Automatic sensor identification
11224496 · 2022-01-18
Assignee
Inventors
- Hendrikus Bernardus Van Den Brink (Eindhoven, NL)
- Ruud Van Dijk (Best, NL)
- Frans Henk Kremer (Eindhoven, NL)
- Kasper Gerard Van Wouw (Veldhoven, NL)
- Ivo Don Stuyfzand (Eindhoven, NL)
Cpc classification
A61B2562/06
HUMAN NECESSITIES
A61B1/31
HUMAN NECESSITIES
G16H50/20
PHYSICS
A61B5/7264
HUMAN NECESSITIES
A61B5/0002
HUMAN NECESSITIES
A61B5/7232
HUMAN NECESSITIES
G06F9/44521
PHYSICS
A61B5/0024
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
A61B5/0022
HUMAN NECESSITIES
A61B2562/085
HUMAN NECESSITIES
A61B2562/226
HUMAN NECESSITIES
A61B5/107
HUMAN NECESSITIES
A61B5/02
HUMAN NECESSITIES
A61B2560/0223
HUMAN NECESSITIES
A61B5/0084
HUMAN NECESSITIES
A61B5/14507
HUMAN NECESSITIES
A61B5/02055
HUMAN NECESSITIES
A61B2560/0242
HUMAN NECESSITIES
A61B5/029
HUMAN NECESSITIES
A61B2560/0475
HUMAN NECESSITIES
A61B5/02007
HUMAN NECESSITIES
A61B2562/0219
HUMAN NECESSITIES
A61B5/01
HUMAN NECESSITIES
International classification
A61B5/02
HUMAN NECESSITIES
A61B5/029
HUMAN NECESSITIES
A61B5/01
HUMAN NECESSITIES
A61B1/31
HUMAN NECESSITIES
A61B5/318
HUMAN NECESSITIES
A61B5/24
HUMAN NECESSITIES
A61B5/00
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
Abstract
The present invention relates to patient monitoring, such as hemodynamic monitoring. In order to perform provide monitoring in various scenarios, a patient monitoring device (10) is provided that comprises a patient medical monitoring unit (12) and an information unit (14). The patient medical monitoring unit is configured to perform monitoring at least one physiological parameter of a patient. The information unit is configured to provide a data carrier signal (16) indicative of information about the patient medical monitoring unit, for example, upon connection to a monitoring system. The data carrier signal is provided as an analogue sequence (18) comprising a predetermined waveform (20) indicative of the information about the patient medical monitoring unit.
Claims
1. A patient monitoring system, comprising: a patient monitoring device that includes: a patient medical monitor configured to perform monitoring of at least one physiological parameter of a patient and to provide measurement data of the at least one physiological parameter; an information processor with a memory, the information processor configured to: store configuration information regarding the patient monitoring device, and provide a data carrier signal indicative of the configuration information, and wherein the data carrier signal is provided as an analogue sequence comprising a variable waveform that is converted from the configuration information stored in the memory so as to be transmitted over an analogue interface, and wherein the configuration information comprises at least one of the group of: serial number; batch number; production data; and/or calibration parameters; a data processor configured to identify the configuration information based on the data carrier signal and to adapt functionality of the patient monitoring system based on the identified configuration information; and an interface device configured to receive the data carrier signal from the patient monitoring device and to provide the data carrier signal to the data processor.
2. The patient monitoring system as claimed in claim 1, wherein the information processor is configured to send data upon connection to the patient monitoring system.
3. The patient monitoring system as claimed in claim 1, wherein the patient medical monitor comprises at least one sensor configured to monitor the at least one physiological parameter; and wherein the at least one sensor is provided at an interventional device; and wherein the interventional device relates to at least one of the group of: a flexible elongated object to be inserted in a cavity or lumen of an anatomic structure; and/or a rigid or flexible elongate object to be penetrate at least a part of an anatomic structure.
4. The patient monitoring system as claimed in claim 1, wherein the patient medical monitor is provided as at least one of: a hemodynamic monitoring processor configured to provide at least one physiological parameter of the patient of the group of: blood pressure, blood volume, blood flow, blood flow speed, blood consistency, elasticity of a vessel, and geometry of a vessel; a cardiac monitor configured to provide at least one cardiac related parameter of the patient of the group of: heart rate, cardiac index, or cardiac electric activity; a gastroenterological monitor configured to provide at least one parameter of the patient of the group of: images inside cavities of an intestinal tract, chemical consistence of content inside a cavity of the intestinal tract, or temperature; and/or a neurological monitor configured to provide a signal indicative of a neurological electric activity of the patient.
5. The patient monitoring system as claimed in claim 1, wherein the patient medical monitor is provided as a catheter insertable into a vessel structure of a patient and provided as: a hemodynamic monitor configured to measure at least one physiological parameter of the patient of the group of: blood pressure, blood volume, blood flow, blood flow speed, blood consistency, elasticity of a vessel, and geometry of a vessel; and/or a cardiac monitor configured to measure at least one cardiac related parameter of the patient of the group of: heart rate, and cardiac index.
6. The patient monitoring system as claimed in claim 1, wherein the data processor is configured to detect the variable waveform of the analogue sequence of the received data carrier signal, and to identify the configuration information based on the detected variable waveform.
7. The patient monitoring system as claimed in claim 1, wherein the data processor is configured: to enable or disable at least one locked functionality of the patient monitoring system based on the identified configuration information; and/or to enable the use of a standard input port of the patient monitoring system to measure a new parameter that does not have a dedicated input port on the patient monitoring system based on the identified configuration information.
8. The patient monitoring system as claimed in claim 1, wherein a secondary monitor configured to provide an analogue signal that is used as a carrier signal; wherein the secondary monitor includes the information processor; and wherein the information processor is configured to add the data carrier signal indicative of the configuration information to the carrier signal.
9. The patient monitoring system as claimed in claim 1, wherein the data processor is configured to enable or disable at least one locked functionality of the patient monitoring system based on the identified configuration information, wherein the at least one locked functionality comprises at least one of the group of: fractional flow reserve measurement; pressure measurement; instant wave-free ratio measurement; and/or new functionality comprising flow, oxygenation and viscosity.
10. The patient monitoring system as claimed in claim 1, wherein both the measurement data and the configuration information are transmitted as analogue data.
11. A method for operating a patient monitoring system, comprising: storing, in memory, configuration information regarding a patient monitoring device of the patient monitoring system; providing, by the patient monitoring device, a data carrier signal indicative of the configuration information about a patient monitoring device upon connecting a hemodynamic monitor to a patient monitoring system, wherein the hemodynamic monitor is configured to perform monitoring of at least one physiological parameter of a patient to provide measurement data of the at least one physiological parameter; receiving, by an interface device, the data carrier signal from the patient monitoring device and providing the data carrier signal to a data processor; identifying, by the data processor, the configuration information about the patient monitoring device based on the received data carrier signal; and adapting, by the data processor, the functionality of the patient monitoring system based on the identified configuration information, wherein the data carrier signal is provided as an analogue sequence comprising a variable waveform that is converted from the configuration information stored in the memory so as to be transmitted over an analogue interface, and wherein the configuration information comprises at least one of the group of: serial number; batch number; production data; and/or calibration parameters.
12. The method as claimed in claim 11, further comprising: detecting the variable waveform of the analogue sequence of the received data carrier signal, and identifying the configuration information based on the detected variable waveform.
13. The method as claimed in claim 11, further comprising: enabling or disabling at least one locked functionality of the patient monitoring system based on the identified configuration information; and/or enabling the use of a standard input port of the patient monitoring system to measure a new parameter that does not have a dedicated input port on the patient monitoring system based on the identified configuration information.
14. The method as claimed in claim 11, wherein both the measurement data and the configuration information are transmitted as analogue data.
15. A non-transitory computer readable medium having stored thereon instructions that when executed by processing circuitry of a patient monitoring system cause the processing circuitry to: store, in memory, configuration information regarding a patient monitoring device of the patient monitoring system; provide a data carrier signal indicative of configuration information about a patient monitoring device upon connecting a hemodynamic monitor to the patient monitoring system, wherein the hemodynamic monitor is configured to perform monitoring of at least one physiological parameter of a patient to provide measurement data of the at least one physiological parameter; receive, by an interface device, the data carrier signal and provide the data carrier signal to a data processor; identify, by the data processor, the configuration information about the patient monitoring device based on the received data carrier signal; and adapt, by the data processor, the functionality of the patient monitoring system based on the identified configuration information, wherein the data carrier signal is provided as an analogue sequence comprising a variable waveform that is converted from the configuration information stored in the memory so as to be transmitted over an analogue interface, and wherein the configuration information comprises at least one of the group of: serial number; batch number; production data; and/or calibration parameters.
16. The non-transitory computer readable medium as claimed in claim 15, further comprising instructions that when executed by the processing circuitry cause the processing circuitry to detect the variable waveform of the analogue sequence of the received data carrier signal, and identify the configuration information based on the detected variable waveform.
17. The non-transitory computer readable medium as claimed in claim 15, further comprising instructions that when executed by the processing circuitry cause the processing circuitry to: enable or disable at least one locked functionality of the patient monitoring system based on the identified configuration information; and/or enable the use of a standard input port of the patient monitoring system to measure a new parameter that does not have a dedicated input port on the patient monitoring system based on the identified configuration information.
18. The non-transitory computer readable medium as claimed in claim 15, wherein both the measurement data and the configuration information are transmitted as analogue data.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Exemplary embodiments of the invention will be described in the following with reference to the following drawings:
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DETAILED DESCRIPTION OF EMBODIMENTS
(6)
(7) It is noted that in the following description, aspects are discussed for the embodiments in relation with a hemodynamic monitoring device as an example for the patient monitoring device. It is noted that these aspects are also provided in relation with other types of patient monitoring devices, which are described below, although this is not explicitly mentioned when discussing the particular aspects.
(8) The term “hemodynamic monitoring” relates to collection and analysis of qualitative and quantitative data of cardiopulmonary function. This monitoring may include the use of electrical, photometric, pressure transducing, and other non-invasive devices, as well as the application of a number of intravascular catheters. For example, fluid-filled monitoring systems attach to intravascular catheters and are used for continuous invasive measurement of arterial and cardiac pressures.
(9) The term “hemodynamic monitoring device”, also referred to as “input device”, relates to a device that measures and monitors cardiopulmonary function. This may include, for example, electrical, photometric, pressure transducing, and other non-invasive devices, as well as a number of intravascular catheter, e.g. for providing IVUS (intravascular ultrasound), FFR, OCT (optical coherence tomography) and other intravascular modalities. The term “hemodynamic monitoring device” may also relate to a multi-measurement device that may provide the measurements of e.g. ECG (electrocardiography), respiration, SpO2 (pulse oximetry), and non-invasive blood pressure.
(10) For example, not shown in detail, the patient medical monitoring unit comprises at least one sensor for monitoring the at least one physiological parameter. The at least one sensor is provided at an interventional device, and the interventional device relates to at least one of the group of: flexible elongate object to be inserted in a cavity or lumen of an anatomic structure, and rigid or flexible elongate object to be penetrate at least a part of an anatomic structure.
(11) For example, the patient medical monitoring unit is provided as at least one of the group of: i) a hemodynamic monitoring unit providing at least one physiological parameter of the patient of the group of: blood pressure, blood volume, blood flow, blood flow speed, blood consistency, elasticity of a vessel, and geometry of a vessel; ii) a cardiac monitoring unit providing at least one cardiac related parameter of the patient of the group of: heart rate, cardiac index, cardiac electric activity; iii) a gastroenterological monitoring unit providing at least one parameter of the patient of the group of: images inside cavities of an intestinal tract, chemical consistence of content inside a cavity of the intestinal tract, and temperature; and iv) a neurological monitoring unit providing a signal indicative of a neurological electric activity of the patient.
(12) For example, also not shown in detail, the patient medical monitoring unit is provided as a catheter insertable into a vessel structure of a patient and provided as: i) hemodynamic monitoring unit measuring at least one physiological parameter of the patient of the group of: blood pressure, blood volume, blood flow, blood flow speed, blood consistency, elasticity of a vessel, and geometry of a vessel; and/or ii) cardiac monitoring unit measuring at least one cardiac related parameter of the patient of the group of: heart rate, and cardiac index.
(13) The term “hemodynamic monitoring system” relates to a system provided to measure and monitor cardiopulmonary function. Besides the actual hemodynamic monitoring devices, the system may comprise further components such as data processing unit(s), storage devices, displays and other types of data interfaces.
(14) The term “hemodynamic monitoring unit”, relates to the sensing part of a hemodynamic monitoring device, such as sensors for central venous pressure measurement, arterial pressure measurement, and airway pressure measurement. A hemodynamic monitoring device may have several hemodynamic monitoring units for performing so-called multi-measurements, i.e. measuring several hemodynamic parameters at the same time with several hemodynamic monitoring units, for example a combination of ECG, Respiration, SpO2, and/or non-invasive blood pressure measurements.
(15) The term “information unit”, also referred to as “information providing unit”, relates to an electronic component, such as a signal generator IC (integrated circuit), which generates a data carrier signal, for example, in form of electrical waveforms over a certain range of frequencies carrying the information about the hemodynamic monitoring device. Hence, the information unit may also be referred to as “signal generating unit” or as “signal generator”. The information unit 14 may comprise a memory element, such as a read-only memory (ROM) circuit, in which the information is stored. The information may be read-only, such as a factory-assigned serial number, or may be read/write, where the information data can be written into the memory element or amended by a user.
(16) The term “information about the hemodynamic monitoring device” may relate to identifying information about the hemodynamic monitoring device, such as a unique tag serial number. The information may also be product-related information such as a stock number, lot or batch number, production date, or other specific information like calibration parameters that are needed for processing signals.
(17) The term “data carrier signal”, also referred to as “encoded signal”, relates to a signal modulated or encoded to carry data. The data carrier signal comprises, i.e., is modulated with, information data (e.g. serial number) that is uniquely assigned to the particular hemodynamic monitoring device. For example, the information unit 14 may convert the information data stored in the memory element, i.e. a digital stream, into data carrier signal.
(18) The data carrier signal may be provided in several ways. For example, the data carrier signal may be provided or generated when the hemodynamic monitoring device is powered, for example, upon connection to a hemodynamic monitoring system, which provides an external power source for the hemodynamic monitoring device. In a further example, the data carrier signal may be generated upon a user action, for example, by pushing a “connect” button.
(19) In this way, a hemodynamic monitoring system may advantageously collect the information about the connected hemodynamic monitoring device, such as the manufacturer or geographic region of use, and then determine the further steps based on the information, for example, to unlock further extra functionalities if the device has an authorized manufacturer and an authorized geographic region of use. The information may also enable the hemodynamic monitoring system to adapt a standard input port e.g. for pressure for measuring new parameters like flow of blood, and to display the measurement results of the new parameters to a user, e.g. a medical doctor or a nurse.
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(21) The horizontal axis in
(22) The interface between a hemodynamic monitoring device and a hemodynamic monitoring system may be analogue to support the transmission of analogue data, such as the data collected by a Doppler ultrasound sensor or a venous pressure sensor. Thus, the data carrier signal in form of an analogue sequence makes it possible to transmit the information over such an analogue interface.
(23) Also shown in
(24) It is also noted that the analogue sequence in
(25) In a further example, the information unit 14 sends data upon connection to a hemodynamic monitoring system (not further shown). Besides the analogue sequence 18, the data may further comprise other measured hemodynamic parameters, such as blood pressure or ECG, which are provided to the hemodynamic monitoring system.
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(27) The term “interface device” relates to a device that facilitates the data communication between one or more hemodynamic monitoring devices and the hemodynamic monitoring system. In an example, a hemodynamic monitoring device, such as a pressure sensor, may be part of the interface device. In a further example, a hemodynamic monitoring device may be a separate component, and may be connected to the interface device e.g. via cables. In a still further example, the interface device may comprise one or more processing units for analyzing, interpreting, and presenting hemodynamic data. Hence, this type of interface devices may also be referred to as hemodynamic monitoring system, such as Philips Xper Flex Cardio physiomonitoring system.
(28) In an example, the data processing device 28 is configured to detect the predetermined waveform 20 (see an example in
(29) The information about the patient monitoring device may be identified, e.g. by comparing the received data carrier signal to the tag (or marker) waveform, e.g. the fixed part 24 in
(30) Other methods for identifying the information about the patient monitoring devices will also be appreciated. For example, the interface device 26 may further comprise a memory unit (not further shown) that stores the tag waveform as a reference waveform. The data processing device may compare the received data carrier signal and the stored reference waveform to identify the tag waveform. Likewise, the information waveform followed after the beginning tag waveform may be converted to a digital bit stream by any suitable demodulation and decoding methods (depending on the modulation methods).
(31) In a further example, the data processing device 28 is configured to enable or disable at least one locked functionality of the patient monitoring system based on the identified information.
(32) The term “locked functionality” means that certain functionalities of the patient monitoring system are disabled e.g. to prevent unauthorized usage, unless the patient monitoring device has an authorized identity, for example, an authorized manufacturer, or an authorized geographic region of use.
(33) The term “to enable”, also referred to as “to unlock”, relates to permitting usage of certain “locked” functionality when the patient monitoring device has an authorized identification, for example, an authorized serial number, batch number, and/or calibration parameters.
(34) Likewise, the term “to disable”, also referred to as “to lock”, relates to preventing usage of certain “locked” functionality when the patient monitoring device does not have an authorized identification.
(35) The enabling/disabling (or locking/unlocking) process may be implemented by electrical circuit and/or software. The process may also be in form of a pop-up question allowing a user to determine whether to lock or unlock certain functionalities.
(36) In an example, not further shown, a secondary monitoring unit is provided that provides an analogue signal that is used as a carrier signal. The information unit belongs to the secondary monitoring unit. The information unit is configured to add the data carrier signal indicative of information about the patient medical monitoring unit to the carrier signal.
(37) In some embodiments, the interface device 26 may be configured to enable a sub-set of the at least one locked functionality based on the detected identity or identities of the hemodynamic monitoring device. For example, certain locked functionalities are allowed for hemodynamic monitoring devices from certain manufacturers. Some locked functionalities are permitted for use in certain geographic regions. Particular locked functionalities have a permissible number of uses. The interface device may thus unlock only a sub-set of the locked functionalities according to the identified information about the hemodynamic monitoring device (e.g. manufacturer, geographic regions of use, and permitted number of uses). In this way, many features of the hemodynamic monitoring systems may be customized without any further hardware changes.
(38) The at least one locked functionality may e.g. comprise at least one of the group of: FFR measurement; pressure measurement; iFR measurement; and new functionality comprising flow, oxygenation and viscosity.
(39) Certain functionality may be incorporated in the hemodynamic monitoring system. For example, it is possible to connect FFR catheters to the hemodynamic monitoring system for quantifying the hemodynamic severity of intracoronary lesions, providing information that can help determine if a stent is required. In this way, no additional hardware may be required to be able to carry out FFR measurements,
(40) Similarly, the iFR functionality can be switched on if the right catheter has been detected.
(41) The mechanism can also be used to prevent double use of a patient monitoring device, e.g. a hemodynamic monitoring device (e.g. a catheter), based on e.g. serial number. Furthermore, it can be used to transmit a signal, for which the hemodynamic monitoring system does not have an input port. For example, the analogue pressure input ports of a hemodynamic monitoring system might be used for measuring parameters for which today no catheters and dedicated input ports exist, like flow, oxygenation of blood, viscosity of blood. By transmitting and identifying the information about the hemodynamic monitoring device (e.g. for measuring flow of blood), an input port that is usually a pressure input port might be used for the new parameters. The software that is used to display the signal will adapt to the new input parameter, the hardware does not have to change. For example, instead of interpreting and displaying the input signal in mmHg/mV, it could interpret it as ml/s/mV, %/mV, or St/mV. In other words, the limited numbers of standard input ports of a hemodynamic monitoring system may be extended to measure new hemodynamic parameters, thus allowing the hemodynamic monitoring system to adapt to different clinical scenarios, for example, in different countries as well as in different departments.
(42) Although not illustrated, the hemodynamic monitoring system may be further configured to generate reports and auto-fills report fields and billing information. A user interface, e.g. a touch screen, may be provided to display and record waveforms. The user interface may also be configured to allow a user, e.g. a medical doctor or a nurse, to power the hemodynamic monitoring device by pushing a virtual “connect” button. If the information about the hemodynamic monitoring device is provided to the user e.g. in form of a pop-up question, the user may decide whether or not to unlock further functions or enable a standard input port of the hemodynamic monitoring system for measuring a new hemodynamic parameter. These features may of course be customized to each cath lab's needs.
(43)
(44) The data carrier signal is provided as an analogue sequence comprising a predetermined waveform indicative of the information about the patient monitoring device.
(45) The data carrier signal that carries data of measurements (e.g. flow, oxygenation of blood, viscosity of blood) may be sent over an input port (or channel) of the hemodynamic monitoring system that is standard used for measuring a certain parameter (e.g. pressure). In this way, the functionality of this input port (or channel) may be extended, for example, by switching on FFR or iFR, or even performing a completely new measurement like viscosity of blood.
(46) According to a further exemplary embodiment, shown as an option in
(47) According to a further exemplary embodiment, also shown as an option in
(48) In another exemplary embodiment of the present invention, a computer program or a computer program element is provided that is characterized by being adapted to execute the method steps of the method according to one of the preceding embodiments, on an appropriate system.
(49) The computer program element might therefore be stored on a computer unit, which might also be part of an embodiment of the present invention. This computing unit may be adapted to perform or induce a performing of the steps of the method described above. Moreover, it may be adapted to operate the components of the above-described apparatus. The computing unit can be adapted to operate automatically and/or to execute the orders of a user. A computer program may be loaded into a working memory of a data processor. The data processor may thus be equipped to carry out the method of the invention.
(50) This exemplary embodiment of the invention covers both, a computer program that right from the beginning uses the invention and a computer program that by means of an up-date turns an existing program into a program that uses the invention.
(51) Further on, the computer program element might be able to provide all necessary steps to fulfil the procedure of an exemplary embodiment of the method as described above.
(52) According to a further exemplary embodiment of the present invention, a computer readable medium, such as a CD-ROM, is presented wherein the computer readable medium has a computer program element stored on it which computer program element is described by the preceding section.
(53) A computer program may be stored and/or distributed on a suitable medium, such as an optical storage medium or a solid state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the internet or other wired or wireless telecommunication systems.
(54) However, the computer program may also be presented over a network like the World Wide Web and can be downloaded into the working memory of a data processor from such a network. According to a further exemplary embodiment of the present invention, a medium for making a computer program element available for downloading is provided, which computer program element is arranged to perform a method according to one of the previously described embodiments of the invention.
(55) It has to be noted that embodiments of the invention are described with reference to different subject matters. In particular, some embodiments are described with reference to method type claims whereas other embodiments are described with reference to the device type claims. However, a person skilled in the art will gather from the above and the following description that, unless otherwise notified, in addition to any combination of features belonging to one type of subject matter also any combination between features relating to different subject matters is considered to be disclosed with this application. However, all features can be combined providing synergetic effects that are more than the simple summation of the features.
(56) While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. The invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing a claimed invention, from a study of the drawings, the disclosure, and the dependent claims.
(57) In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfil the functions of several items re-cited in the claims. The mere fact that certain measures are re-cited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.