Abstract:
Device and methods for the treatment of wounds using ultrasound energy are disclosed. The portable wound treatment device may deliver ultrasound energy to a wound through direct contact with the ultrasound tip and/or through a liquid coupling medium. Several ultrasound tips specially designed to concentrate and focus ultrasound energy onto a wound are also disclosed. The ultrasound tip may also possess an abrasive peripheral boundary to aid in debriding the wound and/or removing necrotic tissue. The disclosed invention may have multiple beneficial effects in treating a wound such as sterilizing a wound, reducing external bleeding, and/or providing pain relief.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. patent application Ser. No. 11/625,074 filed Jan. 19, 2007, which is a continuation-in-part of U.S. patent application Ser. No. 11/467,382 filed Aug. 25, 2006 both of which are now abandoned. Both applications are incorporated in there entirety herein. 
     
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to a portable ultrasound wound treatment device for use in hospitals, doctors offices, ambulances, and/or for use by soldiers on a battlefield. 
         [0004]    2. Description of the Related Art 
         [0005]    There are a variety of known devices and methods for the treatment of wounds. These methods include wound dressings, hyperbaric oxygen treatment, growth factor therapy, antibiotics, surgery, physical therapy, vacuum therapy, electrical stimulation, bioengineered tissue, and ultraviolet light therapy. There are also a variety of known devices and methods for the treatment of wounds using ultrasound energy. 
         [0006]    U.S. patents that disclose devices and methods for wound treatment using an ultrasound spray include: U.S. Pat. No. 6,478,754 to Babaev; U.S. Pat. No. 6,761,729 to Babaev; U.S. Pat. No. 6,533,803 to Babaev; U.S. Pat. No. 6,569,099 to Babaev; U.S. Pat. No. 6,663,554 to Babaev; and finally U.S. Pat. No. 6,960,173 to Babaev. These devices and methods can only achieve limited results because they fail to sufficiently deliver ultrasound energy due to a lack of direct contact with the target area. U.S. Pat. No. 7,025,735 to Soring and U.S. Pat. No. 6,916,296 also to Soring disclose a method and device for the treatment of septic wounds that uses both a liquid aerosol and direct contact. The Soring method and device, however, are not intended for use on fresh or acute wounds. U.S. Patent Application 2004/0030254 to Babaev discloses a device and method for ultrasound wound debridement through mechanical vibration in the ultrasound tip. 
       SUMMARY OF THE INVENTION 
       [0007]    A portable device and methods for the treatment of wounds are disclosed. An embodiment of the portable device may comprise an ultrasound tip, an ultrasound transducer, a generator, a power supply, and a fluid supply. The ultrasound transducer, generator, and power source may be located within a housing member, and the ultrasound tip may protrude out of the outer casing/housing member. The ultrasound device may be powered by a battery or batteries and/or powered by an external power supply. 
         [0008]    The ultrasound tip generally contains two portions: a concentrator portion and a radiation portion. The maximum diameter of the radiation portion may be approximately two or more times greater than the minimum diameter of the concentrator portion leading up to the radiation portion. A diameter ratio of this magnitude between the concentrator and the radiation portion is sufficient to ionize water and create free radicals. The point at which the concentrator portion connects to the radiation portion may lie on or near a nodal point of an ultrasound wave passing through the ultrasound tip. The distal end of the radiation portion may lie on or near an anti-nodal point of an ultrasound wave passing through the ultrasound tip. The shape of the distal end of the radiation portion may be concave, conical, a special concave-convex design, or a similar shape that allows for the ultrasound tip to focus ultrasound energy. A flat distal end radiation portion may also be utilized with the portable wound care device. The peripheral boundary of the radiation portion may include abrasive members to allow for the precise debridement of a wound and scrapping away of necrotic tissue. Examples of abrasive members include, but are not limited to, jagged teeth-like protrusions, a sharp edge, and a sandpaper-like material all of which are capable of scraping away at a surface. 
         [0009]    Ultrasound energy may be delivered to a wound through a fluid coupling medium. The fluid coupling medium may be delivered through means external to the device. An example of external delivery would be application of a fluid coupling medium to the radiation portion, which would then be delivered to the wound. The fluid coupling medium may also be delivered through means internal to the device. Internal delivery may be achieved via a lumen located within the ultrasound tip originating in a fluid entry port and terminating in an orifice located on the distal end of the radiation portion of the ultrasound tip. The fluid entry point may lie on or near a nodal point of an ultrasound wave passing through the ultrasound tip. A fluid supply may be separate from and/or connected to the device. Fluids such as, but not limited to, tap water, distilled water, saline, antibiotics, and/or anti-inflammatories may be utilized with the device. 
         [0010]    The disclosed device may focus ultrasound energy, mechanical energy, and a fluid coupling medium onto a wound. If fluids are introduced into the device at high pressures they may result in a jet stream spray pattern. If fluids are introduced at low pressures they may result in an atomized spray. Cavitations may be created in the coupling medium as it is delivered from the orifice onto the radiation portion and/or cavitations may be created in the coupling medium as it accumulates on the surface of the wound. Ultrasound energy may also be delivered to the wound through contact with the radiation portion. 
         [0011]    Methods of wound treatment utilizing the disclosed device will vary according to the type and/or condition of the wound to be treated. It may be preferable to first deliver ultrasound energy at a distance from the wound via the fluid coupling medium. The ultrasonically activated fluid may irrigate the wound and provide for less painful treatment. After irrigation, it may be desirable to contact the wound with the ultrasound tip. The wound may be contacted with the distal end radiation portion of the ultrasound tip, but it is preferred to contact the wound with the peripheral boundary of the radiation portion, particularly when the peripheral boundary possesses abrasive members. The ultrasound tip may be moved across the surface of the wound in order to debride the wound and/or remove necrotic tissue. The method disclosed utilizes ultrasound energy from both the fluid coupling medium and the ultrasound tip, as well as mechanical energy to treat wounds. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1   a  is a cross-sectional view of an embodiment of the portable ultrasound device for the treatment of wounds. 
           [0013]      FIG. 1   b  is a depiction of the propagation of ultrasound waves through the tip of the embodiment of the portable ultrasound device depicted in  FIG. 1   a.    
           [0014]      FIG. 1   c  is a perspective view of the embodiment of the portable ultrasound device depicted in  FIG. 1   a.    
           [0015]      FIG. 2   a  is a cross-sectional view of an embodiment of an ultrasound tip with a flat distal end radiation portion and a central orifice that may be used with the portable ultrasound device depicted in  FIG. 1 . 
           [0016]      FIG. 2   b  is a cross-sectional view of an embodiment of an ultrasound tip with a concave distal end radiation portion and a central orifice that may be used with the portable ultrasound device depicted in  FIG. 1 . 
           [0017]      FIG. 2   c  is a cross-sectional view of an embodiment of an ultrasound tip with a special concave-convex distal end radiation portion and a central orifice that may be used with the portable ultrasound device depicted in  FIG. 1 . 
           [0018]      FIG. 2   d  is a cross-sectional view of an embodiment of an ultrasound tip with a conical distal end radiation portion and a central orifice that may be used with the portable ultrasound device depicted in  FIG. 1 . 
           [0019]      FIG. 2   e  is a cross-sectional view of an embodiment of an ultrasound tip with a concave and a chamfer distal end radiation portion with no orifice that may be used with the portable ultrasound device depicted in  FIG. 1 . 
           [0020]      FIG. 3   a  is a cross-sectional view of an embodiment of the peripheral boundary of the ultrasound tip with jagged teeth-like protrusions that may be used with the portable ultrasound device depicted in  FIG. 1 . 
           [0021]      FIG. 3   b  is a cross-sectional view of an embodiment of the peripheral boundary of the ultrasound tip with a sharp cutting edge that may be used with the portable ultrasound device depicted in  FIG. 1 . 
           [0022]      FIG. 3   c  is a cross-sectional view of an embodiment of the peripheral boundary of the ultrasound tip with a sandpaper-like surface that may be used with the portable ultrasound device depicted in  FIG. 1 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0023]    Disclosed is a method and device for the treatment of wounds. Preferred embodiments of the disclosed device and methods are illustrated in the figures and described in detail below. 
         [0024]      FIG. 1   a  is a cross-sectional view of an embodiment of the portable ultrasound wound treatment device. The embodiment comprises a power supply  101  connected to a generator  102  by electrical wires  103 , a generator  102  connected to an ultrasound transducer  104  by electrical wires  105 , and an ultrasound tip  106 . The power supply  101  may be a battery or batteries, and said battery or batteries may be rechargeable. In the embodiment depicted, the power supply  101  is located within the device; in other embodiments the device may be connected to an external power source. The power supply  101  supplies electrical current to the generator  102  which supplies a signal of alternating voltage to drive the transducer  104 . The transducer  104  converts the alternating voltage signal into mechanical motion within the ultrasound tip  106  which ultimately delivers ultrasound energy to the wound. The power supply  101 , generator  102 , transducer  104 , and/or electrical wires  103  and  105  may be enclosed within an outer casing  113 . 
         [0025]    The ultrasound tip  106  comprises a concentrator portion  107  and a radiation portion  108 . The proximal end of the concentrator portion  107  is in contact with transducer  104 . The distal end of the concentrator portion  107  is in contact with the proximal end of the radiation portion  108 . The maximum diameter D of the distal end of the radiation portion  108  should be greater than or equal to the minimum diameter d of the concentrator portion  107  leading up to the distal end of the radiation portion  108 , with the diameter D approximately two-times or greater than diameter d. Diameter D is also preferably at least thirteen millimeters. The embodiment depicted also comprises a fluid supply  109 . An exemplar fluid supply  109  is a syringe. The fluid supply  109  may be separate from the wound treatment device and/or it may be attached to the device. Fasteners  110  may be used to attach the fluid supply  109  to the wound treatment device. A fluid coupling medium may be delivered from the fluid supply  109  to a wound in several ways: fluid may be delivered directly from the fluid supply  109  to the distal end of radiation portion  108  of the ultrasound tip  106 , and/or fluid may be delivered from the fluid supply  109  to an entry port  111  on the radial surface of the ultrasound tip  106  proximate to the concentrator portion  107 . Fluid delivered to the fluid entry port  111  may travel through a lumen  112  located within the ultrasound tip  106  and ultimately be delivered to a wound through an orifice  113  in the distal end of the radiation portion  108  of the ultrasound tip  106 . Preferably, the orifice  113  is centrally located on the distal end of the radiation portion  108 . In the alternative or in combination, the fluid entry port  111  may be located on the proximal end of the device and/or the lumen  112  may originate in the proximal surface the ultrasound tip  106  and terminate in the orifice  113 . Fluids such as, but not limited to, tap water, distilled water, saline, antibiotics, and/or anti-inflammatories, may be utilized. 
         [0026]      FIG. 1   b  is a depiction of the propagation of the amplitude of the ultrasound waves passing through the ultrasound tip of the embodiment described above. The fluid entry port  111  and the point where the distal end of the concentrator portion  107  contacts the proximal end of the radiation portion  108  may lie on or near nodal points. The distal end of the radiation portion  108  may lie on or near an anti-nodal point. 
         [0027]      FIG. 1   c  is a perspective view of the embodiment depicted in  FIG. 1   a . As illustrated, the device may also comprise a power switch  114  located on outer casing  113 . 
         [0028]      FIGS. 2   a - FIG. 2   e  depict various embodiments of ultrasound tips that may be used with the embodiment depicted in  FIG. 1 .  FIG. 2   a  depicts an ultrasound tip  202  with a radiation portion  212  comprising a flat distal end  202 , a fluid supply port  111 , and an orifice  113 .  FIG. 2   b  depicts an ultrasound tip  203  with a radiation portion  213  comprising a concave distal end  204 , a fluid supply port  111 , and an orifice  113 .  FIG. 2   c  depicts an ultrasound tip  205  with a radiation portion  214  comprising a concave-convex designed distal end  206 , a fluid supply port  111 , and an orifice  113 .  FIG. 2   d  depicts an ultrasound tip  207  with a radiation portion  215  comprising a conical distal end  208 , a fluid supply port  111 , and an orifice  113 .  FIG. 2   e  depicts an ultrasound tip  209  with a radiation portion  216  comprising a concave distal end  210  with a chamfer for convenient external delivery of a fluid. In the depicted embodiment, fluid is delivered directly to the distal end  210  of the radiation portion  216  from exit port  211 . Preferably, the distance x between the exit port  211  and the distal end  210  of the radiation portion  216  of the ultrasound tip  209  should be less than the diameter of the liquid drop  217  delivered from the exit port  211 . 
         [0029]      FIGS. 3   a - 3   c  depict various embodiments of abrasive peripheral edges that may be used with the ultrasound tips depicted in  FIGS. 2   a - 2   e . The abrasive peripheral edges depicted may be used in the alternative or in combination.  FIG. 3   a  depicts an embodiment of an ultrasound tip comprising a peripheral boundary with teeth-like protrusions  301 .  FIG. 3   b  depicts an embodiment of an ultrasound tip comprising a sharp cutting edge  302 .  FIG. 3   c  depicts an embodiment of an ultrasound tip comprising a sandpaper-like surface  303 . The abrasive peripheral edges depicted allow for precise debridement of a wound and the scrapping away of unwanted surface tissue. 
         [0030]    In a method of wound treatment, ultrasound energy is first delivered at a distance from the wound through a fluid coupling medium. The ultrasonically activated fluid coupling medium may irrigate the wound and allow for less painful treatment of the wound. After irrigation, the ultrasound tip may come into contact with the wound. The wound may be contacted with the distal end of the radiation portion of the ultrasound tip, but it is preferred to contact the wound with the abrasive peripheral boundary. The ultrasound device may be moved longitudinally to remove necrotic tissue with the abrasive peripheral boundary, while continually debriding and ultrasonically treating the wound. The device may be moved in a single direction or it can be moved back-and-forth. The manner in which ultrasound energy is delivered may depend on the type and/or condition of the wound being treated. 
         [0031]    The intensity of the ultrasound energy may be controlled through variations in the ultrasound parameters, such as frequency, amplitude, and treatment time. The intensity of the ultrasound energy should be at least 0.1 watt/cm 2 . The preferred intensity range is approximately 1 watt/cm 2 -10 watt/cm 2  and the more preferred intensity range is approximately 1 watt/cm 2 -2 watt/cm 2 . The recommended intensity of the ultrasound energy is approximately 2 watt/cm 2 . The transducer may operate in a frequency range of 20 kHz to 40 MHz. The preferred frequency range in which the transducer operates is 30 kHz-50 kHz, and the recommend frequency value in which the transducer operates is 30 kHz. The transducer may displace at an amplitude of at least 1 micron. The preferred amplitude range is approximately 5 microns-150 microns with a more preferred amplitude range of approximately 60 microns-80 microns. The recommended amplitude value is approximately 80 microns. The generator may be capable of generating a continuous, pulsed, fixed, and/or modulated frequency depending on the wound to be treated. The generator may also be capable of generating different types of wave forms such as, but not limited to, sinusoidal, rectangular, trapezoidal and triangular. 
         [0032]    It should be appreciated that elements described with singular articles such as “a”, “an”, and/or “the” and/or otherwise described singularly may be used in plurality. It should also be appreciated that elements described in plurality may be used singularly. 
         [0033]    Although specific embodiments of apparatuses and methods have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement, combination, and/or sequence of that is calculated to achieve the same purpose may be substituted for the specific embodiments shown. It is to be understood that the above description is intended to be illustrative and not restrictive. Combinations of the above embodiments and other embodiments as well as combinations and sequences of the above methods and other methods of use will be apparent to individuals possessing skill in the art upon review of the present disclosure. 
         [0034]    The scope of the claimed apparatus and methods should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.