AU2005218674B2 - A therapeutic apparatus and a method of treatment using the apparatus - Google Patents

Description

WO 2005/084603 PCT/AU2005/000247 A THERAPEUTIC APPARATUS AND A METHOD OF TREATMENT USING THE APPARATUS Technical Field 5 This invention relates to a therapeutic apparatus and a method of treatment using the apparatus. Background to the Invention The lymphatic system is an extensive drainage system 10 that transports water and molecules from tissue to the bloodstream in a liquid known as lymph. The lymph flows from the tissue to the blood stream via a network of lymphatic vessels that return the lymph to the bloodstream via a large vein that is located in the upper chest (near 15 the neck). One of the major lymphatic vessels is the thoracic duct which receives lymph from the pelvis, lower limbs, abdomen, and lower chest and returns the lymph to the bloodstream via a large vein in the upper chest. In addition to returning water and molecules to the 20 bloodstream, the lymphatic system also serves to filter out foreign materials such as microorganisms and toxins. This filtering process is carried out by lymph nodes which lie along the network of lymphatic vessels. Lymph nodes are swollen nodes along the lympatic vessels which consist 25 of a fine network of tissue that contains macrophage. Microorganisms and toxins that are contained in the lymph are trapped as the lymph passes through the lymph node and subsequently phagocytised by the macrophages to thereby remove the foreign material and toxins from the lymph 30 prior to re-entry of the lymph into the bloodstream. The amount of toxins that remain in the lymph following processing in the lymph nodes is generally greatly reduced if not eliminated. Following entry of the 2 lymph into the bloodstream, removal of the remaining toxins is completed mainly by the liver and kidney and through the skin. Under some circumstances, however, the lymph nodes 5 may be overwhelmed with microorganisms and/or toxins, resulting in accumulation of toxins in the lymph nodes and lymphatic system. This reduces the effectiveness of the lymph nodes and can lead to further accumulation of toxins, resulting in low 'energy levels, fatigue, general 10 malaise, muscle pain, poor mental state, poor skin tone, insomnia or restless sleep. It has been tried to assist in the expulsion of these toxins from the body by performing a lymphatic drainage massage. In such a massage, a skilled masseur manipulates 15. a person at regions of their body associated with the lymph system to mobilise the contents of the lymph system to encourage drainage into the blood system and subsequent processing by the liver. Such a massage can be time consuming and requires a skilled masseur. 20 Further, subjects have reported that following such a massage they often feel very unwell. This is thought to be due to the increased level of toxins in the blood due to the mobilisation of the lymph fluid caused by the massage. 25 Summary of the Invention In a first aspect the present invention provides a therapeutic apparatus including: a tank arranged to hold a body of fluid being sufficiently deep to submerge an 30 upright person at least up to their neck; means for agitating the fluid to effect a generalised perturbation massage upon a person submerged in the fluid to mobilize Amended Sheet

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Oeceiveu I oUwnw xV -3- toxins in the person's lymph system; and further including means to maintain the person in the submerged position. When submerged in. the tank, the person is subjected to a generalised perturbation massage caused by the 5 agitation of the fluid. This mobilises substances in the lymph system of the person. Further, there is a pressure gradient in the tank due to the weight of the fluid. The pressure is greatest at the bottom of the tank and decreases upwardly to atmospheric pressure at the surface 10 of the fluid at a point near to the neck of the person. This pressure gradient naturally urges lymphatic fluid upwards in the body towards the neck. Fluid in the head area drains downwardly under the force of gravity. Lymph from the lower periphery and trunk drains into the 15 lymphatic duct from which the lymph drains into the blood system at the base of the left subclavian vein at the junction of the left subclavian and internal jugular veins. The combined effect of the pressure gradient in the tank and the mobilisation of lymph fluid assists in 20 lymphatic drainage. This lymphatic drainage is achieved without the need to employ a skilled.masseur. The body of fluid and the fluid may have a density greater than water. This provides a greater pressure gradient in the tank and increases the tendency for lymph 25 fluid to drain upwardly. The fluid may be a mixture of water and a salt. The salt may include a salt of magnesium such as magnesium sulphate. The means for agitating may include a pump and an 30 arrangement of nozzles for delivering jets of pressurised fluid. The nozzles may be arranged to rotate. The apparatus includes means to maintain the person in the submerged position such as a system of weights or Amended Sheet

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-4 tethers. This is because the buoyancy of the person in a high density fluid needs to be counteracted to maintain them in a submergedposition about up to their neck. This is particularly the case where a fluid that is more dense 5 than water is utilised. In a second aspect the present invention provides A method of effecting lymphatic drainage in a person including the steps of: submerging the person in a body of fluid with a density greater than water up to about their 10 neck and in a substantially vertical orientation; and agitating the fluid to effect a generalised perturbation massage upon the person submerged in the fluid to mobilise toxins in the person's lymph -system. In a third aspect the present invention provides a 15 therapeutic method including the steps of: submerging the person in a body of fluid up to about their neck and in a substantially vertical orientation; agitating the fluid to effect a perturbation massage upon the person submerged in the fluid; and elevating the body temperature- of the 20 person to thereby cause the person to perspire. In a fourth aspect the present invention provides a method of treating a condition in a person comprising the steps of: submerging the person in a body of fluid up to about their neck and in a substantially vertical 25 orientation; and agitating the fluid to effect a perturbation massage upon the person submerged in the fluid to mobilise toxins in the person's lymphatic system; and further comprising the step of elevating the body temperature of the person to thereby cause the person to 30 perspire. The mobilised toxins are carried by the draining lymph into the person's blood stream from where the toxins Amended Sheet

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is~1vuI,- OCFp-IUUI /UVJ_ - 4a can be removed from the person's body through organs such as the liver, kidney and skin. Mobilised toxins may be removed from the person's bloodstream via the skin through perspiration. Thus, the 5 method may further comprise the step of-elevating the body temperature of the person to thereby cause the person to perspire. The body temperature may be elevated while the Amended Sheet

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WO 2005/084603 PCT/AU2005/000247 -5 person is submerged in the fluid, or subsequent to removal of the person from the fluid. The body temperature of the person may be elevated by any means that causes the person to perspire. The body 5 temperature may be elevated by exposing the person to an amount of infra-red radiation that is sufficient to cause the person to perspire. The person may be exposed to infra-red radiation in an infra-red sauna. The infra-red sauna may be a far infra-red sauna. The far infra-red 10 sauna may be operated at a temperature of between 500 and 70. The body temperature of the person may be elevated by elevating the temperature of the fluid in which the person is submerged to a temperature that causes the person to 15 perspire. The condition may be a condition that results from toxins in the lymphatic system of the person. Without wishing to be bound by theory, the inventor believes that some conditions result from toxins in the lymphatic system 20 of a person, and that a method which effects lymphatic drainage may be used to treat such conditions. The condition may be associated with one or more of the following: low energy levels, fatigue, general malaise, muscle pain, poor mental state, poor skin tone, insomnia 25 or restless sleep. The condition may result from exposure to toxins from the environment. Toxins from the environment may include, for example, pesticides such as organophosphates, organochlorines, carbamates, pyrethrums, herbicides, 30 insecticides, plastics such as formaldehyde, phenol, phthalates, vinyl chloride, dioxins, bisphenol A, PBDE's, toxic metals such as aluminium, arsenic, lead, mercury, organic pollutants such as PCB's, dioxins, furans, PCBD's, WO 2005/084603 PCT/AU2005/000247 -6 trichloromethane, organochlorine pesticides, cosmetics and perfumes such as acetone, benzaldehyde, ethanol, phthalates, lead, paints constituents such as benzene, diisocyanates, toluene, trichloroethane, xylene, inorganic 5 compounds such as flourides, nitrates/nitrites, nitrogen dioxide, sulphur dioxide, ozone, phosphates, sodium hypochlorite, sulphites, ink constituents such as benzene, formaldehyde, phenol, petrol constituents such as benzene, ethylene dibromide, hexanes, toluene, trimethylpentane, 10 xylene, MTBT, food and drug preservatives such as butylated hydroxyl anisole, butylated hydroxytoluene, nitrites, sulfites, thimersol, food contaminants such as lipid peroxidase, trans fatty acids, acrylamides, polycyclic aromatic hydrocarbons, mycotoxins, fungicides, 15 herbicides, insecticides, antibiotics, hormones, mercury, lead, cadmium, water contaminants such as trichloromethanes, arsenic, flouride, aluminium, lead, nitrates, volatile organic compounds, cleaning compounds such as ethylene dichloride, tetrachhloroethylene, 20 trichloroethylene, trichloroethane, ammonia, enzymes, formaldehyde, perfume, phenol, phosphate, sodium hypochlorite, combustion products such as carbon dioxide, carbon monooxide, tars, hydrocarbons, ash/soot, carpet and furniture constituents such as butylated hydroxytoluene, 25 formaldehyde, isooctane, phencyclohexane, propanediol, styrene, vinyl acetate, polybrominated diethyl ether (PBDE's), alchohols such as ethyl, methyl, isopropyl alcohols, propylene glycol, glycerol, adhesives such as butadiene diisocyanates, formaldehyde, styrene, toluene, 30 fragments of organisms such as bacteria, viruses, fungi, protozoans, molecules, allergens, etc that have been partially degraded by the immune system.

WO 2005/084603 PCT/AU2005/000247 -7 The condition may result from accumulation of toxins from drug use. It is envisaged that the use of a drug will result in accumulation of the drug, or a metabolite of the drug, in the lymphatic system, and that the method 5 will therefore be of some benefit to conditions resulting from drug use. For example, drug use may be chemotherapy for the treatment of diseases such as cancer or infectious disease, for pain management therapies such as use of morphine, or for chronic disease therapies such as use of 10 insulin for diabetes. The condition may result from accumulation of toxins from normal metabolism. For example, free radicals, ammonia, hybrogen sulfide, methane, butane, cadaverine, putrescine and other toxic molecules can accumulate over 15 time in the lymphatic system as a result of immune system activity and general metabolism. The condition may be lethargy, fatigue, malaise, weakness, arthralgia, myalgia, insomnia, sleep disturbance, sinus congestion, chest congestion, poor 20 immunity (which can result in, for example, increased incidence of viral and bacterial infections, recurrent Herpes "cold sores" or genital herpes, recurrent mouth ulcers), cognitive dysfunction such as poor concentration, impaired memory, mental vagueness, confusion, and learning 25 difficulties, mood disorders such as mood swings, anxiety, irritability, depression, lack of motivation, loss of libido, Skin rashes and acne, fluid retention, headaches, tachycardia and ectopics. The condition may be a condition selected from the 30 group consisting of gulf war syndrome, diabetes, Cancer, heart failure, kidney failure, liver failure, chronic auto-immune conditions, lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis, emphysema, chronic WO 2005/084603 PCT/AU2005/000247 -8 viral illnesses such as Hepatitis C and HIV, chronic substance abuse such as alcohol, tobacco and/or recreational drug abuse, dysbiosis, Leaky gut syndrome, chronic fatigue syndrome, fibromyalgia, recurrent 5 infections, detoxification of toxic drug metabolites from prescription medication, chemotherapy drugs, etc. Brief Description of the Drawings An embodiment of the present invention will now be 10 described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a cross sectional view of an embodiment of a therapeutic apparatus according to the present invention; 15 Figure 2 is a perspective view of the tank of the apparatus of figure 1 illustrating the layout of nozzles; and Figures 3 and 4 are cut away views showing a person submerged in the tank of Figure 1 up to about their neck. 20 Detailed Description of the Preferred Embodiment Referring to Figure 1, a therapeutic apparatus 10 is shown including a tank 12 being the inner wall of moulded fibreglass unit 13. Tank 12 holds a body of fluid in the 25 form of a hyperosmolar solution 14 being a solution of magnesium sulphate in water. The solution has a specific gravity of around 1.3-1.4. Apparatus 10 includes means for agitating the fluid being a combination of a pump and rotating spa jet nozzles 30 16. The pump is mounted in machinery housing area 18 which also houses a heater, a filter unit, an ozone generator and a high pressure air pump which also delivers air to the spa jet nozzles 16. The pump acts to expel WO 2005/084603 PCT/AU2005/000247 -9 fluid 14 through nozzles 16. Overflow inlet 20 channels overflow fluid back to the pump. Fluid 14 is continuously recirculated though the pump and is maintained at about 32-34 degrees celsius. Spa nozzles 16 are connected to 5 the air pump via a one-way valve to stop fluid 14 from entering the air pump. Tank 12 is about 2m deep and 1.2m in diameter. Referring to Figure 2, spa nozzles 16 are shown in a concentric staggered arrangement. 10 Referring to Figure 3, a person 22 is shown submerged in fluid 14 up to about their neck. Weights 24 are attached to the person to maintain them submerged in the high density fluid. About 30lbs of weights are required for an adult, depending upon their weight. 15 Referring to Figure 4, an alternative arrangement to Figure 3 is shown. Tether cord 26 passes through a loop 28 fixed to the bottom of tank 12 and is attached to the ankles of the person. By pulling upwards on cord 26, the person is maintained submerged in fluid 14. Weights 24 20 maintain the arms of person 22 submerged. A clamp 30 retains tether cord 26 in the correct position. Alternatively, the person 22 can hold onto cord 26 to keep themselves in the correct position. The person enters tank 12 from a platform (not shown) 25 level with the top of the tank. Example A pilot study was conducted to determine whether therapy in the apparatus, combined with far infra-red sauna 30 therapy, led to significant improvements in the energy levels and sense of well-being of participants.

WO 2005/084603 PCT/AU2005/000247 - 10 Fifteen study participants were recruited through general practitioners and local newspaper advertising. All participants were female, aged between 29 and 54 years of age. All participants were experiencing current health 5 issues of low energy, fatigue or malaise that was significantly affecting their quality of life and performance of their normal daily activities. The study was conducted over a 6 week period as follows: Week 1-2 Baseline control - No treatment Survey monitoring Week 3-4 5 combined therapy sessions per week (20 minutes treatment in apparatus + 20 minutes Far infra-red therapy) Survey monitoring Week 5-6 No treatment Survey monitoring 10 The participants completed ten questionnaires over a 6 week period to establish the three phases for the study: two at baseline (week 1 and 2) before the participants commenced treatment, 6 during the two week course of the 15 ten treatments (weeks 3-4), and two at post-treatment (weeks 5-6). The questionnaire was based on three broad components: (a) the CDC healthy days instrument from the US Centres 20 for Disease Control (Measuring Healthy Days, Population Assessment of Health Related Quality of Life, US Department of Health and Human Services, Center for Disease Control and Prevention, Atlanta Georgia, November 2000); WO 2005/084603 PCT/AU2005/000247 - 11 (b) a set of questions relating to health impairments and energy levels; and (c) the full SF-36 Health Survey (Short-form 36 questions developed by John Ware (VP-004 available from Quality 5 Metric Incorporated) that includes overlapping domains for energy and vigour. The CDC Healthy Days instrument and the SF-36 are well known and universally recognised questionnaires for the assessment of fatigue. 10 Results: The results of the questionnaires prior to treatment are summarised in Table 1. 15 Table 1: Baseline to week 4 Section II % of % of Healthy Day Effect participants participants who who experienced an experienced a improvement in deterioration the effect in the effect listed in the listed in the left hand left hand column. column. Number of days lost due to 46.7% >50% poor physical health The number of days lost due 46.7% 7% to poor mental health The number of days lost 46.7% >50% overall due to poor health state to do usual activities WO 2005/084603 PCT/AU2005/000247 - 12 Section III Health Impairment Change The self-reported number of 40% 20% health impairments suffered by participants The sad/blue/depressed 40% 20% level in the previous 30 days The number of days of 66.7% 0% feeling no energy in the previous 30 days Section IV Changes in fitness and energy levels The ability to concentrate 60% 6.7% on daily tasks Current overall levels of 46.7% 6.7% energy Section V Overall Health status and Quality of life (Feelings experienced in previous 4 weeks) Physical and emotional 53.3% 6.7% health affecting interactions with the family The feeling of calm and 46.7% 0% peacefulness experienced The feeling of energy 53.3% 6.7% experienced The feeling of experiencing 46.7% 13.4% the blues WO 2005/084603 PCT/AU2005/000247 - 13 The feeling of being worn 60% 6.7% out The feeling of being happy 46.7% 6.7% The feeling of tiredness 46.7% 20% The personal feeling of 40% 13.3% healthiness The post-treatment monitoring for fourteen participants was conducted in weeks 5 & 6 of the study. The data were compared for fifty-four indicators in week 1 (baseline), 5 week 4 (week 2 of treatment) and week 6 (week 2 post treatment) and summarised in Table 2. Table 2: Post-treatment analysis from baseline to week 6 Section II % of % of Healthy Day Effect participants participants who who experienced an experienced a improvement in deterioation the effect in the effect listed in the listed in the left hand left hand column. column. Number of days lost due to 57.1% 7.1% poor physical health The number of days lost due 50% 0% to poor mental health The number of days lost 50% 21.4% overall due to poor health state to do usual activities Section III WO 2005/084603 PCT/AU2005/000247 - 14 Health Impairment Change The self-reported number of 42.9% 21.4% health impairments suffered by participants The sad/blue/depressed 50% 14.3% level in the previous 30 days The number of days of 50% 14.3% feeling no energy in the previous 30 days Section IV Changes in fitness and energy levels The ability to concentrate 42.9% 7.1% on daily tasks Current overall levels of 57.1% 7.1% energy Section V Overall Health status and Quality of life (Feelings experienced in previous 4 weeks) Physical and emotional 71.4% 7.1% health affecting interactions with the family The feeling of calm and 50% 0% peacefulness experienced The feeling of energy 71.4% 0% experienced The feeling of experiencing 50% 7.1% the blues WO 2005/084603 PCT/AU2005/000247 - 15 The feeling of being worn 64.3% 0% out The feeling of being happy 57.1% 7.1% The feeling of tiredness 64.3% 7.1% The personal feeling of Not provided Not provided healthiness The body pain felt 57.1% 21.4% The amount of pain felt 57.1% 14.3% affecting work The feeling of being very 57.1% 7.1% nervous The down-in-the-dumps 50% 0% feeling experienced The amount of time physical 42.9% 21.4% and emotional problems has interfered with social activities Conclusion: 5 The analysis showed there were a number of positive movements towards the desired outcomes on a number of key indicators within the group both in the treatment phase versus baseline and in the post-treatment comparison with baseline. 10 Any reference to prior art contained herein is not to be taken as an admission that the information is common general knowledge, unless otherwise indicated. Finally, it is to be appreciated that various alterations or additions may be made to the parts 15 previously described without departing from the spirit or ambit of the present invention.

Claims (12)

1. A method of treating a condition in a person comprising the steps of: submerging the person in a 5 body of fluid up to about their neck and in a substantially vertical orientation; and agitating the fluid to effect a perturbation massage upon the person submerged in the fluid to mobilise toxins in the person's lymphatic system; and further comprising 10 the step of elevating the body temperature of the person to thereby cause the person to perspire, wherein the body temperature is elevated subsequent to removal of the person from the fluid.

2. A method according to claim 1 wherein the fluid has a 15 density greater than water.

3. A method according to claim 2 wherein the fluid includes a mixture of water and a salt.

4. A method according to claim 2 wherein the salt includes a salt of magnesium. 20

5. A method according to any one of claims 1 to 4 wherein the step of agitating includes pumping the fluid.

6. A method according to any one of claims 1 to 5 wherein the step of agitating includes the step of 25 delivering the fluid into the tank through nozzles for delivering a jet of pressurised fluid.

7. A method according to claim 6 wherein the nozzles are arranged to rotate.

8. A method according to any one of claims 1 to 7 30 wherein the person is maintained in the submerged position by a system of weights or tethers.

9. A method according to anyone of claims 1 or 8 wherein the body temperature is elevated by exposing the person to a dose of infra-red radiation that is Amended Sheet IPEA/AU PCT/AU2005/000247 -17- Received 6 April 2006 sufficient to cause the person to perspire.

10. A method according claim 9 wherein the person is exposed to infra-red radiation in an infra-red sauna.

11. A method according to any one of claims 1 to 10 5 wherein the condition is associated with the accumulation of toxins in the lymphatic system of the person.

12. A method according to any one of claims 1 to 11 wherein the condition is selected from the group 10 consisting of lethargy, fatigue, malaise, weakness, arthralgia, myalgia, insomnia, sleep disturbance, sinus congestion, chest congestion, poor immunity, cognitive dysfunction, learning difficulties, mood disorders, lack of motivation, loss of libido, Skin 15 rashes, acne, fluid retention, headaches, tachycardia, ectopics, gulf war syndrome, diabetes, cancer, heart failure, kidney failure, liver failure, chronic auto-immune conditions, lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis, 20 emphysema, Hepatitis C, HIV, chronic substance abuse, dysbiosis, Leaky gut syndrome, chronic fatigue syndrome, fibromyalgia, recurrent infections, and detoxification of toxic drug metabolites from prescription medication or chemotherapy drugs. 25 Dated this 5 th day of April 2006 NUTRIPHARMA LTD By their Patent Attorneys GRIFFITH HACK 30 Amended Sheet IPEA/AU