Systems and methods for clinician control of stimulation systems

• US 10,293,168 B2
• Filed: 12/17/2015
• Issued: 05/21/2019
• Est. Priority Date: 06/10/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Inventors: Bennett, Maria E., Rundle, Kenneth P., Rubin, Stuart F., Coburn, James, Pack, Danny R., Strother, Robert B., Thrope, Geoffrey B., Mrva, Joseph J.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Ghand, Jennifer
• Application Number:
  US14/972,431
• Publication Number:
  US 20160129270A1
• Time in Patent Office: 1,251 Days
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Systems and methods for programming and logging medical device and patient data are provided. The systems include a handheld device, which is capable of communicating with a medical device, and a base station, which provides connectivity for the handheld device to accomplish various functions such as recharging, programming, data back-up and data entry. The methods comprise the steps of detecting a medical device, obtaining and recording information from the medical device. Additionally, medical device parameters may be modified and the recorded information may be archived for future reference.

Claims

1. A system comprising:

an off-the-shelf handheld device having a display screen; and

a housing that is distinct from the off-the-shelf handheld device, the housing being configured to encase a communications module configured to communicate with both an implantable pulse generator (IPG) and with the off-the-shelf handheld device,

wherein the communications module comprises a wireless module that uses a first communication protocol to communicate wirelessly with the IPG using a unique identifier of the IPG, the first communication protocol comprising a custom communication protocol that is determined based on one or more capabilities of the IPG,

wherein the communications module is configured to receive, wirelessly from the IPG via the custom communication protocol, a plurality of stimulus parameters used by the IPG, and to send the plurality of stimulus parameters to the off-the-shelf handheld device,

wherein the off-the-shelf handheld device is configured to receive the plurality of stimulus parameters from the communications module, to display the plurality of stimulus parameters using the display screen, to receive input from a user to adjust at least one stimulus parameter of the plurality of stimulus parameters, and to send the unique identifier of the IPG and the at least one adjusted stimulus parameter to the communications module, and

wherein the communications module comprises a protocol translator that translates data between different communication protocols, the communications module being configured to receive the unique identifier of the IPG and the at least one adjusted stimulus parameter from the off-the-shelf handheld device via a second communication protocol, and to send, wirelessly to the IPG via the custom communication protocol, the unique identifier of the IPG and the at least one adjusted stimulus parameter, wherein the second communication protocol is different than the custom communication protocol.

2. The system of claim 1, wherein the communications module is configured to communicate wirelessly with the IPG while the communications module is up to six feet away from the IPG.

3. The system of claim 1, further comprising:

a base station configured to receive the off-the-shelf handheld device, the base station being further configured to provide power to the off-the-shelf handheld device.

4. The system of claim 3, wherein the off-the-shelf handheld device comprises a user interface that is configured to allow a user to control the base station.

5. The system of claim 3, wherein the base station comprises at least one port configured to provide the off-the-shelf handheld device with connectivity to at least one external device.

6. The system of claim 1, wherein the display screen of the off-the-shelf handheld device is a touch screen.

7. The system of claim 1, wherein the off-the-shelf handheld device includes at least one serial communications port, and wherein the off-the-shelf handheld device is configured to communicate with the communications module via the at least one serial communications port.

8. The system of claim 7, wherein the at least one serial communications port comprises a Universal Serial Bus port.

9. The system of claim 1, further comprising:

a database configured to store patient data,

wherein the off-the-shelf handheld device is configured to at least one of (1) provide user access to the patient data stored in the database or (2) allow storing of information from the IPG in the database.

10. The system of claim 9, wherein the database is accessible by the off-the-shelf handheld device via a network.

11. The system of claim 1, wherein the unique identifier of the IPG comprises one of an electronic signature or a device serial number associated with the IPG.

12. The system of claim 1, wherein the communications module is configured to determine whether the IPG is within a scannable range and to establish a wireless communications link with the IPG prior to receiving the plurality of stimulus parameters from the IPG.

13. The system of claim 1, wherein the communications module is further configured to receive, wirelessly from the IPG via the custom communication protocol, compliance data that includes recharge history information associated with the IPG.

14. The system of claim 1, wherein one or more of the plurality of stimulus parameters are associated with a pulse amplitude, a pulse duration, or a pulse frequency.

15. The system of claim 1, wherein the off-the-shelf handheld device is further configured to display one or more recommended stimulus parameters associated with the plurality of stimulus parameters received from the IPG.

16. The system of claim 1, wherein the housing is attachable to the off-the-shelf handheld device.

17. The system of claim 1,

wherein the communications module is configured to receive the unique identifier of the IPG and the at least one adjusted stimulus parameter at least by receiving one or more packets from the off-the-shelf handheld device that include the unique identifier of the IPG and the at least one adjusted stimulus parameter,

wherein the communications module is configured to convert the one or more packets into one or more wireless messages that include the unique identifier of the IPG and the at least one adjusted stimulus parameter, and

wherein the communications module is configured to send, wirelessly to the IPG via the custom communication protocol, the one or more wireless messages.

18. A system comprising:

an off-the-shelf handheld device having a display screen;

an implantable pulse generator (IPG); and

a housing that is distinct from the off-the-shelf handheld device, the housing being configured to encase a communications module configured to communicate with both the IPG and with the off-the-shelf handheld device,

wherein the communications module comprises a wireless module that uses a first communication protocol to communicate wirelessly with the IPG using a unique identifier of the IPG, the first communication protocol comprising a custom communication protocol that is determined based on one or more capabilities of the IPG,

wherein the communications module is configured to receive, wirelessly from the IPG via the custom communication protocol, a plurality of stimulus parameters used by the IPG, and to send the plurality of stimulus parameters to the off-the-shelf handheld device,

wherein the off-the-shelf handheld device is configured to receive the plurality of stimulus parameters from the communications module, to display the plurality of stimulus parameters using the display screen, to receive input from a user to adjust at least one stimulus parameter of the plurality of stimulus parameters, and to send the unique identifier of the IPG and the at least one adjusted stimulus parameter to the communications module, and

wherein the communications module comprises a protocol translator that translates data between different communication protocols, the communications module being configured to receive the unique identifier of the IPG and the at least one adjusted stimulus parameter from the off-the-shelf handheld device via a second communication protocol, and to send, wirelessly to the IPG via the custom communication protocol, the unique identifier of the IPG and the at least one adjusted stimulus parameter, wherein the second communication protocol is different than the custom communication protocol.

19. The system of claim 18, wherein the communications module is configured to communicate wirelessly with the IPG while the communications module is up to six feet away from the IPG.

20. The system of claim 18, further comprising:

a base station configured to receive the off-the-shelf handheld device, the base station being further configured to provide power to the off-the-shelf handheld device.

21. The system of claim 20, wherein the off-the-shelf handheld device comprises a user interface that is configured to allow a user to control the base station.

22. The system of claim 20, wherein the base station comprises at least one port configured to provide the off-the-shelf handheld device with connectivity to at least one external device.

23. The system of claim 18, wherein the display screen of the off-the-shelf handheld device is a touch screen.

24. The system of claim 18, wherein the off-the-shelf handheld device includes at least one serial communications port, and wherein the off-the-shelf handheld device is configured to communicate with the communications module via the at least one serial communications port.

25. The system of claim 24, wherein the at least one serial communications port comprises a Universal Serial Bus port.

26. The system of claim 18, further comprising:

a database configured to store patient data,

wherein the off-the-shelf handheld device is configured to at least one of (1) provide user access to the patient data stored in the database or (2) allow storing of information from the IPG in the database.

27. The system of claim 26, wherein the database is accessible by the off-the-shelf handheld device via a network.

28. The system of claim 18, wherein the unique identifier of the IPG comprises one of an electronic signature or a device serial number associated with the IPG.

29. The system of claim 18, wherein the communications module is configured to determine whether the IPG is within a scannable range and to establish a wireless communications link with the IPG prior to receiving the plurality of stimulus parameters from the IPG.

30. The system of claim 18, wherein the communications module is further configured to receive, wirelessly from the IPG via the custom communication protocol, compliance data that includes recharge history information associated with the IPG.

31. The system of claim 18, wherein one or more of the plurality of stimulus parameters are associated with a pulse amplitude, a pulse duration, or a pulse frequency.

32. The system of claim 18, wherein the off-the-shelf handheld device is further configured to display one or more recommended stimulus parameters associated with the plurality of stimulus parameters received from the IPG.

33. The system of claim 18, wherein the housing is attachable to the off-the-shelf handheld device.

34. A method comprising:

sending at least a first communication between a communications module and an implantable pulse generator (IPG) using a first communication protocol, wherein the communications module is included in a housing that is configured to encase the communications module, wherein the communications module comprises a wireless module that uses the first communication protocol to communicate wirelessly with the IPG using a unique identifier of the IPG, and wherein the first communication protocol comprises a custom communication protocol that is determined based on one or more capabilities of the IPG; and

sending at least a second communication between the communications module and an off-the-shelf handheld device having a display screen, wherein the housing of the communications module is distinct from the off-the-shelf handheld device,

wherein the communications module is configured to receive, wirelessly from the IPG via the custom communication protocol, a plurality of stimulus parameters used by the IPG, and to send the plurality of stimulus parameters to the off-the-shelf handheld device,

wherein the off-the-shelf handheld device is configured to receive the plurality of stimulus parameters from the communications module, to display the plurality of stimulus parameters using the display screen, to receive input from a user to adjust at least one stimulus parameter of the plurality of stimulus parameters, and to send the unique identifier of the IPG and the at least one adjusted stimulus parameter to the communications module, and

wherein the communications module comprises a protocol translator that translates data between different communication protocols, the communications module being configured to receive the unique identifier of the IPG and the at least one adjusted stimulus parameter from the off-the-shelf handheld device via a second communication protocol, and to send, wirelessly to the IPG via the custom communication protocol, the unique identifier of the IPG and the at least one adjusted stimulus parameter, wherein the second communication protocol is different than the custom communication protocol.

35. A non-transitory computer-readable medium comprising instructions that, upon execution, cause a system to:

send at least a first communication between a communications module and an implantable pulse generator (IPG) using a first communication protocol, wherein the communications module is included in a housing that is configured to encase the communications module, wherein the communications module comprises a wireless module that uses the first communication protocol to communicate wirelessly with the IPG using a unique identifier of the IPG, and wherein the first communication protocol comprises a custom communication protocol that is determined based on one or more capabilities of the IPG; and

send at least a second communication between the communications module and an off-the-shelf handheld device having a display screen, wherein the housing of the communications module is distinct from the off-the-shelf handheld device,

wherein the communications module is configured to receive, wirelessly from the IPG via the custom communication protocol, a plurality of stimulus parameters used by the IPG, and to send the plurality of stimulus parameters to the off-the-shelf handheld device,

wherein the off-the-shelf handheld device is configured to receive the plurality of stimulus parameters from the communications module, to display the plurality of stimulus parameters using the display screen, to receive input from a user to adjust at least one stimulus parameter of the plurality of stimulus parameters, and to send the unique identifier of the IPG and the at least one adjusted stimulus parameter to the communications module, and

wherein the communications module comprises a protocol translator that translates data between different communication protocols, the communications module being configured to receive the unique identifier of the IPG and the at least one adjusted stimulus parameter from the off-the-shelf handheld device via a second communication protocol, and to send, wirelessly to the IPG via the custom communication protocol, the unique identifier of the IPG and the at least one adjusted stimulus parameter, wherein the second communication protocol is different than the custom communication protocol.