Abstract:
A method to enable a laser to interact with a structure behind a barrier includes calculating a set of characteristics for a first laser channel to be effective to tunnel through the barrier and calculating a second set of characteristics for a second laser channel to be effective to interact with the structure, generating said first laser pulse to form a tunnel through the barrier and prior to closing of the tunnel, generating the second laser pulse to travel through the tunnel to interact with the structure. A treatment unit associated with this method has a control panel in communication with an electronics package. Data entered into the control panel enables the electronics package to calculate the first and second sets of characteristics and drive a first laser generating a laser pulse of the first laser channel followed after a delay by a laser pulse of the second laser channel.

Description:
CROSS REFERENCE TO RELATED APPLICATION(S) 
       [0001]    This patent application claims a benefit to the filing date of U.S. Provisional Patent Application Ser. No. 61/785,321, titled “Destruction of Target Cells Utilizing Harmonic Resonance Cavitation,” that was filed on Mar. 14, 2013. The disclosure of U.S. 61/785,321 is incorporated by reference herein in its entirety. 
     
    
     U.S. GOVERNMENT RIGHTS 
       [0002]    N.A. 
       BACKGROUND 
       [0003]    1. Field 
         [0004]    Disclosed herein is an apparatus and method to destroy specific covalent bonds or organic molecules of target cells by direct energy transfer from quantized photons, such as multiple lasers, via harmonic resonance cavitation. More particularly, the apparatus and method are useful to destroy under nail fungus. 
         [0005]    2. Description of the Related Art 
         [0006]    To date, treatments utilizing medical lasers primarily rely on heat. During treatment, the precisely quantized photon energy produced by the laser is converted into incoherent thermal energy. This thermal energy, heat, is used to destroy a target. There are a number of shortcomings with current laser heat treatments, including (1) the same heat can harm and burn normal healthy human tissue; (2) attenuation depth of the heat transfer cannot be precisely controlled due to multi-layers of different types of tissue in the human body; and (3) thermodynamics dictates that when one form or energy (laser) is transformed to another form of energy (heat via a thermo decoupling process), a significant quantity of the original energy is lost during the transformation. 
         [0007]    Due to the losses associated with the laser, to generate heat for the thermo decoupling process, current medical lasers use multi-wattage lasers, such as from about 4 watts to over 120 watts. To place in perspective, in the metal fabrication industry, lasers with wattages of between 10 watts and 100 watts are used to cut thick steel plates. 
         [0008]    Laser-to-heat treatments are known to kill toe nail and finger nail fungus (onychomycosis). Exemplary methods and devices are disclosed in U.S. Pat. No. 8,277,495, “Method and Apparatus for Treating a Diseased Nail,” by Demetriou et al. and United States Patent Application Publication No. US 2011/0178510 A1, “Method and Device to Inactivate and Kill Cells and Organisms That Are Undesirable,” by Cumbie et al. Both U.S. Pat. No. 8,277,495 and US 2011/0178510 A1 are incorporated by reference herein in their entireties. 
         [0009]    A normal, healthy, nail plate has between about 25 and 27 layers of dehydrated human skin, keratin. Typically, nail fungi proliferate in a space between the nail plate above and the skin below (nail bed). In order to kill toe nail fungus or finger nail fungus, a medical laser must penetrate the nail plate without harming normal top nail plate layers and then break apart the fungus cell structure without burning nerve endings and skin cells located on the nail bed. Current laser-to-heat treatments are not ideal because: (1) the heat can burn normal nail plate or surrounding skin; (2) attenuation depth, also referred to as therapeutic penetration depth, of heat cannot be controlled effectively because heat loses its kill power effectiveness as different layers are encountered; (3) nail fungus located deeper than the minimum effective threshold of heat power remains untreated (failed to kill the fungus); and (4) because of inefficient conversion of laser photon quantum energy to thermo energy, current medical lasers are rated at between about 4 watts and about 80 watts to kill nail fungus. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    In accordance with a first embodiment, there is provided a method to enable a laser to interact with a structure disposed behind a barrier. This method includes the steps of calculating a set of first characteristics for a first laser channel to be effective to tunnel through the barrier and calculating a second set of characteristics for a second laser channel to be effective to interact with the structure, generating said first laser pulse to form a tunnel through the barrier and prior to closing of the tunnel, generating the second laser pulse to travel through the tunnel to interact with the structure. 
         [0011]    In accordance with a second embodiment, there is provided a treatment unit including a laser that interacts with a structure disposed behind a barrier. The treatment unit has a control panel in communication with an electronics package. Data entered into the control panel enables the electronics package to calculate a first set of characteristics for a first laser channel to be effective to tunnel through the barrier and to calculate a second set of characteristics for a second laser pulse effective to interact with the structure. The electronics package driving the first laser generates a laser pulse of the first laser channel followed within a predetermined time delay by a laser pulse of the second laser channel. 
         [0012]    In one application, the barrier is a finger nail or a toe nail and the structure is a fungus. 
         [0013]    The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects and advantages of the invention will be apparent from the description and drawings, and from the claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  illustrates an apparatus treat nail fungus utilizing harmonic resonance cavitation. 
           [0015]      FIG. 2  is a block diagram of components forming the apparatus of  FIG. 1 . 
           [0016]      FIG. 3  illustrate one embodiment of the apparatus of  FIG. 1 . 
       
    
    
       [0017]    Like reference numbers and designations in the various drawings indicated like elements. 
       DETAILED DESCRIPTION 
       [0018]    The apparatus and method utilized herein combine medicine and electrodynamics. By combining medically known clinical facts with proven biomolecular reactions in physiological and pathological states of human bodies and with also some very specific equations in quantum electrodynamics (exemplary are Schrodinger&#39;s Many Body Equations, Kohn-Sham Equation, and Density Functional Theory) and achieving numerical solutions to such equations, it is possible to calculate precise energy modulation values for therapeutic lasers for specific target molecules and atoms covalent bonds. 
         [0019]    Controlled direct-quantized energy, such as a first set of laser beams, penetrates covalent bonds of organic molecular barriers without interacting with the barrier molecular bonds, but creates a cavity (tunneling effect through the first barrier). Then, a second set of lasers penetrates the barrier without interacting with the barrier molecules through the cavity created by the first set of lasers. This second set of lasers would have interacted with the barrier molecules, such as by a loss of laser energy, breaking molecular covalent bonds, or burning tissue, if the first set of lasers did not create the “cavity” or “tunnel” via harmonic resonance cavitations. 
         [0020]    In medical and biological settings, the main barriers are organic molecules with covalent bonds. Due to their inherent size and geometry as well as distances between the atoms and molecules forming such complex molecular bonds, such as polypeptides, the effective range for low level laser therapy utilizing harmonic resonance cavitations for lasers is a laser with a wavelength between 0.1 nm and 5000 nm. With expected optical laser energy levels of sub milli watt to instantaneous (in pico and femto second pulses) peak laser power of over 25 watts. 
         [0021]    The first set of lasers creates a cavity or tunnel, through which the second set of “kill” lasers can penetrate deeper into tissue layers unchanged until hitting (interacting with) the target organic molecules of target cells. This “kill” laser portion will break certain specific covalent bonds of the target molecule, and only those target cells made of the target molecules will be destroyed. Surrounding cells without “the target molecules” are “transparent” to either the first or second sets of lasers. 
         [0022]    By directly interacting, between precisely controlled and modulated laser photon quantum energy, with the target molecule&#39;s specific organic covalent bond&#39;s electron&#39;s quantum energy levels, a minimum amount of the original laser energy is lost. Therefore, only very low amounts (in milliwatts for killing fungus or bacteria) of laser power is required to achieve breaking of the target organic molecular covalent bonds. 
         [0023]    With harmonic resonance cavitations, it is possible to destroy nail fungus (onychomycosis) under the nail plate, without harming surrounding normal human tissues, such as nail plate, epidermis, and dermis. The first set of lasers will penetrate nail plate creating a cavity (tunneling effect). Then, the second set of lasers will penetrate the nail plate through the cavity created by the first laser set. The second laser set will have no interaction with the nail plate. This second laser set is precisely calibrated to interact with one target organic molecule of covalent bonds. For fungi that is N-Acetyl-D-Glucosamine. This N-Acetyl-D-Glucosamine is the main structural element of cell wall. Fungus and bacteria (and plants) have cell walls, whereas animals (including humans) do not. 
         [0024]    Therefore, the second laser set will break covalent bonds of N-Acetyl-D-Glucosamine, hence breaking fungus cell wall, then the fungus ruptures and dies. Whereas, other surrounding cells that do not have N-Acetyl-D-Glucosamine, such as human nail or skin, are unaffected. All this is achieved with very low power lasers, due to harmonic resonance cavitations. 
         [0025]      FIG. 1  illustrates a first treatment method. A toe  10  includes a nail  12  overlying a nail bed  14 . Nail bed  14  includes an epidermis  16  overlying a dermis  18 . Epidermis  16  includes sensitive nerve endings while dermis  18  includes both a vascular network and nerves. Disposed between the nail  12  and nail bed  14  is a fungus  20 . As noted above, the nail  12  is primarily formed from keratin. A laser  22  includes at least two laser channels. A first channel  24  has a frequency, wavelength and duration effective to tunnel through nail  12 . 
         [0000]    Exemplary values for the first laser channel are: 
       Frequency—2 HZ-200 MHz; 
       [0026]    Wavelength—405 nm with +/−10 nm; and
 
Duration—with less than 5 nano-second Gaussian Power rise time on laser diode, 0.5 second˜5 nano-second.
 
         [0027]    The tunnel formed through the nail  12  by the first laser channel remains open for about 5 nano-seconds. Within that time, a pulse from a second laser channel  26  is directed through the tunnel to interact with the cell wall, N-Acetyl-D-Glucosamine, of fungus  20 . The second laser channel has a frequency, wavelength and duration effective to disrupt the cell wall, thereby killing the fungus, without interacting with the underlying nail bed  14 . Exemplary values for the second laser channel are: 
       Frequency—20 Hz-200 MHz; 
       [0028]    Wavelength—980 nm+/−5 nm; and
 
Duration—with less than 5 nano-second Gaussian Power rise time on laser diode, 0.5 second˜5 nano-second.
 
         [0029]    Calculating the frequency, wavelength and durations for the first and second pulses utilizes the quantum equations disclosed herein above. An exemplary set of equations follows: 
         [0030]    Calculating the lasers frequencies, wavelengths and durations for the first and second pulses utilizing quantum equations disclosed herein above, is only a small part of finalizing and selecting correctly harmonized Laser combinations. It was further researched and verified with already published scientific data, both estimated (simulated) by computer programs, and by experimentally obtained values for electron energy level values and atomic-molecular geometry. An exemplary set of equations and published data follows: 
         [0031]    Density Functional Theory/Kohn-Sham Equations: 
         [0000]    
       
         
           
             
               
                 
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         [0032]    The density functional theory (DFT) is presently the most successful (and also the most promising) approach to compute the electronic structure of matter. Its applicability ranges from atoms, molecules and solids to nuclei and quantum and classical fluids. In its original formulation, the density functional theory provides the ground state properties of a system, and the electron density plays a key role. An example: chemistry. DFT predicts a great variety of molecular properties: molecular structures, vibrational frequencies, atomization energies, ionization energies, electric and magnetic properties, reaction paths, etc. The article, “Targeted Energy Transfer by Fermi Resonance” by Maniadis et al. is appended hereto to further describe the above equation. The article shows that complete energy transfer may also occur by harmonics resonance under a condition similar to those of targeted energy transfer (TET). This effect is called Fermi targeted energy transfer (or FTET). 
         [0033]    Atomistic Methods when describing Interfaces, such as barriers between nail plate and nail fungus:
       SMALL systems (billions of atoms are not that many)   Non-local effects (curvature, strain, magnetic, electric fields) are not easy to capture (if at all)       
 
         [0036]    Continuum Descriptions of Heterogeneous Systems (i. e. with interfaces) 
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         [0037]    Free Energy is not local anymore. The Total free energy of a system now depends on heterogeneities in macroscopic properties, as shown below: 
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         [0038]    The article, “Texas Materials Modeling Network” by Srini et al. is appended hereto to further describe the above equation. 
         [0039]    An article (appended), titled Coherent Laser Control of the Resonance-Enhanced Multiphoton Ionization of HCl″ by Park et al. demonstrated how to ionize (or break certain molecular bonds by breaking that molecule&#39;s covalent electron bond): Also describes how to calculate numerical values for such Laser-Molecule interactions. The same equation can be used for other molecules, other than HCl. 
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                 indicates text missing or illegible when filed 
               
             
           
         
       
     
         [0040]    An article, appended, titled “Generalized Kohn-Sham Approaches” by Baer, discloses such information as phonon dispersion curves (such as Laser photon on to a target molecule), dielectric responses, and ionization potentials in 3-D electron-density contours. While an article titled “Numerical Solution of the Kohn-Sham Equation by Finite Element Methods with an Adaptive Mesh Redistribution Technique” by Bao et al. demonstrates calculating numerical values of Kohn-Sham equations 
         [0041]    Atomization energies of molecules, in eV (leV=23.1 kcal/mol), such molecules as O 2 , H 2 O, CH 4 , NH 3 , etc. are published, as are hydrogen bonding energy landscape: geometry for complex molecules, such as proteins and alpha-helices (organic molecules). Published all-electron numerical and computational calculations for atoms and molecules; such biological atoms and molecules as, 
         [0000]    
       
         
               
               
             
               
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 Atoms, Molecules 
               
             
          
           
               
                   
                 C 
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                 C 6 H 6   
               
               
                   
                   
               
             
          
           
               
                 Size of 
                 ~6.000 
                 ~6.000 
                 ~8.000 
                 ~35.000 
                 ~120.000 
               
               
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                 matrix 
               
               
                 Total Energy 
                 −1018.47 
                 −2026.75 
                 −31.24 
                 −3060.88 
                 −6263.53 
               
               
                 (ev) 
               
               
                 FHI-aims (ev) 
                 −1018.37 
                 −2026.45 
                 −30.95 
                 −3060.53 
                 −6263.83 
               
               
                   
               
             
          
         
       
     
         [0042]    Published calculated/predicted by computer simulation/experimental geometric values of typical organic molecules, in size of 10 nm length through IDFTB SCC-DFTB DFT-LSD methods. 
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                 C═O 
                 1.296 
                 1.224 
                 1.223 
                 1.193 
               
               
                   
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                 1.382 
                 1.358 
                 1.376 
               
               
                   
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                 1.003 
                 0.996 
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                 1.130 
                 1.131 
                 1.122 
                 1.102 
               
               
                   
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                 125.5 
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                 1DFTB—Density-Functional Tight-Binding 
               
               
                   
                 SCC-DFTB—Self-Consistent-Charge Density-Functional Tight-Binding 
               
               
                   
                 DFT-LSD—Density Functional Theory - Local Spin Density 
               
             
          
         
       
     
         [0043]    Published such data as Bond lengths for different bonding situations [in Angstrom]: 
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                 Bond 
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                 BLYP 
                 BP86 
                 Experimental 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 H—H 
                 0.765 
                 0.748 
                 0.752 
                 0.741 
               
               
                   
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                 1.510 
                 1.542 
                 1.535 
                 1.526 
               
               
                   
                   
               
               
                   
                 LDA—Local Density Approximations 
               
               
                   
                 BLYP (also known as B3LYP)—Becke (exchange) and Lee, Young, Palmer (correlation) density functional calculations 
               
               
                   
                 BP86—Becke (exchange) and Perdew (correlation) density functional calculations model-86. 
               
             
          
         
       
     
         [0044]      FIG. 2  illustrates an exemplary apparatus  30  for use with the method described herein. The apparatus  30  includes a control panel  32  where an operator inputs data necessary to calculate required frequencies, wavelengths and durations. This data includes severity of onychomycosis (nail fungus infection); such as nail color changes, dystrophic nail thickness changes, subungual debris presence, onycholysis, secondary infection state (such as secondary bacterial infection), or presence of nail/skin psoriatic changes. Microprocessors located in an electronics package then perform the necessary calculations and drive one or more lasers  22  with the proper frequency modulation and power modulation for the first and second laser channels. Multiple lasers may be employed for the multiple channels. 
         [0045]    A compact unit  40  such as for use in a doctor&#39;s office, hospital or clinic, is illustrated in  FIG. 3 . Housing  42  includes a power unit, microprocessors, lasers and cooling elements. The housing may be on wheels (not shown) to enhance portability. A control panel  32  interfaces with the electronics package contained within the housing  42 . The interface may be by a wire or wireless and utilizes any effective communication system. In one embodiment, the control panel  32  is a digital tablet having touch screen control panel and wireless communication capabilities. A fiber optic cable  44  directs the laser beams (first laser channel and second laser channel) to a target. The fiber optic cable  44  terminates at a laser beam terminal  46  that may be a hand piece with an on/off finger switch  48 . Treatment includes the operator entering data necessary to calculate values required for the first laser channel and for the second laser channel into the control panel. Microprocessors than calculate the values. The operator then positions the laser beam terminal  46  over an infected nail and presses the finger switch  48  causing a tunneling first laser channel pulse followed by a disrupting (fungal killing) second laser channel pulse to be emitted. 
         [0046]    A feature of the apparatus and method described herein is harmonic resonance cavitations, penetration of barriers without interaction, so that the deeper target structures can be manipulated or treated with minimum required energy, without negative side effects, such as burning, to non-target organic or inorganic molecules, cells, tissues and/or organs. While described above for destruction of a nail fungus, many other applications are envisioned. 
         [0047]    With harmonic resonance cavitation, it is possible to excite or denature (destroy) telomere portions of human DNA inside a cell nucleus. Final treatment portion of lasers will penetrate cell membrane, cytoplasm, nucleus membrane (all without interacting with these barrier structures): then, treat only the telomere portion of certain target DNA. 
         [0048]    One alternative for such treatment method is gene therapy. Current gene therapy relies on direct chemical reactions, such as enzymatic reactions, between drugs and target molecules of the cell. Other applications include, but are not limited to, fungus killing lasers, bacteria killing lasers, skin cancer treatment lasers, intra-articular and extra-articular joint treatment lasers, stem cell excitation lasers, cardiac ablation lasers, GI, GU, Pulmonary and OB/GYN ablation lasers, neurological lasers, vascular lasers, analgesic lasers, hair removal lasers, hair growth lasers, tattoo removal lasers, ulcer and wound care lasers, fibroblast and growth factor stimulating lasers, dental lasers and ophthalmic lasers. 
       Example 
       [0049]    Following Phase I with initial testing of treated and not treated plates showing growth, then finding the tested areas marked with Gentian Violet showing no growth, Phase II was initiated. It should also be noted that Phase I was done utilizing the initial prototype which did not have the alignment of the two sets of lasers in synch at the focal point properly. 
         [0000]    
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 Test I Agar plates 
               
             
          
           
               
                   
                   
                   
                 Plate With Sample 
               
               
                 Sample 
                 Plate Without 
                 Plate With Laser 
                 that Had Color and 
               
               
                 Number 
                 Treatment 
                 Treatment 
                 Laser Treated 
               
               
                   
               
               
                 I 
                 Abundant Growth 
                 Increased Growth 
                 Minimal (&lt;5%) 
               
               
                   
                   
                   
                 Growth 
               
               
                 II 
                 No Growth 
                 No Growth 
                 No Growth 
               
               
                 III 
                 Abundant Growth 
                 Abundant Growth 
                 No Growth 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 Test II DTM (Dermatophyte Test Medium) 
               
             
          
           
               
                   
                   
                   
                 DTM With Sample 
               
               
                 Sample 
                 DTM Without 
                 DTM With Laser 
                 that Had Color and 
               
               
                 Number 
                 Treatment 
                 Treatment 
                 Laser Treated 
               
               
                   
               
               
                 I 
                 Growth 
                 Growth 
                 No Growth 
               
               
                 II 
                 Growth 
                 No Growth 
                 No Growth 
               
               
                 III 
                 No Growth 
                 No Growth 
                 No Growth 
               
               
                 IV 
                 Growth 
                 Growth 
                 No Growth 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
             
           
               
                   
               
               
                 Test III Plates colored and targeted 
               
             
          
           
               
                   
                   
                   
                 Portion With 
               
               
                   
                   
                   
                 Sample that Had 
               
               
                 Sample 
                 Portion Without 
                 Portion With Laser 
                 Color and Laser 
               
               
                 Number 
                 Treatment 
                 Treatment 
                 Treated 
               
               
                   
               
               
                 I 
                 Abundant Growth 
                 Abundant Growth 
                 No Growth 
               
               
                 II 
                 Abundant Growth 
                 Abundant Growth 
                 No Growth 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
             
           
               
                   
               
               
                 Test IV Partial In-Vivo tests were performed 
               
             
          
           
               
                   
                   
                 Plate With Color and Laser 
               
               
                 Sample Number 
                 Plate Without Treatment 
                 Treatment 
               
               
                   
               
               
                 I 
                 Growth 
                 No Growth 
               
               
                 II 
                 Growth 
                 No Growth 
               
               
                 III 
                 Growth 
                 Limited Growth 
               
               
                   
               
             
          
         
       
     
         [0050]    This is the initial findings and results demonstrating effectiveness of the laser treatment in vitro testing. Results showed that fungal infection specimen were split into treated and not treated subparts. Those parts were then inoculated onto and grown on agar growth plates. A high percentage of those specimen that were not laser treated, grew fungal species. And when the same specimen was treated prior to inoculation and then grown on the same culture media, a high percentage demonstrated no growth, or translating to effective death of the fungal species. The introduction of the coloring allowed greater penetration and absorption of the Laser therapy. 
         [0051]    One or more embodiments of the present invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.