Microprocessor controlled ambulatory medical apparatus with hand held communication device

• US 7,678,071 B2
• Filed: 04/10/2003
• Issued: 03/16/2010
• 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): Desanto; Matthew F
• Application Number:
  US10/411,424
• Publication Number:
  US 20030176933A1
• Time in Patent Office: 2,532 Days
• Field of Search: 607/30, 607/60, 607/31, 607/32, 607/3, 604 65- 67, 604/891.1, 604131-154, 340/870.16, 600/300
• US Class Current: 604/67
• 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 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, and a communication device (CD) for sending messages to or receiving messages from the MD, the method comprising:

storing a delivery profile containing a plurality of parameter values, each value corresponding to a predefined time period that is used to control the treatment provided to the body;

providing the MD with at least one treatment amount numerical accumulator for accumulating numerical values corresponding to the fractional portions of a quantized amount;

deriving an initial value for the numerical accumulator from the delivery profile;

configuring the MD to provide at least one quantized amount of treatment to the body of the patient, upon the numerical accumulator accumulating a numerical value corresponding to at least one quantized amount of treatment;

adding during each time interval, numerical values corresponding to fractional portions of quantized amounts to the numerical accumulator; and

retaining a numerical value corresponding to the remaining portion of the quantized amount of the treatment in the numerical accumulator for later delivery;

wherein configuring the MD to provide at least one quantized amount of treatment to the body of the patent comprises;

delivering the medium to the body of a patient, with a 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 or a number of fractional pump strokes; and

wherein the numerical value corresponding to fractional pump strokes are added to the numerical accumulator to reach a value corresponding to the volume of a whole pump stroke and the MD is configured to deliver the medium in whole pump strokes.

2. The method of claim 1, wherein the numerical accumulator has a first storage value and a second storage value, the first storage value configured to store whole portions of the quantized amount of treatment and in the second storage value the numerical accumulator stores numerical values corresponding to the fractional portions of the quantized amount of treatment.

3. The method of claim 2, wherein the first and second storage locations digitally store the amount of treatment and increment and decrement the numerical accumulator amount after the delivery of the at least portion of the quantized amount of the treatment.

4. The method of claim 2, wherein the first storage location is at least five bits and the second storage location is at least eleven bits.

5. The method of claim 1, further comprising:

containing a treatment medium in a reservoir of the MD;

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

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

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

6. A method as recited in claim 1, wherein the numerical accumulator comprises an electronic memory.

7. The method of claim 1, wherein providing the MD with at least one treatment amount or monitoring amount numerical accumulator comprises providing a basal rate accumulator, a phase-1 bolus accumulator, and a phase-2 bolus accumulator, and wherein deriving an initial value comprises:

deriving an initial value for the basal rate accumulator from the delivery profile, unless a temporary basal rate is requested in which case the initial value of the numerical accumulator is derived from a temporary basal rate requested;

deriving an initial value for the phase-1 bolus accumulator to the number of pump strokes required to deliver a requested immediate bolus amount; and

deriving an initial value for the phase-2 bolus accumulator to a derived number of pump strokes that must be performed in addition to those required for the basal rate deliveries.

8. The method of claim 7, wherein configuring the MD to provide at least one quantized amount of treatment to or monitoring amount of the body of patient comprises processing deliveries based on values stored in the phase 1 bolus accumulator, followed by processing deliveries based on the values stored in the phase-2 bolus accumulator, and followed by processing deliveries based on the values stored in the basal rate accumulator.

9. 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:

storing a delivery profile containing a plurality of parameter values, each value corresponding to a predefined time period that is used to control the treatment provided to the body;

providing the MD with at least one numerical accumulator for accumulating numerical values corresponding to the fractional portions of a quantized treatment amount;

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;

delivering at least a portion of the quantized amount of the infusion media; and

retaining a numerical value corresponding to the remaining portion of the quantized amount of the infusion media in the numerical accumulator for later delivery;

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

deriving at least one of the quantities from the delivery profile; and

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 volume 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;

delivering the medium to the body of a patient, with a 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 or a number of fractional pump strokes; and

wherein the numerical value corresponding to fractional pump strokes are added to the numerical accumulator to reach a value corresponding to the volume of a whole pump stroke and the MD is configured to deliver the medium in whole pump strokes.

10. The method of claim 9 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.

11. The method of claim 9 wherein the at least two quantities comprise a bolus and a basal quantity.

12. The method of claim 9 wherein at least one of the at least two quantities is programmed as a delivery rate.

13. The method of claim 9 wherein at least one of the at least two amounts of infusion media delivery is a volume of infusion media to be delivered or a rate at which infusion media is to be delivered.

14. The method of claim 9, 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.

15. The method of claim 9,

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.

16. The method of claim 9,

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

17. 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:

storing a delivery profile containing a plurality of parameter values, each value corresponding to a predefined time period that is used to control the treatment provided to the body;

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

deriving the quantized amount from the delivery profile if it represents a basal delivery rate;

adding during each time interval, numerical value corresponding to at least one treatment amount to a numerical accumulator or fractional portions of the quantized amounts;

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

retaining a numerical value corresponding to the remaining portion of the quantized amount of the treatment in the numerical accumulator for later delivery;

delivering the medium to the body of a patient, with a 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 or a number of fractional pump strokes; and

wherein the numerical value corresponding to fractional pump strokes are added to the numerical accumulator to reach a value corresponding to the volume of a whole pump stroke and the MD is configured to deliver the medium in whole pump strokes.

18. The method of claim 17 wherein the numerical accumulator comprises a treatment amount numerical accumulator.

19. The method of claim 18 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 numerical accumulator is a dispensing amount accumulator.

20. The method of claim 19 wherein the infusion mechanism is a pulsatile pumping device.

21. The method of claim 19 wherein the infusion mechanism is a electromagnetically activated piston pump.

22. The method of claim 17, wherein providing the MD with at least one treatment amount or monitoring amount numerical accumulator comprises providing a basal rate accumulator, a phase-i bolus accumulator, and a phase-2 bolus accumulator, and wherein deriving initial values for the numerical accumulators comprises:

setting an initial value for the basal rate accumulator from the delivery profile, unless a temporary basal rate is requested in which case the initial value of the numerical accumulator is derived from a temporary basal rate requested;

setting an initial value for the phase-1 bolus accumulator to the number of pump strokes required to deliver a requested immediate bolus amount; and

setting an initial value for the phase-2 bolus accumulator to a derived number of pump strokes that must be performed in addition to those required for the basal rate deliveries.

23. The method of claim 22, wherein configuring the MD to provide at least one quantized amount of treatment to or monitoring amount of the body of patient comprises processing deliveries based on values stored in the phase 1 bolus accumulator, followed by processing deliveries based on the values stored in the phase-2 bolus accumulator, and followed by processing deliveries based on the values stored in the basal rate accumulator.

24. The method of claim 17 wherein delivering infusion media comprises infusing a quantized amount of the infusion media when an value in the numerical accumulator is equal to or exceeds the quantized amount and wherein the value in the numerical accumulator is decremented by the quantized amount based on each quantized amount infused.

25. The method of claim 17 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.

26. The method of claim 17:

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.

27. The method of claim 17:

wherein the numerical 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 numerical values corresponding to fractional portions of the quantized amounts of treatment to or monitoring of the body of a patient.

28. The method of claim 17:

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 numerical accumulator;

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

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

29. 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:

storing a delivery profile containing a plurality of parameter values, each value corresponding to a predefined time period that is used to control the treatment provided to the body;

providing the MD with at least one numerical accumulator for accumulating numerical values corresponding to fractional portions of a quantized infusion media amount;

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

deriving at least one of the quantities from the delivery profile;

delivering at least a portion of the quantized amount of 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;

retaining a numerical value corresponding to the remaining portion of the quantized amount of the treatment in the numerical accumulator for later delivery;

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;

wherein the numerical value corresponding to fractional pump strokes are added to the numerical accumulator to reach a value corresponding to the volume of a whole pump stroke and the MD is configured to deliver the medium in whole pump strokes.

30. 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:

storing a delivery profile containing a plurality of parameter values, each value corresponding to a predefined time period that is used to control the treatment provided to the body;

providing the MD with at least one numerical accumulator for accumulating numerical values corresponding to the fractional portions of a quantized infusion media amount;

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;

deriving at least one of the quantities from the delivery profile;

delivering at least a portion of the quantized amount of the 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;

providing the numerical accumulator for storing the at least two values of infusion media and the numerical accumulator retaining a numerical value corresponding to the remaining portion of the at least two values of the infusion media in the numerical accumulator for later delivery;

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

wherein a second quantity of the at least two values 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; and

wherein a numerical value corresponding to fractional pump strokes are added to the numerical accumulator to reach a value corresponding to the volume of a whole pump stroke and the MD is configured to deliver the medium in whole pump strokes.