Microprocessor controlled ambulatory medical apparatus with hand held communication device

• US 6,648,821 B2
• Filed: 01/22/2001
• Issued: 11/18/2003
• 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: Morgan, Wayne A., Starkweather, Timothy J., Shahmirian, Varaz, Lebel, Ronald J., Bowman, Sam W. IV
• Primary Examiner(s): Dolinar, Andrew M.
• Application Number:
  US09/768,199
• Publication Number:
  US 20020019606A1
• Time in Patent Office: 1,030 Days
• Field of Search: 600/300, 604/891.1, 604/890.1, 604/67, 128/903, 128/DIG.13, 340/870.07, 340/870.09
• 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 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 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) 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,

c) a memory device for storing an estimated charge time for bringing the drive circuit to a voltage equal to or exceeding the preset voltage;

d) a control circuit for supplying energy to the drive circuit for the estimated time;

e) an analog-to-digital converter for measuring the voltage level on the drive circuit; and

f) circuit elements or a program running in an MD processor configured to compare the measured voltage to the preset voltage, to determine whether the estimated charge time should be modified, to determine whether the drive circuit is sufficiently activated to allow the drive circuit to power the pump, and to determine whether the drive circuit should be further activated prior to allowing activation of the pump,

wherein the medical device includes a component that requires activation to perform an intended function and wherein the activation state for the component is monitored, at least during preselected periods, by a monitoring circuit,

wherein the activation state is monitored to ensure that the drive circuit is not allowed to power the pump until the voltage on the drive circuit has a predefined relationship with preset voltage,

wherein the activation state is measured by a voltage level,

wherein the activation occurs by supplying energy to the drive circuit, and

wherein the medical device comprises an implantable infusion pump and the component is a drive circuit for a pumping mechanism.

2. The system of claim 1 wherein the circuit elements or the program determine that (1) the estimated charge time should be decreased if the measured voltage is greater than an upper range limit, (2) the estimated charge time should be increased if the measured voltage is less than a lower range limit, and (3) the estimated charge time should not be changed if the measured voltage is between the lower range limit and the upper range limit.

3. The system of claim 2 wherein a determination that the estimated charge time should be varied causes the estimated charge time to vary by a predefined amount of time.

4. The system of claim 3 wherein the predefined amount of time is less than 5% of the estimated charge time.

5. 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 includes a component that requires activation to perform an intended function and wherein the activation state for the component is monitored, at least during preselected periods, by a monitoring circuit, and

wherein circuitry or a processor running a program is provided that causes an estimated activation time, for the component, to move incrementally closer to an optimal activation time based on a comparison between a desired activation level and an activation level resulting from activating the component for the estimated activation time.

6. 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 includes a component that requires activation to perform an intended function and wherein the activation state for the component is monitored, at least during preselected periods, by a monitoring circuit, and

wherein the component is activated at least in part by charging a capacitor and the activation state is measured as voltage and wherein a preset voltage amount is determined, at least in part, based on a capacitance of the capacitor that is being charged.

7. 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 includes a component that requires activation to perform an intended function and wherein the activation state for the component is monitored, at least during preselected periods, by a monitoring circuit, and

wherein excessive leaks in the component are determined by activating the component and then monitoring activation state as a function of time.

8. The system of claim 7 wherein the component includes at least one capacitor.

9. 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 includes a component that requires activation to perform an intended function and wherein the activation state for the component is monitored, at least during preselected periods, by a monitoring circuit, and

wherein excess leakage of the component is determined by monitoring activation time and filtering out charge time variations associated with battery drainage.