REMOTE TITRATION OF THERAPY DELIVERED BY AN IMPLANTABLE MEDICAL DEVICE

• US 20140107567A1
• Filed: 12/20/2013
• Published: 04/17/2014
• 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.
• Granted Patent: US 10,806,344 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• 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 (IMD) to a patient according to a first therapy program;

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

comparing, by the IMD system, a value of the patient data to a threshold;

determining whether to transmit the patient data to a remote networking device based on the comparison;

in response to a determination to transmit the patient data, transmitting the patient data from the IMD system to the remote networking device via a network;

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

analyzing, by at least one of the remote networking device or the user, the patient data to determine whether to implement a programming change;

determining the programming change based on the analysis of the patient data;

transmitting, from the remote networking device to the IMD system via the network, at least one of the programming change or a command to implement the programming change; and

receiving, at the IMD system, the at least one programming change or the command to implement the programming change from the remote networking device via the network.

2. The method of claim 1, wherein the programming change comprises at least one of an adjustment to at least one parameter of the first therapy program or an initiation of a second therapy program.

3. The method of claim 2, wherein the adjustment to the at least one parameter of the first therapy program comprises a predetermined adjustment specified by a sequence of predetermined adjustments, and wherein the second therapy program comprises a predetermined therapy program specified by a sequence of predetermined therapy programs.

4. The method of claim 3, wherein at least one of the sequence of predetermined adjustments or the sequence of predetermined therapy programs is preloaded on the IMD.

5. The method of claim 4, wherein the command to implement the programming change received at the IMD system initiates at least one of a next predetermined adjustment in the sequence of predetermined adjustments preloaded on the IMD or a next predetermined therapy program in the sequence of predetermined therapy programs preloaded on the IMD.

6. The method of claim 1, wherein the threshold comprises at least one of a number of therapy events or a physiological parameter threshold.

7. 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 physiological sensor.

8. The method of claim 7, 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.

9. The method of claim 7, 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.

10. The method of claim 7, wherein the therapy is configured to treat gastrointestinal disorders, and the sensor data comprises at least one of blood glucose concentration, insulin concentration, core body temperature, distension of a stomach, or pH level of the stomach.

11. The method of claim 7, wherein the therapy is configured to treat diabetes, and the sensor data comprises at least one of blood glucose concentrations, insulin concentration, patient body temperature, or patient activity levels.

12. A system comprising:

a remote networking device; and

an implantable medical device (IMD) system, the IMD system comprising;

an IMD configured to deliver a therapy to a patient according to a first therapy program; and

at least one device, wherein the at least one device is configured to;

generate patient data, wherein the patient data relates to at least one of an efficacy or a side effect of the therapy;

compare a value of the patient data to a threshold;

determine whether to transmit the patient data to the remote networking device based on the comparison; and

in response to a determination to transmit the patient data, transmit the patient data to the remote networking device via a network,

wherein the remote networking device comprises;

a communication module; and

a processor, wherein the processor is configured to;

receive the patient data via the network and the communication module;

analyze the patient data to determine whether to implement a programming change;

determine the programming change based on the analysis of the patient data; and

transmit, to the IMD system via the network, at least one of the programming change or a command to implement the programming change,

wherein the IMD system is configured to receive the at least one programming change or command to implement the programming change from the remote networking device via the network.

13. The system of claim 12, wherein the at least one device comprises the IMD.

14. The system of claim 12, wherein the at least one device comprises a programmer, and the patient data comprises data manually entered by the patient using the programmer.

15. The system of claim 12, wherein the at least one device comprises a physiological sensor, and the patient data comprises sensor data gathered with the physiological sensor.

16. The system of claim 15, wherein the physiological sensor comprises an implantable physiological sensor.

17. The system of claim 12, wherein the programming change comprises at least one of an adjustment to at least one parameter of the first therapy program or an initiation of a second therapy program.

18. The system of claim 17, wherein the adjustment to the at least one parameter of the first therapy program comprises a predetermined adjustment specified by a sequence of predetermined adjustments, and wherein the second therapy program comprises a predetermined therapy program specified by a sequence of predetermined therapy programs.

19. The system of claim 18, wherein at least one of the sequence of predetermined adjustments or the sequence of predetermined therapy programs is preloaded on the IMD.

20. The system of claim 19, wherein the command to implement the programming change received at the IMD system initiates at least one of a next predetermined adjustment in the sequence of predetermined adjustments preloaded on the IMD or a next predetermined therapy program in the sequence of predetermined therapy programs preloaded on the IMD.

21. The system of claim 12, wherein the threshold comprises at least one of a number of therapy events or a physiological parameter threshold.

22. The system of claim 15, 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.

23. The system of claim 15, 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.

24. The system of claim 15, wherein the therapy is configured to treat gastrointestinal disorders, and the sensor data comprises at least one of blood glucose concentration, insulin concentration, core body temperature, distension of a stomach, or pH level of the stomach.

25. The system of claim 15, wherein the therapy is configured to treat diabetes, and the sensor data comprises at least one of blood glucose concentration, insulin concentration, patient body temperature, or patient activity levels.