Aesthetic method of biological structure treatment by magnetic field

• US 10,245,439 B1
• Filed: 07/23/2018
• Issued: 04/02/2019
• Est. Priority Date: 07/01/2015
• Status: Active Grant

• Current Assignee: BTL Medical Solutions As
• Original Assignee: Medical Technologies CZ as (DXC Technology Company)
• Inventors: Schwarz, Tomas, Prouza, Ondra
• Primary Examiner(s): Gilbert, Samuel G
• Application Number:
  US16/042,093
• Time in Patent Office: 253 Days
• Field of Search: 600 9, 600 13, 600 14
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• 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

Methods for treating a patient using time varying magnetic field are described. The treatment methods combine various approaches for treatment.

Claims

1. A method for treating pelvic floor issues of a patient using a time-varying magnetic field applied to a pelvic floor of the patient wherein the time-varying magnetic field is applied to a muscle and/or a nerve innervating the muscle within a body region between coccyx and pubic bone of the patient in order to cause a contraction of the muscle in the pelvic floor, the magnetic field generated by a treatment device which includes a switching device, an energy storage device and a magnetic field generating device, comprising:

a) charging the energy storage device;

b) switching the switching device on for a first time period having a duration in a range of 3 to 1000 μ

s and enabling a current discharge from the energy storage device to the magnetic field generating device in order to generate an impulse of the time-varying magnetic field and applying the impulse of the time-varying magnetic field to the patient;

c) switching the switching device off for a second time period at least four times longer than the first time period and generating no magnetic field by the magnetic field generating device;

d) repeating steps a)-c) for a third time period having a duration in a range of 5 to 500 ms in order to generate a first train of pulses wherein each pulse consists of the impulse of the time-varying magnetic field and the second time period;

e) switching the switching device off after the third time period for a fourth time period having a duration in a range of 10 to 1200 ms and generating no magnetic field;

f) repeating steps a)-e) at least once during a fifth time period having a duration in a range of 3 to 120 seconds;

g) repeating steps a) and b) and switching the switching device off for a sixth time period at least nine times longer than the first time period and different from the second time period;

h) repeating step g) for a seventh time period having a duration in a range of 1.5 to 6 seconds in order to generate a second train of pulses of the time-varying magnetic field wherein the second train of pulses differs from the first train of pulses and wherein the seventh time period consists of first, second, and third subperiods each having a duration in a range of 0.5 to 2 seconds;

wherein an amplitude of a magnetic flux density of each subsequent magnetic pulse of the second train of pulses increases to a predetermined magnetic flux density value during the first subperiod;

wherein the amplitude of the magnetic flux density of each subsequent magnetic pulse of the second train of pulses maintains the predetermined magnetic flux density value during the second subperiod; and

wherein the amplitude of the magnetic flux density of each subsequent pulse of the second train of pulses decreases during the third subperiod from the predetermined magnetic flux density value;

i) switching the switching device off after the seventh time period for an eighth time period having a duration in a range of 1 to 5 seconds and generating no magnetic field by the magnetic field generating device; and

j) repeating steps g)-i) at least once during a ninth time period having a duration of at least 30 seconds.

2. The method of claim 1 further comprising providing a current pulse of at least 100 A to the magnetic field generating device from the energy storage device.

3. The method of claim 1 wherein a maximal value of a magnetic flux density derivative is in a range of 300 T/s to 800 kT/s, and wherein a rate of change of the magnetic flux density is sufficient to induce at least motor-threshold current in the muscle and/or the nerve innervating the muscle of the pelvic floor of the patient.

4. The method of claim 1 wherein the time-varying magnetic field has a winding magnetic fluence in a range of 5 to 40000 T·

cm².

5. The method of claim 1 wherein the magnetic field generating device has a winding area in a range of 4 to 7900 cm².

6. The method of claim 1 wherein the energy storage device has a capacitance in a range of 5 nF to 100 mF.

7. The method of claim 1 wherein step b) is repeated at least 500 times per treatment.

8. A method for treating pelvic floor issues of a patient using a time-varying magnetic field applied to a pelvic floor of the patient, wherein the time-varying magnetic field is applied to a muscle of a pelvic floor of the patient and/or to a nerve innervating the muscle of the pelvic floor in order to cause a contraction of the muscle, the magnetic field generated by a treatment device which includes a connection to an energy source, a switching device, an energy storage device and a magnetic field generating device, comprising:

a) charging the energy storage device;

b) switching the switching device;

c) discharging the energy storage device to the magnetic field generating device in order to generate the time-varying magnetic field with a repetition rate in a range of 1 to 700 Hz, an impulse duration in a range of 3 to 1000 μ

s and a magnetic flux density up to 7 Tesla;

d) generating a plurality of bursts wherein each said burst consists of a train of a plurality of subsequent magnetic pulses, wherein the train has a trapezoidal envelope, followed by a time period with no magnetic field generation;

wherein each said train includes three subperiods, each said subperiod lasting at least 0.5 seconds, and wherein a magnetic flux density of each subsequent pulse of each said train increases during a first subperiod, an amplitude of the magnetic flux density of each subsequent pulse of each said train is constant or substantially constant during a second subperiod, and the magnetic flux density of each subsequent pulse of each said train decreases during the third subperiod;

e) applying to the pelvic floor of the patient and/or to a nerve innervating the muscle of the pelvic floor at least one first burst having a duration in a range of 2.5 to 10 seconds, a repetition rate of the magnetic pulses in a range of 5 to 60 Hz, and having a first burst duty cycle;

f) applying to the pelvic floor of the patient and/or to a nerve innervating the muscle of the pelvic floor at least one second burst having a duration in a range of 2.5 to 10 seconds, a repetition rate of the magnetic pulses in a range of 30 to 75 Hz, and having a second burst duty cycle; and

g) alternating applying the at least one first burst and applying the at least one second burst for at least 60 seconds, wherein the first bursts differ from the second bursts in at least one of the magnetic flux density, the repetition rate of the magnetic pulses, the burst duration, the train duration or the at least one subperiod duration and/or the burst duty cycle.

9. The method of claim 8 wherein a maximal value of a magnetic flux density derivative is at least 300 T/s.

10. The method of claim 8 wherein the energy storage device has a capacitance in a range of 5 nF to 100 mF.

11. The method of claim 8 wherein the time-varying magnetic field has a magnetic fluence up to 60000 T·

cm².

12. The method of claim 8 further comprising generating subsequent bursts with an increasing maximal amplitude of the time-varying magnetic field.

13. The method of claim 8 further wherein the time-varying magnetic field has a winding magnetic fluence in a range of 5 to 40000 T·

cm².

14. A method for treating pelvic floor issues of a patient using a time-varying magnetic field applied to a pelvic floor of the patient, wherein the time-varying magnetic field is applied to a muscle of the pelvic floor and/or nerve innervating the muscle of the pelvic floor in order to cause a contraction of the muscle, the magnetic field generated by a treatment device which includes a connection to an energy source, a switching device and a magnetic field generating device, comprising:

a) placing the magnetic field generating device proximate to sacral nerves of the patient and/or the region between the coccyx and pubic bone of the patient;

b) switching on the switching device;

c) generating the time-varying magnetic field with a repetition rate in a range of 1 to 700 Hz and with a maximal magnetic flux density derivative in a range of 300 T/s to 800 kT/s;

d) applying the time-varying magnetic field to the patient in order to determine a maximal acceptable value of the magnetic flux density perceived by the patient;

e) generating a plurality of subsequent pulses of the time-varying magnetic field;

f) disabling the switching device and generating no magnetic field by the magnetic field generating device;

g) repeating steps e) and f) for at least 10 seconds with a first burst repetition rate and a first burst duty cycle and incrementally increasing or decreasing an amplitude maximal value of the magnetic flux density of the subsequent first bursts up to a predetermined value or up to the maximal acceptable value of the magnetic flux density perceived by the patient with an increment of at least 1% of the maximal acceptable value of the magnetic flux density perceived by the patient; and

h) repeating steps e) and f) with a second burst duty cycle different from the first burst duty cycle and with a second burst repetition rate different from the first burst repetition rate.

15. The method of claim 14 wherein the treatment device further comprises a human machine interface and a sensor, configured to determine an operation parameter including a voltage, current or phase, of the treatment device and configured to adjust treatment parameters including the magnetic flux density and/or the repetition rate.

16. The method of claim 14 further comprising determining at least a presence of the patient by using at least one sensor.

17. The method of claim 14 wherein the magnetic field generating device has an inductance in a range of 1 nH to 1 H.

18. The method of claim 17 further comprising providing a current pulse of at least 100 A to the magnetic field generating device from an energy storage device.

19. The method of claim 14 further comprising generating a sequence of bursts of the time-varying magnetic field wherein each subsequent burst has an increasing amplitude.

20. The method of claim 14 wherein the time-varying magnetic field has a winding magnetic fluence in a range of 5 to 40000 T·

cm².

21. The method of claim 20 wherein the magnetic field generating device has a winding surface area up to 7900 cm².

22. A method for treating pelvic floor issues of a patient using a time-varying magnetic field generated by a treatment device comprising a magnetic field generating device, the time-varying magnetic field applied to a pelvic floor of the patient, comprising:

a) generating a plurality of pulses of the time-varying magnetic field with a magnetic flux density up to 7 Tesla and with a maximal magnetic flux density derivative in a range of 300 T/s to 800 kT/s;

b) assembling subsequent magnetic pulses into a train lasting at least 0.5 seconds and having a trapezoidal envelope;

c) generating no magnetic field for a time period having a duration of up to 10 seconds after a last pulse of the train;

d) repeating steps b) and c) with a repetition rate of the pulses of the time-varying magnetic field in a range of 5 to 60 Hz for at least 15 seconds with a treatment duty cycle over 10%;

e) generating a plurality of the pulses of step a) with a repetition rate up to 10 Hz for a time period up to 120 seconds;

f) repeating a plurality of steps d) and at least one step e) for at least 60 seconds; and

g) applying the pulses of the time-varying magnetic field to the pelvic floor of the patient in order to cause a contraction of a muscle in the pelvic floor of the patient.

23. The method of claim 22 further comprises increasing an amplitude of the time varying magnetic field in subsequent trains.

24. The method of claim 22 wherein the treatment device comprises an energy storage device having a capacitance in a range of 5 nF to 100 mF.

25. The method of claim 24 further comprising providing a current pulse of at least 100 A to the magnetic field generating device from the energy storage device.

26. The method of claim 22 wherein the time-varying magnetic field has a winding magnetic fluence in a range of 5 to 40000 T·

cm².

27. The method of claim 26 wherein the magnetic field generating device has a total surface area, and has a core area in a range of 0.01 to 99% of the total surface area.

28. The method of claim 22 wherein the magnetic field generating device has an inner diameter in a range of 1 to 99% of an outer diameter of the magnetic field generating device.

29. The method of claim 28 wherein the magnetic field generating device has an inductance in a range of 1 nH to 1 H.

30. The method of claim 29 wherein the time-varying magnetic field has a magnetic fluence in a range of 5 to 60000 T·

cm².