Trial stimulation systems

• US 9,878,168 B2
• Filed: 03/06/2013
• Issued: 01/30/2018
• 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 DIPAYAN
• Application Number:
  US14/396,671
• Publication Number:
  US 20150100106A1
• Time in Patent Office: 1,791 Days
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

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 disposable external trial electrical stimulator comprising:

a therapy delivery module configured to deliver electrical stimulation via at least one percutaneous stimulation lead configured to be connected to the disposable external trial stimulator;

a lead coupler configured to connect a plurality of types of percutaneous stimulation leads configured to be coupled to the disposable trial stimulator directly to the disposable external trial stimulator without any intervening lead connection devices, the at least one percutaneous stimulation lead configured to be connected to the disposable external trial stimulator being one type of percutaneous stimulation lead of the plurality of types of percutaneous stimulation leads;

a lead coupler door comprising a portion of an exterior wall of the disposable external trial stimulator and configured to expose the lead coupler when opened; and

a processor configured to;

control the therapy delivery module to deliver the electrical stimulation via the at least one percutaneous stimulation lead;

automatically detect, when the at least one percutaneous stimulation lead is connected to the disposable external trial stimulator, the at least one percutaneous stimulation lead as the one type of percutaneous stimulation lead instead of another type of percutaneous stimulation lead of the plurality of types of percutaneous stimulation leads;

automatically, based on the detected one type of percutaneous stimulation lead connected to the trial stimulator, perform one or more of the following;

(1) limit one or more stimulation programming options available to a programmer, (2) limit one or more stimulation parameter values, or (3) select one or more different programs according to stimulation that the therapy delivery module can deliver via the detected one type of percutaneous stimulation lead;

detect when the lead coupler door is open; and

responsive to detecting that the lead coupler door is open, automatically, and without user interaction, control the therapy delivery module to cease delivery of stimulation,

wherein the disposable external trial stimulator is sterilized.

2. The disposable external trial stimulator of claim 1, further comprising a housing that is configured to resist ingress of liquid into an interior chamber defined by the housing.

3. The disposable external trial stimulator 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 disposable external trial stimulator of claim 1, wherein the therapy delivery module comprises a stimulation generator configured to deliver current controlled stimulation via one or more electrodes connected to the at least one percutaneous stimulation lead.

5. The disposable external trial stimulator of claim 4, wherein the therapy delivery module is configured to simulate voltage controlled stimulation with the current controlled stimulation delivered by the stimulation generator.

6. The disposable external trial stimulator of claim 1, wherein the processor is configured to automatically, and without user interaction, control the therapy delivery module to cease delivery of stimulation when the at least one percutaneous stimulation lead is disconnected from the disposable external trial stimulator.

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

8. The disposable external trial stimulator of claim 7, wherein the at least one commercially available primary cell battery comprises at least one AAAA battery.

9. The disposable external trial stimulator of claim 1, wherein the processor is configured to:

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

generate an alert when the stimulation intensity delivered by the therapy delivery module does not equal a programmed stimulation intensity.

10. The disposable external trial stimulator of claim 9, wherein the processor is configured to control the therapy delivery module to cease delivery of stimulation when the stimulation intensity does not equal a programmed stimulation intensity.

11. The disposable external trial stimulator of claim 1, further comprising a power management module configured to operate the disposable external trial stimulator in a plurality of power consumption modes, wherein the plurality of power consumption modes comprises a shelf mode, and wherein the power management module is configured to limit one or more components of the disposable external trial stimulator to which power is supplied in the shelf mode.

12. The disposable external trial stimulator of claim 1, further comprising

a lead retention clip configured to hold the at least one percutaneous stimulation lead in place when the lead coupler door is opened.

13. The disposable external trial stimulator of claim 1,

wherein the therapy delivery module is configured to deliver stimulation via the at least one percutaneous stimulation lead while one or more additional percutaneous stimulation leads are being connected to the disposable external trial stimulator via the lead coupler.

14. The disposable external trial stimulator of claim 1, further comprising a single user interface integral with the disposable external trial stimulator, wherein the user interface is configured to control the disposable external trial stimulator to be capable of wireless communications with an electronic programming device and to turn off stimulation being delivered by the disposable external trial stimulator.

15. The disposable external trial stimulator of claim 1, wherein the therapy delivery module is configured to deliver neurostimulation to a nervous system of a patient via the at least one percutaneous stimulation lead connected to the external trial stimulator.

16. The external trial stimulator of claim 1, wherein the processor is configured to automatically detect the at least one percutaneous stimulation lead as the one type of percutaneous stimulation lead by comparing a first resistance of a conductor of the at least one percutaneous stimulation lead to a plurality of resistances associated with respective percutaneous stimulation lead types of the plurality of percutaneous stimulation lead types stored in a memory of the disposable external trial stimulator.

17. The external trial stimulator of claim 1, wherein the processor is configured to automatically detect the at least one percutaneous stimulation lead as the one type of percutaneous stimulation lead by comparing a voltage drop across the disposable external trial stimulator and a conductor of the at least one percutaneous stimulation lead to a plurality of voltage values associated with respective percutaneous stimulation lead types of the plurality of percutaneous stimulation lead types stored in a memory of the external trial stimulator.

18. The disposable external trial stimulator of claim 1, wherein the lead coupler is configured to connect to, and the processor is configured to detect, each type of percutaneous stimulation lead of the plurality of types of percutaneous stimulation leads that comprises at least one of a different number of contacts, contacts having different sizes, or contacts having different shapes than other types of percutaneous stimulation leads of the plurality of types of percutaneous stimulation leads.

19. A method comprising:

implanting a percutaneous stimulation lead configured to be connected to a disposable external trial stimulator to deliver stimulation to a target tissue location;

connecting the percutaneous stimulation lead directly to the disposable external trial stimulator via a lead coupler integral with the disposable external trial stimulator, wherein the lead coupler is configured to connect a plurality of types of percutaneous stimulation leads configured to be coupled to the disposable trial stimulator directly to the disposable external trial stimulator without any intervening lead connection devices, the percutaneous stimulation lead configured to be connected to the disposable external trial stimulator being one type of percutaneous stimulation lead of the plurality of types of percutaneous stimulation leads;

automatically detecting, by a processor of the disposable external trial stimulator and when the percutaneous stimulation lead is connected to the disposable external trial stimulator, the percutaneous stimulation lead as the one type of percutaneous stimulation lead instead of another type of percutaneous stimulation lead of the plurality of types of percutaneous stimulation leads;

automatically, by the processor of the disposable external trial stimulator and based on the detected one type of percutaneous stimulation lead connected to the trial stimulator, performing one or more of the following;

(1) limiting one or more stimulation programming options available to a programmer, (2) limiting one or more stimulation parameter values, or (2) selecting one or more different programs according to stimulation that the external trial stimulator can deliver via the detected one type of percutaneous stimulation lead;

programming, with an electronic programming device, the disposable external trial stimulator to deliver stimulation via the percutaneous stimulation lead, wherein the electronic programming device is configured to wirelessly communicate with the disposable external trial stimulator;

delivering stimulation to the target tissue location via the percutaneous stimulation lead with the disposable external trial stimulator for a trial period of time;

detecting, by the processor of the disposable external trial stimulator, that a lead coupler door is open, the lead coupler door comprising a portion of an exterior wall of the disposable external trial stimulator and configured to expose the lead coupler when opened;

responsive to detecting that the lead coupler door is open, automatically, by the processor of the disposable external trial stimulator and without user interaction, controlling the disposable external trial stimulator to cease delivery of stimulation; and

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

20. The method of claim 19, further comprising sterilizing the percutaneous stimulation lead and the disposable external trial stimulator prior to implanting the percutaneous stimulation lead.

21. The method of claim 19, further comprising:

selecting a user interface integral with the disposable external trial stimulator after connecting the percutaneous stimulation lead to the disposable external trial stimulator; and

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

22. The method of claim 19, further comprising:

monitoring stimulation intensity delivered by the disposable external trial stimulator via the percutaneous stimulation lead; and

generating an alert when the stimulation intensity delivered by the disposable external trial stimulator does not equal a programmed stimulation intensity.

23. The method of claim 22, further comprising controlling the disposable external trial stimulator to cease delivery of stimulation when the stimulation intensity does not equal a programmed stimulation intensity.

24. The method of claim 19, wherein the percutaneous stimulation lead comprises a first percutaneous stimulation lead, and wherein the method further comprises:

connecting a second percutaneous stimulation lead to the disposable external trial stimulator via the lead coupler; and

continuing delivering stimulation to the target tissue location via the first percutaneous stimulation lead while the second percutaneous stimulation lead is being connected to the disposable external trial stimulator via the lead coupler.

25. The method of claim 19, wherein delivering stimulation to the target tissue location via the percutaneous stimulation lead with the disposable external trial stimulator comprises delivering neurostimulation to a nervous system of a patient.

26. A disposable external trial electrical stimulator comprising:

a therapy delivery module configured to deliver electrical stimulation via at least one percutaneous stimulation lead configured to be connected to the disposable external trial stimulator, wherein the disposable external trial stimulator is sterilized;

a lead coupler configured to connect the at least one percutaneous stimulation lead directly to the disposable external trial stimulator, wherein the lead coupler is configured to connect a plurality of types of percutaneous stimulation leads configured to be coupled to the disposable trial stimulator directly to the disposable external trial stimulator without any intervening lead connection devices;

a lead coupler door comprising a portion of an exterior wall of the disposable external trial stimulator and configured to expose the lead coupler when opened; and

a processor configured to;

control the therapy delivery module to deliver the electrical stimulation via the at least one percutaneous stimulation lead;

detect when the lead coupler door is open; and

responsive to detecting that the lead coupler door is open, automatically, and without user interaction, control the therapy delivery module to cease delivery of stimulation.

27. The disposable external trial electrical stimulator of claim 26, further comprising a lead retention clip configured to hold the at least one percutaneous stimulation lead in place when the lead coupler door is opened.