Selective nerve stimulation with optionally closed-loop capabilities

• US 8,406,877 B2
• Filed: 03/19/2007
• Issued: 03/26/2013
• Est. Priority Date: 03/19/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Smith, David J., Westlund, Randy, Libbus, Imad
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US11/687,809
• Publication Number:
  US 20080234780A1
• Time in Patent Office: 2,199 Days
• Field of Search: 607/17, 607116-118
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Systems and methods for steering one or more stimulation fields to a selected nerve target, thereby optimizing one or a combination of low stimulation thresholds, desired therapy outcomes, or a minimization of adverse stimulation side-effects. An array of electrodes disposed, at least in part, on two or more neural stimulation leads are used for steering the stimulation fields to the selected nerve target and are positioned adjacent the selected target. The stimulation may be titrated based on, among other things, a detected physiologic response to the applied stimulation.

Claims

1. A system for stimulating a selected nerve target, the system comprising:

two or more neural stimulation leads;

an array of electrodes disposed, at least in part, on the two or more neural stimulation leads and adapted to be implantably positioned adjacent a single peripheral nerve trunk, the array of electrodes including at least a first electrode disposed on a first neural stimulation lead and a second electrode disposed on a second neural stimulation lead;

an implantable medical device including a programmable memory adapted to receive a programming signal, at least partially based on a physiologic signal generated by a physiologic sensor and indicative of a status of one or more physiologic parameters, for selectively applying electrical stimulation to a stimulation electrode vector combination of at least two electrodes within the electrode array; and

wherein the two or more neural stimulation leads include or are attached to a positioning feature configured for allowing the leads to be implantably positioned adjacent to the single peripheral nerve trunk.

2. The system of claim 1, further comprising one or more lead positioning members adapted to connect to and maintain a desired geometric relationship between portions of the two or more neural stimulation leads near the single peripheral nerve trunk;

wherein the one or more lead positioning members extend in a direction different than a lead axis at the point of connection.

3. The system of claim 2, wherein the one or more lead positioning members are adapted to position the two or more neural stimulation leads adjacent the single peripheral nerve trunk, and include at least one electrode thereon.

4. The system of claim 1, further comprising an external programmer adapted to receive and communicate one or more remotely generated inputs to the implantable medical device.

5. The system of claim 1, further comprising a cardiac stimulation lead including at least one electrode thereon, the cardiac stimulation lead adapted to be implantably positioned within, on, or about a heart and in electrical contact with the implantable device.

6. The system of claim 1, wherein the implantable medical device is programmable to cause the electrodes to assume positive or negative polarity.

7. The system of claim 1, wherein the two or more neural stimulation leads include one or more of a neural stimulation cuff lead, a neural stimulation intravascular lead, or a neural stimulation subcutaneous lead.

8. The system of claim 1, wherein the one or more physiologic parameters include at least one of a heart rate parameter, a heart rate variability parameter, a PR interval parameter, a T-wave velocity parameter, or an action potential duration parameter.

9. The system of claim 1, wherein the one or more physiologic parameters include at least one of a heart contractility parameter, a heart remodeling parameter, a stroke volume parameter, a cardiac output parameter, or a blood pressure parameter.

10. The system of claim 1, wherein the one or more physiologic parameters include at least one of a minute ventilation parameter or a tidal volume parameter.

11. The system of claim 1, wherein the one or more physiologic parameters include at least one of an adverse cardiac event parameter, an activity parameter, an abdominal pain parameter, an appetite parameter, an emotions parameter, a personality parameter, a muscle tone parameter, a sleep parameter, an allergy parameter, or a posture parameter.

12. The system of claim 1, comprising one or more physiologic sensors adapted to generate a physiologic signal indicative of a status of one or more physiologic parameters.

15. The system of claim 12, wherein the one or more physiologic sensors include a cough sensor, and wherein the implantable medical device is adapted to receive a cough status indicative signal from the cough sensor and determine whether a detected cough is attributable to the applied electrical stimulation and automatically titrate the electrical stimulation to reduce or abate the cough.

13. A system for stimulating a nerve target, the system comprising:

two or more neural stimulation leads;

an array of electrodes disposed, at least in part, on the two or more neural stimulation leads and adapted to be implantably positioned adjacent a single peripheral nerve target, the array of electrodes including at least a first electrode disposed on a first neural stimulation lead and a second electrode disposed on a second neural stimulation lead;

and

an implantable medical device including,

a programmable memory adapted to receive a programming signal, which is at least partially based on a physiologic signal generated by a physiologic sensor and indicative of a status of one or more physiologic parameters, for selectively applying electrical stimulation to a stimulation electrode vector combination of at least two electrodes within the electrode array, and

a means for titrating one or more parameters of the applied electrical stimulation;

wherein the two or more neural stimulation leads include a bias portion, a cuff, a transvascular size and shape, or attach to a lead position member to maintain a desired geometric relationship relative to one another near the single peripheral nerve target.

14. The system of claim 13, further comprising means for choosing the at least two electrodes of the electrode array used in the selective application of electrical stimulation.

16. A method of stimulating a nerve target, the method comprising:

disposing a portion of two or more neural stimulation leads carrying an array of electrodes adjacent a single peripheral nerve target, the array of electrodes including at least a first electrode disposed on a first neural stimulation lead and a second electrode disposed on a second neural stimulation lead;

selectively employing a stimulation electrode vector combination of at least two of the electrodes within the array to direct electrical stimulation applied to the electrodes to the nerve target;

delivering electrical stimulation to the selectively employed electrodes; and

modulating autonomic balance.

17. The method of claim 16, further comprising evaluating a plurality of electrode vector combinations for an ability to sense or stimulate the single peripheral nerve target.

18. The method of claim 16, further comprising detecting a physiologic response to the electrical stimulation.

19. The method of claim 18, wherein detecting the physiologic response to the electrical stimulation includes detecting a non-cardiac response to the electrical stimulation.

20. The method of claim 18, wherein detecting the physiologic response to the electrical stimulation includes detecting a cardiac response to the electrical stimulation.

21. The method of claim 18, further comprising titrating the electrical stimulation using the detected physiologic response.

22. The method of claim 21, wherein titrating the electrical stimulation includes titrating one or more of an amplitude, a frequency, a burst frequency, a duty cycle, or a pulse width of an electrical stimulation signal.

23. The method of claim 18, further comprising employing at least one electrode within the array other than the at least two electrodes initially used to direct the electrical stimulation to the single peripheral nerve target.

24. The method of claim 16, comprising maintaining the desired geometric relationship between the two or more neural stimulation leads near the single peripheral nerve target, including connecting the leads via one or more lead positioning members;

wherein the one or more lead positioning members extend in a direction different than a lead axis at the point of connection.

25. The method of claim 16, wherein disposing the two or more neural stimulation leads adjacent the single peripheral nerve target includes disposing at least one neural stimulation lead carrying an electrode in a venous or arterial vessel adjacent the single peripheral nerve target.

26. The method of claim 16, wherein disposing the two or more neural stimulation leads adjacent the single peripheral nerve target includes disposing at least one neural stimulation lead using a surgical dissection procedure, an endoscopy procedure, or a transvascular procedure.

27. The method of claim 16, wherein disposing the two or more neural stimulation leads adjacent the single peripheral nerve target includes disposing the two or more leads adjacent a single vagus nerve.

28. The method of claim 16, wherein delivering the electrical stimulation to the selectively employed electrodes includes delivering an electrical stimulation signal and minimizing stimulation side-effects.