Ambulatory medical apparatus and method having telemetry modifiable control software

• US 6,635,014 B2
• Filed: 01/22/2001
• Issued: 10/21/2003
• Est. Priority Date: 01/21/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Weiss, Philip T., Starkweather, Timothy J., Shahmirian, Varaz, Lebel, Ronald J.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US09/768,045
• Publication Number:
  US 20010041831A1
• Time in Patent Office: 1,002 Days
• Field of Search: 600/300, 600/301, 128/903, 128/904, 604/890.1, 604/891.1, 604/65, 604/163, 604/214
• US Class Current: 600/300
• 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 implanted medical device (e.g. infusion pump) and handheld communication device wherein the implantable device is capable of operating under control of different software programs, wherein a first program operates after resetting the implantable device and is not capable of providing significant medical functionality but is capable of selected telemetry operations including telemetry operations that allow replacement software to be downloaded, and wherein a second program may be caused to take control of the device and is capable of significant medical functionality and selected telemetry operations but is incapable of receiving replacement software. A software image may be received in multiple messages where each message is provided with its own validation code and wherein a validation code for the whole image is provided and wherein each provided validation code must compared to a derived validation code prior to accepting the validity of the replacement software.

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 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 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 MD processor is software controlled,

wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system such that the infusion device is configured to limit provision of the drug to the body of the patient,

wherein the software is transferable to the infusion device via the CD telemetry system, and

wherein the communication device acts as a conduit for passing replacement software from a second device to the infusion device.

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, or 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 second 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 1 wherein the infusion device is configured to cause software that allows infusion operations to occur to become inoperable prior to allowing any download of the replacement software to begin.

5. The system of claim 1 wherein when in the state for receiving the replacement software the infusion device is configured to provide a reduced amount of the drug to the body of the patient relative to an amount of the drug provided to the body of the patient when the infusion device is not in the state for receiving the replacement software.

6. The system of claim 1 wherein the communication device comprises a memory for storing the replacement software that may be transferred to the infusion device.

7. 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, or (5) an implantable electrode for selectively stimulating a portion of the body of the patient.

8. The system of claim 1 wherein replacement software for the second MD processor is downloadable to the first MD processor and is then transferable via an inter-processor communication link to one of (1) a RAM internal to the second MD processor, (2) a RAM external to the second MD processor, or (3) a non-volatile memory accessible by the second MD processor.

9. The system of claim 1 wherein at least a portion of the replacement software for the first MD processor is transferable to a non-volatile memory module that is external to the first MD processor.

10. The system of claim 1 wherein at least a portion of the replacement software for the first MD processor is transferable to a volatile memory module that is external to the first MD processor.

11. The system of claim 1 wherein the replacement software for the first MD processor is downloadable to RAM that is internal to the MD processor.

12. The system of claim 1 wherein at least a portion of the replacement software for the second MD processor is transferable to a non-volatile memory module that is external to the second MD processor.

13. The system of claim 1 wherein at least a portion of the replacement software for the second MD processor is transferable to a volatile memory module that is external to the second MD processor.

14. The system of claim 1 wherein the replacement software for the second MD processor is downloadable to RAM that is internal to the second MD processor.

15. 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 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) an ambulatory 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; and

c) a second device (SD), that comprises;

an SD user readable display;

an SD touch-sensitive input device;

an SD processor and an SD memory for receiving commands from the SD touch-sensitive input device and for controlling the SD display; and

an SD communication system, controlled by the SD processor, for sending and receiving signals to and from the communication device via a CD communication system within the communication device that is compatible with the CD communication system;

wherein the medical device comprises an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to the program held in the MD memory, and

wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of the medical device, and

wherein before the MD program may be downloaded to the medical device, the medical device is configured for limited medical activity.

16. The system of claim 15 wherein before the MD program may be downloaded to the medical device, the medical device is configured for reduced medical activity relative to a level of medical activity maintained when the MD program is not being downloaded to the medical device.

17. The system of claim 15 wherein the SD communication system comprises an infrared communication system.

18. The system of claim 15 wherein the MD program within the communication device is transferable from the second device to the communication device via the SD communication system.

19. The system of claim 15 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, or 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.

20. The system of claim 19 wherein (1) the MD electronic control circuitry comprises at least one external MD functional module, other than the second 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.

21. 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 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 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 medical device comprises an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to the program held in the MD memory,

wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device;

wherein before the MD program may be downloaded to the medical device, the medical device is configured for limited medical activity, and

wherein the medical device is implantable.

22. The system of claim 21 wherein the communication device further comprises:

a) a CD housing;

b) a user readable display supported by the CD housing and controlled by the CD processor; and

c) a touch sensitive input device supported by the housing and controlled by the CD processor.

23. The system of claim 21 wherein the program in the CD memory comprises a backup copy of the MD program stored in the MD memory.

24. The system of claim 21 wherein the program in CD memory is an upgrade version of the MD program stored in the MD memory.

25. The system of claim 21 wherein the communication device is controlled, at least in part, by a program running in the CD processor and wherein the MD program held in the CD memory is held in at least one memory module that is separate from a CD memory module holding CD program information.

26. The system of claim 25 wherein the CD memory module holding the MD program comprises a non-volatile memory.

27. The system of claim 26 wherein the non-volatile memory is replaceable so that the program carried therein may be replaced by a different program by installing a replacement non-volatile memory module holding the new program.

28. The system of claim 21 wherein the MD program in the CD memory comprises calibration factors for operating the medical device.

29. The system of claim 21 wherein before the MD program may be downloaded to the medical device, the medical device is configured for a reduced level of medical activity relative to a level of medical activity maintained when the MD program is not being downloaded to the medical device.

30. 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 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 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 MD processor is software controlled,

wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system such that quantities of the drug provided to the body of the patient while receiving the replacement software are different than quantities of the drug provided to the body while not receiving the replacement software; and

wherein the medical device is implantable.

31. The system of claim 30 wherein when in the state for receiving the replacement software reduced quantities of the drug are provided to the body of the patient by the infusion device relative to quantities of the drug provided to the body of the patient by the infusion device when the infusion device is not in the state for receiving the replacement software.

32. 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 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 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 MD processor controls, at least in part, operation of the medical device according to a program held in the MD memory,

wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device,

wherein before the MD program may be downloaded to the medical device, the medical device is configured for limited medical activity,

wherein at least a portion of the messages transferable to the medical device include patient definable parameters that can be used on a regular basis to modify the treatment or monitoring performed by the medical device; and

wherein the medical device is implantable.

33. 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 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 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 is software controlled,

wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and

wherein replacement software for a second MD processor is downloadable to the at least one MD processor and is then transferable via an inter-processor communication link to one of (1) a RAM internal to the second MD processor, (2) a RAM external to the second MD processor, or (3) a non-volatile memory accessible by the second MD processor.

34. 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 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 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 MD processor is software controlled,

wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is system, and capable of being put into a state for receiving replacement software via the MD telemetry

wherein the replacement software includes an error detection code that the at least one MD processor must confirm as correct prior to allowing the replacement software to be executed.

35. 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 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 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 medical device comprises an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to the program held in the MD memory,

wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device,

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, or (5) an implantable electrode for selectively stimulating a portion of the body of the patient,

wherein the communication device is controlled, at least in part, by a program running in the CD processor and wherein the MD program held in the CD memory is held in at least one memory module that is separate from a CD memory module holding CD program information,

wherein the CD memory module holding the MD program comprises a non-volatile memory, and

wherein the non-volatile memory is replaceable so that the program carried therein may be replaced by a different program by installing a replacement non-volatile memory module holding the new program.

36. 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 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 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 medical device comprises an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to the program held in the MD memory,

wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device,

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, or (5) an implantable electrode for selectively stimulating a portion of the body of the patient, and

wherein the MD program in the CD memory comprises calibration factors for operating the medical device.

37. 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 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 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 MD processor is software controlled,

wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and

wherein the replacement software for a second MD processor is downloadable to RAM that is internal to the second MD processor.

38. 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 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 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 MD processor is software controlled,

wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and

wherein the infusion device includes at least two MD processors, wherein the at least two MD processors execute different software, and wherein replacement software is transferable to a first memory module that is accessible by a first MD processor and to a second memory module that is accessible by a second MD processor.

39. 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 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 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 MD processor is software controlled,

wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and

wherein at least a portion of the replacement software for a second MD processor is transferable to a volatile memory module that is external to the second MD processor.

40. 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 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 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 MD processor is software controlled,

wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and

wherein at least a portion of the replacement software for a second MD processor is transferable to a non-volatile memory module that is external to the second MD processor.