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

• US 8,725,268 B2
• Filed: 07/31/2007
• Issued: 05/13/2014
• 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: Cates, Adam W., Gilkerson, James O., Hoyme, Kenneth P.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US11/831,683
• Publication Number:
  US 20080021523A1
• Time in Patent Office: 2,478 Days
• Field of Search: None
• US Class Current: 607/59
• 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 indication-based programming device configured to receive patient-specific information and device-specific information and automatically produce values of a set of operational parameters of a plurality of programmable parameters using the patient-specific information and the device-specific information, the patient-specific information including indications for use of the implantable medical device, the indications each including a symptom or circumstance that indicates advisability of one or more medical treatments deliverable by the implantable medical device, the device-specific information including a device type of the implantable medical device, the device type associated with the plurality of programmable parameters;

a telemetry circuit configured to communicate with the implantable medical device;

a device identification module configured to identify the device type using information received from the implantable medical device via telemetry;

a telecommunication network; and

one or more storage devices coupled to the indication-based programming device via the telecommunication network the one or more storage devices configured to store the patient-specific information as electronic medical records.

2. The system of claim 1, comprising a user interface coupled to the indication-based programming device, the user interface including an election input device configured to receive a user election to accept, modify, or discard the values of the set of operational parameters.

3. The system of claim 2, wherein the user interface comprises a programming command input configured to allow the user to enter a command for programming the implantable medical device using the values of the set of operational parameters.

4. The system of claim 1, 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.

5. The system of claim 1, comprising:

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,

wherein the indication-based programming device is distributed in the external device and the one or more remote devices.

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

a patient information storage system including one or more storage devices configured to store patient-specific information as electronic medical records including indications for use of the implantable medical device, the indications each including a symptom or circumstance that indicates advisability of one or more medical treatments deliverable by the implantable medical device;

a device information storage device configured to store device-specific information of the implantable medical device;

an indication-based programming device coupled to the patient information storage system and the device information storage device, the indication-based programming device configured to automatically produce values of a set of operational parameters of the implantable medical device using the patient-specific information and the device-specific information.

7. The system of claim 6, wherein the indication-based programming device comprises a programming module configured to program the implantable medical device using the values of the set of operational parameters.

8. The system of claim 7, comprising a user interface coupled to the indication-based programming device, the user interface including:

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

a parameter input device configured to allow modification of the values of the set of operational parameters.

9. The system of claim 8, comprising:

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.

10. The system of claim 9, wherein the external device comprises the indication-based programming device.

11. The system of claim 9, wherein the one or more remote devices comprise the indication-based programming device.

12. The system of claim 9, wherein the indication-based programming device is distributed in the external device and the one or more remote devices.

13. A method for programming an implantable medical device using an external system, the method comprising:

receiving information indicative of a device type of the implantable medical device from the implantable medical device via a telemetry link;

collecting patient-specific information including indications for use of the implantable medical device, the indications each including a symptom or circumstance that indicates advisability of one or more medical treatments deliverable by the implantable medical device;

automatically producing values of a set of operational parameters by the external system using the patient-specific information and the device type;

receiving one or more modified values of the set of operational parameters in response to receiving a user election to modify the set of operational parameters;

checking the received one or more modified values of the set of operational parameters against one or more predetermined safety limits; and

programming the implantable medical device using the values of the set of operational parameters via the telemetry link.

14. The method of claim 13, wherein collecting the patient-specific information comprises collecting information stored as electronic medical records.

15. The method of claim 13, wherein collecting the patient-specific information comprises collecting information acquired by an outpatient system performing continuous patient monitoring.

16. The method of claim 13, wherein programming the implantable medical device comprises programming the implantable medical device automatically after the values of the set of operational parameters are produced.

17. The method of claim 13, wherein programming the implantable medical device comprises programming the implantable medical device after allowing a user to review and modify the values of the set of operational parameters.

18. The method of claim 13, comprising 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, and wherein the set of operational parameters comprises a set of operational parameters of the plurality of programmable parameters, and automatically producing the values of the set of operational parameters comprises automatically producing values of the set of operational parameters using the patient-specific information and the device-specific information.

19. The method of claim 18, wherein automatically producing the values of the set of operational parameters comprises:

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

producing 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.

20. A method for programming an implantable medical device using an external system, the method comprising:

collecting patient-specific information including indications for use of the implantable medical device, the indications each including a symptom or circumstance that indicates advisability of one or more medical treatments deliverable by the implantable medical device, wherein the collecting includes collecting the patient-specific information from electronic medical records via a telecommunication network;

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

extracting stored device-specific information according to the device type;

automatically producing values of a set of operational parameters of the plurality of programmable parameters using the patient-specific information and the device-specific information; and

programming the implantable medical device using the values of the set of operational parameters.

21. The method of claim 20, wherein automatically producing the values of the set of operational parameters comprises:

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

producing 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.

22. The method of claim 20, wherein programming the implantable medical device comprises programming the implantable medical device after allowing a user to review and modify the values of the set of operational parameters, and allowing the user to review and modify the values of the set of operational parameters includes:

receiving a user election to modify the set of operational parameters;

receiving one or more modified values of the set of operational parameters after receiving the user election to modify the set of operational parameters;

checking the one or more modified values of the set of operational parameters against one or more predetermined safety limits; and

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