Trial stimulation systems

• US 10,369,370 B2
• Filed: 03/06/2013
• Issued: 08/06/2019
• Est. Priority Date: 04/26/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shishilla, John, Pederson, Kathryn A., Jain, Mukul, Mairs, Nicholas S.
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US14/396,659
• Publication Number:
  US 20150088227A1
• Time in Patent Office: 2,344 Days
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A trial stimulation system includes a disposable trial electrical stimulator that, in some examples, is sterilized for a single use in a stimulation trial of one patient. Additionally, systems for securing a disposable trial stimulator to the body of a patient are described, which may function to improve the durability of the system during the trial period and reduce the risk of damage or malfunction to the system due to lead/electrode dislocation and/or off-label uses like showering or bathing with the trial stimulator still secured to the body.

Claims

1. A medical system comprising:

a disposable trial electrical stimulator comprising one of a button, a rocker switch, a slider switch, or a rotary dial switch as a single user interface integral with the disposable trial electrical stimulator;

at least one percutaneous stimulation lead connected to the disposable trial electrical stimulator; and

an electronic programming device configured to wirelessly communicate with the disposable trial electrical stimulator to program the disposable trial electrical stimulator to deliver stimulation therapy via the at least one percutaneous stimulation lead,

wherein the one of the button, the rocker switch, the slider switch, or the rotary dial switch is configured to cause the disposable trial electrical stimulator to be capable of wireless communications with the electronic programming device and to turn off stimulation being delivered by the disposable trial electrical stimulator.

2. The system of claim 1, wherein the disposable trial electrical stimulator comprises a housing that is configured to resist ingress of liquid into an interior chamber defined by the housing.

3. The system of claim 2, wherein the housing comprises a first half and a second half connected to one another via an ultrasonic weld configured to resist ingress of liquid into the interior chamber defined by the housing.

4. The system of claim 2,

wherein the disposable trial electrical stimulator comprises a battery bay comprising a cavity configured to receive one or more batteries to power the disposable trial electrical stimulator and a door that forms a portion of the housing, and

wherein the disposable trial electrical stimulator comprises a gasket interposed between the battery bay door and the housing to resist ingress of fluids into the battery bay.

5. The system of claim 1, wherein at least one of the disposable trial electrical stimulator and the electronic programming device comprises a processor configured to automatically, and without user interaction, detect a type of the at least one percutaneous stimulation lead connected to the disposable trial electrical stimulator.

6. The system of claim 5, wherein the processor is configured to automatically detect the type of the at least one percutaneous stimulation lead at least by:

determining an actual resistance of a conductor of the at least one percutaneous stimulation lead; and

comparing the actual resistance of the conductor to a plurality of resistances associated with a plurality of lead types stored in memory of at least one of the disposable trial electrical stimulator and the electronic programming device.

7. The system of claim 6, wherein the processor is configured to automatically, and without user interaction, select at least one of a number of stimulation programming options available via the electronic programming device and one or more stimulation parameter values according to which the disposable trial electrical stimulator can deliver stimulation via the at least one percutaneous stimulation lead based on the type of the at least one percutaneous stimulation lead.

8. The system of claim 1, wherein the disposable trial electrical stimulator comprises a stimulation engine configured to deliver current controlled stimulation via one or more electrodes connected to the at least one percutaneous stimulation lead.

9. The system of claim 1, wherein the disposable trial electrical stimulator is configured to automatically, and without user interaction, cease delivery of stimulation when the at least one percutaneous stimulation lead is disconnected from the trial electrical stimulator.

10. The system of claim 1, further comprising at least one commercially available primary cell battery connected to and configured to power the disposable trial electrical stimulator.

11. The system of claim 10, wherein the at least one commercially available primary cell battery comprises at least one AAAA battery.

12. The system of claim 1, wherein the disposable trial electrical stimulator comprises a diagnostics module configured to:

monitor stimulation intensity delivered by the disposable trial electrical stimulator; and

cause the trial stimulation to cease delivery of stimulation when the stimulation intensity delivered by the disposable trial electrical stimulator does not equal a programmed stimulation intensity.

13. The system of claim 1, further comprising a lead extension interposed between and connected to the disposable trial electrical stimulator and the at least one percutaneous stimulation lead.

14. The system of claim 13, further comprising a gasket interposed between the lead extension and the disposable trial electrical stimulator and configured to seal the connection there between from ingress of liquid.

15. The system of claim 1, wherein the single user interface consists of the button, and wherein the disposable trial electrical stimulator is configured to initiate wireless communication with the electronic programming device in response to a press of the button.

16. The system of claim 1, wherein the one of the button, the rocker switch, the slider switch, or the rotary dial switch is configured to initiate wireless communication between the disposable trial electrical stimulator and the electronic programming device to cause the disposable trial electrical stimulator to be capable of wireless communications with the electronic programming device.

17. A method comprising:

implanting at least one percutaneous stimulation lead to deliver stimulation to a target tissue location;

connecting the at least one percutaneous stimulation lead to a disposable trial electrical stimulator comprising one of a button, a rocker switch, a slider switch, or a rotary dial switch as a single user interface integral with the disposable trial electrical stimulator, wherein the one of the button, the rocker switch, the slider switch, or the rotary dial switch is configured to cause the disposable trial electrical stimulator to be capable of wireless communications with an electronic programming device and to turn off stimulation being delivered by the disposable trial electrical stimulator;

programming the disposable trial electrical stimulator to deliver stimulation via the at least one percutaneous stimulation lead with the electronic programming device configured to wirelessly communicate with the disposable trial electrical stimulator;

delivering stimulation to the target tissue location via the at least one percutaneous stimulation lead with the disposable trial electrical stimulator for a trial period of time; and

disposing of the disposable trial electrical stimulator after expiration of the trial period of time.

18. The method of claim 17, further comprising sterilizing the at least one percutaneous stimulation lead and the disposable trial electrical stimulator prior to implanting the at least one percutaneous stimulation lead.

19. The method of claim 17, further comprising:

selecting the one of the button, the rocker switch, the slider switch, or the rotary dial switch integral with the disposable trial electrical stimulator after connecting the at least one percutaneous stimulation lead to the disposable trial electrical stimulator; and

initiating a wireless communication session between the disposable trial electrical stimulator the electronic programming device prior to programming the disposable trial electrical stimulator to deliver stimulation.

20. The method of claim 17, further comprising:

monitoring stimulation intensity delivered by the disposable trial electrical stimulator via the at least one percutaneous stimulation lead; and

causing the disposable trial electrical stimulation to cease delivery of stimulation when the stimulation intensity delivered by the disposable trial electrical stimulator does not equal a programmed stimulation intensity.

21. The method of claim 17, further comprising automatically, and without user interaction, detecting a type of the at least one percutaneous stimulation lead after connecting the at least one percutaneous stimulation lead to the disposable trial electrical stimulator.

22. The method of claim 21, wherein automatically detecting the type of the at least one percutaneous stimulation comprises:

determining an actual resistance of a conductor of the at least one percutaneous stimulation lead; and

comparing the actual resistance of the conductor to a plurality of resistances associated with a plurality of lead types stored in a computer readable storage medium of at least one of the disposable trial electrical stimulator and the electronic programming device.

23. The method of claim 22, further comprising automatically, and without user interaction, selecting at least one of a number of stimulation programming options available via the electronic programming device and one or more stimulation parameter values according to which the disposable trial electrical stimulator can deliver stimulation via the at least one percutaneous stimulation lead.

24. The method of claim 17, wherein the single user interface consists of the button, and wherein the method further comprises initiating, by the disposable trial electrical stimulator, wireless communication with the electronic programming device in response to a press of the button.