ZA200209550B - Treatment and therapy apparatus. - Google Patents

Description

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TREATMENT AND THERAPY APPARATUS

) This invention relates to a bodily treatment and medical therapy apparatus, in “ 5 particular a modality for topical treatment of the human or animal body, for prevention and/or improving health conditions. The apparatus provides non-invasive, painless, relatively inexpensive yet effective modalities.

The skin is an organ which performs important though sometimes not sufficiently recognised roles in health; subcutaneous regions and regions not far removed from the skin also include important organs, for example the venous and lymphatic systems, linked to bodily health. The treatment of the skin and regions below the skin can have valuable curative, preventative, health and well-being enhancing results. Examples of these will be referred to below in the course of discussing the invention, without - 1S limitation to the particular effects described.

The invention is apparatus, including assemblies of apparatuses, having the characteristics to be described below, without reference or limitation to any particular usage or effect. Similarly methods or techniques of using the apparatus will be : 20 described below as non-limiting examples, but again merely as convenient to assist in the course of describing the invention, which is the apparatus having the characteristics described.

An abbreviated overview of various key features of the invention now follows, these will be discussed more fully further below.

The present invention provides apparatus which is adapted to supply a massaging flow of a purified compressed air and/or a medical grade oxygen to the skin, preferably [iY with a pulsating effect. The apparatus may draw air from a suitable source of pure air w oo

Co 30 or from ambient and must comprise filters and/or purifiers particularly if drawn from ambient air. Where air is used the apparatus is preferably provided with a mechanism for the air to be enriched with oxygen by supply on a proportionate basis of oxygen.

To this end purified compressed air and/or purified oxygen at pressures of various \

fa ra A calibrations can be provided by the apparatus, to provide a range of air/oxygen blends varying form 21% to 100% oxygen content. The expression air/oxygen is used herein to indicate air and/or a blend in selected proportions of air and oxygen. In all cases ) highly purified air and oxygen are used. § 5

Adaptation of the apparatus for a range of massaging actions at various depths of body tissue, is provided for. A range of pressures of the gases from 0,5 bar to 5,0 bar applied in straight-through flows or a range of preset compounded air and/or oxygen pulsations.

A range of means for topically applied heating is provided for, as a preliminary to, or during, application of the air/oxygen applying a massaging action.

The apparatus for supply of near pure or pure oxygen, i.e. medically pure oxygen, is subject to safety measures of the invention, and suitable usage precautions. The apparatus must provide control to a suitable level of pressure and flow volume, preferably with means for regulating these parameters over appropriate ranges, for various applications. The apparatus may be provided with a pulsating device, adapted to provide the pulsating effect in the air supply, preferably means of adjusting the frequency and amplitude of pulsation of the air is also provided, over a desirable range.

The apparatus preferably includes a means of monitoring the quality of air/oxygen being supplied for topical application to the body, intermittently or even continuously.

The apparatus is provided with a nozzle and preferably a set of nozzles from which one suitable for selected applications can be chosen in a given treatment regimen. The nozzle or nozzles can better be described as an implement or implements for * application of the air flow to a surface of the skin. Preferably the implement is provided with an aperture or orifices for emitting the gas orthogonal to a surface of the implement to be applied to the skin, the internal delivery passages being designed to minimise turbulence effects and to direct the gas in a direction as it approaches the aperture or orifice mouth which is conducive to orthogonal exit of the gas.

€ 2D a ~ WO 01/89633 PCT/ZA01/00066

The implement preferably has the surface referred to oriented at an ergonomically convenient angle relative to a handle portion of the implement for ease of use and an absence of fatigue as well as enabling accurate presentation of the implement for the : orthogonal delivery of air to the skin surface. In particular, the aperture or orifices . 5 and the surface at which they have their opening are designed to provide that over an area of the skin to which they are applied the kinetic energy of the air stream is efficiently converted into pressure energy. This is aptly described in air flow theory as a nul point, i.e. where as near as possible all kinetic energy is converted to pressure energy in the gas stream. The design of the implement is thus directed to provide a localised application of gas under pressure greater than ambient to the skin and this is preferably oxygen rich gas, e.g. oxygen enriched air or near pure or pure oxygen. By movement of the implement over the skin surface progressive treatment of the whole required area at super-ambient pressure can be achieved without having to place the person in an isostatic chamber.

The apparatus thus typically can comprise a compressor capable of delivery of high quality air, in particular oil free air, drawn from ambient. A rotary screw compressor with an air receiver, pre-filter, air dryer, final filter and electronic condensate drain is suitable. An intake filter, a separate oil filter, an oil separator, oil cooler, air dryer, a pre-filter to 3 micron, final filter to 0.01 micron are provided. A third filter to 0.003 micron can be added in the form of an active carbon filter. This standard exceeds medical standard authorities requirements for “medical grade” air and is considered a “super grade” of air. This is important because a degree of absorption of the air and its oxygen component, in particular where the air is oxygen enhanced, into the skin and subcutaneous layers occurs during treatment. Avoidance of harmful effects, in particular carcinogenic effects is thus central to this invention. A control box is provided and detection of air supply is preferred. If desired, an air humidifier can be “ included in the apparatus, with suitable control means to provide a measured degree . of humidity of the air supplied. This can be adjusted to avoid desiccation effects of . 30 the skin being treated by infusing moisture. A vapouriser can also or alternatively be added for dispensing of aromatic therapy oils and other therapeutic liquids. The humidity can be adjusted from patient to patient and/or according to the use or

~ WO 01/89633 PCT/ZA01/00066 otherwise of other treatments of the skin to control skin condition and moisture levels.

In particular, the apparatus is provided with a means of controlling oxygen administration in order to achieve beneficial effects in respect of the following. . 5 - Animportant feature of the invention is that the delivery components of the apparatus which have contact with the gas being delivered to the skin is carefully chosen tobe : free of any toxic properties. For example, aluminium is avoided and other metals which have a toxic capacity against the body, especially considering the application of the gas to the skin results in a degree of absorption by the skin and hence substances in the gas which can be picked up from toxic metals. Similarly certain polymers are avoided, for example, polyvinylchloride in flexible tubes and other components of the apparatus. Non-toxic formulations of urethane or polyethylene can, for example, be used instead. According to the invention, a metal such as aluminium can be used provided that surfaces that are exposed to the air/oxygen to be applied to the person are coated, for example, by a ceramic or other suitable coating.

It is known that certain dermal problems exhibit hypoxia and certain other skin conditions. Healing and repair can be excellent by increasing topical oxygen supply to the affected area.

The apparatus of the invention is thus adapted to supply a combination of oxygenation of tissues with a pulsating massaging.

As will be mentioned more fully below, the apparatus includes means of producing heat as a feature of the therapy which can be applied using the apparatus. The heat can be applied by heating the air/oxygen and/or the heat can be applied by the use of heating pads which are applied before the application of the massaging air/oxygen. te

The invention thus comprises a transdermal oxygen delivery system, apart from being i 30 a massaging system, which will be described further below. The delivery of oxygen .via the oxygen enriched air under pressure permeates the skin and subcutaneous layers. This allows the oxygen to diffuse below the skin level. Thus, although the

A ' hd WO 01/89633 PCT/ZA01/00066 oxygen enriched air issues from the aperture or nozzles as a jet or jets orthogonal to - the skin surface, it then converts to oxygen enriched air at the skin surface at an enhanced pressure above ambient and diffuses into the skin also spreading under the skin surface. The oxygen permeates through the epidermis into the corium and . 5 subcutaneous fatty tissue. Treatment of cellulite is an important application of the invention. The oxygen supplies the cells with energy which enhances the metabolic breakdown of starches and fats. The supply of oxygen in this way compensates for the inadequate supply from the body systems themselves, which tends to occur in people no longer young and no longer physically active. In these conditions the skin tends to be last in the supply chain of oxygen from the body systems themselves and oxygen levels are depleted. This leads to an increased susceptibility to infection due to the low metabolic rate of surrounding tissues. A further result is a low rate of wound repair. The treatment of this invention can be directed to have a therapeutic effect against these adverse conditions.

Only medical grade oxygen will be employed as a source to be supplied for oxygen enrichment of the air.

The features of the apparatus according to this invention are also directed to optimise effectiveness in therapeutic treatment of the lymphatic system of the body. The greater part of the lymph system of the body is located fairly close to the surfaces of the body, not deep in the tissues, e.g. on the lower limbs, arms and facial areas. The lymph system is thus mostly accessible to treatment by the apparatus according to the invention easily. The lymph system contains white blood cells which are vital for defence against infections. The oxygen enhancement improves the effectiveness of the immune system. It appears also that oxygen has a beneficial effect in relaxation therapy and is helpful to combat stress.

The apparatus of the invention is also optimised to supply oxygen to the tissues ) | 30 generally with the effect of slowing necrosis of cells which results in ageing of the skin. Oxygen fulfils a vital role in the repair mechanisms and rejuvenation and is helpful in preventing the development of and healing of scar tissue.

te WO 01/89633 PCT/ZA01/00066

The oxygen is effective in treating and preventing infections by anaerobic organisms in general. It aids in cases of hypoxic skin in restoring vitality. ) The apparatus of the invention is thus usefully seen as an oxygen delivery system to o 5 the superficial layers of the body, in particular the skin and superficial tissues. By this invention the oxygen enriched air is delivered to the skin at pressures above - atmospheric. The invention makes this possible without need for hyperbaric chambers or the use of oxygen rich creams or other known means. | :

The invention is also to be seen as a means of providing a massaging and draining effect on the skin and subcutaneous layers of tissue at various depths of the body. The depth of this effect can be varied by varying the pressure of the air/air-oxygen mixture which is supplied to the implement and hence the strength of the delivery of the mixture to the surface. The pulsating effect provides a massaging result on the tissues.

A particular application for which the apparatus is adapted is the treatment of the lymphatic system which is mostly located in the near-surface layers of the body cells and the apparatus is made so that the lymph system is accessible to treatment using the apparatus. The pulsating causes alternating expansion and contraction of the lymph passages which are extremely small and delicate but are readily invigorated by therapy treatment which can be given using the apparatus. The detoxification function of the lymph system can be enhanced with resulting benefits to the bodily health and vitality. Lymph drainage is enhanced by the pressurised pulsed massaging made possible by the invention also the heating and oxygenation can have beneficial effects.

Build up of toxic substances in the lymph system can be reduced or eliminated. The apparatus of the invention thus enables assistance and/or enhancement of the natural & lymph propulsion morphology, in the form of intrinsic truncal contraction. As is known, lymph stasis is implicated in a large range of pathological conditions of the : 30 body.

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® WO 01/89633 PCT/ZA01/00066

The use of the invention can also be helpful in a synergy existing between reduction of cellulite, which is desirable for its own sake and which the inventor believes plays a role in reduced effectiveness of the lymph transport system. It is believed that this is due to enhanced levels of inter-cellular pressure resulting from the cellulite build up . 5 placing constrictive pressure on the lymph vessels which is combined with the adverse effects of gravity on lymph transport. By virtue of the use of the pulsating massaging effects of the invention, not only is the lymph system directly massaged but a modification of connective tissue fibres with the release of excess inter cellular fluid by this massage process, resulting in a reduction of the cellulite, reduces the adverse pressure which the cellulite causes. At the same time, oxygen absorption has the beneficial effects described above. Disposal of metabolic waste is accelerated, the heat application by the apparatus of the invention dilates lymph vessels in addition to the cyclic constriction and expansion of the system. The apparatus can also be used to concentrate on areas of lymph nodes and glands for enhanced efficacy.

The apparatus of the invention can also be adapted for application to cosmetic treatment of skin regions of persons. In particular the apparatus can be adapted for application of pulsed air, oxygen enriched or unenriched, to the face regions, neck and other parts of the body.

The apparatus of this invention preferably further comprises a capacity for heating the body surface and near-surface layers. In accordance with a preferred embodiment of the invention, the apparatus is adapted for heating of the gas, e.g. air with or without oxygen enhancement, before it is delivered by the implement. Thus the pressurised and purified gas can be passed through a heat exchanger to gently heat it to a temperature which is suitable for application to the skin. The heating of the skin causes dilation of the capillaries near the surface of the body with enhanced activity & of the cells and bodily functions related thereto and enhanced absorption of oxygen from compressed or oxygen enriched air. The vaso-dilation caused by the heating i. 30 also stimulates other related body functions which are beneficial.

According to the invention, the apparatus is provided combined with suitably adapted heating pads which can be laid onto body surfaces to be treated with the pulsed air therapy to provide an initial warming of the body parts affected. Thereafter the heating of the air can maintain the body surfaces at advantageous temperatures.

The invention will be more fully described by way of example, with reference to the drawings, in which : - figure 1 is a schematic drawing of component connections of only one example of apparatus according to the invention, figure 2 is a schematic drawing of component connections of another example of apparatus according to the invention, figure 3 is a drawing of a control panel for the figure 2 example, figure 4 is a schematic drawing of component connections for yet another example of apparatus according to the invention, figure 5 is an electrical connection drawing for the embodiment shown in figure 4, figure 6 is a schematic drawing of component connections of another example of apparatus according to the invention, figure 7 is a schematic drawing of component connections of another example of apparatus according to the invention, figures 8, 9 and 10 are views of an implement forming part of the apparatus of the invention, in one embodiment, . 30 figures 11 and 12 are views of an implement forming part of the apparatus of the 5 invention, in another embodiment, with figures 13, 14 and 15 showing certain alternatives,

figures 16, 17 and 18 are views of an implement forming part of the apparatus of the invention, in yet another embodiment, and ) figures 19, 20 and 21 are views of an implement forming part of the apparatus of the . 5 invention, in still another embodiment.

Figure 1 shows a fairly simple embodiment of the invention. Such embodiment can be important, however, in supplying the home market and small treatment centres, for example.

The apparatus 1 comprises a compressor which 2 supplies air at a pressure within the : range one half a bar to 6 bar, adjustable as required. Preferred range of use is within one bar to four and a half bar. Selection of the pressure will vary according to the nature of treatment, the stage in a course of treatment and the areas being treated together with the objectives of a particular treatment. Special care in the selection of the parameters must be taken where there is any health risk involved, especially, for example, where there is any risk of a thrombotic condition. The air is led to a pulsator 3 which introduces a pulsation to the supply of the air. Again the frequency of the pulsation can be selected by means of the apparatus making adjustment possible. Not only the frequency of the pulsating but also the wave form of the pulsating can be selected to have differing effects. For example, a fast rise time pulse., a fast fall time pulse or a near sinusoidal pulse can be selected. A range of frequencies giving a periodicity of between one twentieth of a second and sixty seconds is desirable, in accordance with the invention. Again, the apparatus enables varying the frequency according to the treatment regimen. A solenoid valve 4 allows control of the air flow. Three filters 5, 6 and 7 provide progressive filtration to 0.003 micron. A flow control valve 8 provides an adjustable flow rate control. The final part of the apparatus is an implement located at 9, figures 6 to 19 are referred to. The i implement can be selected according to the parts of the body being treated and the effects sought. ’ 30

Figure 2 shows a more sophisticated embodiment 10 of the invention. A compressor 11 supplies high quality compressed air to a dryer 12, thence through a triple step purification of filters 13 (0,3 micron), 14 (0,01 micron) and 15 (0,003 micron) and thence to a pressure control 16. The air then continues to other components located . 5 ina control box which can be close to the patient. The preceding parts can be located in another room, for example. The pulsator 17 introduces an adjustable pulsation to the air, a further filtration to 0,003 micron at filter 18 is added for safety sake, a vaporiser 19 allows providing a selected vapour level. A heat exchanger 20 allows heating of the air to a required temperature. A large range of temperature can be provided, though not above 40 degrees centigrade, for normal purposes. From the heater the air passes to a device 21 (e.g. a venturi based device) for introduction of oxygen of medical grade. The proportion of oxygen to air is retained by the device at a given setting independent of air delivery rate, which can vary as the implement is used. The air is then led via a non-toxic plastic tube to an implement 22 (see figures 6to 19).

Figure 3 shows a control panel 25 for the apparatus. The panel carries a key switch 26, an on-off \switch 27, a flow meter 28, a pressure control 29, a gauge pressure (pressure ‘above ambient) meter 30 and a pulsator control 31.

Figure 4 shows a pneumatic circuit which can be used in accordance with the invention. The air inlet 60 is where atmospheric air is drawn into the system. An air pump and regulator 61 drives the air to a pulsating valve 62, thence to a micro filter 63 which filters to 0,003 micron.. From there the air passes to a clean air valve 64 where it can be switched either to a line 65 or a line 66. The line 65 has a vaporiser 67 in it to introduce a desired or required vapour to the clean air stream. The vaporised air passes then to an exit where a hand held applicator nozzle is connected.

S The line 66 leads to an exit at 69 where a hand held applicator nozzle is connected. A source of medical grade oxygen at 70 leads to a valve and regulator 71 which allows

N 30 oxygen to pass a non-return valve 72 and enter the air stream leading to exit 69.

Oxygen enriched air is provided at exit 69 in this way. A venturi or other means can be used to provide a proportional flow of oxygen to the air stream flow rate.

Figure 5 shows electric circuitry for the system shown in figure 4. A live supply 75 provides power to the system via a master switch 76 onto a live bus 77, with a neutral bus 78 being provided. A switch 79 allows switching on a pulsator 80, if this switch ’ 1s on a switch 81 allows a pulsator valve 82 to be switched on. A switch 83 allows

R 5 either vaporised air or clean air to be switched on or off, leading to relay 84 and the control device 85 which allows only the one or the other but not both to be switched on at any one time. Switch 83 is mounted in the hand held nozzle. Switch 86 allows power to be brought to a switch 87 also located in the nozzle which allows power to be brought to the oxygen supply 88-89. Switch 90 allows switching on or off the oxygen generator 91, from the main power supply line.

Figure 6 shows the air line 60 where compressed air passes an upstream pressure - regulator 61, controlled by a solenoid activated on-off valve 62. If no oxygen is added, the air is heated by the coils 63 and is led to the applicator nozzle at the outlet 64. Oxygen supply 65 (e.g. form a cylinder of oxygen) is admitted by solenoid valve 66 opening. Pressure is regulated by an upstream regulator 67 and admitted to the air line by a bleed valve 68. The air-oxygen blend is heated by coils 63 and pass to the exit 64 at which an applicator nozzle is connected. A temperature probe 74 is included in the line, to provide a temperature sensing means, for allowing control of the temperature to which the blend is raised. At the same time as solenoid 66 opening, to admit oxygen, solenoid 69 opens, to admit the air-oxygen blend via capillary cooling coil 70 and bleed valve 71, to a sensor 72 to provide a continuous oxygen analysis of a sample.

Figure 7 shows an apparatus in which ambient air is provided by a screw compressor to a heat exchanger 80, to extract heat of compression, by means of a circulating liquid as a cooling medium. A second unit 81 provides a temperature control function.

Two condensate drains 82 and 83 are provided giving an automatically controlled oo drain, the second including a filter. The air then passes to a an air receiver 84, a . 30 manual drain 85 for an optional manual drain facility and thence to two successive filters to provide filtration to eliminate particles above 0,003 micron. The air then : passes a pressure regulator 88, which has a pressure gauge, thence via a solenoid valve 89. Oxygen is supplied to a receiver 90, through two regulators 91 and 92, each with a gauge, then a solenoid valve93 and affixed restriction or bleed valve 94. The air and oxygen flows blend at junction 95. At 96 the main supply passes to a heat exchanger : 97 which uses air as heating medium circulating and a second unit 98 which serves as ) a temperature controller. The blend then passes to an applicator 102. A fraction of the i 5 blend passes from 96 to a cooling device 99, through a restriction 100 and then to an oxygen content analyser 101.

The receiving tank and any other components in the circuit if they are of metal are coated with a polymeric material for example, an epoxy which can be baked and hardened, to prevent contamination of the gases and prevent rusting which might arise if there is moisture in the system.

Figures 8 to 10 show a hand held implement 35 for application of the pulsed oxygen- enriched air massaging therapy to the body. A handle part 36 has a passage 37 for passage of air from an end 38 where a tube is connected by means of a suitable connector (not shown). The distal end of the passage communicates with a transverse cylindrical plenum chamber 39 located in a head part 40 of the implement.

A delivery aperture 41 emerges orthogonal at the applicating face 42 of the implement, leaving the chamber tangentially, to minimise turbulence of the air. The implement is made from aluminium but is coated inside and outside with a ceramic which is inert to human tissues and does not allow any toxic contaminant to enter the air stream or to be rubbed off onto the skin at the face 42. The face 42 is oriented at an angle 43 to a plane transverse to the longitudinal direction of the implement. The angle is 70 degrees which means that the face 42 is at 20 degrees to the longitudinal of the implement. This gives an ergonomically convenient orientation to the face. The implement can e held comfortably in the hand for application to general body parts of : a person prone on a treatment table. In this comfortable position the face can easily be kept parallel to the skin surface and the air jets are then orthogonal to the skin : surface. This achieves optimal conversion of kinetic energy of the air stream to pressure energy and so optimal benefits from the massaging action and penetration of the oxygen into the tissues. The passage 37 can be made of smaller diameter, but if it is, the passage must be made to bell-mouth outwardly towards the orifices to give a good spread of the air jet over the full width of the nozzle.

Figures 11 and 12 illustrate a further implement 45 which is in many respects the

RN same as that shown in figures 8 to 10, the same reference numerals are used for the parts that are the same and the description with reference to figures 8 to 10 is referred \ 5 to, for convenience. The implement 45 differs in having a plurality of orifices 46. As shown in figures 13, 14 and 15 three other implements are provided which give a choice of an implement with a seven, nine or twelve orifice configuration. Again the important angle of the application face is preserved.

Figures 16 to 18 show an implement 50 adapted for application to the face and/or other upright surfaces of a person standing or sitting upright. Again parts of the implement that are the same as in the implement 35 are given the same reference numerals and the description of them is referred to. This implement 50 differs in having a face 42, which is at an angle 51 to a transverse plane to the length of the : 15 implement which angle is thirty degrees. Again, for this application, the handle may be held at an ergonomically comfortable position and it is easy to keep the application face 42 parallel to the skin surface. : Figures 19 to 21 show another version 55 of the implement differing from that shown in figures 16 to 18 only in having orifices 56 instead of an aperture 57. In both implements 50 and 55 a plenum chamber is not used, due to the angles involved, and the passage 58 leads direct to the exit mouth.

Claims (7)

1. Apparatus which is adapted to supply a massaging flow of a purified compressed air and/or a medical grade oxygen to the skin, adapted to serve as " 5 a transdermal oxygen delivery system , which comprises a means of connection to a supply of air under pressure and a means of connection to a supply of oxygen under pressure, filters and/or purifiers for the air and for the oxygen, a means of control of the admission of air to the apparatus, a means of control of admission of oxygen to the apparatus, a pressure control means for the air and a pressure control means for the oxygen, a mechanism for the air to be enriched with oxygen by supply on a proportionate basis of purified oxygen at pressures of various calibrations, to provide a range of air/oxygen blends varying form 21% to 100% oxygen content, connection means for connection of the air/oxygen blend to a applicator means adapted for topical application.

2. Apparatus as claimed in claim 1, which further comprises a means of heating the air and/or the oxygen and/or the air/oxygen blend and further comprises a analyser means for analysing oxygen content in the air/oxygen blend by means of a bleed-off circuit from a main circuit which delivers the air/oxygen blend to the means for connection to a topical applicator.

3. Apparatus as claimed in either one of claims 1 or 2, provided in combination with a set of topical applicators, in the form of nozzles, each of which has an applicator surface oriented at an ergonomically convenient angle, with orifices for exit of the blend, for topical application of air/oxygen blend at an angle which is substantially orthogonal to the surface of the body to be treated, so as . to produce aml point condition of the blend, for substantially complete conversion of kinetic energy of the blend issuing from the orifices, to pressure no 30 energy.

= oo ® WO 01/89633 PCT/ZA01/00066

4. Apparatus as claimed in any one of claims 1 to 3, provided in combination with heating pads adapted to be laid onto the surface of a body to be treated, to be electrically or otherwise heated, to prepare the surface by raising it to a desired temperature for topical dilation. n 5

5. Apparatus as claimed in any one of claims 1 to 4, in which the apparatus is provided with a pulsator device, which can cause a pulsation of the air/oxygen blend supply to the means for connection to an applicator.

6. Apparatus as herein specifically described with reference to any one of the : embodiments shown in figures 1, 2 and 3,4 or 5, 6, 7,

7. Apparatus as claimed in claim 6, provided in combination with an applicator or applicators as described with reference to any one or more of figures 8 to 21, of the drawings.