Ambulatory medical apparatus with hand held communication device

• US 6,668,196 B1
• Filed: 01/22/2001
• Issued: 12/23/2003
• Est. Priority Date: 01/21/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medical Research Group, Inc. (Medtronic Plc)
• Inventors: Villegas, Daniel H., Meadows, Paul M., Choy, David Y., Weiss, Philip T.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/768,210
• Time in Patent Office: 1,065 Days
• Field of Search: 607/30-32, 607/59, 607/60, 128/903, 128/904
• US Class Current: 607/60
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37254 : Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: A61N 1/37258 : Alerting the patient
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3727 : characterised by the modulation technique
• CPC Class Codes: A61N 1/37276 : characterised by means for reducing power consumption during telemetry
• CPC Class Codes: A61N 1/37512 : Pacemakers
• CPC Class Codes: G06F 3/0619 : in relation to data integrity, e.g. data losses, bit errors
• CPC Class Codes: G06F 3/065 : Replication mechanisms
• CPC Class Codes: G06F 3/0673 : Single storage device
• CPC Class Codes: G06F 8/60 : Software deployment
• CPC Class Codes: G06F 8/65 : Updates security arrangements therefor G06F21/57
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: Y02D 10/00 : Energy efficient computing, e.g. low power processors, power management or thermal management
• CPC Class Codes: Y10S 128/13 : Infusion monitoring
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49117 : Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

A communication device (CD) exchanges messages with an implantable infusion pump via telemetry such that commands are supplied thereto and operational information is obtained therefrom. The CD is controlled, at least in part, by a processor IC according to a software program operating therein and provides feedback to a user via a visual display, an audio alarm, and a vibrational alarm, and allows input from the user via a touch sensitive keypad. Certain input functions are restricted by password. The visual display includes an icon and fixed element display region and a bitmap display region. The fixed element display region includes time and date displays, battery and drug level displays that decrement, and a moving delivery state display. Various screens allow operational or log information to be displayed and/or user entry of commands. Program features when disabled are removed from a series of screen options that can be scrolled through.

Claims

1. A medical system, comprising:

a) an ambulatory medical device (MD) comprising MD electronic control circuitry, the MD electronic control circuitry including at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and

b) a communication device (CD) comprising CD electronic control circuitry, the CD electronic control circuitry including at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system,

wherein at least one of the MD electronic control circuitry and the CD electronic control circuitry further includes at least one watchdog circuit,

wherein at least one of the MD electronic control circuitry and the CD electronic control circuitry generates a first signal and a second signal, which is different from the first signal, and

wherein the at least one watchdog circuit causes the CD processor to undergo a predefined process in the event that the watchdog circuit does not receive the first signal and the second signal within a predefined time period.

2. The system of claim 1 wherein a first portion of the MD telemetry system is incorporated into the MD processor and a second portion of the MD telemetry system is external to the MD processor.

3. The system of claim 2 wherein the MD electronic control circuitry comprises at least one MD functional module, other than the second portion of the MD telemetry system, that is external to the MD processor.

4. The system of claim 2 wherein, the MD processor comprises an internal MD CPU and at least one other internal MD functional module.

5. The system of claim 1 wherein the medical device comprises at least one of (1) an implantable infusion pump for selectively dispensing a selected drug, (2) an implantable infusion pump for selectively dispensing insulin, (3) an implantable sensor for sensing a selected state of the body, (4) an implantable sensor for sensing glucose level, or (5) an implantable electrode for selectively stimulating a portion of the body of the patient.

6. The system of claim 1 wherein the CD processor is reset as a result of undergoing the predefined process.

7. The system of claim 6, further including mainline software for execution by the at least one of the MD electronic control circuitry and the CD electronic control circuitry, wherein one of the first or second signals is a signal generated by the mainline software.

8. The system of claim 7 wherein the at least one of the MD electronic control circuitry and the CD electronic control circuitry further includes interrupt hardware that generates the other of the first or second signals.

9. The system of claim 1 wherein the at least one watchdog circuit comprises a watchdog monitor for monitoring operation of the at least one CD processor.

10. The system of claim 9 wherein the watchdog monitor comprises a register;

wherein the at least one CD processor generates a data pattern and provides the data pattern to the register; and

wherein the watchdog monitor is activated by the data pattern.

11. The system of claim 10 wherein the at least one of the MD electronic control circuitry and the CD electronic control circuitry generates at least one of a first system reset and a first system power-on reset, and

wherein the data pattern is provided to the register following the generation of the at least one of a first system reset and a first system power-on reset.

12. The system of claim 11 wherein the at least one of the MD electronic control circuitry and the CD electronic control circuitry generates at least one of a second system reset and a second system power-on reset, and

wherein once activated by the data pattern, the watchdog monitor remains active until generation of the at least one of a second system reset and a second system power-on reset.

13. The system of claim 1 wherein the first signal includes data having a first pattern and the second signal includes data having a second pattern different from the first pattern.

14. The system of claim 13 wherein the CD electronic control circuitry comprises at least one CD functional module, other than the second portion of the CD telemetry system, that is external to the CD processor.

15. The system of claim 13 wherein the CD processor comprises an internal CD CPU and at least one other internal CD functional module.

16. The system of claim 1 wherein a first portion of the CD telemetry system is incorporated into the CD processor and a second portion of the CD telemetry system is external to the CD processor.

17. A medical system, comprising:

a) an ambulatory medical device (MD) comprising MD electronic control circuitry, the MD electronic control circuitry including at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body;

b) a communication device (CD) comprising CD electronic control circuitry, the CD electronic control circuitry including at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system; and

c) at least one watchdog circuit comprising a watchdog monitor for monitoring operation of the at least one CD processor;

wherein at least one of the MD electronic control circuitry and’

the CD electronic control circuitry generates a first signal and a second signal, which is different from the first signal, and

wherein the at least one watchdog circuit causes the CD processor to undergo a predefined process when the watchdog circuit does not receive the first signal and the second signal within a predefined time period.

18. The system of claim 17 wherein the watchdog monitor comprises a register;

wherein the at least one CD processor generates a data pattern and provides the data pattern to the register; and

wherein the watchdog monitor is activated by the data pattern.

19. The system of claim 18 wherein the at least one of the MD electronic control circuitry and the CD electronic control circuitry generates at least one of a first system reset and a first system power-on reset, and

wherein the data pattern is provided to the register following the generation of the at least one of a first system reset and a first system power-on reset.

20. The system of claim 19 wherein the at least one of the MD electronic control circuitry and the CD electronic control circuitry generates at least one of a second system reset and a second system power-on reset, and

wherein once activated by the data pattern, the watchdog monitor remains active until generation of the at least one of a second system reset and a second system power-on reset.

21. The system of claim 17 wherein the first signal includes data having a first pattern and the second signal includes data having a second pattern different from the first pattern.

22. A method for communicating with a medical device for providing a treatment to a body of a patient or to monitor a selected state of the body, comprising:

providing an ambulatory medical device (MD) comprising MD electronic control circuitry, the MD electronic control circuitry including at least one Mb telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device;

sending messages to or receiving messages from the MD telemetry system via a communication device (CD) comprising CD electronic control circuitry, the CD electronic control circuitry including at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device; and

generating from a portion of at least one of the MD electronic control circuitry and the CD electronic control circuitry a first signal and a second signal, which is different from the first signal,

causing the CD processor to undergo a predefined process in the event that the first signal and the second signal are not received at another portion of the at least one of the MD electronic control circuitry and the CD electronic control circuitry within a predefined time period.

23. The method of claim 22 wherein the CD processor is reset as a result of undergoing the predefined process.

24. The method of claim 22, further including mainline software, wherein one of the first or second signals is a signal generated by the mainline software.

25. The method of claim 22 wherein the at least one of the MD electronic control circuitry and the CD electronic control circuitry further includes interrupt hardware that generates the other of the first or second signals.

26. The method of claim 22 wherein the ambulatory medical device comprises at least one of (1) an implantable infusion pump for selectively dispensing a selected drug, (2) an implantable infusion pump for selectively dispensing insulin, (3) an implantable sensor for sensing a selected state of the body, (4) an implantable sensor for sensing glucose level, or (5) an implantable electrode for selectively stimulating a portion of the body of the patient.

27. The method of claim 22 wherein the first signal includes data having a first pattern and the second signal includes data having a second pattern different from the first pattern.