WO2010104978A2 - Système et procédé de remise de déclarations de médecin - Google Patents

Système et procédé de remise de déclarations de médecin Download PDF

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Publication number
WO2010104978A2
WO2010104978A2 PCT/US2010/026864 US2010026864W WO2010104978A2 WO 2010104978 A2 WO2010104978 A2 WO 2010104978A2 US 2010026864 W US2010026864 W US 2010026864W WO 2010104978 A2 WO2010104978 A2 WO 2010104978A2
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WIPO (PCT)
Prior art keywords
patient
physician
display
parameter
notification
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PCT/US2010/026864
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English (en)
Other versions
WO2010104978A3 (fr
Inventor
Badri Amurthur
Yatheendhar D. Manicka
Imad Libbus
Original Assignee
Corventis, Inc.
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.)
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Publication date
Application filed by Corventis, Inc. filed Critical Corventis, Inc.
Publication of WO2010104978A2 publication Critical patent/WO2010104978A2/fr
Publication of WO2010104978A3 publication Critical patent/WO2010104978A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4833—Assessment of subject's compliance to treatment

Definitions

  • the present invention relates to systems, methods and devices for patient monitoring that may be used to diagnose and treat patients. Although specific reference is made to monitoring with an adherent patch device, embodiments of the present invention can be used with many kinds of patient monitoring and treatment devices, for example extended monitoring with implanted monitoring devices, injectable monitoring devices and wearable devices.
  • Patient monitoring has the potential to significantly improve patient care by monitoring physiological variables and notifying the physician if these physiological variables indicate a worsening disease state.
  • Patient monitoring also has the potential to help people live longer with an improved quality of life.
  • remote patient monitoring the patient is generally located at a location remote from the treating physician.
  • remote patient monitoring can allow people to live at home or in an extended care facility when such persons might otherwise be forced to reside in a hospital near a treating physician.
  • a physician can have access to the patient data and review the data to diagnose the condition of the patient.
  • Patient monitoring systems can be complex and configured to analyze patient health conditions in many complex ways.
  • a monitoring system may issue an alarm automatically to indicate a worsening condition of the patient, and in some instances the physician can direct care based on the alarm, possibly without further evaluating the patient.
  • the alarm is triggered by a known vital sign, such as breathing or heart rate
  • the treating physician may be able to readily verify the validity alarm.
  • the physician may have difficulty verifying the machine based determination, such that in at least some instances there may be an increased proclivity for the treating physician to rely on the machine based determination.
  • the treating physician may be under immense workload and time pressures and, for the sake of expediency, may choose to direct treatment based on incomplete information, rather than examining the patient or at least thoroughly reviewing patient data.
  • At least some of the current remote patient monitoring systems may not provide patient data to the treating physician in a complete and/or manner, such that the physician may be inclined to direct patient treatment based on incomplete patient information.
  • the physician may be provided with too much patient data, for example data from a patient having several weak organs that can fail, such that the treating physician may be burdened with data that is not relevant to the diagnosis and treatment in at least some instances.
  • Embodiments of the present invention provide systems, devices and methods to monitor a patient such that the physician receives appropriate data and can treats the patient appropriately, for example without undue reliance on output from the patient monitor.
  • Patient data are measured, for example with a remote adherent sensor device, and the physician can be sent a notification in response to the measured data.
  • the data displayed with the notification can be limited, for example blocked, until the physician signs a compliance statement.
  • the physician may sign the compliance statement with an electronic signature to display the identity of the patient. This use of a compliance statement with physician notifications having patient identities can help to ensure that the physician treats the patient without undue reliance on the information contained in the notification.
  • embodiments of the present invention provide a method of monitoring a patient receiving care from a physician, in which the patient has identity.
  • Patient physiological data are measured from the patient.
  • a physician notification is sent to the physician in response to the patient physiological data.
  • the physician notification and a compliance statement are shown on a display visible to the physician.
  • An electronic physician signature is accepted, and the patient identity is shown on the display in response to acceptance of the electronic physician signature.
  • At least one heterogeneous patient parameter is shown on the display with the patient identity in response to the physician signature, and the heterogeneous patient parameter is determined from at least two separate homogeneous patient parameters.
  • the at least two separate homogeneous patient parameters may comprise a first homogeneous patient parameter measured from a first organ of the patient and a second homogeneous patient parameter measured from a second organ of the patient.
  • the first homogeneous patient parameter may comprise at least one of a patient heart rate parameter, a patient respiration rate parameter, a patient blood pressure parameter, a patient body temperature parameter, a patient tissue hydration parameter, a patient blood oxygen parameter or a patient activity parameter.
  • the second homogeneous patient parameter may comprise at least one of the patient heart rate parameter, the patient respiration rate parameter, the patient blood pressure parameter, the patient body temperature parameter, the patient tissue hydration parameter or the patient blood oxygen parameter.
  • the first organ corresponding to the first homogeneous patient parameter may differ from the second organ corresponding to the second homogeneous patient parameter.
  • the heterogeneous patient parameter triggers the alert and the homogeneous patient parameters used to determine the heterogeneous parameter are each shown on the display along with the patient identity in response to the physician signature for the compliance statement, such that the physician can readily view relevant patient parameters.
  • the compliance statement indicates that the physician agrees to use his or her medical judgment and further evaluate physiological status of the patient based on at least one of a phone call, an in person visit, or physiological data from the device.
  • the patient identity of the physician notification is not shown to the physician until the physician signs the compliance statement.
  • the physician may be directed to the patient physiological data in response to the physician signing the compliance statement.
  • the patient physiological data and the patient identity may be shown on the display in response to the physician signing the compliance statement.
  • a patient physiological condition is determined in response to the patient physiological data.
  • the patient identity and the patient physiological condition can be excluded from the physician notification shown on the display when the physician receives the physician notification.
  • the patient physiological condition may be displayed when the patient identity is displayed.
  • the patient physiological condition is determined with at least one derived patient condition parameter, the derived patient condition parameter determined from the patient physiological data.
  • the patient physiological data may comprise two or more homogeneous patient parameters.
  • the two or more homogeneous patient parameters are combined to determine a heterogeneous patient parameter, and the patient physiological condition can be determined in response to the heterogeneous patient parameter.
  • the two or more homogenous patient parameters may comprise at least one of a patient heart rate, a patient temperature, a patient respiration or a patient hydration.
  • the two or more homogeneous patient parameters can be combined with at least one of a calculation, an addition, a subtraction, a multiplication, a division, a look up table, a weighted combination, a tiered combination, a logic gated combination, a time weighted combination or a rate of change.
  • the heterogeneous patient parameter comprises at least one of an apnea hypopnea index, a risk of cardiac decompensation, a include heart failure status, a cardiac arrhythmia risk, a hydration status, a dysautonomia status, a fall risk, a decubitus ulcer risk, a chronic obstructive pulmonary disorder risk, an asthma risk, a movement disorder risk.
  • the movement disorder risk may be related to many movement disorders, such as agitation or over sedation in an institutionalized patient.
  • the patient condition comprises a risk of cardiac decompensation determined with an algorithm that combines the two or more homogeneous patient parameters, and the heterogeneous parameter from the algorightm is displayed after the physician signs the compliance statement.
  • the physician notification comprises at least one of an email, a phone call, a page, a fax or a text message.
  • the physician notification may comprise a level of urgency visible to the physician before the compliance statement is signed.
  • the patient physiological data can be sent from the patient to a server remote from the patient and the physician notification can be sent from the server to the display.
  • the patient may be located remote from the server, and the physician and the display can be located remote from the server and the patient.
  • the patient physiological data are transmitted from the server to the display, and the patient physiological data can be shown on the display to the physician when the patient identity of the physician notification is excluded from the display.
  • the physician has access to the patient physiological data and derived patient parameters to determine the condition of the patient when the patient identity of the physician notification is excluded from the display.
  • embodiments of the present invention provide a system to monitor a patient receiving care from a physician.
  • the system comprises a device to measure patient physiological data, and a display visible to the physician to show the physiological data.
  • a processor system comprises at least one tangible medium.
  • the processor system is configured to receive the patient physiological data from the device, and the processor system is configured to show a physician notification and a physician compliance statement on the display.
  • the processor system is configured to receive an electronic signature from the physician to affirm the physician compliance statement and display the patient identity to the physician in response to receipt of the electronic signature.
  • the patient device comprises at least one of an adherent device adhered to a skin of the patient, an implantable device implanted beneath the skin of the patient, an injectable device injected under the skin of the patient or a wearable device configured to be worn by the patient.
  • the processor system is configured to exclude the patient identity of the physician notification from the display until the electronic signature is received.
  • the processor system can be configured to show the patient identity and the patient physiological data on the display when the patient identity of the physician notification is excluded from the display.
  • the processor system is configured to determine a patient condition in response to the patient physiological data and show the patient condition on the display with the physician notification in response to receiving the electronic signature from the physician.
  • the processor system can be configured to process the patient physiological data to determine at least one derived patient condition parameter that corresponds to the patient condition.
  • the processor system may be configured to show the at least one derived patient condition parameter on the display in response to the processor system receiving the electronic signature, and the processor system may be configured to show the physician notification without the at least one patient condition parameter before the electronic signature is received.
  • the processor system comprises a device processor, a server processor and a display processor.
  • the device processor comprises a device tangible medium configured to transmit the patient physiological data.
  • the server processor comprises a server tangible medium at a location remote from the patient configured to receive the patient physiological data.
  • the display processor comprises a display tangible medium, and the display processor system can be coupled to the display.
  • the display processor can be configured to receive the physician notification from the server processor and display the patient identity on the display in response to receiving the electronic signature from the physician.
  • the display processor may be configured to receive the physician notification comprising the patient identity and display the patient identity in response to receiving the electronic signature from the patient.
  • the display processor can be configured to exclude the patient identity of the physician notification until the electronic signature is received
  • the display processor can be configured to download and show on the display the patient identity and the patient physiological data in response to physician input when the patient identity of the physician notification is excluded from the display.
  • the display processor is configured to download the patient physiological data from the server processor in response to receiving the electronic signature from the physician.
  • the display processor can be configured to direct the physician to download the patient physiological data from the server processor in response to receiving the physician electronic signature.
  • the processor system is configured to show on the display at least one of the patient physiological data, the physician notification, the patient identity or a patient condition with at least one of a window or a tab shown on the display.
  • the processor system is configured to receive the electronic signature of the physician from at least one of a user ID, a password, a biometric identification, a biometric thumb print, an RFID, a magnetic badge, a bar code scan, or an optical scan.
  • the processor system can be configured to display the physician notification with at least one of a pager, a web browser, a hand held device or an email client.
  • the processor system is configured to display the patient data and at least two homogeneous patient parameters derived from the patient data in response to the physician logging into the processor system.
  • the processor system is configured to combine the at least two homogeneous patient parameters to determine a heterogeneous patient parameter corresponding to a condition of the patient.
  • the processor system can be configured to display the heterogeneous patient parameters in response to the electronic signature from the physician.
  • embodiments of the present invention provide a display device to show patient data to a physician.
  • the device comprises a display to show patient data to the physician.
  • a display processor is coupled to the display.
  • the display processor comprises a tangible medium configured to receive a physician notification and show a portion of the notification on the display.
  • the display processor is operationally coupled to a source of patient parameter data and configured to show a compliance statement on the display and accept an electronic signature acknowledging the compliance statement.
  • the display processor is configured to show the patient identity in response to the electronic signature acknowledging the compliance statement.
  • embodiments of the present invention provide a method of showing patient data to a physician.
  • a physician notification is received, in which the notification comprises a patient identity.
  • the physician notification and a compliance statement are displayed on a display visible to the physician.
  • An electronic physician signature is accepted, and the patient identity is shown on the display in response to acceptance of the electronic physician signature.
  • inventions of the present invention provide a system to monitor a patient under the care of a physician.
  • the system comprises a server operationally coupled to a source of patient parameter data of the patient.
  • the server comprises at least one tangible medium configured to determine at least one heterogeneous patient parameter and transmit a physician notification comprising a patient identification in response to the at least one heterogeneous patient parameter.
  • the server is operationally coupled to a physician display device.
  • the server is configured to transmit instructions to the display device such that the display device is configured with the instruction to display the patient identification in response to an electronic signature from the physician acknowledging a compliance statement.
  • embodiments of the present invention provide a computer- readable storage medium comprising a set of instructions for a computer to display identification of a patient and physiological information of the patient to a physician.
  • the set of instructions comprises an input routine operatively associated with a first source of patient data and a second source of physician input data.
  • a run routine is configured to display the patient identification with the physiological information in response to the physician input data.
  • An output routine is configured to provide the identification of the patient available for external use outside the computer.
  • the patient data comprises heterogeneous patient data
  • the run routine is configured to display a parameter based on the heterogeneous patient data in response to an electronic signature of the physician.
  • Figure IA shows a patient and a monitoring system comprising an adherent device, according to embodiments of the present invention
  • Figure IAl shows a physician notification and a compliance statement shown on a display visible to the physician with the patient identifier and patient data excluded from the display;
  • Figure 1A2 shows the physician notification of Fig. IAl shown on the display with patient identifier and patient data shown on the display in response to the physician signing the compliance statement;
  • Figure 1 A3 shows computer programs with instructions embodied in the tangible media of the processor system as in Fig. IA;
  • Figure 1A4 shows patient parameters stored on the tangible medium 106M of a server as in Fig. 1A3;
  • Figure 1A5 shows a mobile device configured to receive and display physician notification, as in Figs. IA to 1A4;
  • Figure IB shows a bottom view of the adherent device as in Figure IA comprising an adherent patch
  • Figure 1C shows a top view of the adherent patch, as in Figure IB;
  • Figure ID shows a printed circuit boards and electronic components over the adherent patch, as in Figure 1C;
  • Figure ID-I shows an equivalent circuit that can be used to determine optimal frequencies for determining patient hydration, according to embodiments of the present invention;
  • Figure IE shows batteries positioned over the printed circuit board and electronic components as in Figure ID;
  • Figure IF shows a top view of an electronics housing and a breathable cover over the batteries, electronic components and printed circuit board as in Figure IE;
  • Figure IG shows a side view of the adherent device as in Figures IA to IF;
  • Figure IH shown a bottom isometric view of the adherent device as in Figures IA to IG;
  • Figure 2A shows a method of predicting an impending cardiac decompensation, according to embodiments of the present invention.
  • Figure 3 A shows a method 300 of predicting an impending cardiac decompensation by combing homogeneous patient data to determine a heterogeneous output parameter, for example the level of risk of impending cardiac decompensation;
  • Figure 4A shows a method 400 of monitoring a sleep apnea and/or hypopnea in a patient by combining homogeneous patient data to determine a heterogeneous patient parameter, for example an apnea / hypopnea index; and
  • Figure 5 A shows a method of monitoring a patient receiving care from a physician and sending notifications to the treating physician.
  • Embodiments of the presenting invention comprise systems, devices and methods to allow a patient monitoring system to deliver a physician notification in a manner that can decrease the physician's ability to inappropriately direct treatment when the physician is located remote from the patient. Blinded notification may occur, such that the physician receives the notification without access to the patient identification corresponding to the notification, and in some instances such that the physician receives details of the notification only after electronically signing a compliance statement.
  • homogeneous patient data encompasses patient data corresponding to a body function performed by an organ, such as the heart. Examples of distinct homogeneous data include but are not limited to electrocardiogram data, hydration data, respiration data, temperature data and activity data.
  • Heterogeneous data encompasses data determined from at least two sources of homogeneous data, for example data determined by combining heart data with hydration data.
  • Work in relation to embodiments of the present invention suggests that heterogeneous data can be particularly helpful in assisting a physician to diagnose and/or treat a patient.
  • heterogeneous data may comprise an index that combines data from two or more types of homogeneous data, for example a combination with ECG data with respiration data.
  • heterogeneous patient data and heterogeneous patient data statistics may also be potentially risk for misuse by the treating physician, such that embodiments of the present invention may help to ensure that heterogeneous patient data is used properly by the treating physician.
  • Embodiments of the present invention may comprise a home-based remote monitoring system.
  • an adherent system with multiple electrodes is capable of monitoring a variety of physiological parameters, for example heart rate, respiration, body fluid, activity, etc., and transmitting that data to a remote center via a wireless intermediate device.
  • the remote center can perform data analysis and issue physician notifications in response to a calculated worsening of patient status.
  • Physician notifications may include a phone call, page, e-mail, fax, etc.
  • the physician notification does not specify the reason for the alert or include any patient identifying information.
  • the information provided can be intentionally insufficient so as to allow the physician to identify the patient and adjust therapy.
  • the notification may direct the physician to the data server to retrieve notification details.
  • the physician Before the details of the notification are displayed for the physician, for example patient identity, reason for alert, etc., the physician can be required to read and electronically sign a brief compliance statement. Although many compliance statements can be used, the compliance statement can indicates that the physician shall not use the physiological data, or the calculated patient status, to direct treatment in the absence of additional patient evaluation.
  • the physician With the data server, the physician can have continuous access to all patient data at any time, with the exception of the details of the notification.
  • the notification details may be contained in a sequestered section of the user interface, and only retrievable upon receipt of the electronic signature of the compliance statement.
  • Figure IA shows a patient P and a monitoring system 10.
  • Patient P comprises a midline M, a first side Sl, for example a right side, and a second side S2, for example a left side.
  • Monitoring system 10 comprises an adherent device 100.
  • Adherent device 100 can be adhered to a patient P at many locations, for example thorax T of patient P.
  • the adherent device may adhere to one side of the patient, from which data from the one side can be collected. Work in relation with embodiments of the present invention suggests that location on a side of the patient can provide comfort for the patient while the device is adhered to the patient.
  • Monitoring system 10 includes components to transmit data to a remote center 106 at a location remote from the patient.
  • Monitoring system 10 comprises a closed loop system in which patient care can be monitored and implemented from the remote center in response to signals from the adherent device.
  • the patient can be located in a first building and the remote center located at a second site in a second building, for example with both the first building and the second building located in the same town.
  • the remote center and patient can be located much farther from each other, and the patient can be located on a first continent and the remote center located at a site on a second continent.
  • Adherent device 100 can communicate wirelessly to an intermediate device 102, for example with a single wireless hop from the adherent device on the patient to the intermediate device.
  • Intermediate device 102 can communicate with remote center 106 in many ways.
  • intermediate device 102 may comprise a gateway device connected to the Internet.
  • monitoring system 10 comprises a distributed processing system with at least one processor on device 100, at least one processor 102P on intermediate device 102, and at least one processor 106P at remote center 106, each of which processors is in electronic communication with the other processors.
  • At least one processor 102P comprises a tangible medium 102M
  • at least one processor 106P comprises a tangible medium 106M.
  • At least one processor 106P may comprise a central server where data is stored retrieved as appropriate.
  • Remote center 106 can be in communication with a health care provider 108A with a communication system 107A, such as the Internet, an intranet, phone lines, wireless and/or satellite phone.
  • Health care provider 108A for example a family member, can be in communication with patient P with a communication, for example with a two way communication system, as indicated by arrow 109A, for example by cell phone, email, landline.
  • Remote center 106 can be in communication with an emergency responder 108B, for example a 91 1 operator and/or paramedic, with a communication system 107B, such as the Internet, an intranet, phone lines, wireless and/or satellite phone.
  • Emergency responder 108B can travel to the patient as indicated by arrow 109B.
  • Remote center 106 can be in communication with a health care professional, for example a physician, via a remote physician mobile device 108C used by the physician, with a communication system 107C, such as the Internet, an intranet, phone lines, wireless and/or satellite phone.
  • the physician can use remote physician mobile device 108C to communicate with patient P, for example with a two way communication system, as indicated by arrow 109C, for example by cell phone, email, landline.
  • Remote physician mobile device 108C comprises at least one processor 108P comprising at least one tangible medium 108M and at least one display 108D coupled to the at least one processor.
  • Remote physician mobile device 108C may comprise at least one of a personal computer, a personal digital assistant, a cell phone with display, a pager with display, or a smartphone.
  • Remote physician device comprises an input device 1081.
  • display 108D may comprise a touch screen display.
  • Input device 1081 may also comprise at least one of a keyboard, a pointing device, a mouse, a trackball, a track pad or a microphone configured to receive voice commands.
  • System 10 comprises a processor system 1OP.
  • the processor system of system 10 may comprise at least one of a patient device processor 146P comprising a patient device tangible medium 146M, intermediate device processor 102P, a server having at least one processor 106P and remote physician device processor 108P.
  • the patient device processor 146P may comprise a processor of an adherent device comprising a tangible medium 146M supported with the adherent device.
  • the processor system 1OP can be configured to measure signals from sensors on the patient and process and/or record the signals to generate patient data.
  • the patient data can be stored and transmitted to intermediate device 102, for example a gateway, and subsequently stored and/or transmitted to the server having at least one processor 106P.
  • the patient data can be further processed with at least one processor 106P.
  • the patient device may continuously monitor physiological parameters, communicate wirelessly with a remote center, and provide alerts when necessary.
  • the system comprises the patient device, for example an adherent patch which attaches to the patient's thorax and contains sensing electrodes, battery, memory, logic, and wireless communication capabilities.
  • the patch can communicate with the remote center, via the intermediate device in the patient's home.
  • the remote center receives the data and applies the prediction algorithm. When a flag is raised, the center may communicate with the patient, hospital, nurse, and/or physician to allow for therapeutic intervention to prevent decompensation.
  • the adherent device may be affixed and/or adhered to the body in many ways. For example, with at least one of the following an adhesive tape, a constant-force spring, suspenders around shoulders, a screw-in microneedle electrode, a pre-shaped electronics module to shape fabric to a thorax, a pinch onto roll of skin, or transcutaneous anchoring.
  • Patch and/or device replacement may occur with a keyed patch (e.g. two-part patch), an outline or anatomical mark, a low-adhesive guide (place guide
  • the patch and/or device may comprise an adhesiveless embodiment (e.g. chest strap), and/or a low-irritation adhesive model for sensitive skin.
  • the adherent patch and/or device can comprise many shapes, for example at least one of a dogbone, an hourglass, an oblong, a circular or an oval shape.
  • the adherent device may comprise a reusable electronics module with replaceable patches (the module collects cumulative data for approximately 90 days) and/or the entire adherent component (electronics + patch) may be disposable.
  • a "baton" mechanism may be used for data transfer and retention, for example baton transfer may include baseline information.
  • the device may have a rechargeable module, and may use dual battery and/or electronics modules, wherein one module 101 A can be recharged using a charging station 103 while the other module 101B is placed on the adherent device.
  • the intermediate device 102 may comprise the charging module, data transfer, storage and/or transmission, such that one of the electronics modules can be placed in the intermediate device for charging and/or data transfer while the other electronics module is worn by the patient.
  • the system can perform the following functions: initiation, programming, measuring, storing, analyzing, communicating, predicting, and displaying.
  • the adherent device may contain a subset of the following physiological sensors: bioimpedance, respiration, respiration rate variability, heart rate (average, minimum, maximum), heart rhythm, HRV, HRT, heart sounds (e.g. S3), respiratory sounds, blood pressure, activity, posture, wake/sleep, orthopnea, temperature/heat flux, and weight.
  • the activity sensor may be one of the following: ball switch, accelerometer, minute ventilation, HR, bioimpedance noise, skin temperature/heat flux, BP, muscle noise, posture.
  • the patch wirelessly communicates with the remote center.
  • Fig. IAl shows a physician notification 108DPN and a physician compliance statement 108DCS shown on display 108D visible to the physician with the patient identifier PI and pertinent patient data PD not shown, for example excluded from the display.
  • Physician notification 108DPN comprises a message 108DPM on the display stating, "Dr. Great: You have patients requiring level 1, 2 and 3 care.”
  • Physician notification 108DPN can be customized.
  • the physicians name may comprise a field that shows the physician's name.
  • the message can be customized based on the number of patients and level of care required. For example, for the first patient the notification may state, "Dr. Great: You have a patient requiring level 3 care" when the first patient sent since the last session requires level 3 care.
  • Compliance statement 108CS indicates that the physician agrees to exercise his or her medical judgment and further evaluate the physiological status of the patients shown in the physician notifications. For example, the compliance statement may state, "I, Dr. Great, agree to use my medical judgment and further evaluate the physiological status of the patient(s) shown in the physician notification(s) before prescribing, performing or withholding a medical intervention.”
  • the physician is prompted to respond with digital signature 108S which can be signed by entering Y or not signed by entering N. When the physician responds with Y to the digital signature the signature for the compliance statement is accepted and can be time stamped and dated.
  • Fig. 1A2 shows the physician notification 108DPN of Fig. IAl shown on the display with patient identifier PI and patient data PD shown on the display in response to the physician signing the compliance statement.
  • the physician notification 108DPN can include several fields relevant to the identification and treatment of the patient, and the physician notification may comprise a plurality of physician notifications for a plurality of patients, for example first physician notification 108DPN1 for a first patient, second physician notification 108DPN2 for a second patient, third physician notification 108DPN3 for a third patient and fourth physician notification 108DPN4 for a fourth patient.
  • the notifications can be arranged, for example sorted.
  • the notification can indicate where the message originates, for example from the at least one processor 106P of center 106 indicated as from "Monitor".
  • the subject of the notification display indicates that the subject is a note, for example a physician notification.
  • the level of the notification can comprise a plurality of levels, for example from 1 -4, where 1 indicates a severe condition, 2 moderate, 3 mild and 4 normal.
  • a level 4 notification may comprise a reminder to check on a patient with routine follow up, for example 3 month follow up when the patient is successfully treated.
  • the notification includes a patient identification PID field, for example a name of the patient.
  • the notification also includes a patient data field, for example the relevant patient data that triggered the physician notification.
  • a physician can sort the notifications based on level, and can delete the notifications once reviewed. The physician can also open and/or preview each of the notifications in a manner similar to an email client.
  • the physician notifications can comprise useful information to expedite and facilitate examination of the patient.
  • additional relevant patient information can be shown in an additional window, for example a preview window or separate window.
  • the useful information sent with the notification can be keyed to the condition of the patient, and the physician can select which notification to view in detail with a selection field 108DSEL.
  • a notification for a patient at risk of decompensation can include the data used to determine the risk, such as hydration data.
  • a notification for a patient determined to be at risk for sleep disordered breathing may include the apnea hypopnea index (AHI).
  • AHI apnea hypopnea index
  • the additional information of a selected physician notification can be shown in a selected notification window 108DPNSW.
  • Selected notification window 108DPNSW can show additional data from the notification for a selected patient, for example notification 108DPN1 for the first patient such as John Doe.
  • Patient John Doe has an severe AHI of >30 which triggered the physician notification when the patient stopped breathing for 30 seconds at night, triggering a 5% decrease in blood oxygen.
  • Additional relevant patient information includes vital signs such as heart rate (H. R.), respiration rate and blood pressure.
  • the physician can be directed to a server with additional patient data by selecting Y, for example directed to at least one processor 106P at the center.
  • the physician device can download additional data likely to be relevant to the physician for review, for example an EGC signal data for arrhythmia patients, so as to expedite review of the patient data.
  • Fig. 1 A3 shows computer programs with instructions embodied in the tangible media of the processor system 1OP.
  • Patient device processor 146P has a computer program comprising instructions to implement an input routine 146MI, a run routine 146MR and an output routine 146MO embodied in the patient device tangible medium 146M.
  • the input routine 146MI is operatively coupled to a source of patient data, for example patient sensors.
  • the run routine 146MR is operationally coupled the input routine and configured to process the patient data, for example to determine patient vital signs from the measured patient data.
  • the output routine is operationally coupled to the run routine and configured to output the processed patient data, for example the patient vital signs.
  • the output routine 146MO can be operationally coupled an input routine 102MI of the intermediate device processor 102P with a wireless connection 102PW.
  • the intermediate device 102P has a computer program comprising instructions to implement an input routine 102MI, a run routine 102MR and an output routine 102MO embodied in the intermediate device tangible medium 102M.
  • the input routine 102MI is operatively coupled to a source of patient data, for example output data from output routine 146MO of the patient device processor 146P.
  • the run routine 102MR is operationally coupled input routine 102MI and configured to process the patient data, for example to compress the data for subsequent wireless transmission.
  • the output routine 102MO is operationally coupled to the run routine and configured to output the processed patient data.
  • the patient vital signs in compressed form can be output from output routine 102MO to a wireless connection 106PW, such that the patient data can be received by an input routine 106MI of the server.
  • the server 106PS comprising at least one processor 106P has a computer program comprising instructions to implement an input routine 106MI, a run routine 106MR and an output routine 106MO embodied in the server tangible medium 106M.
  • the input routine 106MI is operatively coupled to a source of patient data, for example output data from output routine 102MO of the intermediate device processor 102P.
  • the run routine 106MR is operationally coupled to input routine 106MI and configured to process the patient data, for example to store homogeneous patient parameters and determine heterogeneous patient parameters such as an apnea hypopnea index.
  • the output routine 106MO is operationally coupled to the run routine 106MR and configured to output the processed patient data.
  • the physician notifications can be output from output routine 106MO to a wireless connection 108PW, such that the physician notification can be received by an input routine 108Ml of the physician device processor 108M.
  • the physician device 108P has a computer program comprising instructions to implement an input routine 108MI, a run routine 108MR and an output routine 108MO embodied in the physician device tangible medium 108M.
  • the input routine 108MI is operatively coupled to a source of physician notifications, for example physician notifications from output routine 106MO of the server 106PS.
  • the run routine 108MR is operationally coupled to input routine 108MI and configured to process the physician notifications and instructions that can accompany the physician notification.
  • the notification may comprise an identity of the target physician and the identity of the patient.
  • the output routine 108MO is operationally coupled to the run routine 108MR and configured to output the notification to the display of the physician device.
  • the physician notifications can be output from output routine 108MO to display 108D of the physician device, such that the physician notification and acknowledgement can be displayed for the physician to sign.
  • Fig. 1 A4 shows patient parameters stored on the tangible medium 106M of server 106PS.
  • the parameters stored for each patient may comprise at least one of homogeneous patient heart rate parameters, homogeneous patient respiratory rate parameters, homogeneous patient body temperature parameters, homogeneous patient body temperature parameters, homogeneous patient blood pressure parameters, homogeneous patient blood oxygen parameters, homogeneous patient tissue hydration parameters, or homogeneous patient activity parameters. At least two of the homogeneous patient parameters can be combined to determine one or more heterogeneous patient parameters.
  • Fig. 1A4 shows mobile device 108C configured to receive and display physician notification, as in Figs. IA to 1A4.
  • Mobile device 108C may comprise many known mobile hand held devices such as a BlackberryTM or iPhoneTM
  • Remote physician device comprises input device 1081.
  • display 108D may comprise a touch screen display.
  • Input device 1081 may also comprise at least one of a button, a keyboard, a pointing device, a mouse, a trackball, a track pad or a microphone configured to receive voice commands.
  • the physician can install a mobile application on mobile device 108C so as to configure the mobile device to display the physician notifications as described herein.
  • the mobile device 108C can be configured to show a new notification indicator on the display of the mobile device, and the new notification indicator may include known indicators and display interface windows configured in accordance with the teachings described herein.
  • the components of the interface can be developed by a software engineer of ordinary skill in the art based on the teachings described herein, for example a software engineer having familiarity with known email clients.
  • the mobile application can be configured to display the physician notifications in response to the physician signing the compliance statement.
  • the physician can input a command into the hand held mobile device the run the application so as to receive and display the alerts without patient identification.
  • the compliance statement may comprise a component, instructions or data of the mobile app and the mobile application can be configured so as to allow for mobile device based retrieval of identified alerts.
  • the mobile application may comprise instructions of a computer program embodied on a tangible medium of the mobile device to display the information to the physician in accordance with the teachings described herein .
  • the mobile application may be downloaded onto the mobile device, for example from the server.
  • Figure IB shows a bottom view of adherent device 100 as in Figure IA comprising an adherent patch 1 10.
  • Adherent patch 1 10 comprises a first side, or a lower side HOA, that is oriented toward the skin of the patient when placed on the patient.
  • adherent patch 1 10 comprises a tape HOT which is a material, preferably breathable, with an adhesive 1 16A.
  • Patient side 1 1OA comprises adhesive 1 16A to adhere the patch 1 10 and adherent device 100 to patient P.
  • Electrodes 112A, 1 12B, 1 12C and 1 12D are affixed to adherent patch 1 10. In many embodiments, at least four electrodes are attached to the patch, for example six electrodes.
  • the patch comprises at least two electrodes, for example two electrodes to measure an electrocardiogram (ECG) of the patient.
  • Gel 114A, gel 1 14B, gel 114C and gel 114D can each be positioned over electrodes 112A, 1 12B, 1 12C and 1 12D, respectively, to provide electrical conductivity between the electrodes and the skin of the patient.
  • the electrodes can be affixed to the patch 1 10, for example with known methods and structures such as rivets, adhesive, stitches, etc.
  • patch 1 10 comprises a breathable material to permit air and/or vapor to flow to and from the surface of the skin.
  • FIG. 1C shows a top view of the adherent patch 100, as in Figure IB.
  • Adherent patch 100 comprises a second side, or upper side HOB.
  • electrodes 1 1 OA, 11 OB, 1 1 OC and 1 1 OD extend from lower side 11 OA through the adherent patch to upper side HOB.
  • an adhesive 116B can be applied to upper side 1 1OB to adhere structures, for example, a cover, to the patch such that the patch can support the electronics and other structures when the patch is adhered to the patient.
  • the printed circuit board (PCB) comprise completely flex PCB, rigid PCB combined flex PCB and/or rigid PCB boards connected by cable.
  • Figure ID shows a printed circuit boards and electronic components over adherent patch 110, as in Figure 1C.
  • a printed circuit board for example flex PCB 120
  • Flex PCB 120 can be positioned above HOB of patch HO.
  • Flex PCB 120 can include traces that extends to connectors 122 A, 122B, 122C and 122D on the flex PCB.
  • Connectors 122A, 122B, 122C and 122D can be positioned on flex PCB 120 in alignment with electrodes 1 12 A, 1 12B, 1 12C and 1 12D so as to electrically couple the flex PCB with the electrodes.
  • connectors 122A, 122B, 122C and 122D may comprise insulated wires or a flex circuit that provide strain relief between the PCB and the electrodes.
  • additional PCB's for example PCB 120A, 120B, 120C and 120D be connected to flex PCB 120.
  • Electronic components 130 can be connected to flex PCB 120 and/or mounted thereon. In some embodiments, electronic components 130 can be mounted on the additional PCB's.
  • Electronic components 130 comprise components to take physiologic measurements, transmit data to remote center 106 and receive commands from remote center 106.
  • electronics components 130 may comprise known low power circuitry, for example complementary metal oxide semiconductor (CMOS) circuitry components.
  • Electronics components 130 comprise an activity sensor and activity circuitry 134, impedance circuitry 136 and electrocardiogram circuitry, for example ECG circuitry 136.
  • electronics circuitry 130 may comprise a microphone and microphone circuitry 142 to detect an audio signal from within the patient, and the audio signal may comprise a heart sound and/or a respiratory sound, for example an S3 heart sound and a respiratory sound with rales and/or crackles.
  • Electronics circuitry 130 may comprise a temperature sensor, for example a thermistor, and temperature sensor circuitry 144 to measure a temperature of the patient, for example a temperature of a skin of the patient.
  • Electronics circuitry may comprise a heat flux sensor and heat flux sensor circuitry to measure a skin heat flow of a patient.
  • skin temperature may effect impedance and/or hydration measurements, and that skin temperature measurements may be used to correct impedance and/or hydration measurements.
  • increase in skin temperature can be associated with increased vaso-dilation near the skin surface, such that measured impedance measurement decreased, even through the hydration of the patient in deeper tissues under the skin remains substantially unchanged.
  • use of the temperature sensor can allow for correction of the hydration signals to more accurately assess the hydration, for example extra cellular hydration, of deeper tissues of the patient, for example deeper tissues in the thorax.
  • Electronics circuitry 130 may comprise a processor 146.
  • Processor 146 comprises a tangible medium, for example read only memory (ROM), electrically erasable programmable read only memory (EEPROM) and/or random access memory (RAM).
  • Electronic circuitry 130 may comprise real time clock and frequency generator circuitry 148.
  • processor 136 may comprise the frequency generator and real time clock.
  • the processor can be configured to control a collection and transmission of data from the impedance circuitry electrocardiogram circuitry and the accelerometer.
  • device 100 comprise a distributed processor system, for example with multiple processors on device 100.
  • electronics components 130 comprise wireless communications circuitry 132 to communicate with remote center 106.
  • the wireless communication circuitry can be coupled to the impedance circuitry, the electrocardiogram circuitry and the accelerometer to transmit to a remote center with a communication protocol at least one of the hydration signal, the electrocardiogram signal or the accelerometer signal.
  • wireless communication circuitry is configured to transmit the hydration signal, the electrocardiogram signal and the accelerometer signal to the remote center with a single wireless hop, for example from wireless communication circuitry 132 to intermediate device 102.
  • the communication protocol comprises at least one of Bluetooth, ZigBee, WiFi, WiMAX, IR, amplitude modulation or frequency modulation.
  • the communications protocol comprises a two way protocol such that the remote center is capable of issuing commands to control data collection.
  • intermediate device 102 comprises a data collection system to collect and store data from the wireless transmitter.
  • the data collection system can be configured to communicate periodically with the remote center.
  • the data collection system can transmit data in response to commands from remote center 106 and/or in response to commands from the adherent device.
  • Activity sensor and activity circuitry 134 can comprise many known activity sensors and circuitry.
  • the accelerometer comprises at least one of a piezoelectric accelerometer, capacitive accelerometer or electromechanical accelerometer.
  • the accelerometer may comprise a 3-axis accelerometer to measure at least one of an inclination, a position, an orientation or acceleration of the patient in three dimensions. Work in relation to embodiments of the present invention suggests that three dimensional orientation of the patient and associated positions, for example sitting, standing, lying down, can be very useful when combined with data from other sensors, for example ECG data and/or hydration data.
  • Impedance circuitry 136 can generate both hydration data and respiration data.
  • impedance circuitry 136 is electrically connected to electrodes 1 12A, 1 12B, 1 12C and 1 12D such that electrodes 1 12A and 1 12D comprise outer electrodes that are driven with a current, or force electrodes.
  • the current delivered between electrodes 1 12A and 1 12D generates a measurable voltage between electrodes 1 12B and 1 12C, such that electrodes 1 12B and 1 12C comprise inner electrodes, or sense electrodes that measure the voltage in response to the current from the force electrodes.
  • the voltage measured by the sense electrodes can be used to determine the hydration of the patient.
  • Figure ID-I shows an equivalent circuit 152 that can be used to determine optimal frequencies for measuring patient hydration.
  • Work in relation to embodiments of the present invention indicates that the frequency of the current and/or voltage at the force electrodes can be selected so as to provide impedance signals related to the extracellular and/or intracellular hydration of the patient tissue.
  • Equivalent circuit 152 comprises an intracellular resistance 156, or R(ICW) in series with a capacitor 154, and an extracellular resistance 158, or R(ECW). Extracellular resistance 158 is in parallel with intracellular resistance 156 and capacitor 154 related to capacitance of cell membranes.
  • impedances can be measured and provide useful information over a wide range of frequencies, for example from about 0.5 kHz to about 200 KHz.
  • Work in relation to embodiments of the present invention suggests that extracellular resistance 158 can be significantly related extracellular fluid and to cardiac decompensation, and that extracellular resistance 158 and extracellular fluid can be effectively measured with frequencies in a range from about 0.5 kHz to about 20 kHz, for example from about 1 kHz to about 10 kHz.
  • a single frequency can be used to determine the extracellular resistance and/or fluid.
  • many embodiments of the present invention employ measure hydration with frequencies from about 0.5 kHz to about 20 kHz to determine patient hydration.
  • impedance circuitry 136 can be configured to determine respiration of the patient.
  • the impedance circuitry can measure the hydration at 25 Hz intervals, for example at 25 Hz intervals using impedance measurements with a frequency from about 0.5 kHz to about 20 kHz.
  • ECG circuitry 138 can generate electrocardiogram signals and data from electrodes 1 12A, 1 12B, 1 12C and 1 12D.
  • ECG circuitry 138 is connected to inner electrodes 12B and 122C, which may comprise sense electrodes of the impedance circuitry as described above.
  • the inner electrodes may be positioned near the outer electrodes to increase the voltage of the ECG signal measured by ECG circuitry 138.
  • the ECG circuitry can share components with the impedance circuitry.
  • Figure IE shows batteries 150 positioned over the flex printed circuit board and electronic components as in Figure ID.
  • Batteries 150 may comprise rechargeable batteries that can be removed and/or recharged. In some embodiments, batteries 150 can be removed from the adherent patch and recharged and/or replaced.
  • Figure IF shows a top view of a cover 162 over the batteries, electronic components and flex printed circuit board as in Figure IE.
  • an electronics housing 160 may be disposed under cover 162 to protect the electronic components, and in some embodiments electronics housing 160 may comprise an encapsulant over the electronic components and PCB.
  • electronics housing 160 may comprise a water proof material, for example a sealant adhesive such as epoxy or silicone coated over the electronics components and/or PCB.
  • electronics housing 160 may comprise metal and/or plastic, which may be potted with silicone, epoxy, etc.
  • Cover 162 may comprise many known biocompatible cover, casing and/or housing materials, such as elastomers, for example silicone.
  • the elastomer may be fenestrated to improve breathability.
  • cover 162 may comprise many known breathable materials, for example polyester or polyamide fabric.
  • the breathable fabric may be coated to make it water resistant, waterproof, and/or to aid in wicking moisture away from the patch.
  • the breathable fabric may be coated in order to make the outside hydrophobic and the inside hydrophilic.
  • Figure IG shows a side view of adherent device 100 as in Figures IA to I F.
  • Adherent device 100 comprises a maximum dimension, for example a length 170 from about 4 to 10 inches (from about 100 mm to about 250mm), for example from about 6 to 8 inches (from about 150 mm to about 200 mm). In some embodiments, length 170 may be no more than about 6 inches (no more than about 150 mm).
  • Adherent device 100 comprises a thickness 172. Thickness 172 may comprise a maximum thickness along a profile of the device. Thickness 172 can be from about 0.2 inches to about 0.4 inches (from about 5 mm to about 10 mm), for example about 0.3 inches (about 7.5 mm) .
  • FIG. 1H shown a bottom isometric view of adherent device 100 as in Figures IA to IG.
  • Adherent device 100 comprises a width 174, for example a maximum width along a width profile of adherent device 100.
  • Width 174 can be from about 2 to about 4 inches (from about 50 mm to 100 mm), for example about 3 inches (about 75 mm).
  • Homogeneous data from the patient device can be combined and/or processed in many ways to determine the patient condition. For example, at least two of hydration data, electrocardiogram data, respiration data or activity data can be combined to determine a risk of impending cardiac decompensation, as described in U.S. App. Nos. 60/972,512, entitled “Multi-Sensor Patient Monitor to Detect Impending Cardiac Decompensation", filed September 14, 2007; 60/972,537, entitled “Adherent Device with Multiple Physiological Sensors", filed September 14, 2007, attorney docket no. 026843-000200US; and 61/055,666, entitled “Adherent Device with Multiple Physiological Sensors", filed May 23, 2008, attorney docket no.
  • FIG. 2A shows a method 200 of predicting an impending cardiac decompensation with arrhythmia data.
  • Method 200 can be performed with at least one processor of a processor system, as described above.
  • a step 205 measures an ECG signal.
  • the ECG signal may comprise a differential signal measured with at least two electrodes and may be measured in many known ways.
  • a step 210 determines an incidence of arrhythmias from the ECG signal. The incidence of arrhythmias can be determined using known methods and apparatus to detect arrhythmias, for example as described in U.S. Pat. Nos.
  • a step 215 measures an impedance signal.
  • the impedance signal can be used determine hydration and/or respiration of the patient.
  • the impedance signal may comprise a four pole impedance signal, and may be measured in many known ways.
  • a step 220 measures an activity signal.
  • the activity signal may be measured in many known ways and may comprise a three dimensional accelerometer signal to determine a position of the patient, for example from a three dimensional accelerometer signal.
  • a step 225 measures a temperature signal.
  • the temperature signal may be measured in many ways, for example with a thermistor, a thermocouple, and known temperature measurement devices.
  • a step 230 records a time of day of the signals, for example a local time of day such as morning, afternoon, evening, and/or nighttime.
  • a step 235 processes the signals.
  • the signals may be processed in many known ways, for example to generate at least one of a derived signal, a time averaged signal, a filtered signal.
  • the signals may comprise raw signals.
  • the ECG signal may comprise at least one of a raw ECG signal, a digitally filtered ECG signal, a heart rate signal, a heart rate variability signal, an average heart rate signal, a maximum heart rate signal or a minimum heart rate signal.
  • the impedance signal may comprise a transthoracic impedance measurement signal. The impedance signal may be used to measure hydration of the patient.
  • the impedance signal may be used to determine a respiration signal that may comprise a least one of a respiration rate, a maximum respiration rate, a minimum respiration rate, an average respiration rate or respiration rate variability.
  • the activity signal may comprise at least one of an accelerometer signal, a position signal indicating the orientation of the patient, such as standing, lying, or sitting.
  • the temperature may comprise an average temperature or a peak temperature.
  • a step 240 compares the incidence of arrhythmias and/or other patient data with baseline values.
  • the baseline values may comprise arrhythmia measurements and/or values from the same patient at an earlier time.
  • the baseline values comprise baseline arrhythmia values for a patient population.
  • the baseline values for a patient population may comprise empirical data from a suitable patient population size, for example at least about 144 patients, depending on the number of variables measured, statistical confidence and power used. Additional measured signals, as described above, may be compared to baseline values to determine changes and/or deviations from the baseline values.
  • a step 245 transmits the signals.
  • the measurement signals which may comprise derived and/or processed measurement signals, are transmitted to the remote site for comparison.
  • at least some of the measurement signals may be transmitted to the intermediate device, for example a processor of the gateway as described above, for comparison. This distribution of the processing of the signals to various locations including the processor on the patient, the processor of the gateway, and the processor of the remote site, can optimize performance of the system.
  • the patch worn by the patient may be smaller as some of the processing can be done off the patch, and the communication of the patient information and/or date from the patch to the remote site can occur quickly some processing of the data has extracted the relevant information so as to decrease the size of the transmitted signal, thereby lowering the bandwidth requirements of the system that transmits from the patch to the remote site, for example an internet connection from the gateway to the remote site.
  • a step 250 combines the incidence of arrhythmias with additional patient information, for example at least one of a heart rate, a heart rate variability, a bioimpedance signal, an activity, a hydration signal or a respiration of the patient to determine the risk of impending decompensation.
  • these signals may comprise signals derived from a common measurement, for example hydration signals and respiration signals derived from an impedance measurement.
  • at least two and sometime at least three of the signals are combined.
  • at least four signals are combined to detect the impending decompensation.
  • the signals can be combined in many ways. In some embodiments, the signals can be used simultaneously to determine the impending cardiac decompensation.
  • the signals can be combined by using a look up table, for example to look up a value in a previously existing array.
  • Table 1 Lookup Table for Incidence of Arrhythmias and Heart Rate Signals
  • Table 1 shows combination of the incidence of arrhythmias with heart rate signals to look up a value in a pre-existing array.
  • the value in the table may comprise Y.
  • the values of the look up table can be determined in response to empirical data measured for a patient population of at least about 100 patients, for example measurements on about 1000 to 10,000 patients.
  • the incidence of arrhythmias can be determined in many ways, for example based on the number of arrhythmias over time, for example number per day.
  • the incidence of arrhythmias can also be determined with an index that is determined in response to the duration and/or severity of the arrhythmias, for example with calculations that include the duration of the arrhythmia and/or severity of the arrhythmias.
  • the table may comprise a three or more dimensional look up table.
  • the signals may be combined with at least one of adding, subtracting, multiplying, scaling or dividing.
  • the measurement signals can be combined with positive and or negative coefficients determined in response to empirical data measured for a patient population of at least about 100 patients, for example data on about 1000 to 10,000 patients.
  • a weighted combination may combine at least 3 measurement signals to generate an output value according to a formula of the general form
  • a, b and c comprise positive or negative coefficients determined from empirical data and X, Y and Z comprise measured signals for the patient, for example at least three of the incidence of arrhythmias, the heart rate, the heart rate variability, the bioimpedance and/or hydration signal, the respiration signal or the activity signal. While three coefficients and three variables are shown, the data may be combined with multiplication and/or division. One or more of the variables may be the inverse of a measured variable.
  • the ECG signal comprises a heart rate signal that can be divided by the activity signal.
  • a heart rate signal that can be divided by the activity signal.
  • Work in relation to embodiments of the present invention suggest that an increase in heart rate with a decrease in activity can indicate an impending decompensation.
  • the signals can be combined to generate an output value with an equation of the general form
  • OUTPUT aX /Y + bZ [0117] where X comprise a heart rate signal, Y comprises a hydration rate signal and Z comprises a respiration signal, with each of the coefficients determined in response to empirical data as described above.
  • the output value can be combined with other data, for example the lookup table and/or weighted combinations as described above.
  • the data may be combined with a tiered combination. While many tiered combinations can be used a tiered combination with three measurement signals can be expressed as
  • ( ⁇ X), ( ⁇ Y), ( ⁇ Z) may comprise change in arrhythmias from baseline, change in heart rate from baseline and change in respiration signal from baseline, and each may have a value of zero or one, based on the values of the signals. For example if the incidence of arrhythmias increase by 50% or more, ( ⁇ X) can be assigned a value of 1. If the heart rate increases by 100%, ( ⁇ Y) can be assigned a value of 1. If respiration decreases below 50% of a baseline value ( ⁇ Z) can be assigned a value of 1. When the output signal is three, a flag may be set to trigger an alarm. [0121] In some embodiments, the data may be combined with a logic gated combination. While many logic gated combinations can be used a logic gated combination with three measurement signals can be expressed as
  • ( ⁇ X), ( ⁇ Y), ( ⁇ Z) may comprise change in the incidence of arrhythmias from baseline, change in heart rate from baseline and change in respiration signal from baseline, and each may have a value of zero or one, based on the values of the signals. For example if the incidence of arrhythmias increase by 50%, ( ⁇ X) can be assigned a value of 1. If heart rate increases by 100%, ( ⁇ Y) can be assigned a value of 1. If activity decreases below 50% of a baseline value ( ⁇ Z) can be assigned a value of 1. When each of ( ⁇ X), ( ⁇ Y), ( ⁇ Z) is one, the output signal is one, and a flag may be set to trigger an alarm.
  • the output signal is zero and a flag may be set so as not to trigger an alarm.
  • the data can be combined in may ways with known gates for example NAND, NOR, OR, NOT, XOR, XNOR gates.
  • the gated logic may be embodied in a truth table.
  • One of ordinary skill in the art will recognize that the above ways of combining data can be used with known statistical techniques such as multiple regression, logistical regression and the like to fit data base on an empirical sampling of patient data.
  • the above examples show specific combinations based on patient measurements, and other combinations and/or patient measurements can be used to determine the risk of impending decompensation.
  • a step 255 determines the risk of impending cardiac decompensation, for example in response to the combined data, for example low, medium or high risk.
  • a step 260 sets a flag.
  • the flag can be set in response to the output of the combined signals.
  • the flag may comprise a binary parameter in which a value of zero does not triggers an alarm and a value of one triggers an alarm.
  • a therapy for example cardiac rhythm management therapy, can be delivered when the flag is set to one.
  • a step 265 communicates with the patient and/or a health care provider.
  • the remote site may contact the patient to determine if he or she is okay and communicate the impending decompensation such that the patient can receive needed medical care and/or therapies.
  • the remote site contacts the health care provider to warn the provider of the impending decompensation and the need for the patient to receive medical care.
  • a step 270 collects additional measurements.
  • Additional measurements may comprise additional measurements with at least two signals, for example with greater sampling rates and or frequency of the measurements.
  • the additional measurements for example the electrocardiogram signal, can be transmitted to the health care provider to diagnose the patient in real time.
  • the processor system can be configured to perform the method 200, including many of the steps described above. It should be appreciated that the specific steps illustrated in Figure 2A provide a particular method of predicting an impending cardiac decompensation, according to an embodiment of the present invention. Other sequences of steps may also be performed according to alternative embodiments. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order. Moreover, the individual steps illustrated in Figure 2A may include multiple sub-steps that may be performed in various sequences as appropriate to the individual step. Furthermore, additional steps may be added or removed depending on the particular applications. One of ordinary skill in the art would recognize many variations, modifications, and alternatives.
  • FIG. 3 A shows a method 300 of predicting an impending cardiac decompensation by combing homogeneous patient data to determine a heterogeneous output parameter, for example the level of risk of impending cardiac decompensation.
  • a step 305 measures an ECG signal.
  • the ECG signal may comprise a differential signal measured with at least two electrodes and may be measured in many known ways.
  • a step 310 measures an hydration signal.
  • the hydration signal may comprise an impedance signal, for example a four pole impedance signal, and may be measured in many known ways.
  • a step 315 measures a respiration signal.
  • the respiration signal may comprise an impedance signal, and may be measured in many known ways.
  • a step 320 measures an activity signal.
  • the activity signal may be measured in many known ways and may comprise a three dimensional accelerometer signal to determine a position of the patient, for example from a three dimensional accelerometer signal.
  • a step 325 measures a temperature signal.
  • the temperature signal may be measured in many ways, for example with a thermistor, a thermocouple, and known temperature measurement devices.
  • a step 330 records a time of day of the signals, for example a local time of day such as morning, afternoon, evening, and/or nighttime.
  • a step 335 processes the signals.
  • the signals may be processed in many known ways, for example to generate at least one of a derived signal, a time averaged signal, a filtered signal.
  • the signals may comprise raw signals.
  • the ECG signal may comprise at least one of a heart rate signal, a heart rate variability signal, an average heart rate signal, a maximum heart rate signal or a minimum heart rate signal.
  • the hydration signal may comprise an impedance measurement signal.
  • the activity signal may comprise at least one of an accelerometer signal, a position signal indicating the orientation of the patient, such as standing, lying, or sitting.
  • the respiration signal may comprise a least one of a respiration rate, a maximum respiration rate, a minimum respiration rate, an average respiration rate or respiration rate variability.
  • the temperature may comprise an average temperature or a peak temperature.
  • a step 340 compares the signals with baseline values.
  • the baseline values may comprise measurements from the same patient at an earlier time.
  • the baseline values comprise values for a patient population.
  • the baseline values for a patient population may comprise empirical data from a suitable patient population size, for example at least about 144 patients, depending on the number of variables measured, statistical confidence and power used.
  • the measured signals may comprise changes and/or deviations from the baseline values.
  • a step 345 transmits the signals.
  • the measurement signals which may comprise derived and/or processed measurement signals, are transmitted to the remote site for comparison.
  • the signals may be transmitted to a processor supported with the patient for comparison.
  • a step 350 combines at least two of the ECG signal, the hydration signal, the respiration signal, the activity signal and the temperature signal to detect the impending decompensation. In many embodiments, at least three of the signals are combined. In some embodiments, at least four signals comprising ECG signal, the hydration signal, the respiration signal and the activity signal are combined to detect the impending decompensation. In specific embodiments, at least four signals comprising the ECG signal, the hydration signal, the respiration signal, the activity signal and the temperature signal are combined to detect the impending decompensation.
  • the signals can be combined in many ways. In some embodiments, the signals can be used simultaneously to determine the impending cardiac decompensation.
  • the signals can be combined by using the at least two of the electrocardiogram signal, the hydration signal, the respiration signal or the activity signal to look up a value in a previously existing array.
  • Table 2 Lookup Table for ECG and Hydration Signals
  • Table 2 shows combination of the electrocardiogram signal with the hydration signal to look up a value in a pre-existing array.
  • the value in the table may comprise Y.
  • the values of the look up table can be determined in response to empirical data measured for a patient population of at least about 100 patients, for example measurements on about 1000 to 10,000 patients.
  • the table may comprise a three or more dimensional look up table.
  • the signals may be combined with at least one of adding, subtracting, multiplying, scaling or dividing the at least two of the electrocardiogram signal, the hydration signal, the respiration signal or the activity signal.
  • the measurement signals can be combined with positive and or negative coefficients determined in response to empirical data measured for a patient population of at least about 100 patients, for example data on about 1000 to 10,000 patients.
  • a weighted combination may combine at least 3 measurement signals to generate an output value according to a formula of the general form
  • OUTPUT aX + bY + cZ [0143] where a, b and c comprise positive or negative coefficients determined from empirical data and X, Y and Z comprise measured signals for the patient, for example at least three of the electrocardiogram signal, the hydration signal, the respiration signal or the activity signal. While three coefficients and three variables are shown, the data may be combined with multiplication and/or division. One or more of the variables may be the inverse of a measured variable.
  • the ECG signal comprises a heart rate signal that can be divided by the activity signal.
  • a heart rate signal that can be divided by the activity signal.
  • Work in relation to embodiments of the present invention suggest that an increase in heart rate with a decrease in activity can indicate an impending decompensation.
  • the signals can be combined to generate an output value with an equation of the general form
  • OUTPUT aX /Y + bZ [0146] where X comprise a heart rate signal, Y comprises a hydration rate signal and Z comprises a respiration signal, with each of the coefficients determined in response to empirical data as described above.
  • the data may be combined with a tiered combination. While many tiered combinations can be used a tiered combination with three measurement signals can be expressed as
  • ( ⁇ X), ( ⁇ Y), ( ⁇ Z) may comprise change in heart rate signal from baseline, change in hydration signal from baseline and change in respiration signal from baseline, and each may have a value of zero or one, based on the values of the signals. For example if the heart rate increase by 10%, ( ⁇ X) can be assigned a value of 1. If hydration increases by 5%, ( ⁇ Y) can be assigned a value of 1. If activity decreases below 10% of a baseline value ( ⁇ Z) can be assigned a value of 1. When the output signal is three, a flag may be set to trigger an alarm.
  • the data may be combined with a logic gated combination. While many logic gated combinations can be used a logic gated combination with three measurement signals can be expressed as
  • ( ⁇ X), ( ⁇ Y), ( ⁇ Z) may comprise change in heart rate signal from baseline, change in hydration signal from baseline and change in respiration signal from baseline, and each may have a value of zero or one, based on the values of the signals. For example if the heart rate increase by 10%, ( ⁇ X) can be assigned a value of 1. If hydration increases by 5%, ( ⁇ Y) can be assigned a value of 1. If activity decreases below 10% of a baseline value ( ⁇ Z) can be assigned a value of 1. When each of ( ⁇ X), ( ⁇ Y), ( ⁇ Z) is one, the output signal is one, and a flag may be set to trigger an alarm.
  • the output signal is zero and a flag may be set so as not to trigger an alarm. While a specific example with AND gates has been shown the data can be combined in may ways with known gates for example NAND, NOR, OR, NOT, XOR, XNOR gates. In some embodiments, the gated logic may be embodied in a truth table.
  • a step 355 sets a flag.
  • the flag can be set in response to the output of the combined signals.
  • the flag may comprise a binary parameter in which a value of zero does not triggers an alarm and a value of one triggers an alarm.
  • a step 360 communicates with the patient and/or a health care provider.
  • the remote site may contact the patient to determine if he or she is okay and communicate the impending decompensation such that the patient can receive needed medical care.
  • the remote site contacts the health care provider to warn the provider of the impending decompensation and the need for the patient to receive medical care.
  • a step 365 collects additional measurements. Additional measurements may comprise additional measurements with the at least two signals, for example with greater sampling rates and or frequency of the measurements. Additional measurements may comprise measurements with a additional sensors, for example an onboard microphone to detect at least one of rales, Sl heart sounds, S2 heart sounds, S3 heart sounds, or arrhythmias. In some embodiments, the additional measurements, for example sounds, can be transmitted to the health care provider to diagnose the patient in real time. [0156]
  • the processor system as described above, can be configured to perform the method 300, including many of the steps described above. It should be appreciated that the specific steps illustrated in Figure 3 A provide a particular method of predicting an impending cardiac decompensation, according to an embodiment of the present invention.
  • Figure 4A shows a method 400 of monitoring a sleep apnea and/or hypopnea in a patient by combining homogeneous patient data to determine a heterogeneous patient parameter, for example an apnea / hypopnea index.
  • Method 400 can be performed with the processor system, as described above.
  • a step 405 measures an impedance signal of the patient.
  • the impedance signal can be measured with a four pole impedance system as described above.
  • a step 410 determines the respiration rate of the patient, for example from the impedance signal.
  • Step 410 can be performed with at least one processor supported with the adhesive patch as descried above, so as to decrease data storage requirements of the electronic components supported with the adhesive patch.
  • a step 415 measures extracellular fluid of the patient.
  • the extracellular fluid can be used to monitor the hydration status of the patient and detect edema.
  • a step 420 measures an accelerometer signal.
  • the accelerometer signal can be generated with many accelerometers as described above, for example a three axis accelerometer.
  • the accelerometer may correspond to patient activity, for example patient activity and orientation may be determined from the accelerometer signal.
  • a step 425 determines orientation and/or activity of the patient, for example in response to the accelerometer signal.
  • a step 430 measures an electrocardiogram signal of the patient.
  • a step 435 determines a heart rate of the patient in response to the electrocardiogram signal.
  • the heart rate of the patient can be determined with at least one processor supported with the adhesive patch, so as to decrease data storage requirements of the electronic components supported with the adhesive patch.
  • a step 440 determines that the patient is asleep, for example in response to the respiration rate from the impedance signal, the activity and orientation of the patient from the accelerometer signal, and the heart rate from electrocardiogram signal. For example, a combination of low heart rate, low respiration rate, low activity amount and/or horizontal position can be used to determine the patient sleep state of the patient, for example that the patient is asleep
  • a step 445 determines the apnea hypopnea index.
  • the apnea hypopnea index is determined at the remote center and/or the intermediate device in response to the heart rate and respiration rate determined with at least one processor supported with the adhesive patch.
  • Known methods of calculating the apnea hypopnea index can be used, and at least some of the following U.S. patent publications and patents describe calculation of the apnea hypopnea index (AHI): 2007/0129643 (Kwok et al.); 2007/0123756 (Kitajima et al.); 2006/0173257 (Nagai et al.); and 6,641,542 (Cho et al.).
  • a step 450 transmits patient information to the remote center, for example the patient apnea hypopnea index.
  • a step 455 transmits data collection commands from the remote center to a processor supported with the adhesive patch.
  • a step 460 provides the apnea hypopnea index to a decompensation prediction algorithm, for example as described above.
  • a step 465 can alter a health care provider in response to one or more of the measured signals, for example the heart rate signal and/or the respiration rate signal, and provide the apnea hypopnea index to the treating physician and/or health care provider as a report.
  • the processor system can be configured to perform the method 400, including many of the steps described above. It should be appreciated that the specific steps illustrated in Figure 4A provide a particular method of monitoring a patient for sleep disordered breathing, according to an embodiment of the present invention. Other sequences of steps may also be performed according to alternative embodiments. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order. Moreover, the individual steps illustrated in Figure 4A may include multiple sub-steps that may be performed in various sequences as appropriate to the individual step. Furthermore, additional steps may be added or removed depending on the particular applications. One of ordinary skill in the art would recognize many variations, modifications, and alternatives.
  • Figure 5 A shows a method 500 of monitoring a patient receiving care from a physician and sending notifications to the treating physician.
  • the processor system as described above, can be configured to perform methods 200 and 500.
  • a step 505 measures patient data with sensors, for example as described above.
  • a step 510 determines homogeneous patient parameters, for example at least one of a heart rate, a temperature, a respiration, a hydration or an activity. The homogeneous patient parameters are determined in response to the measured patient data.
  • a step 515 determines at least one heterogeneous patient parameter, for example by combining two or more homogeneous patient parameters as described above.
  • a step 520 transmits the patient data to a server, for example as described above.
  • a step 525 determines the patient condition, for example in response to the heterogeneous patient parameter.
  • a step 530 sends a physician notification, for example at least one of an email or a page.
  • a step 535 may exclude the patient ID and at least one heterogeneous patient parameter from the notification, so that the physician does not know for what patient the notification has been sent or the heterogeneous patient parameter associated with the notification.
  • a step 540 displays the notification visible to the physician.
  • the patient ID and heterogeneous patient parameter are sent with the notification such that notification is visible to the physician and such that the patient ID and heterogeneous patient parameter are not visible to the physician when the physician initially views the notification.
  • a step 545 displays a level of urgency to the physician when the notification is initially visible to the physician. .
  • a step 555 signs the compliance statement with a physician signature.
  • a step 560 displays the patient ID with the physician notification in response to the step 535 of signing the compliance statement.
  • a step 565 transmits the patient condition and/or the heterogeneous patient parameters, for example from the server to the display device by the physician after the physician signs the compliance statement.
  • the patient condition and/or the heterogeneous patient parameters can be transmitted to the physician display device before the compliance statement is signed, but not shown on the display until after the physician signs the compliance statement.
  • a step 565 displays the patient condition and/or heterogeneous patient parameters.
  • a step 575 directs the physician to the patient data, for example with a link to a website where the data is stored.
  • homogeneous patient data used to determine the heterogeneous patient parameter can be sent with the notification and not displayed, such that the relevant patient data is readily available on the physician display for expedited review and analysis by the physician.

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Abstract

Selon l'invention, des données sur les malades sont mesurés à l'aide d'un détecteur adhérent distant, et une déclaration est envoyée au médecin traitant en réponse aux données mesurées. La déclaration de médecin et une déclaration de conformité sont présentées sur un écran visible pour le médecin. Les données présentées avec la déclaration peuvent être limitées, par exemple bloquées, jusqu'à ce que le médecin signe la déclaration de conformité. Par exemple, le médecin peut signer la déclaration de conformité au moyen d'une signature électronique pour afficher l'identité du malade.
PCT/US2010/026864 2009-03-10 2010-03-10 Système et procédé de remise de déclarations de médecin WO2010104978A2 (fr)

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