Instrumentation and software for remote monitoring and programming of ...

(12) United States Patent

Lee

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US006442432B2

(io) Patent No.: US 6,442,432 B2 (45) Date of Patent: Aug. 27,2002

(54) INSTRUMENTATION AND SOFTWARE FOR REMOTE MONITORING AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES (IMDS)

(75) Inventor: Michael Thomas Lee, Minnetonka, MN (US)

(73) Assignee: Medtronic, Inc., Minneapolis, MN (US)

( * ) Notice: Subject to any disclaimer, the term ol this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.

(21) Appl. No.: 09/745,038

(22) Filed: Dec. 20, 2000

Related U.S. Application Data

(60) Provisional application No. 60/173,080, filed on Dec. 24, 1999.

(51) Int. C I. A61N 5/00

(52) U.S. C I 607/59

(58) Field of Search 607/59, 32

(56) References Cited

U.S. PATENT DOCUMENTS

5,544,661 A 8/1996 Davis et al 128/700

5,593,426 A 1/1997 Morgan et al 607/5

5,626,630 A 5/1997 Markowitz et al 607/60

5,640,953 A 6/1997 Bishop et al 128/630

5,720,770 A 2/1998 Nappholz et al 607/30

A data communication system is provided which permits collaboration between distributed clinicians regarding distributed or remote implantable medical devices (IMDs). A central computing resource capable ol storing and distributing patient device and clinician location and contact data is provided, as well as a network providing communication with the computing resource. A deployed IMD may be polled by an interlace device external to the host patient, and data may be transmitted to the interlace device by wireless communication. This data may be transmitted to a central computer for storage and distribution. The data may be distributed to various clinicians in communication with the central computer. These clinicians may use this information, either directly or indirectly, to contact remote clinicians and medical devices in communication with the network.

53 Claims, 2 Drawing Sheets

1

INSTRUMENTATION AND SOFTWARE FOR
REMOTE MONITORING AND
PROGRAMMING OF IMPLANTABLE
MEDICAL DEVICES (IMDS)

This application claims the benefit of U.S. Provisional Application Ser. No. 60/173,080 filed Dec. 24, 1999. The specification and drawings of the provisional application are specifically are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention generally relates to implantable medical devices (IMDs). Specifically, the invention relates to a system providing real-time communication between the IMDs, medical instruments associated with or compatible with the IMDs, and a specialized remote expert data center, a central IMD support information network, or other remote collaborators. A display may be provided to allow users, particularly remote users, to track connection status and progress. More specifically, the invention relates to a central network to provide for a easily-accessed connection to the expert data center, central IMD information center, or other remote collaborators to promote reliable real-time connectivity between clinicians, IMDs and related medical devices as well as providing remote monitoring for proactive patient therapy and clinical care. The expert data center may be a web-enabled remote server which stores device registration and patient management data.

BACKGROUND OF THE INVENTION

In the traditional provision of any medical services, including routine check-ups and monitoring, a patient is required to physically present themselves at a provider's office or other clinical setting. In emergency situations, health care providers may travel to a patient's location, typically to provide stabilization during transport to a clinical setting, e.g., an emergency room. In some medical treatment applications, accepted medical practice for many procedures will naturally dictate physical proximity of medical providers and patients. However, the physical transport of patients to various clinical settings requires logistical planning such as transportation, appointments, and dealing with cancellations and other scheduling complications. As a result of such logistical complications, patient compliance and clinician efficiency may suffer. In certain situations, delays caused by patient transport or scheduling may result in attendant delays in detection of medical conditions including life-threatening situations. It is desirable, therefore, to minimize situations in which the physical transport of a patient to a particular clinical setting is required.

After the implantation of an IMD, for example, a cardiac pacemaker, clinician involvement with respect to the IMD has typically only begun. The IMD usually cannot be merely implanted and forgotten, but must be monitored for optimal results, and may require adjustment of certain parameters or settings, or even replacement, in response to or in anticipation of changes in patient condition or other environmental factors, or based on factors internal to the device. IMDs may also contain logic devices such as digital controllers, which may need to undergo firmware or software upgrades or modifications. In addition, information about the IMD may be gathered for treatment or research purposes. For example, many IMDs are capable of storing certain state information or other data regarding their operation internally.

Because IMD operation and patient physiology is preferably monitored to help effect the desired patient outcome, it

2

would be desirable if data collected by an IMD could be viewed and administered remotely. Similarly, it would also be desirable that the instructions installed in an IMD may be modified in response to patient physiologic information, or

5 perhaps be upgraded remotely as well.

In the event a change, modification or reprogramming of the IMDs is indicated, it would be desirable if the instruction could be implemented in the IMD as soon as possible, thus providing more continuous monitoring to proactively effect

10 changes in the IMDs for efficient therapy and clinical care. This scenario may be contrasted with a reactive practice of responding to an adverse patient event or subjecting the patient to the inconvenience or expense of frequent in-person encounters with a clinician, for example after an

15 unexpected therapy by the device, or to effect other monitoring of device functioning, e.g., spontaneous therapies by the device. For example, an implanted cardioverter defibrillator may administer to the host patient a cardioversion or defibrillation therapy. After such therapy, it is typically

20 desirable to determine the parameters of, for example, an arrhythmia that a therapy was administered in response to, or of the therapy administered.

Prior art methods of clinical services, particularly IMD monitoring and adjustment, are generally limited to

25 in-hospital procedures or other scenarios involving patient transportation to a clinical setting. For example, if a physician needs to review the performance parameters of an IMD in a patient, it is likely that the patient has to go to the clinic. Further, if the medical conditions of a patient with an IMD

30 warrant a continuous monitoring or adjustment of the device, the patient would have to stay in a hospital indefinitely. Such a continued treatment plan poses both economic and social problems. Under the prior art, as the segment of the population with IMDs increases, many more hospitals

35 and clinics, and attendant clinicians and service personnel will be needed to provide in-hospital service for the patients, thus escalating the cost of healthcare. Additionally, the patients will be unduly restricted and inconvenienced by the need to either stay in the hospital or make very frequent

40 visits to a clinic.

Yet another condition of the prior art practice requires that a patient visit a clinic center for occasional retrieval of data from the implanted device to assess the operations of the device and gather patient history for both clinical and

45 research purposes. Such data is acquired by having the patient in a hospital/clinic to download the stored data from the IMD. Depending on the frequency of data collection, this procedure may pose serious difficulty and inconvenience for patients who live in rural areas or have limited mobility.

50 Similarly, in the event a need arises to upgrade the software of an implantable medical device, the patient will be required to come into the clinic or hospital to have the upgrade installed.

In addition to the patient concerns described above, the

55 implantation and ongoing administration of a medical device must be carefully documented or recorded by various clinicians and commercial entities. For example, a clinician may wish to record information about the device such as its serial and model number in order to inform the patient of any

60 firmware or software updates or upgrades involving the device, and to issue reminders to the patient regarding significant dates involving the IMD in order to generally aid in patient compliance. The IMD may also have a regular maintenance period suggested or prescribed, for example,

65 for renewal of a power supply or refill of a reservoir containing a drug administered by the device. Similarly, the manufacturer and/or seller of the device will probably wish