Implantable microstimulators and methods for unidirectional propagation of action potentials

• US 8,548,604 B2
• Filed: 12/06/2010
• Issued: 10/01/2013
• Est. Priority Date: 06/20/2002
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Whitehurst, Todd K., Carbunaru, Rafael, McGivern, James P., Haller, Matthew I., He, Tom Xiaohai, Bradley, Kerry, Kuzma, Janusz A.
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US12/960,722
• Publication Number:
  US 20110077721A1
• Time in Patent Office: 1,030 Days
• Field of Search: 607/46, 607/118
• US Class Current: 607/118
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient

Abstract

Miniature implantable stimulators (i.e., microstimulators) are capable of producing unidirectionally propagating action potentials (UPAPs). The methods and configurations described may, for instance, arrest action potentials traveling in one direction, arrest action potentials of small diameters nerve fibers, arrest action potentials of large diameter nerve fibers. These methods and systems may limit side effects of bidirectional and/or less targeted stimulation.

Claims

1. A system for directing action potentials unidirectional comprising:

a microstimulator including;

a capsule;

a plurality of electrodes comprising at least one cathode and at least two anodes, configured with the at least one cathode between the at least two anodes, wherein at least two of the plurality of electrodes are disposed on the capsule;

electrical circuitry disposed within the capsule and electrically connected to the at least one cathode and at least two anodes, wherein the electrical circuitry generates electric current applied by the at least one cathode and the at least two anodes;

programmable memory disposed within the capsule and connected to the electrical circuitry, which programmable memory stores parameters determining the electric current generated by the electrical circuitry and applied by the at least one cathode and the at least two anodes; and

a power source disposed with in the capsule and providing operating power to at least the electrical circuitry, wherein the microstimulator is configured and arranged to operate independently using the electrical circuitry, programmable memory, and power source to generate electric current for application to the at least one cathode and the at least two anodes;

wherein the microstimulator is configured and arranged to generate and apply at least one depolarizing current and at least one hyperpolarizing current.

2. The system of claim 1 wherein the microstimulator is configured and arranged so that the depolarizing current triggers action potentials in a first direction and in a second direction and the at least one hyperpolarizing current interrupts the action potentials in at least one of the first direction and second direction, thereby allowing the action potentials to propagate in one direction.

3. The system of claim 1 wherein the microstimulator further includes a lead extending from the capsule with at least one of the plurality of electrodes disposed on the lead.

4. The system of claim 1 further including a nerve cuff coupled to the microstimulator.

5. The system of claim 1 further including a fixation device coupled to the microstimulator.

6. The system of claim 5 wherein the fixation device includes a nerve cuff.

7. The system of claim 1 further including at least one sensor for sensing at least one physical condition of a patient.

8. The system of claim 7 further comprising circuitry disposed within the capsule and configured and arranged for using the sensed physical condition to adjust the parameters determining the electric currents.

10. The system of claim 1 wherein the microstimulator includes a plurality of programmably configurable electrodes, wherein at least three of the programmably configurable electrodes correspond to the at least one cathode and the at least two anodes.

11. A method for arresting propagation of action potentials in small diameter nerve fibers, the method comprising:

providing the system of claim 1, wherein the at least one cathode comprises a first cathode and the at least two anodes comprise a first anode;

applying a depolarizing cathodic current to one or more nerves via the first cathode, which current initiates bidirectional action potentials in small diameter nerve fibers and large diameter nerve fibers;

waiting an amount of time allowing the action potentials to propagate in the large diameter nerve fibers past the first anode at a side of the first cathode where arrest of action potentials in the small diameter nerve fibers is desired;

applying a hyperpolarizing anodic current to the nerve via the first anode at the side of the first cathode where arrest of action potentials in the small diameter nerve fibers is desired, which current arrests action potentials in the small diameter nerve fibers, the anodic current being of an amount effective in maintaining hyperpolarization in a segment of the small diameter nerve fibers during the time the action potential would have traveled through the segment; and

tapering the anodic current.

12. The method of claim 11 wherein providing the microstimulator with at least the first cathode and the first anode comprises providing a programmably configurable microstimulator with at least two activated electrodes configured as the first cathode and the first anode.

13. The method of claim 11

wherein the at least two anodes further comprises at least one additional anode;

wherein the method further comprises applying at least one additional anodic current via the at least one additional anode, which additional anodic current inhibits stimulation at a virtual cathode.

14. The method of claim 13 wherein providing the microstimulator with the first cathode, the first anode, and the at least one additional anode comprises providing a programmably configurable microstimulator with at least three activated electrodes programmably configured as the first cathode, the first anode, and the additional anode.

15. The method of claim 13 wherein the side of the first cathode where arrest of action potentials in the small diameter nerve fibers is desired comprises more than one side of the first cathode and further comprising applying the hyperpolarizing anodic current via the first anode and the additional anode.

16. The method of claim 11 wherein the microstimulator includes a fixation device.

17. The method of claim 11 further comprising sensing a physical condition of a patient and adjusting the application of currents to the nerve based on the sensed physical condition.

18. The method of claim 17 wherein the sensed physical condition of the patient comprises the action potentials propagating along the nerve.

19. A method of stimulating a nerve, comprising:

providing the system of claim 1, wherein the at least one cathode comprise at least a first cathode and the at least two anodes comprise a first anode;

configuring the electrodes to apply stimulation that unidirectionally propagates action potentials of a nerve;

applying the stimulation to the nerve to effectively select orthodromic action potentials traveling in one direction along the nerve, thereby limiting side effects of bidirectional stimulation.

20. The method of claim 19, further comprising:

applying a depolarizing cathodic current to a nerve via the first cathode, which cathodic current initiates bidirectional action potentials in large diameter nerve fibers and small diameter nerve fibers;

applying a hyperpolarizing anodic current to the nerve via the first anode at a side of the first cathode where arrest of action potentials is desired; and

tapering the anodic current.

21. The method of claim 20 wherein the hyperpolarizing current is relatively high-amplitude hyperpolarizing current, which high-amplitude hyperpotarizing current arrests action potentials in large diameter nerve fibers and small diameter nerve fibers.

22. The method of claim 20 further comprising waiting an amount of time allowing the action potentials to propagate in the large diameter nerve fibers, then applying the hyperpolarizing anodic current to the nerve at the side of the first cathode where arrest of action potentials in the small diameter nerve fibers is desired, which hyperpolarizing current arrests action potentials in the small diameter nerve fibers.

23. The method of claim 20 further comprising applying the hyperpolarizing current before the action potentials pass the first anode, which hyperpolarizing current is a relatively low-amplitude hyperpolarizing current, which low-amplitude hyperpolarizing current arrests action potentials in large diameter nerve fibers and allows propagation of action potentials in small diameter nerve fibers.

24. The method of claim 19 wherein the microstimulator includes a fixation device.

25. The method of claim 24 wherein the fixation device includes a nerve cuff.

26. The method of claim 19 further comprising sensing a physical condition of a patient and adjusting the application of stimulation to the nerve based on the sensed physical condition.

27. The method of claim 26 wherein the sensed physical condition of the patient comprises the action potentials propagating along the nerve.

28. The method of claim 27 wherein the sensed action potentials are used to determine the stimulation to apply to the nerve, and wherein determining the stimulation to apply includes determining the timing of the stimulation.

9. The system of faith 8 wherein sensing at least one physical condition of the patient comprises sensing action potentials.