Microprocessor controlled ambulatory medical apparatus with hand held communication device

• US 7,831,310 B2
• Filed: 07/28/2004
• Issued: 11/09/2010
• Est. Priority Date: 01/21/2000
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Weiss, Philip T., Starkweather, Timothy J., Lebel, Ronald J.
• Primary Examiner(s): Bockelman; Mark W
• Assistant Examiner(s): Dinga; Roland
• Application Number:
  US10/900,823
• Publication Number:
  US 20050010269A1
• Time in Patent Office: 2,295 Days
• Field of Search: 128/903, 128/904, 607/60, 607/32, 607/30, 600/347, 600/365, 604/891.1
• 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

An implantable infusion pump possesses operational functionality that is, at least in part, controlled by software operating in two processor ICs which are configured to perform some different and some duplicate functions. The pump exchanges messages with an external device via telemetry. Each processor controls a different part of the drug infusion mechanism such that both processors must agree on the appropriateness of drug delivery for infusion to occur. Delivery accumulators are incremented and decremented with delivery requests and with deliveries made. When accumulated amounts reach or exceed, quantized deliverable amounts, infusion is made to occur. The accumulators are capable of being incremented by two or more independent types of delivery requests. Operational modes of the infusion device are changed automatically in view of various system errors that are trapped, various system alarm conditions that are detected, and when excess periods of time lapse between pump and external device interactions.

Claims

1. A medical system, comprising:

a) an ambulatory medical device (MD) comprising MD electronic control circuitry that further comprises 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 MD, wherein the MD 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 that further comprises 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 the at least one MD processor that controls, at least in part, the operation of the MD telemetry system and the operation of the MD comprises an application specific integrated circuit (ASIC) configured to monitor an electrical activity of a first component or module;

wherein the MD telemetry system comprises the ASIC configured to monitor the electrical activity of the first component or module; and

wherein a remaining portion of the MD telemetry system is external to the ASIC and is free of any digital modules.

2. 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.

3. The system of claim 2, wherein (1) the MD electronic control circuitry comprises at least one external MD functional module, other than the remaining portion of the MD telemetry system, that is external to the MD processor, (2) the CD electronic control circuitry comprises at least one external CD functional module, other than the second portion of the CD telemetry system, that is external to the CD processor, (3) the MD processor comprises an internal MD CPU and at least one other internal MD functional module, or (4) the CD processor comprises an internal CD CPU and at least one other internal CD functional module.

4. The system of claim 2,

wherein the MD electronic control circuitry comprises at least one external MD functional module, other than the remaining portion of the MD telemetry system, that is external to the MD processor;

and

wherein the CD electronic control circuitry comprises at least one external CD functional module, other than the remaining portion of the MD telemetry system, that is external to the CD processor.

5. The system of claim 4,

wherein the MD processor comprises an MD central processing unit and at least one other MD functional module;

and

wherein the CD processor comprises a CD central processing unit and at least one other CD functional module.

6. The system of claim 1, wherein the MD 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, and (5) an implantable electrode for selectively stimulating a portion of the body of the patient.

7. The system of claim 6,

wherein the first component or module is a firing circuit for the infusion pump;

and

wherein the electrical activity being monitored is a voltage.

8. The system of claim 7, wherein the voltage is monitored during a charging cycle.

9. The system of claim 8, wherein the voltage is also monitored after firing the infusion pump.

10. The system of claim 6,

wherein the first component or module is the sensor;

and

wherein the electrical activity being monitored is a current being drawn by the sensor.

11. The system of claim 1, wherein the electrical activity being monitored is a voltage on the first component or module.

12. The system of claim 1, wherein the electrical activity being monitored is a current used by the first component or module.

13. The system of claim 1, wherein the electrical activity being monitored is a power consumed by the first component or module.

14. The system of claim 1, wherein the electrical activity being monitored is a shape of a waveform.

15. The system of claim 1, wherein the monitored electrical activity is compared to at least one of a predefined value, range of values, and waveform.

16. The system of claim 15, wherein the monitored electrical activity is compared to the at least one of a predefined value, range of values, and waveform to ensure that the first component or module is operating under acceptable conditions.

17. The system of claim 1, wherein the monitored electrical activity is compared to the at least one of a predefined value, range of values, and waveform to modify the operation of the first component or module.

18. The system of claim 1, wherein the first component or module is located within the ASIC.

19. The system of claim 1, wherein the first component or module is located external to the ASIC.

20. The system of claim 1, wherein the MD processor includes an oscillator for providing one or more clock signals to the ASIC.

21. The system of claim 1, wherein the MD includes at least two MD processors each comprising an ASIC.

22. The system of claim 21, wherein the MD further comprises at least one oscillator for providing one or more clock signals to the at least two MD processors each comprising an ASIC.

23. The system of claim 21, wherein each of the at least two MD processors includes at least one oscillator for providing one or more clock signals to each of the respective MD processors.

24. The system of claim 1, wherein the ASIC of the MD telemetry system comprises at least one of a mixer circuit and a low-pass filter circuit.

25. The system of claim 1, wherein the remaining portion of the MD telemetry system external to the ASIC comprises at least one of a radio frequency tuning circuit and a receiver amplifier.

26. The system of claim 1, wherein the remaining portion of the MD telemetry system external to the ASIC comprises at least one of an antenna and a radio frequency receiver arranged external to the application specific integrated circuit.

27. The system of claim 1, wherein the ASIC comprises a radio frequency modulator.

28. The system of claim 1, the MD telemetry system configured to transmit data using Quadrature Fast Acquisition Spread Spectrum Technology (QFAST®

).

29. The system of claim 1, wherein the MD telemetry system comprises one or more analog modules;

wherein at least one of the one or more analog modules is external to the ASIC; and

wherein the at least one of the one or more analog modules located external to the ASIC is substantially isolated from digital noise generated by the ASIC.

30. The system of claim 1,

wherein the MD is configured to be implantable in the body of the patient.

31. The system of claim 1,

wherein the MD includes at most one MD processor;

wherein the at most one MD processor is the ASIC of the MD telemetry system; and

wherein the ASIC of the MD telemetry system is configured to monitor the electrical activity of the first component or module.

32. The system of claim 1,

wherein the remaining portion of the MD telemetry system that is external to the ASIC comprises circuitry configured to switch between a first mode and a second mode;

wherein, in a case where the circuitry is in the first mode, the circuitry is configured to allow data from the CD to be receivable by the remaining portion of the MD telemetry system; and

wherein, in a case where the circuitry is in the second mode, the circuitry is configured to allow data to be transmittable by the remaining portion of the MD telemetry system to the CD.

33. The system of claim 32,

wherein, in a case where the circuitry is in the first mode, the circuitry is configured to not allow data to be transmittable by the remaining portion of the MD telemetry system to the CD;

and

wherein, in a case where the circuitry is in the second mode, the circuitry is configured to not allow data from the CD to be receivable by the remaining portion of the MD telemetry system.