TRIAL STIMULATION SYSTEMS

• US 20150100106A1
• Filed: 03/06/2013
• Published: 04/09/2015
• 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.
• Granted Patent: US 9,878,168 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• 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 trial electrical stimulator comprising;

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

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

a processor configured to control the therapy delivery module to deliver the electrical stimulation via the at least one stimulation lead,

wherein the trial stimulator is sterilized.

2. :

The 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 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 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 stimulation lead.

5. :

The 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 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 stimulation lead is disconnected from the trial stimulator.

7. :

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

8. :

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

9. :

The trial stimulator of claim 1, wherein the processor is configured to;

monitor stimulation intensity delivered by the 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 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 trial stimulator of claim 1, further comprising a power management module configured to operate the 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 trial stimulator to which power is supplied in the shelf mode.

12. :

The trial stimulator of claim 1, further comprising;

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

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

13. :

The trial stimulation of claim 12, wherein the processor is configured to detect when the lead coupler door is open and to automatically, and without user interaction, control the therapy delivery module to cease delivery of stimulation.

14. :

The trial stimulator of claim 1,

wherein the lead coupler is configured to connect a plurality of stimulation leads directly to the trial stimulator without any intervening lead connection devices, and

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

15. :

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

16. :

A method comprising;

implanting a stimulation lead to deliver stimulation to a target tissue location;

connecting the stimulation lead directly to a disposable trial stimulator via a lead coupler integral with the trial stimulator, wherein the lead coupler is configured to connect a plurality of types of stimulation leads directly to the trial stimulator without any intervening lead connection devices;

programming the trial stimulator to deliver stimulation via the stimulation lead with an electronic programming device configured to wirelessly communicate with the trial stimulator;

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

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

17. :

The method of claim 16, further comprising sterilizing the stimulation lead and the trial stimulator prior to implanting the stimulation lead.

18. :

The method of claim 16, further comprising;

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

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

19. :

The method of claim 16, further comprising;

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

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

20. :

The method of claim 19, further comprising controlling the trial stimulator to cease delivery of stimulation when the stimulation intensity does not equal a programmed stimulation intensity.

21. :

The method of claim 16, wherein the stimulation lead comprises a first stimulation lead, and wherein the method further comprises;

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

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