US20020026223A1 - Method and a system for using implanted medical device data for accessing therapies - Google Patents

Method and a system for using implanted medical device data for accessing therapies Download PDF

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Publication number
US20020026223A1
US20020026223A1 US09/740,127 US74012700A US2002026223A1 US 20020026223 A1 US20020026223 A1 US 20020026223A1 US 74012700 A US74012700 A US 74012700A US 2002026223 A1 US2002026223 A1 US 2002026223A1
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Prior art keywords
patient
data
medical device
implanted medical
data processor
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US09/740,127
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English (en)
Inventor
Kenneth Riff
Patrick Mahoney
Clifton Owens
Rahul Mehra
Michael Hess
Nirav Sheth
Nancy Pool
Michael Ujhelyi
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Medtronic Inc
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Medtronic Inc
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Priority to US09/740,127 priority Critical patent/US20020026223A1/en
Assigned to MEDTRONIC, INC reassignment MEDTRONIC, INC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MEHRA, RAHUL, OWENS, CLIFTON W., HESS, MICHAEL F., MAHONEY, PATRICK M., SHETH, NIRAV V., UJHELYI, MICHAEL R., POOL, NANCY PERRY, RIFF, KENNETH M.
Publication of US20020026223A1 publication Critical patent/US20020026223A1/en
Priority to US10/376,061 priority patent/US7366570B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37258—Alerting the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37254—Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • 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
    • A61B5/0031—Implanted circuitry
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof

Definitions

  • the present invention generally relates to a method and a system for using implanted medical device data to access medical data processing systems. Specifically, the invention relates to a method and a system for remotely accessing medical data processing systems adapted to provide implanted device therapies in response to patient diagnostic data received from an implanted medical device.
  • implantable medical device technology has rapidly advanced. Sizes and weights have decreased, while functionality has increased. These advances have created a corresponding demand for two-way communication between the implantable medical device and an external device, for example, a programmer device.
  • a programmer device downloads to an implanted pacemaker data such as operating parameters.
  • data may flow from the implanted device to the programmer device.
  • Modern pacemakers are capable of storing significant amounts of data about the patient, for example, physiological data such as electrocardiogram (EGM), and information pertaining to the pacemaker itself, for example, battery voltage level. This data may need to be transmitted to the programmer device for evaluation by a physician.
  • EMM electrocardiogram
  • implanted medical device programmers typically include an extendible head portion that includes an antenna.
  • the antenna is connected to other circuitry in the programmer device via a stretchable coil cable.
  • the head portion can be positioned over the patient's implanted device site for programming or telemetry interrogation of the implanted device.
  • Command instructions or data that are downloaded to the implanted device are referred to as downlink transmissions
  • data transmitted from the implanted device to the programmer device are referred to as uplink transmissions.
  • a technology-based health care system that fully integrates the technical and social aspects of patient care and therapy should be able to flawlessly connect the patient with care providers irrespective of separation distance or location of the participants. While clinicians will continue to treat patients in accordance with accepted modem medical practice, developments in communications technology are making it ever more possible to provide medical services in a time and place independent manner.
  • Prior art methods of clinical services are generally limited to in-hospital operations. For example, if a physician needs to review the performance parameters of an implanted device, the patient will likely visit the clinic. If the medical condition of the patient with the implanted device warrants a continuous monitoring or adjustment of the device, the patient will have to stay in the hospital for an extended period of time. Such continuous treatment plans pose both economic and social hardship on patients. Depending on the frequency of data collection this procedure may seriously inconvenience patients that live in rural areas or have limited physical mobility. The need for upgrading the software of an implanted medical device also requires another trip to the hospital to have the upgrade installed. Further, as the segment of the population with implanted medical devices increases many more hospitals, clinics and service personnel will be needed to provide in-hospital care to patients, thus escalating the cost of healthcare.
  • Various embodiments of the present invention are directed to addressing various needs in connection with reducing healthcare costs by facilitating the access of general and specific information on a patient's implanted medical device (IMD), thereby allowing the patient to participate in their own clinical care and therapy. Accordingly, the present invention provides a method and system for facilitating a patient's access to current IMD diagnostic data for timely administration of medical therapies with the assistance of an data processor.
  • IMD implanted medical device
  • the present invention supports a communications system for providing web-based data resources to capture, analyze, format and display patient-specific information on demand and in real-time.
  • the invention provides an Internet-based secure site to enable a patient to uplink their IMD to transfer data into a data management center where the data is analyzed and relevant therapy/clinical care is dispensed accordingly.
  • Another aspect of the invention pertains to arrhythmia management via a programmable patient arrhythmia notification device in coordination with the patient's IMD.
  • the notification device can also communicate with a web-based remote data management center.
  • IMD patients have access to a web-based data management system for IMDs for accessing various clinical and therapy alternatives and related information/services.
  • a method and system facilitates the access by a patient of implanted medical device related data for patient participation in clinical care and therapy.
  • the method includes establishing a communications link between an implanted medical device and a data processor via an implanted medical device interface. Access to a secured database is obtained via the implanted device data processor using a set of patient identification data. A query is then submitted via the data processor to the secured database in response to input of patient diagnostic data. Data received from the secured database is then displayed for use in a patient evaluation.
  • a method and system facilitates access by an IMD patient to their own IMD diagnostic data for patient education and evaluation.
  • the method includes establishing a communications link between an implanted medical device and a data processor via an implanted medical device interface. Access to a secured database is obtained via the data processor by using a set of patient identification data. Further, a set of patient diagnostic data from the implanted medical device is then transmitted to the data processor for processing. A set of formatted data is then generated, as a function of a data request from the patient, via the data processor using the patient diagnostic data. The set of formatted data received from the secured database via the data processor is then displayed for use in a patient evaluation regimen as required by the doctor or established medical care.
  • FIG. 1A illustrates a block diagram of a system for facilitating the access by an MD patient to a data processor capable of processing IMD related data in accordance with an example embodiment of the invention
  • FIG. 1B is a flow diagram illustrating an example manner of implementing therapies in connection with detected heart conditions in accordance with an example embodiment of the invention
  • FIG. 2 is a flow diagram illustrating another manner of accessing IMD diagnostic data and implementing therapies in connection with detected heart conditions in accordance with another example embodiment of the invention.
  • FIG. 3 is a diagram of a system for accessing and processing IMD information as a function of an IMD patient's request in accordance with an example embodiment of the invention.
  • the present invention is generally directed to a method and system for generating an IMD related data response as a function of a detected condition in connection with a patient's IMD. While the present invention is not necessarily limited to such an application, the invention will be better appreciated using a discussion of example embodiments in such a specific context.
  • an external messaging system is provided and adapted to communicate with an IMD and use an alpha-numeric messaging program to instruct the patient when to schedule drug therapy.
  • a configurable treatment process is incorporated into an arrhythmia monitoring and notification system for guiding medication therapy for arrhythmia termination, fast ventricular response, or anticoagulation therapy.
  • the configurable features cooperate with the external messaging circuit to assist in scheduling or rescheduling therapy based on patient action and drug delivery timing.
  • the process also provides closed loop communications between an implantable drug delivery system and an implanted electrical therapy device.
  • the system of the present invention greatly simplifies the patient's role in the decision loop for self-administration of IMD therapies.
  • FIG. 1A illustrates a block diagram of a system 100 for facilitating the access by a patient to an implanted medical device data processor that is capable of detecting various conditions in accordance with an example embodiment of the invention.
  • System 100 facilitates the access by a patient to implanted medical device related data for the patient's participation in clinical care and therapy.
  • System 100 in this example, includes an IMD port interface 104 that is coupled to an IMD 102 via a communications link 106 .
  • Communications link 106 is established, in this example, via telemetry when port interface 104 is in close proximity to the MD.
  • the link can also be established, for example, with radio frequency signal based telemetry.
  • MD interface 104 includes features of a programming head or wand that is incorporated into a programming unit for detecting and transmitting IMD diagnostic data.
  • IMD interface 104 includes an IRM (Interactive Remote Monitor) that is used to uplink data from the implanted device to IMD data processor 108 or to a related website.
  • IMD port interface 104 is coupled via communications link 110 to an IMD data processor 108 , which includes a database 109 .
  • Communications link 110 can be established via a telephone, a video conference call, a cellular telephone, via a separate Internet connection or other related communications formats for the transmission of data and voice to IMD data processor 108 .
  • IMD data processor 108 is coupled via a communications link 111 to a communications network 112 , which includes a server 113 .
  • Network 112 is in turn coupled to a data processing center 114 via a communications link 116 .
  • the data processing center includes medical personnel that analyze and evaluate diagnostic data received from an MD.
  • the data processing center may be co-located with the patient or may be located remote from the patient and accessed through communications network 112 .
  • a patient messaging system (PMS) 118 co-located with IMD 102 is coupled to IMD data processor 108 via IMD interface 104 .
  • PMS 118 includes a display 119 and a circuit adapted to assess and detect heart conditions in conjunction with the IMD.
  • the circuit includes a processor 118 A and a memory arrangement 118 B as well as an audio signal arrangement (not shown) for emitting sounds that are audible by a patient having IMD 102 .
  • a similar circuit is also within data processor 108 for remote detection of heart conditions.
  • PMS 118 is coupled to IMD 102 via a telemetry link 120 and is adapted to access IMD status information and independently alert the patient of a heart condition that requires some form of therapy or treatment. The patient is then advised of the therapy options available for treating the detected condition. In another embodiment, the patient initiates a patient query to determine IMD status. In both embodiments, PMS 118 generates at least one suggested therapy (medicinal and/or electrical pulse) that is displayed on display 119 and that is be exercised or administered primarily by the patient. In yet another embodiment, PMS 118 is also capable of programming or reconfiguring certain program features within IMD 102 .
  • System 100 of the present invention provides the capabilities of notifying a patient of an arrhythmia onset and guiding the patient and/or physician to administer the appropriate drug or electrical therapy.
  • PMS 118 which in this example is an alphanumeric messaging and programmable patient notification device
  • the patient is guided through various pharmacological and electrical therapies as required.
  • the patient can now critically time the taking of medications to terminate an arrhythmic event or slow down the ventricular rate or use the medication in combination with electrical therapies. The longer the arrhythmia duration, the less successful medications will be in terminating the arrhythmia.
  • anticoagulation drug therapy may have to be extended for an additional 3-4 weeks to reduce the risk of a stroke to the patient.
  • Notification via PMS 118 is useful in guiding the patient through anticoagulation therapy when events are long lasting and unresponsive to medical and/or electrical therapies.
  • System 100 via PMS 118 , provides the feature of advising the patient in real time of the success or progress of the elected treatment or therapy. Furthermore, since some medications can increase the likelihood that antitachycardia pacing or defibrillation therapies will terminate an arrhythmia, PMS 118 will guide the patient as to the appropriate time to take certain medication in order for electrical therapies to be more successful.
  • a communications link is first established between IMD 102 and MD data processor 108 via IMD port interface 104 .
  • the communications link is established directly between the IMD and data processor 118 A in order to establish two way communications between the patient and PMS 118 for the patient implemented therapies scenario.
  • Implanted medical device database 108 which is a secured database or website provided via MD data processor 108 , is then accessed by using a set of patient identification data.
  • the patient identification data is the serial number of the IMD but can be a special code that is assigned to the IMD patient for obtaining access to the secured database.
  • System 100 facilitates access by the patient having IMD 102 of the secured database using the IMD serial number as the password, after which the patient requests information and/or data from the database.
  • Information available to the patient includes, but is not limited to, information about the particular IMD in use, latest technological developments, clinical trials, patient/lifestyle guidelines, support group information, special HOT LINE numbers for emergencies, dietary and exercise programs and additional links to other websites.
  • System 100 detects the condition at the IMD patient location that the patient is seeking information or data and proceeds to provide the data as a function of the inquiry made. The data response is then generated by IMD data processor 108 and displayed (e.g., on a CRT or LCD screen or LED display) for use by the patient in educating himself on current IMD health concerns or issues.
  • processor 118 A communications with the patient is initiated by either the patient or by PMS 118 where a heart condition is detected.
  • the patient of IMD 102 actively seeks a status evaluation of (or a treatment strategy for) his IMD with respect to his heart and either activates PMS 118 or obtains access to IMD data processor 108 for an evaluation or detection of at least one of a plurality of current heart conditions.
  • patient diagnostic data is uplinked to the IMD data processor (or PMS 118 ) for evaluation and detection of the patient's heart condition.
  • Detectable heart conditions include, but are not limited to, arrhythmia, tachycardia, bradycardia and eventual heart failure and are detected over IMD port interface 104 for processor 108 (or directly by 118 A from the IMD).
  • a data response as a function of the detected heart condition is then generated by IMD data processor 108 (or PMS 118 ) and is displayed for use in patient evaluation.
  • the data response is displayed on display 119 of PMS 118 and includes a list of recommended medicinal and/or electrical impulse therapies that are administered by the patient (or a medical assistant).
  • a flow diagram 140 illustrates an example manner of processing IMD diagnostic data and implementing therapies in connection with detected heart conditions, in accordance with an example embodiment of the invention.
  • the system guided drug therapy process is illustrated is programmable and is intended to interact and communicate with external messaging systems.
  • a patient activator (not shown) communicates with PMS 118 to properly time electrical therapies with medication therapies.
  • at step 142 atrial fibrillation (AF) is initiated or commences and lasts for a certain duration of time, with the time value exceeding a predefined time value before the patient notification process starts or before the patient notices that a problem may be occurring.
  • AF atrial fibrillation
  • PMS 118 initiates communication with the patient, and depending on the time duration or other defined criteria, will follow either steps 144 , 150 , 154 or 158 .
  • PMS 118 advises patient that AF has exceeded a time value of T 1 and/or that the Burden has exceeded a certain Burden limit value (B limit) and that it is time to initiate therapy.
  • the patient is alerted by an alarm signal coming from PMS 118 and is instructed at step 146 , via an alphanumeric message on display 119 , as to his treatment options.
  • his treatment options include either drugs or pacing options or a combination of both.
  • the patient exercises one of the treatment options and advises PMS 118 of the treatment option exercised.
  • PMS 118 notifies the patient whether AF has terminated. If AF has not terminated, the process can loop back to step 144 or move to another step in process 140 .
  • step 150 the patient is notified by PMS 118 that the time duration has exceed a time value of T 2 , or a burden limit (or any other criteria that is a function of AF duration).
  • step 152 the patient is advised on patient management treatment options, which in this example includes taking anticoagulant medication. The patient again proceeds to exercise one of the treatment options and advises PMS 118 of the option exercised. As in the example described above, the process moves to step 148 where the patient waits to be notified that AF has terminated.
  • PMS 118 notifies the patient that the ventricular rate metric has exceeded a time value of T 3 .
  • the patient is advised on patient management treatment options, which in this example includes taking rate-controlling medication. The patient again proceeds to exercise one of the treatment options and advises PMS 118 of the option exercised. As in the example described above, the process moves to step 148 where the patient waits to be notified that AF has terminated.
  • PMS 118 notifies the patient that heart failure is beginning due to a prolonged AF condition.
  • a sensor input that detects heart failure communicates the condition to PMS 118 in order that the patient is alerted of this condition.
  • the patient is advised on patient management treatment options, which in this example includes taking medication to control on the onset of heart failure and/or to call his physician immediately. The patient again proceeds to exercise one of the treatment options and advises PMS 118 of the option exercised.
  • the process moves to step 148 where the patient waits to be notified that AF has terminated.
  • the patient has the choice of taking control of his own therapy with the guidance and regular feedback (via two-way communication) of PMS 118 .
  • a flow diagram 200 illustrates another manner of accessing and processing IMD diagnostic data, and implementing therapies in connection with detected heart conditions, in accordance with an example embodiment of the invention.
  • IMD data processor 108 (or processor 118 A of PMS 118 ) detects an atrial fibrillation and the patient is notified by an audible sound emitted by PMS 118 .
  • the audible sound is prompted by a notification signal 117 sent by IMD data processor 108 via interface 104 to PMS 118 .
  • the patient of IMD 102 is advised of the detection of one of three conditions: patient alert for Atrial fibrillation (AF; step 204 ); patient alert for anticoagulation (step 230 ); and patient alert for rapid and prolonged ventricular rate (step 240 ).
  • patient alert for Atrial fibrillation AF
  • step 204 patient alert for anticoagulation
  • step 230 patient alert for rapid and prolonged ventricular rate
  • step 240 patient alert for rapid and prolonged ventricular rate
  • a different path is followed by the IMD patient in administering therapy with the assistance of PMS 118 and system 100 .
  • the patient is notified via PMS 118 to take a medication 206 and to advise PMS 118 when the medication has been taken.
  • a determination is made whether the AF is still present. If not, at step 210 the patient is notified that AF is terminated.
  • step 212 the patient is advised accordingly and another set of therapy options is communicated to the patient.
  • antitachycardia pacing will be automatically delivered at an optimal drug rate, which is set by either a fixed time interval or by a change in sensed atrial cycle length (a surrogate of drug effect).
  • step 214 another determination is made whether the AF is still present; if not, at step 216 the patient is advised accordingly. If so, at step 218 either automatic pacing continues with a return path to 212 , or the patient, at step 220 , activates the defibrillation mode of IMD 102 and applies a shock to terminate the arrhythmia.
  • programmable PMS 118 instructs the patient to perform electrical therapies in order to terminate the arrhythmia. If this approach is not successful PMS 118 advises the patient to follow another course of action by taking the medication and activating PMS 118 to repeat the pacing therapies after a fixed time interval or when atrial cycle length changes. Shock therapy may be in order at this point with notification being programmed for a fixed time interval to allow the medication ample time to terminate the heart condition before having to provide the shock treatment. In most of the embodiments, the patient has the option of receiving continuous feedback via PMS 118 (or other display methods) regarding medication efficacy.
  • system 100 along with PMS 118 is helpful in assisting in the management of anticoagulation therapy.
  • the programmable features of PMS 118 have a burden threshold. For example, if atrial arrhythmia is present for greater than a certain portion of a 24-hour interval, the patient is notified to start anticoagulation therapy and/or see a physician.
  • system 100 assists in the management of ventricular rate control for patients with paroxysmal AF.
  • PMS 118 and system 100 provide guidance in the use of medication only when needed, since rate controlling medications are poorly tolerated. This treatment strategy greatly improves a patient's quality of life by using the programmable feature of PMS 118 ; at step 242 , to intermittently use rate control medications.
  • a determination is made whether the ventricular response is in the alert criteria zone, such as a fast zone. If so, at step 246 the patient is notified via the alert feature of PMS 118 that an AF is occurring (ventricular response is in the fast zone) and to start taking the rate control medication.
  • step 248 the patient is notified that the ventricular response is normal.
  • step 250 another determination is made whether AF is present. If so, at step 252 patient continues the rate control medication. If AF is not present, at step 254 the patient is notified that AF has terminated and rate controlling medication therapy is to be terminated.
  • PMS 118 alerts the patient to take an extra dose of rate control medication. If that dose is ineffective, or more than two extra doses are needed within a 24 hour to prevent a fast ventricular response, then the patient is notified to visit a physician.
  • the antiarrhythmic, anticoagulation and ventricular rate control medication therapies guided by system 100 are simultaneously implemented.
  • a patient that has an episode of AF is notified to take an antiarrhythmic medication in an attempt to terminate the arrhythmia.
  • PMS 118 also notifies the patient that the ventricular response is in the fast zone and should also take a rate control medication. If no such therapies are successful and AF burden falls into the anticoagulation zone, the patient is notified to start anticoagulation therapy.
  • PMS 118 provides instructions to the patient on when medications and electrical therapies should be delivered based upon programmable features.
  • the programmable features complement any device in the system that monitors, detects and notifies patient when an arrhythmia is occurring.
  • Treatment options generated by PMS 118 include: 1) medications only and not implementing any electrical therapies, such as in the equipment sold under the brand RevealTM; 2) implementing pacing backup for drug-induced bardycardia; 3) implementing pacing backup with antitachycardia (AT500TM); or 4) implementing pacing backup, antitachycardia pacing and defibrillation (Jewel AFTM).
  • PMS 118 in one embodiment, is a handheld device using standard telemetry communications protocols or a wristwatch device using radio frequency signals to establish the telemetry link with the IMD.
  • the patient uses the handheld device upon receiving an audible notification tone (from PMS 118 ) to place the handheld device in close proximity to the IMD or an IPG (implanted pulse generator).
  • the alphanumeric messaging circuit then instructs the patient regarding rhythm status and the type of medication or electrical therapies need to be administered.
  • the patient also uses the handheld device to instruct the IPG as to when a medication was taken in order that electrical therapies are timed to occur at a maximal medication effect. Thus, any synergies between medication and electrical therapies are exploited.
  • Some of the advantages provided by the various embodiments of the present invention include: early recognition of the need for therapy; proper diagnosis and therapy early in the detection process; and reduced risk of toxicity from medications that would normally be taken chronically due to an inability to properly diagnose the heart condition.
  • antiarrhythmic medications are administered when an atrial fibrillation occurs and the patient is not be burdened with the expense, toxicity and inconvenience of daily medication consumption.
  • quantifying the daily AF burden and ventricular response can guide usage of anticoagulation and rate control drug.
  • diagnosis and patient awareness will document drug therapy efficacy on a real time basis.
  • a patient's heart condition such as an arrhythmia
  • undesirable consequences such as chronic AF, congestive heart failure or thromboembolic events can be avoided.
  • Continuous monitoring of heart rhythm with patient notification of arrhythmia onset and termination will allow the patient to be in control of their AF management.
  • the patient is alerted to take medication, to deliver electrical therapy (pacing or defibrillation) or seek medical attention before onset of conditions requiring anticoagulation therapy.
  • FIG. 3 illustrates a system 300 for accessing and processing IMD patient diagnostic data, as well as formatting such data as a function of the IMD patient's request, in accordance with an example embodiment of the invention.
  • the method and system facilitate the access by an IMD patient of diagnostic data for patient education and evaluation.
  • IMD information is retrievable from and is displayable at a home environment 302 , for example. Additional information is retrievable through a database located at a data processing center or hospital via the Internet 304 . Patient information that is retrieved in a healthcare facility 306 , and stored in a secured database, is accessible by the patient via the Internet 304 or by telephone or other communication systems.
  • the patient first establishes a communications link between the IMD and the IMD data processor 108 via the IMD device interface as in FIG. 1.
  • a secured IMD database provided by the MD data processor is then accessed using a set of patient identification data (e.g., IMD serial number or an alpha-numeric password assigned by database manager).
  • a set of patient diagnostic data from IMD 102 is then transmitted via an uplink transmission to IMD data processor 108 for processing.
  • a set of formatted data is generated, as a function of a request from the patient, by IMD data processor 108 using the patient's diagnostic data.
  • current diagnostic data is compared with the patient's historical information stored in database 109 .
  • the data is also formatted to draw comparisons with information from other IMD users to illustrate a trend or for recognition of a pattern in the patient's IMD operation.
  • the formatted data generated by IMD data processor 108 is then displayed for use in the patient's own evaluation or as an interactive tool to be used with the physician or with a data processing center having staff knowledgeable in implanted medical devices.
  • the interactive component is available for discussing the patient formatted data with a remotely located expert data center or physician. This can include a voice connection via a home PC or using the telephone to have a discussion concerning the displayed data.
  • the patient diagnostic data is retrievable from the IMD and certain heart conditions are detectable by IMD data processor 108 (or PMS 118 ) that include, but are not limited to, Atrial Fibrillation, Ischemia, Mich. (Myocardial Infarction) and SCD (Sudden Cardiac Death) detection and prediction.
  • IMD data processor 108 or PMS 118
  • Other equipment that can be incorporated into system 100 for improved diagnostic capability of a patient's IMD condition include: implanted event recorders, implanted diagnostic monitors and pacing/defibrillation systems.
  • Other non-invasive physiological information can also be gathered by system 100 that would assist the patient in conducting a minimal level of self-health evaluation.
  • ECG information is retrievable for analysis by the patient well before a health condition occurs that requires hospitalization. This information is recorded in the database 109 for later use in patient diagnostic data analysis and is accessible through server 113 of communications network 112 or through the Internet 304 .
  • Some of the advantages provided by the various embodiments of the present invention include enhanced patient availability for regular IMD and ECG evaluations and a comfortable interrogation session in a patient's home or familiar environment that eliminates the necessity of traveling to the hospital.
  • the present invention is compatible with a number of techniques for interrogating implanted medical devices, such as drug pumps, neurological implants, nerve stimulators, various cardiac implants and equivalent medical devices.
  • implanted medical devices such as drug pumps, neurological implants, nerve stimulators, various cardiac implants and equivalent medical devices.
  • embodiments described are compatible with remote patient management systems that interact with remote data and expert data centers and compatible with a data communication system that enables the transfer of clinical data from the patient to a remote location for evaluation, analysis, data reposition, and clinical evaluation.

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US09/740,127 1999-12-24 2000-12-18 Method and a system for using implanted medical device data for accessing therapies Abandoned US20020026223A1 (en)

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