Wound treatment method and device with combination of ultrasound and laser energy

[0002] The present invention relates to the treatment of wounds using ultrasound and laser energy. In particular, the present invention relates to a method of spraying liquid drugs to the wound surface using ultrasonic waves for delivering drugs, killing bacteria, cleansing a surface, and stimulating healthy tissue cells and treating wound with laser energy.

[0003] Ultrasonic waves and laser beams have been widely used in medical applications, including diagnostics and therapy, as well as many industrial applications. 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 object) 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 comparing the signals of the ultrasonic wave as 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, and the like.

[0004] Three therapeutic medical uses of ultrasound waves include aerosol mist production, contact physiotherapy and soft tissue ablation. The ultrasound contact therapy 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 drug to the lungs.

[0005] Ultrasonic nebulizers operate by the passage of 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.

[0006] 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.

[0007] Ultrasonic sprayers, produced by Sonic and Materials Inc., Misonix Inc., Sono-Tek Inc., Zevex International, Inc., and others, operate by passing liquid trough central orifice of an ultrasound instrument-tip. See, for example, U.S. Pat. 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.

[0008] Ultrasonic inhalers and drug delivery systems from Medisonic USA, Inc., 3M, Siemens GmbH, The Procter & Gamble Company, Sheffield Pharmaceuticals, Aradigm, Inc., and others, operate by atomizing liquid using piezoceramic film. See, for example, U.S. Pat. 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.

[0009] Medical usage of lasers can be divided in several groups: laser blood flow meters (Doppler), tissue ablation, therapy, revasculation and treatment devices, surgery devices, diagnostic devices, and others. Medical laser devices from HGM Medical Lasers Inc., Level Laser Medical Systems, Coherent, Inc., ESC Medical Systems, PLC Medical Systems, Inc., Palomar Medical, Altus Medical, Tissue Medical Lasers, Inc., and others, are appropriate for the therapy, dermatology, surgery, gynecology, urology, dentistry, veterinary, and other applications, operate by atomizing liquid using piezoceramic film. See, for example, U.S. Pat. Nos. 5,374,266, 5,527,350, 5,616,140, 5,707,403, 5,658,323, 6,027,495, and 5,989,245.

[0010] It is an object of the invention to provide an improved method and device for treating wounds.

[0011] It is also an object of this invention to provide an improved method and device for treating wounds using combination of different energy sources as ultrasound and laser.

[0012] It is a further object of the invention to provide a method and device for delivering drug, killing bacteria, cleansing a surface and stimulating healthy tissue cell growth.

[0013] It is a yet further object of the invention to treat a wound by spraying the surface of the wound with aerosol mist produced by ultrasonic waves and radiating by laser bearm.

[0014] These and other objects of the invention will become more apparent from the discussion below.

[0015] The present invention is a method and device using a combination of ultrasonic waves and laser beams to treat wounds. More particularly, the device of invention creates, directs and delivers ultrasound liquid aerosol spray and a laser beam to the wound surface for delivering drugs, killing bacteria, cleansing the surface, stimulating healthy tissue cells and treating the wound with ultrasound and laser energy. The method of the invention for treating wounds involves the use of a combination of a continuous or pulsed ultrasound waves and a beam of pulsed, scanned or gated continuous wave laser or incoherent radiation.

[0016] More particularly the method of the invention comprises producing a directed spray of liquid particles produced by contact of the liquid with a free end surface of an ultrasonic transducer, and the particle spray beam in combination with a laser beam are directed onto the wound. According to the method of the present invention a combination of ultrasonic waves, laser beams and energized medicines (highly activated by ultrasonic waves and laser beams) destroys the surface bacteria and results in a higher level of disinfection by the energized liquids as compared to ordinarily applied liquids. Additionally, the ultrasound and laser energy also stimulates healthy cell growth to aid in granulization and epithelization of healing tissue. Other applications of the method of the invention include non-medical uses such as cleansing, sterilizing and coating surfaces of objects and food with various agents.

[0017] The method of the present invention offers an approach that may re-establish use of some traditional antibiotics and presents a method for fighting bacteria without antibiotics when necessary. The effect of the method of the present invention in highly activating antibiotics may allow some traditional antibiotics to overcome bacteria which have become resistant to that antibiotic. Moreover, independent of the energizing effect on antibiotics, the ultrasonic waves and laser beams which are applied in the method of the present invention also directly physically destroy bacteria. This combined effect has been shown to significantly increase the healing of purulent infected wounds.

[0018] This method of wound treatment is particularly advantageous on wounds for which local topical application of a drug is desirable but contact with the wound must be avoided.

[0019] The method of the present invention also provides a system of non-contact drug delivery with combination of laser and ultrasound energy. Finally the wound treatment method is effective when applied to the surface whether the liquid sprayed is a drug, such as an antibiotic, antiseptic, or equivalent agent, oil, saline, water or a combination of any of the foregoing.

[0020] The overall concept of the present invention relates to a method and apparatus for wound treatment using a combination of different energy sources, such as a laser, ultrasound, electric current, magnetic field, ultraviolet, microwaves, radio frequency, and or equivalent sources, as will be apparent to one skilled in this art.

[0021] While the invention has been described in general terms, the construction and obvious advantages of the device and method of the present invention will be more clearly understood from the following description of the various specific embodiments when read in conjunction with the accompanying drawings.

[0022] FIG. 1 is a schematic representation of a combined ultrasound and laser wound treatment system for use according to the present invention;

[0023] FIG. 2ais a schematic representation of a basic concept of the ultrasonic/laser device of the present invention, showing the ultrasonic spray and laser beams as mutually parallel;

[0024] FIG. 2bis a schematic representation of a basic concept of the ultrasonic/laser device of the present invention showing the ultrasonic spray and laser beams as non-parallel;

[0025] FIG. 2cis a schematic representation of a basic concept of the ultrasonic/laser device of the present invention showing the ultrasonic spray and laser beams as coaxial; and

[0026] FIGS. 3a-3dare schematic representations of possible variations in the interaction of the laser beam and ultrasonic spray beam of the device depicted in FIG. 1.

[0027] A device for wound treatment according to the present invention is illustrated in FIG. 1, which is a schematic representation of a side elevation of a preferred embodiment of the invention for wound treatment using ultrasound and laser energy. A body 12 has a front panel 13 having various regulatory controls, including on/off, display, intensity and others. Body 12 is connected to a handpiece 5 by an ultrasound cable 9 and a laser cable 10.

[0028] Handpiece 5 comprises a laser probe 15, an ultrasound transducer 14, and a liquid reservoir 2. Wound treatment solution 1 from a reservoir 2 is dispensed and delivered by valve 3 to contact the distal end of ultrasound transducer 14 and spray 6 onto the wound surface 8. At the same time, before or after laser source 15 has to be turned on and radiates the same wound surface 8. More detailed discussion of the operation of the ultrasound transducers can be found in commonly assigned, co-pending U.S. patent application Ser. No. 09/684,044, filed Oct. 6, 2000, and U.S. patent application Ser. No. 09/704,099, filed Nov. 1, 2000, both of which are incorporated herein by reference.

[0029] FIGS. 2a-2cillustrate the basic concept of ultrasound—laser treatment of a wound according to present invention. FIG. 2ais a schematic representation of the wound treatment method according to the present invention, where ultrasound spray and laser beam are directed to the wound in parallel. FIG. 2bis a schematic representation of the wound treatment method of the invention showing a coaxial-targeted ultrasound spray and laser beam. FIG. 2cis a schematic representation of the wound treatment according to the invention showing a targeted ultrasound spray and laser beam angle θ to each other.

[0030] FIGS. 3a-3ddepict schematic representations of possible locations of laser probe 15 and ultrasound transducer 14 relative to main body 5. The preferred location of the laser probe and the ultrasound transducer is shown in FIG. 3a, since it has been determined that this arrangement is most convenient, easy to handle and use. The alternative locations depicted in FIGS. 3b-3dmay provide more convenient arrangements in certain applications, as will be apparent to one skilled in this art.

[0031] Laser radiation and spray sonication can be activated simultaneously or separately. The preferred treatment method is a simultaneous radiation and sonication procedure, since simultaneous treatment results in a doubling of laser and ultrasonic enhancement effect.

[0032] Main body 5 may or may not have disposable parts on the distal end to facilitate ease of use and sterilization.

[0033] It is provided that the ultrasound transducer 14 operates at a frequency from 18 kHz to 10,000 MHz. It is also provided that the liquid reservoir 2 is filled with one or more of the following components: antibiotics, antiseptics, saline, oil, and water. It is further provided that the free or distal end of the ultrasonic transducer 14 can be driven with a constant, modulated or pulsed frequency and that it is positioned at least 0.1 inch from the surface of the wound. It is also provided that the free or distal end can be driven with a sinusoidal, rectangular, trapezoidal or triangular wave form. Finally, it is provided that the laser beam can be coherent, pulsed, modulated, diverged (dispersed), converged (focused), and Q-switched.

[0034] The free or distal end of the ultrasonic transducer 14 can be modified by providing a thread, slot (groove), etc. The ultrasonic transducer 14 and the laser probe 15 can be housed together within one handpiece or separately within at least two handpieces.

[0035] While the preceding specific embodiments are illustrative of the practice of the invention, it will be understood by one skilled in this art 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.