Title of Invention

INJECTION SOLUTION FOR THE TREATMENT OF ARTHROSES

Abstract

An injection solution including a mixture of a solution A of a gold compound as gold (III) compound, a solution B of a Calendula extract, moreover it contains a Hamamelis extract and/or an Arnica extract and/or an Aconitum extract and/or a Bellis perennis extract and/or a Hypericum extract and/or an Echinacea angustifolia extract and/or an Echinacea purpurea extract and/or Chamomilla extract and/or a Millefolium extract and/or a Symphytum extract and/or Mercuris solubilis Hahnemanni and/or Hepar sulfuris and/or an extract from Fruct. Symphoricarpi and/or an extract from Herb. Euphorbiae cyp and said solution moreover contains NaCl, in particular in a physiological concentrations, and water.

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 Of 1970) COMPLETE SPECIFICATION (See Section 10, rule 13) INJECTION SOLUTION FOR THE TREATMENT OF ARTHROSES DR. MED. ADUSUMALLI CHAKRAVARTY of KACHLETSTRASSE 50, D-94034 PASSAU, DEUTSCHLAND, GERMANY , GERMAN national The following specification particularly describes the nature of the invention and the manner in which it is to be performed : - Description Injection Solution for the Treatment of Arthroses The present invention relates to the treatment of arthroses, primarily of arthroses of the hip and knee joint, In particular, the present invention relates to an injection solution in accordance with claim 1 which includes a mixture of a solution A of a gold compound and of a solution B of a Calendula extract and of a Belladonna extract, use of a like injection solution for the treatment of arthroses in accordance with claim 15, and a kit including a solution A and a solution B in accordance with claim 16. In addition, the present invention relates to use of a dextrane solution for the irrigation of joints in accordance with claim 18. Arthroses are primarily degenerative^ joint ailments of various causes, which afflict the articular cartilage and are comparatively widespread among the populace. Arthroses are favored by wear of the articular carti¬lage due to old age, so that according]y they frequently occur in patients advanced in years. Excessive strain on the cartilage tissue, however, such as in the case of competitive athletes or various other professional groups subject to excessive strain, for instance, also brings about an increased arthrosis risk. Tnnate disorders such as, e.g., a congenital carti¬lage inferiority, growth disorders, or i.nflammatory joint diseases may lastly equally result in arthroses. Severe arthroses could hitherto only be treated through surgery involving replacement of the afflicted joint such as, e.g., through hip joint surgery, knee joint surgery by introducing an arthroplasty, etc.. These surgical procedures are, however, both painful and involve high expenditure in terms of time and costs. Thus the costs for hip arthroplasty average about 55,000 PM in Germany, for example, with prolonged hospi¬talisation and at least eight weeks of rehabilitation being necessary in addition to the suryery itself. Tliere moreover exists a risk of infections and the risk of the inserted joint prosthesis being dislocated or coming loose, or in extreme cases even being rejected by the body. Beside this, there is a multiplicity of treatment methods whereby it is attempted to bring about an improvement while conserving the joint. These include, for example, spongiosa bone transplantation, decompres¬sion and rotation osteotomy. The multiplicity of possible treatments shows that no one successful method for the treatment, of arthroses has hitherto been found, Starting out from this prior art, it is an object of the present invention to furnish a nove3 joint-conserving option for treating arthroses, which exhibits a high success rate, minor side effects and secondary diseases, and is moreover inexpensive. This object is achieved in accordance with the inven¬tion through an injection solution in accordance with claim 1, use of such injection solution in accordance with claim 15, a kit in accordance with claim 16, and use of a dextrane solution in accordance with claim IB. The injection solution of the invention includes a mixture of a solution A of a gold compound and of a solution B of a Calendula (calendula) extract and of a Belladonna (deadly nightshade) extract, With this injection solution, arthroses which could hitherto only be treated by major surgical intervention may be treated successfully while achieving conservation of the joints. For the treatment of arthroses, the injection solu¬tion according to the invention is preferably injected repeatedly into the joint cavity so as to be able to act on the degenerated articular cartilage. The gold compound preferably is a gold(III) compound such as, for example, the gold(III) compound tetrachloro-auric(III) acid"3 H2O which is particularly preferred. The injection solution may moreover contain a Hamamelis (witch hazel) extract and/or an Arnica (arnica) extract and/or an Aconitum (aconite) ox tract and/or a Bellis persnnis (English daisy) extract and/or a Hypericum (St. John's wort) extract and/or an Echinacea angustifolia (narrowleaf coneflower) extract and/or an Echinacea puzyurea (purple coneflower) extract, whereby a further improvement of the treatment success is achieved. The injection solution may moreover contain a Chamomilla (chamomile) extract and/or a Millefolium (milfoil) extract. The injection solution may be improved even further if in additionally contains a Symphytum (comfrey root) extract and/or Mercuris solubilis Hahnemann! (liquid mercury produced in accordance with Hahnemann) and/or Hepar sulfuris (liver of sulphur). The above mentioned additional constituents are preferably contained in solution A. As further constituents of the injection solution, which are preferably contained in solution B, an extract from Fruct. Symphoricarpi (snowberry) and/or an extract from Herb. Euphorbias cyp. (wolf's-milk plants) may be contained. The plant extracts are preferably employed in the form of Dl to D6 dilutions in accordance with Hahnemann for preparing solutions A and B and subsequently prepar¬ing the injection solution. A Dl dilution in accordance with Hahnemann is, for example, obtained by diluting a pressed-out sap with 45% alcohol in a ratio of It 10. The further dilutions D2, D3 etc. may then be obtained by renewed 1:10 dilution with alcohol; i.e., in order to produce a 02 dilution, one part of the Dl dilution is diluted with 9 parts alcohol - A preferred injection solution is an injection solu¬tion in accordance with claim 2-, wherein solution A contains between 0.01 and 10 µl/ml of Arnica D2, Calen¬dula D2, Chamomllla D3, Symphytum D6, Millefolium D3, Belladonna D2, Aconibum D2, Bellis porennis D2, Hypericum D2, Echinacea angustifolia D2, Echinacea purpurea D2, Hamamelis Dl, Mercuris solubilis Hahnemann! DS and Hepar sulfuris DG, and solution B contains a gold(III) compound, Fruct. Symphoricarpi and Herb. Buphorbiae cyp.. A particularly preferred injection solution is an injection solution in accordance with claim 3, wherein solution A contains 0,1 to 10 µl/ml each of Arnica D2, Calendula 02, Chainomilla D3, Symphytum 06, Millefolium D3 and Belladonna D2, 0.05 to 5 µl/ml of Aconitum D2, 0.05 to 5 µl/ml of Bel lis perennis D2, 0.05 to 5 µl/ml of Hypericum D2, 0.02 to 2 µl/ml of Echinacea angustifolia D2, 0.02 to 2 µl/ml of Echinacea purpurea 02, 0.01 to 1 µl/ml of Hamamelis Dl, 0.05 to 5 mg/m) of Mercuris solubilis Hahnemannl D6, 0.1 to 10 µl/ml of Hepar sulfurls D6; NaCl in physiological concentration, and water; and solution D contains 0.001 to 0.1 mg/ml of gold in the form of a gold(III) compound, an aqueous extract (10:1 to 1:10) from Fruct. Symphoricarpi (0.2 to 20 mg/ml) and Herb. Euphorbiae cyp. (0.1 to 10 mg/ml), as well as NaCl in physiological concentration and water. The most preferred injection solution is the injection solution in accordance with claim 04' wherein solution A contains approx. 1 ul/ml each of Arnica D2, Calendula D2, Chamomilla D3, Symphytum D6, Millefolium D3 and Belladonna D2, approx. 0.6 µl/ml of Aconitum 02, approx. 0.5 µl/ml of Bellis perennis D2, approx. 0.3 µ 1/ml of Hypericum D2, approx. 0.25 µl/ml of Echinacea angustifolia D2, approx. 0,25 µl/ml of Echinacea purpurea D2, approx. 0.1 µl/ml of Hamamelis Dl, approx. 0.5 mg/ml of Mercuris solubilis Hahnemann! D6, approx, 1 µl/ml of Hepar sulfuris D6; NaCl in physiological concentration, and water; and solution B contains approx, 0.01 mg/ml of gold in the form of a gold (III) compound, an aqueous extract (approx. 1:1) from Fruct. Symphoricarpi (approx. 2 mg/ml) and Herb. Euphorbiae cyp. (approx. 3 mg/ml), as well as NaCl in physiological concentration and water. A like injection solution may, for example, be obtained by mixing the commercially available solution Traumeel® S by Biologische Heilmittel Heel GmbH of Baden-Baden (DE), and the solution Cefossin® H, equally commercially available, by Cefak Arzneimittel of Kempten (DE) in a volume ratio of approx, 1:1. The injection solution is generally supplemented with a physiological salt solution, for example a physiologi¬cal saline solution, and is normally water-based. It is an essential point of the present invention that the injection solution is particularly ertective where produced only shortly prior to administration, by mixing the respective solutions A and B. The longer the time period between mixing and administration, the less effective is the injection solution. Solutions A and B are herein preferably mixed in a volume ratio of 1:10 to 10:1, in particular of 1:2 to 2:1, and in a particularly preferred manner of approx. 1:1. In a particularly preferred manner, the injection solution of the invention is present in the form of an intra-articular injection solution. Another essential aspect of the present invention is the use of the injection solution according to the inven¬tion for the treatment of arthroses in particular of knee and hip joint arthroses, through intra-articular injec¬tion. In contrast with the customary treatment methods, use in accordance with the invention results in joint-conserving methods {"outsider" methods) and results in excellent curative effects, thereby eliminating a need for surgical treatment of the arthroses. The present invention moreover furnishes a kit including both solution A and solution B. This kit offers the possibility of preparing the injection solution of the invention in a simple and rapid manner immediately prior to use by mixing the two solutions, The kit may contain one or even several sterile ampoules with the various solutions, The kit may moreover include a dextrane solution which may be employed for irrigating the joint prior to and/or after injection of the injection solution of the invention. A like dextrane solution is, e.g., the commer¬cially available Makrodex® solution by Schiwa GmbH of Glandorf (DE). Use of a like dextrane solution for irrigating the joints equally contributes to a successful treatment with the injection solution according to the invention. Further advantages and features of the present inven¬tion result from the description of embodiments and from reference to the illustrations, wherein: Fig, 1 shows a video X-ray of a hip joint after 10-time injection of the injection solution according to the invention, however before irrigation; Fig. 2 shows a video X-ray of the same hip joint during treatment, with a cannula located in the hip joint cavity through which the joint is irrigated; Fig. 3 shows a video X-ray of the same hip joint following irrigation; Fig. 4 shows a video X-ray of a knee joint following 10-time treatment with the injection solution according to the invention, however before irrigation; Fig. 5 shows a video x-ray of the same knee joint during treatment, with two cannulae located in the knee joint cavity through which the joint is irrigated; and Fig, 6 shows a video X-ray of the same knee joint following irrigation. In the following, a study conducted by the inventor Of the instant application with 127 arthrosis patients will be described. Between December of 1990 and July of 1997, 127 patients (168 hips) were treated, under supervision by the instant inventor, with an injection solution prepared as follows: 2.5 ml of a solution A, hereinafter referred to as Cartilase A, and 2,5 ml of a solution B (referred to as Cartilase 8) were mixed shortly before the respective injection in order to prepare the injection solution. The compositions of the two solutions were as follows: Cartilase A Pharmaceutically active (1 ml): constituents: Gold (in the form of 0.02 09 mg n m ma of tetrachloroauric(ill) acid-3 H20) £"xtr. aquas, (1:1) from 2 mg Fruct. Symphovicarpi Herb. EuphorbX&e cyp, 1 mg Other constituents: sodium chloride and wator. Cartilase B: (2.2 ml) Arnica D2 2.2 µl The treated patients were between 31 and 76 years of age. All patients had been diagnosed with osteoarthritis and traumatic bone necrosis. Before the treatment, all of the patients were in strong pain when carrying heavy loads, in pain during nights, and even in pain when at rest in the absence of strain. The X-rays before treatment showed osteoarthritis and necrosis with bone sequestration, with varying degrees of a Jesion of the femur head in 15% of the cases. In the study, the joint interstice, or joint cavity, was meas¬ured in millimeters before and after the treatment. The width of the joint interstice in the last examination was then, in the end, compared with earlier X-rays. The treatment was carried out in accordance with the following description: Through 10 weeks, the patients received a weekly intra-articular injection with 5 ml of the above mentioned injection solution which was thus able to act on the degenerated articular cartilage so as to dissolve it. After completion of this treatment, the patient was anaesthetised, and the hip joint was extended with the aid of a 25-kg weight. A cannula was thon introduced into the joint cavity, the hip joint was filled with a high-molecular liquid in the form of a Makrodex© solution so as to rinse out and remove the adhesions present in the joint cavity or to remove the dissolved degenerated articular cartilage, respectively, and subsequently the above mentioned injection solution was injected again. Following this cleansing of the joint, a contrast medium or a colorant, respectively, was injected for radiologi¬cal examination. In contrast with conventional hip joint surgery, the patient could be discharged from hospital after 24 to 48 hours with this treatment. Following the treatment, the patients were moreover monitored for 24 months. After these 24 months, 85% of the patients showed excellent results, and an additional 7% showed satisfac¬tory results, which meant that these patients could walk without pain. Only 8% of the patients did not present satisfactory results, and the latter had a conventional hip acetabuloplasty implanted, Figures 1, 2 and 3 illustrate the results of a hip joint treatment with an injection solution in accordance with the invention. As can be seen in Fig. 1, the joint cavity 1 of the hip joint, which is located between the femur head 2 and the opposite acetabulum 3, is clogged by degenerated articular cartilage material 4. Fig, 2 shows, the same hip joint during washing out of the injection solution, with a cannula 5 being visible inside the joint cavity 1. By means of the cannula 5, the joint cavity 1 was irrigated six to eight times with 20 ml each of a high-molecular dextrane solution, i.e., the dextrane solution was injected into the joint cavity 1 and evacuated so as to cleanse the joint. As can be seen in Fig. 3, a clear improvement of the situation has occurred following completion of the treatment, with a major part of the degenerated cartilage material having been removed from the joint cavity 1, The same result may also be seen in Figs. 4 to 6 which analogously show a knee joint during and after treatment, respectively, with the injection solution according to the invention. In this case, as well, the cavity of the knee joint is free of the major part of the degenerated articular cartilage materials following treatment and irrigation. These studies 'make it clear that the treatment with the injection solution according to the invention consti¬tutes a successful alternative treatment option which ie capable of staying progress of the ailment in 85% of cases. I CLAIM: 1. An injection solution including a mixture of a solution A of a gold compound as gold (III) compound, a solution B of a Calendula extract, moreover it contains a Hamamelis extract and/or an Arnica extract and/or an Aconitum extract and/or a Bellis perennis extract and/or a Hypericum extract and/or an Echinacea angustifolia extract and/or an Echinacea purpurea extract and/or Chamomilla extract and/or a Millefolium extract and/or a Symphytum extract and/or Mercuris solubilis Hahnemanni and/or Hepar sulfuris and/or an extract from Fruct. Symphoricarpi and/or an extract from Herb. Euphorbiae cyp and said solution moreover contains NaCl, in particular in a physiological concentrations, and water. 2. An injection solution as claimed in claim 1, wherein said solution A contains between 0.01 and 10 µl/ml of Arnica D2, Calendula D2, Chamomilla D3, Symphytum D6, Millefolium D3, Belladonna D2, Aconitum D2, Bellis perennis D2, Hypericum D2, Echinacea angustifolia D2, Echinacea purpurea D2, Hamamelis Dl, Mercuris solubilis Hahnemanni D6 and Hepar sulfuris D6, and said solution B contains a gold (III) compound, Fruct. Symphoricarpi and Herb. Euphorbiae cyp. 3. An injection solution in accordance with any one of claim 1, wherein said solution A contains 0.1 to 10 µl/ml each of Arnica D2, Calendula D2, Chamomilla D3, Symphytum D6, Millefolium D3 and Belladonna D2, 0.05 to 5 µl/ml of Aconitum D2, 0.05 to 5 µl/ml of Bellis perennis D2, 0.05 to 5 µl/ml of Hypericum D2, 0.02 to 2 µl/ml of Echinacea angustifolia D2, 0.02 to 2 µl/ml of Echinacea purpurea D2, 0.01 to 1 µl/ml of Hamamelis Dl, 0.05 to 5 mg/ml of Mercuris solubilis Hahnemanni D6, 0.01 to 10 µl/ml of Hepar sulfuris D6; NaCl in physiological concentration, and water; and said solution B contains 0.001 to 0.1 mg/ml of gold (III) compound, an aqueous extract (10:1 to 1:10) from Fruct. Symphoricarpi (0.2 to 20 mg/ml) and Herb. Euphorbiae cyp. (0.1 to 10 mg/ml), as well as NaCl in physiological concentration, and water. 4. An injection solution as claimed in claims 1, wherein said solution A contains 1 µl/ml each of Arnica D2, Calendula D2, Chamomilla D3, Symphytum D6, Millefolium D3 and Belladonna D2, 0.6 µl/ml of Aconitum D2, 0.5 µl/ml of Bellis perennis D2, approx. 0.3 µl/ml of Hypericum D2, 0.25 µl/ml of Echinacea angustifolia D2, 0.25 µl/ml of Echinacea purpurea D2, 0.1 µl/ml of Hamamelis Dl, 0.5 mg/ml of Mercuris solubilis Hahnemanni D6, 1 µl/ml of Hepar sulfuris D6; NaCl in physiological concentration, and water; and said solution B contains 0.01 mg/ml of gold (III) compound, an aqueous extract (1:1) from Fruct. Symphoricarpi (2 mg/ml) and Herb. Euphorbiae cyp. (1 mg/ml), as well as NaCl in physiological concentration and water. 5. An injection solution as claimed in claims 1, wherein said gold (III) compound is tetrachloroauric (III) acid3 H2O. 6. An injection solution as claimed in claims 1, wherein it is freshly prepared immediately prior to injection by mixing solution A with solution B. 7. An injection solution as claimed in claim 6, wherein said solutions A and B are mixed in a volume ratio of 1:10 to 10:1, in particular of 1:2 to 2:1, and in a particularly preferred manner of 1:1. 8. An injection solution as claimed in claims 1, wherein said injection solution is an intra-articular injection solution. Dated this 16th day of August, 2001. HIRAL CHANDRAKANT JOSHI AGENT FOR DR. MED.ADUSUMALLI CHAKTRAVARTY

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