Ambulatory medical apparatus and method having telemetry modifiable control software
First Claim
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; 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 processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system such that the infusion device is configured to limit provision of the drug to the body of the patient, wherein the software is transferable to the infusion device via the CD telemetry system, and wherein the communication device acts as a conduit for passing replacement software from a second device to the infusion device.
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Accused Products
Abstract
An implanted medical device (e.g. infusion pump) and handheld communication device wherein the implantable device is capable of operating under control of different software programs, wherein a first program operates after resetting the implantable device and is not capable of providing significant medical functionality but is capable of selected telemetry operations including telemetry operations that allow replacement software to be downloaded, and wherein a second program may be caused to take control of the device and is capable of significant medical functionality and selected telemetry operations but is incapable of receiving replacement software. A software image may be received in multiple messages where each message is provided with its own validation code and wherein a validation code for the whole image is provided and wherein each provided validation code must compared to a derived validation code prior to accepting the validity of the replacement software.
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Citations
40 Claims
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1. A medical system, comprising:
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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 processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system such that the infusion device is configured to limit provision of the drug to the body of the patient, wherein the software is transferable to the infusion device via the CD telemetry system, and wherein the communication device acts as a conduit for passing replacement software from a second device to the infusion device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A medical system, comprising:
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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) an ambulatory 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; and
c) a second device (SD), that comprises;
an SD user readable display;
an SD touch-sensitive input device;
an SD processor and an SD memory for receiving commands from the SD touch-sensitive input device and for controlling the SD display; and
an SD communication system, controlled by the SD processor, for sending and receiving signals to and from the communication device via a CD communication system within the communication device that is compatible with the CD communication system;
wherein the medical device comprises an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to the program held in the MD memory, and wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of the medical device, and wherein before the MD program may be downloaded to the medical device, the medical device is configured for limited medical activity. - View Dependent Claims (16, 17, 18, 19, 20)
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21. A medical system, comprising:
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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 comprises an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to the program held in the MD memory, wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device;
wherein before the MD program may be downloaded to the medical device, the medical device is configured for limited medical activity, and wherein the medical device is implantable. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29)
a) a CD housing;
b) a user readable display supported by the CD housing and controlled by the CD processor; and
c) a touch sensitive input device supported by the housing and controlled by the CD processor.
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23. The system of claim 21 wherein the program in the CD memory comprises a backup copy of the MD program stored in the MD memory.
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24. The system of claim 21 wherein the program in CD memory is an upgrade version of the MD program stored in the MD memory.
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25. The system of claim 21 wherein the communication device is controlled, at least in part, by a program running in the CD processor and wherein the MD program held in the CD memory is held in at least one memory module that is separate from a CD memory module holding CD program information.
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26. The system of claim 25 wherein the CD memory module holding the MD program comprises a non-volatile memory.
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27. The system of claim 26 wherein the non-volatile memory is replaceable so that the program carried therein may be replaced by a different program by installing a replacement non-volatile memory module holding the new program.
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28. The system of claim 21 wherein the MD program in the CD memory comprises calibration factors for operating the medical device.
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29. The system of claim 21 wherein before the MD program may be downloaded to the medical device, the medical device is configured for a reduced level of medical activity relative to a level of medical activity maintained when the MD program is not being downloaded to the medical device.
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30. A medical system, comprising:
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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 processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system such that quantities of the drug provided to the body of the patient while receiving the replacement software are different than quantities of the drug provided to the body while not receiving the replacement software; and
wherein the medical device is implantable. - View Dependent Claims (31)
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32. A medical system, comprising:
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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 processor controls, at least in part, operation of the medical device according to a program held in the MD memory, wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device, wherein before the MD program may be downloaded to the medical device, the medical device is configured for limited medical activity, wherein at least a portion of the messages transferable to the medical device include patient definable parameters that can be used on a regular basis to modify the treatment or monitoring performed by the medical device; and
wherein the medical device is implantable.
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33. A medical system, comprising:
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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 at least one MD processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and wherein replacement software for a second MD processor is downloadable to the at least one MD processor and is then transferable via an inter-processor communication link to one of (1) a RAM internal to the second MD processor, (2) a RAM external to the second MD processor, or (3) a non-volatile memory accessible by the second MD processor.
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34. A medical system, comprising:
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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 processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is system, and capable of being put into a state for receiving replacement software via the MD telemetry wherein the replacement software includes an error detection code that the at least one MD processor must confirm as correct prior to allowing the replacement software to be executed.
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35. A medical system, comprising:
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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 comprises an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to the program held in the MD memory, wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device, 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, or (5) an implantable electrode for selectively stimulating a portion of the body of the patient, wherein the communication device is controlled, at least in part, by a program running in the CD processor and wherein the MD program held in the CD memory is held in at least one memory module that is separate from a CD memory module holding CD program information, wherein the CD memory module holding the MD program comprises a non-volatile memory, and wherein the non-volatile memory is replaceable so that the program carried therein may be replaced by a different program by installing a replacement non-volatile memory module holding the new program.
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36. A medical system, comprising:
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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 comprises an MD memory for holding an MD program and wherein the MD processor controls operation of the medical device, at least in part, according to the program held in the MD memory, wherein a CD memory holds an MD program that may be downloaded to the medical device and then used to control, at least in part, the operation of medical device, 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, or (5) an implantable electrode for selectively stimulating a portion of the body of the patient, and wherein the MD program in the CD memory comprises calibration factors for operating the medical device.
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37. A medical system, comprising:
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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 processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and wherein the replacement software for a second MD processor is downloadable to RAM that is internal to the second MD processor.
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38. A medical system, comprising:
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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 processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and wherein the infusion device includes at least two MD processors, wherein the at least two MD processors execute different software, and wherein replacement software is transferable to a first memory module that is accessible by a first MD processor and to a second memory module that is accessible by a second MD processor.
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39. A medical system, comprising:
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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 processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and wherein at least a portion of the replacement software for a second MD processor is transferable to a volatile memory module that is external to the second MD processor.
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40. A medical system, comprising:
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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 processor is software controlled, wherein the medical device comprises an ambulatory infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system, and wherein at least a portion of the replacement software for a second MD processor is transferable to a non-volatile memory module that is external to the second MD processor.
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Specification