The present invention relates to medical and physiological measurement systems allowing for diagnosis analysis, in particular for sleep and blood pressure diagnosis, by simple ways of operation and at low cost enabled by mass storage device connectivity.
Optimization in healthcare requires technology to be increasingly used in patient diagnostics. By doing simple medical and physiological measurements it becomes possible to make referrals which are based on well substantiated information and thereby lead to well focused and more efficient diagnosis results. This is especially important in long term monitoring, such as sleep diagnostics, where the patient is unaware of his condition and therefore unable to provide accurate information. It may consequently often be possible to bypass the necessity of involving the patient in otherwise required but expensive and complicated treatments or studies.
Despite these obvious benefits, the efficiency of currently available medical and physiological measurement systems, hereinafter referred to as medical systems, are known to be limited by two attributes, namely by either being very complicated and expensive or oversimplified and inaccurate. The more complicated medical systems typically require a computer software application for synchronizing, reviewing and analyzing acquired data gathered by measurement devices and for generating corresponding reports. Such software applications are known to be highly complex and associated with expensive technical support needed for setup, maintenance and personnel-training. The continuous advancements in the computer environment require the medical software to be capable of running in inconsistent environments, using different types of operating systems, different constellations of accessories drivers, different versions, etc. It follows that the medical software must be continuously maintained and verified to run correctly in the different environments. Due to safety requirements in medical development, this maintenance is required even after release of the software and it often results in software updates at the customer site, causing customer inconvenience, support cost and periods of down-time when the medical device is non-functional due to maintenance. It follows that the development and service cost of medical systems using conventional computer applications can be quite substantial, in particular when features provided by the underlying operating system, such as printing capabilities or display features, are being used. Consequently, the price of such medical systems is driven high enough to cover all costs, often in low volume markets, which eventually may defer potential customers away from buying.
The simpler and lower cost solutions avoid these complications by completing processing and visualization of results onboard the measurement device. Due to size limitations, power requirements and other factors, the approach is most often based on displaying a single parameter on a display with very limited review possibilities. This has been criticized by the medical community as imposing a “black-box” approach, giving the medical practitioners no opportunity to review prerequisites leading to the diagnosis conclusion. The limited onboard processors are most often incapable of computing and delivering accurate results, also since working with large datasets can be very problematic in embedded systems. The consequences are limited accuracy, imprecise analysis, limited delivery of parameters and limited possibilities of comparing parameters originating from different measurements due to lack of concise electronic reporting. It follows that overall diagnosis conclusions may represent unreliable diagnosis results.
The following publications give an overview and discussion on topics related to this field:
The object of the present invention is to provide improved medical systems for avoiding the complications, as described above, found to be inherent in current medical systems. For this purpose, the medical system defined according to this invention is capable of collecting measurements taken from a patient or at a patient's location, where measurements taken from a patient are provided by sensors attached to the patient's body and measurements taken at a patient's location are given by sensors located in the patient's proximate environment, and processing the full acquired measurement dataset, for making accurate diagnostics, and it offers possibilities for generating and providing electronic analysis and reports containing extensive sets of appropriate parameters, graphs and/or other visualizations of diagnostic results and/or data. Furthermore, for lowering costs and complexity, the medical system according to this invention is designed with the aim of operational independency in regard to the continuously changing computer environment.
In one of the embodiments of a medical system defined according to the present invention, the medical system comprises at least one medical device defined according to the invention, which collects measurement data taken from a patient or at a patient's location, and stores these in at least one memory component comprised by the corresponding medical device for instant and/or later data processing and/or analysis. The respective processing of data for diagnosis purposes can take place in the medical device itself, by use of an inbuilt microprocessor, or in a software application which runs on a computer. The medical device according to the invention allows connectivity with a computer via a data communication port, whereas when connected to the computer, the medical device appears as an MSD (Mass Storage Device) on the computer, allowing direct access to collected measurement data and/or data processing results stored and/or generated by the medical device.
By using the MSD interface the communication taking place between the medical device according to this invention and a computer is supported by standard and consistent protocols of data transfer, based on well known features provided by most commercially available computer platforms, and can therefore be considered as being largely independent on the underlying computer environment. The MSD interface approach allows all kinds of data, files and computer software to be accessed in the device the same way as if it was stored on the computer hard-disk or CD-ROM. By this approach, the invention allows the user to open or generate reports on standard formats as soon as the device has been connected to the computer, making it possible to avoid the usual steps of running pre-installed computer software that uploads recorded data for visualization and depends on independent execution of scoring procedures.
The medical device according to this invention allows accessing data and/or data processing results stored in the memory of the medical device, by having the medical device connected to a computer in such a way that it appears as an MSD on the computer. Consequently, the medical device according to this invention allows the implementation of medical systems which are simpler to maintain and use, and are therefore subject to lower costs than other medical systems which have been available up to now. In contrast to other approaches of simplification, the medical system based on this invention is not simplified at the cost of reduced quality in diagnosis or representation.
The above mentioned microprocessor comprised by the medical device of this invention can be selected to be powerful enough to perform data processing on data stored in the medial device's memory, for generating analyses and/or reports which are also stored in the medical device's memory. Such analysis and/or reports can simply be accessed by the respective computer which is connected to the medical device and views its content as an MSD. By this approach the medical system can easily be designed to achieve computer platform and software independency, lowering the corresponding complexity of implementation, costs of use and maintenance. Furthermore, display and/or input elements can be implemented in the medical device of this invention, for allowing displaying data, analysis results and reports without the use of other data processing units such as computers.
It is furthermore possible to store computer software applications in the memory of the medical device given according to this invention, which can be accessed and executed by the respective computer which is connected to the medical device and views its content as being an MSD. Such computer software applications can be used, for example, for data analyzing, report generation, viewing, synchronizing or manipulating data stored in medical devices, such as measurement data, results, reports or various parameters used for configuring the medical device or settings of diagnosis procedures.
Another object of this invention offers similar functionalities but represents a modification of the medical system which uses medical devices according to the present invention, wherein the medical devices are replaced by a combination of components, comprising at least one medical data interface device which can be connected to the respective computer and appears on the computer as an MSD. The medical data interface device furthermore comprises an interface to one or more smart sensors. The smart sensors comprise a combination of a sensor and additional components required to perform and store measurements in a memory component comprised by the smart sensor. The smart sensors can furthermore comprise a microprocessor for pre-processing measurements and they offer data transfer via a comprised communication port. By these means, the smart sensors can be organized in a distributed manner on a patient or at a patient's location for collecting, storing and possibly pre-processing measurement data. By this way, the medical data interface device collects and stores measurement data and/or pre-processed measurement data from the smart sensors in its comprised memory component for instant or later data processing and/or analysis, for example by a microprocessor comprised by the medical data interface device. The medical data interface device can comprise a display and/or input elements for allowing display of data, analysis results and/or reports without the use of other data processing units such as computers. The medical data interface device can store computer software applications in the medical data interface device's memory which can be accessed and executed by the respective computer which is connected to the medical data interface device and views its content as being an MSD. Such computer software applications can be used, for example, for viewing, synchronizing and/or manipulating data stored in the medical data interface device, such as measurement data, results, reports or various parameters for configuring the pre-diagnosis system or settings of pre-diagnosis procedures.
Other possible embodiments according to the present invention are introduced in the description of preferred embodiments.
Referring to the embodiment illustrated in Figure la, the first embodiment of a medical system according to this invention is to have at least one medical device (1) of this invention, which each contains or is connected to at least one sensor, such as for example a respiratory effort belt sensor, body position signal/activity sensor, light detection sensor, snoring sound sensor, snoring vibration sensor, pressure cannula sensor, mask pressure sensor, EMG sensor, LM Vibration sensor, ECG sensor, pulse oximeter, EEG/EOG sensor, flow generator digital or analog output sensor, bruxism sound/vibration sensor, blood pressure sensor or any other sensor recognized by a person skilled in the art to be applicable for measuring signals taken from a patient or at a patient's location for diagnosis purposes. Such signals can include for example ECG (electrocardiogram), eeg (electroencephalogram), SpO2 (oxygen saturation), respiratory effort and flow signals, body activity signals, body position signals, blood pressure signals and could be applied for analyzing syndromes such as apnea/hypapnea, respiratory flow limitation, RLM, snoring, activity, heart rate variations, high/low blood pressure for diagnosis purposes, such as for example for detecting and/or evaluating quality of sleep and/or sleep disorders. Such measurements are recorded and stored, at least partly, by each medical device (1), possibly in a pre-processed format, in a memory component, such as for example DRAM. SRAM, NVRAM, memory cards inserted in a respective memory card slot, or other possible memory types known to a person skilled in the art, which is comprised by each medical device (1). The aforementioned pre-processing of measurement data can, for example, involve signal filtering, noise cancellation, event counting, compression or any other related pre-processing task of measurement data known to a person skilled in the art. Each medical device (1) comprises at least one microprocessor for supporting various tasks such as sampling of above mentioned data, the aforementioned pre-processing of measurement data, data processing, data storing, control of data transfer and/or mass storage data device computer interfacing, visualization etc. This microprocessor can be selected powerful enough to perform complex analysis of respective collected data and to generate results, such as analysis and/or reports which are stored in electrical form in the respective memory of each medical device (1). Such analysis and/or reports could contain data related to various medical and physiological measurements for various diagnosis reasons such as for example count of apnea events, count of oxygen desideration, trend view of blood pressure, sleep reports, ECG reports, epilepsy, etc. As shown in
As illustrated in
The medical device (1) furthermore comprises a data interface which is used for connecting the medical device (1) to a computer (3). In this sense the computer can be comprised by data processing unit, such as a Personal Computer, Workstation or any other type of digital computing devices which may be suitably selected to accomplish the underlying computing tasks. When connected to a computer (3), the medical device (1) acts as a USB memory stick or USB, FireWire or Ethernet connected hard disk, external CD drive or any other possible type of a Mass Storage Device (MSD) accessible by the computer (3). This requirement on the medical device (1) is met by selecting it's comprised microprocessor to be powerful enough to run the necessary services for enabling the MSD connectivity, that is to handle both the onboard data processing and simultaneously the mass storage device interface towards the computer, including the file system access to the data stored in the medical device's (1) memory.
After collecting and processing measurements in the medical devices (1), each medical device (1) can be accessed by the computer (3) as illustrated in
To allow for more sophisticated data analyses to be performed than can be implemented within the medical device (1), the computer (3) can feed the electronic data, analysis and/or reports provided by the medical devices (1) according to FIG. 1c, into a computer software application for further data processing. This allows the full power of the computer (3) to be used for analyses and report generation, without compromising the simplicity of the operating procedure. Such data processing can include the execution of complicated and sophisticated diagnosis algorithms, combining by synchronization and extraction by evaluation, information which is inherent in results stored by the medical devices (1) in form of electronic data, analysis and/or reports. The respective computer software application can be stored either in the computer (3) or in a medical device's (1) memory, whichever may be more appropriate for each case of a medical application. For the case that the computer software has been stored in the medical device's memory (1), it can be configured such that upon connecting the medical device (1) to the computer (3) as an MSD, according to
By this constellation the overall medical system and procedure represents a very effective and efficient means to collect relevant information from a patient or at a patient's location and to process these for gaining diagnosis results in the medical devices (1) and/or in software applications which runs on the connectable computer (3). Consequently, the respective computer software application can be designed in an efficient manner, offering transparent functionalities which are easy and simple to learn, manage and use by the corresponding operator. These software application features may include, for example, processing of large datasets, synchronizing data and/or medical devices, viewing data on computer monitors or storing data in appropriate memory locations.
By this approach the above described system does solve many of the problems inherent in conventional medical diagnosis systems of today. The medical system according to this invention does not necessarily require computer software application installation and training, but is still capable of providing the user with a sophisticated diagnostic result and electronic reporting. This automation greatly simplifies the operating procedure for the user, allowing new users to perform professional and sophisticated diagnostics with minor efforts invested in system operation related specialization and training. The main benefits are lower installation costs, lower training costs and overall easier operation. It follows, that the medical system according to this invention represents an efficient and effective system which can easily and in a cost efficient manner be implemented, maintained and understood by respective technicians and/or operators.
The smart sensors (4) each comprises at least one of the respective sensors for measuring signals taken from a patient or at a patient's location. Such measurements are recorded and stored, at least partly, by each smart sensor (4), possibly in a pre-processed format, in a memory which is comprised by each smart sensor (4). For possible pre-processing the smart sensors can also comprise a microprocessor. Such pre-processing can involve signal filtering and noise cancellation, event counting etc. One possible purpose of the pre-processing would be to ensure that data are recorded and stored in such a way that all the relevant information for the intended use of the medical system becomes available and fits in the smart sensor's memory. This could include reducing data size by data compression, band-width limitations and noise cancellations or adapting sampling rates to allow higher signal resolution during events of interest. This could also include high-resolution time-stamping of events for later data synchronization and overall preparation of data for transfer to the medical data interface device (5). Each smart sensor (4) comprises a data interface which offers connectivity with a medical data interface device (5), see
The medical data interface device (5) comprises at least one microprocessor for supporting various tasks such as data processing, data transfer and possibly also visualization. The corresponding microprocessor can be selected powerful enough to perform complex analysis of respective collected data and to generate results, such as analysis and/or reports which are stored in electrical form in the respective memory component of the medical data interface device (5). As shown in
Synchronization of data, such as sampled measurement data, is one of the most important features of medical diagnoses and can be critical for accurate diagnoses of specific diseases. Medical symptoms are often identified by analyzing the time difference between events in the human body which must be viewed by extracting chronological relations. Examples of such approaches can be found in the detection of hypopnea in sleep monitoring, where a reduction in breathing airflow follows the oxygen desaturation of the blood. Another example is the calculation of pulse transit time (PTT) and arousal connected with body events.
Connectivity can be provided by wireless or wired connections, whereby the wireless systems are obviously more convenient in many ways. Cables used for wired connections can represent a source of unreliability and clearly cause more inconveniences to patients due to their nature. Completely wireless solutions suffer from the fact that they must have an internal powersource which may result in impractical size and weight of devices. Other aspects, such as reliability issues due to noise and interferences inherent in wireless communication systems, can play a significant role when selecting appropriate means of communications to be implemented in medical systems. It follows that all wired or wireless connections as given in described embodiments of this inventions, see
Number | Date | Country | |
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60837941 | Aug 2006 | US |