Spinal cord stimulation with interferential current

• US 9,604,062 B2
• Filed: 03/22/2016
• Issued: 03/28/2017
• Est. Priority Date: 01/22/2003
• Status: Active Grant

• Current Assignee: Meagan Medical, Inc.
• Original Assignee: Meagan Medical, Inc.
• Inventors: Carroll, William J.
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US15/076,834
• Publication Number:
  US 20160199652A1
• Time in Patent Office: 371 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/36192 Amplitude modulation
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

A stimulator and a method for the treatment of intractable pain syndromes by electrical stimulation of the spinal cord is disclosed in which implantable electrodes positioned around a targeted area of the spinal cord transmit an interferential current that has a base medium frequency alternating current between 500 Hz-20 KHz. A digital signal processor generates a sine-wave-like waveform from a pulse generator which after further processing is used to generate at least two circuits for use in producing the beat frequency signal. An effective area of stimulation is controlled by the quantity of electrodes, positioning of the electrodes and electrode cross pattern orientation. Amplitude modulation of electrical circuits created at the electrode placements also augments the effective area of stimulation. The stimulator and method reduce accommodation of the body to the electrical stimulation and provide deeper penetration of the resultant signal.

Claims

1. A method for the treatment of chronic pain syndromes using electrical stimulation of the spinal cord, the method comprising:

positioning a first pair of implantable electrodes to a dura matter in an epidural space proximate to a subject'"'"'s spinal cord at predetermined locations;

positioning a second pair of implantable electrodes to the dura matter in the epidural space proximate to the subject'"'"'s spinal cord at predetermined locations;

positioning the first pair of implantable electrodes and the second pair of implantable electrodes so that a first circuit is created between a first electrode of the first pair of implantable electrodes and a first electrode of the second pair of implantable electrodes and so that a second circuit is created between a second electrode of the first pair of implantable electrodes and a second electrode of the second pair of implantable electrodes, wherein the first circuit and the second circuit are arranged to cross one another; and

transmitting signals of first and second frequencies through the first and second pairs of implantable electrodes respectively, so that the signals of the first and second frequencies interfere with each other to produce at least one beat signal proximate to the subject'"'"'s spinal cord, and wherein a majority of the at least one beat signal is directionally distributed and controlled, enabling the at least one beat signal to avoid remaining in and shunting through cerebrospinal fluid proximate to the subject'"'"'s spinal cord, thereby recruiting dorsal column fibers,

wherein the first circuit and the second circuit interfere to create a resultant signal having a resultant beat frequency that is a difference between the first and second frequencies and an amplitude that is additive and more than an amplitude of the signal of the first frequency, wherein the first and second circuits cross at about 90°

resulting in a maximum amplitude of the resultant signal.

2. The method of claim 1, wherein a resulting modulation of the resultant signal is a deepest level of modulation at about 45°

between the first and second circuits.

3. The method of claim 1, wherein the first and second circuits cross and a resulting modulation of the resultant signal varies in intensity between the first and second circuits.

4. The method of claim 1, further comprising altering a targeted area of the subject'"'"'s spinal cord by modulating amplitudes of the signals of first and second frequencies.

5. The method of claim 1, further comprising:

supplying digital signal pulses to a digital signal processor via a pulse generator;

the digital signal processor processing the digital signal pulses to approximate a sine-wave-like output waveform; and

transmitting the sine-wave-like output waveform as signals of the first and second frequencies through the first and second pairs of implantable electrodes.

6. The method of claim 1, further comprising varying locations of the first and second pairs of implantable electrodes along the spinal cord.

7. The method of claim 1, further comprising modulating amplitudes of outputs of the first and second pairs of implantable electrodes.

8. The method of claim 1, wherein the method includes transmitting signals using a current with a resultant beat frequency of no more than 250 Hz.

9. The method of claim 1, wherein the method includes transmitting signals using a current with a voltage output of 11 volts maximum.

10. The method of claim 1, wherein the method includes transmitting signals using a current with a pulse width of 210 microseconds.

11. The method of claim 1, wherein the method includes transmitting signals using a current with a pulse width comprising a range of at least 10 microseconds but no more than 600 microseconds.

12. The method of claim 1, wherein the first pair of implantable electrodes and the second pair of implantable electrodes are included on two quadripolar leads.

13. A method for treatment of chronic pain syndromes using electrical stimulation of the spinal cord, the method comprising:

positioning a first implantable lead to a dura matter in an epidural space proximate to a subject'"'"'s spinal cord at predetermined locations proximate to a targeted area, the first implantable lead including at least four electrodes;

positioning a second implantable lead to a dura matter in an epidural space proximate to a subject'"'"'s spinal cord at predetermined locations proximate to a targeted area, the second implantable lead including at least four electrodes; and

positioning the first implantable lead and the second implantable lead so that a first circuit is created between a first electrode of the first implantable lead and a first electrode of the second implantable lead and so that a second circuit is created between a second electrode of the first implantable lead and a second electrode of the second implantable lead, wherein the first circuit and the second circuit are arranged to cross one another; and

transmitting signals of first and second frequencies through the first implantable lead and the second implantable lead so that the signals of the first and second frequencies interfere to create at least one beat signal proximate to the targeted area, and wherein a majority of the at least one beat signal is directionally distributed and controlled, enabling the at least one beat signal to avoid remaining in and shunting through cerebrospinal fluid proximate to the subject'"'"'s spinal cord, thereby recruiting dorsal column fibers,

wherein the first circuit and the second circuit interfere to create a resultant signal having a resultant beat frequency that is a difference between the first and second frequencies and an amplitude that is additive and more than an amplitude of the signal of the first frequency, wherein the first and second circuits cross at about 90°

resulting in a maximum amplitude of the resultant signal.

14. The method of claim 13, further comprising:

connecting a pulse generator to a digital signal processor and supplying digital signal pulses to a field-programmable gate array which produces a sine-wave-like current waveform which is output to the first implantable lead and the second implantable lead.

15. An electrical stimulator for the treatment of intractable pain syndromes, comprising:

an interferential current generator which generates an interferential alternating current output comprising first and second signals having different first and second frequencies; and

at least two pairs of implantable electrodes wherein each electrode has a first and a second end, wherein the first ends are connected to said interferential current generator and the second ends are configured to be implanted to a dura matter in an epidural space at predetermined locations proximate to a subject'"'"'s spinal cord,

wherein a first pair of implantable electrodes and a second pair of implantable electrodes are positioned so that a first circuit is created between a first electrode of the first pair of implantable electrodes and a first electrode of the second pair of implantable electrodes and so that a second circuit is created between a second electrode of the first pair of implantable electrodes and a second electrode of the second pair of implantable electrodes, wherein the first circuit and the second circuit are arranged to cross one another,

wherein each pair of said at least two pairs of implantable electrodes transmits one of said first and second signals such that the first and second frequencies interfere with each other to produce at least one beat frequency signal proximate to the subject'"'"'s spinal cord, and wherein a majority of the at least one beat frequency signal is directionally distributed and controlled, enabling the at least one beat frequency signal to avoid remaining in and shunting through cerebrospinal fluid proximate to the subject'"'"'s spinal cord, thereby recruiting dorsal column fibers,

wherein the first circuit and the second circuit interfere to create a resultant signal having a resultant beat frequency that is a difference between the first and second frequencies and an amplitude that is additive and more than an amplitude of the signal of the first frequency, wherein the first and second circuits cross at about 90°

resulting in a maximum amplitude of the resultant signal.

16. The electrical stimulator of claim 15, wherein said interferential current generator comprises:

a pulse generator that generates digital signal pulses; and

a digital signal processor connected to said pulse generator that processes the digital signal pulses to approximate a sine-wave-like output waveform.

17. The electrical stimulator of claim 15, wherein said interferential current generator comprises:

a pulse generator that generates digital signal pulses; and

a field-programmable gate array connected to said pulse generator that processes the digital signal pulses to approximate a sine-wave-like output waveform.