Treatment of autoimmune diseases with deep brain stimulation

• US 10,201,707 B2
• Filed: 01/23/2018
• Issued: 02/12/2019
• Est. Priority Date: 08/27/2014
• Status: Active Grant

• Current Assignee: Aleva Neurotherapeutics
• Original Assignee: Aleva Neurotherapeutics
• Inventors: Hartig, Ingo, Mercanzini, Andre, Jordan, Alain, Michalis, Alexandre, Boers, Marc, Dransart, Alain
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US15/878,066
• Publication Number:
  US 20180161574A1
• Time in Patent Office: 385 Days
• Field of Search: 600377, 600378
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/50 specially adapted for specific body parts; specially adapted for specific clinical applications
• CPC Class Codes: A61B 6/501 for diagnosis of the head, e.g. neuroimaging or craniography
• CPC Class Codes: A61B 6/505 for diagnosis of bone
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/36185 : Selection of the electrode configuration
• CPC Class Codes: H05K 1/118 : specially for flexible printed circuits, e.g. using folded portions

Abstract

Techniques using electrical stimulation for treating an Autoimmune Disease by means of an implantable pulse generator and at least one electrode. An electrode lead is surgically implanted in a region of the insular cortex to deliver electrical stimulation. The at least one electrode lead and implantable pulse generator contain features that allow the electrical stimulation to be directed to specific volumes of the insular cortex, and ensure that non-therapeutic volumes do not receive electrical stimulation.

Claims

1. A method of treating an autoimmune disorder, comprising:

implanting an implantable stimulator into a patient;

implanting a lead into the patient, the lead having a MEMS film comprising;

a plurality of traces defined in a first metal layer;

a first barrier layer disposed on at least a portion of the first metal layer and defining a plurality of through-holes; and

a plurality of electrodes defined in a second metal layer, the plurality of electrodes coupled with the plurality of traces through the plurality of through-holes;

driving the lead toward a first target area in the patient, wherein the first target area comprises one of a first, a second, a third, or a fourth gyms of an anterior insular cortex;

a superior-anterior insula;

an inferior-anterior insula;

an anterior-anterior insula;

a posterior-anterior insula;

a large insular gyms of a posterior insula;

a superior-posterior insula;

or an inferior-posterior insula;

generating, by the implantable stimulator, an electrical signal; and

delivering the electrical signal to the first target area via at least one of the plurality of electrodes.

2. The method of claim 1, comprising:

treating an autoimmune disorder with the electrical signal, the autoimmune disorder comprising at least one of rheumatoid arthritis;

psoriasis;

psoriatic arthritis;

spondyloarthritis;

collagenosis;

vasculitis;

guillain-barré

syndrome;

morbus chrohn;

ulcerative colitis;

igg4-related disease;

osteoarthritis;

fibromyalgia; and

Marie-Bamberger syndrome.

3. The method of claim 1, comprising:

driving a second lead toward a second target area located on a contralateral side of the patient with respect to the first target area.

4. The method of claim 1, wherein at least one of the plurality of electrodes is a directional electrode.

5. The method of claim 4, comprising:

recording neurological activity from the first target area; and

selecting a portion of the plurality of electrodes to deliver the electrical signal based on the neurological activity.

6. The method of claim 1, comprising:

detecting a presence of an autoimmune disorder symptom; and

increasing a characteristic of the electrical signal.

7. The method of claim 6, wherein the characteristic of the electrical signal is at least one of an amplitude, a frequency, and a pulse width.

8. The method of claim 1, comprising:

detecting a presence of a side effect caused at least partially by the electrical signal; and

decreasing a characteristic of the electrical signal.

9. The method of claim 1, comprising:

determining neurological activity of the first target area is below a predetermined threshold; and

applying the electrical signal with a frequency between about 120 Hz and about 140 Hz.

10. The method of claim 1, comprising:

determining neurological activity of the first target area is above a predetermined threshold; and

applying the electrical signal with a frequency between about 40 Hz and about 60 Hz.

11. The method of claim 1, wherein at least one of the plurality of electrodes is an omnidirectional electrode.

12. The method of claim 1, wherein each of the plurality of electrodes are coupled with at least two of the plurality of traces.

13. The method of claim 1, wherein the MEMS film comprises:

a ribbon cable extending form a distal end of the MEMS film and into a lumen defined by the MEMS film.

14. The method of claim 13, wherein the ribbon cable comprises a plurality of contact pads, wherein each of the plurality of traces are coupled to one of the plurality of contact pads.

15. The method of claim 1, wherein each of the plurality of electrodes comprise a second metal layer.

16. The method of claim 15, wherein the second metal layer comprises at least one of platinum, iridium oxide, or titanium.

17. The method of claim 1, comprising:

generating the electrical signal with a frequency between about 2 Hz and about 500 Hz.

18. The method of claim 1, comprising:

generating the electrical signal with a pulse width between about 10 μ

s and about 500 μ

s.

19. The method of claim 1, comprising:

generating the electrical signal with a current between about 0.1 mA and about 12 mA.

20. The method of claim 1, comprising:

selecting a different one of the at least one of the plurality of electrodes for delivering the electrical signal; and

delivering the electrical signal to the first target area via the different one of the at least one of the plurality of electrodes.