Abstract:
An infrared energy photo-biotherapy medical treatment device incorporating a Class IV laser light source is disclosed. The medical treatment device comprises a head assembly, a coupling device and the Class IV laser light source. A liquid light guide connects the head assembly to the coupling device and the Class IV laser light source is connected to the coupling device by a plurality of silica optical fibers. Optical lenses are incorporated in both the head assembly and the coupling device permitting the infrared energy photo-biotherapy medical treatment device to direct the infrared energy from the Class IV laser light source through the optical fibers, coupling device, liquid light guide and head assembly so as to penetrate into a living organism.

Description:
TECHNICAL FIELD 
       [0001]    The present invention relates, in general, to an infrared energy photo-biotherapy medical treatment device and, more particularly, to the optical coupling apparatus associated with an infrared energy photo-biotherapy medical treatment device that can produce a light that penetrates into a living organism. 
       BACKGROUND ART 
       [0002]    Infrared light at specific wavelengths has been proven to be effective in improving the healing process for some medical conditions that exist in both human beings and other warm-blooded animals. When applied to the skin, normal visible white light, visible red light, or invisible light and/or light with wavelengths from 300 nm to 1400 nm produces an increased thermal effect on the skin and the dermal layer to a depth of 1.0 mm. The relatively high level of energy being absorbed by the skin causes this effect. In numerous studies and clinical trials, infrared photo-biotherapy has been shown to provide significant therapeutic benefits. For example, tests conducted utilizing a scanning laser Doppler have indicated an increase in microcirculation from 400% to 3200% after one infrared light emitting diode treatment. Studies have also shown that human tissue exposed to infrared light from light emitting diodes grows at a rate of 150 to 200% faster than cells not stimulated by such light. Also, it has been shown that cells treated with infrared light exhibited a five-fold increase in growth phase specific DNA synthesis. Thus, the therapeutic benefits of infrared energy photo-biotherapy medical treatment are well documented. 
         [0003]    One of the medical needs for which photo-biotherapy has proven to be useful is the treatment of decubitis ulcers. The typical medical approach to treat decubitis ulcers is to utilize cleansing agents, antiseptic agents, topical agents and/or dressings. While not typically utilized as a method of treatment, infrared energy photo-biotherapy has shown promise in the treatment of such ulcers. Such infrared energy photo-biotherapy has also shown promise in the medical treatment of numerous acute and chronic conditions including, but not limited to, carpal tunnel syndrome, back and neck pain, migraine headaches, wound healing, tendonitis, sprains, strains, repetitive stress injuries, arthritis and peripheral neuropathy. 
         [0004]    Even though infrared energy photo-biotherapy medical treatment offers such promise, the use of such a therapy method is limited since most therapeutic devices that produce infrared energy are limited to an output power of less than 1.0 watt. Those infrared energy therapeutic medical treatment devices that produce significantly greater output power, e.g., 4.0 watts, are typically very expensive, large, cumbersome and difficult to transport. 
         [0005]    In view of the foregoing disadvantages associated with presently available infrared energy therapeutic medical treatment devices, it has become desirable to develop a relatively low cost, portable, therapeutic medical treatment device utilizing a Class IV laser light source which produces a relatively high output power level. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention solves the problems associated with presently available infrared energy therapeutic medical treatment devices, and other problems, by providing a durable optical coupling apparatus that can be utilized by an infrared energy photo-biotherapy medical treatment device incorporating a Class IV laser light assembly. In this instance, the overall infrared energy photo-biotherapy medical treatment device or system comprises a head assembly, a coupling device and the Class IV laser light assembly. A liquid light guide is utilized to provide light delivery and connects the head assembly to the coupling device which, in turn, is connected to the Class IV laser light assembly via a plurality of silica optical fibers. In this manner, the liquid light guide, coupling device and plurality of optical fibers interconnects the head assembly with the Class IV laser light assembly. Optical lens are incorporated in both the head assembly and the coupling device permitting the laser light produced by the Class IV laser light assembly and transmitted via the plurality of optical fibers, coupling device and liquid light guide to be focused so as to penetrate into a living organism. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1  is a perspective view of the overall infrared energy photo-biotherapy medical treatment device of the present invention. 
           [0008]      FIG. 2  is a perspective view of the head assembly, liquid light guide, coupling device, optical fibers and laser light assembly utilized by the infrared energy photo-biotherapy medical treatment device illustrated in  FIG. 1 . 
           [0009]      FIG. 3  is a perspective view of the head assembly shown in  FIG. 2 . 
           [0010]      FIG. 4  is an elevational view of the head assembly shown in  FIGS. 2 and 3 . 
           [0011]      FIG. 4A  is a cross-sectional view of the head assembly taken across section-indicating lines  4 A- 4 A in  FIG. 4 . 
           [0012]      FIG. 5  is a perspective view of the head assembly shown in  FIGS. 2 and 3  and illustrates the illumination “spot” produced thereby. 
           [0013]      FIG. 6  is a perspective view of the coupling device shown in  FIG. 2 . 
           [0014]      FIG. 7  is an elevational view of the coupling device shown in  FIGS. 2 and 6 . 
           [0015]      FIG. 7A  is a cross-sectional view of the coupling device taken across section-indicating lines  7 A- 7 A in  FIG. 7 . 
           [0016]      FIG. 7B  is a cross-sectional view of the coupling device showing the optical fiber ferrule member in the removed position from the coupling device. 
           [0017]      FIG. 7C  is a cross-sectional view of the coupling device showing the optical fiber ferrule member inserted into the coupling device. 
           [0018]      FIG. 8  is a perspective view of the Class IV laser light assembly utilized by the infrared energy photo-biotherapy medical treatment device of the present invention. 
           [0019]      FIG. 9  is a perspective view of one of the Class IV laser light sources utilized by the infrared energy photo-biotherapy medical treatment device of the present invention. 
           [0020]      FIG. 10  is an exploded view of the Class IV laser light source shown in  FIG. 9 . 
           [0021]      FIG. 11  is a top plan view of the mounting plate assembly utilized by the Class IV laser light source shown in  FIG. 9 . 
           [0022]      FIG. 11A  is a cross-sectional view of the mounting plate assembly taken across section-indicating lines  11 A- 11 A in  FIG. 11 . 
           [0023]      FIG. 12  is a top plan view of the mounting plate assembly utilized by the Class IV laser light source shown in  FIG. 9 . 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0024]    Referring now to the drawings where the illustrations are for the purpose of describing the preferred embodiment of the present invention and are not intended to limit the invention described herein,  FIG. 1  is a perspective view of the overall infrared energy photo-biotherapy medical treatment device  10  of the present invention. As shown in  FIG. 2 , the medical treatment device  10  of the present invention is comprised of a head assembly  100 , a liquid light guide  200 , an optical fiber coupler  300  and a plurality of silica optical fibers  400 , which is utilized to interconnect the coupler  300  to a Class IV laser light assembly  500 . The liquid light guide  200  interconnects the head assembly  100  with the coupler  300 . 
         [0025]    The head assembly  100 , as shown in  FIGS. 3 ,  4 ,  4 A and  5 , is comprised of an inner housing  102  and an outer housing  104 , both of which are generally cylindrical in configuration. A portion of inner housing  102  is received within outer housing  104 . End  106  of outer housing  104  has a blind bore  108  therein which terminates in a first bore  110  having a diameter slightly less than the diameter of blind bore  108 . The surface of first bore  110  is provided with female threads  112  therein. First bore  110  terminates in a second bore  114  that has a diameter that approximates the diameter of blind bore  108 . Second bore  114  terminates in a third bore  116  that terminates in opposite end  118  of outer housing  104 . The diameter of third bore  116  is slightly less than the diameter of second bore  114 . An optical lens  120  is received within third bore  116  and retaining rings  122 ,  124  are positioned on opposite sides of optical lens  120  to retain same in third bore  116 . 
         [0026]    End  126  of inner housing  102  has a blind bore  128  therein which terminates in a first bore  130  having a diameter less than the diameter of blind bore  128 . First bore  130  terminates in a second bore  132  having a diameter slightly less than the diameter of first bore  130 . Second bore  132  terminates in a third bore  134  that terminates in opposite end  136  of inner housing  102 . The diameter of third bore  134  is greater than the diameter of second bore  132  and approximates the diameter of first bore  130 . An optical lens  138  is received within second bore  132  and retaining rings  140 ,  142  are positioned on opposite sides of optical lens  138  to retain same in second bore  132 . The outer surface of male housing  102  is comprised of a first circumferential portion  144  and a second circumferential portion  146  that has male threads  148  on a portion of the outer surface thereof. End  136  of inner housing  102  is received within end  106  of outer housing  104  and threadingly engages same through male threads  148  on the outer surface of second circumferential portion  146  of inner housing  102  and female threads  112  on first bore  110  of outer housing  104 . 
         [0027]    A liquid light guide ferrule  150  is received within bore  130  in inner housing  102  and is positioned therein such that its light emitting end  152  faces optical lens  138 . Liquid light guide ferrule  150  is retained within bore  130  by set screws  154  which are oppositely disposed to one another and are received within threaded bores  156  in male housing  102 . 
         [0028]    The liquid light guide  200  is comprised of a plastic tube that is covered by a protective spiral of aluminum wire and a PVC jacket. The plastic tube is filled with a transparent, anaerobic, non-toxic fluid that facilitates the transmission of near infrared light. The tube is sealed at each of its oppositely disposed ends with a fused silica or glass window and is protected by an interlocking steel sheathing. One end  202  of the liquid light guide  200  is received within liquid light guide ferrule  150  that is within bore  130  in male housing  102 . 
         [0029]    Referring now to  FIG. 5 , a perspective view of the head assembly  100  is shown and illustrates the size of the illumination “spot”  160  that can be produced thereby. The size of the illumination “spot”  160  can be varied by threadably advancing and or retracting the male housing  102  within the female housing  104 . For example, when the inner housing  102  rotated clockwise within the outer housing  104 , i.e., the inner housing  102  is threadably advanced into the outer housing  104 , the size of the illumination “spot”  160  increases. Conversely, when the inner housing  102  is rotated counterclockwise with respect to the outer housing  104 , i.e., the inner housing  102  is threadably retracted from the outer housing  104 , the size of the illumination “spot”  160  decreases. It is also possible to utilize a fixed spot size wherein the head assembly  100  comprising the inner housing  102  and the outer housing  104  are molded as a unit preventing the inner housing  102  from being threadably advanced or retracted within the outer housing  104 . 
         [0030]    Referring now to  FIG. 6 , a perspective view of the optical fiber coupler  300  is illustrated. As shown in  FIGS. 7 ,  7 A,  7 B and  7 C, the coupler  300  is typically cylindrical in configuration and has a blind bore  302  in end  304  thereof. Blind bore  302  terminates in a first bore  306  having a diameter less than the diameter of blind bore  302 . First bore  306  terminates in second bore  308  provided in opposite end  310  of coupler  300 . An optical lens  312  is received within first bore  306  and retaining rings  314 ,  316  are positioned on opposite sides of optical lens  312  to retain same in first bore  306 . An optical fiber ferrule  318  is received within blind bore  302  of coupler  300 . The other end  320  of the liquid light guide  200  is received in second bore  308  and is retained therein by oppositely disposed set screws  322  that are threadably received within threaded bores  324  in coupler  300  adjacent end  310  thereof, as shown in  FIG. 7C . It should be noted that  FIGS. 7B and 7C  illustrate the lateral positioning of optical fiber ferrule  318  in blind bore  302  of coupler  300  to achieve the proper focal distance from the emission end of the optical fiber ferrule  318 , through the optical lens  312 , and into the end  320  of the liquid light guide  200 . After the optical fiber ferrule  318  has been laterally positioned in blind bore  302  in coupler  300 , the position of the optical fiber ferrule  318  is maintained by oppositely disposed set screws  326  that are received within threaded bores  328  in coupler  300 . 
         [0031]    Referring now to  FIGS. 8 and 9 , perspective views of the Class IV laser light assembly  500  and a laser light source  510  within the assembly  500 , respectively, are illustrated. Similarly, an exploded view of laser light source  510  is illustrated in  FIG. 10 . Laser light source  510  includes a mounting plate assembly  520  comprised of a top plate  522  and a bottom plate  524 . Referring now to  FIGS. 11 ,  11 A and  12 , top plate  522  has an aperture  526  therein and is laterally movable within bottom plate  524 . Apertures  528  are provided in bottom plate  524  permitting bottom plate  524  to be affixed to the emission surface of the laser light source  510 . Lateral movement of the top plate  522  with respect to the bottom plate  524  optimizes the output power of the laser light source  510  into the plurality of silica optical fibers  400 . The position of top plate  522  within bottom plate  524  is maintained by oppositely disposed set screws  530  that are received within threaded bores  532  in bottom plate  524 . 
         [0032]    To investigate the efficacy of low-level exposure to 980 nm laser light produced by the infrared energy photo-biotherapy medical treatment device  10  of the present invention, cell growth rates following wound induction using an in-vitro model of wound healing were investigated. A small pipette was used to mechanically induce a wound in fibroblast cell cultures, which were then imaged at specific time intervals following wound induction and exposed to various doses of laser light. Results indicate that exposure to low and medium intensity laser light significantly accelerated cell growth and that high intensity laser light negated the beneficial effects of laser light exposure on cell growth. Further experimentation demonstrated that cell growth was accelerated over a wide range of exposure durations using medium intensity laser light with no marked reduction in cell growth at the longest exposure duration. The test results confirm clinical observations that low-level exposure to 980 nm laser light can accelerate the healing of superficial wounds. 
         [0033]    Regarding the testing procedure utilized, a range of exposure doses was investigated by varying the output power of the laser light source over a fixed exposure duration, or by varying the exposure duration at a fixed output power of the laser light source. In the first experiment, the output power of the laser light source was varied from 1.5-7.5 watts to produce an exposure level of 2.6-120 mw/cm 2  over a two minute exposure interval, resulting in exposure doses from 3.1-15.4 J/cm 2 . It was found that regardless of exposure levels, significant cell recovery was observed within three hours of wound induction, however, exposure to moderate exposure levels (26-97 mw/cm 2 ) appeared to enhance cell growth at all time intervals relative to control experiments in which no laser light exposure was applied. The results also showed that the beneficial effects of laser light exposure were negated by over-exposure since fibroblasts exposed to exposure levels of 120 mw/cm 2  for two-minute intervals did not show any significant increase in cell growth rates relative to control experiments. 
         [0034]    In the second experiment, exposure durations were varied from 20 seconds-15 minutes at a substantially constant output power of 4.5 watts of the laser light source to produce an exposure level of 73 mw/cm 2 , resulting in exposure doses from 1.5-66 J/cm 2 . As with changes in exposure levels, significant cell recovery was observed within three hours of wound induction regardless of exposure duration, and a wide range of exposure durations appeared to enhance cell growth at all time intervals relative to control experiments in which no laser light exposure was applied. 
         [0035]    The foregoing test results confirm the clinical observation that low-level exposure to 980 nm of laser light can accelerate cell growth in a wound healing model. Because the test measurements were obtained from an in-vitro culture model, the results also suggest that the mechanisms involved in the acceleration of cell growth following laser light exposure are cellular or molecular in nature. The results also demonstrate the importance of appropriate supervision of laser light exposure. In particular, the average cell growth rate formed a non-monotonic function of laser light exposure levels and exposure doses with peak growth rates at moderate exposures and reduced benefit at higher exposure intensities and doses. 
         [0036]    Certain modifications and improvements will occur to those skilled in the art upon reading the foregoing. It is understood that all such modifications and improvements have been deleted herein for the sake of conciseness and readability, but are properly within the scope of the following claims.