External magnetic field impulse pacemaker non-invasive method and apparatus for modulating brain through an external magnetic field to pace the heart and reduce pain

• US 4,723,536 A
• Filed: 09/11/1985
• Issued: 02/09/1988
• Est. Priority Date: 08/27/1984
• Status: Expired due to Term

• Current Assignee: Elizabeth A. Rauscher, William L. Van Bise
• Original Assignee: Elizabeth A. Rauscher, William L. Van Bise
• Inventors: Rauscher, Elizabeth A., Van Bise, William L.
• Primary Examiner(s): Kamm, W.
• Application Number:
  US06/775,100
• Time in Patent Office: 881 Days
• Field of Search: 128/1.3, 128/1.5, 128/419 R
• US Class Current: 600/14
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

This invention incorporates the discovery of new principles which utilizes magnetic fluxes generated by time varying square wave currents of precise repetition, width, shape and magnitude to cause them to move through multi-turns of conductive material generally in the form of a coil, in order to stimulate the cardiovascular system in humans or animals by directing the fields externally through the chest wall or the skull in order to correct arrhythmias and/or heart blocks. The new method of cardiovascular stimulation evolved from experimental observations of cardiac muscle cells which when separated, oscillate at different frequencies and propagate at different rates at specific sites in and around the heart and a cell oscillating at a higher frequency when touching a cell oscillating at a lower frequency causes the lower oscillating one to speed up and synchronize at the higher rate. The Purkinje cells both in heart muscle and the brain appear to respond to the external magnetic fluxes and entrain, stepwise downward to the normal muscle contractile rate of about 1.25 Hertz. The repetition rate for normalizing a human heart lies between 7 and 8 Hertz, to within 1/100 Hertz for each patient, and a superimposed frequency at about ten times the adjusted rate has been seen to diminish or extinguish angina pain in some patients. A timer device, an adjustment device, and a device to deliver current to a coil which emits the magnetic flux is described. A theoretical model of the process is described.

Claims

1. A process for influencing the cardiac function of a human being comprising:

a. displaying the human being'"'"'s cardiac output on an analyzer means such that the cardiac output is displayed as a frequency in a Fourier series;

b. subjecting an area of the human being'"'"'s body adjacent to the human being'"'"'s heart to an external cyclic expanding and collapsing magnetic field;

c. said cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and a field strength of at least 0.5 gauss; and

d. adjusting the frequency of said cyclic expanding and collapsing magnetic field such that the frequency of said cyclic expanding and collapsing magnetic field corresponds to the second Bessell Null of the Fourier series of the human'"'"'s being'"'"'s cardiac output as displayed on said analyzer means;

e. whereby said cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat to thereby pace the human being'"'"'s heart.

2. The invention as defined in claim 1 wherein said magnetic field comprises a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency specifically at 7.6 Hertz to thereby create a Fourier series up to about the fifth harmonic at 38 Hertz.

3. A process for influencing the cardiac function of a human being comprising:

a. displaying the human being'"'"'s cardiac output on an analyzer means such that the cardiac output is displayed as a frequency in a Fourier series;

b. subjecting an area of the human being'"'"'s body adjacent to the human being'"'"'s heart to a first external cyclic expanding and collapsing magnetic field;

c. said first cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and a field strength of at least 0.5 gauss;

d. concurrently subjecting the same area of the human being'"'"'s body adjacent to the human being'"'"'s heart to a second external cyclic expanding and collapsing magnetic field;

e. said second cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency about ten times the frequency of said first cyclic expanding and collapsing magnetic field, having a duty cycle of from about 15% to about 50%, and a field strength of at least 0.5 gauss;

f. said second cyclic expanding and collapsing magnetic field operating only during the active portion of the duty cycle of said first cyclic expanding and collapsing magnetic field; and

g. adjusting the frequency of said first cyclic expanding and collapsing magnetic field such that the frequency of said first cyclic expanding and collapsing magnetic field corresponds to the second Bessell Null of the Fourier series of the human'"'"'s being'"'"'s cardiac output as displayed on said analyzer means;

h. whereby said first cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat, said second cyclic expanding and collapsing magnetic field reduces angina pain, and the first and second cyclic expanding and collapsing magnetic fields operate in concert to thereby pace the human being'"'"'s heart.

4. A process for influencing the cardiac function of a human being comprising:

a. displaying the human being'"'"'s cardiac output on an oscilloscope means such that the cardiac output is displayed in the shape of an EKG wave in the time domain;

b. subjecting an area of the human being'"'"'s body adjacent to the human being'"'"'s heart to an external cyclic expanding and collapsing magnetic field;

c. said cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and a field strength of at least 0.5 gauss; and

d. adjusting the frequency of said cyclic expanding and collapsing magnetic field such that the QRS portion of the human being'"'"'s EKG wave lies between two adjacent square wave outputs of the cyclic expanding and collapsing magnetic field as displayed on said oscilloscope means;

e. whereby said cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat to thereby pace the human being'"'"'s heart.

5. A process for influencing the cardiac function of a human being comprising:

a. displaying the human being'"'"'s cardiac output on an oscilloscope means such that the cardiac output is displayed in the shape of an EKG wave in the time domain;

b. subjecting an area of the human being'"'"'s body adjacent to the human being'"'"'s heart to a first external cyclic expanding and collapsing magnetic field;

c. said first cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.5 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and a field strength of at least 0.5 gauss;

d. concurrently subjecting the same area of the human being'"'"'s body adjacent to the human being'"'"'s heart to a second external cyclic expanding and collapsing magnetic field;

e. said second cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency about ten times the frequency of said first cyclic expanding and collapsing magnetic field, having a duty cycle of from about 15% to about 50%, and a field strength of at least 0.5 gauss;

f. said second cyclic expanding and collapsing magnetic field operating only during the active portion of the duty cycle of said first cyclic expanding and collapsing magnetic field; and

g. adjusting the frequency of said first cyclic expanding and collapsing magnetic field such that the QRS portion of the human being'"'"'s EKG wave lies between two adjacent square wave outputs of the first cyclic expanding and collapsing magnetic field as displayed on said oscilloscope means;

h. whereby said first cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat, said second cyclic expanding and collapsing magnetic field reduces angina pain, and the first and second cyclic expanding and collapsing magnetic fields operate in concert to thereby pace the human being'"'"'s heart.

6. A process for influencing the cardiac function of a human being comprising:

a. displaying the human being'"'"'s cardiac output on an analyzer means such that the cardiac output is displayed as a frequency in a Fourier series;

b. subjecting an area of the human being'"'"'s body adjacent to the human being'"'"'s heart to a first external cyclic expanding and collapsing magnetic field;

c. said first cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and a field strength of at least 0.5 gauss;

d. concurrently subjecting an area of the human being'"'"'s body adjacent to the occiput of the human being'"'"'s brain to a second external cyclic expanding and collapsing magnetic field;

e. said second cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency about ten times the frequency of said first cyclic expanding and collapsing magnetic field, having a duty cycle of from about 15% to about 50%, and a field strength of at least 0.5 gauss;

f. said second cyclic expanding and collapsing magnetic field operating only during the active portion of the duty cycle of said first cyclic expanding and collapsing magnetic field; and

g. adjusting the frequency of said first cyclic expanding and collapsing magnetic field such that the frequency of said first cyclic expanding and collapsing magnetic field corresponds to the second Bessell Null of the Fourier series of the human'"'"'s being'"'"'s cardiac output as displayed on said analyzer means;

h. whereby said first cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat, said second cyclic expanding and collapsing magnetic field reduces angina pain, and the first and second cyclic expanding and collapsing magnetic fields operate in concert to thereby pace the human being'"'"'s heart.

7. A process for influencing the cardiac function of a human being comprising:

a. displaying the human being'"'"'s cardiac output on an oscilloscope means such that the cardiac output is displayed in the shape of an EKG wave in the time domain;

b. subjecting an area of the human being'"'"'s body adjacent to the human being'"'"'s heart to a first external cyclic expanding and collapsing magnetic field;

c. said first cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and a field strength of at least 0.5 gauss;

d. concurrently subjecting an area of the human being'"'"'s body adjacent to the occiput of the human being'"'"'s brain to a second external cyclic expanding and collapsing magnetic field;

e. said second cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency about ten times the frequency of said first cyclic expanding and collapsing magnetic field, having a duty cycle of from about 15% to about 50%, and a field strength of at least 0.5 gauss;

f. said second cyclic expanding and collapsing magnetic field operating only during the active portion of the duty cycle of said first cyclic expanding and collapsing magnetic field; and

g. adjusting the frequency of said first cyclic expanding and collapsing magnetic field such that the QRS portion of the human being'"'"'s EKG wave lies between two adjacent square wave outputs of the first cyclic expanding and collapsing magnetic field as displayed on said oscilloscope means;

h. whereby said first cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat, said second cyclic expanding and collapsing magnetic field reduces angina pain, and the first and second cyclic expanding and collapsing magnetic fields operate in concert to thereby pace the human being'"'"'s heart.

8. A device for influencing the cardiac function of a human being, comprising:

a. a conducting wire coil;

b. a core positioned in said coil;

c. first means to produce a flow of first electric current through said coil;

d. means to cause said first electric current to create a first cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and being sufficient to induce a magnetic field having a strength of at least 0.5 gauss in said core; and

e. means to adjust the frequency of said first cyclic expanding and collapsing magnetic field such that the frequency of said first cyclic expanding and collapsing magnetic field corresponds to the second Bessell Null of the Fourier series of the human'"'"'s being'"'"'s cardiac output when the human being'"'"'s cardiac output is displayed on an analyzer means as a frequency in a Fourier series;

f. whereby said first cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat to thereby pace the human being'"'"'s heart.

9. The invention as defined in claim 8, further comprising:

a. second means to produce a second flow of electric current through said coil only during the duty cycle period of time when said first means to produce a flow of first electric current through said coil is causing electric current to flow through said coil; and

b. means to cause said second electric current to create a second cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 71.5 Hertz and 77.8 Hertz, having a duty cycle from about 15% to 50%, and being sufficient to induce a magnetic field having a strength of at least 0.5 gauss in said core;

c. whereby said second cyclic expanding and collapsing magnetic field reduces angina pain, and the first and second cyclic expanding and collapsing magnetic fields operate in concert to thereby pace the human being'"'"'s heart.

10. The invention as defined in claim 8 wherein said core is made of mu-metal.

11. The invention as defined in claim 8 wherein said coil terminates in an electrode.

12. The invention as defined in claim 8 wherein a portion of said device has a shield to prevent the magnetic field from being directed away from the human being.

13. The invention as defined in claim 12 wherein said shield is made of mu-metal.

14. A device for influencing the cardiac function of a human being, comprising:

a. a first conducting wire coil;

b. a first core positioned in said first conducting wire coil;

c. first means to produce a flow of first electric current through said first conducting wire coil;

d. first means to cause said first electric current to create a first cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and being sufficient to induce a magnetic field having a strength of at least 0.5 gauss in said first core;

e. first means to adjust the frequency of said first cyclic expanding and collapsing magnetic field such that the frequency of said first cyclic expanding and collapsing magnetic field corresponds to the second Bessell Null of the Fourier series of the human'"'"'s being'"'"'s cardiac output when the human being'"'"'s cardiac output is displayed on an analyzer means as a frequency in a Fourier series;

f. a second conducting wire coil;

g. a second core positioned in said second conducting wire coil;

h. second means to produce a flow of second electric current through said second conducting wire coil;

i. second means to cause said second electric current to create a second cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 71.5 Hertz and 77.8 Hertz, having a duty cycle from about 15% to 50%, and being sufficient to induce a magnetic field having a strength of at least 0.5 gauss in said second core; and

j. said first means to produce a flow of first electric current through said first coil and second means to produce a flow of second electric current through said second coil being set so that the second means operates to produce electric current in the second coil only during the active portion of the duty cycle of the first means;

k. whereby said first cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat, said second cyclic expanding and collapsing magnetic field reduces angina pain, and the first and second cyclic expanding and collapsing magnetic fields operate in concert to thereby pace the human being'"'"'s heart.

15. The invention as defined in claim 14 wherein said first core and said second core are each made of mu-metal.

16. The invention as defined in claim 14 wherein said first coil terminates in an electrode and said second coil terminates in an electrode.

17. The invention as defined in claim 14 wherein a portion of said device has a shield to prevent the magnetic field from being directed away from the human being.

18. The invention as defined in claim 17 wherein said shield is made of mu-metal.

19. A device for influencing the cardiac function of a human being, comprising:

a. a conducting wire coil;

b. a core positioned in said coil;

c. first means to produce a flow of first electric current through said coil;

d. means to cause said first electric current to create a first cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and being sufficient to induce a magnetic field having a strength of at least 0.5 gauss in said core; and

e. means to adjust the frequency of said first cyclic expanding and collapsing magnetic field such that the frequency of said first cyclic expanding and collapsing magnetic field corresponds to having the QRS portion of the human being'"'"'s EKG wave lie between two adjacent square wave outputs of the first cyclic expanding and collapsing magnetic field when the human being'"'"'s EKG wave and the frequency of the first cyclic expanding and collapsing magnetic field are displayed on a oscilloscope means;

f. whereby said first cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat to thereby pace the human being'"'"'s heart.

20. The invention as defined in claim 19, further comprising:

a. second means to produce a second flow of electric current through said coil only during the duty cycle period of time when said first means to produce a flow of first electric current through said coil is causing electric current to flow through said coil; and

b. means to cause said second electric current to create a second cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 71.5 Hertz and 77.8 Hertz, having a duty cycle from about 15% to 50%, and being sufficient to induce a magnetic field having a strength of at least 0.5 gauss in said core;

c. whereby said second cyclic expanding and collapsing magnetic field reduces angina pain, and the first and second cyclic expanding and collapsing magnetic fields operate in concert to thereby pace the human being'"'"'s heart.

21. The invention as defined in claim 19 wherein said core is made of mu-metal.

22. The invention as defined in claim 19 wherein said coil terminates in an electrode.

23. The invention as defined in claim 19 wherein a portion of said device has a shield to prevent the magnetic field from being directed away from the human being.

24. The invention as defined in claim 23 wherein said shield is made of mu-metal.

25. A device for influencing the cardiac function of a human being, comprising:

a. a first conducting wire coil;

b. a first core positioned in said first conducting wire coil;

c. first means to produce a flow of first electric current through said first conducting wire coil;

d. first means to cause said first electric current to create a first cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 7.15 Hertz and 7.78 Hertz, having a duty cycle of from about 15% to about 65%, and being sufficient to induce a magnetic field having a strength of at least 0.5 gauss in said first core;

e. first means to adjust the frequency of said first cyclic expanding and collapsing magnetic field such that the frequency of said first cyclic expanding and collapsing magnetic field corresponds to having the QRS portion of the human being'"'"'s EKG wave lie between two adjacent square wave outputs of the first cyclic expanding and collapsing magnetic field when the human being'"'"'EKG wave and the frequency of the first cyclic expanding and collapsing magnetic field are displayed on a oscilloscope means;

f. a second conducting wire coil;

g. a second core positioned in said second conducting wire coil;

h. second means to produce a flow of second electric current through said second conducting wire coil;

i. second means to cause said second electric current to create a second cyclic expanding and collapsing magnetic field comprising a ringing square wave form to produce a Fourier series of harmonics having a fundamental frequency between 71.5 Hertz and 77.8 Hertz, having a duty cycle from about 15% to 50%, and being sufficient to induce a magnetic field having a strength of at least 0.5 gauss in said second core; and

j. said first means to produce a flow of first electric current through said first coil and second means to produce a flow of second electric current through said second coil being set so that the second means operates to produce electric current in the second coil only during the active portion of the duty cycle of the first means;

k. whereby said first cyclic expanding and collapsing magnetic field produces a series of pulses which resemble the PQRSTU shape of the human being'"'"'s heartbeat, said second cyclic expanding and collapsing magnetic field reduces angina pain, and the first and second cyclic expanding and collapsing magnetic fields operate in concert to thereby pace the human being'"'"'s heart.

26. The invention as defined in claim 25 wherein said first core and said second core are each made of mu-metal.

27. The invention as defined in claim 25 wherein said first coil terminates in an electrode and said second coil terminates in an electrode.

28. The invention as defined in claim 25 wherein a portion of said device has a shield to prevent the magnetic field from being directed away from the human being.

29. The invention as defined in claim 28 wherein said shield is made of mu-metal.