Pulsed electromagnetic energy treatment apparatus and method

• US 6,334,069 B1
• Filed: 01/15/1999
• Issued: 12/25/2001
• Est. Priority Date: 01/15/1998
• Status: Expired due to Term

• Current Assignee: Regenesis Biomedical Incorporated
• Original Assignee: Regenesis Biomedical Incorporated
• Inventors: Loya, Arthur A., Bryant, Robert T., Ritz, Mary C., George, Frank R.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/231,790
• Time in Patent Office: 1,075 Days
• Field of Search: 607/2, 607/50, 607/96, 607/101, 607/103, 607/149-152, 607/154, 607/155, 600/14-15, 606/41
• US Class Current: 607/2
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

A method of and apparatus for the treatment of chronic wounds using pulsed electromagnetic energy provides a constant, known and replicable dosage output which remains unaffected by the capacitance of the patient'"'"'s body. The apparatus is simple to operate, requiring little operator training or interaction with the apparatus. All specifications of the apparatus relating to the generation and emission of electromagnetic energy are fixed, with the specifications based on actual scientific studies of the various technical parameters involved, such as pulse width and RF dosage. The apparatus includes a pulsed electromagnetic energy generator, a power level controller and one or more thin applicators which can be flexible. The applicators are located immediately adjacent to the patient'"'"'s body, without the aid of a support member or removal of any dressings or bandages. The generator, which can be battery-operated, is a low power, programmable compact unit whose output is controlled by multiple control circuits for ensuring accurate treatment dosage, for confirming that the treatment was properly administered, and for disabling the generator when appropriate. The generator output is automatically adjusted in response to instructions from the field strength sensor located on or near the applicator. Multiple applicators selected to operate simultaneously at different treatment dosage levels are connected to the generator by multi-conductor cables and readily located directly on the treatment area. Each applicator is a pad including etched printed circuits. The circuits are matched and pre-tuned. An applicator-to-patient proximity detector is also incorporated in or on each applicator and connected to the generator via a power controller to provide for direct monitoring of the treatment site and precise control of treatment dosage.

Claims

1. An electromagnetic energy treatment apparatus comprising means for generating pulsed high frequency signs and at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area, wherein said applicator is solely connected to said generating means by a cable, wherein said applicator is flexible, and wherein said applicator comprises a circuit means for delivering an electromagnetic treatment dosage, and wherein said circuit means has a fixed capacitance while delivering said energy treatment dosage.

2. An electromagnetic energy treatment apparatus, comprising:

means for generating pulsed high frequency signals;

at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area, wherein said applicator is solely connected to said generating means by a cable; and

means for securing said applicator to a patient, and wherein said applicator comprises a circuit means for delivering an electromagnetic treatment dosage, and wherein said circuit means has a fixed capacitance while delivering said energy treatment dosage.

3. An electromagnetic energy treatment apparatus, comprising:

means for generating pulsed high frequency signals; and

at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area, wherein said at least one self supporting applicator comprises a circuit means for delivering an electromagnetic energy treatment dosage, and wherein said circuit means has a fixed capacitance while delivering said energy treatment dosage.

4. Apparatus according to claim 3, wherein said circuit means further comprises a first circuit and a second circuit positioned proximate said first circuit, and wherein said first and second circuits have fixed capacitance.

5. Apparatus according to claim 4, wherein said first circuit has a first fixed capacitor, and wherein said second circuit has a second fixed capacitor.

6. Apparatus according to claim 3, wherein said circuit means further comprises a coil, a fixed capacitor configured with said coil, and a ground plane located directly below said coil.

7. Apparatus according to claim 3, wherein said circuit means comprises a secondary circuit and a primary circuit positioned proximate said secondary circuit, wherein said secondary circuit comprises an inductor and a fixed capacitor configured as a tank circuit, and wherein said primary circuit comprises an inductor and a capacitor in series with said inductor.

8. Apparatus according to claim 3, wherein said circuit means further comprises a substrate and multiple circuits for inducing a treatment dosage, wherein said multiple circuits are generally concentrically located on said substrate.

9. Apparatus according to claim 8, wherein said multiple circuits further comprise a secondary circuit and a primary circuit positioned proximate said secondary circuit, wherein said secondary circuit comprises an inductor and a fixed capacitor configured as a tank circuit, and wherein said primary circuit comprises an inductor and a capacitor in series with said conductor.

10. Apparatus according to claim 8, wherein said multiple circuits further comprise a coil, a fixed capacitor configured with said coil, and a ground plane located beneath said coil.

11. Apparatus according to claim 8, wherein said multiple circuits further comprise a first circuit printed on said substrate and a second circuit printed on said substrate.

12. Apparatus according to claim 11, wherein said substrate has an upper surface and a lower surface, and wherein said first circuit is printed on said upper surface and said second circuit is printed on said lower surface.

13. Apparatus according to claim 8, wherein said substrate is flexible.

14. Apparatus according to claim 13, wherein said substrate further comprises multiple sheets, and wherein said multiple circuits are positioned between said multiple sheets.

15. Apparatus according to claim 14, wherein said sheets are made of a high dielectric material.

16. Apparatus according to claim 3, wherein said circuit means further comprises means for radiating electromagnetic energy into a target area and means for monitoring a position of said radiating means.

17. Apparatus according to claim 16, wherein said monitoring means further comprises a proximity sensor switch.

18. Apparatus according to claim 16, wherein said radiating means further comprises a substrate and at least one circuit carried by said substrate, and wherein said monitoring means is located on said radiating means.

19. Apparatus according to claim 3, wherein said circuit means further comprises means for radiating electromagnetic energy into a treatment area, said radiating means including a substrate and at least one circuit carried by said substrate, means located proximate said at least one circuit for directly detecting the electromagnetic energy emitted by said radiating means, and means located proximate said substrate for monitoring a position of said radiating means.

20. Apparatus according to claim 3, wherein said circuit means further comprises a rigid member comprising one or more rigid sheets, wherein said circuit means is carried by said rigid member.

21. Apparatus according to claim 20, wherein said circuit means further comprises a secondary circuit and a primary circuit positioned proximate said secondary circuit, wherein said secondary circuit comprises an inductor and a fixed capacitor configured as a tank circuit, and wherein said primary circuit comprises an inductor and a capacitor in series with said conductor.

22. An electromagnetic energy treatment apparatus, comprising:

means for generating pulsed high frequency signals; and

at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area, wherein said at least one self supporting applicator comprises a circuit means, wherein said circuit means comprises means for radiating electromagnetic energy into a target area and means for continuously detecting the electromagnetic energy emitted by said radiating means.

23. Apparatus according to claim 22, wherein said detecting means is a field strength sensing and measuring circuit.

24. Apparatus according to claim 22, wherein said radiating means further comprises a substrate and at least one circuit carried by said substrate, and wherein said detecting means is positioned on said substrate.

25. An electromagnetic energy treatment apparatus comprising means for generating pulsed high frequency signals and at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area, wherein said applicator is solely connected to said generating means by a cable, and wherein said at least one self-supporting applicator comprises multiple applicators having said pulsed high frequency signals as inputs for inducing said pulsed high frequency signals into a target site.

26. Apparatus according to claim 25, wherein said applicators operate simultaneously.

27. Apparatus according to claim 25, wherein said generating means further comprises means for simultaneously delivering different signals to each applicator.

28. Apparatus according to claim 25, wherein said applicators operate independently.

29. Apparatus according to claim 25, wherein said generating means further comprises means for independently delivering different signals to each applicator.

30. An electomagnetic energy treatment apparatus comprising:

means for generating pulsed high frequency signals, wherein said generating means comprises a pulse generator for generating energy pulses, at least one amplifier connected to said generator for amplifying said energy pulses into said pulsed high frequency signal output, and automatic control means for automatically controlling said pulsed high frequency signal output, wherein said control means comprises at least one power level controller connected to said at least one amplifier and at least one control circuit connected to said power level controller for automatically controlling said pulsed high frequency signal output; and

at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area, wherein said applicator is solely connected to said generating means by a cable.

31. Apparatus according to claim 30, wherein said pulse generator further comprises a pulse rate timer circuit for generating a time setting output, a pulse width timer circuit for receiving said time setting output and for producing a single, fixed width, fixed shaped enabling pulse, and a high frequency oscillator for receiving said enabling pulse and for generating high frequency energy signals.

32. Apparatus according to claim 31, wherein said at least one control circuit further comprises a pulse shaper and repetition controller circuit connected to said pulse generator and to said power level controller.

33. Apparatus according to claim 30, wherein said at least one control circuit further comprises a control logic circuit.

34. Apparatus according to claim 30, wherein said at least one control circuit further comprises a programmable means for automatically controlling characteristics of said pulsed high frequency signal output generated by said generating means, said programmable means having outputs connected to said power level controller and said pulse generator.

35. Apparatus according to claim 34, wherein said programmable means further comprises a programmable logic array and means connected to said array for selecting a pulse profile from multiple profiles stored in said array.

36. Apparatus according to claim 34, further comprising at least one treatment selector means for selecting a desired treatment profile.

37. Apparatus according to claim 30, wherein said at least one circuit further comprises a power measuring circuit means for measuring said pulsed high frequency signal output from said amplifier of said generating means and for generating an output, and wherein said power level controller further comprises means for comparing said output of said power measuring circuit means to a predetermined value and means for disabling said generating means when said output of said power measuring circuit means exceeds said predetermined values.

38. Apparatus according to claim 37, wherein said power controller further comprises means for triggering alarms when said generating means is disabled.

39. Apparatus according to claim 30, wherein said at least one circuit further comprises means located proximate to said applicator for measuring an energy output emitted from said applicator and for generating a feedback signal corresponding to said measured output.

40. Apparatus according to claim 39, wherein said power level controller further comprises means for comparing said feedback signal to predetermined values and means for disabling said generating means when said feedback signal fails said comparison.

41. Apparatus according to claim 39, wherein said power level controller further comprises means for adjusting an output of said generator in response to said feedback signal.

42. Apparatus according to claim 39, wherein said power controller further comprises means for triggering alarms when said generating means is disabled.

43. Apparatus according to claim 30, wherein said control circuit further comprises treatment timer means for controlling a time period for production of said pulsed high frequency signal output by said generating means.

44. Apparatus according to claim 43, wherein said power level controller further comprises means for disabling said treatment timer means.

45. Apparatus according to claim 44, wherein said treatment timer means is preset to clock a predetermined treatment dosage.

46. Apparatus according to claim 44, further comprising a treatment selector means operationally connected to said treatment timer means, wherein a desired treatment time is selected using said treatment selector means.

47. Apparatus according to claim 30, further comprising a battery power supply connected to said power level controller, and wherein said at least one control circuit further comprises means for monitoring an output of said power supply and for disabling operation of said generating means when low power is detected.

48. An electromagnetic energy treatment apparatus comprising:

means for generating pulsed high frequency signals comprising;

automatic control means for automatically controlling said pulsed high frequency signal output, wherein said control means comprises

at least one power level controller connected to said at least one amplifier and at least one control circuit connected to said power level controller for automatically controlling said pulsed high frequency signal output said at least one control circuit comprising;

means for controlling treatment time;

a power measuring circuit means having an input connected to said amplifier;

a power supply control circuit means;

means for monitoring placement of said applicator having an output connected to said power level controller; and

means for detecting strength of treatment energy emitted by said applicator,

wherein each of said means has an output connected to said power level controller;

a pulse generator for generating energy pulses; and

at least one amplifier connected to said generator for amplifying said energy pulses into said pulsed high frequency signal output; and

at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area, wherein said applicator is solely connected to said generating means by a cable.

49. An electromagnetic energy treatment apparatus comprising:

means for generating pulsed high frequency signals comprising;

automatic control means for automatically controlling said pulsed high frequency signal output, wherein said control means comprises

at least one power level controller connected to said at least one amplifier and at least one control circuit connect ed to said power level controller for automatically controlling said pulsed high frequency signal output said at least one control circuit comprising;

means for controlling treatment time;

a power measuring circuit means having an input connected to said amplifier;

a power supply control circuit means;

means for monitoring placement of said applicator having an output connected to said power level controller;

means for detecting strength of treatment energy emitted by said applicator and

means located on said applicator for monitoring a position of said applicator and for generating a feedback signal corresponding to said position;

wherein each of said means has an output connected to said power level controller;

a pulse generator for generating energy pulses; and

at least one amplifier connected to said generator for amplifying said energy pulses into said pulsed high frequency signal output; and

at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area, wherein said applicator is solely connected to said generating means by a cable.

50. Apparatus according to claim 49, wherein said power level controller further comprises means for actuating an appropriate indicator in response to said feedback signal.

51. Apparatus according to claim 49, wherein said monitoring means is a body proximity sensor switch.

52. An electromagnetic energy treatment apparatus, comprising:

means for generating pulsed high frequency signals;

at least one self-supporting applicator having said pulsed high frequency signals as an input for inducing said pulsed high frequency signals into a target area; and

a power supply, wherein said generating means has an input from said power supply and said power supply has an average power output of less than about 3 watts.

53. Apparatus according to claim 52, wherein said power supply has an average power output of less than about 1 watt.

54. An electromagnetic energy treatment apparatus in accordance with claim 52, wherein said power supply is a battery power supply, wherein said generating means has an input from said battery power supply.

55. An electromagnetic energy treatment apparatus in accordance with claim 52, wherein said generating means weighs less than about 3 pounds.

56. An electromagnetic energy treatment apparatus in accordance with claim 52, wherein said generating means has a height of about 8 inches, a length of about 5 inches and a thickness of about 2.5 inches.