Microprocessor controlled ambulatory medical apparatus with hand held communication device

• US 20050010269A1
• Filed: 07/28/2004
• Published: 01/13/2005
• Est. Priority Date: 01/21/2000
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medical Research Group, Inc. (Medtronic Plc)
• Inventors: Weiss, Philip T., Starkweather, Timothy J., Lebel, Ronald J.
• Granted Patent: US 7,831,310 B2
• Time in Patent Office: Days
• 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

1-19. -19. (Cancelled)

20. A method of delivering a medium to a patient employing a medical system having an ambulatory medical device (MD) for providing treatment to a body of a patient or to monitor a selected state of the patient'"'"'s body, and a communication device (CD) for sending messages to or receiving messages from the MD, the method comprising:

containing a flowable medium in a reservoir of the MD;

transferring at least a portion of the flowable medium from the reservoir to the patient with a pumping mechanism;

programming the communication device with at least two quantities relating to drug delivery; and

configuring the medical device to deliver a drug based on the combined amounts associated with the at least two quantities.

21. The method of claim 20, wherein the MD comprises at least one of (1) an implantable infusion pump for selectively dispensing a selected drug, (2) an implantable sensor for sensing a selected state of the body, and (3) an implantable electrode for selectively stimulating a portion of the body of the patient.

22. The method of claim 20, wherein the MD comprises at least one of (1) an implantable infusion pump for selectively dispensing insulin, and (2) an implantable sensor for sensing glucose level.

23. The method of claim 20:

wherein the at least two quantities represent amounts of a medium to be delivered;

wherein the method includes adding the at least two quantities together; and

wherein said transferring includes delivering a net amount of drug that is equal to the sum of the at least two quantities.

24. The method of claim 20:

wherein a first quantity of the at least two quantities comprises a basal rate at which the medium is continuously delivered;

wherein a second quantity of the at least two quantities comprises a bolus dose amount of the medium;

wherein a third quantity of the at least two quantities comprises a bolus dose duration during which the bolus dose amount of the medium is administered;

wherein a bolus rate is set as the bolus dose amount divided by the bolus dose duration; and

wherein said transferring comprises delivering the medium at a rate equal to the sum of the basal rate and the bolus rate for a time equal to the bolus duration so as to cause a temporary increase in the rate at which the medium is delivered.

25. A method of delivering a medium to a patient employing a medical system having an ambulatory medical device (MD), for providing treatment to a body of a patient or to monitor a selected state of the patient'"'"'s body, and a communication device (CD) for sending messages to or receiving messages from the MD, the method comprising:

providing the MD with at least one treatment amount or monitoring amount accumulator for accumulating fractional portions of a quantized amount;

configuring the MD to provide at least one quantized amount of treatment to or monitoring of the body of a patient, upon the accumulator accumulating at least one quantized amount of treatment or monitoring; and

periodically adding fractional portions of quantized amounts to the accumulator.

26. The method of claim 25, further comprising:

containing a treatment medium in a reservoir of the MD;

providing a pumping mechanism for delivering a quantized amount of the medium to the body of a patient for each pump stroke of the pumping mechanism;

delivering medium to the body of a patient, with the pumping mechanism, in a series of discrete time intervals, wherein the amount of the medium to be delivered in each time interval is represented as a number of whole pump strokes and a number of fractional pump strokes;

adding, during each time interval, the amount of the medium to be delivered in the time interval to the accumulator;

wherein said delivering comprises operating the pumping mechanism to provide any whole number of pump strokes indicated by the accumulator in the time interval; and

decrementing the accumulator by one for each pump stroke that is delivered.

27. A method for operating an ambulatory medical device (MD) having MD electronic control circuitry that has at least one MD telemetry system and at least one MD processor, and a communication device (CD) having CD electronic control circuitry that has at least one CD telemetry system and at least one CD processor, the method comprising

providing, with the MD, a treatment to a body of a patient or monitoring a selected state of the body;

and

sending or receiving, with the CD telemetry system, messages to or from the MD telemetry system,

containing an infusion media in a reservoir of the MD;

transferring infusion media from the reservoir of the MD to the body of the patient,

programming the CD with at least two quantities relating to at least two amounts of infusion media delivery;

delivering the infusion media with the medical device by generating a number of pump strokes of the pumping mechanism to transfer a volume of infusion media that corresponds to the simultaneous delivery of the at least two amounts;

wherein the at least two quantities represent volumes of the infusion media to be delivered; and

wherein the medical device generates a number of pump strokes to cause a net volume of infusion media to be delivered that is equal to the sum of the at least two quantities.

28. The method of claim 27 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, or (5) an implantable electrode for selectively stimulating a portion of the body of the patient.

29. The method of claim 27 wherein the at least two quantities comprise a bolus and a basal quantity.

30. The method of claim 27 wherein at least one of the at least two quantities is programmed as a delivery rate.

43. The method of claim 27 wherein at least one of the at least two amounts of infusion media delivery is a volume of infusion media to be delivered.

44. The method of claim 27 wherein at least one of the at least two amounts of infusion media delivery is a rate at which infusion media is to be delivered.

45. The method of claim 27, further comprising

calculating, with the CD, from the at least two quantities, the number of pump strokes to be generated in a specified time interval by the medical device, and

sending, with the CD, a message containing the number of pump strokes to the medical device.

46. The method of claim 27,

calculating, from the at least two quantities, the number of pump strokes to be generated in a specified time interval by the medical device;

wherein the number of pump strokes consists of an integer number of pump strokes and a fractional number of pump strokes.

47. The method of claim 27,

determining, with the MD, from the at least two quantities, the number of pump strokes to be generated in a specified time interval.

31. A method for operating an ambulatory medical device (MD) having MD electronic control circuitry that has at least one MD telemetry system and at least one MD processor, and a communication device (CD) having CD electronic control circuitry that has at least one CD telemetry system and at least one CD processor, the method comprising

providing, with the MD, a treatment to a body of a patient or monitoring a selected state of the body;

and

sending or receiving, with the CD telemetry system, messages to or from the MD telemetry system;

providing, with the MD, a quantized amount of treatment to or monitoring of the body of the patient;

periodically adding to at least one treatment amount accumulator or monitoring amount accumulator fractional portions of the quantized amounts;

holding a first value and a second value in the accumulator, wherein the first value represents whole portions of the quantized amounts of treatment to or monitoring of the body of the patient and wherein the second value represents fractional portions of the quantized amounts of treatment to or monitoring of the body of the patient.

32. The method of claim 31 wherein the accumulator comprises a treatment amount accumulator.

33. The method of claim 32 wherein the medical device comprises an infusion mechanism controlled by the MD processor, wherein the medical device is configured to provide a quantized amount of an infusion media to the body of the patient, and wherein the treatment amount accumulator is a dispensing amount accumulator.

34. The method of claim 31 wherein delivering infusion media comprises infusing a quantized amount of the infusion media when an amount in the accumulator is equal to or exceeds the quantized amount and wherein the amount in the accumulator is decremented by the quantized amount based on each quantized amount infused.

35. The method of claim 33 wherein the infusion mechanism is a pulsatile pumping device.

36. The method of claim 33 wherein the infusion mechanism is a electromagnetically activated piston pump.

37. The method of claim 31 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.

38. The method of claim 31:

wherein the at least two quantities represent amounts of a drug to be delivered; and

wherein the at least two quantities are added together to cause a net amount of drug to be delivered that is equal to the sum of the at least two quantities.

41. The method of claim 31:

wherein the accumulator comprises a memory device for holding a first value and a second value;

wherein the first value represents whole portions of the quantized amounts of treatment or monitoring of the body of a patient; and

wherein the second value represents fractional portions of the quantized amounts of treatment to or monitoring of the body of a patient.

42. The system of claim 31:

wherein the medical device comprises a reservoir capable of containing an infusion media and a pumping mechanism for transferring the infusion media from the reservoir to the body of the patient;

wherein a quantized amount of the infusion media is delivered to the body of the patient for each pump stroke of the pumping mechanism;

wherein the medical device provides the infusion media to the body of the patient in a series of discrete time intervals;

wherein the amount of the infusion media to be delivered in each time interval is represented as a number of whole pump strokes and a number of fractional pump strokes;

wherein during each time interval, the amount of the infusion media to be delivered in the time interval is added to the accumulator;

wherein any whole number of pump strokes indicated by the accumulator are delivered in the time interval; and

wherein the accumulator is decremented by one for each pump stroke that is delivered.

39. A method for operating an ambulatory medical device (MD) having MD electronic control circuitry that has at least one MD telemetry system and at least one MD processor, and a communication device (CD) having CD electronic control circuitry that has at least one CD telemetry system and at least one CD processor, the method comprising

providing, with the MD, a treatment to a body of a patient or monitoring a selected state of the body;

and

sending or receiving, with the CD telemetry system, messages to or from the MD telemetry system;

containing an infusion media in a reservoir of the MD;

containing a pumping mechanism in the MD for transferring the infusion media from the reservoir to the body of the patient;

programming the communication device with at least two quantities relating to at least two amounts of infusion media delivery, and

delivering infusion media with the MD by generating a number of pump strokes of the pumping mechanism to transfer a volume of infusion media that corresponds to the simultaneous delivery of the at least two amounts;

wherein a first quantity of the at least two quantities comprises a basal rate at which the infusion media is continuously delivered;

wherein a second quantity of the at least two quantities comprises a bolus dose volume of the infusion media;

wherein a third quantity of the at least two quantities comprises a bolus dose time duration during which the bolus dose volume of the infusion media is administered;

wherein a bolus rate is set as the bolus dose volume divided by the bolus dose time duration; and

wherein the MD generates pump strokes to transfer the infusion media at a rate that corresponds to the sum of the basal rate and the bolus rate for a time equal to the bolus duration so as to cause a temporary increase in the rate at which the infusion media is delivered.

40. A method for operating an ambulatory medical device (MD) having MD electronic control circuitry that has at least one MD telemetry system and at least one MD processor, and a communication device (CD) having CD electronic control circuitry that has at least one CD telemetry system and at least one CD processor, the method comprising

providing, with the MD, a treatment to a body of a patient or monitoring a selected state of the body;

and

sending or receiving, with the CD telemetry system, messages to or from the MD telemetry system;

containing an infusion media in a reservoir of the MD;

containing a pumping mechanism in the MD for transferring the infusion media from the reservoir to the body of the patient;

programming the communication device with at least two quantities relating to at least two amounts of infusion media delivery, and

delivering infusion media with the MD by generating a number of pump strokes of the pumping mechanism to transfer a volume of infusion media that corresponds to the simultaneous delivery of the at least two amounts;

wherein a first quantity of the at least two quantities comprises a basal rate at which the infusion media is continuously delivered;

wherein a second quantity of the at least two quantities comprises a bolus dose volume of the drug;

wherein the medical device generates pump strokes as quickly as possible to transfer the bolus dose volume in addition to the volume of infusion media transferred at the basal rate, so that the net amount of the infusion media delivered corresponds to the sum of the bolus dose volume and the volume of the infusion media delivered at the basal rate.