WO2001047600A1 - A method and a system for using implanted medical device data for accessing therapies - Google Patents

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

Info

Publication number
WO2001047600A1
WO2001047600A1 PCT/US2000/034519 US0034519W WO0147600A1 WO 2001047600 A1 WO2001047600 A1 WO 2001047600A1 US 0034519 W US0034519 W US 0034519W WO 0147600 A1 WO0147600 A1 WO 0147600A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
data
medical device
implanted medical
data processor
Prior art date
Application number
PCT/US2000/034519
Other languages
French (fr)
Inventor
Kenneth M. Riff
Patrick M. Mahoney
Clifton W. Owens
Rahul Mehra
Michael F. Hess
Nirav V. Sheth
Nancy Perry Pool
Michael R. Ujhelyi
Original Assignee
Medtronic, 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.)
Filing date
Publication date
Application filed by Medtronic, Inc. filed Critical Medtronic, Inc.
Priority to EP00986583A priority Critical patent/EP1242146A1/en
Publication of WO2001047600A1 publication Critical patent/WO2001047600A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37258Alerting the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37254Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT 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
    • G16H40/60ICT 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
    • G16H40/63ICT 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
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT 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
    • G16H40/60ICT 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
    • G16H40/67ICT 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031Implanted circuitry
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00ICT 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.
  • 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 modern 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 IMD patient to a data processor capable of processing IMD related data in accordance with an example embodiment of the invention
  • FIG. IB 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. While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
  • 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.
  • a device guided antiarrhythmic therapy would allow patients to use drug therapy based upon implanted device notification rather than having to seek medical attention for recurring arrhythmic events.
  • One of the capabilities provided by the present invention is that of arrhythmic detection with programmable notification tailored to specific drug therapies. Accurate detection of atrial fibrillation is a component of a properly operating patient notification device and IMD therapy implementation system.
  • 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. 1 A 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 IMD.
  • the link can also be established, for example, with radio frequency signal based telemetry.
  • IMD 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 1 12, 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 IMD.
  • 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 118A and a memory arrangement 118B as well as an audio signal arrangement (not shown) for emitting sounds that are audible by a patient having IMD 102
  • 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
  • the patient initiates a patient query to determine IMD status
  • PMS 118 generates at least one suggested therapy (medicinal and/or electrical pulse) that is displayed on display 1 19 and that is be exercised or administered primarily by the patient
  • 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
  • a communications link is first established between IMD 102 and IMD data processor 108 via IMD port interface 104
  • the communications link is established directly between the IMD and data processor 118A 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 IMD 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 1 18A communications with the patient is initiated by either the patient or by PMS 118 where a heart condition is detected
  • 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 at ⁇ al 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
  • 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 Tl and/or that the Burden has exceeded a certain Burden limit value (B limit) and that it is time to
  • the patient is notified by PMS 118 that the time duration has exceed a time value of T2, or a burden limit (or any other criteria that is a function of AF duration)
  • 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.
  • 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 T3.
  • 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 1 18 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 1 18 notifies the patient that heart failure is beginning due to a prolonged AF condition. In one example, a sensor input that detects heart failure communicates the condition to PMS 1 18 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 1 18 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 1 18.
  • 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.
  • EMD 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 1 17 sent by IMD data processor 108 via interface 104 to PMS 1 18.
  • 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).
  • AF Atrial fibrillation
  • 230 patient alert for anticoagulation
  • 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 1 18 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 If so, at 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)
  • 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 defibrill
  • system 100 along with PMS 1 18 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 1 18, 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 If the ventricular response is not in the criteria zone, at step 248 the patient is notified that the ventricular response is normal
  • 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
  • AF is present
  • 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 w ⁇ stwatch 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)
  • 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
  • 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 IMD 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
  • 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, MI (Myocardial
  • 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.
  • the 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.

Abstract

A method and system facilitates the access by a patient of implanted medical device related data for patient participation in their own clinical care and therapy. In an example embodiment, 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 patient diagnostic data. Data received from the secured database is then displayed for use in a patient evaluation.

Description

A METHOD AND A SYSTEM FOR USING IMPLANTED MEDICAL DEVICE DATA FOR ACCESSING THERAPIES
FIELD OF THE INVENTION
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.
BACKGROUND OF THE INVENTION
In recent years, 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. In a pacemaker system, for example, a programmer device downloads to an implanted pacemaker data such as operating parameters. Likewise, 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. Currently 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. Thus, 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, and 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 modern 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.
Emergency trips to the hospital or clinic also increase the cost of healthcare due to lack of early detection of heart conditions, such as arrhythmias, that are treatable with less invasive practices such as medicinally, if the condition is detected on a timely basis. As the heart condition worsens, the need for physician intervention and long term hospitalization and medication increases. Current detectors of heart conditions, such as arrhythmia detectors, are available but these devices suffer from the shortcomings of external monitoring devices. The difficulties of patients to educate and inform themselves about medical devices prospectively or devices implanted in them, outside of the confines of the hospital, and to participate in their own clinical care and therapy by learning of the latest developments in this area are additional factors that contribute to the increasing costs of healthcare. SUMMARY OF THE INVENTION
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.
In various embodiments 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. In addition, 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. In another aspect of the invention, IMD patients have access to a web-based data management system for IMDs for accessing various clinical and therapy alternatives and related information/services. According to one embodiment of the invention, 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.
According to another embodiment of the invention, 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.
The above summary of the present invention is not intended to describe each illustrated embodiment or every implementation of the present invention. The figures in the detailed description that follow more particularly exemplify these embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
FIG. 1A illustrates a block diagram of a system for facilitating the access by an IMD patient to a data processor capable of processing IMD related data in accordance with an example embodiment of the invention;
FIG. IB 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; and
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. While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
DETAELED DESCRIPTION
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.
Early patient notification of various heart conditions can empower a patient to take direct action regarding management of the identified heart condition. In the case of arrhythmias, a device guided antiarrhythmic therapy would allow patients to use drug therapy based upon implanted device notification rather than having to seek medical attention for recurring arrhythmic events. One of the capabilities provided by the present invention is that of arrhythmic detection with programmable notification tailored to specific drug therapies. Accurate detection of atrial fibrillation is a component of a properly operating patient notification device and IMD therapy implementation system.
In an example embodiment, 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.
Referring now to the figures, FIG. 1 A 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 IMD. The link can also be established, for example, with radio frequency signal based telemetry. IMD interface 104 includes features of a programming head or wand that is incorporated into a programming unit for detecting and transmitting IMD diagnostic data. In another embodiment, 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 1 12, 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 IMD. 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.
In this example embodiment, 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 118A and a memory arrangement 118B 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 In one example embodiment, 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 1 19 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 By using PMS 1 18, 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 In addition, 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, which is proximate to IMD 102 (via a wrist worn device or a personal digital assistant type device), 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 defibπllation 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
Referring again to FIG 1 A, a communications link is first established between IMD 102 and IMD data processor 108 via IMD port interface 104 In a related embodiment, the communications link is established directly between the IMD and data processor 118A 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 IMD data processor 108, is then accessed by using a set of patient identification data
In this example embodiment, 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 In another example embodiment, processor 1 18A communications with the patient is initiated by either the patient or by PMS 118 where a heart condition is detected In this example, 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 Once the link with the IMD data processor 108 (or PMS 118) is established, patient diagnostic data is uphnked to the IMD data processor (or PMS 1 18) 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 In an example embodiment, the data response is displayed on display 1 19 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)
Referring now to FIG IB, 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 In general, the system guided drug therapy process is illustrated is programmable and is intended to interact and communicate with external messaging systems In a related embodiment, a patient activator (not shown) communicates with PMS 118 to properly time electrical therapies with medication therapies In this example embodiment, at step 142 atπal 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 At step 143 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 At step 144, PMS 118 advises patient that AF has exceeded a time value of Tl and/or that the Burden has exceeded a certain Burden limit value (B limit) and that it is time to initiate therapy In this example, the patient is alerted by an alarm signal coming from PMS 118 and is instructed at step 146, via an alphanumeric message on display 1 19, as to his treatment options In this example, his treatment options include either drugs or pacing options or a combination of both Two way communications already having been established as discussed earlier, the patient exercises one of the treatment options and advises PMS 1 18 of the treatment option exercised At step 148, PMS 1 18 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
At step 150, the patient is notified by PMS 118 that the time duration has exceed a time value of T2, or a burden limit (or any other criteria that is a function of AF duration) At 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.
At step 154, PMS 118 notifies the patient that the ventricular rate metric has exceeded a time value of T3. At step 156, 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 1 18 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. At step 158, PMS 1 18 notifies the patient that heart failure is beginning due to a prolonged AF condition. In one example, a sensor input that detects heart failure communicates the condition to PMS 1 18 in order that the patient is alerted of this condition. At step 160, 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 1 18 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. In all of the embodiments described, the patient has the choice of taking control of his own therapy with the guidance and regular feedback (via two-way communication) of PMS 1 18.
Referring now to FIG. 2, 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. At step 202, EMD 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. In another example embodiment, the audible sound is prompted by a notification signal 1 17 sent by IMD data processor 108 via interface 104 to PMS 1 18. In this example embodiment, 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). Depending on the detected condition, a different path is followed by the IMD patient in administering therapy with the assistance of PMS 1 18 and system 100 In one example, the patient is notified via PMS 118 to take a medication 206 and to advise PMS 118 when the medication has been taken At step 208, a determination is made whether the AF is still present If not, at step 210 the patient is notified that AF is terminated If so, at step 212 the patient is advised accordingly and another set of therapy options is communicated to the patient Depending on the programming of PMS 1 18, 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) At 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 In another embodiment, programmable PMS 118 instructs the patient to perform electrical therapies in order to terminate the arrhythmia If this approach is not successful PMS 1 18 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 1 18 (or other display methods) regarding medication efficacy
Referring to step 230 of FIG 2, system 100 along with PMS 1 18 is helpful in assisting in the management of anticoagulation therapy At step 232, 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
Referring to step 240, 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 1 18, at step 242, to intermittently use rate control medications At step 244, 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 If the ventricular response is not in the criteria zone, at step 248 the patient is notified that the ventricular response is normal At 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 In this example embodiment, for patients with chronic AF with accelerated (or breakthrough) fast ventricular response,
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 In another embodiment, 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 Reveal™, 2) implementing pacing backup for drug-induced bardycardia, 3) implementing pacing backup with antitachycardia (AT500™), or 4) implementing pacing backup, antitachycardia pacing and defibrillation (Jewel AF™) PMS 118, in one embodiment, is a handheld device using standard telemetry communications protocols or a wπstwatch 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 With the present invention, 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 In addition, quantifying the daily AF burden and ventricular response can guide usage of anticoagulation and rate control drug Moreover such diagnosis and patient awareness will document drug therapy efficacy on a real time basis By diagnosing on a timely basis a patient's heart condition, such as an arrhythmia, undesirable consequences such as chronic AF, congestive heart failure or thromboembohc 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 With improved arrhythmia management provided by the present invention 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
In this example embodiment, 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 IMD 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 In one example, current diagnostic data is compared with the patient's historical information stored in database 109 In another example, 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 In another embodiment, 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
As illustrated in FIG 3, 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, MI (Myocardial
Infarction) and SCD (Sudden Cardiac Death) detection and prediction 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 For example, 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. In addition, the 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. Various modifications, equivalent processes, as well as numerous structures to which the present invention may be applicable will be readily apparent to those of skill in the art to which the present invention is directed upon review of the present specification. The claims are intended to cover such modifications and devices.

Claims

WE CLAIM
1 A method for accessing implanted medical device for patient alert and therapy dispensation data comprising establishing a communications link between an implanted medical device and a data processor via an implanted medical device interface, obtaining access to a secured database via the data processor using a set of patient identification data, submitting via the data processor a query to the secured database in response to input patient diagnostic data, and displaying the data received from the secured database for use in a patient evaluation
2 The method of claim 1 , wherein the step of submitting the query includes the step of detecting via the data processor at least one of a plurality of predefined conditions of the patient's implanted medical device, and generating a data response as a function of the detected conditions
3 The method of claim 2, wherein the step of detecting a condition includes the steps of performing an uplink transmission of a set of patient diagnostic data from the implanted medical device to the data processor, and processing the patient diagnostic data to detect at least one of the plurality of conditions
4 The method of claim 2, further comprising the steps of notifying the patient via the data processor of the detected condition, monitoring the implanted medical device, and displaying a first implanted medical device status
5 The method of claim 4, further comprising displaying a first set of treatment options as a function of the first implanted medical device status and of the patient notification, and exercising at least one of the treatment options
6 The method of claim 5, wherein displaying treatment options includes displaying at least one medical option along with a time interval for exercising the displayed option
7 The method of claim 5, wherein the treatment options are selected from the group consisting of medication, electrical impulse from the implanted medical device, and a request for medical assistance
8 The method of claim 5, further comprising the step of notifying the data processor of the exercised treatment option
9 The method of claim 8, further comprising the steps of monitoring the implanted device continuously after notification of exercise of the displayed option, and notifying the patient of a second medical device status and of a second set of treatment options, the second set of treatment options being a function of the exercised option and the second medical device status
10 The method of claim 4, further comprising the step of reconfiguring patient notification of the detected condition such that the patient notification is responsive to a second plurality of conditions
1 1 The method of claim 1, wherein obtaining access to the secured database includes obtaining access to a remotely located secured database via a communications network
12 The method of claim 1, wherein input patient diagnostic data includes an IMD patient request for information from the secured database
13 The method of claim 1, wherein the step of establishing a communications link includes automatically retrieving the set of patient identification data from the IMD
14 The method of claim 8, further comprising the step of reconfiguring the treatment options as a function of the exercised option and the IMD status
15 A system for accessing implanted medical device data comprising means for establishing a communications link between an implanted medical device and a data processor via an implanted medical device interface, means for obtaining access to a secured database via the data processor using a set of patient identification data, means for submitting via the data processor a query to the secured database in response to input patient diagnostic data, and means for displaying the data received from the secured database for use in a patient evaluation
16 The system of claim 15, wherein said display means includes an LCD, CRT and an LED screen adapted to display the data received
17 The system of claim 15, wherein the set of patient identification data includes an implanted medical device serial number
18 The system of claim 15, wherein the data received from the secured database includes a set of implanted medical device treatment options
19 The system of claim 18, further comprising means for notifying a patient of the detection of a heart condition at the implanted medical device coupled to the data processor and display means, the data processor configured and arranged to receive notification of an exercise of a treatment option
20 A system of claim 19, wherein the data processor is adapted to reconfigure the treatment options as a function of the exercised option and the IMD status.
21 A method for accessing implanted medical device data comprising establishing a communications link between an implanted medical device and a data processor via an implanted medical device interface, obtaining access to a secured database via the data processor using a set of patient identification data, transmitting a set of patient diagnostic data from the implanted medical device to the data processor, submitting via the data processor a query to the secured database in response to detecting a condition at the implanted medical device from the patient diagnostic data, and displaying the data received from the secured database for use in a patient evaluation
22 The method of claim 21 , wherein the step of submitting the query includes the step of detecting via the data processor at least one of a plurality of predefined conditions of the patient's implanted medical device, and generating a data response as a function of the detected conditions
23 The method of claim 22, further comprising the steps of notifying the patient via the data processor of the detected condition, monitoring the implanted medical device, and displaying a first implanted medical device status
24 The method of claim 23, further comprising the steps of displaying a first set of treatment options as a function of the first implanted medical device status, exercising at least one of the treatment options, notifying the data processor of the exercised treatment option, monitoring continuously the implanted device; and notifying the patient of a second medical device status and of a second set of treatment options, the second set of treatment options being a function of the exercised option and the second medical device status.
25. A method for accessing implanted medical device data comprising: establishing a communications link between an implanted medical device and a data processor via an implanted medical device interface; obtaining access to a secured database provided via the data processor using a set of patient identification data; transmitting a set of patient diagnostic data from the implanted medical device to the data processor; generating a set of formatted data via the data processor using the patient diagnostic data as a function of a data request from the patient; and displaying the set of formatted data received from the secured database via the data processor for use in a patient evaluation.
26. A method of claim 25, wherein generating the formatted data includes extracting a set of historical patient diagnostic data from the secured database.
27. The method of claim 26, further comprising the step of using the communications link between the implanted medical device and the data processor to address a patient query on the formatted data after the formatted data has been displayed.
28. The method of claim 26, further comprising the step of establishing a communications link with a patient having the implanted medical device to provide an interactive exchange of information with a data processing center located remote from the patient.
29. The method of claim 25, wherein the step of generating the formatted data includes the step of formatting the patient diagnostic data to illustrate a trend.
30. A system for accessing implanted medical device data comprising: means for establishing a communications link between an implanted medical device and a data processor via an implanted medical device interface; means for obtaining access to a secured database via the data processor using a set of patient identification data; means for transmitting a set of patient diagnostic data from the implanted medical device to the data processor; means for generating a set of formatted data via the data processor using the patient diagnostic data as a function of a data request from the patient; and means for displaying the set of formatted data from the implanted medical data processor for use in a patient evaluation.
31. A system for accessing implanted medical device data comprising: means for establishing a communications link between an implanted medical device and a data processor via an implanted medical device interface; means for obtaining access to a secured database via the data processor using a set of patient identification data; means for transmitting a set of patient diagnostic data from the implanted medical device to the data processor; means for submitting via the data processor a query to the secured database in response to detecting a condition at the implanted medical device from the patient diagnostic data; and means for displaying the data received from the secured database for use in a patient evaluation.
AMENDED CLAIMS
[received by the International Bureau on 1 June 2001 (01.06.01); original claims 1-31 replaced by new claims 1-15 (3 pages)]
1. A system for patient-guided delivery of therapy for a medical condition having an implantable medical device (IMD) (102) accessible by an external interface unit
(104) that communicates over a communications link (106) with a data processing facility having a secure data base (109) accessed using- patient identification data, characterized in that a patient messaging system (118) is. coupled to the IMD and to the data processing facility to provide data for detecting and assessing a medical condition of the patient and to obtain therapy data that is a function of the medical condition far use in guiding the patient in delivering a therapy.
2. The system of claim 1 wherein the communication -link (106) is Internet-based and the data processing facility is accessed by a page of an Internet website.
3. The system of claim 1 wherein the external interface unit (104) is a programmer.
4. The system of claim 1 wherein the patient messaging system is a personal digital assistant
5. The system of claim 1 wherein the implantable medical device (IMD) is a device selected from a group consisting of a cardiac . pacemaker or a cardiac defibrillator.
6. The system of claim 5 wherein the communications link provides for up- linking diagnostic data from the IMD for evaluation of the patient's heart condition.
7. The system of claim 6 wherein the data processing facility includes a data processor (108) generating a data response as a function of a detected heart condition for display on the patient messaging system.
8. The system of claim 6 wherein the external interface unit is a programmer and the data processing facility includes a data processor (108) generating a data response as a function of a detected heart condition for routing to ,the programmer to provide programming data for the MD.
9. The system of claim 1 wherein the patient messaging system displays treatment options.
10. The system of claim 9 wherein the patient messaging system communicates a selected treatment option to the data processing facility.
11. The system of claim 1 wherein the patient messaging system operates in a mode providing an interactive exchange of information with the data processing facility.
12. A method for patient-guided delivery of therapy for a medical condition of a patient having an implantable medical device (IMD) comprises: accessing the IMD using an external interface unit; establishing a communication link between the external interface unit and a data processing facility having a secure data base; accessing the data processing facility using patient identification data; providing data to the data processing facility for detecting and assessing a medical condition of the patient; generating therapy data that is a function of the medical condition for use in guiding a patient in delivering a therapy; and displaying the therapy data to the patient.
13. The method of claim 12 wherein the implantablei medical device (MD) is a device selected from a group consisting of a cardia- pacemaker or a cardiac defibrillator.
14. The method of claim 13 wherein the therapy data ϊs generated as a function of a detected heart condition.
15. The method of claim 14 wherein the therapy data iricludes treatment options.
STATEMENT UNDER ARTICLE 19(1) The amendments provided by new claims 1-15 do neither alter the disclosure in the drawings nor introduce new matter.
The difference between the new claims 1-15 being presented and the original claims is that the subject matter of the invention is set forth in a more concise fashion and emphasizes the patient messaging system feature of the claimed system.
The new claims 1-15 are distinguished from the subject matter disclosed in the references cited in the International Search Report in that none of the citations discloses a
system wherein a patient messaging system is coupled to an IMD and to a data processing facility to provide data for detecting and assessing a medical condition of the patient and to obtain therapy data that is a function of the medical condition for use in guiding the patient in delivering a therapy.
The closest one of the cited reference is EP 1 057 448. This reference merely provides for the uplink over the Internet of diagnostic dau from an IMD to a data processing center having a database for diagnostic data collection purposes and feedback of a patient status indicator.
Accordingly, the cited reference either alone or in combination with the other references does not anticipate or render obvious the claimed elements of the present invention.
PCT/US2000/034519 1999-12-24 2000-12-19 A method and a system for using implanted medical device data for accessing therapies WO2001047600A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP00986583A EP1242146A1 (en) 1999-12-24 2000-12-19 A method and a system for using implanted medical device data for accessing therapies

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17306299P 1999-12-24 1999-12-24
US60/173,062 1999-12-24

Publications (1)

Publication Number Publication Date
WO2001047600A1 true WO2001047600A1 (en) 2001-07-05

Family

ID=22630370

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/034519 WO2001047600A1 (en) 1999-12-24 2000-12-19 A method and a system for using implanted medical device data for accessing therapies

Country Status (3)

Country Link
US (2) US20020026223A1 (en)
EP (1) EP1242146A1 (en)
WO (1) WO2001047600A1 (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004041352A1 (en) * 2002-10-31 2004-05-21 Medtronic, Inc. Distributed system for neurostimulation therapy programming
EP1480153A2 (en) * 2003-05-20 2004-11-24 Olympus Corporation Medical tool mangement and support system
WO2006050405A1 (en) * 2004-10-29 2006-05-11 Medtronic, Inc. Alert system and method for an implantable medical device
US7103578B2 (en) 2001-05-25 2006-09-05 Roche Diagnostics Operations, Inc. Remote medical device access
US7706889B2 (en) 2006-04-28 2010-04-27 Medtronic, Inc. Tree-based electrical stimulator programming
US8306624B2 (en) 2006-04-28 2012-11-06 Medtronic, Inc. Patient-individualized efficacy rating
US8380300B2 (en) 2006-04-28 2013-02-19 Medtronic, Inc. Efficacy visualization

Families Citing this family (137)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6976958B2 (en) 2000-12-15 2005-12-20 Q-Tec Systems Llc Method and apparatus for health and disease management combining patient data monitoring with wireless internet connectivity
US6602191B2 (en) * 1999-12-17 2003-08-05 Q-Tec Systems Llp Method and apparatus for health and disease management combining patient data monitoring with wireless internet connectivity
US7156809B2 (en) 1999-12-17 2007-01-02 Q-Tec Systems Llc Method and apparatus for health and disease management combining patient data monitoring with wireless internet connectivity
US20020026223A1 (en) * 1999-12-24 2002-02-28 Riff Kenneth M. Method and a system for using implanted medical device data for accessing therapies
US6328699B1 (en) * 2000-01-11 2001-12-11 Cedars-Sinai Medical Center Permanently implantable system and method for detecting, diagnosing and treating congestive heart failure
US7483743B2 (en) * 2000-01-11 2009-01-27 Cedars-Sinai Medical Center System for detecting, diagnosing, and treating cardiovascular disease
US8298150B2 (en) 2000-01-11 2012-10-30 Cedars-Sinai Medical Center Hemodynamic waveform-based diagnosis and treatment
US6622050B2 (en) * 2000-03-31 2003-09-16 Medtronic, Inc. Variable encryption scheme for data transfer between medical devices and related data management systems
US7860583B2 (en) 2004-08-25 2010-12-28 Carefusion 303, Inc. System and method for dynamically adjusting patient therapy
AU6172301A (en) 2000-05-18 2001-11-26 Alaris Meidical Systems Inc Distributed remote asset and medication management drug delivery system
US11087873B2 (en) * 2000-05-18 2021-08-10 Carefusion 303, Inc. Context-aware healthcare notification system
US9427520B2 (en) 2005-02-11 2016-08-30 Carefusion 303, Inc. Management of pending medication orders
US10062457B2 (en) 2012-07-26 2018-08-28 Carefusion 303, Inc. Predictive notifications for adverse patient events
US9741001B2 (en) 2000-05-18 2017-08-22 Carefusion 303, Inc. Predictive medication safety
US10353856B2 (en) 2011-03-17 2019-07-16 Carefusion 303, Inc. Scalable communication system
US7574368B2 (en) * 2000-12-15 2009-08-11 Ric Investments, Llc System and method for upgrading a pressure generating system
JP4498636B2 (en) 2001-04-27 2010-07-07 日本サーモスタット株式会社 Thermostat device
US7047076B1 (en) 2001-08-03 2006-05-16 Cardiac Pacemakers, Inc. Inverted-F antenna configuration for an implantable medical device
US6766198B1 (en) * 2001-08-09 2004-07-20 Pacesetter, Inc. System and method for providing patient status information during interrogation of an implantable cardiac stimulation device
US20030050566A1 (en) * 2001-09-07 2003-03-13 Medtronic, Inc. Arrhythmia notification
US6763269B2 (en) * 2001-11-02 2004-07-13 Pacesetter, Inc. Frequency agile telemetry system for implantable medical device
US7383088B2 (en) * 2001-11-07 2008-06-03 Cardiac Pacemakers, Inc. Centralized management system for programmable medical devices
US6985771B2 (en) * 2002-01-22 2006-01-10 Angel Medical Systems, Inc. Rapid response system for the detection and treatment of cardiac events
US20040122294A1 (en) 2002-12-18 2004-06-24 John Hatlestad Advanced patient management with environmental data
US7043305B2 (en) 2002-03-06 2006-05-09 Cardiac Pacemakers, Inc. Method and apparatus for establishing context among events and optimizing implanted medical device performance
US8391989B2 (en) 2002-12-18 2013-03-05 Cardiac Pacemakers, Inc. Advanced patient management for defining, identifying and using predetermined health-related events
US20040122486A1 (en) * 2002-12-18 2004-06-24 Stahmann Jeffrey E. Advanced patient management for acquiring, trending and displaying health-related parameters
US20040122296A1 (en) * 2002-12-18 2004-06-24 John Hatlestad Advanced patient management for triaging health-related data
US8043213B2 (en) * 2002-12-18 2011-10-25 Cardiac Pacemakers, Inc. Advanced patient management for triaging health-related data using color codes
US20040122487A1 (en) 2002-12-18 2004-06-24 John Hatlestad Advanced patient management with composite parameter indices
US7983759B2 (en) 2002-12-18 2011-07-19 Cardiac Pacemakers, Inc. Advanced patient management for reporting multiple health-related parameters
US7468032B2 (en) * 2002-12-18 2008-12-23 Cardiac Pacemakers, Inc. Advanced patient management for identifying, displaying and assisting with correlating health-related data
US7113825B2 (en) * 2002-05-03 2006-09-26 Cardiac Pacemakers, Inc. Method and apparatus for detecting acoustic oscillations in cardiac rhythm
FR2839650B1 (en) * 2002-05-17 2005-04-01 Ela Medical Sa TELEASSISTANCE SYSTEM FOR PROGRAMMING ACTIVE IMPLANTABLE MEDICAL DEVICES SUCH AS CARDIAC STIMULATORS, DEFIBRILLATORS, CARDIOVERTERS OR MULTISITE DEVICES
US20040049245A1 (en) * 2002-09-09 2004-03-11 Volker Gass Autonomous patch for communication with an implantable device, and medical kit for using said patch
US7972275B2 (en) * 2002-12-30 2011-07-05 Cardiac Pacemakers, Inc. Method and apparatus for monitoring of diastolic hemodynamics
US7378955B2 (en) 2003-01-03 2008-05-27 Cardiac Pacemakers, Inc. System and method for correlating biometric trends with a related temporal event
US20040172284A1 (en) * 2003-02-13 2004-09-02 Roche Diagnostics Corporation Information management system
US8116868B2 (en) * 2003-04-11 2012-02-14 Cardiac Pacemakers, Inc. Implantable device with cardiac event audio playback
US20040210273A1 (en) * 2003-04-18 2004-10-21 Medtronic, Inc. Presentation of patient image with implantable medical device information
US20040230456A1 (en) * 2003-05-14 2004-11-18 Lozier Luke R. System for identifying candidates for ICD implantation
US7539803B2 (en) * 2003-06-13 2009-05-26 Agere Systems Inc. Bi-directional interface for low data rate application
WO2005006969A1 (en) * 2003-07-16 2005-01-27 Koninklijke Philips Electronics N.V. A device and a computerized method arranged to enable a health-related coaching of an individual
US7206632B2 (en) * 2003-10-02 2007-04-17 Medtronic, Inc. Patient sensory response evaluation for neuromodulation efficacy rating
WO2005052717A2 (en) * 2003-11-26 2005-06-09 Bryan Sidders Information system
US8712510B2 (en) * 2004-02-06 2014-04-29 Q-Tec Systems Llc Method and apparatus for exercise monitoring combining exercise monitoring and visual data with wireless internet connectivity
WO2005062823A2 (en) * 2003-12-19 2005-07-14 Savacor, Inc. Digital electrode for cardiac rhythm management
US20050192649A1 (en) * 2004-02-27 2005-09-01 Cardiac Pacemakers, Inc. Systems and methods for providing variable medical information
US7751894B1 (en) * 2004-03-04 2010-07-06 Cardiac Pacemakers, Inc. Systems and methods for indicating aberrant behavior detected by an implanted medical device
US20050234307A1 (en) * 2004-04-15 2005-10-20 Nokia Corporation Physiological event handling system and method
US7324850B2 (en) * 2004-04-29 2008-01-29 Cardiac Pacemakers, Inc. Method and apparatus for communication between a handheld programmer and an implantable medical device
US20060074464A1 (en) * 2004-07-20 2006-04-06 Subera Steven J System and method for creating a customizable report of data from an implantable medical device
US7265676B2 (en) * 2004-07-20 2007-09-04 Medtronic, Inc. Alert system and method for an implantable medical device
CA2573785A1 (en) * 2004-07-20 2006-02-02 Medtronic, Inc. Therapy programming guidance based on stored programming history
US7819909B2 (en) * 2004-07-20 2010-10-26 Medtronic, Inc. Therapy programming guidance based on stored programming history
US20060074519A1 (en) * 2004-08-27 2006-04-06 Barker Kenneth N Medication accuracy comparison system
US20060149330A1 (en) * 2004-12-30 2006-07-06 Brian Mann Digitally controlled cardiac rhythm management
US20060149324A1 (en) * 2004-12-30 2006-07-06 Brian Mann Cardiac rhythm management with interchangeable components
US7662104B2 (en) 2005-01-18 2010-02-16 Cardiac Pacemakers, Inc. Method for correction of posture dependence on heart sounds
US7922669B2 (en) 2005-06-08 2011-04-12 Cardiac Pacemakers, Inc. Ischemia detection using a heart sound sensor
US8251904B2 (en) * 2005-06-09 2012-08-28 Roche Diagnostics Operations, Inc. Device and method for insulin dosing
US20070032345A1 (en) * 2005-08-08 2007-02-08 Ramanath Padmanabhan Methods and apparatus for monitoring quality of service for an exercise machine communication network
US20080288023A1 (en) * 2005-08-31 2008-11-20 Michael Sasha John Medical treatment using patient states, patient alerts, and hierarchical algorithms
US8965509B2 (en) 2005-08-31 2015-02-24 Michael Sasha John Methods and systems for semi-automatic adjustment of medical monitoring and treatment
US9089713B2 (en) * 2005-08-31 2015-07-28 Michael Sasha John Methods and systems for semi-automatic adjustment of medical monitoring and treatment
US8108034B2 (en) 2005-11-28 2012-01-31 Cardiac Pacemakers, Inc. Systems and methods for valvular regurgitation detection
US20070168227A1 (en) * 2006-01-06 2007-07-19 Fleming Joseph E System and Method for Automated Screening of Individuals for Various Weight Loss Treatment Options
US9549688B2 (en) * 2006-04-24 2017-01-24 Medtronic, Inc. Implantable medical device detection
US20070288266A1 (en) * 2006-06-02 2007-12-13 Suzanne Sysko System and methods for chronic disease management and health assessment
WO2008008009A1 (en) 2006-07-13 2008-01-17 St. Jude Medical Ab Medical information management in a patient information hub system
WO2008103827A1 (en) 2007-02-22 2008-08-28 Welldoc Communications, Inc. System and method for providing treatment recommendations based on models
US10860943B2 (en) 2007-02-22 2020-12-08 WellDoc, Inc. Systems and methods for disease control and management
US10872686B2 (en) 2007-02-22 2020-12-22 WellDoc, Inc. Systems and methods for disease control and management
US8170609B2 (en) * 2007-06-20 2012-05-01 Qualcomm Incorporated Personal virtual assistant providing advice to a user regarding physiological information received about the user
EP2060296B1 (en) * 2007-11-19 2016-08-24 Hollister Incorporated Vapor hydrated catheter assembly and method of making same
US20090150877A1 (en) * 2007-12-07 2009-06-11 Roche Diagnostics Operations, Inc. Data driven communication protocol grammar
JP2011512945A (en) * 2008-02-27 2011-04-28 アビ リブナット, Atrial defibrillation using an implantable defibrillation system
US20100010832A1 (en) * 2008-07-09 2010-01-14 Willem Boute System and Method for The Diagnosis and Alert of A Medical Condition Initiated By Patient Symptoms
EP2389207B1 (en) * 2009-01-22 2016-12-14 Medtronic, Inc. User interface indicating fluid location for an implantable fluid delivery device
EP2389640A2 (en) * 2009-01-22 2011-11-30 Medtronic, Inc. User interface that displays pending and selected programming for an implantable medical device
US9122785B2 (en) * 2009-01-22 2015-09-01 Medtronic, Inc. Display of supplemental bolus in relation to programmed dose
US8890681B2 (en) * 2009-04-17 2014-11-18 Medtronic, Inc. Management of session history data for implantable fluid delivery device
US20110257710A1 (en) * 2010-04-20 2011-10-20 Boston Scientific Neuromodulation Corporation Method and apparatus for alerting a user of neurostimulation lead migration
JP2013529508A (en) * 2010-06-25 2013-07-22 ラファエル デベロップメント コーポレイション リミテッド Pulse parameters and electrode configuration to reduce patient discomfort from defibrillation
US9037477B2 (en) * 2010-10-08 2015-05-19 Cardiac Science Corporation Computer-implemented system and method for evaluating ambulatory electrocardiographic monitoring of cardiac rhythm disorders
US8613708B2 (en) 2010-10-08 2013-12-24 Cardiac Science Corporation Ambulatory electrocardiographic monitor with jumpered sensing electrode
US8239012B2 (en) 2010-10-08 2012-08-07 Cardiac Science Corporation Microcontrolled electrocardiographic monitoring circuit with differential voltage encoding
US20120089000A1 (en) 2010-10-08 2012-04-12 Jon Mikalson Bishay Ambulatory Electrocardiographic Monitor For Providing Ease Of Use In Women And Method Of Use
US11182728B2 (en) 2013-01-30 2021-11-23 Carefusion 303, Inc. Medication workflow management
US10430554B2 (en) 2013-05-23 2019-10-01 Carefusion 303, Inc. Medication preparation queue
WO2014159280A1 (en) 2013-03-13 2014-10-02 Carefusion 303, Inc. Patient-specific medication management system
EP2973370A4 (en) 2013-03-13 2016-08-17 Carefusion 303 Inc Predictive medication safety
US20140275827A1 (en) * 2013-03-14 2014-09-18 Pacesetter, Inc. Method and system for deriving effectiveness of medical treatment of a patient
US9619660B1 (en) 2013-09-25 2017-04-11 Bardy Diagnostics, Inc. Computer-implemented system for secure physiological data collection and processing
US9615763B2 (en) 2013-09-25 2017-04-11 Bardy Diagnostics, Inc. Ambulatory electrocardiography monitor recorder optimized for capturing low amplitude cardiac action potential propagation
US9700227B2 (en) 2013-09-25 2017-07-11 Bardy Diagnostics, Inc. Ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation
US10251576B2 (en) 2013-09-25 2019-04-09 Bardy Diagnostics, Inc. System and method for ECG data classification for use in facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer
US10667711B1 (en) 2013-09-25 2020-06-02 Bardy Diagnostics, Inc. Contact-activated extended wear electrocardiography and physiological sensor monitor recorder
US20190167139A1 (en) 2017-12-05 2019-06-06 Gust H. Bardy Subcutaneous P-Wave Centric Insertable Cardiac Monitor For Long Term Electrocardiographic Monitoring
US9408551B2 (en) 2013-11-14 2016-08-09 Bardy Diagnostics, Inc. System and method for facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer
US10624551B2 (en) 2013-09-25 2020-04-21 Bardy Diagnostics, Inc. Insertable cardiac monitor for use in performing long term electrocardiographic monitoring
US9655537B2 (en) 2013-09-25 2017-05-23 Bardy Diagnostics, Inc. Wearable electrocardiography and physiology monitoring ensemble
US9545204B2 (en) 2013-09-25 2017-01-17 Bardy Diagnostics, Inc. Extended wear electrocardiography patch
US9504423B1 (en) 2015-10-05 2016-11-29 Bardy Diagnostics, Inc. Method for addressing medical conditions through a wearable health monitor with the aid of a digital computer
US11723575B2 (en) 2013-09-25 2023-08-15 Bardy Diagnostics, Inc. Electrocardiography patch
US9717432B2 (en) 2013-09-25 2017-08-01 Bardy Diagnostics, Inc. Extended wear electrocardiography patch using interlaced wire electrodes
US10433751B2 (en) 2013-09-25 2019-10-08 Bardy Diagnostics, Inc. System and method for facilitating a cardiac rhythm disorder diagnosis based on subcutaneous cardiac monitoring data
US10463269B2 (en) 2013-09-25 2019-11-05 Bardy Diagnostics, Inc. System and method for machine-learning-based atrial fibrillation detection
US10165946B2 (en) 2013-09-25 2019-01-01 Bardy Diagnostics, Inc. Computer-implemented system and method for providing a personal mobile device-triggered medical intervention
US9717433B2 (en) 2013-09-25 2017-08-01 Bardy Diagnostics, Inc. Ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation
US10888239B2 (en) 2013-09-25 2021-01-12 Bardy Diagnostics, Inc. Remote interfacing electrocardiography patch
US10806360B2 (en) 2013-09-25 2020-10-20 Bardy Diagnostics, Inc. Extended wear ambulatory electrocardiography and physiological sensor monitor
US10799137B2 (en) 2013-09-25 2020-10-13 Bardy Diagnostics, Inc. System and method for facilitating a cardiac rhythm disorder diagnosis with the aid of a digital computer
US9737224B2 (en) 2013-09-25 2017-08-22 Bardy Diagnostics, Inc. Event alerting through actigraphy embedded within electrocardiographic data
US9364155B2 (en) 2013-09-25 2016-06-14 Bardy Diagnostics, Inc. Self-contained personal air flow sensing monitor
US10820801B2 (en) 2013-09-25 2020-11-03 Bardy Diagnostics, Inc. Electrocardiography monitor configured for self-optimizing ECG data compression
US9408545B2 (en) 2013-09-25 2016-08-09 Bardy Diagnostics, Inc. Method for efficiently encoding and compressing ECG data optimized for use in an ambulatory ECG monitor
US9775536B2 (en) 2013-09-25 2017-10-03 Bardy Diagnostics, Inc. Method for constructing a stress-pliant physiological electrode assembly
US9345414B1 (en) 2013-09-25 2016-05-24 Bardy Diagnostics, Inc. Method for providing dynamic gain over electrocardiographic data with the aid of a digital computer
US9655538B2 (en) 2013-09-25 2017-05-23 Bardy Diagnostics, Inc. Self-authenticating electrocardiography monitoring circuit
US9433380B1 (en) 2013-09-25 2016-09-06 Bardy Diagnostics, Inc. Extended wear electrocardiography patch
US10736529B2 (en) 2013-09-25 2020-08-11 Bardy Diagnostics, Inc. Subcutaneous insertable electrocardiography monitor
WO2015048194A1 (en) 2013-09-25 2015-04-02 Bardy Diagnostics, Inc. Self-contained personal air flow sensing monitor
US10736531B2 (en) 2013-09-25 2020-08-11 Bardy Diagnostics, Inc. Subcutaneous insertable cardiac monitor optimized for long term, low amplitude electrocardiographic data collection
US9433367B2 (en) 2013-09-25 2016-09-06 Bardy Diagnostics, Inc. Remote interfacing of extended wear electrocardiography and physiological sensor monitor
US10433748B2 (en) 2013-09-25 2019-10-08 Bardy Diagnostics, Inc. Extended wear electrocardiography and physiological sensor monitor
US11213237B2 (en) 2013-09-25 2022-01-04 Bardy Diagnostics, Inc. System and method for secure cloud-based physiological data processing and delivery
USD744659S1 (en) 2013-11-07 2015-12-01 Bardy Diagnostics, Inc. Extended wear electrode patch
USD801528S1 (en) 2013-11-07 2017-10-31 Bardy Diagnostics, Inc. Electrocardiography monitor
USD892340S1 (en) 2013-11-07 2020-08-04 Bardy Diagnostics, Inc. Extended wear electrode patch
USD717955S1 (en) 2013-11-07 2014-11-18 Bardy Diagnostics, Inc. Electrocardiography monitor
USD831833S1 (en) 2013-11-07 2018-10-23 Bardy Diagnostics, Inc. Extended wear electrode patch
USD793566S1 (en) 2015-09-10 2017-08-01 Bardy Diagnostics, Inc. Extended wear electrode patch
USD766447S1 (en) 2015-09-10 2016-09-13 Bardy Diagnostics, Inc. Extended wear electrode patch
US11696681B2 (en) 2019-07-03 2023-07-11 Bardy Diagnostics Inc. Configurable hardware platform for physiological monitoring of a living body
US11096579B2 (en) 2019-07-03 2021-08-24 Bardy Diagnostics, Inc. System and method for remote ECG data streaming in real-time
US11116451B2 (en) 2019-07-03 2021-09-14 Bardy Diagnostics, Inc. Subcutaneous P-wave centric insertable cardiac monitor with energy harvesting capabilities

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5113869A (en) * 1990-08-21 1992-05-19 Telectronics Pacing Systems, Inc. Implantable ambulatory electrocardiogram monitor
WO1996011722A1 (en) * 1994-10-12 1996-04-25 Ael Industries, Inc. Telemetry system for an implanted device
US5720770A (en) * 1995-10-06 1998-02-24 Pacesetter, Inc. Cardiac stimulation system with enhanced communication and control capability
US5752976A (en) * 1995-06-23 1998-05-19 Medtronic, Inc. World wide patient location and data telemetry system for implantable medical devices
WO2000030529A1 (en) * 1998-11-24 2000-06-02 Medtronic, Inc. World wide patient location and data telemetry system for implantable medical devices
EP1057448A1 (en) * 1999-06-03 2000-12-06 Gust H. Bardy System and method for automated collection and analysis of regularly retrieved patient information for remote patient care

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269301A (en) * 1987-10-06 1993-12-14 Leonard Bloom Multimode system for monitoring and treating a malfunctioning heart
US4930604A (en) * 1988-10-31 1990-06-05 United Technologies Corporation Elevator diagnostic monitoring apparatus
US5311449A (en) * 1991-03-25 1994-05-10 Angeion Corporation Sterilizable hand-held programmer/interrogator
US5490862A (en) * 1991-04-12 1996-02-13 Adams; John M. Atrial defibrillator having patient activated modality
US5366896A (en) * 1991-07-30 1994-11-22 University Of Virginia Alumni Patents Foundation Robotically operated laboratory system
US5437278A (en) * 1992-01-10 1995-08-01 Wilk; Peter J. Medical diagnosis system and method
US5330513A (en) * 1992-05-01 1994-07-19 Medtronic, Inc. Diagnostic function data storage and telemetry out for rate responsive cardiac pacemaker
US5714726A (en) * 1992-12-22 1998-02-03 Kone Oy Method for performing an alarm call in an elevator system
JP3202396B2 (en) * 1993-03-26 2001-08-27 株式会社日立ビルシステム Elevator abnormality analysis data collection device
US5925066A (en) * 1995-10-26 1999-07-20 Galvani, Ltd. Atrial arrythmia sensor with drug and electrical therapy control apparatus
JP3083465B2 (en) * 1995-09-06 2000-09-04 フクダ電子株式会社 Patient information analysis management system and method
US5713937A (en) * 1995-11-07 1998-02-03 Pacesetter, Inc. Pacemaker programmer menu with selectable real or simulated implant data graphics
US5697959A (en) * 1996-01-11 1997-12-16 Pacesetter, Inc. Method and system for analyzing and displaying complex pacing event records
US5693076A (en) * 1996-01-16 1997-12-02 Medtronic, Inc. Compressed patient narrative storage in and full text reconstruction from implantable medical devices
US5792205A (en) * 1996-10-21 1998-08-11 Intermedics, Inc. Cardiac pacemaker with bidirectional communication
US5999851A (en) * 1998-04-15 1999-12-07 Cardiac Pacemakers, Inc. Atrial defibrillation system having patient selectable atrial fibrillation detection
US6250309B1 (en) * 1999-07-21 2001-06-26 Medtronic Inc System and method for transferring information relating to an implantable medical device to a remote location
US6687547B2 (en) * 1999-09-14 2004-02-03 Medtronic, Inc. Method and apparatus for communicating with an implantable medical device with DTMF tones
US6442433B1 (en) * 1999-10-26 2002-08-27 Medtronic, Inc. Apparatus and method for remote troubleshooting, maintenance and upgrade of implantable device systems
DE10053118A1 (en) * 1999-10-29 2001-05-31 Medtronic Inc Remote self-identification apparatus and method for components in medical device systems
US6363282B1 (en) * 1999-10-29 2002-03-26 Medtronic, Inc. Apparatus and method to automatic remote software updates of medical device systems
US6411851B1 (en) * 1999-11-04 2002-06-25 Medtronic, Inc. Implantable medical device programming apparatus having an auxiliary component storage compartment
US6386882B1 (en) * 1999-11-10 2002-05-14 Medtronic, Inc. Remote delivery of software-based training for implantable medical device systems
US6418346B1 (en) * 1999-12-14 2002-07-09 Medtronic, Inc. Apparatus and method for remote therapy and diagnosis in medical devices via interface systems
US6497655B1 (en) * 1999-12-17 2002-12-24 Medtronic, Inc. Virtual remote monitor, alert, diagnostics and programming for implantable medical device systems
US20020026223A1 (en) * 1999-12-24 2002-02-28 Riff Kenneth M. Method and a system for using implanted medical device data for accessing therapies

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5113869A (en) * 1990-08-21 1992-05-19 Telectronics Pacing Systems, Inc. Implantable ambulatory electrocardiogram monitor
WO1996011722A1 (en) * 1994-10-12 1996-04-25 Ael Industries, Inc. Telemetry system for an implanted device
US5752976A (en) * 1995-06-23 1998-05-19 Medtronic, Inc. World wide patient location and data telemetry system for implantable medical devices
US5720770A (en) * 1995-10-06 1998-02-24 Pacesetter, Inc. Cardiac stimulation system with enhanced communication and control capability
WO2000030529A1 (en) * 1998-11-24 2000-06-02 Medtronic, Inc. World wide patient location and data telemetry system for implantable medical devices
EP1057448A1 (en) * 1999-06-03 2000-12-06 Gust H. Bardy System and method for automated collection and analysis of regularly retrieved patient information for remote patient care

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7103578B2 (en) 2001-05-25 2006-09-05 Roche Diagnostics Operations, Inc. Remote medical device access
US7933656B2 (en) 2002-10-31 2011-04-26 Medtronic, Inc. Distributed system for neurostimulation therapy programming
US8214051B2 (en) 2002-10-31 2012-07-03 Medtronic, Inc. Distributed system for neurostimulation therapy programming
WO2004041352A1 (en) * 2002-10-31 2004-05-21 Medtronic, Inc. Distributed system for neurostimulation therapy programming
US7181286B2 (en) 2002-10-31 2007-02-20 Medtronic, Inc. Distributed system for neurostimulation therapy programming
EP1480153A3 (en) * 2003-05-20 2012-01-18 Olympus Corporation Medical tool mangement and support system
EP1480153A2 (en) * 2003-05-20 2004-11-24 Olympus Corporation Medical tool mangement and support system
WO2006050405A1 (en) * 2004-10-29 2006-05-11 Medtronic, Inc. Alert system and method for an implantable medical device
US7715920B2 (en) 2006-04-28 2010-05-11 Medtronic, Inc. Tree-based electrical stimulator programming
US7801619B2 (en) 2006-04-28 2010-09-21 Medtronic, Inc. Tree-based electrical stimulator programming for pain therapy
US7706889B2 (en) 2006-04-28 2010-04-27 Medtronic, Inc. Tree-based electrical stimulator programming
US8306624B2 (en) 2006-04-28 2012-11-06 Medtronic, Inc. Patient-individualized efficacy rating
US8311636B2 (en) 2006-04-28 2012-11-13 Medtronic, Inc. Tree-based electrical stimulator programming
US8380300B2 (en) 2006-04-28 2013-02-19 Medtronic, Inc. Efficacy visualization

Also Published As

Publication number Publication date
US7366570B2 (en) 2008-04-29
US20030139785A1 (en) 2003-07-24
EP1242146A1 (en) 2002-09-25
US20020026223A1 (en) 2002-02-28

Similar Documents

Publication Publication Date Title
US7366570B2 (en) Method and a system for using implanted medical device data for accessing therapies
EP1310272B1 (en) Presentation architecture for network supporting implantable cardiac therapy devices
US6473638B2 (en) Medical device GUI for cardiac electrophysiology display and data communication
US6754538B2 (en) Apparatus and method for remote self-identification of components in medical device systems
US7058453B2 (en) Apparatus and method for remote therapy and diagnosis in medical devices via interface systems
US6648823B2 (en) Method and system of follow-up support for a medical device
US6385593B2 (en) Apparatus and method for automated invoicing of medical device systems
EP1505816B1 (en) Data feedback loop for medical therapy adjustment
US7265676B2 (en) Alert system and method for an implantable medical device
EP1246663B1 (en) A communications system for an implantable device and a drug dispenser
US8438039B2 (en) User customizable workflow preferences for remote patient management
US20070250130A1 (en) Remote Communication System with Availability Indicator for an Implantable Medical Device
US9486153B2 (en) Medical device system having an implanted medical device and an external device
WO2001049368A1 (en) System of notification of recalled components for a medical device
US9440088B2 (en) Implanted lead analysis system and method
Sermasi et al. Remote Patient Management of ICD: Of What Value Is It in Clinical Practice?

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): CA JP

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2000986583

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 2000986583

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: JP