Method and apparatus for indication-based programming of cardiac rhythm management devices

• US 20060241712A1
• Filed: 04/20/2005
• Published: 10/26/2006
• Est. Priority Date: 04/20/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Gilkerson, James O., Hoyme, Kenneth P., Cates, Adam W.
• Granted Patent: US 7,257,447 B2
• Time in Patent Office: Days
• US Class Current: 607/30
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• 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 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A cardiac rhythm management (CRM) system includes a programming device that determines parameters for programming an implantable medical device based on patient-specific information including indications for use of the implantable medical device. By executing an indication-based programming algorithm, the programming device substantially automates the process between the diagnosis of a patient and the programming of an implantable medical device using parameters individually determined for that patient.

Claims

1. An external system for programming an implantable medical device, the system comprising:

an external telemetry circuit configured to communicate with the implantable medical device; and

an indication-based programming device including;

a patient information input to receive patient-specific information including indications for use of the implantable medical device;

a device information input to receive device-specific information including a device type indicative of a plurality of programmable parameters;

an indication-based parameter generation module coupled to the patient information input and the device information input, the indication-based parameter generation module adapted to produce values for a set of operational parameters of the plurality of programmable parameters based on the patient-specific information and the device-specific information; and

a programming module coupled to the external telemetry circuit and the indication-based parameter generation module, the programming module adapted to program the implantable medical device using the values of the set of operational parameters.

2. The system of claim 1, wherein the indication-based parameter generation module comprises:

an operational mode selector to select at least one operational mode from a plurality of available operational modes of the implantable medical device based on the patient-specific information and the device-specific information; and

a parameter value generator to produce the values of the set of operational parameters being values of parameters enabling the implantable medical device to operate in the selected at least one operational mode.

3. The system of claim 1, wherein the indication-based parameter generation module comprises:

an operational mode selector to select at least one operational mode from a plurality of available operational modes of the implantable medical device based on a user selection, the operational mode selector including a mode input to receive the user selection; and

a parameter value generator to produce the values of the set of operational parameters being values of parameters enabling the implantable medical device to operate in the selected at least one operational mode.

4. The system of claim 1, wherein the indication-based parameter generation module comprises a mapping algorithm execution module adapted to execute a mapping algorithm relating the patient-specific information to the device-specific information.

5. The system of claim 1, further comprising a user interface device coupled to the indication-based programming device, the user interface device including:

a display screen including a parameter field to display the values for the set of operational parameters; and

an election input device to receive a user election to accept, modify, or discard the values of the set of operational parameters.

6. The system of claim 5, wherein the election input device comprises election buttons displayed on the display screen.

7. The system of claim 5, wherein the user interface device further comprises a parameter input device allowing modification of the values for the set of operational parameters.

8. The system of claim 7, wherein the display screen is an interactive screen, the parameter field is adapted to allow modification of the displayed values for the set of operational parameters, and the parameter input device comprises portions of the parameter field.

9. The system of claim 5, wherein the user interface further comprises a user-controllable programming mode switch configured for selecting one of an indication-based programming mode and a parameter-based programming mode and for switching between the indication-based programming mode and the parameter-based programming mode.

10. The system of claim 1, further comprising a patient information storage system coupled to the patient information input, the patient information storage system including one or more storage devices configured to store the patient-specific information.

11. The system of claim 10, wherein the one or more storage devices are each configured to store one or more of the indications for use of the implantable medical device, demographic data, cardiac history, electrogram, electrocardiogram, echocardiogram, physical attributes, non-cardiac disease history, and drug regimens.

12. The system of claim 10, further comprising a telecommunication network, and wherein at least one of the one or more storage devices are coupled to the patient information input via the telecommunication network.

13. The system of claim 12, further comprising a device information storage device to store the device-specific information for a plurality of device types.

14. The system of claim 13, further comprising a device identification module to identify the device type of the implantable medical device based on information received by the external telemetry circuit from the implantable medical device.

15. A cardiac rhythm management (CRM) system, comprising:

an implantable medical device of a type identified by a device type indicative of one or more available operational modes and a plurality of programmable parameters; and

an external system including;

an external telemetry circuit configured to communicate with the implantable medical device; and

an indication-based programming device including;

a patient information input to receive patient-specific information including indications for use of the implantable medical device;

a device information input to receive device-specific information including the device type;

an indication-based parameter generation module coupled to the patient information input and the device information input, the indication-based parameter generation module adapted to produce values for a set of operational parameters of the plurality of programmable parameters based on the patient-specific information and the device-specific information, the values for the set of operational parameters enabling the implantable medical device to operation in at one of the one or more operational modes; and

a programming module coupled to the indication-based parameter generation module and the external telemetry circuit, the programming module adapted to program the implantable medical device using the values of the set of operational parameters.

16. The CRM system of claim 15, further comprising a user interface device configured to allow modification of the values of the set of operational parameters before the programming module programs the implantable medical device using the values of the set of operational parameters.

17. The CRM system of claim 15, wherein the external system comprises a patient management system including:

an external device communicatively coupled to the implantable medical device via telemetry;

a telecommunication network coupled to the external device; and

one or more remote devices coupled to the telecommunication network.

18. The CRM system of claim 17, wherein the one or more remote devices comprises at least one storage device configured to store portions of the patient-specific information.

19. The CRM system of claim 18, wherein the external system further comprises a device identification module to identify the device type of the implantable medical device based on information received from the implantable medical device via the telemetry link.

20. The CRM system of claim 15, wherein the implantable medical device comprises one or more of a pacemaker and a cardioverter/defibrillator.

21. The CRM system of claim 15, wherein the implantable medical device comprises one or more of a cardiac resynchronization device and a cardiac remodeling device.

22. A method for programming an implantable medical device, the method comprising:

collecting patient-specific information including indications for use of the implantable medical device;

receiving device-specific information including a device type of the implantable medical device, the device type indicative of one or more available operational modes and a plurality of programmable parameters;

executing an indication-based programming algorithm to produce values for a set of operational parameters of the plurality of programmable parameters based on the patient-specific information and the device-specific information; and

receiving a user election to accept, modify, or discard the values for the set of operational parameters.

23. The method of claim 22, wherein executing the indication-based programming algorithm comprises:

selecting at least one operational mode from the one or more available operational modes; and

producing the values for the set of operational parameters being values of parameters enabling the implantable medical device to operate in the selected at least one operational mode.

24. The method of claim 22, wherein executing the indication-based programming algorithm comprises:

receiving a user selection of at least one operational mode of the one or more available operational modes; and

producing the values for the set of operational parameters being values of parameters enabling the implantable medical device to operate in the user-selected at least one operational mode.

25. The method of claim 22, wherein executing the indication-based programming algorithm comprises executing a mapping algorithm relating the patient-specific information to the device-specific information of the implantable medical device.

26. The method of claim 22, further comprising programming the implantable medical device using the values for the set of operational parameters if a user election to accept the values for the set of operational parameters is received.

27. The method of claim 26, further comprising:

receiving one or more modified values for the set of operational parameters if a user election to modify the set of operational parameters is received; and

programming the implantable medical device using the one or more modified values for the set of operational parameters.

28. The method of claim 27, further comprising checking the one or more modified values for the set of operational parameters against one or more predetermined safety limits before programming the implantable medical device using the one or more modified values for the set of operational parameters.

29. The method of claim 27, wherein programming the implantable medical device comprises programming an implantable pacemaker.

30. The method of claim 27, wherein programming the implantable medical device comprises programming an implantable cardioverter/defibrillator.

31. The method of claim 27, wherein programming the implantable medical device comprises programming an implantable cardiac resynchronization therapy device.

32. The method of claim 27, wherein programming the implantable medical device comprises programming an implantable cardiac remodeling control therapy device.

33. The method of claim 22, wherein collecting patient-specific information comprises collecting one or more of the indications for use of the implantable medical device, demographic data, cardiac history, electrogram, electrocardiogram, echocardiogram, physical attributes, non-cardiac disease history, and drug regimens.

34. The method of claim 33, wherein collecting patient-specific information comprises extracting information from an electronic medical record.

35. The method of claim 33, wherein collecting patient-specific information comprises extracting information from results of one or more electrophysiology tests.

36. The method of claim 33, wherein collecting patient-specific information comprises receiving at least a portion of the patient-specific information from a remote location via a telecommunication network.