Proactive interactive limits override for implantable medical device user interface

• US 8,121,689 B2
• Filed: 10/01/2007
• Issued: 02/21/2012
• Est. Priority Date: 10/01/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kalgren, James, Peterson, Les, Kelly, Jonathan H., Huang, Hai, Wu, Gang
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US11/865,506
• Publication Number:
  US 20090088815A1
• Time in Patent Office: 1,604 Days
• Field of Search: 607/30, 607/32, 607 59- 60
• US Class Current: 607/30
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

An external device includes a communication circuit, a programming interface including a display, and a processor. The processor includes a parameter analyzer to apply a rule to a combination of operating parameter values of the IMD to determine operating parameter interaction. The display includes a first warning that is displayed when the parameter analyzer determines that a combination of operating parameter values entered via the programming interface is not allowed, and a second warning that is displayed when the parameter analyzer determines that a combination of operating parameters values entered via the programming interface is allowable but not recommended. The processor is configured to program the operating parameter values associated with the second warning into the IMD only after a user acknowledgement of the second warning is received from a user via the programming interface.

Claims

1. A system comprising an external device including:

a communication unit configured to communicate information with an implantable medical device (IMD);

a programming interface including a display; and

a processor communicatively coupled to the communication circuit and the programming interface, wherein the processor includes;

a parameter analyzer configured to apply a rule to a combination of operating parameter values of the IMD to determine operating parameter interaction; and

wherein;

the display includes a first warning that is displayed when the parameter analyzer determines that a combination of operating parameter values entered via the programming interface is not allowed;

the display includes a second warning that is displayed when the parameter analyzer determines that a combination of operating parameters values entered via the programming interface is allowable but not recommended, the second warning including text identifying a specific risk reason why the combination of operating parameter values is allowable but not recommended, and wherein the combination of operating parameters values that is allowable but not recommended and the text content of the second warning are a function of whether the programming interface is local to or remote from the IMD; and

the processor is configured to enable programming of the allowable but not recommended combination of operating parameter values associated with the second warning into the IMD only after a user overrides the second warning by affirmatively acknowledging having read the second warning, wherein the acknowledgement of the second warning is received from the user via the programming interface.

2. The external device of claim 1, wherein the text identifying a specific risk reason why the combination of operating parameter values is allowable but not recommended includes educational text concerning a risk to the patient from the entered combination of operating parameters.

3. The external device of claim 1, wherein the parameter analyzer is configured to determine that a combination of operating parameter values is an allowable but not recommended combination of operating parameter values based on an expected efficacy of a therapy provided by the IMD.

4. The external device of claim 1, wherein the display uses a first color to display the first warning and a different second color to display the second warning.

5. The external device of claim 1, wherein the display is configured to alter display of the operating parameter values associated with the first warning or the second warning when displaying at least one of the first warning and the second warning.

6. The external device of claim 1, wherein the display is configured to inhibit display of the operating parameter values associated with the first warning or the second warning when displaying at least one of the first warning and the second warning.

7. The system of claim 1, including a repeater, wherein the repeater includes a communication circuit configured to communicate information with the IMD and the external device, and

wherein the processor is configured to display different text with the second warning when the external device communicates with the IMD via the repeater than when the external device communicates with the IMD directly.

8. The system of claim 1, including the IMD and a repeater, wherein the repeater includes a communication unit configured to communicate information with the IMD and the external device, and

wherein the parameter analyzer is configured to categorize a different combination of operating parameters as being allowable but not recommended when the external device communicates with the IMD via the repeater than when the external device communicates with the IMD directly.

9. The system of claim 8, wherein the IMD provides a therapy to a patient, and wherein the parameter analyzer is configured to categorize a combination of operating parameter values as being allowable but not recommended when the combination of operating parameter values results in reduced efficacy of the therapy.

10. The system of claim 9, wherein the IMD includes a therapy unit configured to provide at least one of bradycardia pacing therapy and cardioversion/defibrillation therapy, and a detection unit configured to detect tachyarrhythmia.

11. A method comprising:

receiving from a user, at an external device, a combination of operating parameter values for an implantable medical device (IMD);

applying a rule, using the external device, to the combination of operating parameter values to determine operating parameter interaction;

displaying a first warning when a disallowed combination of operating parameter values is received from the user;

displaying a second warning when an allowable but not recommended combination of operating parameter values is received from the user, the second warning including text identifying a specific risk reason why the combination of operating parameter values is allowable but not recommended, and wherein the combination of operating parameters values that is allowable but not recommended and the text content of the second warning are a function of whether a programming interface of the external device is local to or remote from the IMD; and

enabling the combination of allowable but not recommended operating parameter values associated with the second level warning to be programmed into the IMD only after affirmatively acknowledging having read the second warning via the programming interface of the external device to override the second warning.

12. The method of claim 11, wherein displaying the text includes displaying educational text concerning risk to the patient resulting from the combination of operating parameter values associated with the second warning.

13. The method of claim 11, comprising selecting the rule as a function of whether the external device is local to or remote from the IMD.

14. The method of claim 11, comprising excluding a combination of operating parameter values from a recommended set of operating parameter values based on an expected efficacy of the combination of operating parameter values.

15. An apparatus comprising:

means for receiving from a user, at an external device, a combination of operating parameter values for an implantable medical device (IMD);

means for applying a rule, using the external device, to the combination of operating parameter values to determine operating parameter interaction;

means for displaying a first warning when a disallowed combination of operating parameter values is received from the user;

means for displaying a second warning when an allowable but not recommended combination of operating parameter values is received from the user, the second warning including text identifying a specific risk reason why the combination of operating parameter values is allowable but not recommended, and wherein the combination of operating parameters values that is allowable but not recommended and the text content of the second warning are a function of whether a programming interface of the external device is local to or remote from the IMD; and

means for enabling the combination of allowable but not recommended operating parameter values associated with the second level warning to be programmed into the IMD only after affirmatively acknowledging having read the second warning via the programming interface of the external device to override the second warning.