Change log for implantable medical device

• US 7,089,056 B2
• Filed: 11/13/2001
• Issued: 08/08/2006
• Est. Priority Date: 08/20/1999
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Koshiol, Allan T., Mackey, LeAnne Marie
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US10/010,845
• Publication Number:
  US 20020042636A1
• Time in Patent Office: 1,729 Days
• Field of Search: 607 27- 31, 607/59, 607/60
• US Class Current: 607/27
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

A method and system for recording changes to programmable parameters in an implantable pulse generator. An executable program is stored in an implantable pulse generator. A parameter log is maintained in the implantable pulse generator, where the parameter log is used to record changes to the state of one or more programmable parameters of the executable program. When a change is detected in the state, from a first state to a second state, of the one or more programmable parameters the first state of the one or more programmable parameters changed to the second state are recorded in the parameter log. The parameter log is retrievable to allow for analysis of when and how changes took place to the executable program.

Claims

1. A method, comprising:

storing an executable program in an implantable pulse generator, wherein the executable program includes at least one programmable parameter having a first state;

storing a parameter log in the implantable pulse generator;

detecting an error in a change in the first state of the at least one programmable parameter to a second state; and

storing in the parameter log the first state of the at least one programmable parameters changed in error to the second state.

2. The method of claim 1, wherein detecting the error in a change in the first state of the at least one programmable parameter to the second state includes detecting the error after one of a deactivation of the executable program and an activation of the executable program.

3. The method of claim 1, wherein storing the parameter log includes:

establishing a communication link between the implantable pulse generator and a medical device programmer; and

transmitting the parameter log stored in the implantable pulse generator to the medical device programmer.

4. The method of claim 3, wherein establishing the communication link includes:

transmitting a first signal from the medical device programmer to change the first state of the one or more programmable parameters to the second state; and

receiving the first signal to change the first state of the one or more programmable parameters to the second state.

5. The method of claim 1, wherein detecting the error in a change in the first state of the at least one programmable parameter to the second state includes detecting the error after a non-programmer initiated change from the first state of the one or more programmable parameters to the second state.

6. The method of claim 1, wherein detecting the error in a change in the first state of the at least one programmable parameter to the second state includes detecting the error after an expiration of energy supplied by a battery in the implantable pulse generator.

7. The method of claim 1, wherein detecting the error in a change in the first state of the at least one programmable parameter to the second state includes detecting the error after execution of an electronic circuitry reset program.

8. The method of claim 1, wherein detecting the error in a change the error in a change in the first state to the second state includes detecting the error after termination of the executable program.

9. The method of claim 1, wherein detecting the error in a change in the first state of the at least one programmable parameter to the second state includes detecting the error after use of a magnetic signal to control operation of the implantable pulse generator.

10. The method of claim 1, wherein storing includes recording execution of an integrity correction program in the implantable pulse generator.

11. The method of claim 1, wherein detecting the error in a change in the first state of the at least one programmable parameter to the second state includes detecting the error after a change due to an influence external to the implantable pulse generator.

12. A system including an implantable pulse generator, programmer and a communication link between the implantable pulse generator and the programmer, the implantable pulse generator comprising:

an executable program in an implantable pulse generator, wherein the executable program includes one or more programmable parameters having a first state and a second state;

a parameter log for storing a change in a state of the one or more programmable parameters;

the programmer comprising means for producing a first signal to change the first state of the one or more programmable parameters to the second state, the first signal being transmitted to the implantable pulse generator by the communication link; and

the implantable pulse generator further comprising;

means for receiving the first signal to change the first state of the one or more programmable parameters to the second state; and

means for detecting a change in the first state of the one or more programmable parameters to the second state, the change being stored in the parameter log, wherein the means for detecting a change includes means for detecting the first state of the one or more programmable parameters changed in error to the second state, the first state being stored in the parameter log.

13. The system of claim 12, wherein the means for detecting includes means for detecting a non-programmer initiated change from the first state of the one or more programmable parameters.

14. A method, comprising:

storing an executable program in a cardiac rhythm management device, wherein the cardiac rhythm management device includes a parameter log and the executable program includes one or more programmable parameters having a first state;

transmitting a signal from a medical device programmer to change the first state of at least one programmable parameter to a second state;

detecting an error in a change from the first state of the at least one programmable parameter to the second state; and

storing in the parameter log the first state of the at least one programmable parameters changed to the second state.

15. The method of claim 14, wherein storing the executable program includes storing the executable program in an implantable device.

16. The method of claim 14, wherein detecting the change of the at least one programmable parameter to the second state includes detecting a change due to an influence external to the cardiac rhythm management device.

17. A cardiac rhythm management device, comprising:

a sensor for sensing cardiac signals;

an electrical pulse generation circuit;

a control circuit operable connected to both the sensor to receive sensed cardiac signals and the electrical pulse generation circuit;

a memory operably connected to the control circuit, wherein the memory stores data indicative of sensed cardiac signals, an executable program used by the control circuit, parameters for the executable program, a device activity log, and a parameter change log; and

means for detecting an error in a change in a first state of at least one programmable parameter to a second state, and for storing the first state of the at least one programmable parameter changed in error to the second state in the parameter change log.

18. The device of claim 17, wherein the sensed cardiac data includes arrhythmic episodes, and wherein the device activity log stores information related to one or more electrical energy shocks delivered by the pulse generation circuit.

19. An implantable pulse generator, comprising:

means for storing an executable program that includes at least one programmable parameter having a first state;

means for storing a parameter log in the implantable pulse generator;

means for detecting an error in a change in the first state of the at least one programmable parameter to a second state; and

means for storing in the parameter log the first state of the at least one programmable parameters changed in error to the second state.

20. The implantable pulse generator of claim 19, wherein the means for storing in the parameter log the first state of the at least one programmable parameters changed in error to the second state includes means for transmitting the first state data to a programmer.