SYSTEM AND METHOD FOR TEMPORARY PROGRAMMING FOR IMPLANTED MEDICAL DEVICES

• US 20090076570A1
• Filed: 11/26/2008
• Published: 03/19/2009
• Est. Priority Date: 11/19/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Smythe, Alan H., Simms, Howard D. JR., Hoyme, Kenneth P., Quiles, Sylvia, Ternes, David, Sowder, Conrad L.
• Granted Patent: US 8,718,772 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system and method for temporary programming of an implantable medical device. The system and method include a repeater uploading temporary programming and instructions to a temporary memory of the device and then instructing the device to operate according to the temporary instructions. If during a first time period, the device is not in continuous periodic communication with the repeater, the device automatically reverts to operation under the normal operating instructions. At the end of the first time period, the caregiver or the patient may decide to revert to the normal programming. During a second time period, the device operates according to the temporary programming unless the caregiver or the patient instructs the device to revert to the normal programming, or the device fails to receive a periodic continuation signal from the repeater. Adverse health affects to the patient may also trigger the device to revert to the normal programming during either the first or second time period.

Claims

1. A system comprising:

an implantable medical device, configured to be implanted within a body of a patient, the implantable medical device comprising;

electrical circuitry, configured to deliver electrical therapy to the patient;

a first digital storage area for holding normal operation instructions and settings;

a second digital storage area for holding temporary operating instructions and settings;

a communication subsystem; and

a timing subsystem, and

wherein upon receiving from an external interface device an instruction to use the temporary operating instructions and settings to deliver the electrical therapy to the patient, the implantable medical device initiates a first predetermined period of time during which the implantable medical device begins delivering the electrical therapy using the temporary operation instructions and settings, and wherein the implantable medical device will revert to the normal operation instructions and settings if the implantable medical device fails to receive a continuation signal from the external interface device within a first time interval during the first predetermined period of time; and

wherein upon completion of the first predetermined period of time without reverting to normal operation, the implantable medical device initiates a second predetermined period of time during which the implantable medical device is configured to revert to the normal operation instructions and settings if the implantable medical device fails to receive a continuation signal from the external interface device within a second time interval during the second predetermined period of time.

2. The system of claim 1, further comprising the external interface device, wherein the external interface device is configured to be located external of the patient'"'"'s body, and wherein the external interface device comprises a communication subsystem configured to communicate with the communication subsystem of the implantable medical device.

3. The system of claim 2, wherein the external interface device comprises a local external interface device close to the patient, and further comprising a remote interface device capable of being located far from the patient and communicating with the implantable medical device via the local external interface.

4. The system of claim 2, wherein the external interface device is configured to communicate the temporary operating instructions and settings to the implantable medical device for storage in the second digital storage area, and wherein the external interface device is configured to instruct the implantable medical device to use the temporary operating instructions and settings to deliver therapy to the patient.

5. The system of claim 1, wherein the continuation signal received from the external interface device during the second predetermined period of time includes a request to transfer device function information from the implantable medical device.

6. The system of claim 1, wherein the external interface device is configured to generate the continuation signal in response to an input obtained from the patient in which the implantable medical device is implanted.

7. The system of claim 1, wherein the external interface device is configured to generate the continuation signal in response to an input obtained from a caregiver to the patient in which the implantable medical device is implanted.

8. The system of claim 1, wherein the system is configured to determine whether the continuation signal should be generated in response to data obtained from the patient in which the implantable medical device is implanted.

9. The system of claim 8, wherein the system is configured to determine whether the continuation signal should be generated in response to device function data obtained from the patient in which the implantable medical device is implanted.

10. The system of claim 8, wherein the system is configured to determine whether the continuation signal should be generated in response to physiological data obtained, from the patient in which the implantable medical device is implanted, while the delivering the electrical therapy using the temporary operation instructions and settings is in effect.

18. The method of claim 1, comprising determining whether the continuation signal should be generated in response to obtaining data from the patient in which the implantable medical device is implanted.

19. The method of claim 18, comprising determining whether the continuation signal should be generated in response to obtaining device function data from the patient in which the implantable medical device is implanted.

20. The method of claim 18, comprising determining whether the continuation signal should be generated in response to obtaining physiological data, from the patient in which the implantable medical device is implanted, while the delivering the electrical therapy using the temporary operation instructions and settings is in effect.

11. A method comprising:

receiving at an implantable medical device an instruction, from an external interface device, to use temporary operating instructions and settings to deliver electrical therapy to the patient;

in response to the receiving the instruction, initiating a first time predetermined period of time;

during the first predetermined period of time, using the implantable medical device for delivering electrical therapy using the temporary operation instructions and settings;

during the first predetermined period of time, reverting to normal operation instructions and settings if the implantable medical device fails to receive a continuation signal from the external interface device within a first time interval during the first predetermined period of time;

upon completion of the first predetermined period of time without reverting to normal operation, initiating a second predetermined period of time;

during the second predetermined period of time, using the implantable medical device for delivering electrical therapy using the temporary operation instructions and settings; and

during the second predetermined period of time, reverting to normal operation instructions and settings if the implantable medical device fails to receive a continuation signal from the external interface device within a second time interval during the second predetermined period of time.

12. The method of claim 11, wherein the receiving the instruction comprises receiving the instruction from the external interface device located in the vicinity of the patient.

13. The method of claim 12, wherein the receiving the instruction comprises receiving the instruction, via the external interface device located in the vicinity of the patient, from a remote interface device capable of being located far from the patient.

14. The method of claim 11, comprising communicating the temporary operating instructions and settings to the implantable medical device and instructing the implantable medical device to use the temporary operating instructions and settings to deliver therapy to the patient.

15. The method of claim 11, wherein the receiving the continuation signal includes receiving a request to transfer device function information from the implantable medical device.

16. The method of claim 11, comprising generating the continuation signal in response to obtaining an input from the patient in which the implantable medical device is implanted.

17. The method of claim 11, comprising generating the continuation signal in response to obtaining an input from a caregiver to the patient in which the implantable medical device is implanted.