EXTERNAL PULSE GENERATOR DEVICE AND ASSOCIATED METHODS FOR TRIAL NERVE STIMULATION

• US 20170239483A1
• Filed: 02/13/2017
• Published: 08/24/2017
• 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
• Granted Patent: US 10,376,704 B2
• Time in Patent Office: 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. A rechargeable external pulse generator comprising:

an outer housing having at least one port;

a connector receptacle accessed via the at least one port, the receptacle adapted for receivably coupling with a proximal portion of an implantable neurostimulation lead so as to electrically couple the external pulse generator with one or more neurostimulation electrodes of the neurostimulation lead when coupled thereto;

a pulse generator electrically coupled with the connector receptacle and adapted for generating neurostimulation pulses to the one or more neurostimulation electrodes of a neurostimulation lead connected to the connector receptacle; and

a rechargeable battery electrically coupled to the pulse generator and the connector receptacle and configured for recharging by electrical power delivered via the connector receptacle.

2. The system of claim 1, further comprising:

electrical circuitry coupling each of the pulse generator, the rechargeable battery and the connector receptacle, wherein the circuitry is configured to;

power the pulse generator with the charged battery; and

charge the battery with electrical power delivered via the connector receptacle.

3. The system of claim 2, wherein the electrical circuitry is further configured to switch between differing operating modes of the external pulse generator that include a therapy mode and a charging mode.

4. The system of claim 3, wherein the electrical circuitry is configured with one or more stimulation programs operable within the therapy mode.

5. The system of claim 3, wherein the electrical circuitry is further configured to switch to the charging mode when the connector receptacle is coupled to a power connector of a charging cord coupled to an external power source.

6. The system of claim 3, wherein the electrical circuitry is further configured to switch to the therapy mode when the connector receptacle is coupled to a proximal connector of the neurostimulation lead.

7. The system of claim 1, wherein the connector receptacle is adapted for alternatingly connecting with a plurality of differing connectors that include the proximal portion of the neurostimulation lead and a power connector of a charging cord.

8. The system of claim 7, wherein the circuitry is adapted for charging the battery when the charging cord is electrically coupled with a standard 120 volt outlet.

9. The system of claim 7, wherein the circuitry is further adapted for suspending pulse generation in a therapy mode in response to disconnecting of the proximal connector of the neurostimulation lead from the connector receptacle.

10. The system of claim 9, wherein the circuitry is adapted for suspending pulse generation in response to a detection of loss of electrical connectivity within the connector receptacle while in the therapy mode.

11. The system of claim 2, wherein the circuitry is further configured to:

switch to a charging mode when the battery is electrically connected to the connector receptacle and in which the battery is disconnected from the pulse generator, and

switch to a therapy mode when the pulse generator is operatively connected to the battery in response to electrically disconnecting the battery from the connector receptacle.

12. The system of claim 2, wherein the connector receptacle is the one and only connector receptacle of the pulse generator.

13. The system of claim 2, wherein the external pulse generator is reusable.

14. An external pulse generator comprising:

an outer housing having at least one port;

a connector receptacle accessed via the at least one port;

a pulse generator electrically coupled with the connector receptacle and adapted for generating neurostimulation pulses to the one or more neurostimulation electrodes of a neurostimulation lead coupled to the connector receptacle; and

a plurality of connectors selectively coupleable within the connector receptacle, wherein the plurality of connectors includes at least two of;

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

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

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

a fourth connector coupled to a charging cord and adapted for use in charging a rechargeable battery of the external pulse generator.

15. A method of performing a neurostimulation treatment during a trial period, the method comprising:

electrically coupling a neurostimulation lead to an external pulse generator, the neurostimulation lead having at least a distal end with one or more neurostimulation electrodes implanted at or near a target tissue within the patient, wherein the neurostimulation lead is coupled to the external pulse generator via a first receptacle port;

delivering the neurostimulation treatment from the one or more neurostimulation electrodes with the external pulse generator; and

electrically coupling a rechargeable battery of the external pulse generator with an external power source via the first receptacle port of the external pulse generator; and

charging the rechargeable battery of the external pulse generator with the external power source.

16. The method of claim 15, wherein the delivering the neurostimulation lead is performed in a neurostimulation operating mode of the external pulse generator and the charging of the external pulse generator is performed in a charging operating mode, the method further comprising:

switching to the neurostimulation mode upon connection of the neurostimulation lead; and

switching to the charging mode upon connection of a charging cord connected to an external power source and/or grounding.

17. An external pulse generator affixation device for affixing an external pulse generator on a patient, the device comprising:

a substrate having a patient coupling feature disposed along a first side and a mounting portion disposed along a second side opposite the first side;

wherein the mounting portion includes a plurality of tabs that engage the external pulse generator along an outer perimeter thereof so as to releasably couple the external pulse generator with the substrate, wherein the plurality of tabs are dimensioned and arranged so that a majority of the outer perimeter remains exposed so as to allow a patient to readily detach the external pulse generator from the substrate while coupled to the patient.

18. The system of claim 17, wherein the mounting portion is non-electrically conductive.

19. The system of claim 17, wherein the affixation device is without any electrodes or electrically conductive path between a connector receptacle of the external pulse generator and a skin of the patient.

20. The system of claim 17, wherein the plurality of tabs are configured such that about ⅔

or more of the outer perimeter remains exposed.

21. The system of claim 17, wherein the plurality of tabs are configured such that about ⅘

or more of the outer perimeter remains exposed.

22. The system of claim 17, wherein the external pulse generator is substantially rectangular and the plurality of tabs are arranged such that at least two opposing corners of the external pulse generator are exposed.

23. The system of claim 22, wherein the plurality of tabs are arranged such that all four corners of the substantially rectangular external pulse generator are exposed.

24. The system of claim 17, wherein the plurality of tabs include at least two resiliently deflectable tabs, each having a retention feature that engages an outer housing of an external pulse generator so as to releasably secure the external pulse generator to the substrate.

25. The system of claim 24, wherein the retention features of each of the at least two deflectable tabs are adapted to be received within corresponding retention features on opposite sides of the external pulse generator.

26. The system of claim 25, wherein the retention features of each tab comprises a contoured or stepped portion of each tab and the retention feature of the external pulse generator comprises a recess having a corresponding contour or stepped portion for receiving the retention features of the at least two tabs.

27. The system of claim 24, wherein the external pulse generator is substantially rectangular in shape, and the at least two resiliently deflectable tabs are adapted to engage opposing sides of the external pulse generator along a length dimension of the external pulse generator.

28. The system of claim 27, wherein the plurality of tabs includes at least two additional tabs that engage opposing sides of the external pulse generator along a width dimension.

29. The system of claim 28, wherein the at least two deflectable tabs engage the external pulse generator along a mid-portion thereof so that the external pulse generator can be removed by grasping the exposed sides and/or corners and twisting the external pulse generator along one or more axes.

30. The system of claim 17, wherein the plurality of tabs includes a first pair of deflectable tabs adapted to engage opposite sides of the external pulse generator along a first axis so as to constrain movement along the first axis and a second pair of deflectable tabs adapted to engage opposite sides of the external pulse generator along a second axis substantially orthogonal to the first axis so as to constrain movement along the second axis, wherein the second pair of deflectable tabs each include a retention feature that engage a corresponding retention feature of the external pulse generator so as to constrain movement along a third axis orthogonal to each of the first and second axis, such that the plurality of tabs, in combination, constrain movement of the external pulse generator relative the substrate in all three dimensions.

31. The system of claim 17, wherein the substrate is substantially rigid between the plurality of tabs.

32. The system of claim 17, wherein the patient coupling feature is a flexible adhesive patch having a pressure-sensitive adhesive with sufficient strength to support an external pulse generator mounted on the adhesive patch adhered to a skin of the patient.

33. The system of claim 17, wherein the patient coupling feature is a clip having an elongate member extending along and separable from the substrate, wherein the elongate member is biased towards the substrate so that the device is securable by insertion of a portion of a garment or belt between the elongate member and the substrate.

34. The system of claim 33, wherein the elongate member is pivotally coupled to the substrate and biased toward the substrate via loading with a spring.

35. 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.

36. The external pulse generator of claim 35, 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.

37. The external pulse generator of claim 35, wherein the external cable is between 1 inch and 12 inches in length.

38. The external pulse generator of claim 35, wherein the battery is non-removable by the patient.

39. The external pulse generator of claim 35, wherein the battery is non-rechargeable.

40. The external pulse generator of claim 35, further comprising:

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

41. The external pulse generator of claim 40, wherein the actuatable user interface comprises a button or switch.

42. The external pulse generator of claim 40, 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.

43. The external pulse generator of claim 42, 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.

44. The external pulse generator of claim 40, 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.

45. The external pulse generator of claim 40, 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.

46. The external pulse generator of claim 45, 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.

47. The external pulse generator of claim 35, 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 the 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.

48. The external pulse generator of claim 35, further comprising:

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

49. The external pulse generator of claim 48, 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.

50. The external pulse generator of claim 48, 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.