The invention relates to a new use and improved design of a low level therapy laser device for treating body cavities, especially ear and mouth and in which in the light path a light conducting adapter is arranged that can be inserted in the body cavity to be treated.

The biostimulation effect of low level lasers is well known. In 1970 professor Endre M ESTER has discovered that wounds that hardy heal or do not heal at all will heal under the effect of laser light of small intensity (called also as soft laser). The phenomenon was name as biostimulation. The lasers used emitted monochromatic, coherent, polarized and parallel light. The biostimulation effect was due to the small bandwidth of wavelength (colour) coherence and polarized nature. The summary of such research can be found at the article of Mester E, A.F and Mester A. "the biomedical effects of laser applications" (Lasers Surg. Med. 5, 1985, pp 31-39).

The pioneer work of professor Mester was followed by numerous other research and the relevant literature is substantial, it has reach almost a size that cannot be overlooked at all. One of the most detailed and broadest summaries can be found in the book of Lars Hode & Jan Tuner "Laser Phototherapy - Clinical Practice and Scientific Background" wich is 900 pages long and has 2500 reference ( Prima Books edition, Coeymans Hollow, NY, USA - extended edition 2015).

The biostimulation effects of light (not limited only to laser applications) is broadly described by the study professor Michael R. Hamblin (Department of Dermatology, Harvard Medical School, BAR 414, Wellman Center for Photomedicine, Massachutes General Hospital: Mechanisms of Low Level Light Therapy, published on August 14, 2008 which can be read e.g. at the web address: hhtp://www.photobiology.info/Hamblin.html. Chapter 7 of the study deals with the issues yet to e solved, and it is described there what properties of light are responsible for the biostimulation effect, namely the spectral distribution, the monochromatic nature, the degree of polarization, the specific light intensity or the appropriate combination of these properties.

Low level lasers are widely used for treating long lasting ear buzzing called tinnitus. In connection with such treatments numerous publications were disclosed, just a few examples are as listed below:

1. Efficacy of transmeatal low power laser irradiation on tinnitus: a preliminary report.

Shiomi Y, Takahashi H, Honjo I, Kojima H, Naito Y, Fujiki N. Department of Otolaryngology,

Faculty of Medicine, Kyoto University, Japan

2. The Role of LILT in Treatment of Tinnitus, Laser Partner, 26.2.2002, Miroslav Prochazka, M.D., Head doctor of the Jarov Private Rehab Clinic, Prague, CZ

3. Low-level laser for treatment of tinnitus: a self-controlled clinical trial.

Okhovat A, Berjis N, Okhovat H, Malekpour A, Abtahi H., Department of Otorhinolaryngology, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran

4. On The Effectiveness of Low Level Laser Light (LLLL) in the Inner Ear

Dr. med. Lutz Wilden, Kurallee 16, D-94072 Bad Fussing

5. Low-level laser therapy for the treatment of tinnitus with TinniTool EarLaser

Dr. Domenico Cuda, Dr. Antonio R. de Caria, ENT Department, Piacenza Clinic, Italy

6. TinniTool Low level laser therapy in patients with complaints of tinnitus

Ahmed H Salahaldin, Khalid Abdulhadi, Nihal Najjar, General Hospital, Hamad Medical Corporation, Qatar

7. Low-level laser therapy for tinnitus

Peng Z, Yiu-Qi Chen, Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, China

The out power of lasers used for the treatment of tinnitus are adjusted to 5 mW or below. The treatments were carried our by using a fiber optics connected with one end to a Iser source and the other end was inserted in the ear hole. The power limit of 5 mW is supported by the Hungarian standard MSZ EN 60825-1 that corresponds to the international recommendation IEC 60825-1:2007. Here for the irradiation safety of laser devices a power of 5 mW was indicated as a limit which can be sold to the general population in case of law level laser sources. The reason of it lies in that lasers emit parallel beams, and the indicated power density of such beams does not cause harm of tissues when the power is distributed at an average spot size (however, the irradiation of the eye should be prohibited because owing to the focusing effect of the eye even this power can cause a huge and impairing power density on the surface of the retina).

In case of lasers used up to the present a fiber optic was attached to the exiting light of the laser light source and the size of this optics was chosen to fit to the ear ole, and the treatments were carried out through these connecting elements. According to experiments in case of ear treatments about 95% of light power will be absorbed before the light can reach the inner parts of the ear.

The properties of such connecting elements are such that the light which was polarized at the entry surface will lose its polarization or a high portion of polarization as it reaches the end of the element due to the multiple reflections occurring therein.

A high choice of low level lasers can be obtained in normal commerce, of which a preferred embodiment is disclosed at the website: http://www.safelaser.co.uk/index.php/products/safe- laser-sl-150 . In this device having the typ Safe Laser 150 a beam expander is used which coinverts the laser beams with a small diameter into a beam having a diameter of about 21 mm. The device as such can be used for a number of conventional therapies, and with a beam narrowing adapter the nostrils can also be illuminated thereby. The websites refers also to a then not yet published patent application by which the device can also be used in an unique way for treating the eye.

The referred websites describe furthermore a laser of 500 mW power which is recommended primarily for the treatment of the pains in the joints and injuries.

The device has a light conducting adapter for the treatment of the ear and the mouth which has a diameter of 7 mm which is also capable of treating tinnitus according to the recommendations there. The diameter of the fiber optics is substantially smaller that the output diameter of the beam expander used in the device, and out of the original power of 150 mW of the device only a power smaller than 5 mW can reach the ear hole.

In the written recommendations of the device not only the treating of tinnitus but also for moderating the problems in case of certain inflammations, ear problems can be read.

In practice for the different kind of treatments respective low level laser devices are used optimized for the given fields of use.

The primary objective of the invention is the using of a certain type of known low level therapy laser device for a new and surprising therapy.

Further tasks include the increase of the efficiency of the therapies carried out by low level laser devices for the treatment of body cavities.

A further task of the invention is to provide a low level laser device that can be adapted for several therapeutic applications whereby the expensive laser device can have multiple uses.

As the first solution of the first task it has been recognized if in the light path of the low level laser a light conducting adapter is placed that has an end which can be fitted and inserted in the ear hole and from the end of which not only parallel but scattered light exits, furthermore if the wavelength of the laser light source is between 600 and 1500 nm, and the power level exiting at the exit end of the light conducting adapter exceeds 25 mW, and it is preferably between 40 and 60 mW, then the treatments carried out by such a device can improve hearing problems and in case of certain subjects in a surprising efficient extent.

For solving the second task it has been recognized that for the treatment of body cavities the therapeutic efficiency of the low level laser device will substantially improve if a polarizer, preferably a polarizer sheet is positioned to the end of the light conducting adapter, because thereby the laser light that has lost its polarized properties will become again polarized, and the therapeutic efficiency of polarized light is better than that of the light being only monochromatic and coherent. According to a third aspect of the invention in the above referred "safe laser 150 and 500" device there is a beam expander that expands the beam of the small exit beam of the laser source and the beam expander has an output end portion that scatters the direction of the exiting light, and to the housing of the beam expander a light conducting adapter can be attached by a releasable connection which is made of a solid light transparent material, that has a convex rear surface facing the light source, and this convex lens leads the scattered light into the interior of the light conducting adapter, whereby a major part of the exiting light will be directed into the interior of the adapter.

The solution of the first task of the invention is a new use of a low lever therapy laser device for the treatment of hearing defects, in which the light of a laser emitting monochromatic and coherent light is lead by a light conducting adapter that has an end fitting in the ear hole of a subject and through the front end of the adapter scattered light will exit having a power of at least 25 mW and a wavelength between 600 and 1500 nm.

The efficiency of the treatment can be increased if in the path of the exiting non polarized light a polarizer is inserted.

It is preferred if the exiting light power is between 40 and 60 mW. or higher but it is still under the level that causes tissue damages.

With the invention a universally usable low level therapy laser devices has been provided for treating body cavities, especially ear and mouth comprising a laser emitting parallel beams of monochromatic and coherent light, a beam expander is arranged in front of the laser across the light path having a concave inner end surface facing the laser and a light exiting surface having a raster of small lenses that scatter light, and the size of the exiting surface has a diameter of at least 15 and preferably 20 to 30 mm, and the device has a head part receiving and holding the beam expander that comprises a sleeve extending over the beam expander, and according to the third aspect of the invention in front of the beam expander a light conducting adapter is arranged held by the sleeve and having a front section with a size fitting in the body cavity to be treated, the adapter has a rear section being about as large as the exiting surface of the beam expander, and the rear end thereof has a slightly arced convex surface to direct the scattered incident light to the interior of the light conducting adapter, and in the rear section the light conducting adapter gets gradually narrower in the direction of the light path, then through a middle section with an almost constant size ends in a slightly curved front section, and the light power exiting the front section is at least 25 mW.

In a preferred embodiment a polarizer is arranged across the light path at the end of the front section or in front thereof. It is preferred furthermore, if the light conducting adapter is made of a solid homogeneous plastic material being preferably polycarbonate or plexiglas.

The scattering of the exiting light is facilitated if the front section of the light conducting adapter has a slightly convex end.

The suggested use of the low level therapy laser device according to the invention has very serious advantages since a part of hearing problems held so far not to be cured can be decreased or fully healed without the administration of any drug or using any invasive intervention.

The use of the polarizer restores the polarization properties lost otherwise in the light conducting adapter.

The third aspect of the invention renders possible the multi-purpose use of the same laser device.

The solution according to the invention will now be described in connection with preferable embodiments thereof, in which reference will be made to the accompanying drawings. In the drawing:

Fig. 1 is a schematic side-view of a first embodiment of the invention;

Fig. 2 is an enlarged view of the front section of the first embodiment shown in Fig. 1;

Fig. 3 shows the sectional side view of a part of the head of a universal low level laser;

Fig. 4 is the cross-sectional view of a beam expander 23;

Fig. 5 is the front view of the beam expander shown in Fig. 4; and

Fig. 6 is a detail of a second embodiment of the invention.

A device 10 shown in Fig. 1 has a cylindrical housing 11 and in this a laser 12 can be operated supplied by a power source not shown in the drawing. The laser 12 belongs to the type of low level lasers, its power falls into the 40-500 mW range, the wavelength of the light lies between 600 and 1500 nm, preferably between 600-700 or 780-950 nm. The housing 11 protrudes to a certain extent in forward direction in front of the laser 12 and it has a hollow interior into which an optical light conducting adapter 13 extends and releasably fixed by means of a threaded connection or of an appropriate elastic member. The optical light conducting adapter 13 has preferably a circular cross section and it is made by a transparent light conducting material or of a bundle of light conducting fibers and its external dimension fits to that of the ear-hole, thus it can be easily inserted therein and its diameter typically falls between 6,5-8 mm. The length of the optical light conducting adapter 13 is not critical its size is determined by the ease of use. For facilitating the insertion of the light conducting adapter 13 into the ear-hole its frontal end portion is slightly arced and curved as it can be seen in Fig. 1. The rear end of the light conducting adapter 13 that is in front of the laser 12 is preferably but not necessarily designed as a concave lens, and the incident laser light that has a much smaller diameter will get distributed in the light conducting adapter 13 due to the multiple reflections occurring therein, and thus the exiting laser light will have a substantially uniform distribution in a wide angular range. The light exiting at the front end of the light conducting adapter 13 will become scattered as a result of the multiple reflections, whereas it comprises scattered and not parallel beams and because of the scattering its polarization will get mostly lost. For an efficient scattering of the exiting beams it is preferred if the light exiting surface of the light conducting adapter 13 is slightly convex and functions as a scattering lens. The attenuation of the light conducting adapter 13 depends on its design and length, therefore under the term "power" the power of the exiting light will be meant.

In the preferred embodiment shown in the enlarged detailed view of Fig. 2, a polarizer 14 can be pulled on the front end of the light conducting adapter 13 and can be attached thereto e.g. by using a resilient thin sleeve 15. The presence of the polarizer 14 means such a slight increase in the diameter that cannot influence normal use. In case the light conducting adapter 13 is made of a solid material, for example polycarbonate, it is possible to reduce the diameter of the light conducting adapter 13 in its front end according to the thickness of the sleeve 15, thus the attachment of the polarizer 14 will not cause any increase in size at all. With appropriate technology the polarizer 14 can also be provided on the front convex surface of the light conducting adapter 13 either by vacuum deposition or in any other way to form of a thin layer. This is the most preferred embodiment since then the sleeve 15 is not needed at all. The application of the polarizer 14 restores the polarized nature of the exiting laser light, thus the light will be coherent, monochromatic and polarized however the direction of the beams will not be parallel. The output light power is reduced to about 45% of the original one by the presence of the polarizer 14, therefore the power of the laser light source can be increased proportionally when using such a device to provide the same output power. The efficiency of the treatments will be improved by this solution wherein the light loses first then regains its polarization. The extent of improvement of the treatment is not uniform at all fields of applications but is definitely present.

The embodiment of the solution according to the invention is the simplest as shown in Figs. 1 and 2 and this embodiment can be used primarily for treating the ear and as a second application also the mouth, but for treating the eye and the nostrils different embodiments are required. Since the most expensive and most sensitive unit in the device is the laser 12, it is preferred to create a laser based treatment device which can be used for several different applications.

The common attribute of these other applications is that a laser light source is required to all these applications as a basis that has a large diameter of about 15-25 m and produces scattered light. An embodiment of the end portion of a universal device 20 designed this way is shown in Figs. 3-5 The hollow body of the device 20 shown in the enlarged sectional view of Fig. 3 has a conically widening head 21, in which a laser 22 is arranged that has the same design as the laser 12 shown in Fig. 1 but in given case it can have a higher output. In front of the laser 22 a beam expander 23 is arranged which consists of a concave lens made of a light transparent material, for example polycarbonate and its design is shown in Figures 4 and 5.

In Fig. 4 arrow 24 shows the direction of the propagation of the laser light. The entering cross-section of the beam expander 23 is smaller than the exiting cross-section. An inner surface 25 of the beam expander 23 which is facing the laser 22 is concave and its diameter is greater than the diameter of the incident beams and it is preferably covered with an antireflective coating. The preferred diameter of the concave surface 25 is e.g. 8 mm. The beam expander 23 widens in the direction of the light and has a flaring conical shape and it has a slightly convex or flat exiting surface 26 on which grooves 27 are arranged in a raster pattern. The grooves 27 consist of a plurality of small convex lenses arranged in a regular array and have respective spaces between them as shown in Fig. 5. The diameter of the exiting surface 26 is exemplarily and preferably 22 mm, which is nearly three times the diameter of the inner surface 25. The grooves 27 make sure that the light beams exiting the beam expander 23 will be scattered in all directions, however the luminance of the scattered light exiting the arrangement is substantially uniform. The material of the beam expander 23 is a transparent plastic or glass, its optical attenuation is negligibly low.

It can be seen in Fig. 3 that the head portion 21 protrudes in form of a sleeve 28 in front of the beam expander 23 and makes sure that an adapter needed and designed for the actual application can be attached to the device 20. The inside of the sleeve 28 is threaded in a preferred embodiment, and the required type of adapter can be releasably attached to the device 20 by means of a threaded connection. The design of the device 20 shown in Figs. 3-5 is known in itself and there were applications where it could be used as a standalone device without the connection of any adapter or with an adapter that could be inserted into the nostrils.

Now reference is made to Fig. 6 in which a preferred embodiment of the device 20 is shown which is capable of being used for the application according to the invention. A light conducting adapter 30 can be placed in the interior of the sleeve 28 which is releasably fixed thereto by an intermediate member 29 having e.g. an outer thread. The simplest way here is also the use of a threaded connection however an elastic, slightly convex rubber sleeve which can be pushed into and pulled out of the sleeve 28 can also serve this purpose. The light conducting adapter 30 is made of a transparent, stiff material, preferably of polycarbonate and along its length its diameter decreases in the direction of the passage of light. The decrease is not uniform, thus the light conducting adapter 30 has a conical rear section 31 which decreases in a greater extent, a middle section 32 whose cross-section slightly decreases and a front section 33 which is arced and curved and whose size allows to be fitted in the ear hole and can be inserted smoothly therein. The rear end face of the light conducting adapter 30 which is facing the beam expander 23 has a convex design and this facilitates the entry of the scattered laser light beams arriving from the device 20 into the light conducting adapter 30, and as a result of this design the so introduced light beams will be exposed to multiple reflections at the internal wall surface of the light conducting adapter 30, thus scattered light will exit the preferably convex end of the front section 33. The rear diameter of the rear section 31 of the light conducting adapter 30 is roughly identical with the diameter of the exiting surface 26 of the beam expander 23, the diameter of the end of the front section 33 of the beam expander 30 is around 7-8 mm (obviously smaller when treating children) and its total length preferably falls between 70 and 100 mm.

A polarizer 35 can be placed to the end of the front section 33 by means of a sleeve 36 similar to what is shown in Fig. 2 but as described earlier, the polarizer can also be formed on the end surface of the front section 33 in the form of a thin layer.

The light conducting adapter 30 can be cleaned and sterilized with an appropriate disinfectant after every use.

The treatments made by the devices 10 and 20 according to this invention will be equivalent if the same light power and wavelength of the light are used.

As it has been mentioned in the description of the prior art portion of this specification the light power used during such ear treatments is chosen generally not to exceed 5 mW. It has been recognized that the considerations establishing this power limit are not well grounded any more, and because of the scattered and non parallel nature of the light beams exiting from the device 10 or 20 the light will be distributed and scattered along a large surface, thus the power density which has taken a relatively dangerous value when the light beams were parallel (especially in case of small beam diameters ) even when the light power was only around 5 mW in case of using scattered light which is distributed along a much larger surface, a much higher light power can be allowed that provides the same specific intensity.

Therefore the treatments were carried out by using a device with a power of at least 25 mW. Initially the treatments were intended to provide biostimulation for treating tinnitus and inflammations occurring in the ear. An audiometric examination was carried out in almost every case during the treatments and it has been experienced with surprise during these audiometric examinations that in a substantial number of the treated patients a significant improvement in their hearing has occurred. The treatments have been done with lasers emitting light of 660 nm and 808 nm, respectively and the light power was increased into the range around 60 mW and sometimes even to higher levels, and it has been experienced that after 2 to 3 minutes long treatments once or twice a day, a perceptible improvement in the hearing of the patients has taken place even after a few days treatment, and the gradual improvement has become stabilized and ceased to continue any further after 2 to 3 months of treatment (differing at different subjects), and the achieved improved state of hearing has been sustained. The extent of the improvement was different for every subject but in the average of a group of 20 people the extent of the improvement was around 15 dB even after the first treatments, which can be regarded as a very significant figure.

There were a few old patients who suffered from elderly deafness and were treated initially in order to facilitate the healing of inflammations or wounds which were present in their ears. The improvement of the hearing in the case of these old deaf patients took place in a miraculous way, since specialists have previously determined and declared that the hearing loss of these elderly people was permanent and not curable, however, with such treatments they have regained their hearing to such a healthy level which they had experienced only during their youth, whereby the quality of their life has made a sudden improvement.

It has been supposed that in the red to infrared spectral ranges the beams can penetrate deep into the tissues but their energy gradually decreases because of the attenuation caused by the tissues. Because of the higher light power used, the biological processes might have accelerated in the deeper tissues, and the circulation in the capillaries has improved which might have caused the experienced improvement in the quality of hearing.

A slightly increased improvement was experienced when polarized light was used.

Although the primary indication of the device according to the invention is to improve hearing, at the same time it is perfectly capable of decreasing inflammations, wounds and certain types of pain occurring in the mouth. Although the application of lasers for treating the mouth is known, the higher power and especially the restoration of the polarization ensured by the device according to the invention has resulted in a faster and more efficient improvement.

The fact that the second embodiment of the invention is additionally capable of carrying out these last mentioned treatments when different adaptors are coupled to the same basic device other treatments can also be carried out. Therefore, it can be sufficient to invest a single piece of this expensive basic laser device for the whole family or in case of a smaller medical department, and separate adapters can be attached to the same basic device by the respective family members when they need different kinds of laser treatments. The price of the suitable adapters is only a fragment of the price of the whole device.