MXPA99008245A - Method, apparatus, and operating system for real-time monitoring and management of patients'health status and medical treatment regimens - Google Patents

Method, apparatus, and operating system for real-time monitoring and management of patients'health status and medical treatment regimens

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Publication number
MXPA99008245A
MXPA99008245A MXPA/A/1999/008245A MX9908245A MXPA99008245A MX PA99008245 A MXPA99008245 A MX PA99008245A MX 9908245 A MX9908245 A MX 9908245A MX PA99008245 A MXPA99008245 A MX PA99008245A
Authority
MX
Mexico
Prior art keywords
patient
data
monitoring device
medical monitoring
medical
Prior art date
Application number
MXPA/A/1999/008245A
Other languages
Spanish (es)
Inventor
A Kehr Bruce
Original Assignee
Benson Robert H
Chapman Dean
Farrage David
Informedix Inc
A Kehr Bruce
Maurer David
Sohn Evan
Starnes James E
Stowell Davin
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Benson Robert H, Chapman Dean, Farrage David, Informedix Inc, A Kehr Bruce, Maurer David, Sohn Evan, Starnes James E, Stowell Davin filed Critical Benson Robert H
Publication of MXPA99008245A publication Critical patent/MXPA99008245A/en

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Abstract

A medical monitoring device (5), operating system, and method is providedfor managing administration of medical treatment regimens for treating a patient's medical conditions. The device stores information relating to the medical treatment regimens being administered, including medication schedule data, treatment data, patient query data, patient response data, and interactively provides the information to the patient and health care providers (105). A method and apparatus for performing real-time monitoring of a patient's health status using a medical monitoring device (5) capable of wireless transmission, is also provided. Various aspects of the patient's treatment regimens are modified accordingly. The medical monitoring device (5) further analyzes monitored data in view of predefined criteria, and is capable of promptly communicating information concerning the patient's health status and treatment progress to remote devices (105) which notify appropriate health care providers, and is capable of modifying the patient's treatment regimens based on the results of the analysis. A system of monitoring devices and sensors are further provided for performing real-time monitoring and analysis of the patient's treatment regimens. The wireless monitoring facilitates various real-time tasks including, conducting a health status assessment, monitoring adverse effects experienced by the patient, monitoring treatment progress, assessing physiologic, cellular, molecular, endrocrine, and metabolic data, and assessing the patient's general quality of life.

Description

W? BACKGROUND OF THE INVENTION The prior art discloses a number of electronic devices that help with the administration of prescribed medication and monitoring of the medical treatment process. The devices for monitoring medication, such as those set forth in U.S. Patent Nos. 5,200,891 and 5,642,781, provide a number of functions to facilitate patient adherence to prescribed therapies and to facilitate mutual correlation of compliance data and clinical information about the patient. patient. Such devices have a plurality of medication compartments, a microprocessor with associated circuitry to provide signals to regulate time, signals and display messages and to read the inputs of buttons that transmit programming information and operation. They are based on scheduled schedules to provide audible and / or visual warning * signals at the times planned to take certain medications indicating the specific compartment from which the particular medication should be taken and the amount to be taken. 5,642,731 is also capable of gathering contemporary data concerning the patient's adherence to the medication schedule, the progress of the medical conditions being treated, the symptoms and side effects the patient is experiencing and other pertinent information * to monitor and treat the patient's medical conditions.
However, the prior art suffers from a number of inherent disadvantages that have been solved by the present invention. The prior art devices contain complex operating systems and make it difficult to understand how to operate and extract medical information and i. ? 5 educational, and lack the functionality to easily present patient inquiries and obtain patient responses, and easily communicate with remote devices. The operation systems of the The devices of the prior art are also inadequate in their ability to * provide differentiation of relevant sequences of operation for i "* I 10 specific medications and the progress of treatment, further complicating i:. ^ its operation and the monitoring of treatment regimens. * • & , In addition, the devices of the technique previous lack the ability to gather contemporary data that reflect the * - p_.rog # treatment, compliance with medical treatment, and the patient's health status 15 either through simple interface of patient inquiries or monitors physically connected to the patient that monitor physiological, cellular, molecular, endocrine and / or metabolic events.The prior art devices also lack the ability to automatically adjust the treatment regimen based on an algorithm within the device that analyzes the contemporary data collected and automatically adjust the treatment regime accordingly. positive of the prior art also lack the ability to provide positive and negative feedback, and patient notifications, based on the Contemporary data collected. The devices of the prior art < they also suffer from a difficulty in giving repetitive reinforcement information 3 * on a medication basis, to encourage better compliance with the entire medical treatment regimen. In addition, the prior art devices stop providing automatic communication and transfer of data and information between the device and remote devices. In that regard, the prior art devices also lack the ability to provide immediate transmission of contemporary data reflecting the progress of the treatment of the patient. Immediate transmission would make it possible for a health service provider to make a real-time evaluation of contemporary data and adjust the patient's treatment regimen accordingly * adjustment may vary from simply reviewing medication schedules to requesting that patient plan an appointment with a doctor or even require that the patient proceed to the emergency room of a hospital). . The prior art devices also lack the functionality for intensive, real-time monitoring of outpatients, which would provide the ability to monitor outpatients at an intensity relatively equal to that of monitoring patients in a hospital. With respect to the identification of the medications stored in the device, the prior art lacks the ability to provide easy identification of the medication contained in each compartment. Additionally, the devices of the prior art * include fixed volume medication storage capabilities that - limit the flexibility and portability of the device and are able to provide it. easily reminders to the patient, as to when to recharge ? J 5 specific medications, what medication compartments to recharge, how many recharge and what appearance does the medication have. In view of the foregoing disadvantages of the prior art, it is an object of the present invention to provide a monitoring device - * doctor, a system of operation and a communication system that% 10 significantly automates the administration of medical treatment regimens and that is simple to use. It is also an object of the present invention to provide various methods and algorithms that automate the •to. The operating system of the present invention provides additional advantages over the devices of the prior art by differentiating % # - clearly between the sequences of operation associated with each medication ^ specific, also simplifying the operation of the device and the * _ * * - "* 5 administration of treatment regimens Also, the present invention readily provides reminders to patients as to when I fill out specific medications, what medication compartments i fill, how much medication to fill and what the medication looks like, • ñ Simplifying even further the operation of the device and administration of f: 10 treatment regimes. It is a further object of the present invention to provide a medical monitoring device, an operating system and a method for conferring the administration of medical treatment regimens capable of performing the real-time meeting, storage and / or communication. from contemporary treatment data, facilitating real-time analysis of treatment progress. According to the above, the present invention provides advantages over the prior art devices making it possible for the medical monitoring device to gather contemporary data of the patient (data reflecting the progress of the treatment, compliance with the regime < u 20 of medical treatment and the state of health of the patient) either through a simple i terface of inquiries to the patient or monitors physically connected to the patient (monitors that monitor physiological, cellular, molecular, endocrine and / or metabolic events). i "i It is a further object of the present invention to provide a function by which the medical monitoring device automatically adjusts the treatment regime based on an algorithm within the device that analyzes contemporary data and adjusts automatically and in a corresponding treatment regime. It is a further object of the present invention to provide * 4 - automatic communication and transfer of data and information between the device and remote devices. In this aspect, the present invention _ * provides advantages over the prior art, making possible the immediate transmission of contemporary data, which allows the health service provider to perform a real-time evaluation of contemporary data i and adjust the patient's treatment regimen accordingly ? (Adjustment may vary from simply reviewing medication schedules to requesting the patient to schedule an appointment with a physician or even requiring the patient to proceed to a hospital emergency room). - 1, It is a further object of the present invention to provide functionality for intensive real-time external patient monitoring. According to the above, the present mention provides advantages over prior art devices, making it possible to monitor the 20 external patients at an intensity relatively equal to that of monitoring the patient in a hospital. It is a further object of the present invention to provide the patient with feedback and positive and negative warnings, based on the _ i t contemporary data, and provide repetitive reinforcement information on an X based on medication, to encourage better compliance with the entire medical treatment regimen. It is a further object of the present invention to provide a feature that, based on contemporary data, offers the patient or service provider positive and negative feedback concerning the treatment regimen and patient progress, and provides repetitive reinforcement information on a medication basis. According to the above, the present invention provides advantages over the devices of the previous technique encouraging the best compliance with the entire regime of medical treatment controlled by the device. It is a further object of the present invention to provide a medical monitoring device, an operating system and a method for controlling the administration of prescribed regimens of medical treatment. that provide identifying characteristics of the medication contained in each compartment of the device facilitating the easy identification of the appropriate medications. It is a further object of the present invention to provide the variability of the volume capacities of the compartments of medication, extending the flexibility and portability of the device over prior art devices. Additional objects and concomitant advantages of the present invention will be set forth, in part, in the description that follows, or can be ' 1 learn by the practice and use of the present invention. You can perform ? and achieving the objects and advantages by means of the excise and the combinations indicated in particular in the appended claims. It should be understood that the following general and detailed descriptions are 5 copies and explanatory only and should not be considered as "Restrictive V of the invention, as claimed.
BRIEF DESCRIPTION OF THE INVENTION The present invention provides an electronic medical monitoring device, an operating system and a method for controlling and monitoring the administration of medical treatment regimens. The present invention provides real-time access to important treatment information, real-time adjustment of treatment regimens and monitoring sequence devices, real-time patient / health service provider interaction, facilitate efficient and improved monitoring and control of medical treatment regimens. The present invention also provides for the collection of information concerning the treatment of the patient's medical conditions in order to health services professional in monitoring the progress of the 4 medical conditions of the patient and the results of the treatment. The invention gathers contemporary information concerning the patient's compliance with the treatment regime, the progress of the conditions? l patient's medical records, symptoms and side effects experienced by the patient, physiological information (ie, blood pressure and glucose levels), endocrine and cellular functioning (ie, presence and amount of circulation levels or serum polypeptide or spheroid hormones, hepatic enzymes or other detectable cellular metabolites for a specific analysis device containing receptors or antibodies, etc.), and the general health status and quality of life of the patient. This information facilitates the immediate, accurate and real-time analysis of the patient's progress, resulting in more efficient control of conditions medical, health and improved treatment outcomes of the patient. The present invention provides a medical monitoring device that is interfaced with a communications support or a base unit for transferring data to and from remote devices. The present invention also provides a medical monitoring device that is capable of direct communication to and from remote devices by means of wireless communication methods commonly known to ordinary experts in electronic communication technology. Information % * _ or communicates immediately to a remote device or is stored in a medical monitoring device for subsequent communication. In one embodiment, the present invention provides a key, a button or a tactile dot allocated on a screen associated with each medication being administered or with each disease that is being administered.
J ft trying. Each one of the destined keys facilitates the access to the information related to the medication or associated disease (ie, electronic prescription labeling, illustrations and color of the medication, description of the medication's function, conditions and diseases that the medication treats, side effects associated with the medication, drugs with which the medication interacts, etc.). An additional set of soft keys, buttons or tactile points facilitates additional functionality (ie flexible applications, programming, switching between modes of operation, response to patient inquiries, patient introduction of physiological values, additional access information, with respect to doses not planned and % 10 omitted, communication with remote devices, browsing through additional messages, etc.). In a further embodiment, the present invention tracks the regulation of time and provides planned medication alarms indicating specific prescribed medication doses to be taken at hours individuals. The alarms comprise an audible signal and warnings or visual messages displayed on a display unit. The invention further provides medication compartments for storing the prescribed medications and, during a planned medication alarm, the invention provides signals indicating the particular compartments of which they are to be stored. '^ - 20 take the medications and / or the amounts of liquid medications, , it is injectable or aerosol to be taken. * r In a further embodiment, the present invention provides a? Selectable medium of sound and / or light alarm that shows signals _ $ go audible and / or visible that indicate the messages or instructions to the patient. Audible signals may include music, a melody, a series of tones or other sounds that convey a message, and visible signals .i t can include lights, which also transmit a message. The provider of health services selects audible and / or visible signals during programming of the device and the user can change the settings of 'signals during the execution of the programming mode of the device. He The medical monitoring device of the present invention thus provides a means by which the patient who suffers from a disabling condition (ie, senility, Alzheimer's disease, cerebral organic, etc.). .) can *% 'f * * operate the medical monitoring device and understand the messages and / or instructions transmitted during the operation of the device. In a further embodiment, the present invention provides an i method by which a medical monitoring device provides access to • * • 15 refrigerated or frozen medications. The device provides alarms Planned medication, as specified above, and provides indications or codes that unlock or provide access to a device - refrigerator or freezer that stores the prescribed medications that are \ • have to take. Alternatively, the device provides access electronically $ £ * 20 to the prescribed medications refrigerated or frozen when a particular medication compartment is opened. In a further embodiment, the present invention further provides a variable capacity compartment tray and a system storage that provides complete flexibility in the quantities and volumes of solid, liquid or aerosol doses contained within the unit. The variable capacity compartment tray also provides preload, and pre-trigger mediations. According to the above, when a patient runs out of a supply of medication in a tray, a second pre-loaded and pre-labeled tray can quickly and easily replace the tray. In an additional embodiment, the present invention provides a graphic display, allowing the display of graphic images or text Jf 10 in any language, and allowing a symbolic or pictorial set of instructions to illiterate patients. The graphical visualization can visualize graphic images that indicate the progress of the patient. For example, if the patient is adhering to the treatment regimen, the graphic image may comprise a representation of the patient's body that shows improved health and well-being, or a smiling face, or other symbols of improvement of health, well-being or achievement. Similarly, if the patient does not, is adhering to the treatment regimen, the graphic image may include a representation of deteriorating health and welfare, or a scowl, or other symbols of health, welfare or deteriorating achievement. A The algorithm in the device itself updates or automatically and periodically changes the graphic images, based on the recording of the adherence of the patient's behavior to the treatment regime but united and stored in the device.
In a further embodiment, the present invention tracks? also the consumption by the patient of each medication and provides the patient with "fill in" reminders. "Fill-in" reminders inform the patient when to reload mediation, which medication to recharge, the amount of 5 to recharge, when to call the health service provider or the pharmacy for refills, etc. The device automatically presents the "fill-in" messages, or presents the "fill-in" messages when the patient presses a key destined for a particular medication. Additionally, a software algorithm automatically adjusts the reminders of i f. 10"refill", future dosing regimens instructions, on the basis that the patient takes previous doses too early, too late or does not take them; and relying additionally on the property aspects * 4 pharmacokinetics of a particular drug contained within a particular compartment. In an additional compartment, the present invention provides a 3 method and means for wireless communication with the medical monitoring device and the scrutiny thereof. The wireless communication to _ 4 may be through a link by cellular phone, satellite link or other means of radio communication, known to ordinary experts in the technique of electronic communions. The wireless communication feature allows the transmission of data with inquiries to the patient to the medical monitoring device, to conduct an assessment of the health status and the adverse effects of monitoring for side effects experienced by the patient, the progress of the treatment and the quality 1 general life of the patient. The wireless communication feature also facilitates the scrutiny of medical monitoring device or other monitoring devices to recompile patient response data, physiological data, hormones, enzymes or other concentrations of metabolites, and any other physical, chemical, molecular, endocrine or metabolic data related to the patient for the real-time analysis of the patient's health status and the progress of the treatment. A The wireless communication feature provides improvements over the prior art in the sense that a medical monitoring device with such a feature does not necessarily require a memory storage function of extended duration (ie, week or month). The wireless communication feature also facilitates periodic, spontaneous and / or random data transmission or scrutiny, related to the treatment regimen and the patient's health status. In addition, the device is capable of transmitting data concerning the condition of the patient immediately after the user inserts a data element, a sequence of data elements or a particular combination of data elements. The wireless transmission feature thus makes it possible to increase the frequency and intensity of monitoring, up to the capacity of real-time monitoring of external patients. Furthermore, the wireless communication feature provides the immediate transfer of data in which the patient's condition guarantees attention immediate The wireless communication feature thus allows for the treatment of outpatients, seriously ill patients, keeping them out of hospitals and private sanitariums, with more independence and less expenses for health services.
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates an electronic circuitry circuit diagram of the medical monitoring device of the present invention. % 10 Figures 2 (a) and 2 (b) illustrate a top / side view and a * f bottom / rear side view of the medical monitoring device. i present invention, including the intended and soft fusion keys, ** infrared communications display and door. Figure 3 illustrates the support of the present invention and the interface between the support and the medical monitoring device. _r •• i. * Figure 4 illustrates a flowchart of the general operation $ of the medical monitoring device, the operating system and the method of the present invention. Figure 5 illustrates the liquid crystal display, the intended keys 20 and soft melting keys in the passive mode of medical device 1 and monitoring, the operating system and the method of the present invention. ¥ tt 17 Figures 6 (a) - (c) illustrate the liquid crystal display, the target keys and the soft-melt keys during a sequence of operation with the keys intended for medical monitoring device, the operating system and the method of the present invention. 5 Figures 7 (a) - (e) illustrate the liquid crystal display, the X target keys and soft fusion keys during a sequence of operation of a planned medication alarm operating the sequence of medical monitoring device, operating system and method of the present invention. 10 Figures 8 (a) - (b) illustrate the liquid crystal display, the target keys and the soft-melt keys during an unplanned medication alarm operation sequence of medical monitoring device, the operating system and the method of the present invention. i. Figures 9 (a) - (b) illustrate the liquid crystal display, the destined keys and soft fusion keys during different general signals of medical monitoring device, operating system and method of the present invention. Figures 10 (a) - (b) illustrate the liquid crystal display, the designated keys and the soft-melt keys during a function of mode selection of medical monitoring device, operating system and method of the present invention Figures 11 (a) - (c) illustrate the liquid crystal display, the target keys and the soft fusion keys during a sequence from operation of the "compliance with measurement" mode of the medical monitoring device, the operating system and the method of the present invention. Figures 12 (a) - (d) illustrate the liquid crystal display, the target keys and the soft fusion keys during an operation sequence in the "patient inquiry" mode of the medical monitoring device, the operating system and the method of the present invention. yes Figures 13 (a) - (h) illustrate the liquid crystal display, 10 10 the target keys and the soft-melt keys during a sequence of operation in the "medication program" mode the medical monitoring device, the operating system and the method of the present invention. Figures 14 (a) - (c) illustrate the liquid crystal display, the destined keys and soft melting keys during a sequence of operation with "fill" alarm of medical monitoring device, the "4 * 1 operation system and the method of the present invention 4 Figures 15 (a) - (b) illustrate the liquid crystal display, the target keys and the soft melt keys during a sequence of "3" operation in the "fill-in" mode of the medical monitoring device, the operating system and the method of the present invention. x. F Figure 16 illustrates a removable tray of a modality for use with the medical monitoring device, the operating system and the method of the present invention. Figure 17 illustrates a removable tray of an additional embodiment for use with the medical monitoring device, the operating system and the method of the present invention. Figure 18 illustrates a removable tray of an additional mode for use with the medical monetary device, system operation and method of the present invention. Figure 19 illustrates a removable tray that stores a bottle of pills for use with the medical monitoring device, the -A operating system and the method of the present invention. Figure 20 illustrates a removable tray with sealed and labeled medication compartments for use with the medical monitoring device, operating system and method of the present invention. Figures 21 (a) and 21 (b) illustrate two views of the medical monitoring device and the removable tray with labels on the lower part of the device. Figure 22 illustrates a removable tray and a behavioral insert for use with the medical monitoring device, which the operating system and the method of the present invention. 1 Figure 23 illustrates the removable tray and supporting support frame for use with the medical monitoring device, the operating system and the method of the present invention. 4 Figure 24 illustrates a block diagram of a medical monitoring system of monitors, sensors, supply devices and remote devices according to the present invention.
DETAILED DESCRIPTION OF EXEMPLARY MODALITIES All patents, patent applications and publications cited in this description are incorporated herein by reference in their 1, totality In case of inconsistencies, the present exposition is expected to prevail, including definitions. t% The present invention provides an electronic device, a system of operation and a method that helps the patient user with administration of medical treatment regimens and helps health service providers with the provision of the most efficient and effective treatment __t * for medical conditions. Similar devices are exposed in the patents of E.U.A. No. 5,200,891 and 5,642,731 incorporated herein by * 20 reference in their totalities. In an exemplary embodiment, as illustrated in FIG. 1, the medical monitoring device of the present invention utilizes an integrated 4-bit driver circuit 10 connected to the interface with a V i liquid crystal display ("LCD") of 320 x 100 image elements with graphics capabilities. The operating system of the device is stored in an external EPROM 12 of 128 x 8 bit and the variable data (ie the data to program the medication, the information on the treatment, patient inquiry data and response data) are stored in an external 128 x 8 bit SRAM 13. The crystal oscillator circuit 14 provides a clock signal to microcontroller 10, the clock circuit 15 goes to date and time of day. Five 16-20 compartment switches, five keys for 21-25 and four fusion keys 26-29 are connected to the inputs of the microcontroller 10 to provide status signals, function commands and responses to - 4 And inquiries of the patient to the microcontroller 10 for processing. The device possibly makes reaction with health service providers through a communication gate 17. The communication gate 17 comprises an infrared input / output gate capable of communicating directly with a personal computer 18. Alternatively, the communication gate It can comprise a serial door capable of communicating with a modem or directly with a PC. The health service provider may transfer information to the device, such as programming data concerning the prescribed medication schedules, programming data concerning the selection and control of audible and / or visible signals (ie, sounds, music, melodies, tones, colored lights, etc. for communication with worsened patients), h and training regarding the medication described and the medical conditions being treated and patient inquiries associated with the medical condition being treated. The health service provider may also retransfer device information, such as data concerning patient adherence to prescribed medication schedules, information representing patient responses to patient inquiries. The device itself, as illustrated in Figures 2 (a) and 2 (b) has an upper face 51. Upper face 51 includes openings for LCD 11, dedicated keys, 21-25, soft melt keys 26-29 in medication compartments 31-35. The medication compartments 31-35 have the respective compartment doors 36,40 covering them. The device also has a top cover 52 hinged to open and close the device. The medication compartments 31-35 are housed in a tray that is inserted to the bottom of the device. The tray can be of various sizes and can even be large enough to • keep a bottle of pills, a medication inhaler, a syringe, and a large medication container. In addition, the medication compartments can give direct cavity to liquid, injectable or aerosol medications. The compartment switches 16-20 send signals to microcontroller 10, indicating when the compartment doors are opened and closed. Each of the medication compartments 31-35 and their respective compartment doors are associated with a compartment switch that detects the opening and closing of the compartment door. When a particular compartment door is opened, the associated compartment switch sends a signal to a microcontroller And 5 10 and the microcontroller processes the signal according to the specific state s of the device at that moment. For example, as described in detail in Next, if a compartment door is opened during a planned medication alarm, the microcontroller 10 interprets this as an indication that the patient has complied with the prescribed schedule for the treatment. particular medication contained in that compartment. The compartment switches thus facilitate tracking of the device of patient adherence to the prescribed medication schedules. The device provides a means to interact with the patient through a series of operations controlled by the dedicated keys 21-15 and the soft fusion keys 26-29. The designated keys 21-25 make it possible for the patient to collect information concerning specific medications contained in the device medication compartments or concerning specific diseases. The soft fusion keys 26-29 make it possible for the patient to respond to patient inquiries concerning medication side effects, adherence to medication schedules, progress of treatment, assessment of health status and quality of life of the patient. The soft fusion letters 26-29 also facilitate other operations, such as programming mode for modify device regulations and adjust medication schedules and treatment data, and other types of information capture.
Alternatively, the present invention may employ point on a touch screen that function in the same manner as the keys intended for 21-25 and the soft-melt keys 26-29. Each of the keys assigned is associated with the particular medication compartment located adjacent thereto. Specifically, the target key 21 is associated with the medication compartment 31, the target key 22 is associated with the medication compartment 32, the dedicated key 23 is associated with the medication compartment 31, the dedicated key 21 is associated with the compartment of medication 33, the target key 24 is associated with the medication compartment 34, and the target key 25 is associated with the medication compartment 35. Each key destined controls the visualization and insertion of information related to the specific medication stored in its medication compartment associated or related to the medical condition for which the medication is prescribed. With reference to Figures 4 and 5, once programmed, the device remains in a passive mode 61 from which a plurality of events can occur. In passive mode, the device displays the current time of day, the patient's name and the patient's next medication schedule. Alternatively, the device can display the date. The display of the patient's medication schedule consists of a display, located directly above each key destined, of the following prescribed key to which the patient must take the medication contained in the medication compartment associated with the key. For example, as illustrated in Figure 5, the time of day is 3:15 P.M. and the drug schedule of the • 5 patients involve taking the mediation contained in compartments 21 and 22 at 5:00 pm, compartments 23 and 24 at 8:00 pm and compartment 25 at 9:00 A.M. the next morning. In passive mode 61, the patient can easily obtain information concerning any of the medications contained in the .1 10 medication compartments by pressing or pressing the designated key «F associated with the medication with respect to which the information is sought. When the patient presses or presses a key once, the patient * device displays a message with a description label concerning the medication contained in the medication compartment associated with the medication key activated. For example, as illustrated in FIG. 6A, if the patient operates the target key 23, the device displays the name of the medication contained in the associated medication compartment 33 ("Coumadin 50 mg"), the prescribed time for that medication. particular medication ("Take two pills at 8:00 p.m."), the graphic representation indicating the color of the medication 60, information concerning the optimal conditions for taking the medication ("It must be taken with water") and an arrow 62 indicated to the activated target key and the associated medication compartment. If the patient does not activate any other key during a period of default wait (Preferably from about 5-30 seconds), then the device returns to passive mode 61. If the patient then triggers a different destined key, either within the predetermined waiting period or after that period, the device displays the message with a label concerning the medication contained in the medication compartment associated with that key. For example, as shown in Figure 6 (b), if the patient operates the key 22, the device displays the name of the medication contained in the associated medication compartment 32 ("Demerol 100 mg"), the prescribed time for that particular mediation ("Take three pills") at 05:00 PM "), a graphic representation and the indication of the color of the medication 61, information concerning the optimal conditions to take the medication (" It should be taken after the food ") and an arrow 62 that indicates the activated target key and the associated medication compartment, then, as specified above, if the patient does not activate any other key during a predetermined waiting period, the device returns to the passive mode. the patient operates the same target key 22, enters the predetermined waiting period in relation to the first actuation, then the device displays additional information concerning the Edication contained in the associated medication compartment. For example, as illustrated in Figure 6C, if the patient operates the designated key 22 of either the predetermined waiting period in relation to the In the first actuation, the device displays descriptive information concerning the medication contained in the associated medication compartment (Demerol). Also, the controller designates page up and page down functions to soft function keys 28 and 29, respectively. Actuation of the soft function keys 28 and 29 of page up and page down causes the microcontroller 10 to scan through the screen displays containing additional information concerning the associated medication. Then, as specified above, if the patient does not activate any other key during the predetermined waiting time, the device returns to the passive mode. The additional successive operations of the same key destined will give access to additional information concerning the medication contained in the compartment and medication associated with the operated key. The additional information may include information about the particular medical condition that the medication treats (ie, general information about the medical condition, information about how the condition affects information about the patient's prognosis based on adherence to the schedule of the patient). prescribed medication). Other information may relate to potential side effects and adverse reactions associated with the particular medication, the process of diagnosing or treating the medical condition, noxious or adverse interaction with other medications and laboratory procedures or other diagnostic tests involved in the diagnosis and treatment of the medical condition.
Also in passive mode 61, an alarm can trigger sending signals to the patient by means of visual and / or audible warning signals. The alarm can be either a planned medication alarm or a general alarm. The planned medication alert alerts the patient and indicates that certain doses of planned medication should be taken. The general alarm alerts the patient and indicates that some other action is required. The other action may be one of several possibilities, including responses to certain patient inquiries, operation of a particular test, placement of the device within the support for communication with a remote device, telephoning or making an appointment with the health service provider. , apply an injection, inhale an aerosol medication, etc. Referring to Figure 7 (a), when a planned medication alarm runs, the device continues to view the current time and displays a message indicating that the planned medications should be taken. The device designates particular planned medications with arrows 62 that designate the appropriate medication compartments. The patient can have access to specific information concerning the medications that are the reason for a planned medication alarm, by activating the assigned key associated with one of those medications. In addition, in front of a planned medication alarm, the microcontroller 10 assigns a nap function to the soft function key 26 and the activation of the nap key suspends the alarm for a predetermined period, pre-programmed to the device (i.e. hour), as illustrated in Figure 7 (e). The nap function ends after 15 minutes if it is canceled during the programming of the device. As illustrated in Figure 7 (b), by pressing the designated key 22, the device displays the name of the medication intensity in the upper left corner of LCD 1 1 in reverse video, the description requirements for the associated medication , a request that the patient take a prescribed amount at that time and any special instructions ("Take three now"). When the patient opens the appropriate medication compartments during a planned medication alarm, the compartment switch associated with each compartment sends signals to the microcontroller 10. The microcontroller 10 then displays a message on the LCD 1 1, designated to the prescribed amount for medication in the open compartment and the conditions for taking medication, as illustrated in Figure 7 (c). The message requests that the patient either take the designated amount prescribed for the medication or alternatively act the soft function key 29 to indicate that the medication can not be taken, as illustrated in Figure 7 (c). Then, operation of the soft function key 29"Can not" sends signals to the microcontroller 10, which displays an appropriate message. For example, as illustrated in Figure 7 (d), the message inquires into the patient as to why the planned medication can not be taken, with the potential responses of "I need a refill" and "Side effects" assigned to the keys of soft function 28 and 29, respectively. He ? The soft-key activation assigned to a particular response sends signals to the microcontroller 10 indicates the response of the patient, and the microcontroller 10 records a response together with other associated information (ie the particular medication to which the response refers). and the time of day when the answer is given). The actuation of the soft function key 29 which indicates that the patient is experiencing adverse reactions or side effects can then cause the micro-controller 10 to inquire about the particular reactions or effects that are experienced, as illustrated in FIG. Figures 12 (a) - 10 12 (d). The microcontroller 10 will again record the patient's response along with other associated data. The opening in the closure of a designated compartment, during a planned medication alarm, sends signals to microcontroller 10, indicating that the patient adhered to the written field for the medication contained in the compartment. The microcontroller 10 f then records the adherence of the patient accordingly. If the patient has stopped obeying a planned medication alarm and does not open and close each of the designated medication compartments, within a predetermined period until the next medication alarm As planned, then the alarm will continue at periodic intervals (ie 15 minutes). The alarm will also provide a visual signal (ie "OMITTED MEDICATION"), informing the patient that a planned medication has not been taken and designating the appropriate compartment and quantity necessary The device can display other messages about the LDC 1 1, warning the patient of the adverse consequences associated with the failure to adhere to the particular medication schedule of the planned medication alarm. It will be deactivated once the patient has access to all designated medication compartments associated with the particular alarm. In a further embodiment, the present invention provides an operating system, method and apparatus that automatically adjusts the patient's treatment regimen (ie, the patient's hours and dose of medication planned) based on the data comprised of the patient many monitored aspects of the patient's treatment progress. With patients taking medication for chronic and / or acute illnesses, no health service provider describes medication at fixed intervals or specific times, although it is preferable that patients take medications at prescribed intervals, patients may stop adhering to medications. prescribed hours. At other times, it is more convergent for patients to take a dose earlier than prescribed. For example, in addition to prescribed dosing, a patient may be unable to take a dose because of the attenuation conflict or, for some other reason, the patient may need to take the medication earlier than prescribed. In certain cases, it is critical, however, that patients take all prescribed doses during a given period. The taking of all The doses of certain drugs in a given period use efficacy of drug therapy in the treatment of the disease or the fundamental diseases. In addition, there should not be a too short or too long interval between doses. Too short a range can cause unacceptable, even lethal side effects, or adverse reactions to drugs, and too long an interval between doses can cause unacceptable interruption symptoms, a worsening of the disease, rehospitalization or even death. The present invention therefore provides an algorithm or algorithms that automatically adjust subsequent dosing intervals with the medical monitoring device determines the need for such adjustments to safely administer, appropriate and optimal the remaining doses. For example, the medical monitoring device of the present embodiment would include an algorithm to calculate the next planned dose hour based on the time regulation of a current dose. If the patient opens a compartment outside of a specified time window for a planned dose or while the device is in passive mode as described above, the device provides audible and visual signals indicating that the patient is having access to an unscheduled dose, with reference to figures 8a and 8b. If the patient then operates the soft function key 29"continue" and then the soft function key 27"taking pill", the device would record information concerning the unplanned dose. Additionally, the device would execute an algorithm which analyzes the regulation of the time of the unplanned dose with respect to the previous and the next planned dose for that modification and will calculate a next planned dose modified accordingly. Medical monitoring of the present modality could also include algorithms that analyze the monitored data, as described in detail above, and adjust the subsequent dosing schedules based on the patient's progress and / or actual reactions to the previous doses, or based on in any other monitored aspects of physical health and patient's symptoms. The device of the present embodiment will optimize the dosing intervals of the patient; thus reducing side effects, adverse reactions and symptoms of interruption of the disease; resulting in optimized medical treatment and quality of life. In a further embodiment, the present invention provides a method by which a medical monitoring device provides access to refrigerated or frozen medications. In at least one of the medication compartments, the device stores indicia or keys that provide access to a refrigerated container that stores prescribed mediations that are to be taken. When a planned medication alarm occurs, the device indicates that a keyed indication of a particular compartment must be removed and that the indication or key provides access to the appropriate refrigerated container that stores the medication to be taken. Alternatively, the device electronically provides access to the refrigerated container. In this case, when an alarm occurs Planned medication, the device indicates that a particular compartment has to be opened. Upon opening that compartment, the device transmits, through the wireless medium, a signal unlocking the appropriate refrigerated container that provides access to a prescribed medication as the reason for the alarm. The wireless means may consist of any electronic transmission method known to those skilled in the art, i.e. infrared or radiofrequency reduction. In a further embodiment of the present invention, the audible alarm signal of planned medication includes the use of a transducer or an integrated circuit for voice generation or a horn that emits vocal sounds to give audible instructions concerning the prescribed medications. In this mode, a number of common messages and / or words associated with prescription instructions are stored in the SRAM 13 or the EPROM 12 (ie "intakes", "pills", "al", "pills", " water "," juice "," times "," one "," two "," day ", etc.). Messages and / or words are stored in frame search format and the device plays audible messages by sequencing through specific combinations (ie, "take two pills with milk twice a day"). Additional messages specific to particular medications, SRAM 13 or EPROM 12 may also be programmed for patient alert in certain predefined circumstances. When the patient opens a medication compartment when the device is in passive mode and no alarm occurs Planned medication, an unplanned pill alarm occurs. During an unplanned pill alarm, the device provides audible and visual signals. Referring to Figure 8a, the visual signals consist of a visualized message, with the medication rotor and video intensity immersed in the upper left corner of LCD 11, along with a message that the medication should not be taken at that hour. The device also displays a message indicating that the patient must press the soft function key 29"continue" for more information. Activation of the soft-key "continue" starts the display of the medication rotor and the intensity in reverse video in the upper left corner of the LCD 11, along with the prescribed medication schedule for the medication contained in the open compartment. The device also displays an inquiry as to why the compartment was opened, with potential responses assigned to particular soft-function keys. Other alarms that occur from the passive mode alert the patient to other related medical activities. For example, as illustrated in Figure 9a, an alarm can alert the patient that a dose of an inhaler should be taken. As illustrated in Figure 9, additional alarms may remind the patient to perform certain tests, such as the blood sugar test. In a further embodiment, the present invention provides a selectable sound and / or light alarm means that displays audible and / or visible signals indicating messages or instructions to the patient. By For example, during a medication alarm, the medical monitoring device provides audible and / or visible signals. The audible signals may consist of music, a melody or a series of tones whereby, if the patient opens a wrong compartment during a medication alarm, then the device would play a sad or disturbing piece of music, a melody or a series of tones. . If the patient opens the appropriate compartments during a medication alarm, then the device would play a musical piece, a melody or a series of happy or pleasant tones. In addition, the visible signs may consist of lights, whereby, if the patient opens a wrong compartment during a medication alarm, then the device would illuminate and display a red light indicating "high" or a yellow light indicating "caution" " If the patient opens the appropriate compartments during a medication alarm, then the device will illuminate or display a green light indicating "follow". Audible and / or visible signals would be selected during programming of the device by a health service provider or by a user during the execution of the programming mode of the medical monitoring device. The medical monitoring device of the present invention thus provides a means by which a patient suffering from a disabling condition (ie, senility, Alzheimer's disease, organic brain, etc.) could operate the medical monitoring device and understand messages or instructions transmitted by the device. Also I know They can use many other possible means to communicate with a worsened patient, including vibration. Furthermore, while in the passive mode 61, the soft action key 26 controls a selection function so that it initiates an active mode of operation by which the patient initiates different modes of operation of the device. Referring to Fig. 10 (a), operation of the soft function key 26 for mode selection of the passive mode displays a mode selection screen, in which each soft function key is assigned a different function for mode selection. The soft function key 26 initiates a "medication addition" mode, the soft function key 27 initiates a "dump" mode (to fill the medication compartments), the function key 28 initiates a "inquiry mode" to the patient "and the soft function key 29 is assigned a" plus "function. Operation of the soft function key 29"plus" scans the display to gain access to additional modes of operation, as shown in Figure 10 (b). The additional modes of Figure 10 (b) are in a "schedule and a medication program" mode, or a "regulations and a device program" mode and a "communication" mode. Referring to Figure 11 (a), in the mode of "add-on with medication", the device displays a summary screen with the title "compliance summary" displaying it in reverse video in the upper left corner and a synopsis of the adherence to the schedule of medication of the patient. Specifically, above each medication compartment containing a medication for which the patient omitted planned doses, the device displays the amount of doses omitted for the medication contained in the associated compartment. For example, as illustrated in Figure 11 (a), the patient omitted 4 doses of the medication in compartment 32 (the compartment associated with the designated key 22), one dose of the medication in compartment 34 (the associated compartment). with the key 24) and 2 doses of the medication in compartment 35 (the compartment associated with the key destined 25). The patient then activates a particular key destined to obtain the details concerning the omitted schedules for the medication contained in the associated compartment. For example, as illustrated in Figure 11 (b), when the target key 22 is operated, the device displays the name and intensity of the associated medication in reverse video in the upper left corner of the LCD 1 1 and displays messages indicating that the patient omitted certain doses at specified dates and times. In this case, since only three omitted doses agree on the LCD screen, the soft function keys 28 and 29 serve as scan keys to scan up and down to review the additional entries of the missed medication doses. The additional activation of the assigned key provides the patient with information concerning the potential or probable consequences and omitting the doses of medication, as illustrated in Figure 11 (c). Additionally, the soft function key 28 serves as the "NEXT" function to have access to additional information concerning missed doses of the particular medication and to access information concerning unplanned medication doses taken by the patient. The device thus provides educational information to motivate the patient to comply with medication schedules. Referring to figures 12 (a) - 12 (d), in the mode of "Inquiry to the patient", the device displays a series of inquiries concerning the assessment of the health status, adverse effects or side effects experienced by the patient, progress in the treatment and general cavity of the patient's life. Other inquiries may arise that require responses from the health service provider. During the communication mode, the health service provider can transfer specific programming data associated with the prescribed medication schedule and the medical treatment regimens of a particular patient and transfer the response data to the patient or other information through of the communications door 17. In addition, referring to Figures 13 (a) - 13 (f), in the "schedule of a medication schedule" mode, the device allows the patient or health service provider to modify the medication schedules prescribed for a particular medication. The actuation of the assigned key 21, while in the "schedule and a medication program" mode, facilitates the modification of the prescribed schedule for the medication contained in the associated medication compartment. The device displays an adjustment message, with the name and intensity of the medication being adjusted, in reverse video in the upper left corner of the LCD 11 and display the current prescribed frequency ("take 2 pills 4 times per day"), as illustrated in Figure 13 (a). It is highlighted in the number of pills per dose "2" and the operation of the soft function key 28"+" and the soft function key 29"-" increases or decreases by one is a number enhanced by each actuation, correspondingly. Figure 13 (b) illustrates the display after pressing the soft function key 28"+" once; the number of pills per dose is now "3" instead of "2" ("you take 3 pills 4 times per day"). Activation of the "next" soft function key enhances the following regulation (the frequency at the dose per day) for the modification, as illustrated in Figure 13 (c), and that regulation is modified in the same manner. The user can then regulate the doses of the hours, by pressing the soft function key 27"next", as illustrated in figures 13 (d) - 13 (f). Referring to Figure 13 (d), the first hour of dose and the last hour of dose are displayed on LCD 11, with the first hour of enhanced dose. The first hour of dose is changed in increments of 15 minutes by pressing the soft function keys 28 and 29"+" and "-". The device automatically calculates the last hour of dose by adding 12 hours to the first hour of dose and regulates the intermediate dose times by dividing the 12 hour period by the planned number of doses per day. As shown in Figure 13 (e), pressing the soft function key once "+" 28 increase the first hour of dose 15 minutes to "08:15 A" and, as illustrated in figure 13 (f), pressing the soft function key "+" again 28 increases the first hour of doses another 15 minutes to "08:30 A". After regulating the dosing hours, the operation of the "next" soft function key 27 allows the modification of the filling amount, as illustrated in FIG. 13 (g). The amount of filling on the LCD 11 is enhanced and the soft function keys "+" and "-" 28 and 29 increase and decrease the amount of filling, accordingly. Referring to Figure 13 (h), after the completion of the "schedule and a medication program" mode, the device displays the new regulations and requests the user to check them by pressing the soft function key "yes" 27. If the regulations are incorrect, the user presses the soft function key "no" 28 and the device returns to the beginning of the "schedule and a medication program" mode. In addition, the soft function key of mode 26 makes it possible for the user to modify certain regulations and program information of the device (ie date and time of day regulations, alarm volume, nap interval, etc.). The device tracks the number of pills in each compartment while the patient complies with the planned medication alarms. In the passive mode, with the device considering that a medication compartment is empty, the device provides a "Fill" alarm to alert the patient that it is time to fill a compartment with medication, as illustrated in Figures 14 (a) -14 (c). Referring to Figure 16 (a), with the occurrence of a "Fill" alarm, the device displays the name and intensity of the medication to be filled in reverse video in the upper left corner of LCD 11, together with the graphic representation of the medication 63. The device also indicates the number of pills to be filled and displays an arrow pointing to the appropriate medication compartment (appropriate medication compartment) medication compartment 34 associated with the key destined 24). The alarm continues until the user activates the associated assigned key 24. The device then allows the user to operate the soft function force "Fill it now" 27 or the soft function key "Remember me later" 28, as illustrated in Figure 14 (b). If the user presses the soft function key "Remember me later" 28, then the "Fill" alarm will occur in a programmed future amount of time (the fault is' 2 hours). The "Fill" alarm will continue periodically until the user presses the "Fill it now" soft key 27 unless the associated medication compartment is programmed to be empty. Activation of the "Fill it now" soft function key 27 revisits the previous screen and the associated medication compartment must be opened and closed to deactivate the "Fill" alarm. Once the associated medication compartment is opened and closed, the device instructs the user to verify the delivery charge, as illustrated in Figure 14 (c). If the user Verify the supply load by indicating "Yes", then the device will continue to track the inventory of the associated medication compartment. Otherwise, if the user verifies the supply load by indicating "No", then the device disables the function of enabling the inventory for the associated medication compartment. Referring to Figure 10 (a), the "Fill" mode can be selected by pressing the soft function key in "Fill" mode 27, when the device is in the active mode (after the soft key operation is activated) to select mode 26, from passive mode). After user initiation of the "Fill" mode, the user must activate the assigned key associated with the medication compartment to be filled and can be instructed to do so by means of a message on the display. As illustrated in Figure 15 (a), the device then displays the name of the intensity of the medication to be filled in reverse video in the upper left corner of the LCD 1 1, along with a graphic representation of the medication 63. The device also indicates the number of pills to be filled and displays a pointed arrow to the appropriate medication compartment (the medication compartment 34 associated with the designated key 24). Once the associated medication compartment is opened and closed, the device instructs the user to verify the delivery charge, as illustrated in Figure 15 (b). If the user verifies the supply load by indicating "Yes", then the device will continue to track the inventory of the medication compartment associated. Otherwise, if the user verifies the supply load by indicating "No", then the device disables the function of tracking the inventory for the associated medication compartment. In a further embodiment of the present invention, the medical monitoring device 5 provides for the use of a variable capacity compartment tray and a storage system that provides complete flexibility in the quantities and volumes of two visual, liquid or aerosol contained inside the unit. The variable capacity compartment tray also provides the preload and the pre-calibration of the medications. According to the aboveWhen a patient aborts a supply of medication in a tray, a second pre-loaded and pre-labeled tray can quickly and easily replace the exhausted tray. As illustrated in Figure 16, the medical monitoring device includes a removable tray 75 that can be inserted and moved easily. Tray 75 contains the medication compartments 31-35. The tray 75 has extensions 77 that protrude before each side that is inserted into the corresponding grooves 78 in the upper portion 85 of the device 5. The tray 75 is of a predetermined depth (a). A tray 76, as shown in Figure 17, can be of different predetermined depth (b). The different depths provide variable amounts, volumes and moles of medications necessary for a given treatment regimen.
The default depth is based on functionality. The compartments of a particular tray must be able to store 12 different types of medication that cover a certain period. For example, each compartment of trays of one size can be designated to store 84 tablets of a medication provided in a tablet size of 1 cm in diameter by 0.5 cm in thickness. A tray could store a week's supply of such medication, in which 3 pills would be prescribed to be taken four times a day. In addition to a medication, another compartment in the same tray can store one more supply large of another medication provided in a smaller tablet size. Trays of various sizes can be provided, each capable of storing a name of different combinations of different medications subject to different prescription schedules and covering several periods. In addition, a tray 79 may contain compartments capable of storing a canister 80 for a medication in the form of an inhaler, a container 81 for a medication in the form of liquid or syringes 82 recharged for medication taken by injection, as illustrated in Figure 18. Additionally, as , * illustrated in Figure 19, the tray 75 may be of a depth having a cavity for a medication bottle 83 such as the dispenser * 20 pharmacist. Additionally, trays or compartments can provide direct storage of liquid, injectable or aerosol medications. Trays of varying sizes are provided to accommodate multiple volumes of multiple solid dose medications. By example, at one point the user would like to have a compact design to maintain a medication supply for one to three days. At another time the user could be traveling for an extended period and would then require a larger volume tray to accommodate the one-week supply plus duration for several medications. The user could then replace the compact tray with a larger volume tray containing a larger supply of medication. The device of the present modality thus provides flexibility to meet the particular requirements of the user at a given time. Each tray includes a mechanism for attaching to the upper portion 85 of the device 5, which houses the electronic components and the user interface. The fixing mechanism can be any mechanical device suitable for the phase of insertion of the trays to medical monitoring device and the removal of trays thereof. Such mechanisms are within the competence of persons reasonably skilled in the art. Each tray can be independently labeled by the pharmacist, with signs that are placed on an upper cover for each compartment inside the tray, as shown in figure 20. Additionally or alternatively, the signs could be placed on the lower part of the upper portion 85 of the device, as shown in Figure 21 (b), which is a view in the X direction of the device 5 as presented in Figure 21 (a).
In a further embodiment, as illustrated in Figure 22, the tray 75 accommodates a series of liners 86 that fit in each compartment. Each coating has a capacity for a unit dose each of medications. This embodiment makes it possible for the pharmacist to fill, seal and label the liners, so that the user then needs to insert only a full liner in their respective compartment in the tray 75. Additionally, the label can be refused by expanding it from the liner 86 and placing it on the cover for the respective compartment (as shown in Figure 20) or by placing it on the lower part of the upper portion 85 of the device (as in Figure 21 (b)). The tray and labeling mechanism provides increased accuracy and efficiency and reduces errors that occur when patients recharge to the medical monitoring device. In an additional mode, as illustrated in Figure 23, the upper portion 85 of the device includes a frame or support cover 87 which is connected by a hinged mechanism. The reaction cover or support 87 opens from the upper portion 85 and rotates in the direction of the arrow Y, allowing the insertion of the tray 75. The frame or support cover 87 then rotates backward and is secured to the upper portion. 85, giving cavity to the tray 75 inside the device. In a further embodiment of the present invention, as illustrated in Figure 3, an electronic support 70 is provided for mounting the device 5 to facilitate automatic communications, programming and transfer. The support includes an interface 72 layers of transmitting data to the carrying of communications 17 and receiving data therefrom. The support further includes a modem device 73. The support modem device 73 can be programmed to automatically dial certain numbers at certain times and connect to remote devices or be instructed to do so by the medical monitoring device. Once connected to a remote device, the support then provides information about the patient's identification to the remote device and the programming data of the remote device, and transfers response data to the user to the remote device, either transferring or retransfering automatically . The present invention thus provides the health service providers of the unit to automatically transfer a program to the patient's device and retransfer information concerning the progress in the treatment of the patient, including data reflecting the coverage with the prescribed treatment, from an application remote In a further embodiment, the present invention provides a method and means for wireless communication with the medical monitoring device and for scrutiny thereof. Referring to Figure 1, the medical monitoring device includes a receiver and a transmitter 8 connected to the micro controller 10 and an antenna 7 connected to the receiver of a transmitter 8 for reception and transmission in wireless communication signals. Wireless communication can be between link by cellular phone, satellite link by another means of radio communication, commonly known by persons of ordinary skill in the technique of electronic communications. The method and wireless means of the present embodiment provide for the transmission of treatment data from a remote device 100 to the medical monitoring device, the real-time monitoring of the progress of a treatment regimen being administered and the monitoring of time. real of the elements of health and the physical state of a patient, as illustrated in figures 1 and 24. Real-time monitoring facilitates several tasks, including the conduction of the assessment of health status, monitoring of adverse effects or adverse effects or side effects experienced by the patient, and monitoring the treatment process, the monitoring of physiological data of the serum or urine, the monitoring of events at the cellular, molecular and endocrine levels, and the assessment of life activity general of the patient. The device is able to receive information about the treatment in a continuous and periodic way and at the request of a health service provider. Once the information about the treatment is received by the medical monitoring device, the device performs an interaction with the patient. The interaction may comprise any or a combination of the following: (1) educational information concerning the patient's health status, treatment progress, other information related to the diseases being treated and the treatment regimen that is being treated. administering (2) instructions to the patient (that is, instruct the patient to modify the dose or change medications, instruct the patient to plan a visit or instruct the patient to go to the emergency zone); or (3) data about the patient, monitoring and inquiries. Information about the treatment may also include any other data related to any aspect of the patient's health or general quality of life. In the case in which the information about the treatment includes data about inquiries to the patient, once the data of inquiries to the patient are transmitted to the medical monitoring device, the device is immediately executed by the patient inquiry mode or by storing the patient inquiry data for subsequent execution of the patient inquiry mode, depending on the status of the execution command. The execution command is transmitted with the data of inquiries to the patient or is stored in the medical monitoring device. The execution command is regulated by a health service provider or by the device itself through artificial means of intelligence and depends on the urgency of receiving responses to the particular inquiries transmitted to the device. The time regulation associated with the execution command is based on the disease being treated and the treatment regimen that is being administered. For example, if the patient inquiry data refers to a congestive heart failure condition or the device receives data from sensors that monitor blood pressure, electrocardiogram, cellular elements, molecular and / or endocrine factors related to cardiac function; for examples that include heart rate, blood pressure, sugar level, PO2, pH, ketones, anemia, blood, serum, urine, Ca ++, K +, Na +, etc; then the health service provider could regulate the mode of execution for the immediate transmission of the response data. On the other hand, data on patient inquiries may have been stored briefly in the medical device (ie, during the initial programming of the device for a particular treatment regimen). After the medical monitoring device executes the patient inquiry mode, the resulting response data will be stored by the medical monitoring device for subsequent transmission or transmitted immediately to the remote device 100 for storage and analysis. The time setting of the transmission of the response data depends on an execution mode, as described above. Alternatively, the medical monitoring device analyzes the response data by comparing it with the predetermined data by transmitting with the data on inquiries or the predetermined data stored briefly in the medical monitoring device. Then, if the device determines that the response data is determined in certain predefined criteria, the device immediately transmits the response data to the remote device 100 for storage and analysis by the health service provider. The predefined criteria are set or established by a health service provider and depends on the treatment which is being administered and the particular response data that is being analyzed. For example, if the disease being treated is a condition of congestive heart failure and a single point of the response data indicates that the patient is suffering from moderate or severe chest pain, then the device will immediately transmit the response data to the patient. health service provider. As another example, if a combination of response data points indicates that the patient is suffering from moderate respiratory failure in combination with a slight swelling of the leg, then the device will immediately transmit the response data to the health service provider. As an additional example, if a sequence of response data points indicates that the patient has been suffering from moderate respiratory failure and subsequently experiences an increase in blood pressure to a systolic level of more than 160 mm of mercury, then the device will transmit immediately response data to the health service provider based on the sequence of events experienced for the patient and inserted into the device. The same example applies data notes indicating the heart rate, blood pressure, sugar level, pO2, pH, ketones, anemia, blood, serum, urine Ca ++, K +, Na +, etc., as specified above. The criteria may include predetermined data from which the response data should not diverge, a template with which they compare the response data or any other method to analyze the response data in view of a baseline or predefined range of values. In addition, the response data that originates an expedited or immediate transmission may comprise a single data element, a particular sequence of data elements or a particular combination of data elements, as described in the previous examples. The timing of the transmission depends on the disease being treated and the treatment regimen being administered, and is set or established by a health service provider accordingly, also as described above. Therefore, a health result or particular health outcomes will determine the timing of the information and the content of the transmissions. In this way, the result of the medical treatment can be monitored and analyzed, compared with the predetermined normative objectives and desired in the treatment, and the divergences of the norms or objectives can cause a modification of the monitoring of the patient as well as the treatment regime itself. Additionally, when the data is transmitted to the remote device 100 for analysis, the health service provider may not be available to respond to the data. The response data, however, potentially represent an aspect in the patient's condition that would require issued or immediate critical review, so that immediate action could be taken to examine the patient, and further inquire into the patient. patient, change the treatment regime of the patient or study the patient who goes to the emergency room. In this situation, the remote device 100 executes an algorithm that analyzes the response data alone or in combination with previously transmitted data and immediately transmits a message to a device carried by a health service provider or the service of responses to the provision of health services. Health. Again, the algorithm is developed by a health service provider and depends on the particular diseases that are being treated by the treatment regimen that is being administered. The patient and the health service provider are thus linked, via the wireless medium, through a series of two or more devices, each of which contains algorithms that analyze the information that determines the appropriate time regulation and the content of the information communicated when providing health services concerning the patient's health status. The remote device 100 is also capable of performing a screening feature by which it scrutinizes the medical monitoring device and compiles the desired information. The desired information compiled for the remote device may include: 1) response data; 2) physiological data; 3) data related to cellular, molecular and endocrine or metabolic organisms, as specified above; 4) data concerning the adherence of the patient to a regime of medical treatment; and / or 5) any other information related to any aspect of the patient's general health and quality of life. The remote device 100 Remote 100 scrutinizes the medical monitoring device communicating by the edge of a wireless medium and compiles the desired information from the memory of the medical monitoring device. In cases in which the patient requires specialized care or treatment, the screening feature provides continuous, periodic, spontaneous and / or random monitoring of treatment progress through the health service provider. An algorithm analyzes previous data captured by the medical monitoring device and determines the scrutiny by continuous, periodic, spontaneous and / or random monitoring. Through the scrutiny feature, health service providers can seriously monitor sick patients outside the hospital, almost as if they were receiving bedside monitoring in the hospital. In addition, in cases where the patient's treatment regimen includes an "unforgivable" medication that must be taken according to precise schedules and amounts to avoid fatal critical problems, the screening feature provides the health care provider with the ability remotely monitor, however closely, data on health data and compliance with treatment regimes. In appropriate cases (based on particular requirements of the treatment regimen being treated), physiological, cellular, molecular, endocrine and / or metabolic events can be assessed and monitored and the resulting events transferred to the medical monitoring device from remote monitors 106 and / or sensors 107, as Shown in Figure 24; or to the same medical monitoring device assesses and monitors such events. Remote monitors 106 and sensors 107 can be linked to the medical monitor device directly by wireless means, as illustrated in Figure 24. The resulting data stores them in the medical monitoring device for subsequent transmission (i.e., during a subsequent counting operation) or immediately transmitted to remote device 100 for storage and analysis. As described above, the regulation of the time and the content of the transmission of the resulting data depend on the events or data monitored., or the information generated from them, the disease that is being treated and the treatment regime that is being administered and are fixed or established by a health service provider accordingly. Alternatively, the medical monitoring device analyzes the resulting data comparing them with the predetermined data. Then, if the device is determined that the resulting data satisfy certain predefined criteria, the device immediately transmits the resulting data to the remote device 100 for storage and analysis for the health service provider. The predefined criteria are set or established by a health service provider and depend on the treatment that is being administered and the particular data that is being analyzed, as described above. The criteria may include predetermined data from which the resulting data may diverge. given way, a template with which the resulting data is compared or any other method to analyze the resulting data. In addition, the resulting data governing an immediate transmission may comprise a single data element, a particular sequence of data elements or a particular combination of data elements. The regulation of time or the immediate channel of transmission also depends on the quality that is being treated and the treatment regime that is being administered, and is set by the provision of health services accordingly. The events that are being assessed and monitored may include, but are not limited to, encephalogram, electrocardiogram, blood pressure, pulse, temperature, blood glucose level and / or cellular, endocrine molecular and metabolic events, such as is specified above. The final result is the ability to analyze and correlate physiological and physical data, medication compliance data and data on devaluation of health status and development with a complete picture of the health of the patient's treatment progress. Following the analysis, the immediate transmission of new information, the inquiries to the patient, the inquiries of the sensor or the monitoring device, or the instructions then alter the treatment regime in a real one with respect to the monitored events. The wireless communication feature provides improvements over the prior art in the sense that a medical monitoring device with such a feature does not necessarily require a memory storage function. The communication feature wireless also facilitates continuous, periodic, spontaneous and / or aliatory data transmission and scrutiny of data related to the patient's treatment and the patient's health status. The wireless communication feature thus makes possible a varying degree of frequency and intensity in monitoring the health status and progress of a patient's treatment, including variation in the types of data transmitted and monitored, and makes it possible to monitor at a level that provides interaction of a real with external patients. In addition, the wireless communication feature for immediate data transfer and according to the patient's condition guarantees immediate extension. The wireless communication feature allows the treatment of outpatients, seriously ill patients to maintain vital arms and private sanitariums, with less independence and less health service costs. Furthermore, with the present invention, seriously ill outpatients may be treated by a team of professionals that may include one or more physicians, a medical case supervisor, a visiting disease, a physical therapeutist, a personal emergency response center, a psychiatrist, etc. This equipment is analogous to a "blue code" team, a surgical team or another type of health service team for inpatient care. Although the device of the present invention monitors different aspects of the patient's condition, it may be necessary that one or more equipment will be immediately notified about the appearance of the physical state of the patient. patient. Then, according to the results of algorithms that analyze information monitored with the physical state of the patient, the medical monitoring device determines which team member to notify, the timing of such notification and the others appropriate to transfer; and transmit the data correspondingly. The notification consists in the transmission of information concerning the condition of the patient and occurs by wireless communication through a modem network 102, or other appropriate method of transmission, as illustrated in figure 24. For example, with respect to an external patient with a congestive heart efficiency condition, when the device detects an increase in the patient's blood pressure of at least 30 mm of mercury, an algorithm could load the device to notify the supervisor of clinical cases of the patient about the circumstances that are developing. In addition, if the blood pressure increases and is accompanied by chest pain, then the algorithm could be ordered while the device notifies the clinical case supervisor and the patient's visiting nurse. Moving forward, certain elevations of cardiac enzymes, alterations of muscle receptors or other molecular changes were occurring. Algorithm could ensure that the device notified the visiting nurse and the cardiologist to the clinical case supervisor. Finally, if the patient also increases the intake of nitroglycerin tablets, the algorithm could ensure that the device will notify a nearby emergency response center and request the dispatch of an ambulance, in addition to notifying the aforementioned health service providers. As part of the procedure to change the tension of the patient from the hospital and from the doctor's office to the home and the ambulatory environment, a system of patient monitors has been previously described that includes a monitor of medications that monitors the medical treatment, the use of medications , the state of health and the quality of life of the patient; monitors that are external or implanted, that monitor physiological functions including, but not limited to, temperature, pulse, electrocardiogram and PO2; and external or implanted monitors that monitor levels of hormones, ions, cellular mechanisms and molecular events, described algorithms developed by health service professionals that would determine how, when, where and how urgent the monitors data would be transmitted to the health service providers. The present invention also provides algorithms that function like a physician conducting a clinical examination. Algorithms within the device determine when events should be monitored, what events to monitor, how to monitor those events and the particular monitors and the monitoring sequence used. As shown in FIG. 24, monitoring is performed behind a system of monitors 106 and sensors 107 connected in interface with the medical monitor device or by direct connection or by wireless means. Algorithms analyze then the collected data and determine the urgency of communicating the results of the analysis and coordinates such communications, as described above, for example, in the monitoring and treatment of the patient with congestive heart failure condition, a monitor for the patient is applied use of medications, a monitor for clinical health status, a monitor for blood pressure, a monitor for pulse oximetry, a monitor for electrocardiograms, implanted or external monitors for blood or serum to monitor physiological and cellular events) and others external or implanted monitors. The various monitors are connected to the interface with the medical monitoring device, which contains a series of algorithms to analyze them all assembled from the monitors and coordinate the appropriate treatment and communication procedures. The monitored data, for example, may indicate an increased use of nitroglycerin tablets and increased blood pressure. An algorithm analyzes the data and activates the pulse oximetry monitor, which shows the reduced oxygen in the blood. The analysis originates another algorithm that activates the electrocardiogram monitor and activates the serum monitors to monitor the cardiac enzyme elevations indicative of the year to the cardiac muscle. An additional algorithm analyzes the data of all the monitors and determines that it is initiating a heart attack. The electrocardiogram monitor and activates the serum monitors to monitor the cardiac enzyme elevations indicative of the year to the cardiac muscle. An additional algorithm paralyzes the data of all the monitors and determines that it is starting an attack cardiac. The medical monitoring device then activates a medication discharge device that administers a drug to stop a heart attack and facilitates notification of all relevant providers of health services and ambulance services. While waiting for the ambulance, the medical monitoring device continues to monitor the data of the monitors, transmitting the data to the health service providers and continues the administration of additional drugs, and titrating the dosage of the drugs based on the monitored events that are monitored. relate to blood levels of the drug, the degree of damage to the heart muscle, to the degree of chest pain experienced by the patient, etc. In addition, activates the monitors individually, in sequence or in combination, based on the analyzed data, the medical monitoring device can contain additional algorithms that regulate other functions. For example, algorithms could regulate the duration of patient monitoring by one or more monitors. One such algorithm could determine and control the specific tests administered by a particular monitor. In a further embodiment of the present invention, the same medical monitoring device, in addition to storing and executing the algorithms, contains the monitors to perform the monitoring and tests necessary to analyze the use of medications, in health status, the quality of life, physiological state, cellular function, hormone levels, receptor levels, ions, etc. of the patient.
According to the above, the medical monitoring device continuously analyzes the data coming from certain monitors and continuously alters the selection, the combination, the regulation of time, duration, sequencing and activation of the monitors to monitor more effectively and treat the condition of the patient in real time. The medical monitoring device also controls the communication of information to the treatment team of health services, to create a monitoring and a joint and integrated communication system. Through a series of monitors and patients, algorithms driven by the software and communication links to health service professionals, the present invention provides a real-time patient event monitoring system that automatically conducts clinical examinations that are continuously modify and retinal based on the patient's real-time clinical needs. In a further embodiment, the present invention provides a method and a medical monitoring apparatus that performs real-time monitoring of a patient's health status and the automatic modification of a treatment regimen. The medical monitoring device monitors the patient's data related to one or more physical attributes of the patient and analyzes that data according to an algorithm stored in the medical monitoring device. The medical monitoring device then provides instructions to the patient or modifies the patient's treatment regimen, when the analysis reveals that the physical attributes satisfy certain predefined criteria. As described above, the predefined criteria are set or established by a health service provider and depend on the diseases being treated and the treatment regimen that is being administered. For example, if the medical monitoring device monitors certain conditions or events, or receives response data, indicative of a congestive heart failure condition, the device would then instruct the patient to take certain medications, go to the emergency room or modify the patient's treatment regime (ie, medication schedule) correspondingly, the algorithm is developed by a health service provider and runs an analysis (ie, decision tree analysis) that results in different actions depending on the conditions or events monitored. Other anticipated medical conditions include diabetes, kidney or kidney disease, liver disease, hypertension, endocrine imbalance, cancer and lung and heart disease. Bacterial and fungal diseases, and antigens associated with specific human pathogens are also included (that is, if the patient is on antibiotics, a health service provider will monitor if the organism becomes resistant and increases the number). In a further embodiment, the present invention provides functionality such as that of a nervous system or a neuroregulatory system, conforming, for example, to the neuroendocrine system. In the system Human neuroendocrine, the sensors in the brain monitor a variety of physiological and hormonal processes, and then activate the glands to release varying levels and types of hormones and peptides to maintain homeostasis in the body. The system is linked to each other through neural pathways and a feedback loop system. Common to many morbid states is an interruption of the physiological processes that serve to cause or worsen the fundamental morbid state, whereby the effects of the interruption require correction by the treatment of the disease.
A classic example is the hypothalamic-pituitary-thyroid axis, in which the brain normally detects the amount of circulating thyroid hormone and, based on the levels of thyroid tetritus by the hypothalamus in the brain, increases or decreases the production of thyroid hormone by the thyroid gland. With thyroid disease moon, however, the thyroid gland does not respond appropriately to the regulatory signals of the brain and produces a very, very little hormone regardless of the controls of the brain. According to the foregoing, as illustrated in Figure 24, the present modality provides a single medical monitoring device 5 or a system of monitoring devices 106, which is interfaced with systems and sensors 107 that may be external to the patient or implanted inside it. Different sensors are responsible for monitoring different processes in the body and are designed to communicate with each other via a wireless medium or through a direct connection. For example, a sensor could be responsible for monitoring the circulating peptide, molecular, ionic and hormonal levels in the blood, and additional levels, such as glucose, potassium and oxygen levels (pO2). A second sensor could be responsible for monitoring cardiac function. A third sensor would monitor lung function (of the lungs). A fourth sensor would monitor blood pressure. Additional sensors would monitor additional processes. In addition, a variety of pharmaceutical, hormonal, nutritional and other supplementation supply devices 108, linked with the sensor system and the monitoring devices, provide appropriate types and quantities of pharmaceutical, hormonal, nutritional and other process-based supplements. and the levels monitored by the sensors. The medical monitoring devices include algorithms that contain the release of the supplementary and pharmaceutical substances from the delivery devices, based on an analysis of the data gathered by the sensor system. Algorithms determine and control the activation of particular sensors at particular times or during particular intervals, and communication between particular sensors, including the timing of such communications, the nature and type of communication, and the type of information communicated. The general system is integrated and coordinated to monitor physiological processes related to the morbid states of the patient. Monitors work like a "brain" controlling and monitoring processes and the supply of supplements.
They compare the monitored processes and the levels with normative physiological values, determined and preprogrammed in the monitors by professionals of health services, and then carry out a series of treatments to restore homeostasis. The algorithms are intended to function as neuroregulatory systems of the brain, analyzing the monitored data, comparing the monitored data with predetermined standards, and making outputs in the form of treatments provided to the patient, additional diagnostic tests, alerts sent to medical service professionals, and other therapeutic functions. A central medical monitoring device 105 implanted within the patient, or away from the patient, perform the scrutiny function as described in detail above, by means of which periodic scrutiny of the sensor and monitor system via a wireless means to obtain the monitored data. The central monitor 105 functions as a command and control center, governing and regulating all the previous procedures. The central monitor 105 also performs diagnostics on the other monitors 5 and 106, sensors 107 and delivery device 108 and, if a malfunction is detected, the monitor 105 analyzes and corrects and / or notifies the appropriate health service professional. The present modality makes it possible to replace defective systems in the body by means of a system of sensors and monitoring devices linked to a central medical monitoring device.
For example, a patient may be connected to a glucose monitor that monitors blood glucose levels and reports them to the central medical monitoring device via wireless transmission or to the central glucose monitors memory scrutiny device in terms of stored glucose levels. Upon receiving the data representing the glucose levels, the central device executes an algorithm that compares the levels with normative values. When the glucose levels are within the range of normative values, the central monitor determines that no treatment is necessary. When the reported glucose levels are outside the range of normative values, the central device instructs the patient to administer an injection with additional insulin, or eat a piece of fruit or candy bar, depending on whether the glucose levels are too high or too low, respectively. Alternatively, the central device activates an insulin pump implanted to release the insulin into the patient's bloodstream and / or communicates to a health care professional that the patient is in danger. Through this wireless system that maintains homeostasis, defective patient systems are replaced or supplemented by a wireless and therapeutic monitoring system, which establish rehabilitation circuits and appropriate algorithms, to optimize health outcomes outside the hospital setting.
In a further embodiment of the present invention, the central monitor is linked to one or more database 109 to: (1) better analyze the data input from the peripheral sensors and monitors; (2) transfer appropriate information from the databases and communicate that information to the patient; (3) apply information from the databases to deploy and control other minitors; and (4) apply information from the databases to provide medical treatment and medications. For example, a glucose monitor connected to a patient transmits data indicating the patient's glucose level to the central monitor, at selected time intervals and via a wireless medium. The central monitor also periodically scans a monitor for insulin administration to receive data indicating the date, time, and dosage amount of the patient's insulin medication. The central monitor then scrutinizes a database for the control of diabetic diseases to access and / or transfer algorithms that, when applied to analyze the levels of the glucose data and the insulin dosage levels, provide new instructions for the patient about insulin dosing and glucose monitoring. In addition, the central monitor has access to a nutrition database, transfers new dietary instructions and communicates the new instructions on insulin dietary instructions to the patient. When the additional monitor reveals a level of glucose that is dangerously high, representing a risk to the development of a, hyperglycemic, the central monitor again scrutinizes the database for the control of diabetic diseases and has access to algorithms for a determined need for cardiovascular monitoring. The central monitor then starts monitoring blood pressure and cardiac status. The central monitor receives data concerning the cardiac status of the patient and has access again to the algorithms of the database for the control of diabetic diseases which determine that the next dose of insulin should be increased by 50%. The central monitor communicates the new dosing instructions to the patient. Alternatively, the peripheral system of monitors, sensors and supply devices are preferably equipped with the ability to access the same databases and communicate directly between one and the other, thus bypassing the central monitor. This provides a backup system, if the central monitor fails or alternative power stations are more desirable, based on cost, portability, efficiency or other factors. The present invention, linking a variety of monitors and patient sensors with one another and with several databases; and providing a series of algorithms that analyze monitored data, combined with information from the databases; and initiating various treatment functions (i.e., communicating information about treatments to the patient or administering doses through medication delivery systems) based on the results of the data analysis based on the algorithms; provides monitoring and control of the patient's real-time health status, independently or in conjunction with the health services professional. The system also uses continuously updated databases and knowledge systems, which can be used to guide the treatment of the patient's condition in real time, to optimize the monitoring and control of the disease. Of course, it should be understood that an extensive variety of modifications can be made to the exemplary embodiments described above. A multitude of different algorithms can be developed that provide for the immediate transmission of data to the patient if a single data element, sequence of data elements or combination of data elements concerning the patient's health status were introduced to the medical monitoring device or monitored by it. It is therefore intended that the foregoing detailed description be considered as illustrative rather than limiting and that it be understood that the following claims, including all equivalents, are intended to define the scope of the present invention.

Claims (54)

NOVELTY OF THE INVENTION CLAIMS
1. A medical monitoring device for controlling the administration of medical treatment regimens for treating medical conditions of a patient, comprising: a memory that stores treatment data comprising a plurality of treatment messages; a controller that controls the access of the memory and controls the display of the treatment messages on a display; and a plurality of destiny keys connected in interface with a controller, each destined key being assted with one of the medical treatment regimes initiating each key destined in the visualization of the treatment messages related to its assted medical treatment regime; and characterized in that the number of operations of one of the keys designed starts the visualization of one of the treatment messages related to its regime assted with medical treatment, depending on the treatment message displayed and the number of operations.
2. An operating system for a medical monitoring device that controls the administration of medical treatment regimens to treat the medical conditions of a patient, the operating system is inherent to a storage device and comprises instructions
which: asste each of a number of keys destined for the medical monitoring device with one of the medical treatment regimens; and, upon detecting a number of drives of one of the keys destined within a predetermined period, initiating a controller of the medical monitoring device to display a treatment message on a display of the medical monitoring device, relating the treatment message displayed with the treatment regime assted with the operated key and depending on the number of drives.
3. A medical monitoring device for controlling the administration of medical treatment regimens for treating a patient's medical conditions, comprising: a controller that controls modes of operation of the medical monitoring device and controls the display of information on a display; and a plurality of soft function keys connected in interface with the controller, the controller starting with the operation of the soft function keys, so that it executes the operation modes of the medical monitoring device; and further characterized in that the number of drives of one of the soft function keys within the predetermined period starts the controller to execute a specific mode of the operating modes, the operating mode being dependent on the number of drives.
4. The medical monitoring device according to claim 3, further characterized in that the first number of drives of the single soft function key within the period
default initiates a mode of adherence to the medication schedule, where the controller displays information concerning the patient's adherence to the medical treatment regimens.
5. The medical monitoring device according to claim 3, further characterized in that the second number of operations of the soft function key within the predetermined period initiates the mode of inquiry, wherein the controller displays the data of inquiry to the patient , assigns potential patient responses to the soft function keys, and receives and processes patient response data according to each of the soft function keys operated in response to the patient inquiry data displayed.
6. The medical monitoring device according to claim 3, further characterized in that the third number of drives of the single soft function key within the predetermined period initiates a communication mode, wherein the controller controls a communication gate for communicate with a remote device.
7- The medical monitoring device according to claim 3, further characterized in that a fourth number of drives of the single soft function key within the predetermined period initiates the controller to execute a programming operation mode to change the settings of the device
8. A medical monitoring device for controlling the administration of medical treatment regimens for treating the medical conditions of a patient, comprising: a controller that controls modes of operation of the medical monitoring device and controls the display of information on a display; and a plurality of soft function keys connected in interface with the controller, the controller starting with the operation of the soft function keys, to execute the operation modes of the medical monitoring device; and further characterized in that the controller assigns a different one of the operating modes to each of the soft function keys and displays an indication of the mode of operation assigned to each soft function key and wherein the actuation of one of the function keys Soft starts the operating mode assigned to the soft function key activated.
9. A medical monitoring device for controlling the administration of medical treatment regimens for treating the medical conditions of a patient, comprising: a memory that stores treatment data comprising a plurality of treatment messages; a controller that controls the access of the memory and controls the display of the treatment messages on a display; and a plurality of destiny keys connected in interface with a controller, each destined key being associated with one of the medical treatment regimes, initiating each key destined the visualization of the treatment messages related to its associated regime of
medical treatment; a plurality of soft function keys connected in interface with the controller, the controller starting with the operation of the soft function keys to execute the operating modes of the medical monitoring device; and further characterized in that the controller assigns a different one of the operating modes to each of the soft function keys and displays an indication of the mode of operation assigned to each soft function key and wherein the actuation of one of the function keys Soft starts the operating mode assigned to the soft function key activated; and wherein a number of operations of one of the keys indicated within a predetermined period initiates the display of one of the treatment messages related to its associated medical treatment regime, depending on the treatment message displayed of the number of drives.
10. The medical monitoring device according to claim 9, further comprising a communication door for transferring the medication schedule data, treatment data and inquiry data to the patient from a remote device and for retransferring the Patient response data to a remote device.
11. The medical monitoring device according to any of claims 8 or 9, further characterized in that the controller assigns a "Plus" function to one of the soft function keys and the operation of the soft function "plus" key. starts the controller to assign a different one of the operating modes, which was not assigned
previously to none of the soft function keys before soft key operation "plus", to each of the soft function keys except the soft key "plus" 12.- The medical monitoring device in accordance with any of claims 8 or 9, further characterized in that the actuation of a soft function key assigned to a mode of operation of adherence to the medication schedule initiates the controller to display information concerning the adherence of the patient to the medical treatment regimens.
13. The medical monitoring device according to any of claims 8 or 9, further characterized in that the operation of the soft function key assigned to the mode of inquiry operation initiates the controller to display data of inquiry to the patient., assign potential patient responses to the soft function keys, and receive and process patient response data according to each of the soft function keys operated in response to the patient inquiry data displayed.
14. The medical monitoring device according to any of claims 8 or 9, further characterized in that the operation of the soft function key assigned to a communication operation mode initiates the controller to operate a communication gate so that communicate with a remote device.
15. - The medical monitoring device according to any of claims 8 or 9, further characterized in that the operation of the soft function key assigned to a programming operation mode initiates the controller to facilitate the modification of the regulations of the device.
16. The medical monitoring device according to any of claims 1 or 9, further characterized in that each of the keys allocated associated with the treatment regimen comprises a prescribed medication.
17. The medical monitoring device according to claim 16, further characterized in that the memory also stores a prescribed medication schedule for each prescribed medication and the controller tracks the regulation of time and provides medication signals planned according to the schedules of prescribed medication, each planned medication signal includes a visualization of a treatment message related to the prescribed medications that must be taken.
18. The medical monitoring device according to claim 17, further characterized in that during a planned medication signal, the activation of one of the destined keys associated with one of the prescribed medications that must be taken initiates the display of a message of treatment related to the associated prescribed medication.
19- The medical monitoring device according to claim 18, further characterized in that, during a planned medication signal, a number of drives of the single key destined within a predetermined period initiates the display of an additional treatment message related to its associated prescribed medication, depending on the displayed treatment message of the number of drives.
20. The medical monitoring device according to claim 16, also comprising a plurality of medication compartments, each for storing one of the prescribed medications, further characterized in that each destined key is also associated with one of the compartments of medication.
21. The medical monitoring device according to claim 20, which also comprises a plurality of compartment switches equal in number to the plurality of medication compartments, each compartment switch being linked to one of the medication and connected compartments. in interface with the controller, in such a way that it sends signals to the controller whenever the medication compartment is open or closed.
22. The medical monitoring device according to claim 21, further characterized in that the memory also stores a prescribed medication schedule for each prescribed medication and the controller also tracks the regulation of time and provides warning signals.
medication planned according to the prescribed medication schedules, each planned medication signal includes the display of messages in the treatment indicating the medication compartments from which the prescribed medications should be taken and which provide information related to the medications described. they should take.
23.- The medical monitoring device according to claim 22, further characterized in that, during a signal the planned medication, the activation of one of the destined keys associated with one of the prescribed medications that must be taken initiates the visualization of a treatment message related to the associated prescribed medication.
24. The medical monitoring device according to claim 23, further characterized in that, during a planned medication signal, a number of successive operations of the single key destined within a predetermined period initiates the display of an additional treatment message related to your prescribed prescribed medication depending on the displayed treatment message of the number of successive operations.
25. The medical monitoring device according to claim 22, further characterized in that the controller records compliance data based on the medication compartments to which access is made during the planned medication signals and to which access is sometimes made different than during the signals the
Planned medication, and treatment messages include feedback based on recorded compliance data.
26. The medical monitoring device according to claim 25, further characterized in that the feedback includes graphic images that represent the progress of the patient.
27.- An operation system for a medical monitoring device that controls the administration of medical treatment regimens to treat the medical conditions of a patient, and the operating system is inherent to a storage device and comprises instructions that send signals of send a controller to the medical monitoring device to: associate each of a number of keys destined for the medical monitoring device with one of the medical treatment regimes; and, upon detecting a number of drives of one of the keys destined within a predetermined period, displaying a treatment message on a display of the medical monitoring device, related to the treatment message displayed with the treatment regime associated with the operated key. and depending on the number of drives; and assigning each of a number of soft function keys of the medical monitoring device with a mode of operation of the medical monitoring device and displaying an indication of the mode of operation assigned to each soft function key; and, upon detecting an actuation of one of the soft function keys, execute the associated operation mode.
28. - The operating system according to claim 27, further characterized in that the instructions also send control signals to the controller to: assign a "Plus" function to one of the soft function keys; and, upon detection of a soft-key operation "More", assigning a different operating mode, which was not previously assigned to any of the soft-function keys before operation of the soft-key "More", to each of the soft function keys except for the soft function key "More".
29. The operating system according to claim 28, further characterized in that each of the keys associated with the treatment regime comprises a prescribed medication and the instructions also send control signals to the controller to: track the regulation of time and activate the planned medication signals in accordance with a prescribed medication schedule stored in the medical monitoring device for each prescribed medication; and, with activation of one of the medication signals, visualize a treatment message indicating the prescribed medications that must be taken and providing information related to the prescribed medications that must be taken.
30. The operating system according to claim 29, further characterized by, during a planned medication signal and, upon detecting an actuation of one of the designated keys associated with one of the prescribed medications that must be
take, the instructions also send control signals to the controller to display a treatment message related to their associated prescribed medication.
31. The operating system according to claim 30, further characterized in that, during a signal the planned medication and, upon detecting a successive actuation number of the single key destined within a predetermined period, the instructions also send signals of control to the controller to display an additional treatment message related to its associated prescribed medication, the message of the displayed treatment depending on the number of successive operations.
32. A method for real-time monitoring of the patient's health status using a medical monitoring device capable of wireless transmission, said method comprising the steps of: transmitting data to a medical monitoring device via the wireless medium; Immediately execute an interaction between the medical monitoring device and the patient when an execution command requires immediate execution and store the data in a medical monitoring device for subsequent execution, when the execution command does not require immediate execution. 33.- The method according to claim 32, further characterized in that the interaction generates resulting data, the resulting data comprising any one or more types of data of a
group consisting of response data provided through a mode of inquiry of the medical monitoring device, data concerning adherence to a medical treatment regimen, data concerning physical health, data concerning physiological status, data concerning cellular functions, data concerning molecular events and data concerning endocrine and metabolic events.
The method according to claim 33, further comprising the step of immediately transmitting at least a portion of the resulting data in the medical monitoring device to a remote device via a wireless means when the command of execution requires immediate transmission and storing the response data in the medical monitoring device when the execution command does not require immediate transmission.
The method according to claim 33, further comprising the step of comparing the resulting data with the predetermined data and, when the resulting data satisfy certain predefined criteria, immediately transmit at least a portion of the data resulting from the medical monitoring device or a remote device via the wireless medium.
36.- A method for real-time monitoring of the health status of a patient using a medical monitoring device capable of wireless transmission, said method comprising the steps of: executing an interaction between the medical monitoring device and the patient,
further characterized in that the interaction generates resulting data and the resulting residues comprise any one or more types of data from a group consisting of response data provided during a mode of inquiry of the medical monitoring device, data concerning adherence to medical treatment, data concerning, physical health, data concerning the physiological state, data concerning cellular functions, data concerning molecular events and data concerning endocrine and metabolic events; Immediately transmit at least a portion of the resulting data the medical monitoring device to a remote device via a wireless means when an execution command requires immediate transmission and store the resulting data in the medical monitoring device when the command of execution does not require immediate transmission.
37. The method according to claim 36, further comprising the step of comparing the response data with the predetermined data and, when the response data satisfy certain predefined criteria, immediately transmit at least a portion of the data of response of the medical monitoring device to the remote device via a wireless medium.
38.- A method to perform real-time monitoring of the health status of a patient using a medical monitoring device capable of wireless transmission, further characterized by a remote device conducting a counting operation and compiling information concerning the
Patient's health status of the medical monitoring device via a wireless medium.
39.- The method according to claim 38, characterized in that the information compiled from the medical monitoring device comprises any one or more types of data from a group consisting of response data provided during a mode of inquiry of the medical monitoring device, data concerning adherence to a medical treatment regimen, such as concerning physical health, data concerning the physiological state, data concerning cellular functions, data concerning molecular events and data concerning endocrine and metabolic events.
40.- A method for real-time monitoring of a patient's health status, using a medical monitoring device capable of wireless communication, said method comprising the steps of: monitoring patient data related to one or more physical attributes of the patient. patient; analyze patient data according to a first algorithm stored in the medical monitoring device; transmit immediately information related to the patient's data, which may include at least a portion of the patient's data, via a wireless medium to a second device when the results of the analysis indicate that the patient's data meet certain criteria predefined
41. - The method according to claim 40, characterized in that the patient data comprise any one or more types of data of a group consisting of response data provided during a mode of inquiry of the medical monitoring device, data concerning adherence or a medical treatment regime, data concerning physical health, data concerning the physiological state, data concerning cellular functions, data concerning molecular events and data concerning endocrine and metabolic events.
42. The method according to claim 40, characterized in that the patient data comprise one or more types of data of a group consisting of temperature, blood pressure, heart rate and respiration rate.
43.- The method according to claim 40, characterized in that the patient data are determined by analyzing a body fluid selected from the group consisting of blood, blood serum, urine and saliva.
44. The method according to claim 43, characterized in that the analysis of a body fluid determines the concentration of an indicator selected from the group consisting of a spheroid hormone, a polypeptide hormone, a liver enzyme, a cardiac protein, a muscle protein, glucose, calcium, potassium, sodium, pH, pO2, pCO2, ketones, antibody, bacterial antigen, viral antigen, fungal antigen, tumor antigen, Ca ++, K + and Na +.
45. - The method according to claim 40, characterized in that the second device analyzes the information according to a second algorithm stored in the second device and immediately transmits the information related to the patient data or a third device via the wireless means and means .
46.- The method according to claim 40, characterized in that the medical monitoring device provides one or more input devices that monitor at least one of the physical attributes and transfers the patient data related to the physical attributes monitored to the device of medical monitoring.
47.- A method for real-time monitoring of the health status of a patient and the modification of a treatment regimen, using a medical monitoring device, said method comprising the steps of: monitoring patient data related to one or more physical attributes of the patient; analyze the patient's data according to an algorithm stored in the medical monitoring device; and modify the treatment regimen when the results of the analysis indicate that the patient's data meet certain predefined criteria.
48.- A medical monitoring device capable of wireless transmission to perform real-time monitoring of the health status of a patient and administer a medical treatment regime, comprising: a controller, a memory and a viewer, said controller to control the access memory and control the display of messages from
treatment on the visualizer; and a receiver for receiving data from a remote device via the wireless medium, said receiver receives data related to the patient's health status and the medical treatment regimen; and further characterized in that, after receiving the data, the medical monitoring device immediately performs an interaction between the medical monitoring device and the patient when the execution command requires immediate execution and stores the data in the medical monitoring device for execution subsequent when the execution command does not require immediate execution.
49.- The medical monitoring device according to claim 48, further characterized in that the interaction generates resulting data related to at least one physical attribute of the patient; and the medical monitoring device further comprises a transmitter for transmitting the resulting data to a remote device via a wireless means and the medical monitoring device immediately transmits at least a portion of the resulting data or a remote device via of the wireless medium when an execution command requires immediate transmission and stores the resulting data in the medical monitoring device when the execution command does not require immediate transmission.
50.- The medical monitoring device according to claim 49, further characterized in that the resulting data comprise any one or more types of data of the group consisting of data
of response provided during a means of inquiry of the medical monitoring device, data concerning adherence to a medical treatment regimen, data concerning physical health, data concerning the physiological state, data concerning cellular functions, data concerning molecular events and data concerning endocrine and metabolic events.
51.- The medical monitoring device according to claim 49, further characterized in that the resulting data comprise any one or more types of data of a group consisting of temperature, blood pressure, heart rate and respiration rate.
52. The medical monitoring device according to claim 49, further characterized in that the resulting data are determined by analyzing a body fluid selected from a group consisting of blood, blood serum, urine and saliva.
53. The medical monitoring device according to claim 52, further characterized in that the analysis of a body fluid determines a concentration of an indicator selected from a group consisting of a spheroid hormone, a polypeptide hormone, a liver enzyme, a cardiac protein, a muscle protein, glucose, calcium, potassium, sodium, pH, pO2, pCO2, ketones, antibodies, bacterial antigen, viral antigen, fungal antigen, tumor antigen, Ca ++, K + and Na +.
54. - The medical monitoring device according to claim 49, further characterized in that the medical monitoring device compares the resulting data with the predetermined data and, when the resulting data meet certain predefined criteria, the medical monitoring device immediately transmits at least a portion of the resulting data to the remote device via the wireless medium. 55.- The medical monitoring device according to claim 49, further characterized in that the medical monitoring device analyzes the resulting data according to an algorithm stored therein and immediately transmits the information related to the resulting data, which it may include at least a portion of the resulting data, to a second device via the wireless medium when the results of the analysis indicate that the resulting data satisfy certain predefined criteria. 56.- The medical monitoring device according to claim 49, further characterized in that the medical monitoring device is interfaced with one or more input devices that monitor at least one physical attribute of the patient and transfer the resulting data to the medical monitoring device. 57.- A medical monitoring device to perform real-time monitoring of the state of health and the modification of a treatment regimen for a patient, comprising a controller, a memory and a
display, said controller for controlling the access of the memory and controlling the visualization of the treatment messages on the display; and further characterized in that the medical monitoring device: monitors patient data related to one or more physical attributes of the patient; analyzes the patient's data according to an algorithm stored in it; modifies the treatment regimen when the results of the analysis indicate that the patient's data meet certain predefined criteria. 58.- A medical monitoring device capable of wireless transmission to perform real-time monitoring of the health status of a patient and administer a medical treatment regime, comprising: a controller, a memory and a viewer, said controller to control the memory access and controlling the display of treatment messages on the display; and a transmitter for transmitting data to a remote device via a wireless medium; and further characterized in that the remote device receives information related to the health status of the patient by scrutinizing the medical monitoring device and receiving the information via the wireless medium.
SUMMARY OF THE INVENTION
A medical monitoring device, an operating system, and a method for controlling the administration of medical treatment regimens to treat the patient's medical conditions are provided; the device stores information related to the medical treatment regimes being administered, including medication schedule data, treatment data, patient inquiry data, patient response data and interactively provides patient information to service providers of health; a method and apparatus for real-time monitoring of a patient's health status is also provided, using a medical monitoring device capable of wireless transmission; various aspects of the patient's treatment regimens are modified accordingly; The medical monitoring device also analyzes monitored data in view of predefined criteria and is able to immediately communicate information concerning the health status and progress of the patient's treatment to remote devices which notify appropriate health service providers and is capable of modify the treatment regimens of the patient based on the results of the analysis; a system of monitoring devices and sensors is also provided to perform real-time monitoring and analysis of patient treatment regimens; wireless monitoring facilitates several real-time tasks including conducting a valuation of the
health status, the monitoring of adverse effects experienced by the patient, the monitoring of treatment progress, the assessment of physiological, cellular, molecular, endocrine and metabolic data, and the assessment of the patient's general quality of life.
GC / lr * mmr * aom * mvh * amm * ald * xa jjtc P99-1200F
MXPA/A/1999/008245A 1997-03-07 1999-09-07 Method, apparatus, and operating system for real-time monitoring and management of patients'health status and medical treatment regimens MXPA99008245A (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US60/040128 1997-03-07
US60/044472 1997-04-18
US60/051389 1997-07-01
US08924917 1997-09-08
US08955952 1997-10-22
US60/068,473 1997-12-22

Publications (1)

Publication Number Publication Date
MXPA99008245A true MXPA99008245A (en) 2000-07-01

Family

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