Ambulatory medical apparatus and method using a robust communication protocol

• US 20040210267A1
• Filed: 05/11/2004
• Published: 10/21/2004
• Est. Priority Date: 01/21/2000
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shahmirian, Varaz, Lebel, Ronald J., Armstrong, John T., Bowman, Sam W. IV, Richert, John D., Dennard, Robert C.
• Granted Patent: US 7,024,245 B2
• Time in Patent Office: Days
• US Class Current: 607/32
• 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 external device communicate with one another via telemetry wherein messages are transmitted under a robust communication protocol. The communication protocol gives enhanced assurance concerning the integrity of messages that impact medical operations of the implantable device. Messages are transmitted using a multipart format that includes a preamble, a frame sync, a telemetry ID, data, and a validation code. The data portion of the message includes an op-code that dictates various other elements that form part of the message. The data portion may also include additional elements such as sequence numbers, bolus numbers, and duplicate data elements. A telemetry ID for the transmitting device may be implicitly embedded in the message as part of the validation code that is sent with the message and that must be pre-known by the receiver to confirm the integrity of the received message.

Claims

1-20. -20. (Canceled)

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 MD telemetry system is configured to perform a bit pattern recognition that allows a selected level of fault tolerance in concluding that a selected portion of a message matches an expected pattern to be received.

22. The system of claim 21 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.

23. The system of claim 22 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.

24. The system of claim 21 wherein the bit pattern recognition and the fault tolerance analysis is performed by hardware components.

25. The system of claim 21 wherein at least part of the bit recognition or fault tolerance analysis is performed via software that is being executed by a microprocessor that is operating within the medical device.

26. The system of claim 21 wherein the selected portion of the message is a preamble that is intended to hold the attention of the MD telemetry system for a period of time.

27. The system of claim 26 wherein the period of time is controlled by the length of time that the preamble is being received by the MD telemetry system.

28. The system of claim 26 wherein the period of time is about 24-bit times or more.

29. The system of claim 28 wherein the period of time is about 48-bit times or more.

30. The system of claim 28 wherein the period of time is about 96-bit times or more.

31. The system of claim 21 wherein the fault tolerance is greater than or equal to 1-bit out of 256-bits.

32. The system of claim 31 wherein the fault tolerance is greater than or equal to 1-bit out of 128-bits.

33. The system of claim 32 wherein the fault tolerance is greater than or equal to 1-bit out of 64-bits.

34. The system of claim 21 wherein the fault tolerance is less than or equal to 32-bits out of 256-bits.

35. The system of claim 21 wherein the fault tolerance is less than or equal to 8-bits out of 128-bits.

36. The system of claim 21 wherein the fault tolerance is less than or equal to 4-bits out of 64-bits.

37. The system of claim 21 wherein the fault tolerance is between 1 out of 64-bits and 4 out of 64-bits, inclusive.

38. The system of claim 21 wherein the medical device comprises an implantable infusion pump for selectively dispensing a drug.

39. The system of claim 38 wherein the drug comprises insulin.

40. The system of claim 21 wherein the medical device comprises an implantable sensor for sensing a selected state of the body.

41. The system of claim 40 wherein the sensor comprises a glucose sensor.

42. The system of claim 21 wherein the medical device comprises an implantable electrode for selectively stimulating a portion of the body of the patient.