MICRODEVICE-BASED ELECTRODE ASSEMBLIES AND ASSOCIATED NEURAL STIMULATION SYSTEMS, DEVICES, AND METHODS

• US 20090131995A1
• Filed: 06/13/2008
• Published: 05/21/2009
• Est. Priority Date: 06/14/2007
• Status: Abandoned Application

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Northstar Neuroscience, Inc.
• Inventors: Fowler, Brad, Sloan, Leif R.
• Application Number:
  US12/139,392
• Publication Number:
  US 20090131995A1
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Microdevice-based electrode assemblies and associated neurostimulation systems, devices and methods are disclosed. A system in accordance with a particular embodiment includes a microdevice positioned to send signals or fluids to the patient, and/or to receive signals or fluids from the patient. The microdevice can include a housing having an external surface, and a signal/fluid transmitter/receiver positioned within the housing and coupled to a terminal carried by the housing. The system can further include a patient-implantable, flexible support member attached to the external surface of the housing and carrying the housing. The system can still further include an interface carried by the support member and connected to the terminal, with the interface being positioned to direct signals or fluids into patient tissue, and/or receive signals or fluids from the patient tissue.

Claims

1. A patient treatment system, comprising:

a microstimulator that includes a patient-implantable housing having an external surface, a pulse generator internal to the housing, and first and second microstimulator electrodes accessible from outside the housing;

a patient-implantable, flexible support member attached to the external surface of the housing and carrying the housing;

a first support member electrode carried by the support member and electrically connected to the first microstimulator electrode; and

a second support member electrode carried by the support member and electrically connected to the second microstimulator electrode.

2. The system of claim 1 wherein the housing has a first planform area and wherein the support member has a second planform area larger than the first planform area, and wherein the second planform area surrounds the first planform area.

3. The system of claim 2 wherein the second planform area is at least twice the size of the first planform area.

4. The system of claim 2 wherein the second planform area is at least five times the size of the first planform area.

5. The system of claim 1 wherein the housing is hermetically sealed around the pulse generator, and wherein the support member does not extend into a region internal to the housing.

6. The system of claim 1 wherein the support member includes a first layer and a second layer, and wherein the first and second layers are bonded to each other with the microstimulator sandwiched in between.

7. The system of claim 6, further comprising a first conductive path connected between the first microstimulator electrode and the first support member electrode, and a second conductive path connected between the second microstimulator electrode and the second support member electrode, the first and second conductive paths being sandwiched between the first and second layers of the support member.

8. The system of claim 1 wherein surfaces of the first and second microstimulator electrodes are insulated by the support member, and wherein the first and second electrodes form in whole or in part, a plurality of electrodes carried by the support member and wherein the plurality of electrodes are the only electrodes coupled to the pulse generator and exposed to provide stimulation to the patient.

9. The system of claim 1 wherein the microstimulator is one of multiple microdevices carried by the support member.

10. The system of claim 9 wherein the microstimulator is a first microstimulator and wherein at least one of the microdevices includes a second microstimulator, and wherein the system further comprises a third support member electrode electrically connected to the second microstimulator but not the first microstimulator.

11. The system of claim 9 wherein at least one of the microdevices includes a sensor having a sensor interface positioned to detect a patient characteristic.

12. The system of claim 9 wherein at least one of the microdevices includes a fluid infusion device positioned to deliver a therapeutic fluid to the patient.

13. The system of claim 9 wherein at least one of the microdevices includes a fluid extraction device positioned to remove fluid from the patient.

14. The system of claim 9 wherein the microstimulator is a first microdevice and wherein the support member is a first support member, and wherein the system further comprises:

a second microdevice; and

a second support member carrying the second microdevice.

15. The system of claim 14, further comprising an external communication device wirelessly coupled to both the first microdevice and the second microdevice.

16. The system of claim 1 wherein a first signal path between the first support member electrode and the first microstimulator electrode includes a conductive polymer.

17. The system of claim 16, further comprising a lead wire connected to the first support member electrode, and wherein the conductive polymer forms at least in part a junction between the lead wire and the first microstimulator electrode.

18. The system of claim 16 wherein the support member includes a channel positioned between the first support member electrode and the first microstimulator electrode, and wherein the conductive polymer is disposed in the channel and contacts both the first support member electrode and the first microstimulator electrode.

19. The system of claim 16 wherein the support member includes a generally flat, sheet-like portion carrying the first and second support member electrodes, and a generally cylindrical elongated portion depending from the generally flat portion and having a lumen, and wherein the conductive polymer is disposed in the lumen.

20. The system of claim 1, further comprising a switching unit operatively coupled between the pulse generator and at least one of the first and second support member electrodes.

21. The system of claim 20, further comprising a third support member electrode positioned closer to the pulse generator than is the second support member electrode, and wherein the switching unit is changeable between a unipolar configuration in which the first and second support member electrodes are coupled to the pulse generator, and a bipolar configuration in which the first and third support member electrodes are coupled to the pulse generator.

22. The system of claim 20 wherein the first and second support member electrodes are two of a plurality of support member electrodes, including a first set of support member electrodes and a second set of support member electrodes, and wherein the switching unit is changeable between a first configuration in which the first set of electrodes is coupled to the pulse generator but the second set of electrodes is not, and a second configuration in which the second set of electrodes is coupled to the pulse generator but the first set of electrodes is not.

23. The system of claim 1 wherein the support member has a unitary construction and has the same composition at the microstimulator and at the first and second support member electrodes.

24. The system of claim 1 wherein:

the housing is hermetically sealed and has a length of about 15 millimeters or less, a transverse dimension of about 2 millimeters or less, and an external surface with a first periphery and a first footprint;

the pulse generator includes circuitry to produce electrical pulses;

one of the electrodes operates as a signal delivery electrode and the other operates as a return electrode;

the support member is generally electrically non-conductive and has a second footprint larger than the first footprint and a second periphery that encloses the first periphery, and wherein the support member does not extend into a region internal to the housing, further wherein the support member extends around the microstimulator and insulates the first and second microstimulator electrodes from exposure to the patient;

the first and second support member electrodes are positioned apart from the housing and are exposed through openings in the support member; and

wherein the system further comprises;

a control unit positioned in the housing and coupled to the pulse unit, the control unit being programmed with instructions to control the production of electrical pulses;

a communication unit coupled to the control unit and positioned within the housing to receive power, instruction signals, or both power and instruction signals;

a first electrical signal path carried by the support member and connected between the first microstimulator electrode and the first support member electrode; and

a second electrical signal path carried by the support member and connected between the second microstimulator electrode and the second support member electrode, wherein at least one of the first and second electrical signal paths includes a conductive polymer.

25. The system of claim 1 wherein the support member has openings through which surfaces of the first and second support member electrodes are exposed.

26. A patient treatment system, comprising:

a microstimulator, including;

a hermetically sealed housing having a length of about 15 millimeters or less and a transverse dimension of about 2 millimeters or less, the housing having an external surface with a first periphery and a first footprint;

a pulse unit positioned in the housing, the pulse unit including circuitry to produce electrical pulses;

a control unit positioned in the housing and coupled to the pulse unit, the control unit being programmed with instructions to control the production of electrical pulses;

a communication unit coupled to the control unit and positioned within the housing to receive power, instruction signals, or both power and instruction signals; and

first and second microstimulator electrodes carried by the housing and coupled to the pulse unit, with one of the electrodes operating as a signal delivery electrode and the other operating as a return electrode;

an implantable, flexible support member that does not extend into a region internal to the housing, is generally electrically non-conductive, and has a second footprint larger than the first footprint and a second periphery that encloses the first periphery;

first and second support member electrodes carried by the support member and positioned apart from the housing;

a first electrical signal path carried by the support member and connected between the first microstimulator electrode and the first support member electrode; and

a second electrical signal path carried by the support member and connected between the second microstimulator electrode and the second support member electrode, wherein at least one of the first and second electrical signal paths includes a conductive polymer.

27. The system of claim 26 wherein the support member is generally flat and wherein the first support member electrode is one of three of spaced-apart first support member electrodes connected to the first microstimulator electrode via the first signal path, and wherein the second support member electrode is one of three spaced-apart second support member electrodes connected to the second microstimulator electrode via the second signal path, the first and second support member electrodes forming a 2×

3 array, and wherein the microstimulator is positioned between the first support member electrodes and the second support member electrodes.

28. The system of claim 26 wherein the first support member electrode is one of a plurality of first support member electrodes arranged proximate to the microstimulator, and wherein the support member includes a first portion and a second portion, the first portion carrying the microstimulator and the first support member electrode, the second portion carrying the second support member electrode, the second portion being elongated to position the second support member electrode remote from the microstimulator and the first support member electrodes.

29. A patient system, comprising:

a microdevice positioned to send signals or fluids to the patient, and/or receive signals or fluids from the patient, the microdevice including a housing having an external surface, and a signal/fluid transmitter/receiver positioned within the housing and coupled to a terminal carried by the housing;

a patient-implantable, flexible support member attached to the external surface of the housing and carrying the housing; and

an interface carried by the support member and connected to the terminal, the interface being positioned to direct signals or fluids into patient tissue, and/or receive signals or fluids from the patient tissue.

30. The system of claim 29 wherein the microdevice is a microstimulator that includes a pulse generator programmed to deliver electrical pulses to the patient.

31. The system of claim 30 wherein the microdevice is a first microdevice, and wherein the system further comprises a second microdevice carried by the support member, and wherein the second microdevice is a fluid infusion device.

32. A patient system, comprising:

a support member that includes;

an elongated, flexible lead body portion having at least one lumen;

a conductive polymer disposed in the lumen;

an electrical connector positioned at a proximal end of the lead body portion, the electrical connector being in electrical communication with the conductive polymer; and

a distal portion at a distal end of the lead body, the distal portion carrying at least one patient electrode positioned to deliver electrical signals to a patient, receive electrical signals from the patient, or both deliver and receive electrical signals, the electrode being in electrical communication with the conductive polymer.

33. The system of claim 32, further comprising an implantable pulse generator electrically connected to the support member at the connector.

34. The system of claim 32 wherein the conductive path forms a portion of a conductive path that also includes the connector and a wire connected between the connector and the conductive polymer.

35. The system of claim 34 wherein the conductive polymer is in contact with both the wire and the electrode.

36. The system of claim 34 wherein the conductive polymer is in contact with both the wire and the electrode, and wherein the electrode is also formed from conductive polymer.

37. A method for making a patient treatment system, comprising:

attaching an external surface of a microstimulator housing of a patient-implantable microstimulator to a flexible, implantable support member at a structural connection location, the microstimulator having an electrical pulse generator internal to the housing, and first and second microstimulator electrodes coupled to the pulse generator and accessible from outside the housing;

attaching first and second support member electrodes to the support member;

connecting a first electrical signal path between the first support member electrode and the first microstimulator electrode at a first electrical connection location different than the structural connection location; and

connecting a second electrical signal path between the second support member electrode and the second microstimulator electrode at a second electrical connection location different than the structural connection location.

38. The method of claim 37 wherein the housing has a first planform area and the support member has a second planform area larger than the first planform area, and wherein attaching includes attaching the housing so that the first planform area is located within the second planform area.

39. The method of claim 37 wherein connecting a first electrical signal path includes connecting a first electrical signal path that includes a conductive polymer.

40. The method of claim 39 wherein connecting a first electrical signal path includes coupling a lead wire to the first microstimulator electrode with the conductive polymer forming a conductive connection between the lead wire and the first microstimulator electrode.

41. The method of claim 39 wherein the support member includes a channel located between the first microstimulator electrode and the first support member electrode, and wherein connecting a first electrical signal path includes disposing the conductive polymer in the channel.

42. The method of claim 37 wherein attaching an external surface includes attaching an external surface that is hermetically sealed around the electrical pulse generator, without the support member extending into an internal region of the housing.

43. The method of claim 37 wherein attaching an external surface includes attaching an external surface of a microstimulator having first and second microstimulator electrodes that are configured to be exposed within the patient for patient treatment, and wherein the method further comprises insulating the exposed microstimulator electrodes from exposure to the patient.

44. A method for treating a patient, comprising:

implanting, as a unit, a flexible, implantable support member that carries a microstimulator having an external surface attached to the support member, the microstimulator having first and second microstimulator electrodes;

positioning a first support member electrode relative to a target neural population of the patient, the first support member electrode being carried by the support member and being coupled to the first microstimulator electrode;

positioning a second support member electrode relative to the target neural population of the patient, the second support member electrode being carried by the support member and being coupled to the second microstimulator electrode;

resisting relative motion between the microstimulator and the target neural population by the presence of the support member; and

applying electrical signals to the patient via the first and second electrodes to treat a neural dysfunction.

45. The method of claim 44, further comprising engaging the patient in an adjunctive therapy as part of a treatment regimen that includes the adjunctive therapy and the electrical signals.

46. The method of claim 44 wherein applying electrical signals includes applying electrical signals to treat patient depression.

47. The method of claim 44 wherein applying electrical signals includes applying electrical signals to the dorsolateral prefrontal cortex from a location within the patients'"'"' skull and external to a cortical surface of the patient'"'"'s brain.

48. The method of claim 44 wherein the support member is a first support member and the microstimulator is a first microstimulator, and wherein the method further comprises applying electrical signals to a peripheral target location of the patient via a second microstimulator carried by a second support member spaced apart from the first support member.

49. The method of claim 44, wherein the support member is a first support member, and wherein the method further comprises sensing a state of the patient via a microsensor carried by the first support member or a second support member spaced apart from the first support member.

50. The method of claim 44 wherein the support member includes a third support member electrode positioned closer to the housing than is the second support member electrode, and wherein the method further comprises switching between a unipolar electrode configuration in which the first and second support member electrodes are coupled to the microstimulator, and a bipolar electrode configuration in which the first and third electrodes are coupled to the microstimulator.