. The measured values for blood pressure can, for example, be recorded and stored as a course of the blood pressure over the duration of treatment and further documented and evaluated in parallel or following the treatment. When using an RFID transponder unit in the sense of the use according to the invention, the documentation of the treatment, in particular the course of the blood pressure and also other relevant data, can be carried out in an automated and optimized manner.

In a particularly preferred embodiment of the use according to the invention, the measured values and / or the patient data are forwarded telemetrically, so that, for example, monitoring and / or evaluation of the treatment can take place remotely. Thus, for example, the dialysis treatment can be carried out as home dialysis in the home environment of the patient, and the data on blood pressure and possibly other data can be transmitted via the transponder units on the dialysis machine, in which a reader is integrated, and from here, for example via a telephone line or a appropriate data line, possibly together with further information about the patient to a central office, such as a dialysis center or a doctor's office, forwarded and documented there and taken into account for further treatment of the patient.

With particular advantage, the use according to the invention can be used to detect malfunctions. For example, with a measured drop in blood pressure, which falls below a predefinable threshold, an alarm can be triggered. Preferably, the use according to the invention is provided for triggering one or more emergency measures in the event of a detected malfunction, for example, if suitable threshold values are deposited on the transponder or a control unit, discontinuation of the dialysis treatment can be initiated as soon as a prescribable threshold of blood pressure is reached. Traditionally, critical blood pressure readings during a dialysis session trigger an alarm on the device, allowing a caregiver to go to the patient and check the cause. When using an RFID transponder unit according to the invention can by the Integration of blood pressure values in a medical data system for critical measurement values immediately a specific action, in particular in conjunction with other measurement data, the patient history and, where appropriate, appropriate expert systems proposed by the system itself. As a result, the initiation of possibly life-sustaining measures can be significantly accelerated, so that the risks for the patient are reduced.

In a particularly preferred embodiment of the inventive use, the RFID T ranspondereinheit is used for component identification and / or identification. By storing data on the RFID transponder, an identifier for the corresponding elements of the system can be provided. For example, in the arrangement of a pressure measuring element within the filter device, an identifier can be assigned to the filter component. The same applies to the arrangement of a pressure measuring element in a hose set, for example in a hose set for the arterial part or for the venous part of the extracorporeal blood circulation. This allows testing for the use of the correct filter and / or tubing set with respect to the device or patient. Furthermore, a new part detection, a plagiarism protection, a compatibility check and / or a reuse protection is possible. For example, the workflow in dialysis centers can be optimized by managing the inventory by means of the component identification and / or identification and, for example, placing orders in an automatic manner if the stock falls below a predefinable value.

Overall, the use according to the invention of an RFID transponder unit together with a sensor unit, for example as an integrated component in a disposable tube set or a filter device for hemodialysis, allows a considerably simplified operation in the construction and the installation of the dialysis system on the patient. The RFID transponder unit ensures that the units used are safe against misuse, protection against improper use, plagiarism protection, protection against reuse or protection against use after a best-before date. In addition, the RFID transponder unit can be used to facilitate the monitoring of the patient, for example in telemedicine applications, with the aid of the transponder unit. In addition to the actual measurement data, other patient data can also be transmitted. These benefits are particularly important in home hemodialysis, which is performed by the patient himself or by his relatives or nursing staff in the home environment. The handling and the device, the so-called setup, the blood treatment device is considerably simplified by the RFID transponder unit used according to the invention and operator errors are avoided, especially since practically no prior medical knowledge is required for use in a domestic environment. For example, the problem is solved by unsterile or leaky connections with the associated consequences for the health and life of the patient.

Even when using and device of the invention by medical professionals, for example in a dialysis center, the advantages of the system according to the invention come into play. For example, the setup time per treatment will be significantly reduced. A calibration of the pressure measuring elements can be done automatically. A sterilization of the conventionally required connections for blood pressure measurement is eliminated. As a result, sources of error are avoided and the time required for the technical installation of the hemodialysis reduced. The care required per patient alone for the technical installation is reduced, so that this time can be used for other purposes. There is no need for manual documentation; the data, in particular the blood pressure measurement data, can be archived in an automated manner. A telemedical evaluation of the data facilitates patient monitoring. For example, several patients can be monitored at a central location. In the case of malfunctions, and in particular if the blood pressure can not be predetermined, it is possible, if appropriate, to take the necessary measures very quickly in an automated manner.

Further features and advantages of the invention will become apparent from the following description of the drawings. In this case, the individual features can be implemented individually or in combination with each other.

Brief description of the drawings In the drawings show:

Figure 1 is a schematic representation of the extracorporeal blood circulation when performing a hemodialysis with a device according to the invention;

Figure 2 is a schematic sectional view of a pressure measuring element for

Capture of blood pressure, arranged on a tube and

FIG. 3 (A) shows a schematic representation of the arrangement of pressure measuring elements in a filter device, and (B) shows a detailed view of the pressure measuring element in a sectional view.

embodiments

FIG. 1 shows the extracorporeal blood circulation during hemodialysis. This blood circulation is subdivided into an arterial tube system between the arterial blood donor site 1 and the filter device 2. In the filter device 2, the actual dialysis of the blood takes place via a semipermeable membrane, the osmosis taking place between the blood and the dialysis liquid (not shown). Between the filter device 2 and a venous access 3 to the patient is the venous tube system. The external blood circulation is driven by the blood pump 4. Between the blood pump 4 and the filter device 2 is an addition point 5 for drugs, such as heparin, to reduce blood clotting. Before the blood is returned to the patient via the venous access 3, it passes through an air bubble trap 6. In the arterial tube system, a blood pressure measuring element 10 is provided in front of the blood pump 4. In front of the bubble trap 6, a blood pressure measuring element 11 is provided for venous pressure measurement. Furthermore, a further blood pressure measuring element 12 may be arranged in front of the filter device 2. These various blood pressure measuring elements 10, 11, 12 have a blood pressure sensor unit and an RFID transponder unit. This eliminates a hydrostatic or mechanical coupling of the measuring units to the hose system. The detection and transmission of blood pressure is electronic and contactless. The sphygmomanometers are small and compact, with the transponder unit preferably being a convenient sive transponder unit whose energy supply via a receiver (not shown), which is integrated, for example, in the dialysis machine. The pressure measuring elements are integrated in the various hoses or connections and require no further installation. Preferably, these are disposable units that are used with the already common disposable tubing sets or disposable filter devices and discarded after use. As an alternative or in addition to the pressure measuring elements illustrated here, further measuring elements may be provided for detecting other medical parameters, which likewise include an RFID transponder unit.

Due to the possibility of storing and writing data that the transponder unit offers, it is possible with the device according to the invention to carry out, for example, a documentation of measured values and / or patient data in automated and thus very simple manner for the operating personnel. Furthermore, the RFID tag unit can be used to detect malfunctions and communicate with appropriate control units to trigger emergency response. Finally, the RFID tag unit can be used with particular advantage for component identification and / or identification if the pressure measuring element comprising the RFID tag unit is integrated in, for example, a hose set or a filter device and the tag unit with the corresponding data, the one Component identification and / or identification allow equipped.

FIG. 2 shows a schematic sectional view of a pressure measuring element 20 which is arranged on a hose 21 as part of an extracorporeal circuit of a dialysis machine. The pressure measuring element 20 comprises a housing 22, which is attached to the tube 21 via projections 23 by means of an adhesive layer 24. Within the housing 22, the pressure sensor 25, which is secured by means of an adhesive layer 26 in the interior of the housing 22, is provided. In the sensor 25, an RFID transponder unit 27 is integrated. The sensor 25 is embedded in a biocompatible gel 28 within the housing 22. The sensor 25 is suitable for direct pressure measurement and communicates via the biocompatible gel 28 directly with the liquid or the blood within the tube 21 in connection. The pressure to be detected by the gel 28 on the sensor 25th transfer. Such a pressure measuring element 20 may for example be integrated directly into a tube wall.

FIG. 3 shows a further possibility for the arrangement of pressure measuring elements 30 within an extracorporeal circuit of a dialysis apparatus. FIG. 3 (A) shows the arrangement of the pressure measuring elements 30 in the lids 31 of a filter device 2, for example a fibrillation filter. The pressure measuring elements 30 are arranged in the region of the connections 32 for the blood and the dialysis fluid. FIG. 3 (B) shows the arrangement of the pressure measuring element 30 in detail. The sensor 33 is arranged via an adhesive layer 34 within a housing 35 in the lid 31 of the filter device 2. Here, the sensor 33 is embedded in a biocompatible gel 36, via which the sensor 33 is in direct contact with the liquid or the blood for direct pressure measurement. In the sensor unit 33, an RFID transponder unit 37 is integrated. The measured values for blood pressure or other biological parameters detected by the sensor unit 33, depending on the design of the sensor, are transmitted wirelessly via the RFID transponder unit 37 to an RFID receiving device or a reading device 38. The transponder in the RFID transponder unit 37 is preferably a passive transponder whose power is supplied via the external receiving device or the reading device 38. The lid 31 with the housing 35 may be made, for example, as an injection molded part into which the sensor element is introduced together with the gel, e.g. is pressed into a corresponding recess of the housing.

Claims

claims

A device for treating blood in an extracorporeal circuit with at least one blood pump (4), at least one filter device (2) and at least one pressure measuring element (10, 11, 12; 20; 30) for detecting the blood pressure, characterized in that the pressure measuring element (10, 11, 12; 20; 30) has a sensor unit (25; 33) and an RFID transponder unit (27, 37).

2. Apparatus according to claim 1, characterized in that the pressure measuring element (10, 1 1, 12, 20, 30) is integrated in a hose (21), in a hose connection, in the filter device (2) and / or in a filter connection ,

3. Device according to claim 1 or claim 2, characterized in that the RFID transponder unit (27, 37) comprises a passive transponder.

4. Device according to one of the preceding claims, characterized in that the pressure measuring element for arterial pressure measurement (10) and / or for venous pressure measurement (1 1) is provided.

5. Device according to one of the preceding claims, characterized in that the RFID transponder unit (27, 37) is a disposable unit.

6. Device according to one of the preceding claims, characterized in that the device further measuring elements for detecting further parameters, in particular for detecting the blood flow rate, the temperature and / or gas inclusions, wherein the further measuring elements each comprise a sensor unit and an RFID transponder unit exhibit.

7. Use of an RFID transponder unit (27, 37) and a sensor unit (25, 33) as a measuring element (10, 11, 12, 20, 30) for recording medical parameters, in particular blood pressure, blood flow rate, temperature and /or of gas inclusions, in a device for treating blood in an extracorporeal circuit with at least one blood pump (4) and at least one filter device (2).

8. Use according to claim 7 for the documentation of measured values and / or patient data.

9. Use according to claim 7 or claim 8 for the telemetric forwarding of measured values and / or patient data.

10. Use according to one of claims 7 to 9 for detecting malfunctions.

1 1. Use according to claim 10 for triggering emergency measures.

12. Use according to claims 7 to 11 for component identification and / or identification.