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

• US 9,468,769 B2
• Filed: 04/17/2014
• Issued: 10/18/2016
• 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:
  US14/255,877
• Publication Number:
  US 20140228902A1
• Time in Patent Office: 915 Days
• Field of Search: None
• US Class Current: 1/1
• 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 for a patient, 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 the patient'"'"'s electronic medical records 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; and

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 modify the automatically produced values of a set of operational parameters, wherein the election input device is further configured to present the user with one or more ranges encompassing one or more operational parameter values alternative to the automatically produced values, wherein the one or more alternative operational parameter values encompassed by the one or more ranges are within predetermined safety limits.

2. The system of claim 1, wherein the indication-based programming device is configured to program an implantable pacemaker.

3. The system of claim 2, wherein the indication-based programming device is further configured to program an implantable cardioverter/defibrillator.

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

an operational mode selector configured to select an 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 configured to receive the user selection; and

a parameter value generator configured 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.

5. The system of claim 3, further comprising:

a telecommunication network; and

one or more storage devices configured to store the patient-specific information and including at least one storage device coupled to the indication-based programming device via the telecommunication network.

6. The system of claim 1, wherein the election input device is further configured to receive a user election to accept and a user election to discard the values of operational parameters.

7. A method for programming an implantable medical device for a patient, the method comprising:

receiving device-specific 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 the patient'"'"'s electronic medical records, the patient-specific information 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 using the patient-specific information and the device type;

presenting a user with an option to accept, modify, or discard the automatically produced values of the set of operational parameters,

receiving an election to modify the automatically produced values;

in response to receiving the election, presenting the user with one or more ranges encompassing one or more alternative operational parameter values that are within predetermined safety limits; and

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

8. The method of claim 7, wherein programming the implantable medical device comprises programming an implantable pacemaker.

9. The method of claim 7, wherein programming the implantable medical device comprises programming an implantable cardioverter/defibrillator.

10. The method of claim 7, wherein collecting the patient-specific information comprises collecting information acquired by an outpatient system performing continuous patient monitoring.

11. The method of claim 7, wherein collecting the patient-specific information comprises collecting information from at least one storage device via a telecommunication network.

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

receiving device-specific information indicative of a device type of the implantable medical device from the implantable medical device coupled to the external device via a telemetry link;

collecting patient-specific information from one or more storage devices coupled to the external device via a telecommunication network, 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;

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

providing a user the option to modify the set of automatically produced operational parameter values, wherein an election to modify the set of automatically produced operational parameter values comprises presenting the user with one or more ranges encompassing one or more operational parameter values alternative to the automatically produced values, wherein the one or more alternative operational parameter values encompassed by the one or more ranges are within predetermined safety limits; and

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

13. The method of claim 12, wherein automatically producing the values of the set of operational parameters comprises:

selecting an operational mode from one or more available operational modes of the implantable medical device; and

producing the values of the set of operational parameters including values of parameters enabling the implantable medical device to operate in the selected operational mode.

14. The method of claim 13, wherein selecting the operational mode comprises receiving a selection from a user.

15. The method of claim 12, wherein programming the implantable medical device comprises programming at least one of an implantable pacemaker and an implantable cardioverter/defibrillator.

16. The method of claim 12, further comprising providing a user the option to accept and the option to discard the set of automatically produced operational parameter values.