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`EXHIBIT D
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`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
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`(19) World Intellectual Property Organization
`International Bureau
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`(10) International Publication Number
`(43) International Publication Date
`5July 2001 (05.07.2001)
`PCT
`WO 01/47597 A2
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`(51) International Patent Classification7:
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`A61N 1/00
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`55303 (US). STAUFFER, Ronald, A.;
`Avenue, Princeton, MN 55371 (US).
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`11448 300th
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`(21) International Application Number:
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`PCT/USOO/34486
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`(22) International Filing Date:
`19 December 2000 (19.12.2000)
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`(74) Agent: WOLDE—MICHAEL, Girma; Medtronic, Inc.,
`MS 301, 7000 Central Avenue Northeast, Minneapolis, MN
`55432 (US).
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`(25) Filing Language:
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`English
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`(81) Designated States (national): CA, JP.
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`(26) Publication Language:
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`English
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`(30) Priority Data:
`60/173,064
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`24 December 1999 (24.12.1999)
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`US
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`(84) Designated States (regional): European patent (AT, BE,
`CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC,
`NL, PT, SE, TR).
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`Published:
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`(71) Applicant: MEDTRONIC, INC. [US/US]; 7000 Central
`Avenue Northeast, Minneapolis, MN 55432 (US).
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`Without international search report and to be republished
`upon receipt of that report.
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`(72) Inventors: STOMBERG, Charles, R.; 24101 Heath
`Avenue North, Forest Lake, MN 55025 (US). RINGOLD,
`Jean; 14531 Krypton Street Northwest, Ramsey, MN
`
`For two-letter codes and other abbreviations, refer to the ”Guid-
`ance Notes on Codes andAbbreviations " appearing at the begin-
`ning ofeach regular issue ofthe PCT Gazette.
`
`
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`(54) Title: INFORMATION NETWORK INTERROGATION OF AN IMPLANTED DEVICE
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`(57) Abstract: A communication system is provided which permits of communication between a deployed implantable medical
`device (IMD) and a computing resource capable of storing and distributing patient and device data. A deployed IMD may be polled
`by a network interface external to the host patient, and data may be received by wireless communication. This data may be transmitted
`to a computer for storage and distribution, and changes to a treatment or instruction regimen, or firmware or software upgrades, may
`then be transmitted to the network interface for immediate or eventual loading into the IMD via wireless communication. The system
`is adapted to provide communication service between multiple IMDs deployed in a patient or a number of patients.
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`1/47597A2
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`INFORMATION NETWORK INTERROGATION OF AN IMPLANTED
`DEVICE
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`FIELD OF THE INVENTION
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`The present invention generally relates to implantable medical devices
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`(IMDs). Specifically, the invention pertains to an information network for remotely
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`directing patient device data retrieval and device instruction updates. More
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`specifically, the invention enables autonomous interrogation of the IMDs, without the
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`intervention of an operator or a clinician, in real time. The collected data may be
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`reviewed by a clinician or may be archived to compare patient history and for other
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`future use. An interface medical unit or a programmer may be used to uplink the
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`IMDs to the remote information network.
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`BACKGROUND OF THE INVENTION
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`In the traditional provision of any medical services, including routine check-
`ups and monitoring, a patient is required to physically present themselves at a
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`provider’s office or other clinical setting. In emergency situations, health care
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`providers may travel to a patient’s location, typically to provide stabilization during
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`transport to a clinical setting, e.g., an emergency room. In some medical treatment
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`applications, accepted medical practice for many procedures will naturally dictate
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`physical proximity of medical providers and patients. However, the physical
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`transport of patients to clinical settings requires logistical planning such as
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`transportation, appointments, and dealing with cancellations and other scheduling
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`complications. As a result of such logistical complications, patient compliance and
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`clinician efficiency may suffer. In certain situations, delays caused by patient
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`transport or scheduling may result in attendant delays in detection of medical
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`conditions including life—threatening situations. It is desirable, therefore, to minimize
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`situations in which the physical transport of a patient to a clinical setting is required.
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`It may also be desirable to minimize the extent to which an patient or patient
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`information must be considered by a clinician at a particular time, i.e. during an
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`appointment.
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`After the implantation of an IMD, for example, a cardiac pacemaker, clinician
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`involvement with respect to the IMD has typically only begun. The IMD usually
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`cannot be merely implanted and forgotten, but must be monitored for optimal results,
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`and may require occasional adjustment of certain parameters or settings, or even
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`replacement, in response to or in anticipation of changes in patient condition or other
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`environmental factors, or based on factors internal to the device. IMDs may also
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`contain logic devices such as digital controllers, which may need to undergo firmware
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`or software upgrades or modifications. In addition, information about the IMD may
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`be gathered for treatment or research purposes. For example, many IMDs are capable
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`of storing certain state information or other data regarding their operation internally in
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`addition to physiological data.
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`Because IMD operation and patient physiology is preferably monitored to help
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`effect the desired patient outcome, it would be desirable if data collected by an IMD
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`could be viewed remotely. Similarly, it would also be desirable that the instructions
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`installed in an IMD may be modified in response to patient physiologic information,
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`or perhaps be upgraded remotely as well.
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`In the event a change, modification or reprogramming of the IMDs is indicated, it
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`would be desireable if the instruction could be implemented in the IMD as soon as
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`possible, thus providing more continuous monitoring to proactively effect changes in
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`the IMDs for efficient therapy and clinical care. This scenario may be contrasted with
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`existing practice of responding to an adverse patient event or subjecting the patient to
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`the inconvenience or expense of frequent in-person encounters with a clinician, for
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`example after an unexpected therapy by the device, or to effect other monitoring of
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`device functioning, e.g., spontaneous therapies by the device. For example, an
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`implanted cardioverter defibrillator may administer to the host patient a cardioversion
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`or defibrillation therapy. After such therapy, it is typically desirable to determine the
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`parameters of, for example, an arrhythmia that a therapy was administered in response
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`to, or of the therapy administered.
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`Despite the limitations of IMDs with regard to processing power, IMDs are in
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`a unique position to monitor physiological systems continuously. High-resolution
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`data can be collected, but implantable devices are ill suited to storage and processing
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`of large amounts of complex physiological data. In contrast, computing power and
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`data storage capacity (processor capability, memory, and adequate power supply) is
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`abundantly available in the non-implantable (“external”) world. The computing
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`industry is still following Moore’s Law (stating that transistor density will double
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`every 18 months), delivering increasingly sophisticated computing devices yearly,
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`and some of these gains accrue to the computer power of IMDs. However, frequent
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`upgrading and replacement of IMDs based on more powerful models subjects a
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`patient to additional stresses, and additional costs are imposed on the patient or health
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`care system.
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`Prior art methods of clinical services, particularly IMD monitoring and
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`adjustment, are generally limited to in-hospital procedures or other scenarios
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`involving patient transportation to a clinical setting. For example, if a physician
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`needs to review the performance parameters of an IMD in a patient, it is likely that the
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`patient has to go to the clinic. Further, if the medical conditions of a patient with an
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`IMD warrant a continuous monitoring or adjustment of the device, the patient would
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`have to stay in a hospital indefinitely. Such a continued treatment plan poses both
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`economic and social problems. Under the prior art, as the segment of the population
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`with IMDs increases, many more hospitals and clinics, and attendant clinicians and
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`service personnel will be needed to provide in-hospital service for the patients, thus
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`escalating the cost of healthcare. Additionally, the patients will be unduly restricted
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`and inconvenienced by the need to either stay in the hospital or make very frequent
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`visits to a clinic.
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`Yet another condition of the prior art practice requires that a patient visit a
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`clinic center for occasional retrieval of data from the implanted device to assess the
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`operations of the device and gather patient history for both clinical and research
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`purposes. Such data is acquired by having the patient in a hospital/clinic to download
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`the stored data from the IMD. Depending on the frequency of data collection, this
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`procedure may pose serious difficulty and inconvenience for patients who live in rural
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`areas or have limited mobility. Similarly, in the event a need arises to upgrade the
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`software of an implantable medical device, the patient will be required to come into
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`the clinic or hospital to have the upgrade installed.
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`Further, it is a typical medical practice keep an accurate record of past and
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`contemporaneous procedures relating to an IMD uplink with, for example, an IMD
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`programmer, i.e. a computer capable of making changes to the firmware or software
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`of an IMD. It is typically desired that the report contain the identification of all the
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`medical devices involved in any interactive procedure. Specifically, all peripheral
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`and major devices that are used in downlinking to the IMD may be reported.
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`Currently, such procedures are manually reported, and require an operator or a
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`medical person to manually enter data during each procedure. One of the limitations
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`of such manual reporting procedures is the possibility for human error in data entry,
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`thus motivating rechecking of the data to verify accuracy. Generally, the use of
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`human clinicians and technicians to analyze data and implement changes in device
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`therapy can result in inefficiencies and errors.
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`Yet a further condition of the prior art relates to the interface between a human
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`operator and a programmer system. To aid a patient in the administration of a
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`deployed medical device, clinicians such as pacing clinicians may be made available
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`to implement desirable changes in the treatment regimen effected by an IMD.
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`Generally, a medical device manager/technician should be trained on the clinical and
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`operational aspects of the programmer. Under current practices, a technician may
`attend a class or training session sponsored by a clinic, a hospital, or the manufacturer
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`to successfully manage a programmer-IMD procedure. Further, ideally the operator
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`will keep abreast of new developments and new procedures in the management,
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`maintenance and upgrade of the IMD. Accordingly, it is desirable that operators of
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`programmers, IMDs, and related medical devices receive regular training or
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`information about the IMDs they work with. This information will preferably be
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`widely distributed, because IMDs, programmer devices, and related medical devices
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`are distributed throughout the world. Further, the number of people having implanted
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`medical devices has been increasing over the last few years, with an attendant
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`increase in operator personnel. The total effect of these phenomenon is a widely
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`dispersed and large body of operators. Thus, it is desirable to have a high efficiency
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`communications system that would enhance data communications, both between the
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`IMDs and medical instruments, such as programmers; and between operators and
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`entities providing IMD updates and education such as manufacturers. However,
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`despite any improvement in clinician communication and training that may be
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`effected, it may be desirable to automate device administration, maintenance, and
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`upgrading to the extent possible in order to ensure that device instructions and data
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`are appropriate to the situation.
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`A further limitation of the prior art relates to the management of multiple
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`medical devices in a single patient. Advances in modern patient therapy and
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`treatment have made it possible to implant a number of devices in a patient. For
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`example, IMDs such as a defibrillator or a pacer, a neural implant, a drug pump, a
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`separate physiologic monitor and various other IMDs may be implanted in a single
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`patient. To successfully manage the operations and assess the performance of each
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`device in a patient with multi-implants may require frequent update and monitoring of
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`the devices.
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`Confirmation of basic device functioning following therapy events has been
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`effected in the past using telephonic means. However, former methods of
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`communication with medical devices did not provide for updating of software and
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`firmware, or allow for operator training. In addition, former methods of
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`communication with remote devices required the involvement of clinical personnel in
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`the interpretation of data and prescription of treatment regimens or therapies. It
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`would be desirable to remotely communicate information to and from implantable
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`medical devices, and also provide for authentication of target device as well as
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`confirmation of data integrity following the transmission of the patient data.
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`Furthermore, it would be desirable to limit the degree to which human and
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`particularly clinician involvement is required to effect the communication between an
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`IMD and a remote resource.
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`Further, it may be preferred to have an operable communication between the
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`various implants to provide a coordinated clinical therapy to the patient. Thus, there
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`is a need to monitor the IMDs and the programmer on a regular, if not a continuous,
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`basis to ensure optimal patient care. In the absence of other alternatives, this imposes
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`a great burden on the patient if a hospital or clinic is the only center where the
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`necessary upgrade, follow up, evaluation and adjustment of the IMDs could be made.
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`Further, even if feasible, the situation would require the establishment of multiple
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`service areas or clinic centers to support the burgeoning number of multi-implant
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`patients worldwide.
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`SUMMARY OF THE INVENTION
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`The present invention provides a system for directing remote interrogation of
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`IMDs implanted in patients, even when the patients are in a location remote from the
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`interrogation equipment. In one embodiment, the invention may be used to reduce or
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`eliminate the need for a clinician or other person available to administer device
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`interrogation. The invention may also create a means for gathering device data in
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`advance of its actual review of a clinician. A remote interrogation will preferably
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`allow clinicians to review data intermittently, even while an IMD is still accessing or
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`adding to the same body of data as stored in memory on—board the IMD. In one
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`embodiment of the invention, a computer remote to the host patient may initiate and
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`subsequently store the contents of IMD device memory interrogated and transmitted
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`to the remote computer. This data would then be available for examination in the
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`future. For example, a referring physician could use the ability to examine the patient
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`remotely as a consultation system.
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`A technology-based health care system that fully integrates the technical and
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`social aspects of patient care and therapy will preferably flawlessly connect the client
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`with care providers irrespective of separation distance or location of the participants.
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`Accordingly it is desirable to have a programmer unit that would connect to a
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`centralized data source and repository. This may be termed, for example, a remote
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`interrogator, or a remote data center. This remote data centerwill preferably provide
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`access to an expert system allowing for downloading of upgrade data or other
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`information to a local, i.e., IMD environment. Further, in one embodiment of the
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`present invention, it is possible to enable the gathering of high resolution
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`diagnostic/physiologic data, and to transfer information between the IMDs and a
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`remote data center to dispense therapy and clinical care on real-time basis. Further,
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`the data system contemplated by the present invention enables an efficient system for
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`data storage, collection and processing to effect changes in control algorithms of the
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`IMDs and associated medical units to promote real-time therapy and clinical care.
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`The proliferation of patients with multi-implant medical devices worldwide
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`has made it imperative to provide remote services to the IMDs and timely clinical care
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`to the patient. The use of programmers and related devices to communicate with the
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`IMDs and provide various remote services has become an important aspect of patient
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`care. In addition to the instant invention, the use of programmers may be
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`implemented in a manner consistent with the co-pending applications detailed in the
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`foregoing Cross Reference to Related Applications, and assigned to the assignee of
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`the instant invention. In light of the disclosures of these incorporated references, the
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`present invention provides a vital system and method of delivering efficient therapy
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`and clinical care to the patient.
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`In a representative embodiment of the instant invention, one or more IMDs,
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`such as a pacemaker, defibrillator, drug pump, neurological stimulator, physiological
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`signal recorder may be deployed in a patient. The IMD may be equipped with a radio
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`frequency transmitter or receiver, or an alternate wireless communication telemetry
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`technique or media which may travel through human tissue. For example, the IMD
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`may contain a transmission device capable of transmitting through human tissue such
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`as radio frequency telemetry, acoustic telemetry, or a transmission technique that uses
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`patient tissue as a transmission medium. Altemately, an IMD may be deployed in a
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`configuration where a transmission or receiving device is visible externally to the
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`patient but is connected directly or via wires to the IMD. An external device, which
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`may generally be termed an IMD Network Interface (IMDNI), may be positioned
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`outside the patient, the IMDNI being equipped with a radio frequency or other
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`communication means compatible with the communication media of the IMD or the
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`IMD transmitter/receiver, which may be external to the IMD and may further be
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`external to the patient. In an illustrative embodiment of the subject invention, IMDNI
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`contains a radio frequency transmitter/receiver or similar radio frequency telemetry
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`device. Communication may be effected between the IMD transmitter/receiver and
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`the external IMDNI, e. g. via radio frequency. The IMDNI will be connected via a
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`wireless or physical communication media, e. g. via modem and direct dial
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`connection, with a data network, LAN, WAN, wireless, or infrared network. In an
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`alternate embodiment of the subject invention, the IMDNI may have a direct
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`connection or tunneled connection directly to the centralized computing resource. In
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`yet another alternate embodiment of the subject invention, the system may be
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`implemented as a data network that allows the IMDNI access to the computing center
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`from many locations, for example providing for a IMDNI that is portable.
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`Using the computing power of external computing devices, the monitoring of
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`long-term disease progression (e. g. heart failure, hypertension, diabetes) can be
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`improved. Furthermore, therapies may be adjusted with finer granularity and
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`improved results, with reduced need for human intervention and reduced opportunity
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`for clinician error.
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`In addition to improved modeling of physiologic systems, the amount of
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`historical data, particularly patient-specific historical data used as input to control
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`systems can be virtually unlimited when it is stored externally to the patient.
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`Furthermore, a more thorough comparison can be made between patients with similar
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`diseases as data and therapy direction are centralized, which may be expected to result
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`in gains to the body of medical knowledge and treatment efficacy. Data from other
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`medical systems, either implanted or external, such as etiological databases, can be
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`incorporated easily into the control system. Other anonymous patient experiences or
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`treatment data may be more quickly incorporated into a subject patient’s IMD regime
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`than might be possible with existing systems of IMD programming or upgrading. In
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`addition, a subject patient’s own historical treatment parameters and corresponding
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`outcomes may be used in making IMD programming and other treatment decisions.
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`The instant invention provides IMDs with access to virtually unlimited computing
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`power as part of their data collection and therapy calculation processes. In an
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`alternate embodiment of the present invention, the IMD may be used by an external
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`computing device as a data collection agent, and as an agent to implement changes to
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`a treatment regimen based on a complex dynamical or stochastic physiological model.
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`Rather than continuously increasing the processing power of IMDs, the present
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`invention provides a link with external computing power, which is more easily
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`upgraded. In addition, control system algorithms based on current knowledge about
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`physiologic systems could be more easily updated using a centralized powerful
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`processor, rather than individually updating the firmware or software of thousands of
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`deployed IMDs.
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`When multiple IMDs are deployed within a single patient, the data and
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`therapy from these IMDs may be more easily and efficiently orchestrated, thus further
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`improving treatment efficacy and convenience to the patient and clinician, and in
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`some cases judiciously limiting clinician involvement. In addition, high resolution or
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`finely grained data may be collected and stored from a vast number of subject IMDs.
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`This finely grained patient data may be expected to prove valuable in defining and
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`modifying an individual patient’s treatment regimen as implemented by an IMD. In
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`addition, this high—resolution data may be analyzed on a mass scale, providing
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`opportunities for improvement of existing physiologic models. This data may serve,
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`for example, to validate physiologic models being employed, or may suggest
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`refinement of these models based on numerous patient outcomes.
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`This refinement of therapy and diagnostic algorithms or models may further
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`be refined in conjunction with external medical devices as well. According to the
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`present invention, IMD management and manipulation will be more efficient and
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`efficacious. For example, an embodiment of the present invention permits the use of
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`complex control systems to manage therapy of implantable medical devices. In
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`addition, the invention permits the orchestration of the data collection and therapy
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`functions of IMDs, particularly the functions of multiple IMDs implanted in one
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`patient. In addition, an embodiment of the present invention permits of centralized
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`therapy prescription, and provides the ability to compare disease states, diagnostic
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`data and therapy prescription across patients with fine granularity. The ability to
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`update control system software and hardware at a central location is also provided, as
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`well as the ability to upgrade the firmware or software in distributed deployed IMDs
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`from one central location.
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`A communications system according to the present invention provides the
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`ability to have high-power computing systems interact with implanted medical
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`devices, thus providing the ability to use complex control algorithms and models in
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`implanted medical devices. In addition, even with relatively simple modeling, or in
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`stochastic models, relatively large amounts of historical data from a single or multiple
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`medical devices may be brought to bear for predictive purposes in evaluating alternate
`therapy and IMD instruction prescriptions. The present invention provides a system
`that establishes an external communications device and data network as a ‘data bus’
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`for extending the processing power of deployed IMDs, while minimizing host patient
`and clinician inconvenience.
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`The present invention may be effected, in part, by the provision of an IMDNI
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`device, which may be a standalone device or a computer peripheral device, that is
`capable of connecting an IMD, or simply data telemetrically received from an IMD,
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`to a network or other data communication link. While the interface between a
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`computer data link and an implanted medical device is referred to generally herein as
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`a “Network Interface”, or the like, it will be appreciated to those skilled in the art that
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`the interface may serve as an interface to a variety of data communications systems,
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`including not only networks, but also, without limitation, direct dial-up connections,
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`dedicated lines, direct satellite links, and other non-network data communications
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`connections.
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`In a preferred embodiment of the subject invention, a host patient, i.e., a
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`patient having an IMD implanted within, presents themselves to a IMD network
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`interface device, or IMDNI. This IMDNI will preferably have the capability of
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`communicating with the IMD Via wireless means, such as by radio transmissions. In
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`one embodiment of the subject invention, the IMDNI may be placed, for example, in
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`a patient’s home, or may be available for use by several patients in a treatment facility
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`such as a hospital, nursing home, or ambulatory care center.
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`In one embodiment of the invention, data can be interrogated, with the aid of a remote
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`interrogator device, by an IMDNI in an emergency room and then uploaded to an
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`information network to which a remote interrogator is connected. This information
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`network may be according to any network protocol, for example, TCP/IP over the
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`Internet. The uploading to a central interrogation computer may also be effected over
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`a direct dial-up connection or a dedicated line. Upon uploading of the data, a medical
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`professional or other clinician may be alerted to the fact the data has been uploaded.
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`This clinician may then View the data. A patient could also interrogate his or her
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`device at home and upload it for a medical professional or clinician to view later.
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`Various scenarios according to the invention may provide convenient monitoring of
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`IMD functioning to a host patient or clinician. For example, a patient may effect a
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`test of their IMD with a device tests such as an exercise or stress test in a more natural
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`or real life scenario that may provide more reliable or accurate results than a clinical
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`evaluation, in addition to providing increased convenience to the patient and reducing
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`the need for clinician or other professional attention.
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`In this embodiment of the invention, for example, a host patient may effect a
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`dial-up connection to a remote interrogator following an afternoon walk in their
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`neighborhood or on a treadmill in their home. In addition to evaluation of device
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`function during routine situations, according to this embodiment of the present
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`invention, a home monitoring instrument may be provided to a host patient allowing
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`the patient to send data, i.e., to effect remote interrogation, if, for example, they have
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`a subjective belief that they are symptomatic. For example, a host patient of a
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`cardioverter defibrillator IMD may effect remote interrogation if they believe they
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`have suffered an arrhythmia event. The data resulting from the remote interrogation
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`may then be made remotely accessible for evaluation by a pacing system expert. In a
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`preferred embodiment of the subject invention, IMD function data and physiologic
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`data of the host patient is made available nearly instantaneously to a clinician capable
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`of evaluating the device function, physiologic event or data, or therapy administered
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`by the target IMD.
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`In a preferred embodiment, the remote interrogator of the present invention is
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`implemented as a software application which may be run on a server or central
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`computer accessible via a network or direct connection by the IMDNI device. In an
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`alternate embodiment, the IMDNI may be implemented as a software client which
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`may run on a computer remotely from the interrogator server. Preferably, the remote
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`interrogator program or device is capable of autonomously and dynamically
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`determining the model of an IMD, for example, according to manufacturer, type, and
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`model number, as well as the specific serial number of a particular device. When an
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`IMD is within communication range of an IMDNI, the remote interrogator of the
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`present invention is also preferably capable of configuring a deployed IMD, or
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`commanding the IMDNI to retrieve data from the IMD.
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`In a preferred embodiment, an interaction between a deployed IMD and the
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`remote interrogator may take place within a discrete session. This session may
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`encompass interrogation of one or more IMDs deployed in a single patient. In a
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`representative embodiment, a session according to the present invention may proceed
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`according to the following scenario. In order to begin an interrogation session, a host
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`patient will typically present to an IMDNI. For example, the patient may place
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`themselves in the vicinity of the IMDNI within range of the telemetry capacities of
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`the IMDNI. This may take place at home in the case of a In Home Monitor (IHM) or
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`at a medical facility such as an Emergency Room, Follow-up Clinic or Operating
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`Room. At the initiation of a session, it will be preferable to configure the target IMD
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`for optimal operation for remote interrogation. For example, the IMDNI may be
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`programmed to issue a command to the target IMD to “Cancel Magnet”, “Resume
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`Therapy,” or another command to enter a mode consistent with the interrogation
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`process. Either prior to or af