Patent Application
20150223737
The present embodiments relate to a device for in vivo determination of at least one blood value. The present embodiments also relate to a corresponding method for in vivo determination of at least one blood value.
In clinical practice, a number of blood values of the human or animal patient may be determined before a medical examination or a medical intervention. In order to determine the blood values, blood may be taken from the patient for the purpose before the examination or intervention so that there is sufficient time for values of relevance to the examination to be determined before the examination starts and it is possible to take any particularities into account. External analysis equipment may be used to determine the blood values. This may be located in a laboratory belonging to the hospital. If relevant blood values are missing, perhaps because it was not possible to take samples in advance, the examination or intervention may be postponed or even canceled. If there is an emergency situation, patients are examined or treated without values being available, with the result that there is a higher risk, for example, of kidney failure. If blood samples are taken during an examination or intervention, the samples may also be sent to the hospital's own laboratory. In a favorable scenario, analysis equipment is available, for example, in a catheter laboratory, allowing certain blood values to be determined. If the samples have to be sent to a laboratory, the diagnosis is delayed until the examining physician has the data, even if the laboratory is in proximity to the catheter laboratory. Diagnosis may not take place until the blood values have been received from the laboratory.
The determination of cardiac output CO is described here by way of example. Cardiac output is determined, for example, by way of the oxygen partial pressure PO2 that is measured in two different vessels, or by way of the peripheral capillary oxygen saturation SpO2. This is the most reliable measuring method, but it is not widely used in everyday clinical practice as it is very complex. Other methods are therefore used, such as the determination of cardiac output from output volume and cardiac frequency, referred to as angio, or measured over a temperature progression, referred to as thermo. One particularly important blood value that has to be taken into account during interventions is the creatinine value. Creatinine is an important kidney retention parameter in laboratory medicine. Kidney retention parameters are measurement values determined in medical laboratories, which are used in medicine, specifically nephrology, to assess kidney performance. An increase indicates limited kidney function, referred to as retention. In such cases, iodide may not be injected into the patient as a contrast agent, as it would not be broken down by the kidneys or would only be broken down slowly and therefore in a manner that is damaging to health. Patients frequently have to be treated angiographically in time-critical emergencies without such a laboratory diagnosis, however, even though there is then always the risk of kidney failure. The following blood parameters or blood values may also be mentioned by way of example but not conclusively: erythrocytes, leucocytes (e.g., neutrophil granulocytes, eosinophil granulocytes, lymphocytes and monocytes), thrombocytes, hemoglobin, hematocrit, mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
A method known in principle for determining blood values relates to the non-invasive determination of blood values by reflection spectrometry. The publication “Revolution in der Medizintechnik” (Revolution in medical engineering), SCHOTTsolutions, No. 1/2009, pages 42 to 43, proposes equipment that utilizes this measuring principle. A defined white light spectrum is conducted from a manual device by way of glass fibers into a sensor head and radiated into the tissue below the skin on which it is positioned. Different tissue and blood components either absorb the light or it is reflected differently in a substance-specific manner. The procedure is referred to as reflection spectrometry. The reflected light passes by way of a further light conductor into a spectrometer and is broken down into its wavelengths there. The blood values to be tested are concluded from the spectrum analysis and the measurement values are displayed on a display unit.
The scope of the present invention is defined solely by the appended claims and is not affected to any degree by the statements within this summary. The present embodiments may obviate one or more of the drawbacks or limitations in the related art.
The object of the present embodiments is now to specify a device, which allows in vivo determination of blood values within an examination object. It is also the object of the embodiments to describe a corresponding method for in vivo determination of blood values within an examination object.
A device for in vivo determination of at least one blood value within an examination object includes a catheter-shaped carrier that may be inserted into an examination object. The device further includes at least one measuring device, the measuring position of which is arranged at a definable position of the catheter-shaped carrier and which is configured to determine at least one blood value repeatedly and to supply this value to an evaluation unit.
The device therefore allows at least one blood value of an examination object, (for example, a human or animal patient), to be determined or measured in vivo, (in other words, in the living object). The device has a catheter-shaped carrier, on or in which at least one measuring device is arranged. A catheter-shaped carrier has features of a medical catheter or is a medical catheter. A medical catheter refers, in particular, to a tube-type or rod-type device with a length of approx. 0.3 to 1.5 m and a diameter of approx. 1 to 20 mm, which may be inserted into a human or animal body. A medical catheter may also include integrated instruments or instruments that may be inserted by way of operating channels, (for example, micromechanical devices, such as small forceps or grippers), which may be used to perform examining or intervening procedures. A catheter refers to a medical catheter here and in the following. The catheter-shaped carrier and the at least one measuring device, the measuring position of which on or in the catheter-shaped carrier is known, allow measurements of one or more blood values, (e.g., values of the blood composition or the blood gases), to be performed within the examination object, (for example, in a blood vessel). The measurement may be performed once or a number of times and the measurement values obtained in each instance may be transmitted to an evaluation unit, for example, an electronic circuit or a computer. It is indeed conceivable for the at least one measuring device to be arranged in a spatially distributed manner. Thus, for example, the measuring position of a measuring device may be located with a first part of the measuring device at the distal end of the catheter-shaped carrier and a second part of the measuring device may be located in proximity to the proximal end or even outside the catheter-shaped carrier. Optical or electrical measurement signals may be transmitted by an optical or electrical connection from the first to the second part of the measuring device, where they are converted where applicable to blood values or blood measurement values, which are then available to the evaluation unit. The advantage of this embodiment is therefore, inter alia, that the first part of the measuring device for receiving a, for example, optical, measurement signal, may have a smaller structure than the second part of the measuring device, with the aid of which the measurement signal may be converted to a blood measurement value.
The measuring principle of the measuring device may be based on a spectrometric measuring principle.
As described above, the spectrometric, or in particular the reflection spectrometric, measurement of blood values is based on the principle that different tissue and blood components either absorb incident light or reflect it differently in a substance-specific manner. The reflected light component is analyzed using a spectrometer and the desired blood values are determined therefrom. One advantage of this measuring method is that the structure and composition of the blood are not changed by measuring, as would be the case, for example, with testing using a centrifuge. Also, unlike when an analysis is performed in an external laboratory, the measurement values are available within a short time, (for example, within a few seconds), so the measurement values may be obtained during an examination or intervention.
It is favorable if at least part of the measuring device includes a transmitter, which is designed to supply a blood value wirelessly to the evaluation unit.
This feature provides that the measuring device or, in the case of a multi-part measuring device, at least part of the measuring device is provided for the wireless transmission of an obtained or determined blood value. This may be, for example, a transmitter known per se, (such as a wireless local area network or WLAN), according to a standard from the IEEE-802.11 family, or a transmitter as specified in the industrial standard according to IEEE 802.15.1, also referred to as Bluetooth. If the evaluation unit has a corresponding receiver, it may receive the supplied, in other words, transmitted, blood measurement values.
The catheter-shaped carrier particularly advantageously has at least two openings that form at least one cohesive cavity.
A constant throughflow of blood is possible through the at least two openings in the catheter-shaped carrier. It is conceivable, for example, that a first opening is located at the distal end and a second opening is located on the side of the catheter-shaped carrier. If the measuring principle of the measuring device requires direct contact with the blood to be measured, this is provided by this feature.
In one advantageous development of the device, the catheter-shaped carrier has at least one integrated or insertable catheter instrument.
The fact that the catheter-shaped carrier may be fitted with one or more catheter instruments, or that catheter instruments integrated in the catheter-shaped carrier may be used, provides that the device may be used not only to determine blood values but also as a standard medical catheter, as known in clinical practice.
In a further advantageous embodiment, the at least one measuring device is configured to determine at least one blood value at predefinable time points and to supply this value to the evaluation unit.
By measuring blood values repeatedly, it is possible, (for example, during an intervention), to monitor the progression of a blood value over time and thus identify situations that are dangerous for the patient in a timely manner. The time points or the rate at which measurements are performed may be predefined, for example, by an operator (e.g., a physician).
In a further advantageous embodiment of the device, the evaluation unit is configured to represent the supplied blood value on an output device and/or supply it to a monitoring system and/or supply it to a network and/or record it in a standardized data record.
The device is configured to transmit measured blood values to the evaluation unit, for example, an electronic circuit or a computer. The evaluation unit may also be configured to represent the blood value(s) on an output device, for example, on a computer monitor. This is of particularly significant advantage during a medical intervention, as a physician, for example, may then monitor the current blood value in a live manner and take actions as required. The evaluation unit may also be configured to supply the supplied blood value to a monitoring system. Monitoring may refer to the direct systematic acquisition, in other words the logging, observing or watching, of a procedure or process using technical aids or other observation systems. One important aspect here is the repeated regular performance of test programs. It is also conceivable to intervene in a regulating manner in an observed procedure or process, if it does not follow a desired progression or if results are below or above predefinable limit values. One commercially available monitoring system is known, for example, under the name AXIOM Sensis XP and is produced by Siemens. The evaluation unit may also be configured to supply the blood value(s) to a network, by feeding the data into a data processing network by way of suitable interfaces in a wired or wireless manner. The determined blood value provided by the evaluation unit may be recorded in a standardized data record, (e.g., in a DICOM Structured Report), for further diagnosis.
In a further embodiment, a method for in vivo determination of blood values is provided. The method includes the following acts. In act S1, at least one blood value is determined using at least one measuring device, the measuring position of which is arranged at a definable position of a catheter-shaped carrier and which is inserted into an examination object. In act S2, the at least one blood value is supplied to an evaluation unit.
In one embodiment of the method, at least one time point may advantageously be predefined, at which the measurement of the at least one blood value is performed.
In a further advantageous embodiment, the method is used with one of the devices described above for in vivo determination of at least one blood value within an examination object.
When one of the devices described above is used, method acts for which the embodiment of the respective device is designed are particularly advantageously executed.
In a further advantageous embodiment of the method, the method is executed automatically.
Automatically executed methods have the advantage that an operator is required to perform fewer interventions, which are often time-consuming and error-prone.
Finally,
The evaluation unit 13 is configured to supply the blood value(s) to a network 24 by feeding the data into a data processing network by way of suitable interfaces in a wired or wireless manner. In this exemplary embodiment, the network 24 is depicted symbolically by a receive device. In one embodiment, the network 24 may be a networked hospital information system made up, for example, of a number of decentralized computers that may communicate with one another in a wireless or wired manner.
In conclusion, some features of exemplary embodiments and advantages are summarized. With the aid of a device, (for example, a catheter), which is designed to execute the described functions, a user may save on time and personnel outlay, the time factor may be more significant. There is also constant monitoring and representation of the blood values, for example, the oxygen saturation in the blood. An examination and/or intervention may now be performed on patients for whom there is no current blood picture and therefore no examination and/or intervention may be performed under current guidelines. It may also be documented simultaneously and automatically the blood values that have changed during the examination and/or intervention, at what time and under which circumstances. Conclusions may also be drawn as to the medication the patient requires. One significant advantage is the possibility of representing the measured blood values online. The examining physician sees the body's reaction to the examination method instantly. As described above the creatinine value in particular rises when x-ray contrast agent containing iodide is administered. When a critical tolerance value is reached, the examining physician may terminate the examination in a timely manner or inject fluid, (for example, a NaCl solution), before the patient's kidneys are damaged.
It is to be understood that the elements and features recited in the appended claims may be combined in different ways to produce new claims that likewise fall within the scope of the present invention. Thus, whereas the dependent claims appended below depend from only a single independent or dependent claim, it is to be understood that these dependent claims may, alternatively, be made to depend in the alternative from any preceding or following claim, whether independent or dependent, and that such new combinations are to be understood as forming a part of the present specification.
While the present invention has been described above by reference to various embodiments, it may be understood that many changes and modifications may be made to the described embodiments. It is therefore intended that the foregoing description be regarded as illustrative rather than limiting, and that it be understood that all equivalents and/or combinations of embodiments are intended to be included in this description.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2012 215 389.6 | Aug 2012 | DE | national |
The present patent document is a §371 nationalization of PCT Application Serial Number PCT/EP2013/067674, filed Aug. 27, 2013, designating the United States, which is hereby incorporated by reference, and this patent document also claims the benefit of DE 10 2012 215 389.6, filed on Aug. 30, 2012, which is also hereby incorporated by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2013/067674 | 8/27/2013 | WO | 00 |
