Remote titration of therapy delivered by an implantable medical device

• US 8,615,299 B2
• Filed: 09/29/2008
• Issued: 12/24/2013
• Est. Priority Date: 10/24/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Goetz, Steven M.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US12/682,996
• Publication Number:
  US 20100228314A1
• Time in Patent Office: 1,912 Days
• Field of Search: 607/41
• US Class Current: 607/41
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36071 Pain
• 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 1/37282 characterised by communication with experts in remote locations using a network

Abstract

Techniques for remotely titrating a therapy delivered using an implantable medical device system are disclosed. An implantable medical device delivers therapy according to a first program. The system collects patient data relating to at least one of an efficacy of, or side effects resulting from, the delivered therapy, and transmits the patient data to a remote network device. A clinician may then analyze the patient data and determine if changes to the therapy are warranted. The clinician may then transmit a programming change, e.g., a modification to the first program or a new, second program, to the implantable medical device system, and the implantable medical device may deliver therapy according to the changed programming. The process of receiving patient data and modifying the therapy programming may be repeated multiple times until the therapy is adequately titrated, e.g., until the patient data indicates adequate efficacy and/or acceptable side effects.

Claims

1. A method comprising:

delivering a therapy from an implantable medical device to a patient according to a first therapy program;

generating patient data with an implantable medical device system that comprises the implantable medical device, wherein the patient data relates to at least one of an efficacy or a side effect of the therapy;

transmitting the patient data from the implantable medical device system to a remote networking device via a network;

receiving, at the remote networking device via the network, the patient data;

guiding, by the remote networking device, selection of a second therapy program based on the patient data by at least traversing a programming tree based on the patient data, wherein the programming tree comprises a plurality of nodes in each of a plurality of levels, each of the levels corresponding to one therapy parameter;

transmitting, from the remote networking device to the implantable medical device system via the network, a programming change indicating a change from the first therapy program to the second therapy program; and

receiving, at the implantable medical device system, the programming change from the remote networking device via the network.

2. The method of claim 1, wherein the implantable medical device system comprises a physiological sensor, and generating patient data comprises generating sensor data with the sensor.

3. The method of claim 2, wherein the therapy is configured to treat urinary incontinence, and wherein the sensor data comprises at least one of urine pressure, urine volume, urine flow, urine pH, temperature, bladder contraction, or urinary sphincter contraction.

4. The method of claim 2, wherein the therapy is configured to treat at least one of a neurological disorder, a movement disorder, or pain, and the sensor data comprises at least one of patient motion or posture.

5. The method of claim 2, wherein the therapy is configured to treat gastrointestinal disorders, and the data comprises at least one of blood glucose concentration, insulin concentration, core body temperature, distension of a stomach, or pH level of a stomach.

6. The method of claim 2, wherein the therapy is configured to treat diabetes, and the data comprises at least one of blood glucose concentrations, insulin concentration, patient body temperature, or patient activity levels.

7. The method of claim 1, wherein the medical device system comprises a programmer, and the patient data further comprises data manually entered by the patient using the programmer.

22. The method of claim 1, wherein traversing a programming tree based on the patient data comprises traversing the programming tree along a program path including a first node associated with the first therapy program, comparing an efficacy improvement associated with the first therapy program to a threshold, reversing direction of traversal along the program path if the efficacy improvement is less than the threshold, and continuing in a same direction of traversal along the program path if the efficacy improvement is greater than the threshold.

23. The method of claim 1, wherein traversing a programming tree based on the patient data comprises traversing the programming tree along a program path including a first node associated with the first therapy program, comparing a side effect reduction associated with the first therapy program to a threshold, reversing direction of traversal along the program path if the side effect reduction is less than the threshold, and continuing in a same direction of traversal along the program path if the side effect reduction is greater than the threshold.

8. A system comprising:

an implantable medical device system comprising;

an implantable medical device configured to deliver a therapy to a patient according to a first therapy program; and

at least one device configured to generate patient data, wherein the patient data relates to at least one of an efficacy or a side effect of the therapy and transmit the patient data to a remote networking device via a network; and

the remote networking device comprising;

a communication module; and

a processor configured to receive the patient data via the network and the communication module;

guide selection of a second therapy program based on the patient data by at least traversing a programming tree based on the patient data, wherein the programming tree comprises a plurality of nodes in each of a plurality of levels, each of the levels corresponding to one therapy parameter; and

transmit, to the implantable medical device system via the network and the communication module, a programming change indicating a change from the first therapy program to the second therapy program,

wherein the implantable medical device system is further configured to receive the programming change for the therapy from the remote networking device via the network.

9. The system of claim 8, wherein the at least one device comprises the implantable medical device.

10. The system of claim 8, wherein the at least one device comprises a programming device.

11. The system of claim 8, wherein the at least one device comprises a physiological sensor, and the patient data comprises sensor data gathered with the sensor.

12. The system of claim 11, wherein the sensor comprises an implantable sensor.

13. The system of claim 8, wherein the at least one device comprises a programmer, and the patient data further comprises data manually entered by the patient using the programmer.

14. The system of claim 8, wherein receiving a programming change comprises receiving the programming change at the implantable medical device.

24. The system of claim 8, wherein the processor of the remote networking device is configured to traverse a programming tree based on the patient data by at least traversing the programming tree along a program path including a first node associated with the first therapy program, comparing an efficacy improvement associated with the first therapy program to a threshold, reversing direction of traversal along the program path if the efficacy improvement is less than the threshold, and continuing in a same direction of traversal along the program path if the efficacy improvement is greater than the threshold.

25. The system of claim 8, wherein the processor of the remote networking device is configured to traverse a programming tree based on the patient data by at least traversing the programming tree along a program path including a first node associated with the first therapy program, comparing a side effect reduction associated with the first therapy program to a threshold, reversing direction of traversal along the program path if the side effect reduction is less than the threshold, and continuing in a same direction of traversal along the program path if the side effect reduction is greater than the threshold.

15. A method comprising:

receiving, at a remote networking device via a network, patient data from an implantable medical device system comprising an implantable medical device, wherein the patient data relates to at least one of an efficacy or a side effect of the therapy delivered to a patient by the implantable medical device according to a first therapy program;

guiding, at the remote networking device, selection of a second therapy program based on the patient data by at least traversing a programming tree based on the patient data, wherein the programming tree comprises a plurality of nodes in each of a plurality of levels, each of the levels corresponding to one therapy parameter; and

transmitting to the implantable medical device system via the network a programming change indicating a change from the first therapy program to the second therapy program.

16. The method of claim 15, wherein receiving patient data comprises receiving sensor data collected with a physiological sensor of the implantable medical device system.

17. The method of claim 15, wherein receiving patient data comprises receiving data manually entered by the patient with a programmer of the implantable medical device system.

18. The method of claim 15, further comprising presenting, by the remote networking device, the patient data to a clinician for analysis.

19. The method of claim 15, further comprising automatically analyzing the patient data by the remote networking device.

26. The method of claim 15, wherein traversing a programming tree based on the patient data comprises traversing the programming tree along a program path including a first node associated with the first therapy program, comparing an efficacy improvement associated with the first therapy program to a threshold, reversing direction of traversal along the program path if the efficacy improvement is less than the threshold, and continuing in a same direction of traversal along the program path if the efficacy improvement is greater than the threshold.

27. The method of claim 15, wherein traversing a programming tree based on the patient data comprises traversing the programming tree along a program path including a first node associated with the first therapy program, comparing a side effect reduction associated with the first therapy program to a threshold, reversing direction of traversal along the program path if the side effect reduction is less than the threshold, and continuing in a same direction of traversal along the program path if the side effect reduction is greater than the threshold.

20. A remote networking device comprising:

a communication module;

and

a processor configured to receive, via a network and the communication module, patient data from an implantable medical device system comprising an implantable medical device, wherein the patient data relates to at least one of an efficacy or a side effect of therapy delivered to a patient by the implantable medical device according to a first therapy program;

guide selection of a second therapy program based on the patient data by at least traversing a programming tree based on the patient data, wherein the programming tree comprises a plurality of nodes in each of a plurality of levels, each of the levels corresponding to one therapy parameter; and

transmit to the implantable medical device system, via the network and the communication module, a programming change indicating a change from the first therapy program to the second therapy program.

21. The system of claim 20, wherein the programming change comprises a command that initiates a subsequent therapy program in a sequence of programs.

28. The remote networking device of claim 20, wherein the processor is configured to traverse a programming tree based on the patient data by at least traversing the programming tree along a program path including a first node associated with the first therapy program, comparing an efficacy improvement associated with the first therapy program to a threshold, reversing direction of traversal along the program path if the efficacy improvement is less than the threshold, and continuing in a same direction of traversal along the program path if the efficacy improvement is greater than the threshold.

29. The remote networking device of claim 20, wherein the processor is configured to traverse a programming tree based on the patient data by at least traversing the programming tree along a program path including a first node associated with the first therapy program, comparing a side effect reduction associated with the first therapy program to a threshold, reversing direction of traversal along the program path if the side effect reduction is less than the threshold, and continuing in a same direction of traversal along the program path if the side effect reduction is greater than the threshold.