System and method of managing medical device historical data

• US 20050283210A1
• Filed: 06/20/2005
• Published: 12/22/2005
• Est. Priority Date: 06/21/2004
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Blischak, Brian R., McCormick, Robert L. Jr., Hill, Roger J.
• Granted Patent: US 7,840,268 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• 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 1/3925 Monitoring; Protecting
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Disclosed are systems and methods which provide management of historical information associated with a medical device, such as an implantable neurostimulation pulse generator, drug pump, cardiac device, hearing enhancement device, or vision enhancement device. Such management of historical information includes storage of historical information within an associated medical device. Historical information stored within a medical device may provide a complete summary of the use, configuration, and operation of the medical device, e.g., information spanning the entire in-service life of the medical device. Historical information for which management is provided may include both static data and dynamic data. The historical information may be used in configuring the medical device, analyzing the operation of the medical device, autonomously altering operation of the medical device, etcetera.

Claims

1. A medical device historical information management system comprising:

a therapeutic medical device;

a controller disposed within said therapeutic medical device, said controller controlling operation of said therapeutic medical device to provide a prescribed therapy; and

a historical information memory disposed within said therapeutic medical device, said historical information memory storing non-current information associated with the operation of said medical device.

2. The system of claim 1, wherein said medical device comprises an implantable medical device.

3. The system of claim 2, wherein said medical device is selected from the group consisting of:

a pulse generator used in neurostimulation;

an implantable drug pump used in localized delivery of an infusate;

a pacemaker used in cardiac therapy;

a hearing enhancement device used in aural therapy; and

a vision enhancement device used in sight therapy.

4. The system of claim 1, wherein said non-current information comprises information selected from the group consisting of:

control parameters previously implemented with respect to said medical device;

settings previously implemented with respect to said medical device;

clinician notes;

a snapshot of a selected medical device attribute;

information with respect to the occurrence of an event during operation of said medical device;

information with respect to the non-occurrence of an event during operation of said medical device; and

information provided by a sensor in communication with the medical device.

5. The system of claim 1, wherein said controller is coupled to said historical information memory, and wherein said non-current information includes operational attribute information provided by said controller.

6. The system of claim 1, wherein said controller is coupled to said historical information memory, wherein said controller controls at least one operational aspect of said medical device as a function of said non-current information stored by said historical information memory.

7. The system of claim 1, further comprising:

an external processor-based system in communication with said historical information memory, wherein said external processor-based system uses said non-current information to provide a function selected from the group consisting of;

to present a report to a user;

to verify control parameter changes selected by a user;

to develop a graphical representation of operation of said medical device within a window of time; and

to determine a result associated with a change selected by a user.

8. The system of claim 7, wherein said external processor-based system stores non-current information to said historical information memory.

9. The system of claim 8, wherein said non-current information stored to said historical information memory by said external processor-based system comprises clinician notes.

10. The system of claim 8, wherein said non-current information is stored to said historical information memory by said external processor-based system automatically based upon a function performed by said external processor-based system.

11. A medical device historical information management system comprising:

a therapeutic medical device;

a historical information memory disposed within said therapeutic medical device, said historical information memory storing non-current information associated with the operation of said medical device; and

a clinician programmer adapted to communicate with said medical device to provide control parameters thereto and to obtain information therefrom, wherein an instruction set of said clinician programmer obtains at least a portion of said non-current information from said medical device during a communication session between said medical device and said clinician programmer.

12. The system of claim 11, wherein said instruction set uses said at least a portion of said non-current information obtained from said medical device to verify a control parameter adjustment made by a clinician.

13. The system of claim 11, wherein said instruction set provides at least a portion of said non-current information to said medical device during a communication session between said medical device and said clinician programmer.

14. A method for managing medical device historical information, said method comprising:

providing a therapeutic medical device for delivering a desired therapy to a patient;

providing a memory in association with said therapeutic medical device; and

storing historical information regarding operation of said therapeutic medical device in said memory.

15. The method of claim 14, further comprising:

periodically monitoring an operational attribute of said medical device, wherein said storing historical information in said memory stores information with respect to said periodically monitored operational attribute.

16. The method of claim 14, further comprising:

updating a control parameter of said medical device, wherein said storing historical information in said memory stores information with respect to a previous setting of said updated control parameter.

17. The method of claim 14, further comprising:

detecting a predetermined event, wherein said storing historical information in said memory stores information with respect to occurrence of said event.

18. The method of claim 14, further comprising:

modifying an operational aspect of said medical device as a function of said historical information.

19. The method of claim 14, further comprising:

communicating at least a portion of said historical information to an external processor-based system.

20. The method of claim 14, wherein said storing historical information comprises:

providing temporal information with respect to a record of said historical information; and

varying a resolution of said temporal information as a function of a type of data provided in said record.