External patient alerting system for implantable devices

• US 20040199212A1
• Filed: 04/01/2003
• Published: 10/07/2004
• Est. Priority Date: 04/01/2003
• Status: Abandoned Application

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Fischell, David R., Fischell, Robert E., Harwood, Jonathan
• Application Number:
  US10/403,210
• Publication Number:
  US 20040199212A1
• Time in Patent Office: Days
• US Class Current: 607/32
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Disclosed is a patient alerting device (PAD) that can be positioned close enough for effective near-field communication with an implanted medical device such as a pacemaker or implantable cardiac defibrillator. The PAD is designed to warn the patient when a specific event is detected by the implanted device. The alarm mechanism could be a sound, a vibration and/or a visible display. A communications repeater can be used with the PAD to allow the implanted device to communicate via the PAD with remotely located external equipment through proprietary or standardized means. Means to initiate communication with the implanted device include a magnet within the PAD that triggers a magnetic switch inside the implanted device or by a button which can be depressed to inform the implanted device that the PAD is active and close enough to begin communication. The PAD could also include a button to shut off an alarm that is in the PAD. The PAD can also include means to provide battery status to the patient for both the battery in the implanted device and in the PAD. The significance of the basic alarm PAD is its ability to provide continuous patient alarm capabilities for already implanted devices as well as future implants which have only near-field communication.

Claims

1. A patient alerting system including:

an implanted medical device having short-range telemetry and being capable of detecting one or more different detected events related to the medical condition of a patient in whom the implanted medical device is implanted; and

a patient alerting device situated in close proximity to the implanted medical device and being capable of receiving the short-range telemetry from the implanted medical device, the patient alerting device also having the capability to alert the patient by means of an alarm signal after the detected event is detected by the implanted medical device.

2. The system of claim 1 where the detected event that is detected by the implanted device is selected from the group consisting of bradycardia, ventricular fibrillation, a cardiac arrhythmia, acute myocardial ischemia, a heart attack, a precursor of an epileptic seizure, the aura of a migraine headache, low or high blood glucose, low or high blood pressure, change from a normal R-R interval variation of the electrocardiogram, or any similar medical condition.

3. The system of claim 1 where the alarm signal is selected from the group consisting of a sound, a vibration or a visual display.

4. The system of claim 1 where the patient alerting device is designed to indicate the state of the battery of either or both the implanted medical device or the patient alerting device.

5. The system of claim 1 where the patient alerting device is designed is record in memory data received from the implanted medical device.

6. The system of claim 1 further including a repeater module capable of transmitting data received by the patient alerting device to remotely located external equipment.

7. The system of claim 6 where the repeater module is attached to the patient alerting device.

8. The system of claim 6 where the repeater module is integrated into the patient alerting device.

9. The system of claim 1 where the patient alerting device further comprises an electrical switch capable of interacting with the circuitry in the patient alerting device.

10. The system of claim 9 where the switch is a button on the surface of the patient alerting device.

11. The system of claim 9 where the switch can turn off the alarm signal originating from the patient alerting device.

12. The system of claim 9 where the switch is designed to initiate communication between the patient alerting device and the implanted medical device.

13. The system of claim 9 where the switch can initiate a status check of the patient alerting device.

14. The system of claim 9 where the switch can initiate a check of the status of the operating characteristics of the implanted medical device by means of the short-range telemetry.

15. The system of claim 9 where the switch can initiate a status check of both the patient alerting device and the implanted medical device.

16. The system of claim 1 further including a flash card slot located in the patient alerting device, the flash card slot being designed to receive a flash memory card.

17. The system of claim 16 where the flash memory card is selected from the group consisting of compact flash cards, PCMCIA flash cards, SD (Secure Digital) memory cards, Smart Media memory cards, USB flash memory adaptors, memory stick flash memory cards and multimedia memory cards.

18. A repeater patient alerting device designed to extend the data communication range of an implanted medical device, the repeater patient alerting device having near-field communications capability to send and receive data from the implanted medical device and limited-range telemetry capability to allow the implanted medical device to communicate with external equipment within a distance of less than 100 meters.

19. The device of claim 18 where the limited-range data communication means uses a standardized protocol.

20. The device of claim 19 where the standardized protocol is selected from the group consisting of:

Bluetooth, 802.11.a, 802.11.b or 802.11.g.

21. The device of claim 18 where the external equipment is selected from the group consisting of modems, printers, personal computers, laptop PCs, tablet PCs, cell phones, PDAs, paging devices, and implantable device programmers.

22. The device of claim 18 where the external equipment includes long-range communication means to facilitate data communication between the implanted medical device and remotely located systems and services at a distance of 100 meters or more from the implanted medical device.

23. A repeater patient alerting device designed to extend the data communication range of an implanted medical device, the repeater patient alerting device having near-field communications means to send and receive data from the implanted medical device and long-range data communication means to allow the implanted medical device to communicate with remotely located external equipment located at a distance of more than 100 meters from the implanted medical device.

24. The device of claim 23 where the long-range data communication means uses a standardized protocol.

25. The device of claim 24 where the standardized protocol is selected from the group consisting of CDMA, TDMA, GPRS and SMS.

26. A method for a patient to determine if he or she is having a cardiac event, the method including the following steps:

A) implant within the patient an implanted medical device having short-range telemetry and being capable of detecting one or more different detected events related to the medical condition of a patient in whom the implanted medical device is implanted; and

B) place a patient alerting device in close proximity to the implanted medical device, the patient alerting device being capable of receiving the short-range telemetry from the implanted medical device, the patient alerting device also having the capability to alert the patient by means of an alarm signal when the detected event is detected by the implanted medical device.

27. The method of claim 26 where the implanted medical device has the capability to detect at least one medical condition that is selected from the group consisting of bradycardia, ventricular fibrillation, a cardiac arrhythmia, acute myocardial ischemia, a heart attack, a precursor of an epileptic seizure, the aura of a migraine headache, low or high blood glucose, low or high blood pressure, change from a normal R-R interval variation of the electrocardiogram, or any similar medical condition.

28. A system for detecting if a patient has an anomaly of his or her heart rhythm, the system including:

an implanted medical device having short-range telemetry and being capable of detecting one or more different detected events related to the patient'"'"'s heart rhythm; and

a patient alerting device situated in close proximity to the implanted medical device and being capable of receiving the short-range telemetry from the implanted medical device, the patient alerting device also having the capability to store in memory the electrogram and/or electrocardiogram signal that is detected by the implanted medical device and transmitted to the patient alerting device by the short-range telemetry.

29. The system of claim 28 where the patient alerting device includes a means for the patient to initiate recording of the electrogram or the electrocardiogram.

30. A system for detecting an event related to the medical condition of a human patient the system including:

an implanted medical device having short-range telemetry and being capable of measuring one or more different aspects of a patients medical condition;

a patient alerting device having processing capability situated in close proximity to the implanted medical device and being capable of receiving the short-range telemetry from the implanted medical device, the patient alerting device also having the capability to detect an event related to the medical condition of the patient by processing the telemetry received from the implanted medical device.

31. The system of claim 30 further including means to alert the patient following detection of the event related to the medical condition of the patient.

32. The system of claim 30 further including means to store the telemetry received by the patient alerting device from the implanted medical device.

33. The system of claim 30 further including means to store the time of occurrence of the detected event.

34. The system of claim 30 further including means to transmit data to external equipment following the occurrence of the detected event.