Low frequency vibration assisted blood perfusion emergency system

• US 20050054958A1
• Filed: 07/30/2004
• Published: 03/10/2005
• Est. Priority Date: 09/04/2003
• Status: Active Grant

• Current Assignee: 3921093 Canada Inc., Parallel Biotechnologies, LLP
• Original Assignee: Ahof Biophysical Systems Inc.
• Inventors: Hoffmann, Andrew Kenneth
• Granted Patent: US 7,517,328 B2
• Time in Patent Office: Days
• US Class Current: 601/46
• CPC Class Codes: A61B 17/225 for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
• CPC Class Codes: A61H 1/00 Apparatus for passive exercising A61H5/00 takes precedence; Vibrating apparatus; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
• CPC Class Codes: A61H 2023/0209 powered with frequencies not related to mains frequency
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5061 Force sensors
• CPC Class Codes: A61H 31/00 Artificial respiration or heart stimulation, e.g. heart massage artificial respiration by treatment with gas or air, e.g. mouth-to-mouth respiration A61M16/00; applying electric currents by contact electrodes for stimulation, e.g. heart pace-makers A61N1/36 ; teaching or training models, demonstration models for medical purposes G09B23/288
• CPC Class Codes: A61H 31/005 with feedback for the user
• CPC Class Codes: A61H 31/006 Power driven
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

An emergency system for treatment of a patient (20) experiencing an acute vascular obstruction, employing a non-invasive vibrator (10), optimally in conjunction with drugs, for disrupting and lysing thromboses, relieving spasm (if associated), and thereby restoring blood perfusion. Vibrator (10) is operable in the sonic to infrasonic range, with a source output of up to 15 mm. For acute myocardial infarction cases, a pair of contacts (12), are advantageously placed to bridge the sternum at the fourth intercostal space. Vibration is initiated at 50 Hz (or any frequency, preferably within the 20-120 Hz range), and is ideally adjusted to a maximal amplitude (or force) deemed tolerable and safe to the patient (20), preferably with the administration of thrombolytic agents or other form of drug therapy. A synergistic effect is achieved between vibration and drugs to facilitate the disruption of thromboses, relieve spasm, and restore blood perfusion. In a variation, ultrasonic imaging may be used to direct vibration therapy.

Claims

1. An emergency method of using a vibrator for the restoration of blood flow in a patient experiencing an acute thrombotic arterial obstruction, comprising the step of:

a) applying vibration at a frequency of about 20 Hz-120 Hz and a displacement amplitude of about 1 mm-15 mm from said vibrator upon an external body surface proximate said acute thrombotic arterial obstruction, to restore blood flow in said patient experiencing said acute thrombotic arterial obstruction.

2. The method of claim 1, wherein said acute thrombotic arterial obstruction obstructs blood flow to a vital internal organ.

3. The method of claim 2, wherein said acute thrombotic arterial obstruction is within the coronary vasculature.

4. The method of claim 2, wherein said acute thrombotic arterial obstruction is within the cerebral vasculature.

5. The method of claim 1, wherein said vibration has an amplitude of greater than 2 mm, such as to promote therapeutic penetration of said vibration.

6. The method of claim 1, wherein said vibrator is applied with an engagement force of at least 10 newtons to said external body surface, and said vibration is of an amplitude of at least 4 mm, such as to ensure therapeutic penetration of said vibration.

7. The method of claim 1, further comprising the step of adjusting the intensity of said vibration to a tolerance level of said patient after step 1(a) has been initiated, such as to optimize the delivery of said vibration.

8. The method of claim 7, wherein said intensity level of said vibration is at least one of:

a displacement amplitude level and a force or power level.

9. The method of claim 1, wherein said vibration is emitted, at least in part, during ventricular diastole and ventricular systole of the cardiac cycle of said patient, in coronary applications.

10. The method of claim 1, wherein said vibration has a waveform comprising one of:

a sinusoidal waveform, a substantially square or percussive waveform, a saw-tooth waveform, a curved waveform, a substantially linear waveform, and combinations thereof.

11. The method of claim 1, wherein said vibration is substantially maintained at a constant emission frequency throughout the course of therapy.

12. The method of claim 1, wherein said vibration is alternated in frequency in accordance to cardiac phase.

13. The method of claim 1, wherein said vibration is directed substantially perpendicular to the long axis of the torso of said patient, in coronary applications.

14. The method of claim 1, wherein said vibration is applied to at least one of the anterior chest wall and the upper back of said patient.

15. The method of claim 1, wherein said vibration is applied to a space between the ribs of said patient.

16. The method of claim 1, wherein said vibration is applied via at least one contact with a substantially convex contact surface.

17. The method of claim 1, wherein said vibration is applied via at least a pair of contact nodes to at least a pair of application sites.

18. The method of claim 17, wherein said at least a pair of application sites comprises at least one of:

the anatomic left and right of the sternum, and the anatomic left and right of the spine of said patient.

19. The method of claim 1, wherein said vibrator has an attachment interface comprising at least one low frequency ultrasonic actuator operational within the range of about 20-100 kHz, and further comprising the step of:

a) emitting a low frequency ultrasonic wave form within the range of about 20-100 kHz in concert with said vibration at a frequency of about 20 Hz-120 Hz during step 1(a),

wherein said at least one low frequency ultrasonic actuator transmits said vibration at a frequency of about 20 Hz-120 Hz to said external body surface,

such as to provide a pair of therapeutic oscillatory emissions at differing frequency to said patient, in view to remediate said acute thrombotic arterial obstruction.

20. The method of claim 19, further comprising the step of directing said pair of therapeutic oscillatory emissions via means of ultrasonic imaging, prior to completion of step 1(a).

21. The method of claim 1, further comprising the steps of:

a) providing an ultrasonic imaging system, and

b) locating an application site for said vibrator upon said external body surface via use of said ultrasonic imaging system, prior to completion of step 1(a),

wherein said application site comprises a sonic penetration window enabling visualization of a target of said vibration.

22. The method of claim 1, wherein said vibrator has an attachment interface comprising at least one ultrasonic imaging transducer operatively attached to an active end of said vibrator, and further comprising the steps of:

a) locating an application site for said vibrator upon said external body surface via use of said at least one ultrasonic imaging transducer, prior to completion of step 1(a), and then

b) maintaining a position upon said application site via use of said at least one ultrasonic imaging transducer, after step 22(a) has been initiated, and prior to completion of step 1(a),

wherein said application site comprises a sonic penetration window enabling visualization of a target of said vibration, and

whereby said at least one ultrasonic imaging transducer transmits said vibration at a frequency of about 20 Hz-120 Hz to said external body surface.

23. The method of claim 1, further comprising the steps of:

a) providing a noninvasive ultrasonic imaging system,

b) operatively placing an imaging transducer of said noninvasive ultrasonic imaging system remote from the application site of said vibrator prior to the completion of step 1(a), and then

c) confirming the viability of said application site of said vibrator via use of said ultrasonic imaging system, during step 1(a),

whereby visualization of the effects of said vibration within a target of said vibration via use of said ultrasonic imaging system, confirms said viability.

24. The method of claim 1, further comprising the steps of

a) providing a cardiac phase controlled delivery system adapted to operate in conjunction with said vibrator, and then

b) adjusting the timing of said vibration to coincide with the period of ventricular diastole of said patient prior to completion of step 1(a), in the case said patient deteriorates into a state of hemodynamic compromise at any point prior to the completion of step 1(a).

25. The method of claim 1, wherein said vibrator is engaged to said external body surface by one of:

a clamp, a belt, the upper back support of a chair, the upper back support of a stretcher, and at least one hand of an operator.

26. The method of claim 1, further comprising the additional steps of:

a) delivering said vibrator to said patient via an ambulance prior to step 1(a), and

b) transporting said patient to a treatment facility concurrently with step 1(a),

whereby said vibrator is used in the field.

27. The method according to any one of the preceding claims, further comprising the step of administrating at least one drug to said patient for remediation of said acute thrombotic arterial obstruction, prior to completion of step 1(a).

28. The method of claim 27, wherein said at least one drug comprises at least one member of the group consisting of:

a thrombolytic, a GP 2b 3a platelet inhibitor, an anticoagulant, an oral antiplatelet, a vasodilator, and combinations thereof.

29. An acute care method for improving delivery of a drug to an obstructed artery, comprising the steps of systemically administering said drug, and applying percussion at a frequency of about 20 Hz to about 120 Hz and a displacement amplitude of about 1 mm to about 15 mm to an external body surface proximate said obstructed artery in combination with said drug, in order to improve delivery of said drug to said obstructed artery.

30. The method of claim 29, wherein said obstructed artery contains an acute thrombotic obstruction.

31. The method of claim 29, wherein said obstructed artery comprises a coronary artery.

32. The method of claim 29, wherein said percussion is applied throughout the cardiac cycle in coronary applications.

33. The method of claim 32, wherein said percussion is applied continuously, with a 100% duty factor.

34. The method of claim 32, wherein said percussion is applied intermittently, with a duty factor of less than 100%.

35. The method of claim 29, wherein said percussion has a displacement amplitude of greater than 2 mm, such as to provide a high energy adjunctive system of said percussion towards delivery of said drug to said obstructed artery.

36. The method of claim 29, wherein said percussion is directed substantially perpendicular to the long axis of the torso of said patient, in thoracic cavity applications.

37. The method of claim 29, wherein said percussion has a waveform selected from at least one of a sinusoidal waveform, a substantially square or percussive wave form, a saw-tooth waveform, an exponential waveform, a substantially linear waveform, a curved waveform, and combinations thereof.

38. The method of claim 29, further comprising the step of emitting an oscillatory waveform within the range of about 20 kHz to about 100 kHz coincidentally with said percussion within the range of about 20 Hz to about 120 Hz prior to completion of said applying percussion, such as to provide the simultaneous emission of at least a pair of oscillatory waveforms of substantially differing frequency.

39. The method of claim 29, wherein said percussion is applied substantially within a rib space of a patient receiving said percussion.

40. The method of claim 29, wherein said percussion is applied to at least a pair of application sites.

41. The method of claim 40, wherein said at least a pair of application sites are located to at least one of:

the anatomic left and right of the sternum, and the anatomic left and right of the spine of said patient.

42. The method of claim 29, wherein said percussion is directed by means of ultrasonic imaging.

43. The method of claim 29 wherein the step of systemically administering said drug is accomplished by at least one of:

intravenous drug administration, intra-arterial drug administration, subcutaneous drug administration, sub-lingual drug administration, oral drug administration, and nasal drug administration.

44. The method of claim 29 wherein said drug comprises at least one member of the group consisting of:

a thrombolytic, a GP 23a platelet inhibitor, an anticoagulant, an oral antiplatelet, a vasodilator, and combinations thereof.

45. An emergency method for disrupting a blood clot within the thoracic cavity, comprising the steps of:

a) placing a vibrator with at least one contact adapted to enable seating within a rib space of a patient experiencing said blood clot within the thoracic cavity to an external body surface substantially overlying a region containing said blood clot within the thoracic cavity, and

b) applying vibration at a frequency of about 1-120 Hz and a displacement amplitude of about 1-15 mm via said at least one contact upon said external body surface, to aid in dissolution of said blood clot.

46. The method of claim 45, wherein said blood clot is within a coronary artery and said external body surface substantially overlies the heart of said patient.

47. The method of claim 45, wherein said vibration is applied within at least one rib space of said patient.

48. The method of claim 45, wherein said vibration has a waveform comprising at least one of:

a sinusoidal waveform, a percussive waveform, an exponential waveform, a saw-tooth waveform, a substantially curved waveform, a substantially linear waveform, and combinations thereof.

49. The method of claim 45, further comprising the step of directing said vibration via means of ultrasonic imaging, prior to completion of step 45(b).

50. The method of claim 45, wherein said at least one contact comprises an ultrasonic imaging transducer operatively attached to an active end of said vibrator, and further comprising the step of directing said vibration by means of ultrasonic imaging via use of said ultrasonic imaging transducer, prior to completion of step 45(b).

51. The method of any one of claims 45 through 50, further comprising the step of systemically administering at least one clot disruptive drug as an adjunct to said vibration, prior to completion of step 45(b).

52. A method of using a percussive device with at least a pair of contact nodes for treatment of a patient experiencing an ischemic event to a vital internal organ, comprising the step of:

a) applying percussion at a frequency of about 1-120 Hz and a displacement amplitude of about 1-15 mm from said percussive device with at least a pair of contact nodes to at least a pair of application sites upon an external body surface deemed proximate the source of said ischemic event to a vital internal organ, in order to restore blood flow to said vital internal organ.

53. The method of claim 52, wherein said vital internal organ comprises the heart.

54. The method of claim 52, wherein said percussion is emitted within the frequency range of 20-120 Hz.

55. The method of claim 52, wherein said percussion has a wave shape comprising at least one of:

a sinusoidal wave shape, a substantially square or percussive wave shape, a saw-tooth wave shape, an exponential wave shape, a substantially linear wave shape, a curved waveshape, and combinations thereof.

56. The method of claim 52, wherein said percussion is emitted substantially within at least one rib space of said patient.

57. The method of claim 52, wherein said percussion via said at least a pair of contact nodes is transmitted to said external body surface in a substantially common direction, substantially perpendicular to the external body surface treated.

58. The method of claim 52, wherein said at least a pair of application sites are located to at least one of the anatomic left and right of the sternum, and the anatomic left and right of the spine of said patient.

59. The method according to any one of claims 52-58, further comprising the step of administering at least one drug for-remediation of said ischemic event to a vital internal organ prior to completion of step 52(a), such as to provide an adjunctive system of said percussion and said at least one drug for remediation of said ischemic event to said vital internal organ.

60. An apparatus for therapy, comprising a non invasive percussion device operable to emit percussion at a frequency within the range of 1-120 Hz and a displacement amplitude within the range of 1-15 mm, comprising:

a) a housing,

b) a linear stepper motor adapted to generate reciprocating motion disposed within said housing,

c) an amplitude regulating means for enabling an operator to incrementally regulate the stroke length of reciprocating motion emitted,

d) a power means for supplying power to said linear stepper motor,

e) a control for enabling an operator control of the functions of said percussion device, and

f) an attachment interface adapted to enable human contact operatively linked to said linear stepper motor and projected from said housing.

61. The apparatus of claim 60, wherein said housing is adapted in size and shape to enable hand held placement and operation.

62. The apparatus of claim 60, wherein said linear stepper motor is operable under loads of at least 20 newtons.

63. The apparatus of claim 60, wherein said percussion device is operable to emit at least one wave shape of reciprocating motion, selected from:

a sinusoidal wave shape, a substantially square or percussive wave shape, an exponential wave shape, a saw tooth wave shape, a curved wave shape, a substantially linear wave shape, and combinations thereof.

64. The apparatus of claim 60, further comprising a wave shape selection means for enabling an operator to select one of a plurality of wave shapes of reciprocating motion, operable in conjunction with said amplitude regulating means.

65. The apparatus of claim 60, wherein said attachment interface comprises at least a pair of contacts.

66. The apparatus of claim 60, further comprising a cardiac phase dependent delivery system operational in conjunction with said percussion device, such as to enable the choice of timing of percussive emissions in accordance to cardiac phase, at the discretion of an operator.

67. The apparatus of claim 60, further comprising at least one drug for remediation of an acute vascular obstruction operable in conjunction with said percussion device, such as to enable an adjunctive system of percussion and said at least one drug towards remediation of an acute vascular obstruction.

68. An apparatus for treatment of a patient, comprising a non invasive vibrator comprising:

a) a vibration source adapted to vibrate at a frequency in the range of 1-1000 Hz, and

b) at least one ultrasound imaging transducer operatively attached to an active end of said vibration source,

whereby said at least one ultrasound imaging transducer transmits vibration generated from said vibration source, such as to enable targeting of vibration via an image produced on an ultrasonic display, at the discretion of an operator.

69. The apparatus of claim 68, wherein said vibration source is operable to generate vibration at a frequency in the range of 1-120 Hz, and a displacement amplitude in the range of 1-15 mm.

70. The apparatus of claim 68, wherein said vibration source is operable to generate at least one of:

a sinusoidal wave, a substantially square or percussive wave, a saw-tooth wave, an exponential wave, a curved waved, a substantially linear wave, and combinations thereof.

71. The apparatus of claim 68, further comprising means for emitting an ultrasonic waveform within the range of 20-100 kHz in concert with said vibration in the range of 1-1000 Hz.

72. The apparatus of claim 68, further comprising at least one drug for remediation of an acute thrombotic obstruction operable in conjunction with said vibrator, such as to enable an adjunctive system of vibration and said at least one drug towards remediation of an acute thrombotic obstruction.

73. A kit for treating an acute thrombotic vascular obstruction, comprising the combination of:

a) a non invasive vibrator adapted to emit vibration at a frequency within the range of 20-120 Hz and a displacement amplitude within the range of 1-15 mm, and

b) at least one clot disruptive drug, operable in conjunction with said vibrator,

such as to enable an adjunctive system of vibration and said at least one clot disruptive drug towards remediation of an acute thrombotic vascular obstruction.

74. The kit of claim 73, wherein said vibrator is operable to emit vibration at a displacement amplitude greater than 2 mm.

75. The kit of claim 73, wherein said vibrator is operable to emit vibration substantially perpendicular to the long axis of the torso of a patient receiving said vibration.

76. The kit of claim 73, wherein said vibrator is adapted to emit at least one waveform of vibration selected from:

a sinusoidal waveform, a substantially square or percussive waveform, an exponential waveform, a saw-tooth waveform, a curved waveform, a substantially linear waveform, and combinations thereof.

77. The kit of claim 73, wherein said vibrator has at least a pair of contact nodes.

78. The kit of claim 73, wherein said vibrator has at least one contact comprising, at least in part, an ultrasonic imaging transducer.

79. The kit of claim 78, wherein said at least one contact comprising, at least in part, an ultrasonic imaging transducer, further comprises means for emitting an ultrasonic wave form within the 20 kHz-100 kHz range.

80. The kit of claim 73, further comprising a cardiac phase dependent delivery system operational in conjunction with said vibrator, such as to enable the choice of timing of vibration emissions in accordance to cardiac phase, at the discretion of an operator.

81. The kit of claim 73, wherein said at least one clot disruptive drug comprises at least one of:

a thrombolytic agent, a GP 2b 3a platelet inhibitor, an anticoagulant, an oral antiplatelet, and combinations thereof.