rexresearch.com


Fenyo MARTA
Polarized Light Therapy


http://www.sensolite.com/



The invention

At the beginning of the 1980s a young Hungarian physicist, Márta Fenyo and her research team discovered the stimulative effect of polarized light on all living biological systems, including the significant invigoration of the self-healing abilities of the human body, when used in human therapy. This is mainly explained by the effect of polarized light on the regeneration, revitalization and harmonization of cell function.

Jointly with her team the inventor developed and created the lamp emitting polarized light designed for the treatment of human body. After all, the first therapeutic apparatus based on the Hungarian invention started its worldwide career in Switzerland. Since then this healing apparatus has become indispensable for doctors, hospitals, clinics, private practitioners and private persons. Millions of people use this healing lamp the world over, with excellent results.

The sources of polarized light manufactured earlier were designed to conduct successful treatment of only restricted surfaces at a time. Even this design of the apparatus was highly successful in the treatment of various skin problems, wounds, arthritis, sports injuries, and head skin and hair problems.

THE LATEST DEVELOPMENT

The research conducted so far and the results achieved have decidedly proven that, along with the local treatments, polarized light therapy has new and amazing opportunities. In the background of all spectacular cases of local healing is invariably the stimulating effect of polarized light on the immune system, blood circulation and oxygen supply of the cells. Based on the findings of recent years this effect can now be amplified to cover, in a single treatment of relatively short duration, the entire surface of the human body whereby the effect of biological stimulation is rapidly transmitted to all cells of the body, positively influencing their function.

When treating the entire surface of the body the polarized light immediately gets through to the blood stream via the capillary veins thanks to the roughly 1 cm penetration depth, thus rapidly transmitting through the blood circulation the biological stimulation effect to all cells and vital organs of the human organism such as the heart, the liver, the stomach, the spleen, the kidneys and the endocrine glands, etc., thereby exerting a systemic effect on their function.

WHAT ARE THE BENEFICIAL EFFECTS OF THE SURROUND BODY-SURFACE LIGHT TREATMENT?

Polarized light significantly enhances the activity of the immune-competent cells, stabilises the cell membrane of red blood cells and enhances their ability to bind and retain oxygen.

The treatment using polarized light significantly stimulates the activity of T-lymphocytes responsible for recognising and defeating millions of faulty cells produced minute by minute in the human body that subsequently become responsible for serious illnesses and malignant deformations, thereby preventing more or less serious illnesses as well as facilitating and accelerating the recovery from protracted illnesses.

Through the enhanced ability of the red blood cells to bind and retain oxygen more vital oxygen becomes available for each cell, organ and system thereby enhancing the efficiency of musculature and vital organs in growth and function. To sum up, body surface surround treatment using polarized light may significantly strengthen the immunization of the entire system

Fields of application
 
For the preservation of health
Prevention, improvement of general health condition,
boosting of endurance
Strengthening of the immune system and resistance (prevention of diseases, viral / bacterial and mycotic infections)
Boosting of physical and intellectual performance
Energizing in the case of fatigue and exhaustion
Stimulation of the brain function
Improvement of concentration
Cheering-up



http://www.facebook.com/pages/Dr-Fenyo-Márta/103494999734268?

Dr. Fenyo Márta





http://www.youtube.com/watch?v=RkIzlCmfpOk?

Sensolite Fenyo Márta


http://hu.wikipedia.org/wiki/Feny%C5%91_M%C3%A1rta

Biography ( in Hungarian )


PATENTS

WO2011033329
LIGHT THERAPY DEVICE

Light therapy device for treating the surface of a living organism. The device contains a light emitting surface (2) in which a plurality of light emitting devices are arranged. The light emitting surface (2) has a tunnel-like shape and is adapted to surround at least partially the surface of the living organism in longitudinal direction, and the light emitting devices are LED devices (3) provided with linear polarizing filter (4). The direction of linear polarization of the polarizing filter (4) is in the direction of the longitudinal axis of said tunnel-like light emitting surface (2).



US2011106223
LIGHT THERAPY SKIN CARE DEVICE

The invention is a light therapy skin care device that includes light sources in a layout that is configured for lighting of human body's given skin surfaces (B) or its parts. Among light sources, there is a UV light emitting and a UV-free light emitting device, the light sources are connected to a controlled driver unit. The light sources are divided in two groups, where in the first group there are (1) UV light emitting light sources, in the second group (2) UV-free light emitting light sources, and at least one part of the light sources of the second group (2) emits polarised light towards the skin surface (B). The controlled driver unit is configured to control light emission of the light sources of the first (1) and second (2) groups and/or their proportion.



US7661834
Lighting Unit for Producing Linearly Polarized Light Directed Onto a Target Surface


Inventor:
FENYO MARTA

Lighting unit for producing linearly polarized light directed onto a target surface comprising a source unit producing light in the visible spectral range, and an optically translucent polarizing front unit ( 4 ) providing protection against external effects. The source unit and the polarizing front unit ( 4 ) are placed in a housing ( 8 ) in which an electric cable passes through. The source unit ( 1 ) contains at least one panel ( 2 ) having a number of high intensity LED devices ( 3 ) arranged in a predetermined pattern on one of its sides. The polarizing front unit ( 4 ) contains at least one optically transparent rigid carrier and a polarizing filter foil applied onto the carrier. The housing ( 8 ) keeps the polarizing front unit ( 4 ) in a fixed position so that they confine a hermetically closed inner space.; The panel ( 2 ) is positioned parallel with the polarizing unit ( 4 ) within the inner space so that the LED devices ( 3 ) face towards the polarizing front unit ( 4 ).

[0001] The invention relates to a lighting unit for producing linearly polarized light directed onto a target surface, the lighting unit comprises at least a source unit producing light in the visible spectral range and an optically translucent polarizing front unit providing protection against external effects, the source unit and the polarizing front unit are placed in a housing in which an electric cable passes through.

[0002] It is known that polarized, especially linearly polarized light is beneficial to vital functions and is capable for strengthening the organism to combat disorders. In case of humans it can be used for general conditioning. In case of animal husbandry it can be used in order to increase yield and to treat certain inflammatory diseases.

[0003] Consequently, a compact lighting unit is needed which can be installed easily and is able to emit light with required intensity in the proper direction. Advantageously the units are extendable by simple multiplication of them depending on the purpose and the circumstances.

[0004] EP 0,279,002 described an arrangement for producing polarized light where the spectral range of the emitted light is basically found in the UV range. There is no proposal for special use of the polarized light in the visible range.

[0005] At the same time U.S. Pat. No. 4,612,604 described a polarizer of the Brewster kind to create biostimulation. The light emission efficiency is, however, not properly handled.

[0006] The document WO 9309847 disclosed a device for photometric stimulation of living cells, where diodes produce light in three separate wavelengths. The solution lacks continual emitted light wavelength in a given range, therefore no sufficient effects on the living cells were experienced.

[0007] It has been realized that the recently available relatively cheap so called high intensity LED devices with growing light output and improved efficiency are suitable for embodiments of divided units or panels substantially emitting light from a plane in a continuous wavelength range, and may be used for forming a lighting unit according to the object of the invention.

[0008] Accordingly, the source unit of the lighting equipment described in the preamble contains at least one panel which has a number of high intensity LED devices arranged in a predetermined pattern on one of its sides. The polarizing front unit contains at least one optically transparent rigid carrier, and a polarizing filter foil applied onto the carrier. At least a portion of the housing is made from heat conductive material, and it keeps the polarizing front unit in a fixed position so that they confine a hermetically closed inner space. The panel is positioned in a fixed way parallel with the polarizing unit within the inner space so that the high intensity LED devices face towards the polarizing front unit.

[0009] A detailed description of embodiments of the lighting unit according to the invention will now be disclosed with reference to the accompanying drawings in which:

[0010] FIG. 1 is a perspective view of a fragment of an exemplary lighting unit according to the invention;



[0011] FIG. 2 is a sectional view of the lighting unit of FIG. 1;

[0012] FIG. 3 is a sectional view of a first example embodiment of the polarizing front unit;

[0013] FIG. 4 is a sectional view of a second example embodiment of the polarizing front unit;

[0014] FIG. 5 shows the LED devices arranged in a first pattern;



[0015] FIG. 6 shows the LED devices arranged in a second pattern;

[0016] FIG. 7 shows the LED devices arranged in a third pattern;

[0017] FIG. 8 shows the shape and parts of one of the elements of FIG. 7;

[0018] FIG. 9 shows the LED devices arranged in a fourth pattern;

[0019] FIG. 10 shows the LED devices arranged in a fifth pattern;

[0020] FIG. 11 is a block diagram showing the collimation of the light beams of the LED devices;

[0021] FIG. 12 shows an embodiment of the lighting unit according to the invention when it is bent cylindrically in one dimension;



[0022] FIG. 13 shows another embodiment of the lighting unit according to the invention when it is bent cylindrically in one dimension;

[0023] FIG. 14 is a schematic view of a cylindriform lighting unit according to the invention; and

[0024] FIG. 15 is a schematic view of an extended lighting unit comprising several units connected to each other.

[0025] FIG. 1 is a perspective view of a fragment of an exemplary lighting unit according to the invention, in which a source unit 1 producing light in the
visible and near infrared spectral range and an optically translucent polarizing front unit 4 providing protection against external effects can be seen. Source unit 1 and polarizing unit 4 are placed in a housing 8. Source unit 1 contains at least one panel 2 which has a number of high intensity LED devices 3 arranged in a predetermined pattern on one of its sides. In FIG. 1 this pattern is a matrix. An electric cabel (not shown) passing somewhere through housing 8 supplies energy for LED devices 3. The same source unit 1 may contain a number of separate panels 2 or these panels may be attached to each other in a releasable manner.

[0026] According to FIG. 2 the polarizing front unit 4 contains at least one optically transparent rigid carrier 5 and a polarizing filter foil 7 applied onto the carrier 5. At least a portion of housing 8 is made from heat conductive material, for example metal in order to reduce the heat developing during operation. To reduce the heat of the inner space 11 also any other known means, for example heat-insulating paint layer might be proper. Polarizing front unit 4 is fixed to housing 8 by means of a frame 9 so that they confine a hermetically closed inner space 11. Panel 2 is positioned in a fixed way parallel with the polarizing front unit 4 within inner space 11 so that the high intensity LED devices 3 face towards the polarizing front unit 4. Optionally, cooling flange 16 may also be applied at the bottom part of housing 8 in order to reduce heat developing in the inner space 11.

[0027] In respect of this invention the term LED devices is used for all high-efficiency light emitting semiconductor devices and structures currently manufactured in mass-production and available in trade. These devices and structures are continuously developed in order to reach higher and higher luminous efficiency. Such devices emit light within the visible and near infrared spectral range in the form of white light which may have different colour temperatures. In the present invention the term LED devices 3 is used in a comprehensive meaning, especially for known high-intensity, high-power LED (Light Emitting Diode) or OLED (Organic Light Emitting Diode) devices. The latter renders possible to use a plane luminous foil which-theoretically-may be cut to an optional size. Also LEP (Light Emitting Polymer) devices may be used. To sum it up, according to the present invention all those devices may be regarded as LED devices 3 which are known as SSL (Solid State Lighting) electronic devices in the state of the art. Current possibilities in trade make dominantly the use of discrete LED devices feasible.

[0028] FIG. 3 shows the cross-section of a possible structure of the polarizing front unit 4. The optically transparent rigid carrier 5 together with a similar carrier 6 form a sandwich structure surrounding the polarizing filter foil 7. This polarizing filter foil may be applied onto either carrier 5 or carrier 6. Application may be performed by sticking, heat-treatment, etc. It is also possible that polarizing filter foil 7 is simply kept in its place by exertion of a mechanical force. Polarizing filter foils are known and commercially available. Advantageously, the polarizing filter foil 7 is highly transparent, preferably it has a light-transmitting capacity of more than 40%. Advantageously, the carriers 5 and 6 are made of plexi-glass, transparent polycarbonate or similar plastic material, however glass or hardened glass may also be appropriate.

[0029] According to FIG. 4 only a single carrier 5 is used. In this case polarizing front unit 4 contains a polarizing filter foil 7 applied onto carrier 5 by using one of the applying methods previously described.

[0030] As it was mentioned LED devices 3 are arranged on one of the sides of panel 2 in a predetermined pattern. This pattern may be a matrix containing a number of rows m and columns n as it is shown in FIG. 5 or the LED devices 3 may be arranged concentrically as it can be seen in FIG. 6. Further, the LED devices 3 may be arranged in an undulating line as it is shown in FIG. 9 or they may be distributed along a straight line according to FIG. 10. As it is shown in FIG. 7 the light source may be different in the same pattern. In this case in addition to LED devices 3 compound LED devices 13 containing several LED components 3' arranged in a starlike pattern as shown in FIG. 8 may be used. These LED devices 13 are available in trade. The LED devices 3 and compound LED devices 13 may be arranged in like manner as it is shown in FIG. 6.

[0031] Preferably, in certain applications most of the LED devices 3 placed in the lighting unit emit warm white light. However, it is possible that a small number of LED devices 3 emitting coloured light are also applied.

[0032] It is an object of the lighting unit according to the invention to produce relatively directed linearly polarized light instead of diffused light with divergent beams. For this purpose an additional optical element 15 decreasing the light emitting space angle [alpha] of the LED devices 3 may be positioned before the LED devices 3 or at least before some of them. This can be a lens as it is shown in FIG. 11. The original space angle [alpha] of the light emitted from LED device 3 is cut down to space angle [beta] by means of the optical element (lens) 15. Space angle 1 is smaller than space angle [alpha]. It proves to be good if the resultant space angle 1 before the polarizing front unit 4 has an aperture angle of 10-50[deg.]. For practical purposes in case of large surfaces the optically transparent rigid carriers 5 or 6 of polarizing front unit 4 may contain a Fresnel lens.

[0033] The lighting unit according to the invention can be used for certain therapeutic purposes-not detailed in the present description-if the intensity of the resultant light measured at a distance of 0.5 m from the polarizing front unit 4 is between 5-60 mW/cm<2> . Advantageously this value is between 30-40 mW/cm<2> .

[0034] An alternative embodiment of the lighting unit described with reference to FIG. 1 can be seen in FIG. 12. Panel 12 of the source unit is bent so that it has a convex surface with respect to polarizing front unit 14. Polarizing front unit 14 is bent similarly. In this manner the distance between panel 12 and polarizing front unit 14 is constant. These bendings must be performed in one dimension (in order to guarantee linear polarization) and they result in a cylindrical surface, as it is shown in FIG. 12. The direction of polarization of the polarizing filter foil 7 is parallel with the axis of the cylinder. The shape of the housing 18 is optional, it may be different from the one shown in the Figure. Advantageously, its inner surface is coated with light-reflecting material.

[0035] In another alternative embodiment shown in FIG. 13 the filter and the light source are interchanged, and panel 12' containing LED devices 3 is bent so that it has a concave surface with respect to polarizing front unit 14'. Again, the shape of the housing 18' is optional, it may be different from the one shown in the Figure.

[0036] An extended version of the embodiments shown in FIGS. 12 and 13 can bee seen in FIG. 14 in which the bendings result in a complete cylinder. Cylinder surfaces 20 and 21 are not designated as panels 12, 12' or polarizing front units 14, 14' indicating by this that they are interchangeable.

[0037] The lighting unit according to the invention in its entirety may be disc-shaped or parallelepiped. Especially the latter has an advantage that the shape of the individual lighting units makes possible to extend it by further units, i.e. several lighting units can be connected (both mechanically and electrically) to each other easily. In FIG. 15 the side of housing 8 is provided with a mechanical connecting element 10 by means of which a plurality of rectangular lighting units 22 can be connected to each other so that their polarizing front units are in the same plane. Connecting elements 10 may be provided on all four sides of the housing 8 while counterparts are formed on the opposite sides. In this manner extension according to FIG. 15 can be performed easily. Connecting element 10 is also shown symbolically in FIG. 1.

[0038] The lighting unit according to the present invention has several advantages, for example in the specific utilization of the enhancement of the productivity of dairy farms. Any other kind of breeding animals can also be a scope of utilisation of the present invention. It can be implemented simply, it is mobile and can be extended easily without the need for changing the already installed units. Further, it does not get overheated in spite of the dust- and vapour-resistant closed housing.



WO0145780
PROCESS AND APPARATUS FOR RELAXING HUMAN ORGANISM AND IMPROVING GENERAL CONDITION



Inventor:
FENYO MARTA [HU]     

A procedure for relaxing the human organism, improving its general condition, increasing the capability of its natural protective mechanism, alleviating the state of stress, improving the frame of mind and balancing the blood- and lymph-circulation. During the procedure the patient is made comfortable in a sitting and/or reclining position and is exposed to polarised light of at least 100 but at most 400 Lux intensity, and the light treatment has a duration of at least 20 minutes, and during the whole light treatment at least 4 J but preferably 10 J per cm<2> energy is transmitted to the patient, and simultaneously with the light treatment also sound therapy is applied with an intensity of at least 30dB, but at most 80 dB. Additionally appropriate aroma- and oxygen- therapy is applied.

The invention relates to an arrangement for relaxing the human organism, improving its general condition and for increasing the capability of its natu
ral protective mechanism, alleviating the state of stress, improving the frame of mind and the capacity to perform, balancing the blood-and lymph-circulation, comprising a source of light arranged in an enclosed place and a sitting or reclining contrivance.

HU 186 081 describes an equipment aimed at stimulating the biologic processes connected with the cellular activity, especially at aiding the healing of
the pathologic formations located on the surface of the body e. g. wounds, sores and other lesions, containing a light source producing light of a wavelength in excess of 300 nanometers. There are a polariser and a light deflector system integrated to the light source producing incoherent light ; the light deflector system aligns the light beam into the required direction. The polariser is either attached to the light source or separated from it.

It is a generally accepted concept that both the negative environmental effects and the stress or other negative psychic effects weaken the human immune system.

There is very limited opportunity and time to counterbalance these negative effects under the present conditions and conduct of life. It would be highly desirable to compensate all these negative effects. (See 0. Carl Simonton, Stephanie Matthews-Simonton, James L. Creighton : Getting Well Again (1978, Bantam Books, New York-Toronto-London-Sidney-Auckland, as well as Ernest Lawrence Rossi : Psychobiology of Mind-Body Heating (1986), Norton ISBN 0393-30554-6).

It is a known and experimentally proved fact that the treatment with polarised light has a stimulating effect on the immune system, it improves the peripheral circulation of blood and stimulates the metabolism of the tissues on the body surface and below. (See : Fenyo, M. : Theoretical and Experimental Basis of Biostimulation (Optics and Laser-Technology, 1984 ; 16 : 209-215 ; Kubasova T., Fenyo, M. et al. : Investigations on Biological Effects of Polarised Light (Photochemistry and Photobiology, Vol. 48, No. 4. Pp. 505-509, 1988, and Kubasova T., Fenyo, M. : Effect of Visible Light on Some Cellular and Immune Parameters (Immunology and Cell Biology, Vol. 73, pp. 239-244, 1995).

Physiotherapeutic treatments are generally applied in a successive manner, successively (and independently from one another) while the skilled persons responsible for the treatment monitor the effect achieved during the treatment. In order to avoid the unfavourable co-effect of the treatments and also for the better monitoring of them, it is not customary to apply simultaneously the different treatments.

In this context our experience shows that the treatment with polarised light can be applied simultaneously with other treatments without significant
danger of unfavourable co-effect.

We have recognised that the negative effects can be counterbalanced far more effectively if the light treatment using polarised light to stimulate the immune system is combined with other treatments and/or the stimulation of the sensory organs.

Not only the intensity and the quantity of transmitted energy are important in the treatment with polarised light, but also the colour of the light and even the sight registered with the sensory organ. From a mentalistic aspect the use of suitable sound effect and/or aroma therapy during the light treatment are especially important. Suitable physical stimulations, too have a favourable effect on the results of the treatment with polarised light.

The increase of the oxygen contents and especially of the negative oxygen ion contents of the inhaled air shows favourable physiological effects in the case of all healthy cells of the organism.

When applying stimulus to the sensory organs we have noted that the treatment of a significant part of the body surface with polarised light (for instance one whole side of the body) besides stimulating the immune system WO 01/457803 showed favourable effects both on the metabolism and on the performance capacity and mood of the person treated.

The deficiency of the known equipment is that it is suitable only to stimulate locally the biologic processes connected with the cellular activity.

We have recognised that by applying polarised light of a suitable colour and intensity to the treatment of the entire body and complementing it with
suitably selected sound effects, it is possible to relax the human organism and to improve its general condition. Simultaneously the capability of the natural protective mechanism of the organism increases, the state of stress is alleviated, the blood-and lymph-circulation becomes more balanced and the performance capacity and mood of the treated person improves.

Based on this recognition, a process was developed to relax the human organism, improve its general condition, reduce the state of stress, improve its
performance capability and mood, and to balance the blood-and lymph circulation. In this process a person or patient to be treated is placed in a com
fortable sitting and/or reclining position and is illuminated with a light of suitable intensity. Light treatment is applied for at least 20 but at most 60 minutes. During the full time of this light treatment the patient receives at least 4 J, preferably 10 J but at most 40 J energy per cm2. For values below 4 J either the positive effect becomes negligible or the time of treatment must be continued for unacceptably long periods ; for values over 40 J undesired skin reaction could occur and the too intensive light prevents relaxing. In parallel to the light treatment also sound therapy is applied, having a volume of at least 30 dB, but at most 80 dB. Volumes below 30 dB in a city environment are commensurable with the background noise and therefore lower values, for instance 20 dB can only be used in a very quiet environment. Volumes over 80 dB in most cases do not help relaxation.

Well-known physiotherapeutic treatments like for instance massaging and different electric treatments are applied in conjunction with the light treat
ment and sound therapy if required.

Optionally aroma therapy treatments are applied with the use of suitable aromas in parallel with the light treatment. The harmonisation of the appropriate colour and aroma is of particular importance.

Optionally also visual treatment can be applied in conjunction with the light treatment and sound therapy wherein suitable equipment is used to stimulate the patient with visual effects. Clearly, the colour of the light treatment, the sound effects and the visual effects must harmonise.

It is also possible to monitor the physical condition of the patient during the treatment, for instance the frequency of respiration or heart-beat, blood
pressure, skin resistance, frequency of motions, etc. On the basis of these data the effect achieved by the treatment can be observed and monitored during the treatment, the intensity and duration of the treatment can be adjusted, e. g. weakened, shortened or can be strengthened, intensified and lengthened, respectively, as necessary.

Before starting the light treatment it is necessary to determine the colour and intensity of the light treatment and the character and volume of the sound therapy to be applied in parallel. It can be determined also how the intensity and the colour of the light treatment should change during the light treatment and how should the different sound effects and their volume change.

If necessary, the above prescription has to be complemented by prescribing the duration of the applied physiotherapy and if different types of physiotherapeutical treatments are applied, their sequence and intensity.

Light treatment can be complemented by oxygen treatment where the concentration of ionised oxygen of the air inhaled by the patient is increased.

All these different treatments have therapeutic effect both in conjunction and separately, too. Their joint application however is more far-reaching. For instance, with the use of adequate sound-and image-effects the process of relaxation and learning can be deepened and accelerated. In general it is possible to influence the state of consciousness while instead of becoming tired the patient becomes more lively and his capacity to perform increases significantly.

Our experiences prove that this is enhanced by the polarised character of the light.

In the sense of the invention we have developed an arrangement for relaxing the human organism, improving the general well-being and mood of the
patient, for increasing his capacity to perform and the capability of his natural protective mechanism, for alleviating the state of stress and for balancing the blood-and lymph-circulation, with the arrangement comprising a light source arranged in an enclosed place and a contrivance for sitting and/or reclining. In accordance with the invention there is a polarised filter placed at a distance of at least one of the walls of the room, covering 50% but at least 4 m2 of the wall in question. The light sources are located between the polarising filter and the said wall of the room. The size of the surface illuminated by the light source must be enough to cover in full the reclining and/or sitting contrivance. The light sources emit different light spectrums and each spectrum has a characteristic colour. A colour adjustment device is connected to the light sources which switches on the different colour light sources as prescribed. Furthermore there is at least one loudspeaker in the room, connected to an audio-amplifying equipment In accordance with the invention a physiotherapeutic device, for instance a massaging device can be advantageously connected to the reclining and/or sitting contrivance. Furthermore there is a displaying device, for instance a projection screen is arranged advantageously in the room to which a projecting device, for instance a projector or a video-player is connected.

The room can be equipped also with an oxygen source, with the aid of which for instance, through a mask, the patient can inhale air with high ionised oxygen concentration, and can inhale in this same manner also the appropriate aromatic material. Both the light sources, the physiotherapeutic equipment, the sound sources (acoustical generator) and the aroma source can be connected to a central controller unit through the controllers attached to the different devices.

Sensors connected to the data collector can be arranged near to or attached to the reclining and/or sitting contrivance. The data collector, too, is connected to the central controlling unit. The room can further be equipped with decorations, for instance with a background picture. If necessary, the back WO 01/457806 ground picture can be set up in a manner to allow variability.

The invention will be described on the basis of the attached drawing. In the drawing Figure 1. is the schematic design of the arrangement of the subject matter of the invention.

The implementation shown in Figure 1 is arranged in an enclosed place (room) 1, where a polarising filter 2 is placed below the ceiling 7 at a distance
from it. The polarising filter 2 covers the largest part of the ceiling 7 of the room 1, in the present arrangement part of the room 1 is sectioned out with the partitioning wall 21 and the polarising filter 2 is set up to this partitioning wall 21.

There are light sources 3 arranged between the polarising filter 2 and the ceiling 7, made in the form of fluorescent lamps of different colours and radiating in different spectral ranges. Near to one of the walls of the room 1 there is a reclining and/or sitting contrivance 4 arranged in a position, that allows the person in it to see the furthest wall of the room 1. There is an opening 22 made on the partitioning wall 21 through which the displaying device, for instance projection screen 15 mounted or placed on the wall of the room 1 behind the partitioning wall 21 can be seen. There are loudspeakers 5 in the room 1, which in this case are placed at the two opposite sides of the partitioning wall 21. Furthermore, decoration 6 can be installed in the room 1. There are furthermore an ionizator 18 and an aroma source 14 installed in the room 1. The colour adjustment unit 8 controlling the light sources 3 and the audio-amplifying equipment 9 are connected to the central control unit 12. A physiotherapeutic equipment 10, for in
stance a massaging device, electro-therapeutic device, etc can be attached to the reclining and/or sitting contrivance. Different sensors connected to a data collector 13 can also be attached to the reclining and/or sitting contrivance 4.

With the aid of these sensors it is possible to collect data about the frequency of heart beat or breathing, blood pressure, motions and the different parameters indicating the physical state of the patient being in the reclining and/or sitting contrivance 4.

It is very important, especially if the environment is polluted, to have an WO 01/457807 aerator 20 installed in the room 1 which-equipped with a suitable air filter-will blow clean air into the room 1. An oxygen source 19 can also be connected to the aerator 20 to increase the oxygen concentration in the room 1. An aroma source controller 11 can be connected to the aroma source 14 which can be set up in a form suitable to emit in a controlled manner one or more aromas, equipped for instance with a controllable heating device-which, if adjusted as prescribed can emit different fragrances into the room 1 for the prescribed length of time and in the prescribed order. The aroma source 14 can be combined also with the aerator 20, in which case the air blown in contains the desired aroma. These devices can be combined and then it will be possible to use a device which contains an air filter, a source of oxygen (discharger), an ionizator and also an aroma source. The outlet of the device is-through a flexible tube-connected to a mask which can be put on the face of the patient. Different appliances can be installed in the part of the room 1 separated by the partitioning wall 21, preferably outside the field of vision of the person in the reclining and/or sitting contrivance 4. Such appliance could be for instance the projector 16 associated with the displaying device 15, which projects motion pictures onto the displaying device 15 with the aid of suitable optical accessories, for instance mirrors. The projector 16 could for instance be a video player, while the displaying device 15 could be a large size screen connected to it. One or more different background pictures 17 can also be set up in this separate part of the room 1, which can be mounted on the displaying device 15 or the displaying device 15 can be covered by those.

There should preferably be among the light sources 3 types that emit rays in the ultra violet range (UV-A and UV-B), this should only be done how
ever if the polarising filter 2 is permeable for the radiation in that range. If the polarising filter 2 is not permeable for these ultra violet rays, a separate source of light emitting ultra violet rays could be installed in the room 1, which polarises the ultra violet rays with the aid of suitable optical accessories, for instance with mirrors or filters. This is important because the ultra violet radiation, in spite of all its useful characteristics, can also have harmful effects in certain cases (for WO 01/457808 instance it is known to have carcinogen effect), and these harmful effects can be counterbalanced with polarisation. Polarised light has a stimulating effect on the immune system and it has been proved experimentally that it is useful in arresting and inhibiting the generation or propagation of malign skin deformations.

Thus physiologically polarised ultra violet light is far more favourable than the not polarised one.

There is an adequate number of light tubes mounted on the ceiling 7 of the room 1 in such a manner that there are 6-10 light tubes of different colours
for each 50 cm area evenly distributed by colour.

It is evident that by turning on light tubes in the appropriate number and colour, both the intensity and the colour of the light can be varied within broad
limits. The physiologic effect of light is known and in certain cases is used to influence the state of mind and mood of people. All these effects are enhanced if the immune system of the patient is stimulated with the help of polarised light in parallel with influencing his state of mind. A very positive effect can be achieved by simultaneously improving the state of mind and the performance capacity as well as stimulating the immune system, and stress alleviation effect can be achieved with light treatment of appropriate intensity, colour and duration.

The stress alleviation and relaxing effect of the treatment with polarised light can be enhanced with a sound (audio) treatment applied simultaneously.

With the aid of the audio-amplifying equipment 9 used in the arrangement of the subject matter of the invention the sound, music, noise or background noise corresponding to the desired effect can be produced. Audio tapes, records, synthetisers equipped with suitable programming device, computer, etc. can be used for this purpose, but also other sound generating devices can be utilised, for instance gongs, bells, whistles or other musical instruments.

Certain people feel isolated if they are alone in an enclosed place, room 1. This unpleasant feeling can be significantly reduced with the use of decora
tion 6 which effectively enhances the visual effect exercised through the displaying device 15.

Naturally, it is possible to set up more than one reclining and/or sitting contrivances 4 in the room 1 and thus the different services and treatments can
be offered to several people simultaneously. Naturally, in the treatment of more than one person the provision of the individual programs cannot clash, and therefore the arrangement of the subject matter of the invention on occasions will provide treatment to one person only.

Before starting the procedure which is made possible by the arrangement of the subject matter of the invention, it is necessary to prescribe the steps to be taken, their intensity, duration and sequence. The spectrum to be used (dominant colour, UV-A and UV-B components), the intensity and the fragrances to be used in parallel to them must be determined taking into account the desired effect and the condition of the patient to be treated. The most important aim when determining the sound effect to be used is for it to produce the effect that suits the wishes and health condition of the patient (stress alleviation, relaxation, increase of performance, deepening of knowledge, etc.).



It can be seen that by the arrangement of the subject matter of the invention, a procedure based on the use of polarised light is suitable for a large variety of uses. It is however important to note that the treatment is ineffective if the energy of the light treatment remains below the value of 4 J per cm2 for one treatment. There is practically no upper limit, but in the case of too intensive illumination (with an intensity of over 500 Lux) the light can be disturbing and thus the beneficial effect can be diminished. For this reason, the use of illumination has to happen with an intensity between 100-400 Lux but preferably with 200 Lux.

It is important principally from the aspect of relaxation and stress allevia- tion that the duration of the treatment be at least 20 minutes, but preferably 30 minutes. In the case of treatments of more than 60 minutes the beneficial effect will not increase noticeably. The treatment is more effective if it is periodically repeated for instance every day or at least every week. It is beneficial to apply the treatment in the form of a cure, and a cure should preferably comprise 6-12 sessions. The cure could be advantageously complemented by a diet or nutrition complements ; food additives, teas, medicinal herbs can be used in parallel.



US4686986
Method and apparatus for promoting healing

Inventor:
FENYO MARTA
ANTAL TIBOR (+2)     

FIELD AND BACKGROUND OF THE INVENTION

A method and apparatus for the stimulation of biological processes related to cellular activity, particularly for promoting the healing of lesions on the body surface i.e. wounds, ulcers and various epithelial injuries.

The invention relates to a method and apparatus for the stimulation of biological processes related to cellular activity, particularly for promoting the healing of lesions on the body-surface i.e. wounds, ulcers and various epithelial injuries, which is based upon the use of the biostimulating effect of light.

The irradiation of a living surface with laser light has, as it is widely known, a biostimulating effect. The experiments in this field have been conducted since 1967 under the guidance of professor Endre Mester and the initially modest presumptions have been broadly proven since that time. The healing effect of the treatment with laser light has already a very broad literature. The summary of experiences is included among other publications e.g. in the work of professor Endre Mester: "Laser Application in Promoting of Wound-Healing", published in the 1980 issue of the "Laser in Medicine" (edited by H. K. Koebner, Wiley-Interscience Publ. 1980.). Another work by professor Endre Mester: "Der Laser" can also be regarded as a summary of his experiences (edited by K. Dinstl and P. L. Fischer, Springer-Verlag, 1981.). It should be noted that in contrast to the laser light, no other treatments carried out by natural or artificial light have manifested any biostimulating effect thus far.

The healing effect of the laser light becomes apparent mainly in the healing of refractory wounds and ulcers. It is well known that such lingering ulcers develop fairly frequently on aged people suffering from cardiovascular troubles. Refractory bed-sores also tend to develop as a consequence of prolonged decubitus.

In the course of treatment with laser light, the laser light is directed onto the wound by means of a prism, a mirror or a fibre-optic and the entire surface of the wound is scanned by the correspondingly deflected beam. The specific intensity of the beam is between 20-150 mW/cm@2, and the maximum energy density is set to be about 4 J/cm@2. The treatment is usually recurrent, performed generally twice a week and the average time of healing is estimated to be about 10-12 weeks.

There are a great number of mutually contradictory theories, attempting to explain the biostimulating effect of the laser light, however, none of these could provide a scientifically acceptable explanation.

On the basis of the published results laser light would have a wide field of application, however, practical experiences show that it did not come into general use to an extent which it would deserve by its efficiency.

There are several reasons that slow down the wide scale acceptance of this treatment, one of which might be that the design of continuously operating lasers providing the required output and beam diameter is rather complicated and besides the sophisticated technical environment they also require special skills during manufacture.

SUMMARY OF THE INVENTION

The object of the invention is to provide a method and an apparatus that can establish a biostimulating effect, at least equivalent to that of the laser light, without the technical difficulties connected with the generation of laser light.

For solving this task it has been considered as a starting point that in its physiological state, the lipid bilayer of the cell membrane is in a phase similar to that of liquid crystals. It is known from the interaction between polarized light and liquid crystals, that over a certain intensity threshold polarized light can induce a change of state in liquid crystals. It has been assumed that polarized light of certain properties can reorder the polar heads of the lipid bilayer of the cell membrane or it can induce such a reordering process. It has also been expected that such an internal re-arrangement would bring about a noticable change in the cellular processes related to and taking place through the cell membrane.

The essence of the invention is the recognition of the fact, that the biostimulating effect is attributable in the first place to the application of polarized light rather than to that of laser light, and the laser light has such an effect only because it represents a form of polarized light, too. Consequently, the normal, incoherent light can also trigger a biostimulating effect, provided it is linearly polarized.

According to the invention a method has been provided for the stimulation of biological processes related to cellular activity, particularly for promoting the healing of lesions on the body-surface, i.e. wounds, ulcers and various epithelial injuries, during which the pathological area is irradiated with a light of given intensity in which the improvement lies in that the irradiation is carried out by a linearly polarized light containing non-coherent components of wavelength exceeding 300 nm.

According to a preferable embodiment the intensity of the irradiating light is adjusted between 20 and 150 mW/cm@2.

It is advantageous for the healing process if the irradiation is carried out in intermittent periods and the energy density of the light during the treatment does not exceed 5 J/cm@2. With such an energy the re-arrangement process in the membrane can reach a saturation and the application of higher energies might not provide further benefits.

The light beam used for the treatment should comprise substantially parallel rays of continuous or quasi-continuous spectral distribution at least in the 400-700 nm wave-length range and the beam should fall substantially normal to the surface to be treated.

If the sectional area of the light bundle is less than the area of the pathological body-surface to be treated, it is expedient to perform irradiation by displacing the beam of light and the area under treatment in relation to each other in such a way, that the circumferential region of the area under treatment is irradiated first, then approach is made towards the centre region in a circular path. It is preferable if the beam has at least a 3 cm@2 sectional area and the treatment is performed at normal room temperature.

According to the invention an apparatus has also been provided for the stimulation of biological processes related to cellular activity, particularly for promoting the healing of lesions on the body surface i.e. wounds, ulcers and various epithelial injuries, comprising a light source in which the improvement lies in that the light source comprises a lamp emitting non-coherent light with spectral components exceeding 300 nm, a light deflecting system placed in the path of the light beams to project the light into a given direction of treatment, and a polarizer inserted in said path to produce polarized light beams approaching the surface to be treated. In the preferable embodiment an ultraviolet filter and in given cases an infrared filter is inserted into the path of the beams.

In a preferable embodiment a reflector surface is arranged behind the lampto reflect forward the backwardly projected light beams. The reflector surface can be made of a cold mirror having preferably a spherical shape or the shape of a paraboloid of rotation. The light source can be a normal incandescent bulb or preferably a metal-halogen bulb.

The polarizer may comprise a sheet polarizer, a specular polarizer, a Nicol's prism or any other means capable of producing polarized light beams.

The apparatus according to the invention is preferably mounted in a tubular housing, the length of which is sufficient for the suppression of diverging direct light beams with divergence angles exceeding 15 DEG.

A fan is mounted behind the reflector surface to provide sufficient cooling.

In a preferable embodiment the light deflecting system comprises lenses. The lens, when mounted in front of the reflector surface and provided with different coating materials on each side for filtering out the ultraviolet and infrared wave-length components can offer preferable features from the point of view of directing the light. In an other embodiment the reflector surface is of the shape of a paraboloid of rotation and the lamp is arranged in the focus thereof, and a pressed glass plate is arranged in front of the lamp fixed to the reflector surface and it comprises an annular spherical specular surface.

In a further embodiment the lamp and the reflector surface are arranged in an end portion of a tubular enclosure and a specular polarizer is placed in the opposite end region thereof. The plane of the specular polarizer is inclined in relation to the optical axis of the directed light beam propagating in the enclosure, wherein the angle of incidence of the beams on this plane is equal to Brewster's angle. There is arranged preferably another enclosure beside the first one, with holes defined in the adjacent side walls thereof to enable the passage of light beams reflected from the specular polarizer and there is another mirror in the second enclosure, placed in the path of the reflected light beams to direct these beams in parallel with the optical axis. It is preferable if the second enclosure of this embodiment is mounted closely beside and in parallel with the first one and the angle defined between the reflecting mirror and the specular polarizer is double the complementary of Brewster's angle.

In order to increase the efficiency of polarization it is preferable if the specular polarizer comprises a plurality of plano-parallel plates, made preferably of transparent glass.

The stimulating effect of the treatment with polarized light on the healing of wounds, as suggested by the present invention can be demonstrated effectively by describing the experiences obtained during such a treatment applied to chronic wounds which had been lingering for years.

In response to the treatment the chronic wounds started to heal, first they got purged, then secretion reduced and later completely ceased. Blood-vessel endings appeared on the bases of the wounds, then epithelization started on the edges. The process of healing was continuous. The bases of the wounds got filled up, then they healed in some cases after crustation.

On the basis of cytological examinations of smears taken from the wound secretion before and after each treatment, the effects of irradiation with polarized light can be summarized as follows.

The irradiation increased the proportion of healthy leukocytes which are ready for phagocytosis, to the necrotic ones.

Not only the number of phagocytic leukocytes but also the intensity of phagocytosis increased significantly. This increase in intensity manifested itself both in the highly increased number of bacteria phagolysed by the respective leukocytes and in the higher percentage of healthy and phagocytic leukocytes among all leukocytes.

After a few number of treatments the cells taking part in the immunological protection, namely the eosinophile cells, lymphocytes and monocytes appeared in the smears.

Both the quantity and quality of granuli in the cytoplasm of the cells changed considerably under the effect of the treatment which was demonstrated by the appearance of clearly visible large granuli.

The quantity of fibrin fibers originally not or hardly observable in the smear, multiplied under the effect of the treatment, and the initially thin fibrins with a tendency toward disintegration, increased both in length and thickness and they were often arranged in bundles.

In response to the treatment the composition of immunoproteins in the secretion has changed which could also prove the starting and activation of humoral protection. Irradiation with polarized light facilitated the quantitative growth of immunoproteins, of course to different degrees in case of different fractions. The highest average growth was observed in the immunoglobulin M, being about +85% compared to the pre-treatment average value, whereas the lowest increase of about +21% appeared in the immunoglobulin A fraction.

The biological effects described hereinabove are closely related to the phase transition associated with the change of conformation of the polar heads in the cell membrane's lipid bilayer, i.e. to the effect of polarized light exerted on the lipid bilayer. This can be explained by the supposition that the antigen structures being present in the vicinity of immune cells can provide an immune response under the effect of polarized light by triggering a non-specific response in or increasing the sensitivity of the immune cells which, inter alia, can contribute to the healing of wounds.

If polarized light changes the membrane structure of the lymphocytes, then this intensifies the activity of the receptors of the lymphocytes on one hand, and on the other hand the change in the membrane structure can directly activate the cyclic adenosin monophosphate, which can trigger the energy-generating process of the cell. These two effects can generate a local immunological response.

In the course of the triggered immune response lymphokins are released that are capable of starting an immunological chain reaction. This chain reaction involves the triggering of the factor MIF (Migration Inhibiting Factor) inhibiting the migration of makrophags, the factor MCF (Monocyte Chemotactic Factor), the factor NCF (Neutrophile Chemotactic Factor) and the factor ECF (Eosinophile Chemotactic Factor) and these factors together attract the monocytes, neuotrophile granulocytes and eosinophile cells to the affected area.

Consequently, the aforementioned cells will migrate to that particular area.

On account of the changes in the membrane structure, the quantity of factor SRF (Skin Reaction Factor) that increases the permeability of blood-vessels will increase, thus it facilitates the circulation and in this way the transportation of the protective cells in the blood stream to the wounded area.

The above described events facilitate the cellular immune response (with T lymphocytes, killer cells) and the humoral immune response by means of T-helper cells.

The transport through the cell membrane will also be facilitated by the fact, that the initially irregular configuration of particles in the interstitium take a regular formation under the effect of electric field induced by polarized light. The process of re-arrangement in response to an electrical field is described e.g. in the paper of H. P. Schwan and L. D. Sher "Alternating Current Field-Induced Forces and Their Biological Implications" (J. Electrochem. Society, January 1969, pp 22c-25c).

On the basis of the above described effects it can be stated that the application of polarized light in accordance with the present invention exerts a stimulating effect in general on biological processes related to cellular activity by controlling the behaviour of the cell membrane.

The invention will now be described through exemplary embodiments thereof, in which reference will be made to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the Drawings

FIG. 1 is a simplified schematic sectional and elevational view of the first embodiment of the apparatus according to the invention;



FIG. 2 is a schematic sectional and elevational view of a second embodiment;

FIG. 3 is similar to FIG. 2, in which the direction of the light beams is reverse;



FIG. 4 is a similar view of a further embodiment, in which a Nicol-prism is used as polarizer;

FIG. 5 is a detailed overall sectional and elevational view of the apparatus shown in FIG. 1;



FIG. 6 is a graph which shows typical transmission characteristics of ultraviolet and infrared filters;



FIG. 7 is a graph which shows transmission and cross-over characteristics of different types of polar filters;

FIGS. 8 to 16a, b and c (where applicable) show various photomicrographic pictures of smears taken from wound secretions, demonstrating the cytological status before and after treatment, respectively;







FIGS. 17a and b show patterns used for the measurement of immunoprotein fractions in samples, taken before and after treatment, respectively; and


FIGS. 18 to 20 are various diagrams illustrating the vertical and horizontal sizes of wounds during the process of healing.



DESCRIPTION OF THE PREFERRED EMBODIMENTS

According to the present invention it has been discovered that the application of polarized light of sufficient intensity that falls in a predetermined wavelength range can produce a biostimulating effect. Though there are numerous known ways for the generation of polarized light, in the following description the specific conditions will be summarized and demonstrated by exemplary embodiments which should be taken into account when polarized light sources are being used to stimulate the healing of wounds.

FIG. 1 shows the schematic arrangement of a first embodiment of an apparatus for generating polarized light which can well be used for the healing treatment of wounds. The light source produced by lamp 10 is built integrally with reflecting surface 11 adapted to direct the backward light in an axially forward direction. If lamp 10 is a point source or nearly a point source and the reflector surface 11 has a rotational paraboloid shape, the majority of the light beams will be passed in parallel with the optical axis. In that case the lamp 10 should be placed in the focus of the reflector surface 11.

The next element in an axial direction after lamp 10 is infrared filter 12 for the suppression of infrared components emitted by lamp 10. The filtering or suppressing of the forwardly reflected infrared components will be more effective if the reflector surface 11 is designed as a cold mirror that fully reflects the visible components, whereas having a reflection factor in the infrared range being as small as about 20%, whereby about 80% of the backward infrared beams can pass therethrough. The infrared filter 12 can be of known type which is used commonly in photography such as the infrared filter type KG-4 of the Spezial-Glas GmbH (West Germany).

The transmission characteristics versus wavelength of a filter of this type is shown in FIG. 6 (curve IRF). The application of the infrared filter 12 is considered essential, because the heat load on the treated surface might cause undesirable effects (without the suppression of the infrared components). The density of the luminous flux of the predominantly visible light incident on the body-surface under treatment should be in the range of about 20-150 mW/cm.

In FIG. 1 a light deflecting system 13 is illustrated schematically. The task of the light deflecting system 13 is to project the light of the lamp 10 in parallel with the optical axis, by providing the most uniform spatial distribution possible. The deflecting system 13 can be built of traditional optical lenses, but the lamp 10 with the reflector surface 11 can also be regarded as an embodiment of the deflecting system 13, if they can produce together, the required axial light beams. The apparatus has a tubular enclosure 14 and by increasing its length the beams propagating non-parallel to the optical axis can be suppressed. Consequently it is not essential that the light deflecting system 13 be built of lenses. Indeed, the low value of the light intensity and the relatively significant light reflection is a disadvantage of the embodiments using lenses and due to the higher absorption more powerful bulbs should be chosen to provide a predetermined luminous output. On the other hand, however, the power of the lamp should be chosen as low as possible in order to minimize the problems of cooling.

It is well known in the art that the human body is sensitive to ultraviolet light. This sensitivity is even more intensive in case of ill tissues and wound surfaces, therefore the emitted light should not include ultraviolet components. The ultraviolet beams are effectively eliminated by filter 15. Though the ultraviolet range of the spectrum is filtered by the glass lenses, the application of a separate ultraviolet filter 15 is also advisable in combination with glass lenses. Thorough absorption of the ultraviolet range of the spectrum becomes particularly significant in embodiments operating without lenses.

In FIG. 6 curve UVF illustrates the transmission characteristic of an ultraviolet filter commonly used in photography. The absorption of the ultraviolet light will be more effective if the ultraviolet filter 15 is a yellow filter, also commonly used in photography. This results in a decrease in the visible light output mainly in the range of shorter wavelengths. Diagram YF in FIG. 6 shows the transmission characteristic of a typical yellow filter.

Linearly polarized light is produced by means of a sheet polarizer 16 placed in the path of the light beam. The sheet polarizer 16 can be made of a polarizing plate-filter commonly used in photography. Such a filter is e.g. the polarizing filter type 4K of the Spindler-Hoyer GmbH (W. Germany). Diagram PF in FIG. 7 demonstrates the transmission characteristic of such a filter. The dependence of polar absorption from the wave-length can be determined on the basis of the cross-over characteristics. To obtain such a characteristics a pair of polarizing filters of opposite polarization directions are placed behind each other and as a consequence of this arrangement the opposingly polarised light beams will mutually extinguish each other. Such a cross-over characteristic is shown in diagram CR of FIG. 7. It can be observed that in the infrared range, over the wavelength of about 800 nm, the phenomenon of extinction ceases, which indicates that such filters do not polarize the infrared part of the spectrum.

FIG. 2 shows a further embodiment according to the invention. In this embodiment the lamp 10, the reflector surface 11 and lens 17 produce light beams parallel to the optical axis.

The lens 17 consists of two parts, namely of lens body 20 and of coating 21. The lens body 20 can be made by a glass material providing infrared absorption, in which case the coating 21 should be an ultraviolet filter. The function of the lens body 20 and the coating 21 can also be interchanged, in which case the former provides a UV-absorption and the coating is made of an infrared-absorbing material.

The light beams propagating in an axial direction in tubular enclosure 14 are transformed into polarized light by means of mirrors, as shown in FIG. 2. Specular polarizer 22 is mounted in the enclosure 14 in a remote position from the lamp 10 and in an inclined plane, in which the angle of incidence of the axial beams on this plane is 55 DEG. Light is reflected from the specular polarizer 22 obliquely, in the direction shown with dashed-dotted line in the figure, and it strikes another mirror 23 arranged in parallel with the specular polarizer 22. The mirror 23 is mounted in housing 24, fixed to the enclosure 14. The reflected light beams pass through respective holes 25 and 26 made in the adjacent side walls of the enclosure 14 and of the housing 24. The mirror 23 reflects the light beams back into the axial direction. The housing 24 is closed by glass plate 27, which provides protection for the internal parts against dust and provides ultraviolet filtering. It is known from physics that mirrors arranged under a suitable angle relative to incident light can produce polarized light not only in the visible but also in the infrared ranges.

Reference is made now to FIG. 3, in which an embodiment similar to the one shown in FIG. 2 can be seen. The lamp 10 is built together with a spherical reflector surface 11 and in front of which a condensor 28 is placed. The reflector surface 11 is formed by a cold mirror, therefore a portion of the infrared beams are projected backwardly in a direction opposite to that of the visible beams, into a rear space behind the lamp 10. In this space fan 29 is arranged providing cooling both for the lamp 10 and the tubular enclosure 14. The cooling air streams out through vent holes 30.

The embodiment of FIG. 3 differs from that shown in FIG. 2 also in the arrangement of the light source in the right side of the enclosure 14 and in the opposing directions of the emitted and the outgoing light beams leaving the equipment. In this embodiment the polarizer is made by a plurality of plano-parallel plates of common transparent glass 31, being parallel to each other and being inclined relative to the direction of the incident light. The angle of incidence of the light is equal to the known Brewster's angle, which is 57 DEG, and the light reflected from the layers consists of components which are polarized in one plane. The number of the reflecting surfaces of the plano-parallel layers 31 is double the number of the plates. About 35% of the incident light is reflected if the plate structure consists of four plates. Immediately under the enclosure 14 there is provided a second housing 32 of smaller dimensions built integrally therewith. The common wall of the enclosure 14 and the housing 32 defines a hole 33 having a size enabling the passage of all light beams reflected from each polarizer plate.

An inclined mirror 34 is placed in the path of the reflected light beams passed through hole 33 in such a way that the angle of incidence of the reflected light beams is also 57 DEG. The mirror 34 reflects the incident light beams into a path which is parallel to the path of light emitted by the lamp 10 but having the opposite direction.

In this way reflected light beams 35 pass through the housing 32 and leave it at the right-hand end thereof. This end of the housing is closed by plate 36, made of an ultraviolet filter. The transmission characteristic of a polarizer of this type is shown in FIG. 7 (diagram PR). It can be seen that such polarizers provide polarized light also in the infrared region which eliminates the need of using an infrared filter. Owing to the wider polarized spectral range the required polarized light intensity can be reached with much less lamp-power relative to the designs with an infrared filter. The reduced power generates smaller amounts of heat, which renders the use of forced cooling unnecessary.

In the arrangement shown in FIG. 3 the path of the light is nearly twice as long as the total constructional length of the equipment, due to the reversing of the light beams. This increased length reduces the divergence of the outgoing light beams 35, because the divergent beams will be withheld by the tubular enclosure. It is advisable to provide the internal surface of the enclosure with a light-absorbing black coating. Another advantage lies in the fact that the sectional area of the enclosure 14 comprising the lamp 10 is larger than that of the housing 32, therefore a larger lamp can be used for a given outgoing beam cross-section which is preferable in view of heat engineering. Fan 29 is not essential, but it is recommended, particularly in the case of higher outputs.

During treatment it is often necessary to change the direction of the light beams. This function is performed by support 37 fixed to the enclosure 14 or 32, to be clamped to a console, not shown in the drawing. The console comprises known fixing and control mechanisms providing the required setting and position-adjustment of the light beams.

It should be noted that the embodiment shown in FIG. 3 is operative without the use of the second mirror 34 and the housing 32. In such an arrangement polarized beams are emitted in a downwardly inclined direction through the hole 33. The position of the enclosure 14 can be adjusted to provide polarized beams in any direction including both the horizontal and vertical ones.

A further embodiment of the apparatus according to the invention is shown in FIG. 4.

The light source used in this embodiment is of a special design capable of generating light beams substantially parallel to the axis. The lamp 10 is placed in the focus of the reflector surface 11 having now a shape of a rotational paraboloid. There is provided a pressed glass plate 38 fixed to the reflector surface 11 in front of the lamp 10. The pressed glass plate 38 has a spherical annular outer portion which is provided internally with a mirror surface 39 reflecting the incident light beams towards the centre of the lamp 10 which should now be regarded as a point light source. Within the internal annular edge of the mirror surface 39 the pressed glass plate 38 has a slightly convex form and this internal portion is made of transparent glass. The pressed glass plate 38 can be designed to form an infrared and/or ultraviolet filter.

Owing to this arrangement only light beams extending substantially parallel to the axis can pass through the transparent central portion 40 of the pressed glass plate 38. A ring 41 is provided to attach the pressed glass plate 38 to the reflector surface 11.

Whilst the mirror 39 is designed as a normal reflecting surface, it is recommended that the reflector surface 11 be made of a cold mirror.

It is believed that the compact lamp shown in FIG. 4 is the most appropriate for polarized light treatments which eliminates the need for using a separate light-deflecting optical system.

The polarizer shown in FIG. 4 is a per se known Nicol's prism consisting of a pair of calcite prisms tooled by grinding and glued together with Canadian balsam. Angle 43 shown in FIG. 4 is equal to 66 DEG.

The Nicol's prism 42 is fixed in enclosure 14 by means of retaining washers 44 and 45. The retaining washer 45 has a frontal opening closed by glass plate 46, which can be designed as an infrared filter.

FIG. 5 shows a more detailed assembly drawing of a polarized light source corresponding to the principal arrangement shown in FIG. 1. In this embodiment the lamp 10 and the reflector surface 11 are realized by the commercially available cold mirror-type lamp designated Tungsram 52210 or 52220 which is surrounded by a tube 50 provided with cooling ribs. The lamp 10 is fixed in a ceramic lamp socket 51, clamped onto a fixture 52 which together with a mounting base 37 is fixed to the lower part of the tube 50 by means of a screw joint. Disc 53 with vent-holes provides a rear closure for the tube 50. A hollow screw-mount is arranged in the centre of the disc 53 for supporting the electric cable connections and a bracket 54 adapted to fix the fan 29.

An adapter sleeve 55 with vent-holes is coupled to the frontal end of thetube 50 with cooling ribs and its frontal end is coupled to a sleeve 56 through a threaded joint. The sleeve 56 supports internally a lens holder 57 in which a lens 58 is mounted. The sleeve 56 is extended by a hollow filter support 59 designed to have an open top portion covered by a cover plate 60 attached thereto by a releasable fastening. There are several filter-holding slots (in the exemplary embodiment four slots) in the filter support 59. When the covering plate 60 is removed, suitable filters can be inserted into the respective slots of the filter support 59, or the filter can be changed according to actual requirements. In FIG. 5 infrared filter 61 and polarizing filter 62 have been shown in the slots of the tubular holder for filters. A tubular lens holder 63 is coupled to the filter support 59 in such a manner that an ultraviolet filter 64 can be inserted in the joint. The tubular lens holder 63 is used for holding second and third lenses, 65 and 66.

The apparatus shown in FIG. 5 produces polarized light beams of about 35-40 mm diameter, directed substantially in parallel to the optical axis. The emitted light falls within the visible range of wavelengths, and both its ultraviolet and infrared components are effectively suppressed.

On the basis of the embodiments shown in FIGS. 1 to 5 it can be stated that for the purpose of stimulating the healing of wounds a special light source is required that generates visible light, from which the ultraviolet (and as and if necessary the infrared) components are removed, the emitted light should propagate essentially in a parallel beam of uniform distribution. The light intensity of the beam should not exceed about 150 mW/cm@2. The emitted light should be linearly polarized.

The individual constructional details of the embodiments discussed hereinabove, can naturally be used in any other rational combination. For example, the light source demonstrated in FIG. 4 can be employed in the arrangement according to FIG. 1, however, that would render the use of deflecting system 13 unnecessary. Thus, the polarized light source according to the invention should not be limited to any one of the exemplary embodiments.

Now the application of the method according to the invention and the experiences obtained during such applications will be described through the following examples.

In order to demonstrate the effect of polarized light, patients were treated with anamnesis in which all types of traditional therapy for healing their wounds had been applied, without even a temporary success. Altogether 23 patients were treated and the aetiological distribution of their illness was the following: ulcus cruris developed as a consequence of diabetic angiopathy in the case of 7 patients; ulcus cruris was caused by arteriosclerosis obliterans in 6 cases, and in 6 cases by varicositas or postthrombotic syndrom. Three patients were treated for decubitus and one of the patients had a chronic osteomyelitis in the background of his pathography.

Prior to the treatment with polarized light, during the traditional therapy, dressings with Mikulitz's ointment and Peruvian balm, Oxycort, Panthenol spray, Solcoseryl jelly, Debrisan and various local antibiotic and drying bandages were employed. As a general therapy, the patients took Glyvenol, Padutin, Venoruton, vitamins and other corroborants, and they also received corroborant treatment. The treatment with polarized light was started after the failure of the above mentioned types of conventional therapy. Mentioning only the extreme cases, one of the patients had a non-healing wound for more than 35 years, and in several cases the wounds developed 5-20 years before the treatment was started.

The treatment with polarized light was performed once a day. The area of the spot of the light projected onto the wounds was about 4 cm@2 and the average flux-density of the beams was about 80 mW/cm@2. The spectrum of the light ranged between 300 nm and 700 nm, the spectral distribution did not comprise discrete components with high intensities.

The duration of the treatment was chosen so that the average energy falling on the wound surface under treatment be 4 J/cm@2. When the area to be treated was larger than the cross-section of the beams, this latter was scanned by the intermittent displacement of the light source in such a way that the wound edges were irradiated first circumferentially and the inner region was reached by a circular inwardly directed movement. The typical duration of the treatment in each position of the light source was between one and two minutes.

Before and after each treatment respective samples were taken from the wound secretion and smears were prepared for microscopic evaluation using fixation technique and the May-Grunwald-Giemsa method. With the progress of the treatment as the secretion was gradually reduced and ceased, smears could not be prepared any more.

In addition to the samples for smears larger samples were also taken from the wound secretion--when it was possible--to determine the composition of proteins, particularly immunoproteins, in the serum.

For the duration of the treatment with polarized light the patients did not get any kind of antibiotics and only dry bandages were applied.

On the basis of the cytological examination of smears, taken from the wounds before and after every treatment, the following general results have been obtained:
(a) The ratio of healthy leukocytes ready for bacteriophagocytosis to the necrotic ones increased to a substantial degree as a consequence of irradiation with polarized light. The increase of this ratio showed a fairly varied picture in the examined cases. It occured in several cases that, whilst there were no healthy leukocytes at all in the smear before treatment, the ratio of healthy leukocytes to the necrotic ones increased to 50%:50% in the smear prepared immediately after treatment.

Irradiation with polarized light facilitated the emergence of healthy leukocytes on the wound's surface. The extent of increase of this ratio in favour of the healthy leukocytes could be observed nearly in each sample, however, it was particularly high after the first few treatments of a series.

Most of the leukocytes in the smear were neutrophil granulocytes forming the basis of the cellular defense mechanism of the organism, which is the most elementary form of protection. Sacrificing themselves, the neutrophile granulocytes swallow bacteria in order to protect the organism. The measure of the intensity of bacterio-phagocytosis is the number of bacteria swallowed by a single neutrophile granulocyte.

FIGS. 8a, 8b, 9a and 9b demonstrate these phenomena.

FIG. 8a shows a smear taken before treatment in which a great number of extracellular bacteria can be observed and the overwhelming majority of the leukocytes is formed by necrotic ones. The situation after treatment is illustrated in FIG. 8b, extracellular bacteria have substantially vanished and mainly healthy leukocytes can be seen.

Another typical smear is shown in FIG. 9a, in which the number of necrotic cells was high before treatment, and after treatment as shown in FIG. 9b, a substantial increase occured in the number of healthy cells.

(b) The intensity of phagocytosis has also increased. In addition to the increase in the ratio of healthy phagolytic leukocytes, the intensity of phagocytosis has also increased as a consequence of irradiation with polarized light. The rather sluggish bacteriophagocytosis before treatment, which meant the swallowing of about 8-10 bacteria by a single cell, was becoming more and more intensive, and the leukocytes phagolysed up to 80-100 bacteria under the effect of treatment.

The intensity of phagocytosis is also characterized by the percentual ratio of the actually phagolysing leukocytes within total number of healthy ones. Whilst only 5-10% of the healthy leukocytes were phagocytic before treatment, after treatment this ratio increased to 50-60%.

These two phenomena are particularly significant in the initial phase of healing, because the healing of wounds is impeded mainly by the presence of extracellular bacteria.

The appearance of sound healthy leukocytes in the secretion and both types of the intensification of bacterio-phagocytosis promote the annihilation of extracellular bacteria.

FIG. 10a shows a situation before treatment, where only few cells phagolyse and each of them swallows only few bacteria. FIG. 10b shows the situation after treatment and it demonstrates that the number of phagocytic cells and the number of bacteria swallowed by one cell has increased noticably. A similarly considerable intensification can be seen in FIGS. 11a and 11b, illustrating also respective situations before and after irradiation. The smears taken after irradiation also demonstrate the disappearance of extracellular bacteria.
(c) Under the effect of the treatment with polarized light the immunological (humoral) defense of the organism is also triggered or intensified.

It is known that this type of protection against bacteria is provided by plasma cells, lymphocytes and monocytes. These types of leukocytes produce immunoproteins, killing the bacteria. The appearance of these cells means that the organism mobilizes deeper immunological mechanisms to heal the wound and kill the bacteria.

While the smear taken before irradiation contained generally neutrophile granulocytes only, after irradiation other types of leukocytes have also appeared that can provide higher, humoral form of protection. Such cells are e.g. the eosinophile cells, lymphocytes and monocytes.

In several cases these cells appeared already after a few treatments. The ratio of appearance of these cells relative to other cells varied from one case to the other. It happened that no lymphocytes were found among the leukocytes before treatment, whereas the ratio of lymphocytes increased to 4-10% by the end of the treatment. With increasing number of treatments lymphocytes could be seen in the secretion already before the next day's treatment, but their ratio before treatment was, for example, 2%, which increased to 20% following the treatment.

A similar phenomenon was observed in the case of eosinophile granulocytes, the ratio of which increased from the initial 0% to 1-5%, then in a later phase of the therapy from the initial 1% to 20%. Similar increase of the percentual ratio of monocytes was detected from the initial 0% to the post treatment 5% and in a later phase from 3% to 5%.

The cells that provide the immunological defense of the organism, appeared generally after the second or third treatment, but a significant quantitative growth could be observed generally during and after the seventh-ninth treatment. However, the presence of these cells stabilized only after the 15th-20th treatment, up to which their quantity decreased between subsequent treatments.

By that time there were already visible signs of the ongoing healing process. This is a rather significant demonstration, since before the first treatment there were no traces of the presence of leukocytes in the secretion of any of the patients that would provide immunological defense.

FIG. 12a shows a condition before treatment with visibly high number of extracellular bacteria and sluggish bacteriophagocytosis. Apart from the neutrophile granulocytes no other types of leukocytes can be seen. FIG. 12b shows the situation after treatment and it can be seen that some lymphocytes have appeared, and the extracellular bacteria have disappeared. After a later treatment monocytes can be detected (see FIG. 12c). In FIG. 12c it can also be observed that fibrin-fibers are already present. Similarly, FIG. 13a illustrates a pretreatment condition with low granularity. Only neutrophile granulocytes can be seen. After treatment the eosinophile cell has also appeared (see FIG. 13b). After successive treatments a great number of eosinophile cells appear in the smear as shown in FIG. 13c. In FIG. 14a lymphocytes can be detected even before the treatment and the quantity of which has considerably increased after the treatment (FIG. 14b).

When the process of healing is examined, it will be discovered that at first the quantity and activity of the neutrophile granulocytes increases in a chronic, refractory wound and after that, or partly at the same time cells offering the higher forms of protection appear, and when these mechanisms of protection become relatively stabilized, the spectacular process of healing of the wound starts.
(d) The evolution of immunological protection is verified by the change in the quality and quantity of granuli in the cytoplasm of the cells, taking place under the effect of the treatment.

Granulation comprises the lysosomatic enzymes (that can dissolve all types of organic matter required for protection against bacterii) and the presence of a definite, large-size granulation is the proof of the quantitative growth and appearance of such enzymes.

FIGS. 15a and 15b demonstrate the changes in extent and quality of granulation that occured in response to the treatment with polarized light. Before the treatment the granulation in the neutrophile granulocyte cells was weak, hardly detectable. In the post-treatment state as shown in FIG. 15b a definite, large-grained and well detectable granulation can be seen in the cytoplasm of the cells.
(e) The few fibrins when being present in the pre-treatment smear are thin with a tendency toward disintegration.

The presence of fibrins in the course of the first few treatments was hardly experienced. In response to the treatment with polarized light the quantity of fibrins multiplied in relation to the pre-treatment condition. These fibrins are formed to long, thick, parallel straight fibres arranged often in bundles. This is illustrated in FIGS. 16a and 16b showing smears taken before and after irradiation, respectively. The effect of treatment with polarized light on the composition of immunoproteins in the secretion has also been investigated. The composition measurements were carried out by the immunoelectrophoretic technique. 0.4 .mu.l volume of the secretion was required for each analysis to prepare the samples on a specially prepared plate for immunological tests. Eight different proteins can be measured usually on a single plate. There is a standard sample on each plate, in which the respective areas pertaining to each fraction are known, therefore the measurement can be performed to supply not only relative, but also absolute values.

During immunoelectrophoresis the individual protein fractions separate, and the quantitative ratios of fractions are represented by the ratios of the corresponding areas. By placing the test plate onto an overhead projector and outlining the contours of each fraction projected with the same magnification, the size of the obtained areas can be determined by means of a planimeter. Then the quantities of the fractions are calculated in relation to the standard areas. Such outlined contours are shown in FIGS. 17a and 17b (before and after treatment, respectively). The figures associated with the respective components indicate the relative indices of the related areas.

In the course of the measurements the composition of immunoproteins in the secretion of three patients was analysed and the samples were taken before and after each treatment of a series. The effect of the treatment is reflected in the extent of change of the composition. Table 1. shows the percentual changes of immunoprotein fractions of three patients A, B and C, in response to respective treatments. The missing entries indicate that the low quantity of the secretion that was available during the particular treatment, was not sufficient to perform the measurement of that particular component. In case of patient C, due to the rapid healing of the wound, sufficient amount of secretion was available during a few treatments only.

TABLE 1

Percentual changes of the respective components after treatment relative to pre-treatment values

On the basis of Table 1, in which the respective pre-treatment values have been considered as 100%, it can be seen that irradiation with polarized light intensifies proteinogenesis in the secretion, obviously to different degrees in different fractions. The considerable fluctuations in the entries of the table resulted by the individual differences and by the fact that the samples were taken in different phases of healing. There was no sense of calculating averages due to the high variance of the values, however, the data of table 1 clearly demonstrate the tendency of quantitative growth of the components in response to the treatment. These figures show that the highest increase took place in fraction immunoglobulin-M, then the succession was: Albumin, .alpha.1 -lipoprotein, Immunoglobulin-G, .alpha.1 -antitrypsin, Transferin, .alpha.2 -Macroglobulin and Immunoglobulin-A.

It has also been noticed that the inclination to healing of different patients is proportional to the quantitative growth of immunoproteins that take place in response to respective treatments. The more is the increment of immunoproteins, that is, the more intensive is the response to the treatment with polarized light, the higher is the rate of healing. Taking this relationship into account, the inclination of the wound to healing and the expected total duration of the cure can be estimated already on the basis of a few treatments.

The results of the immunological tests are in accordance with the experiences obtained by the cytological examinations, i.e. in response to the treatment with polarized light:
(i.) protein types providing humoral protection appear,
(ii.) definite granulation, indicating the presence of lysosomatic enzymes,appears in the cytoplasm of the cells;
(iii.) effective protection starts against the bacilliform bacteria, destroyable mainly in the immunological way. Besides cytological and immunological tests, great importance was attached to the general process of healing as well.

In the course of the examinations the macroscopic parameters of the wounds were measured and the obtained results were evaluated. The changes observed in the base of the wounds were measured and recorded including the vertical and horizontal dimensions of the edges of the wounds, as well as their depths and the width of the newly grown epithelial edges were also measured. In the course of treatments the wounds began first to purge, secretion reduced and became clearer even after a few treatments only. At the same time the patients reported on the substantial reduction of their pains. The wounds started to heal visibly after a certain period of latency, which lasted generally one week. After this time the wounds started to heal gradually, even those which showed no tendency of healing before the treatment with polarized light.

After another week of treatment the process of healing usually became more rapid.

Blood vessel endings appeared on the bases of the wounds later with white pearly growths around them, and epithelisation also started on the edges. The new epidermis appeared first as a red area that usually turned white and became a rim-like elevation to the next day.

The beginning and rate of healing largely depends on the age, general condition, medical and haemodynamic state of the patient.

This process is illustrated by FIGS. 18, 19 and 20. The full lines show the horizontal size of the wounds and the dash lines the vertical one.

In the anamnesis of a 54 years old male patient the only disease he suffered from was hepatitis. He has had distinct varicosity for 20 years, but he hasn't had thrombosis. His shin split a first time 15 years ago, then the wound healed spontaneously. This process was repeated since then several times. The ulcer developed on his right shin four years before; the current wounds have not healed since 10 months. He was treated with Venoruton and Padutin, the local medical attendance involved Oxycort, antibiotics, Neogranorman and Panthenol.

The treatment with polarized light was started after such antecedents. At that time he had a 2 mm deep ulcer of 20.times.24 mm size on the border of the middle and lower third of his shank, and a 4 mm deep one of 24.times.18 mm size in the distal third. Approximately after the 5th or 7th treatment the wounds started to heal rapidly, they became shallower and nervate. The distal wound healed with crustation to the 40th treatment (FIG. 18), then the much deeper proximal ulcer also pullulated to the 57th treatment (FIG. 19), and the cure was finished.

FIG. 20 demonstrates the healing of the wounds of a 66 years old male patient. His anamnesis included permanent coxalgia for 21 years, therefore he was provided with an artificial hip (prothesis) 17 years ago and in order to relieve him of lingering pain, cordothomy was performed on him. Due to his mental derangement, which evolved six months before, he was transferred to the psychiatric department. On the body of this patient, who became confined to bed in the meantime, decubiti evolved gradually, on both sides, on the hip and sacralis too. Then the treatment with polarized light was started. At the beginning of the therapy he had two 3 mm-deep wounds on the rightside of the hip, one of 21.times.30 mm and the other of 16.times.25 mm size. On the left side he had a 38 mm deep wound of 66.times.45 mm size. The sacral decubitus was 30.times.13 mm large. The effect of the polarized light began to purge the wounds gradually and after the 7th treatment their size started to recede slowly. Then the rate of healing decelerated temporarily and after the 40th treatment the pouches on the edges subsided and the depth of the hollow also decreased considerably. The patient left the ward upon his request, due to some family affair, after the 50th treatment. At this time the sacral ulcer and the smaller wound on his right side were entirely epithelised, the other one receded to 8.times.17 mm, and the wound on his left side--to 26.times.20 mm.

The experiences obtained by polarized light treatment show that lesions due to diabethes react to the treatment after the longest time and with the slowest rate. The inclination to healing of wounds, developed as a consequence of arteriosclerosis obliterans is somewhat better, but the most striking and rapid are the results obtained in the curing of ulcus cruris developed due to postthrombotic syndrom.

In the foregoing description the stimulating effects of the treatment with polarized light have been demonstrated on the healing of chronic, otherwise non-healing wounds. It became clear that the treatment exerted a significant stimulating effect on the healing process even in case of the most unfavourable pathography. It must be obvious therefore that the stimulating effect of the treatment with polarized light also asserts itself in the healing of acute injuries, cut and contured wounds, where the conditions hindering the healing process are less manifested.

According to the experiments, treatment with polarized light also facilitates the healing of burning lesions. On the leg of a 40 years old male patient autograft was performed for the treatment of a third-degree burn. The skin-graft separated on an area of 1.times.5 cm size, and two additional areas of 1 cm@2 each. The physicians performing traditional treatment suggested a new transplantation, because by their opinion the process of pullulation from the edges of the wound would take several months.

After these antecedents started the treatment of the wound surface with polarized light, once a day, at 4 J/cm@2 density of energy. Following the third treatment pullulation started from the edges of the wound. Then the process of healing sped up, in two weeks full crustation took place, then, having finished the treatment, the whole surface healed. The treatment with polarized light was applied in those places only, where the skin-graft separated.

Whilst the transplanted skin surface, not treated with polarized light was of reddish hue with secondary pouches, the colour of the recovered skin irradiated with polarized light was natural, its surface was smooth, and this was the strongest, soundest portion of the healed area of the third-degree burn.

Considering that the treatment with laser light has been applied in numerous fields of clinical practice during the long years elapsed since its introduction, and the biostimulating effect has been proven, it may be supposed that the biostimulating effect can also be triggered in similar fields of application through treatment with polarized light.

This may apply to various treatments of cosmetic nature, to the liquidation of cicatrices, to the stimulation of miscellaneous lesions on the body-surface on the analogy of laser stimulation, or, in general, to stimulate biological processes, related basically to cellular activity.



US4926861
System for in vivo treatment of tumorous tissues on body surfaces
    
Inventor: FENYO MARTA // BORBERG HELMUT (+1)     

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to a method for in vivo treatment of tumorous tissues on body surfaces.

The medical literature dealing with various treatments of cancer is very extensive and the citation of only a small portion thereof would certainly make the present specification prolix. In spite of worldwide research and numerous significant achievements there have remained much to be solved and any small pace of improvement is significant.

It has been long known in the art that the irradiation of tumorous tissues by specific rays such as X-rays or isotopes have a growth inhibiting effect. Such treatments were based on the selective destructive effects of these rays for tumorous and healthy cells. A different branch of cancer research deals with chemotherapy.

Recently much effort is concentrated on the investigation of the immunotherapy with tumor-infiltrating lymphocytes. Of the pertinent literature a few number of papers will be cited. The first one is the work of Steven A. Rosenberg, Paul Spiess and Rene Lafreniere: `A New Approach to the Adoptive Immunotherapy of Cancer with Tumor-Infiltrating Lymphocytes` (Science, Vol. 233, 19 Sept. 1986, pp. 1318-1321). The second reference is Richard L. Kradin and James T. Kurnick: Adoptive Immunotherapy of Cancer with Activated Lymphocytes and Interleukin-2 published in "The Year in Immunopathology, Pathol. Immunpathol. Res. pp. 193-202 (1986)". Rosenberg et. al have reported that the adoptive transfer of tumor-infiltrating lymphocytes (TIL) expanded in interleukin-2 (IL-2) has proved to be substantially more effective to mice bearing micrometastases from various types of tumors than lymphokine-activated killer (LAK) cells are. The combination of TIL and cyclophosphamide was further potentiated by the simultaneous administration of IL-2. Kradin et. al have disclosed that a measure of therapeutic success has been achieved by the administration of interleukin-2 (IL-2) and IL-2 activated lymphocytes in mice with metastatic malignancies. The Apr. 9, 1987 issue of the New England Journal of Medicine includes reports by two different groups of investigators concerning their experience with adoptive immunotherapy for cancer.

Our purpose of our citing these references was to demonstrate that there exists a certain degree of correlation between the responses of tumor cell on various treatments in mice and in humans.

In a quite different field of art a method has been suggested for the stimulation of biological processes relating to cellular activity, particularly for promoting the healing of wounds, ulcers and epithelial injuries which was based on the recognition that polarization property of laser light was responsible for the well-demonstrated wound-healing effect of laser light, thus the expensive and bulky laser could be replaced by a light source emitting incoherent polarized light. This invention is disclosed in U.S. Pat. No. 4,686,986 issued to Fenyo et. al, Mrs. Fenyo being one of the inventors of the present invention as well.

The polarized lamp has gotten a fairly moderate acceptance and its medical use has been rather limited. A few number of patent applications were directed to particular designs of polarized lights sources for biostimulation. Of these PCT publication WO-A-8 403 049 and published European patent application 84850395.9 can be mentioned as relevant.

SUMMARY OF THE INVENTION

The object of the invention is to provide a new method for in vivo treatment of tumorous tissues on body surfaces which can enhance the available arsenal of means and methods of overcoming or moderating this disease.

The essence of the invention is the recognition of the fact that polarized light (be it incoherent or laser light) can positively influence the tumor-host relationship leading to suppression or rejection of tumors. The exact mechanism of this effect remains to be elucidated.

According to the invention a method has been provided for in vivo treatment of tumorous tissues on body surfaces that comprises the step of irradiating said tissues by polarized light of predetermined intensity, this polarized light predominantly includes wavelength components exceeding 300 nm and substantially excludes ultraviolet components.

It is preferable if the intensity of irradiation is between 20 and 150 mW/cm@2, however, the highest intensity of the irradiation is limited only by the sensitivity of tissues against heat load concomittant with the irradiation.

It has been found that the effects of an irradiation with polarized light last about for 24 hours. This finding can be largely inaccurate, nevertheless it is preferable if the treatment is carried out at least once a day for at least one period of at least 2 minutes duration. It is preferable, if the time of the daily treatment is between 5 and 30 minutes. These time data are, however largely dependent on the individual, on the intensity and spectral distribution of the light, on the depth of the tissues to be treated and on several other factors.

In a preferable embodiment the polarized light includes polarized infrared components. With such components the depth of penetration will be higher than in case of using visible components only. A further advantage of using infrared components lies in the increased efficiency of utilizing the available light output of generally available light sources.

In a preferable embodiment the cross-section of the irradiating light is at least as large as the surface area of the tissues to be treated. By using a sufficiently large cross-section the need for mosaic-like irradiation is eliminated, and the time of treatment is reduced. If substantially larger areas are irradiated than the overall surface of the tumor tissues, the results can even be better, since due to limited penetration of the light into under-surface tissues (including arteries and veins) the stimulation can be more effective.

In a preferable embodiment the irradiating light can have a spectral distribution that corresponds substantially to that of a metal halogen bulb from which components under about 400 nm have been substantially filtered out.

According to the invention a surprisingly new use of a light source emitting polarized light with wavelength components exceeding 300 nm has been suggested, in which said light is used for irradiating tumorous tissues on body surfaces. The term `body surface` covers areas in body cavities to which light can be administered as well as under-surface tissues within the range of penetration of polarized rays.

This new use covers light sources disclosed in U.S. Pat. No. 4,686,986 as well as other conventional light sources like laser sources used up to now for wound healing or general biostimulation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows how mice were irradiated with polarized light,



FIG. 2 shows the increase of tumor area versus time at the mice of the control group,

FIGS. 3 to 8 are curves similar to those of FIG. 2 relating to respective ones of six treated groups,

FIG. 9 shows the average of tumor growth curves,

FIG. 10 shows the average tumor surface at the seven groups on the 29th day of treatment, and

FIG. 11 shows the result of a toxicity test.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

All experiments were performed with inbred BALB/c mice of our own breeding colony originally derived from the Sloan-Kettering Memorial Institute (New York, USA). The used tumor was the methyl-cholanthren induced fibrosarcoma (BALB/c Meth A) originally derived from Dr. Old's Laboratory (Sloan-Kettering Memorial Institute).

The tumor was maintained in its ascites form through serial passage in the peritoneal cavity of BALB/c mice. The cells were harvested, washed three times in Hank's solution, examined for vitality and inoculated subcoutaneously (s.c.) into the abdomen of syngenetic mice. From previous experiments it is well known that the injection of 3.times.10@6 vital cells represent 100% take of the tumor. Therefore always this amount of cells was administered. For the experiments only male mice were used of more than 25 g body weight and of equal age and breed.

In the experiments 7 groups were formed, each included four or five mice. These groups were treated first after 48, 72 and 96 hours, respectively after transplantation and subsequently each day until their death by linearly polarized light. A group of four mice served as tumor bearing untreated control. The treatment consisted of irradiation by polarized light of about 50 mW/cm@2 power density using the lamp sold under the trade name EVOLITE by Bildsystem AB, of Malmo, Sweden, designed according to the published European patent application 84850395.9. FIG. 1 shows the general view of the irradiation arrangement. Mouse 1 under treatment was kept on its back and was temporarily fixed on a board 2. Light source 3 emitted parallel rays of polarized light having a rectangular cross-section of 200.times.300 mm indicated by reference numeral 4. The spectral distribution of the irradiating light was in correspondence with that of a usual metal halogen bulb, however, components under the wave length of about 400 nm were effectively suppressed. The distance of the treated surface of the mouse 1 from the exit opening of the light source 3 was about 18-20 cm. The cross-section of the irradiating light was larger than the whole surface of the mouse 1 therefore the irradiation was not limited to the tumorous area.

Each irradiation was performed under neurolept anaesthesia (Vetranquil 0.01% 0.1 ml intramuscular inj.). The duration of the daily irradiation was 5, 10, 15 and 30 minutes in the respective groups. Each day the mice were irradiated about the same time. Table 1 summarizes the data of irradiation for groups 1 to 6

TABLE 1

Time of the first treatment after tumor injection // Daily time of irradiation // Number Group size

1 4 48 h 30 min

2 4 48 h 15 min

3 5 48 h 10 min

4 5 48 h 5 min

5 4 72 h 30 min

6 5 96 h 30 min

The growth of the tumor grafts was monitored twice every week by measuring the size thereof by means of calipers. The tumor size is expressed in mm@2 units obtained by the product of the largest two diameters of the tumor. FIGS. 3 to 8 illustrate the tumor growth as a function of time for the six groups. A similar diagram for the untreated control group is shown in FIG. 2.

On the basis of the measured data statistical work was performed by using Mann-Whitney test on the 23rd day and Wilcoxon test on the 29th day. The average of the tumor growth curves for the treated and for the control groups is shown in FIG. 9, while FIG. 10 illustrates the average tumor surface on the 29th day for the respective groups including the control group.

The tumor growth curves demonstrate without exception that the treatment with polarized light effectively inhibited tumor growth in each group. On the 23rd day the average surface area of the treated groups was only 31% of the average of the control group, while a similar ratio at the end of the 29th day was only 28%. FIG. 9 shows that the growth rate of the treated animals is practically constant from the 6th day to the end of the 29th day, while this rate in the control group was uneven, the steepness has increased with time.

This fact is reflected also from FIG. 10, in which the group averages can be seen separately. This figure shows that there is no direct relationship between the irradiation time and the extent of response. The timing of the first treatment has probably more influence at least on the initial tumor growth. The survival of the animals was not investigated in this sort of experiments.

To exclude the possibility that a non-specific toxic effect of the polarized light can be responsible for the differences in the tumor growth, a separate toxicity test was carried out. In this test series 10 female mice were irradiated after weaning for twelve hours per day by polarized light. Another group of 10 similar mice was irradiated with non-polarized (normal) light with identical intensity, also for twelve hours a day. The increase of weight was measured for a longer period of time. The results of this test i.e. average weight of the respective groups versus time are illustrated in FIG. 11. This figure shows that apart from a slower weight increase in the first two weeks, the weight after the first month became very close to each other and by the end of the sixth week the average weight of both groups became equal. This demonstrates that the treatment with polarized light does not have a toxic effect on the experimentary mice, and the tumor growth inhibiting effects demonstrated by our tests are due to specific effects of polarized light on the tumor-host system.

Our experience with polarized light treatment on mice obtained during other series of tests than demonstrated here suggest that the effects of polarized light do not last longer than about 24 hours, and this explains why we have chosen the daily irradiation rate.

The essence of the test-series described hereinabove is the fact that polarized light with specific intensity can positively influence the tumor-host relationship leading to suppression or rejection of otherwise untreatable tumors. The exact mechanism of this effect remains to be elucidated.

There are, however, certain facts and phenomena which can assist in understanding the way how polarized light can accomplish its beneficial effects. It is known that the literature (Dvorak, H F; Senger, D R; Dvorak, A M: Fibrin as a component of the tumor stroma; origins and biologic significance, published in Cancer Metastasis Review 1983, 1 pp. 41-73) that the tumor structure is composed of malignant cells surrounded by stroma. The latter regulates the access of inflammatory cells to tumors. In many transplantable tumors lymphocytes are confined largely to the tumor-host interface and do not penetrate into mature tumor stroma or provisional matrix to any important extent (see also Dvorak, H F; Dvorak, A M: Immunhystochemical characterisation of inflammatory cells that infiltrate tumors; In: Haskil S. ed: Tumor immunity in prognosis: The role of mononuclear cell infiltration, Vol. 3 New York, Marcel Dekker 1982, pp. 297-307). According to recent investigations a well-defined permeability factor is produced by the tumor cells which renders local blood vessels permeable for protracted periods (See Senger, D R; Galli, S J; Dvorak, A M; Peruzzi, C A; Harvey, V S; Dvorak, H F: Tumor cells secrete a vascular permeability factor that promotes accumulation of ascites fluid, Science, 1983; 219: 983-5). The discrepancy between rapidly growing tumor cells and imperfect metabolic supply leads to necrosis which phenomenon is often referred to as spontaneous disappearing tumors (See Folkman J: Tumor angiogenesis, Adv. Cancer Res.: 1985; 43 pp. 175-203).

One of our interesting observations during the experiments was that central necrosis occurred earlier and to a greater extent than on the animals without polarized light therapy. Although such observations require more investigations, this can mature to a further verification that polarized light stimulates the immunological defense system.

The tumor used for the experiments belonged to a chemically induced type. It is known from our previous experiments (See Borberg, H; Abdallah, A; Schwulera, U; Sonneborn, H; Inhibition of tumor growth in a mouse fibrosarcoma after interleukin 2 application, Immunbiol. 172. 1986, pp. 383-390 and the references included therein) that the growth of chemically induced tumors can be inhibited by means of non-specific immunostimulants, by lymphocytes from immunised donors and soluble products of activated lymphocytes. The fact, that polarized light proved to be beneficious for decreasing the growth rate of a chemically induced tumor, can also be regarded as a further support for the hypothesis that the mechanism by means of which polarized light can be effective is the general stimulation of the immune system.

In view of the present invention and of the above outlined hypothesis the experiments obtained with wound healing obtain a new interpretation. In such tests the compositions of the wound secretions before and after treatment with polarized light were examined and compared to each other. The treatment resulted in a significant increase in immunoglobulins and other proteins. Also the cellular composition showed a marked difference: among neutrophil granulocytes lymphocytes and monocytes appeared and demonstrated activity within the wound secretion. These had to be caused by changes of the vascular permeability and/or subsequent chemotactic efforts which were otherwise lacking. The second reason why the particular references dealing with the adoptive immunotherapy of cancer were cited in the description of the prior art portion of the present specification will now be understood. In broad sense these papers have pointed out that an increase in activity of lymphocytes at the close proximity of tumor cells had beneficious effects. The above demonstrated increase in activity of the immune system in response to irradiation with polarized light can cause similar effects, thus it can be expected that the irradiation with polarized light can be an alternative (or complementary) to the administration of IL-2 and/or IL-2 activated lymphocytes.

It might be significant that during the experiments not only the tumor area, but the whole body of the mice was irradiated. Since polarized light with infrared components has certain depth of penetration in tissues, it can be expected that a treatment with polarized light on human applications can be more effective if irradiation is not limited physically to the tumor areas.

A major advantage of the method according to the invention lies in the harmless applicability thereof. Further to the above described toxity tests it can be added that polarized light treatment has been in use for more than six years for wound healing, cosmetical and other related applications in several countries and thousands of patients were treated therewith. Not a single case was reported with any side effect.



HK67289
A METHOD AND APPARATUS FOR THE STIMULATION OF BIOLOGICAL PROCESSES RELATED TO CELLULAR ACTIVITY

Inventor:  FENYO MARTA // KERTESZ IVAN (+2)