WO2002060525A2 - Ultrasound wound treatment method and device - Google Patents

Ultrasound wound treatment method and device Download PDF

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Publication number
WO2002060525A2
WO2002060525A2 PCT/US2002/002724 US0202724W WO02060525A2 WO 2002060525 A2 WO2002060525 A2 WO 2002060525A2 US 0202724 W US0202724 W US 0202724W WO 02060525 A2 WO02060525 A2 WO 02060525A2
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WO
WIPO (PCT)
Prior art keywords
ultrasound
wound
waves
wave
transducer
Prior art date
Application number
PCT/US2002/002724
Other languages
French (fr)
Other versions
WO2002060525A3 (en
Inventor
Eilaz Babaev
Original Assignee
Advanced Medical Applications, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Medical Applications, Inc. filed Critical Advanced Medical Applications, Inc.
Priority to JP2002560715A priority Critical patent/JP4164582B2/en
Priority to AU2002243732A priority patent/AU2002243732A1/en
Priority to EP02709235A priority patent/EP1355696B1/en
Priority to CA002436812A priority patent/CA2436812A1/en
Priority to AT02709235T priority patent/ATE431175T1/en
Priority to DE60232304T priority patent/DE60232304D1/en
Publication of WO2002060525A2 publication Critical patent/WO2002060525A2/en
Publication of WO2002060525A3 publication Critical patent/WO2002060525A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy

Definitions

  • the present invention relates to the treatment of wounds using ultrasound standing waves.
  • the present invention relates to a method and device of creating ultrasonic standing waves in air and directing them to a wound for delivering aerodynamic forces as ultrasonic radiation pressure and ultrasonic waves as well.
  • Ultrasound radiation pressure increases the blood flow in the wound area, and ultrasound waves kill bacteria, stimulate healthy tissue cells, and treat the wound. ,
  • Ultrasonic waves have been widely used in medical applications, including diagnostics and therapy as well as many industrial applications, e.g., welding, cutting, fiber optics technology, speed meters, etc.
  • Diagnostic use of ultrasound waves includes using ultrasonic waves to detect underlying structures in an object or human tissue.
  • an ultrasonic transducer is placed in contact with the tissue or obj ect via a coupling medium, and high frequency (1-10 MHz) ultrasonic waves are directed into the tissue.
  • the waves Upon contact with the various underlying structures, the waves are reflected back to a receiver adjacent the transducer.
  • an image of the underlying structure can be produced. This technique is particularly useful for identifying boundaries between components of tissue and can be used to detect irregular masses, tumors, etc.
  • ultrasound waves Three therapeutic medical uses include aerosol mist production, contact physiotherapy, and soft tissue ablation.
  • the ultrasound contact physiotherapy procedure may cause a patient significant discomfort and/or pain, and skin may appear raw and damaged.
  • Aerosol mist production makes use of a nebulizer or inhaler to produce an aerosol mist for creating a humid environment and delivering drugs to the lungs.
  • Ultrasonic nebulizers operate by passing ultrasound waves of sufficient intensity through a liquid, the waves being directed at an air-liquid interface of the liquid from a point underneath or within the liquid. Liquid particles are ejected from the surface of the liquid into the surrounding air following the disintegration of capillary waves produced by the ultrasound. This technique can produce a very fine dense fog or mist.
  • Aerosol mists produced by ultrasound are preferred because a smaller particle size of the aerosol can be obtained with the ultrasonic waves.
  • One of the major shortcomings of ultrasonic inhalers and nebulizers is that there is no directed aerosol to the target. An air stream is then required to direct the aerosol to the target, but this decreases the efficiency of ultrasound.
  • Ultrasonic sprayers (Sonic and Materials Inc., Misonix Inc., Sono-Tek Inc., Zevex International, Inc., operate by passing liquid trough central orifice of ultrasound instrument-tip. See, for example, U.S. Patents Nos. 3,765,606; 4,659,014; 5,104,042; 4,9307,00; 4,153,201; 4,655,393; 5,516,043; 5,835,678; 5,879,364; and 5,843,139.
  • Ultrasonic inhalers and drug delivery systems from Medisonic USA, Inc., 3M, Siemens Gmb, The Procter & Gamble Company, Sheffield Pharmaceuticals, Aradigm, Inc. operate by atomizing liquid using piezoceramic film. See, for example, U.S. Patents Nos. 4,294,407; 5,347,998; 5,520,166; 5,960,792; 6,095,141; 6,102,298; 6,098,620; 6,026,808; and 6,106,547.
  • the present invention is a method and device for using ultrasonic standing waves to treat wounds.
  • Ultrasound standing waves occur as a result of incident and reflected waves from a reflective surface that are traveling in opposite directions.
  • the resultant superposition of the two waves forms standing waves, which create ultrasonic radiation pressure.
  • the standing waves actually ultrasound radiation pressure, occur when the distance between (a) the distal end of a transducer (as a radiant of ultrasound waves) and (b) the reflected surface (e.g., a wound surface) is: n X ⁇ /2, where ⁇ is the wave length and n is a positive integer.
  • the standing waves are more effective in limited space or area as a tube.
  • ultrasound waves are created, directed, and delivered to a wound surface through the air to increase blood flow, kill bacteria, stimulate healthy tissue cells and treat wounds with ultrasound energy.
  • the method of treating wounds involves the use of ultrasound standing waves of a continuous or pulsed ultrasound.
  • the method of the invention comprises producing ultrasound standing waves using a free end surface of an ultrasonic transducer and wound surface.
  • the radiation pressure of ultrasonic standing waves increase blood flow in wound area and destroy the surface bacteria to result in a higher disinfecting property of ultrasound.
  • the ultrasound also stimulates healthy cell growth to aid in granulization and epithelization of the healing tissue.
  • Other applications of the method can be directed to non-medical uses such as cleansing, drying, sterilizing and coating surfaces of objects and food.
  • the method of the present invention offers an approach that may re-establish use of some traditional ultrasound and establish a method of treating wound and fighting bacteria without antibiotics when necessary.
  • the overall concept of the present invention relates in method and apparatus for wound treatment using ultrasonic standing waves through air with no drug.
  • This wound treatment method is possible with combination of different energy sources as an ultrasound, laser, electric current, magnetic field, ultraviolet, microwaves, radio frequency, etc.
  • Fig. 1 is a perspective view of an ultrasound wound treatment system with standing waves, according to the present invention
  • Fig. 2 is a schematic, lateral cross-sectional view of another transducer useful with the system of Fig. 1.
  • Fig. 3 is a schematic, lateral cross-sectional view of a transducer having a bushing
  • Fig. 4 is a schematic, lateral cross-sectional view of a transducer of Fig. 3 where the distal tip has been modified to provide a focussed beam;
  • Fig. 5 is a schematic, lateral cross-sectional view of an embodiment of the invention intended to facilitate dissolution of blood clots.
  • the present invention is a method and system, which uses ultrasound standing wave energy to treat wounds.
  • the system comprises a generator of electrical signals and a handpiece having an ultrasound transducer and tip.
  • FIG. 1 A system for wound treatment according to present invention is illustrated in Fig. 1.
  • the system 2 comprises a signal generator 4 operatively or electrically connected through cable 6 to a transducer 8 in a housing 10.
  • Transducer 8 has an ultrasound tip 12 that generates standing ultrasound waves 14.
  • Standing ultrasound waves 14 are directed to the surface 16 of a wound 18.
  • Standing ultrasound waves 14 occur when activated ultrasound tip 12 is directed through the air to a wound surface 16 as a result of incident and reflected waves from wound surface 16, which creates ultrasonic radiation pressure.
  • the distal end 20 of transducer tip 12 (as a radiant of ultrasound waves) is preferably a distance d from wound surface 16 (a source of reflected waves). Distance d is related to the wavelength ⁇ of the ultrasound wave or signal by the formula
  • n is a positive integer.
  • ultrasound transducer 8 or tip 12 must frequently be moved back and forward toward wound surface 16 by an operator.
  • the waveform of the ultrasound waves generated by transducer 8 preferably corresponds to the waveform of the electrical signals generated by signal generator 4.
  • electrical signals from signal generator 4 with rectangular, sinusoidal, trapezoidal, or triangular waveforms will cause transducer 8 to produce respective similarly shaped ultrasound waveforms.
  • the standing waves are more effective in limited space or area such as a tube.
  • a bushing 26 increases ultrasound radiation pressure.
  • Bushing 26 may or may not be disposable part on the distal end 28 of housing 10.
  • the distal end 28 of ultrasonic tip 12 has been modified to a concave shape to focus ultrasound waves 14.
  • ultrasound tip 12 is directed to a blood vessel 30 with clot or clots 32.
  • ultrasound standing waves 34 create cavitation inside blood vessel 30 and dissolve clot or clots 32.
  • a wound can also be treated with a gel or drug. After the gel or drug is applied to the wound surface, ultrasound standing waves would be directed to the wound. The drug would be activated and penetrate into tissue under ultrasound radiation pressure.
  • Additional possible application of method using ultrasound standing waves is for the diffusion of grafts to a wound with radiation pressure gently.

Abstract

The method and device of the present invention for wound treatment with ultrasound standing waves includes a transducer probe (8) to produce ultrasonic waves. The ultrasonic transducer has a tip with a distal radiation surface that radiates ultrasound energy toward the surface of a wound. Ultrasound standing waves (14) occurring as a result of incident and reflected waves from the wound surface create ultrasonic radiation pressure. ultrasound radiation pressure increases the blood flow in wound area, and ultrasound waves kill bacteria, stimulate healthy tissue cell and treat wounds.

Description

ULTRASOUND WOUND TREATMENT METHOD AND DEVICE
USING STANDING WAVES
FIELD OF INVENTION
The present invention relates to the treatment of wounds using ultrasound standing waves. In particular, the present invention relates to a method and device of creating ultrasonic standing waves in air and directing them to a wound for delivering aerodynamic forces as ultrasonic radiation pressure and ultrasonic waves as well. Ultrasound radiation pressure increases the blood flow in the wound area, and ultrasound waves kill bacteria, stimulate healthy tissue cells, and treat the wound. ,
BACKGROUND OF THE INVENTION
Ultrasonic waves have been widely used in medical applications, including diagnostics and therapy as well as many industrial applications, e.g., welding, cutting, fiber optics technology, speed meters, etc. Diagnostic use of ultrasound waves includes using ultrasonic waves to detect underlying structures in an object or human tissue. In this method, an ultrasonic transducer is placed in contact with the tissue or obj ect via a coupling medium, and high frequency (1-10 MHz) ultrasonic waves are directed into the tissue. Upon contact with the various underlying structures, the waves are reflected back to a receiver adjacent the transducer. By comparison of the signals of the ultrasonic waves sent with the reflected ultrasonic wave as received, an image of the underlying structure can be produced. This technique is particularly useful for identifying boundaries between components of tissue and can be used to detect irregular masses, tumors, etc.
Three therapeutic medical uses of ultrasound waves include aerosol mist production, contact physiotherapy, and soft tissue ablation. The ultrasound contact physiotherapy procedure may cause a patient significant discomfort and/or pain, and skin may appear raw and damaged. Aerosol mist production makes use of a nebulizer or inhaler to produce an aerosol mist for creating a humid environment and delivering drugs to the lungs.
Ultrasonic nebulizers operate by passing ultrasound waves of sufficient intensity through a liquid, the waves being directed at an air-liquid interface of the liquid from a point underneath or within the liquid. Liquid particles are ejected from the surface of the liquid into the surrounding air following the disintegration of capillary waves produced by the ultrasound. This technique can produce a very fine dense fog or mist.
Aerosol mists produced by ultrasound are preferred because a smaller particle size of the aerosol can be obtained with the ultrasonic waves. One of the major shortcomings of ultrasonic inhalers and nebulizers is that there is no directed aerosol to the target. An air stream is then required to direct the aerosol to the target, but this decreases the efficiency of ultrasound.
Ultrasonic sprayers (Sonic and Materials Inc., Misonix Inc., Sono-Tek Inc., Zevex International, Inc., operate by passing liquid trough central orifice of ultrasound instrument-tip. See, for example, U.S. Patents Nos. 3,765,606; 4,659,014; 5,104,042; 4,9307,00; 4,153,201; 4,655,393; 5,516,043; 5,835,678; 5,879,364; and 5,843,139.
Ultrasonic inhalers and drug delivery systems from Medisonic USA, Inc., 3M, Siemens Gmb, The Procter & Gamble Company, Sheffield Pharmaceuticals, Aradigm, Inc., operate by atomizing liquid using piezoceramic film. See, for example, U.S. Patents Nos. 4,294,407; 5,347,998; 5,520,166; 5,960,792; 6,095,141; 6,102,298; 6,098,620; 6,026,808; and 6,106,547.
OBJECT OF THE INVENTION
It is an object of the invention to provide an improved method and device for treating wounds.
It is also an object of this invention to provide an improved method and device for treating wounds using ultrasound standing waves.
It is a further object of the invention to provide a method and device for increasing blood flow, killing bacteria, and stimulating healthy tissue cell growth.
These and other objects of the invention will become more apparent from the discussion below.
SUMMARY OF INVENTION
The present invention is a method and device for using ultrasonic standing waves to treat wounds. Ultrasound standing waves occur as a result of incident and reflected waves from a reflective surface that are traveling in opposite directions. The resultant superposition of the two waves forms standing waves, which create ultrasonic radiation pressure. The standing waves, actually ultrasound radiation pressure, occur when the distance between (a) the distal end of a transducer (as a radiant of ultrasound waves) and (b) the reflected surface (e.g., a wound surface) is: n X λ/2, where λ is the wave length and n is a positive integer. The standing waves are more effective in limited space or area as a tube.
According to the invention ultrasound waves are created, directed, and delivered to a wound surface through the air to increase blood flow, kill bacteria, stimulate healthy tissue cells and treat wounds with ultrasound energy. The method of treating wounds involves the use of ultrasound standing waves of a continuous or pulsed ultrasound.
More particularly, the method of the invention comprises producing ultrasound standing waves using a free end surface of an ultrasonic transducer and wound surface. According to the method of the present invention, the radiation pressure of ultrasonic standing waves increase blood flow in wound area and destroy the surface bacteria to result in a higher disinfecting property of ultrasound. Additionally, the ultrasound also stimulates healthy cell growth to aid in granulization and epithelization of the healing tissue. Other applications of the method can be directed to non-medical uses such as cleansing, drying, sterilizing and coating surfaces of objects and food.
The method of the present invention offers an approach that may re-establish use of some traditional ultrasound and establish a method of treating wound and fighting bacteria without antibiotics when necessary.
The overall concept of the present invention relates in method and apparatus for wound treatment using ultrasonic standing waves through air with no drug. This wound treatment method is possible with combination of different energy sources as an ultrasound, laser, electric current, magnetic field, ultraviolet, microwaves, radio frequency, etc.
BRIEF DESCRIPTION OF DRAWINGS:
Fig. 1 is a perspective view of an ultrasound wound treatment system with standing waves, according to the present invention;
Fig. 2 is a schematic, lateral cross-sectional view of another transducer useful with the system of Fig. 1.
Fig. 3 is a schematic, lateral cross-sectional view of a transducer having a bushing;
Fig. 4 is a schematic, lateral cross-sectional view of a transducer of Fig. 3 where the distal tip has been modified to provide a focussed beam; and
Fig. 5 is a schematic, lateral cross-sectional view of an embodiment of the invention intended to facilitate dissolution of blood clots. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is a method and system, which uses ultrasound standing wave energy to treat wounds. The system comprises a generator of electrical signals and a handpiece having an ultrasound transducer and tip.
The invention can perhaps be better appreciated from the drawings. A system for wound treatment according to present invention is illustrated in Fig. 1. The system 2 comprises a signal generator 4 operatively or electrically connected through cable 6 to a transducer 8 in a housing 10. Transducer 8 has an ultrasound tip 12 that generates standing ultrasound waves 14. Standing ultrasound waves 14 are directed to the surface 16 of a wound 18.
Standing ultrasound waves 14 occur when activated ultrasound tip 12 is directed through the air to a wound surface 16 as a result of incident and reflected waves from wound surface 16, which creates ultrasonic radiation pressure. The distal end 20 of transducer tip 12 (as a radiant of ultrasound waves) is preferably a distance d from wound surface 16 (a source of reflected waves). Distance d is related to the wavelength λ of the ultrasound wave or signal by the formula
d = n X λ/2
where n is a positive integer. To reach this preferred distance and therefore effect wound treatment practice, ultrasound transducer 8 or tip 12 must frequently be moved back and forward toward wound surface 16 by an operator.
The waveform of the ultrasound waves generated by transducer 8 preferably corresponds to the waveform of the electrical signals generated by signal generator 4. For example, electrical signals from signal generator 4 with rectangular, sinusoidal, trapezoidal, or triangular waveforms will cause transducer 8 to produce respective similarly shaped ultrasound waveforms.
The standing waves are more effective in limited space or area such as a tube. In each of Figs. 3 to 5 a bushing 26 increases ultrasound radiation pressure. Bushing 26 may or may not be disposable part on the distal end 28 of housing 10. In the embodiment of the invention set forth in Fig. 4 the distal end 28 of ultrasonic tip 12 has been modified to a concave shape to focus ultrasound waves 14.
One of the possible applications of the method of present invention is the facilitation of dissolution of blood clots by using ultrasound energy. In Fig. 5 ultrasound tip 12 is directed to a blood vessel 30 with clot or clots 32. In this case ultrasound standing waves 34 create cavitation inside blood vessel 30 and dissolve clot or clots 32.
In another embodiment of the present invention a wound can also be treated with a gel or drug. After the gel or drug is applied to the wound surface, ultrasound standing waves would be directed to the wound. The drug would be activated and penetrate into tissue under ultrasound radiation pressure.
Additional possible application of method using ultrasound standing waves is for the diffusion of grafts to a wound with radiation pressure gently.
The preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, however, that other expedients known to those skilled in the art or disclosed herein may be employed without departing from the spirit of the invention or the scope of the appended claims.

Claims

I CLAIM:
1. A method of treating a wound, comprising the step of positioning an ultrasound transducer having a distal radiation surface to direct an ultrasound standing wave at a surface of a wound, wherein the distance d between distal radiation surface and the wound surface is determined by the formula d= n X λ/2
wherein λ is the wavelength of the ultrasound standing wave and n is a positive integer.
2. The method of Claim 1 , wherein the ultrasound transducer operates at a frequency of from about 10kHz to 103 MHz.
3. The method of Claim 1 , wherein d is at least 0.1 in.
4. The method of Claim 1 , wherein the ultrasound transducer is frequently moved back and forth in a longitudinal direction by an operator to reach a preferred distance to create a standing wave.
5. The method of Claim 1, wherein the ultrasound standing wave creates radiation and/or pressure that energizes the wound.
6. The method of Claim 1, wherein in a prior step a gel, drug, or other medicant is applied to the wound surface.
7. The method of Claim 6, wherein any medical effect of the gel, drug, or other medicant is energized by the ultrasound standing wave.
8. The method of Claim 1 , wherein the ultrasound standing wave has an ultrasound radiation, pressure, massage, and/or sterilization effect.
9. A system for treating a wound with ultrasound standing waves, comprising a generator for generating ultrasound waves, an ultrasound transducer operatively connected to said generator and having a distal radiation surface, and means for adjusting the distance between the distal radiation surface and a surface of a wound to create ultrasound standing waves.
10. The system of Claim 9, wherein the ultrasound transducer operates at a frequency of from about lOKHz to 103 MHz.
11. The system of claim 9, wherein the distal end of the ultrasound transducer comprises a bushing.
12. The system of Claim 9, wherein the ultrasound frequency is modulated.
13. The system of claim 9, wherein the ultrasound frequency is pulsed.
14. The system of Claim 9 wherein the waveform of the ultrasound wave is sinusoidal.
15. The system of Claim 9, wherein the wave form of the ultrasound wave is rectangular.
16. The system of Claim 9, wherein the wave form of the ultrasound wave is trapezoidal.
17. The system of Claim 9, wherein the waveform of the ultrasound wave is triangular.
18. The system of Claim 9, wherein the ultrasound beam is focussed.
PCT/US2002/002724 2001-01-30 2002-01-30 Ultrasound wound treatment method and device WO2002060525A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2002560715A JP4164582B2 (en) 2001-01-30 2002-01-30 Ultrasonic wound treatment device
AU2002243732A AU2002243732A1 (en) 2001-01-30 2002-01-30 Ultrasound wound treatment method and device
EP02709235A EP1355696B1 (en) 2001-01-30 2002-01-30 Ultrasound wound treatment device using standing waves
CA002436812A CA2436812A1 (en) 2001-01-30 2002-01-30 Ultrasound wound treatment method and device
AT02709235T ATE431175T1 (en) 2001-01-30 2002-01-30 DEVICE FOR ULTRASONIC WOUND TREATMENT USING STANDING WAVES
DE60232304T DE60232304D1 (en) 2001-01-30 2002-01-30 DEVICE FOR ULTRASONIC WOUND TREATMENT USING STANDING WAVES

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/774,145 2001-01-30
US09/774,145 US6960173B2 (en) 2001-01-30 2001-01-30 Ultrasound wound treatment method and device using standing waves

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WO2002060525A2 true WO2002060525A2 (en) 2002-08-08
WO2002060525A3 WO2002060525A3 (en) 2003-03-20

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Country Status (8)

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US (2) US6960173B2 (en)
EP (1) EP1355696B1 (en)
JP (1) JP4164582B2 (en)
AT (1) ATE431175T1 (en)
AU (1) AU2002243732A1 (en)
CA (1) CA2436812A1 (en)
DE (1) DE60232304D1 (en)
WO (1) WO2002060525A2 (en)

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JP4164582B2 (en) 2008-10-15
EP1355696A2 (en) 2003-10-29
WO2002060525A3 (en) 2003-03-20
ATE431175T1 (en) 2009-05-15
US20060058710A1 (en) 2006-03-16
US20020103448A1 (en) 2002-08-01
JP2004538039A (en) 2004-12-24
EP1355696B1 (en) 2009-05-13
CA2436812A1 (en) 2002-08-08
EP1355696A4 (en) 2006-05-31
US6960173B2 (en) 2005-11-01
DE60232304D1 (en) 2009-06-25
AU2002243732A1 (en) 2002-08-12

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