Microprocessor controlled ambulatory medical apparatus with hand held communication device

• US 6,873,268 B2
• Filed: 01/22/2001
• Issued: 03/29/2005
• 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: Starkweather, Timothy J., Shahmirian, Varaz, Lebel, Ronald J., Bowman, Sam W. IV
• Primary Examiner(s): Horabik, Michael
• Assistant Examiner(s): Dang, Hung Q
• Application Number:
  US09/768,194
• Publication Number:
  US 20020065454A1
• Time in Patent Office: 1,527 Days
• Field of Search: 340/870.16, 607/60, 604/891.1, 604/67, 128/904, 128/920, 600/300, 606/41, 606/42
• US Class Current: 340/870.16
• 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 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; and

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

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

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

2. The method 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 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.

3. The method of claim 1, 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.

4. The method of claim 1:

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.

5. The method of claim 1:

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 time 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.

6. The method of claim 5, wherein the MD includes a pump controlled by an MD processor to selectively stroke to transfer the flowable medium and wherein said transferring further comprises controlling the pump to provide a number of pump strokes to transfer the flowable medium 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 flowable medium is transferred to the patient.

7. The method of claim 1, wherein the MD is configured to provide quantized amounts of flowable media to the body of the patient, the method further comprising adding fractional portions of the quantized amounts to an accumulator.

8. The method of claim 7, wherein the accumulator comprises a memory device for holding values, the method further comprising storing a first value and a second value in the accumulator memory device, the first value representing whole portions of the quantized amounts of treatment and the second value representing fractional portions of the quantized amounts of treatment.

9. The method of claim 7, further comprising transferring a quantized amount of media to the patient upon the amount in the accumulator equaling or exceeding the quantized amount, and decrementing the amount in the accumulator by the quantized amount upon transferring a quantized amount of media to the patient.

10. The method of claim 1, wherein the MD includes a pump controlled by an MD processor to selectively stroke to transfer the flowable medium and wherein the method further comprises controlling the pump to provide a number of pump strokes to cause a net volume of flowable medium to be transferred to the patient that is equal to the sum of the at least two quantities.

11. The method of claim 1:

wherein a first quantity of the at least two quantities comprises a basal rate at which the flowable media is continuously transferred to the patient;

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

wherein the MD includes a pump that is controlled to stroke to transfer the flowable medium to the patient; and

wherein transferring further comprises generating pump strokes at a maximum rate to transfer the bolus dose volume in addition to the volume transferred at the basal rate, so that the net amount of the flowable media transferred to the patient corresponds to the sum of the bolus dose volume and the volume transferred at the basal rate.

12. The method of claim 1 wherein the pumping mechanism provides pump strokes to transfer the flowable medium and wherein transferring further comprises:

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

providing flowable medium to the patient in a series of discrete time intervals, wherein the amount of the flowable 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 to an accumulator, upon each time interval, an amount of flowable medium to be delivered in the time interval;

generating any whole number of pump strokes indicated by the accumulator during each time interval; and

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