External pulse generator device and associated methods for trial nerve stimulation

• US 10,376,704 B2
• Filed: 02/13/2017
• Issued: 08/13/2019
• Est. Priority Date: 02/12/2016
• Status: Active Grant

• Current Assignee: Axonics, Inc.
• Original Assignee: Axonics Modulation Technologies, Inc.
• Inventors: Mathur, Prabodh, Schroeder, Dennis, Woock, John
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US15/431,475
• Publication Number:
  US 20170239483A1
• Time in Patent Office: 911 Days
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3603 Control systems
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Systems and methods for providing a trial neurostimulation to a patient for assesssing suitability of a permanently implanted neurostimulation are provided herein. In one aspect, a trial neurostimulation system includes an EPG affixation device that secures the EPG to the patient when connected to a lead extending through a percutaneous incission to a target tissue location, while allowing for ready removal of the EPG for charging or bathing. In another aspect, the system includes an EPG provided with a multi-purpose connector rectacle through which the EPG can deliver neurostimulation therapy to an implanted lead or the EPG can be charged. In yet another aspect, the EPG can include a multi-purpose connector receptacle that is alternatingly connectable with a plurality of differing connector to faciltiate differing types of therapies with one or more neurostimulation devices, ground patches or various other devices, such as charging or testing devices.

Claims

1. An external pulse generator comprising:

a pulse generator electrically configured for generating neurostimulation pulses along a plurality of stimulation channels;

a battery electrically coupled to the pulse generator;

an outer housing enclosing the pulse generator and battery;

an external cable extending from the housing; and

a multi-pin connector electrically coupleable to the pulse generator through the external cable, wherein a plurality of pins of the multi-pin connector correspond to the plurality of stimulation channels; and

an actuatable user interface feature disposed on the housing and configured for initiating wireless communication with an external programmer when actuated

wherein the actuatable user interface is configured such that;

actuation while the pulse generator is off or in a hibernation state causes the external pulse generator to be receptive to wireless communication with the external programmer for a pre-determined period of time; and

wherein operation or communication by the external pulse generator remains unchanged when actuation occurs while the pulse generator is operating or communicating.

2. The external pulse generator of claim 1, wherein the external cable is permanently attached to the housing such that any electrical connections between the multi-pin connector and the pulse generator are permanently sealed.

3. The external pulse generator of claim 1, wherein the external cable is between 1 inch and 12 inches in length.

4. The external pulse generator of claim 1, wherein the battery is non-removable by the patient.

5. The external pulse generator of claim 1, wherein the battery is non-rechargeable.

6. The external pulse generator of claim 1, wherein the actuatable user interface comprises a button or switch.

7. The external pulse generator of claim 1, wherein the external pulse generator is configured such that if no communication is established with the external programmer during the pre-determined period of time, the external pulse generator returns to an off or hibernation state.

8. The external pulse generator of claim 1, wherein the external pulse generator is wirelessly coupleable with a patient remote and configured to turn off stimulation during operation in response to a command received from the patient remote.

9. The external pulse generator of claim 1, further comprising:

a status indicator interface disposed on the housing and configured to indicate status of;

a communication between the external pulse generator and an external programmer, an operating state, a battery level, an error state, or any combination thereof.

10. The external pulse generator of claim 9, wherein the housing comprises opposing major faces, a contoured top surface and a flattened underside surface for placement against the patient when the external pulse generator is worn during a trial period,

wherein the status indicator interface and the actuatable user interface are disposed on the underside surface of the housing of the external pulse generator.

11. The external pulse generator of claim 1, further comprising:

a plurality of connectors selectively coupleable within the multi-pin connector, the plurality of connectors including at least two of;

a first connector on a proximal portion of a neurostimulation lead,

a second connector coupled in parallel to each of a ground and one or more proximal connectors of one or more implantable neurostimulation leads, each lead having one or more neurostimulation electrodes on a distal portion thereof, and

a third connector coupled in parallel to two or more proximal connectors of two or more neurostimulation leads.

12. The external pulse generator of claim 1, further comprising:

one or more connector cables coupleable with the multi-pin connector and one or more neurostimulation leads.

13. The external pulse generator of claim 12, wherein the one or more connectors comprise a lead extension cable extending between a corresponding multi-pin connector and at least one implantable lead connector having a receptacle configured for receiving a proximal lead connector of a fully implantable neurostimulation lead.

14. The external pulse generator of claim 12, wherein the one or more connectors comprise a multi-lead extension cable extending between a corresponding multi-pin connector and a plurality of lead connectors, each having a lead receptacle for coupling with a neurostimulation lead, and at least one ground connector for coupling with a ground patch.

15. The external pulse generator of claim 1

wherein the battery is non-rechargeable and non-removable by the patient, wherein the battery is single-use power source having sufficient power for operation of the EPG for at least the duration of a trial period.

16. The external pulse generator of claim 15, wherein the external pulse generator is configured for use with both a temporary lead having one electrode and a lead having a plurality of electrodes for a trial or permanent implantation.

17. The external pulse generator of claim 1, wherein the external pulse generator is configured for use with both a temporary lead having one electrode and a lead having a plurality of electrodes for a trial or permanent implantation.

18. An external pulse generator comprising:

a pulse generator electrically configured for generating neurostimulation pulses along a plurality of stimulation channels;

a battery electrically coupled to the pulse generator;

an outer housing enclosing the pulse generator and battery;

a multi-pin connector electrically coupled to the pulse generator, wherein a plurality of pins of the multi-pin connector correspond to the plurality of stimulation channels; and

an actuatable user interface feature disposed on the housing and configured for initiating wireless communication with an external programmer when actuated, wherein the user interface is further configured such that;

actuation while the pulse generator is off or in a hibernation state causes the external pulse generator to be receptive to wireless communication with the external programmer for a pre-determined period of time; and

wherein neurostimulation operation of the external pulse generator remains unchanged when actuation occurs while the pulse generator is operating for neurostimulation.

19. The external pulse generator of claim 18, where the housing comprises opposing major faces, a contoured top surface and a flattened underside surface for placement against the patient when the external pulse generator is worn during a trial period,

wherein the actuatable user interface is disposed on the underside surface of the housing of the external pulse generator that faces toward the patient when worn.

20. The external pulse generator of claim 18, wherein the external pulse generator includes a single button, the single button being the actuatable user interface feature.

21. The external pulse generator of claim 18, further comprising:

an external lead extension cable electrically connected and proximally coupled to the pulse generator via the multi-pin connector, wherein the external lead extension cable comprises a distal connector portion having distal connectors for electrically connecting, in parallel, to each of a ground pad for application to a skin of a patient and one or more proximal connectors of one or more implantable neurostimulation leads, each lead having one or more neurostimulation electrodes on a distal portion thereof.

22. The external pulse generator of claim 21, wherein the distal connector portion of the external lead extension cable comprises two distal lead connectors, each configured for coupling with a proximal connector of an implantable neurostimulation lead having one or more neurostimulation electrodes and a distal ground connector configured for coupling with the ground pad applied to the skin of the patient.

23. The external pulse generator of claim 21, wherein the external pulse generator is configured for use with both a temporary lead having one electrode and a lead having a plurality of electrodes for a trial or permanent implantation.

24. The external pulse generator of claim 18, wherein the external pulse generator is configured for use with both a temporary lead having one electrode and a lead having a plurality of electrodes for a trial or permanent implantation.