External Device for Determining an Optimal Implantable Medical Device for a Patient Using Information Determined During an External Trial Stimulation Phase

• US 20140358194A1
• Filed: 05/06/2014
• Published: 12/04/2014
• Est. Priority Date: 06/04/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Ozawa, Robert D., Vansickle, Dennis A.
• Granted Patent: US 9,327,135 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 providing test stimulations
• 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 1/378 Electrical supply
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation
• CPC Class Codes: G16H 40/63 for local operation

Abstract

An external controller is disclosed for communicating with an external trial stimulator (ETS) for an implantable medical device. The external controller is programmed with a battery algorithm able to assist a clinician in choosing a suitable implant for the patient based on battery performance parameters estimated for a number of implants during an external trial stimulation phase that precedes implantation of the implant. The algorithm is particularly useful in assisting the clinician in choosing between a rechargeable-battery implant or a primary-battery implant for the patient.

Claims

1. An external device useable in an implantable medical device (IMD) system, comprising:

control circuitry programmed with an algorithm, the control circuitry comprising an IMD stimulation program, and information for a plurality of battery-powered IMDs implantable in a patient,

wherein the algorithm is configured to determine at least one battery performance parameter for each of the plurality of IMDs in accordance with the stimulation program and the information for each of the plurality of IMDs.

2. The external device of claim 1, wherein the stimulation program is determined for a patient during an external trial stimulation phase using an external trial stimulator.

3. The external device of claim 2, wherein the external device is further configured to provide the stimulation program to the external trial stimulator.

4. The external device of claim 1, wherein the control circuitry is configured to indicate the at least one battery performance parameter for each of the plurality of IMDs to a user of the external device.

5. The external device of claim 1, wherein the algorithm is further configured to determine one of the plurality of IMDs for implantation in the patient in accordance with the battery performance parameters.

6. The external device of claim 5, wherein the control circuitry is configured to indicate the determined one of the IMDs to the user of the external device.

7. The external device of claim 1, wherein the plurality of IMDs comprise at least one IMD having a rechargeable battery, and at least one IMD having a primary battery.

8. The external device of claim 7, wherein the at least one battery performance parameter for the at least one IMD having a primary battery comprises information indicative of an estimated lifetime of the primary battery, and wherein the at least one battery performance parameter for the at least one IMD having a rechargeable battery comprises information indicative of an estimated recharging performance of the rechargeable battery.

9. The external device of claim 8, wherein the estimated recharging performance comprises an estimated charging frequency and an estimated charging duration.

10. The external device of claim 1, wherein the algorithm is further configured to determine from the stimulation program an expected current draw, and wherein the algorithm is configured to determine the at least one battery performance parameter for each of the plurality of IMDs in accordance with the current draw and the information for each of the plurality of IMDs.

11. The external device of claim 1, wherein the algorithm is further configured to determine from the stimulation program an expected current draw for each of the plurality of IMDs, and wherein the algorithm is configured to determine the at least one battery performance parameter for each of the plurality of IMDs in accordance with the current draw for each of the plurality of IMDs and the information for each of the plurality of IMDs.

12. The external device of claim 1, wherein the stimulation program comprises one or more electrodes of the IMD selected for stimulation, whether selected electrodes are anodes or cathodes, the magnitude of the stimulation, the frequency of the stimulation, and the duration of the stimulation.

13. The external device of claim 1, wherein a user can modify the stimulation program at the external device.

14. The external device of claim 1, further comprising transceiver circuitry configured to receive the stimulation program from a transmitting device.

15. The external device of claim 14, wherein the transmitting device comprises an external trial stimulator configured to provide stimulation to a patient in accordance with the stimulation program during an external trial stimulation phase.

16. The external device of claim 15, wherein the transceiver circuitry is further configured to wirelessly provide the stimulation program to the external trial stimulator.

17. The external device of claim 1, wherein the algorithm is executable by the user via a user interface of the external device.

18. A system, comprising:

an external trial stimulator configured to provide stimulation to a patient during an external trial stimulation period in accordance with an IMD stimulation program, wherein the external trial stimulation period precedes implantation of an implantable medical device (IMD) in a patient; and

an external device, comprising;

control circuitry programmed with an algorithm, the control circuitry comprising the IMD stimulation program, and information for a plurality of battery-powered IMDs implantable in a patient,

wherein the algorithm is configured to determine at least one battery performance parameter for each of the plurality of IMDs in accordance with the stimulation program and the information for each of the plurality of IMDs.

19. The system of claim 18, wherein the external trial stimulator is configured to be coupled to at least one lead implantable in the patient to provide the stimulation to the patient.

20. The system of claim 18, wherein the external device is further configured to provide the stimulation program to the external trial stimulator.

21. The system of claim 18, wherein the control circuitry is configured to indicate the at least one battery performance parameter for each of the plurality of IMDs to a user of the external device.

22. The system of claim 18, wherein the algorithm is further configured to determine one of the plurality of IMDs for implantation in the patient in accordance with the battery performance parameters.

23. The system of claim 22, wherein the control circuitry is configured to indicate the determined one of the IMDs to the user of the external device.

24. The system of claim 18, wherein the plurality of IMDs comprise at least one IMD having a rechargeable battery, and at least one IMD having a primary battery.

25. The system of claim 24, wherein the at least one battery performance parameter for the at least one IMD having a primary battery comprises information indicative of an estimated lifetime of the primary battery, and wherein the at least one battery performance parameter for the at least one IMD having a rechargeable battery comprises information indicative of an estimated recharging performance of the rechargeable battery.

26. The system of claim 25, wherein the estimated recharging performance comprises an estimated charging frequency and an estimated charging duration.

27. The system of claim 18, wherein the algorithm is further configured to determine from the stimulation program an expected current draw, and wherein the algorithm is configured to determine the at least one battery performance parameter for each of the plurality of IMDs in accordance with the current draw and the information for each of the plurality of IMDs.

28. The system of claim 18, wherein the algorithm is further configured to determine from the stimulation program an expected current draw for each of the plurality of IMDs, and wherein the algorithm is configured to determine the at least one battery performance parameter for each of the plurality of IMDs in accordance with the current draw for each of the plurality of IMDs and the information for each of the plurality of IMDs.

29. The system of claim 18, wherein the stimulation program comprises one or more electrodes of the IMD selected for stimulation, whether selected electrodes are anodes or cathodes, the magnitude of the stimulation, the frequency of the stimulation, and the duration of the stimulation.

30. The system of claim 18, wherein a user can modify the stimulation program for the external trial stimulator at the external device.

31. The system of claim 18, wherein the external device further comprises transceiver circuitry configured to receive the stimulation program from the external trial stimulator.

32. The system of claim 18, wherein the algorithm is executable by the user via a user interface of the external device.