CA2529239C - Non-invasive acupuncture device - Google Patents

Non-invasive acupuncture device Download PDF

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Publication number
CA2529239C
CA2529239C CA2529239A CA2529239A CA2529239C CA 2529239 C CA2529239 C CA 2529239C CA 2529239 A CA2529239 A CA 2529239A CA 2529239 A CA2529239 A CA 2529239A CA 2529239 C CA2529239 C CA 2529239C
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patients
group
effectiveness
treatment
tourmaline
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CA2529239A1 (en
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Mengjun Yang
Zhilong Xu
Ping Li
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Priority to JP2008538231A priority Critical patent/JP5015165B2/en
Priority to AT06705333T priority patent/ATE537805T1/en
Priority to EP06705333A priority patent/EP1945171B1/en
Priority to KR1020087010112A priority patent/KR100961595B1/en
Priority to PCT/CA2006/000392 priority patent/WO2007051278A1/en
Priority to US11/377,858 priority patent/US8936815B2/en
Publication of CA2529239A1 publication Critical patent/CA2529239A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H39/00Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H39/04Devices for pressing such points, e.g. Shiatsu or Acupressure
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y40/00Manufacture or treatment of nanostructures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16Physical interface with patient
    • A61H2201/1683Surface of interface
    • A61H2201/169Physical characteristics of the surface, e.g. material, relief, texture or indicia

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Rehabilitation Therapy (AREA)
  • Nanotechnology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Condensed Matter Physics & Semiconductors (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Physics & Mathematics (AREA)
  • Manufacturing & Machinery (AREA)
  • Pain & Pain Management (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Finger-Pressure Massage (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

The therapeutic device is an acupuncture device which is usable for treating chronic, but non-contagious diseases. The device is in the form of a solid chip or tablet having a unique composition. It can be placed on the body of a patient's acupuncture meridian points for the treatment. The treatment with this device is safe, more effective, non-invasive and easy to use over other alternative treatments because it does not involve the use of needles, medication, electricity and radiation.

Description

NON-INVASIVE ACUPUNCTURE DEVICE
FIELD OF THE INVENTION

This invention relates to a therapeutic device usable to provide alternative medical treatment, more particularly it relates to an acupuncture device which can administer acupuncture treatment in a non-invasive manner without the use of needles.
BACKGROUND OF THE INVENTION

Chronic diseases plague people most. They cause the highest death toll and high medical cost for their treatment. Chronic diseases can be attributed to a variety of origins that are often unidentifiable and thus resulting in the lack of development of effective medicine for their treatment. Most chronic diseases require long-term, often lifetime, medical therapy in which the medication may be toxic and can cause harmful side effects.
For instance, VIOXX(a trade mark) developed by Merck & Co., Inc., for the treatment of arthritis, has caused 60 thousand lives worldwide, outnumbering the American casualty in the Viet Nam War. Annually, there are about one million people die of adverse effects of drugs being consumed. In China alone, about 190 thousands of people die of adverse effects of drug treatments annually which is ten times higher than the number of death from major infectious diseases.

In an effort to eschew increasing adverse events caused by taking medications, some non-medication therapies have been widely employed with Complementary and Alternative Medicines (CAM) for treating diseases even in developed countries.
However, current CAM procedures have many drawbacks including difficult to implement, high cost, less evident of their effectiveness and causing too much pain to the patient in the treatment. Therefore, to carry out CAM, new techniques and devices are required so as to mitigate the above drawbacks. In recent decade, numerous devices of rehabilitative CAM
have been developed, outnumbering those intended for diagnosis purposes.
Numerous active machines have been invented for therapeutic purposes. They provide therapeutic treatments by executing operations and/or actions on the human body and the operations and/or action are felt and/or sensed physically by the human body during treatment. Such active machines provide, for example, radiological therapy, microwave therapy, radiofrequency therapy, ultrasound therapy, laser therapy, millimeter wave therapy, and infrared therapy. Other active devices operate with sound, light, electricity, magnetic energy, or mechanical means, and they may even be supplemented with medication.

Some of these active machines and devices can cause harmful risks to human body such as electric shock, unduly high power output, energy distraction, explosion, fire hazard, unreliable and abnormal operation, loss of power, mechanical accident, malpractice by the operator, bacterial contamination, and interference with other machines.
Heretofore, passive medical machines and devices which can be used in a non-invasive manner without utilizing needle, electricity, electromechanical parts and radioactivity for effective treatment of chronic diseases have not been developed. Such passive machines and devices could execute therapeutic treatment in a passive manner without provoking physical senses of the human body during treatment.

SUMMARY OF THE INVENTION

The passive therapeutic device of the present invention is in the form of a unique solid chip or tablet which may be placed at selected meridian locations on the human body in a non-invasive manner for effective treatment of chronic diseases. The main ingredients of the device include a mixture of polar mineral tourmaline, infrared radiating material, pliable magnetic material, photo-catalytic material, composite salt or oxide of rare earth, and calcium oxide molded together with adhesive material and inclusion compound material. The mixture is first formed into a fine powder through super tiny nanometer handle processing prior to the adding of the adhesive material and inclusion compound material and then it is subjected to molding and thermal treatment to form a solid chip or tablet. The chip or tablet is applicable for rehabilitation treatment for a wide variety of chronic diseases in a non-invasive manner. It is safe to human body and is not harmful to the natural ecology and environment. It has been proven to provide more effective therapeutic treatments than other known alternative medical treatments such as acupuncture and moxibustion, massage and scrape therapy; cupping, medicine paste electrotherapy, magnetism, infrared, and physical therapy; meditation, Chinese qigong, Indian yoga; and Chinese herbal medicine; as well as western medicine.

A plurality of the chip or tablet of the present invention is applicable for therapeutic treatment by placing a plurality of the chips or tablets at various selected acupuncture points for a period of less than 24 hours in each treatment. It is non-invasive, safe, not labor intensive and environmentally friendly since no used or waste material need to be discarded following the treatment whereas in traditional acupuncture treatment used needles must be discarded with extreme care. It can be used to treat chronic but non-contagious diseases without the use of needles, medication, electricity, magnetism and radiation.

The main ingredients for making the chip or tablet of the present invention consist of (by weight): polar mineral tourmaline 20-40%; infrared material 30-50%;
pliable magnetic material 1-5%; calcium oxide 5-10%; photo-catalytic material 1-5%;
composites salt or oxide of rare-earth 1-5%; calcium oxide 5-10%; adhesive material 2-5 %; and inclusion compound material 1-5%.

The polar mineral tourmaline is natural jade which possesses a large amount of electrolytes and may contain mainly of more than ten kinds of silicate ores.
For making the chip or tablet of the present invention, preferably one kind of tourmaline or a mixture of different tourmalines selected from the group consisting of iron tourmaline, magnesium tourmaline, iron and magnesium tourmaline, and lithium tourmaline may be used.

The infrared material used should permit infrared ray to pass through it with distinct transmittance, refraction and chromatic dispersion in terms of the distinct wavelength of the infrared ray. Preferably, one or a mixture of both of oxide sapphire (AL203) and magnesium oxide (MgO) meeting such characteristic properties may be used.

The pliable magnetic material may preferably be chosen from the group consisting of one or both iron oxide (FeO) and iron trioxide (Fe2O3) which may be magnetized repeatedly and demagnetized easily under a magnetic field.

The photo-catalytic material (or manometer powder) used may preferably be one or more types of such material chosen from the group consisting of titanic oxide (TiO2), zinc oxide (ZnO), tin oxide (SnO), and tungsten oxide (WO).
The composite salt or oxide of rare-earth is preferably one or a mixture of such material chosen from the group consisting of LaPO4, NdPO4, NdPO4, Ce(N03)3, and La(N03) which are composite oxide of CeO2, Ce203, La203 and Nd203.

The adhesive material may be one or more of the material preferably chosen from the group consisting of stearic acid, polyvinyl chloride, pine resin, flax oil and castor oil.
The inclusion material may be one or more of the material preferably chosen from the group consisting of methyl cellulose, liquid paraffin, colophon, and polyvinyl chloride.
In the chip or tablet fabrication process, the polar mineral tourmaline is transformed into a fine powder in a nanometer processing by either grinding it with a high energy ball mill or pulverizing it through an airflow millstone between 48 to 72 hours. In either one of these processes, the tourmaline will transform into very small particles with crystalline grain diameter of between 50-1000 nanometers. The fine tourmaline particles will then be subjected to a thermal treatment with a temperature in the range between 500-1000 C for about 2 to 3 hours. The same processes also applied to the infrared material. However, the photo-catalytic material may be subjected to either the same processes or only the nanometer process.

The ingredients are placed into a grinding and blending machine for grinding and blending them thoroughly for not less than 1 hour. The ground and blended mixture is then poured onto a mold plate having a plurality of mold form depressions all having a predefined shape and size of the desired chip or tablet. A pressure of 20-50 Mpa is applied to press the mixture fully into the mold form depressions to form a plurality of the chip or tablet. After pressing, the chips or tablets are removed from the mold plate and sintered with a thermal treatment at a temperature of between 500-1000 C
for a period of 2-3 hours. The thermally treated chips or tablets are then cooled at room temperature for 48-72 hours to form the final hard solid chips or tablets.

The chips or tablets may be formed in different sizes, shapes and thicknesses.
For convenient handling during use, the chips or tablets preferably have a diameter > 25mm and a thickness ? 3mm.

A plurality of the chips or tablets are placed on acupuncture meridian points on the patient's body according to the traditional Chinese medicine and acupuncture theory.
The meridian points are skin points of the body at which pathological changes may be provoked in relevant internal organs. Mountain jade awl may be used for searching these sensitive skin points. The mountain jade awl may be obtained from the Liaoning province of China and cut and polished into an awl shape. The awl has a base with a diameter of 0.6 to 0.8 cm, a length of 7 cm, and a dull tip.

A superficial fluid can be applied either to the chips or tablets or to the selected skin points prior to placing the chips or tablets at these skin points. The superficial fluid may be produced by submerging 1-3 chips or tablets into 100 ml of clean water for one hour, and then bottling the treated water for convenient application when it is needed.

An efficiency enhancing membrane may be placed between the chips or tablets and the skin points for securing the chips or tablets on the patient's body.
The enhancing membrane is applied in place for 40-60 minutes. It also enhances the therapeutic effect of the chips or tablets. The enhancing membrane may be produced by mixing LLD-PEC
low density string shaped polythene with corn oil to make a 0.18 mm thick stretchable membrane having heat and cold resistance at high temperature not exceeding 115 C and low temperature not lower than -60 C. It may be rolled and cut into a sheet form having 5 cm in width. Common bandage or cotton band may be used for keeping the chips or tablets in place. However, the bandage or cotton band would not provide the enhancement of the effectiveness for the therapeutic treatment. A session of 40 to 60 minutes of therapeutic treatment can be carried out in the above manner with the chips or tablets of the present invention. The chips or tablets may alternatively be implanted into the patient at the selected meridian points or directly in internal organs for treatment of some chronic diseases.

After the superficial fluid has been applied between the chip and the skin point, the enhancing membrane can be used to secure the chip in place. After 10 minutes of application, there may be chili, sting, pain and hot sensations and redness on the point of application. These sensations will automatically reduce after 40 minutes. The entire treatment is to be carried out for a session of one hour. After finishing one session, the chips are removed from the body, and the sensations and redness will disappear in 30 minutes without any damage to the skin. One course of treatment consists of 10 sessions carried out once daily. The symptom of the diseases will be mitigated and it is recommended that a treatment for 1 to 3 courses be administered.

The unique chip or tablet of the present invention may be used for the rehabilitation treatments of the following chronic diseases:

1. Chronic aches: Headache, Trigeminal pain, Coronary disc disease, Should pain, Waist strain, Lumbar pain, Coexistence of Cervical and Lumbar pain, Disc Disease, Rheumatoid arthritis, Gouty arthritis, Intercostal Neuralgia, Hucklebone nerve pain, Osteoporosis, Lumbar bone hyperplasia, Toothache, Vasculitis, Cancer.
2. Neurological and psychiatric diseases: Facial neuritis, Facial muscular convulsion, bell's palsy, Parkinson disease, Stroke (hemiplegia), Cerebrovascular Atherosclerosis, epilepsy, Dementia, Hysteria, Depression disease, Vertigo (Meniere's disease), Insomnia.

3. Respiratory diseases: Chronic bronchitis, Bronchus asthma, Bronchus Expansion (emptysis), Cold, Emphysema.

4. Digestive diseases: Chronic gastritis, Peptic ulcer, Midriff convulsion, Enteritis, Irritable Bowel Syndrome (IBS), Constipation, Chronic hepatitis, Fatty liver, Chronic cholecystitis, Gallstone.

5. Circulation system diseases: Hypertension, Hyperlipidemia, Coronary Heart Disease, Cardiac Arrhythmias, Cardiovascular Neurosis.

6. Urinary diseases: Chronic prostatitis, Prostate hyperplasia, Chronic Nephritis.
7. Diseases of orthopedics: Fracture, Dislocation of joint.

8. Disease of gynecology: Dysmenorrhea, Irregular menses, Inflammation of pelvic cavity, menopause, Infertility, Galactophore hyperplasia.
9. Diseases of andropathy: Impotence, Nocturnal emission, Prospermia, Infertility.
10. Diseases of facial features: Allergic rhinitis, Nasal sinusitis, Chronic Pharyngitis and tonsillitis, Tinnitus and deafness.
11. Diseases of ophthalmology: Cataract, Myopia, Hyperopia, Poor vision, Glaucoma, Dry eye, Trachoma, Eyes fatigue.
12. Endocrine and metabolic diseases: Hypothyroid disease, Diabetes.
13. Diseases of oncology: Anti-immunity tumor, Toxic and adverse effect of radiation treatment and chemotherapy.
14. Diseases of dermatology: General acne, Yellow speckle, Hives, Nervous dermatitis, Psoriasis disease, Strip anthema, Eczema.
15. Other diseases: idiopathic obesity, Obese breast, Chronic fatigue syndrome (suboptimal health), Air-conditioning related disease, Quit smoking, EX-Drug.
The chip or tablet of this invention offers a new technology for rehabilitation of chronic diseases called surface therapy technology, which can play a versatile role replacing acupuncture and moxibustion, massage, manipulation, scraping, fire cup, herbal plaster, electricity therapy, magnetic therapy, infrared therapy, far infrared therapy, herbal remedies, Chinese Qigong, India Yoga. It can also relieve people from having to subject to exhausting long-term chemotherapy.

Clinical trials were carried out with the chip or tablet of the present invention with 590 patients suffering from 21 kinds of various chronic diseases in 6 health clubs of China Health Way Campaign. Among the 590 patients, 276 were men and 314 were women. The youngest was 8 years old and the oldest was 85. The longest therapeutic course lasted 35 days and the shortest course was in one day. Diseases that were treated with the chip involved the following 21 kinds of maladies: headache, chronic rhinitis, coronary diseases, hypertension, arteriosclerotic brain disease, premature beat, slipped disk, cervical hyperosteogeny, gonitis, scapulohumeral periarthritis, gout, acute lumbar sprain, cyclomastopathy, insomnia, infection in upper respiratory tract, chronic bronchitis, facial palsy, eczema, acute urinary tract infection, acute gastro-enteritis and toothache.
Outcomes of the clinical trials were as follows with the chips or tablets applied at the acupuncture points indicated: 91 patients suffering from the following sicknesses were cured: Headache: 12 patients (Acupuncture Points: Yintang, Fengchi, Yongquan, Hegu, Neiguan, TaiYang, Ashixue) ; Infection in upper respiratory tract: 15 patients (Acupuncture Points: Dazhui, Waiguan, Lieque, Quchi) ; Chronic bronchitis 4 patients (Acupuncture Points: Yingxiang, Yintang, Hegu, Lieque, Zusanli, Feishu) ;
Gout: 2 patients (Acupuncture Points: SanYinjiao, Taixi, Zusanli, Ganshu, Shenshu, Ashixue) ;
Toothache: 10 patients (Acupuncture Points: Xiaguan, Jiache, Fengchi, TaiYang, Ashixue) ; Gonitis: 5 patients (Acupuncture Points: Heding, Dubi, Qiyan, Yinlingquan, Zusanli, Weizhong, Ashixue) ; Insomnia: 5 patients (Acupuncture Points:
Dazhui, Anmian, Fengchi, Neiguan) ; Eczema: I patient (Acupuncture Points: Quchi, Neiguan, Xuehai, Fengshi, Zusanli, SanYinjiao) ; Acute gastro-enteritis: 6 patients (Acupuncture Points: Shangwan, Zhongwan, Zusanli, 4 Acupuncture Points around navel, Ashixue) ;
Acute lumbar sprain: 1 patient (Acupuncture Points: Shenshu, Weizhong, SanYinjiao, Ashixue) ; Chronic bronchitis: 3 patients (Acupuncture Points: Dazhui, Tiantu, RenYing, Feishu, Neiguan, Dingchuan, Shanzhong, Zusanli, Chize) ;
Scapulohumeral periarthritis: 5 patients (Acupuncture Points: Rushu, Jianjing, Jianliao, Jianyu) ;

Cyclomastopathy: 1 patient (Acupuncture Points: Shanzhong, Rugen, Wuyi, Ganshu, Pishu, SanYinjiao) ; Facial palsy: 1 patient (Acupuncture Points: Dazhui, TaiYang, Sibai, Shangguan, Xiaguan, Dicang, Jiache, Juliao) ; Ischialgia: 20 patients (Acupuncture Points: Shenshu, Baihuanshu, Zhibian, Huantiao, Chengfu, Yinmen, Weizhong, SanYinjiao) Up to 455 patients showed some certain effect improvement, and 20 patients did not remit from their diseases. (Mostly due to the diseases were too severe or the patients were unable to persist in the therapy for some unknown reasons).

Another trial that was conducted in the previous two months on 590 patients, who were members of six clubs of the Way to Health Campaign. The result showed that the cure rate was 16%, effectiveness rate was 77% and total effectiveness rate was 93%.

This rehabilitation chip or tablet has also been used in many hospitals in China for trial treatments of chronic diseases. These clinical trials Ito XIII are described below: (In all these clinical trials the contact area on the patient's skin was first moistened with the superficial fluid prior to the placing of the chips or tablets on the acupuncture points. The chips or tablets were secured in place with poromeric adhesive tape. The treatment was conducted for one hour in each session for the therapy. Each treatment was administered once daily, and ten sessions constituted one therapeutic course. A two-day pause was required before the next therapy.) I. This clinical trial was conducted at Guangdong Shanwei Hospital for Traditional Chinese Medicine for treatment of dizziness.

54 patients were treated in this clinical trial in which 24 were outpatients and 30 were inpatients and 21 patients were men and 33 patients were women. The youngest patient was 17 years old and the oldest was 87. The average age was 50. The shortest disease course was 0.5 day and the longest was 21 years. The average time was 2.2 years. 25 patients were suffering brain arteriosclerosis, 10 were suffering hypertension, 8 were suffering cervical spondylopathy, 14 were suffering Meniere's syndrome ' 2 were suffering climacteric syndrome, 3 were suffering hyper viscosity syndrome, 2 were suffering neurasthenia, 1 was victim of brain trauma residue, 2 were suffering from chronic alcoholism. All of the 54 patients had principal symptom of dizziness.

All 54 patients underwent treatment with the rehabilitation chips applied at primary acupuncture points of Baihui, TaiYang, Neiguan, Zusanli; and secondary acupuncture points were added at Taixi and Shenshu in case of the deficiency in kidney Yin; and Geshu and Pishu points were added in case of deficiency in Qi and blood;
Fenglong and Pishu points were added in case of stagnation of phlegm-dampness; and Taichong and Fengchi points were added in case of Excess of Liver Yang.

In the treatment, the chips were applied onto the primary acupuncture points and with the added secondary acupuncture points for the different symptoms as indicated above.
The result of the trials was as follows: Of the 54 patients, 43 were clinically cured;

namely, the patient's symptom completely disappeared, and the patients were able to return to normal life; 38 patients remitted their symptoms (The patient's symptom was obviously alleviate); 2 patients showed no effect (symptoms remained the same). Total effective rate was 96.2% and the average duration for being cured was 18 days.

In addition to the above, 50 patients suffering a stroke were also treated in the same manner with convincing therapeutic effect.

Among the 50 patients in this additional clinical trial, 38 patients were men and 12 patients were women. The youngest patient was 33 years old and the oldest was 76. 46 patients had a disease course shorter than 3 months and 4 longer than 3 months. 30 were suffering sanguineous apoplexy; and 20 patients were suffering from cerebral embolism.
The treatment were carried out with the chips or tablets located at the following acupuncture points: Primary Acupuncture Points: Shuigou, Neiguan, Laogong, Quchi, Weizhong; and also at Secondary Acupuncture Points: Jianyu, Hegu, Waiguan, Huantiao, Yanglingquan, Zusanli, Jiexi, Kunlun, Taichong in case of hemiparalysis; or also at Secondary Acupuncture Points Dicang or Jiache, Hegu, Neiting, ChengQi, Yangbai, Cuanzhu, Kunlun, Yanglao in case of facial hemiparalysis; or also at Secondary Acupuncture Points Lianquan, Tongli, Yamen, Fengfu, Tiantu, and SanYinjiao in case of slurring of speech.

The following terms are used to denote the effectiveness of the treatment in this clinical trial:

Cure: means the patient can speak articulately; walk without need of support, able to raise hand up to grab an article, lead a normal life without nursing care, and have general well feelings.

Obvious effectiveness: means the patient is able to speak relatively articulately, walk with need of support, able to grab an article but feel frail in fist, lead a life with little nursing care, and limbs occasionally feel discomfort.

Some certain effectiveness: means the patient is unable to speak articulately but can communicate, have some improvement in myodynamia of extremities but has poor rehabilitation in functions, and requires nursing care to lead a life.

No effect: means symptoms remain after the therapy.
The outcome of the trial was as follows:

17 (34%) patients were cured; 16 (32%) showed obvious effectiveness; 12 (24%) patients showed some certain effectiveness, 5 (10%) patients showed no effect.

The total effectiveness rate was 90%.

At least one therapeutic course was conducted and the longest was 9 therapeutic courses. The average was 3.8 therapeutic courses.

The relationship between the disease and the effectiveness of the chip is tabulated in table 1 below:

Patients Cure (%) Obvious Some certain No number effectiveness(%) effectiveness(%) effect(%) Sanguineous 30 10 (35) 12(40) 6(18.33) 2(6.67) apoplexy Cerebral 20 6 (31.5) 4 (20) 7 (33.5) 3 (15) embolism The relationship between the disease course and the effectiveness of the chip is tabulated in the table below:

Disease Patients Cure Obvious Some certain No effect course number effectiveness effectiveness 1-3 months 46 15 15 12 4 Longer than 4 1 2 1 3 months Another clinical trial was conducted with the chip or tablet of the present invention in the People's Hospital of Shimen County in China for treatment of constipation-type irritable bowel symptom. The therapeutic effect was satisfactory. The detail of the trial is described below:

II. This clinical trial was conducted in the People's Hospital of Shimen County in China with the chip or tablet of the present invention for treatment of the constipation-type of irritable bowl syndrome.The detail of the trial is described below.

During October 2004-June 2005, 50 patients with irritable bowel syndrome who attended the digestive sector of the hospital were treated in the trial. All patients underwent lab test, barium meal examination and colonoscopy in order to exclude presence of organic changes in either intestinal or entire body that can lead to constipation. All patients met the criteria set by the 1998 Rome Convention.
18 were men, 32 were women. The oldest was 63 years old, the youngest was 15, and the average age was 37. The longest disease course was 20 years and the shortest was half a year, the average disease course was 5 years.

The patients were treated by locating the chips or tablets at different acupuncture points for the various following symptoms:

There were two types of symptoms, namely stagnation of the liver-Qi and deficiency in both the heart and the spleen.

Stagnation of the liver-Qi means feces were dry or somewhat dry, difficult evacuation, infrequent evacuation for less than 3 times each week or even worse for only once each week. Abdominal flatulence and pain involved flanks, bitter taste, dizziness, and symptoms fluctuated with mood. The tongue texture was pale and the coating was thin white. The pulse was fine but weak. Among the 50 patients, 21 had stagnation of the liver-Qi, accounting for 42% and 29 had deficiency in both the heart and the spleen, accounting for 58%.
All patients underwent psychological counseling to help them to relieve from anxiety and depression, and dietary adjustment was made to increase their plant fiber intake. They were also informed of rational habits of feces evacuation by having bowel movement at a certain time, and refraining from smoking or reading during bowel movement. All other medications either chemical or herbal were stopped during the treatment.

The chips or tablets were applied at the following acupuncture points according to the various indicated purposes: Chips were located at primary acupuncture points bilateral Dachangshu, Zusanli and Zhongwan. For stagnation of the liver-Qi, additional chips were located at secondary acupuncture points bilateral Yanglingquan and Xiangjian with a dispelling maneuver (Xiefa). For deficiency in both the heart and the spleen, chips were additionally located at bilateral SanYinjiao and Guanyuan.

The therapy was carried out once daily for ten days to constitute one therapeutic course. One episode of observation lasted two months.

The following terms were used to denote the effectiveness of the treatment:
Obvious effectiveness: means symptoms disappeared and normal bowl movement was restored without relapse within two months.

Some certain effectiveness: means symptoms were strikingly alleviated and relatively normal bowel movement was restored without relapse within two months.

No effect: means no change in symptom after the therapy and medication therapy was resumed.

Among the 50 patients with stagnation of the liver-Qi in this clinical trial, patients showed obvious effectiveness, 4 patients showed some certain effectiveness,.2 patients showed no effect. Among 16 patients with deficiency in both the heart and the spleen, 16 showed obvious effectiveness, 9 showed some certain effectiveness, and 4 showed no effect. Regardless of symptom differentiation, the overall rate of obvious effectiveness was 61% (31 patients), the rate of no effect was 12% (6 patients), and the general effectiveness rate was 88%.

III. This clinical trial was conducted in the No.2 Hospital for Traditional Chinese Medicine of changed City in China for treatment of hypertension. 66 patients were involved in this clinical trial. Among the 66 patients, 41 were men, 35 were women. One patient was younger than 45, 22 were between 45 and 55 years old, and 42 were older than 55. The shortest disease course was half year and the longest was 9 years. Criteria for classifying stage of Ying hypertension were set by the 1978 national conference on cardiovascular diseases and WHO. According to such classification, 12 patients were in stage I, 47 patients were in stage II and 7 patients were in stage III.

In the treatment, the chips were located at the following acupuncture points:
Dazhui, Neiguan, Jiangyaxue, Taichong, Hegu, Fengchi (all were bilateral), Ganshu and Baihui.

Each session of therapy was conducted with 4-5 acupuncture points and alternates the acupuncture points. During the therapy, the patient was refrained from smoking, alcohol consumption, and fretfulness, while maintaining usual urination and bowel movement. All other therapies were terminated.

The results of this clinical trial for half a year for the 66 patients were:
47 were cured with headache and dizziness disappeared, blood pressure returned to normal level, and the symptom did not relapse within half a year on follow-up; 18 patients showed obvious effectiveness with headache and dizziness disappeared, blood pressure returned to normal level, but the symptom relapsed within half a year on follow-up; 6 patients showed some certain effectiveness with headache and dizziness remitted, but blood pressure fluctuated between normal and abnormal levels; 5 patients showed no effect:
with blood pressure not returning to the normal level or failed to restore to the normal range even occasionally. The general effectiveness rate was 92%, and the cure rate was 71%.

IV. This clinical trial was conducted at the No.l Hospital for Traditional Chinese Medicine of Changde City in China for the treatment of coronary disease.

50 patients participated in this trial. Among the 50 patients, 37 were men, 13 were women. The oldest was 76 years old; the youngest was 23. 8 patients were between 40-49 years old, 20 were between 50-59, 16 were between 60-69, 3 were between 70-79.

According to criteria set by western medicine, 17 patients were suffering from angina pectoris, including 16 with stable angina pectoris, one with unstable angina pectoris; 15 were suffering from arrhythmia, including 10 patients with ventricular premature beat, 2 with arterial premature beat, one with sick sinus syndrome, one with arterial fibrillation, one with complete right bundle block; 9 were suffering from myocardial infarct, and 11 were with remote myocardial infarction. According to criteria set by traditional Chinese medicine, 13 belonged to blood stasis, 11 belonged to obstruction by phlegm, 8 belonged to stagnation of Qi, 7 belonged to deficiency in heart-Qi, 11 belonged to deficiency in both Qi and Yin, and 5 belonged to deficiency in heart-Yang.
In the treatment, the chips were applied at the following acupuncture points:
acupuncture points were principally from heart and pericardium channel, matched with acupuncture points that crisscross of eight channels as well as the Xi-points that belong to the heart and the pericardium. The first group of acupuncture points were:
Juque, Xinshu, Geshu, Neiguan, Gongsun and Yinxi; the second group of acupuncture points were:
Shanzhong, JueYinshu, SanYinjiao and Ximen. Additional chips were also located at the following two secondary locations: at Taiyuan in case of obstruction by phlegm; and at Shanzhong or Geshu in case of asthenia cold.

3 therapeutic courses constituted an observation session in this trial.

The 1979 China national Criteria for Evaluating Effectiveness over Treating Angina Pectoris and Illustrated by ECG were used to determine the effectiveness of the treatment of angina pectoris.

The following criteria were used for determining effectiveness over the main symptoms (choked pain, palpitation and shortness of breath):

Obvious effectiveness: means symptoms disappeared either completely or almost completely;

Alleviated: means symptoms became obviously alleviated;

No effect: means symptoms remained unchanged after therapy; and Deteriorated: means symptoms became deteriorated after therapy.

The 1974 Shanghai Panel for Cooperation on study of red sage root compound was used to determine the effectiveness over index of blood fat.

The result of the treatment for effectiveness over the main symptoms is shown in the following table.
Main Number obvious Alleviated No Deteriorated Effectiveness symptoms of effectiveness effect rate(%) patient Chest pain 30 20 6 2 2 86.66 Choked chest 32 12 16 4 0 87.50 Palpitation 23 10 8 5 0 78 Short breath 13 5 7 1 0 92 The result of the treatment for effectiveness over syndrome differentiation of TCM is shown in the following table.

Main symptoms Number of Obvious Alleviated No effect patient effectiveness blood stasis 13 8 4 1 Obstruction by 11 5 5 1 phlegm Stagnation of Qi 8 2 4 2 Deficiency in 7 3 3 1 heart-Qi Deficiency in both 6 3 2 1 Qi and Yin Deficiency in 5 2 2 1 heart Yang.

For the effectiveness over index of blood fat: there were 30 patients who had high cholesterol and 23 of them showed effectiveness; and 20 patients had over high TG and showed effectiveness.

For the effectiveness over changes on ECG: all disorders on ECG were alleviated, including ST-T alterations, V-wave alteration, atria fibrillation, sick sinus syndrome, frequent ventricular premature beat, frequent atria premature, and complete right bundle block.

For the effectiveness over cardiac function: all disorders in cardiac function were alleviated, with LVET elongated, PEP and TICT shortened, and PEP/LVET dropped.

V. The following clinical trial was conducted in Meili and Liu Guang in China for treatment of senile dementia.

The clinical trial was conducted with 76 patients among which 46 were men and 30 were women. Their ages were between 59 to 78 and the average age was 73.
Their disease courses lasted 9 months to 8 years, with an average of two years and eight months.
The chips were applied at the following acupuncture points: Baihui, Sishencong, Dazhui, and Guanyuan.

The usual duration of therapy was 2-3 months. Patients were allowed to use other medications during the therapy, including hypertension relieving pills, fat-reducing medications, sugar-reducing medications and medications that inhibited agglomeration of blood platelet.

In the determination of the effectiveness of the treatment, the following terms were used:

Cure: symptoms disappeared so that the patient could lead a normal life without nursing care, and would return to normal social activities;

Obvious effectiveness: symptoms alleviated, but still suffering from retardation in reaction, intelligence, and was unable to lead a normal life without nursing care;
No effect: patient's condition remained unchanged in symptoms and signs after the therapy.

The result of the treatment was as follows: 7 patients were cured, 33 showed obvious effectiveness; 26 patients showed some certain effectiveness; 10 patients showed no effect. Of those 19 patients who had disease course shorter than one year, 6 were cured, 9 showed obvious effectiveness. All patients who showed no effect, and had a disease course longer than 3 years. The effectiveness rate was 86%.

VI. The following clinical trial was conducted for treatment of chronic enteritis.
64 patients participated in the trial, and among the 64 patients, 38 were men, were women. 8 patients were between 30-40 years old, 18 were between 41-50, 26 were between 51-60, and 12 were older than 61. The shortest disease course was one year and the longest was 12 years.

The condition of the patient's chronic enteritis were : (1) History of acute enteritis or recurrence of enteritis; (2) Upon onset of enteritis, patients suffered from diarrhea and abdominal pain, accompanied by chronic malnutrition and abdominal tenderness.
Routine stool test showed white blood cells and few pyocytes. (3) Being excluded from other non-specific enteritis using X-ray barium meal examination and colonoscopy.

In the treatment, the chips were placed at the following acupuncture points:
four acupuncture points around the navel, Zhongwan, Tianshu, Guanyuan, Zusanli, Shangjuxu, Shenshu, Pishu, Dachangshu, Quchi, and SanYinjiao. These acupuncture points fell into two groups in which the first group included: four acupuncture points around the navel, Zhongwan, Tianshu, Guanyuan, Zusanli, Shangjuxu, Hegu and SanYinjiao, and the second group included: Pishu, Shenshu, Dachangshu, Zusanli, Shangjuxu, and Hegu.
These two groups were alternately used during treatment.

The contact area of the skin was first moistened with the superficial fluid.
The chips were located at the acupuncture points with poromeric adhesive tape. The chips were retained at the acupuncture points for one hour in each session of therapy. 4-5 acupuncture points were used in each session. Ten sessions constituted one therapeutic course.

The following terms were used to determine the effectiveness of the treatment:
Cure: stool restored to the normal shape and being evacuated once daily.

Alleviated: stool had restored to the normal shape and being evacuated twice daily;
No effect: stool condition remained unchanged.

The result of the trial was that among the 64 patients, 31 patients were cured, accounting for 48.4%; 28 patients were alleviated, accounting for 43.7%; 5 patients showed no effect, accounting for 7.9%; The general effectiveness rate was 92.1 %.

VII. The following clinical trial was conducted at the People's Hospital of Tianjin City in China for treatment with the chips of the present invention of 68 patients having chronic prostatitis. All 68 patients were treated in the hospital during June 2004 to June 2005 in this trial. Most of the patients had undergone treatment in using either chemical or herbal medications prior to the trial. The youngest patient was 17 years old and the oldest was 76; 3 patients were younger than 20; 5 patients were between 21-30 years old;
8 were between 31-40; 17 were between 41-50; and 35 patients were older than 50. The shortest disease course was half a year and the longest was 20 years. 57 patients were married, I 1 were single. Main complaints included sore and swelling pain in back and bottom, bearing down pain in lower abdomen and perineum, frequent urination, difficulty in urination, and dripping urination. 6 patients were complicated with severe nervosism and sexual disorder. Examination of the prostatic fluid under microscopy found: 28 patients showed white blood cells (+) , 21 patients showed white blood cells ( +

+) ' 15 patients showed white blood cells (+ + +) , 4 patients showed white blood cells (+ + + +) . 32 patients had prostatomegaly, and 2 patients had calculus of the prostate.

In the treatment, the chips were placed at the following primary acupuncture points: Xiaochangshu, Pangguangshu, Pishu, Ciliao, Guanyuan, and Zhongji and secondary acupuncture points: Yinlingquan, SanYinjiao, and Taixi. For excess of viscera, additional acupuncture points Qugu, and Waigua were used; for deficiency of viscera, additional acupuncture points Shenshu, and Zusanli were used.

Each session of therapy used 4-5 acupuncture points and alternates acupuncture points. The treatment was conducted once daily and ten sessions constituted one therapeutic course. A 3-5 days interval was allowed before the next therapy was administered. In case both acupuncture points and Mu (collecting) points were used, the chips were placed on the patient in the prone position first and then in the supine position afterward. More frequently only one position was used for each session.

The following criteria were used for determining the effectiveness of the treatment:
Cure: self-felt symptoms disappeared, restored to normal examination of the prostatic fluid under microscopy;

Obvious effectiveness: symptoms disappeared with less than 3 WBCIHP found;
Alleviated: symptoms becomed alleviated obviously, with 4-6 WBC/HP found, No effect: symptoms and findings under microscopy remained unchanged.

After subjecting to 2-3 therapeutic courses, 18 patients were cured, accounting for 26.5%; 21 patients showed obvious effectiveness, accounting for 30.9%; 22 patients alleviate their symptoms, accounting for 32.3%; 7patients showed no effect, accounting for 10.3%. General effectiveness rate was 89.7%. For the effectiveness with varying with age, as shown in the table below.

Age Number Cure Obvious Alleviated No effect Effectiveness (Years) of patient effectiveness rate (%) 41-50 17 6 7 3 1 94.1 50-76 35 4 9 16 6 82.9 VIII. The following clinical trial was conducted at No. 1 affiliated Hospital of Gui Yang College for Traditional Chinese Medicine in China for treatment of chronic nephritis and nephrosis with the chip of the present invention.

52 patients in a first group were treated with the rehabilitation chip of the present invention and a second group of 47 patients were treated with medication. CGN
fell into ordinary type, manifesting slow onset, protracted disease course, having little or much proteinuria, hematuria, cylindruria, edema, hypertension, and renal failure;
hypertension type, besides the preceding findings, this type had also strikingly very high blood pressure; type of flare in course of chronic plaguing: manifesting features of acute nephritis in course of chronic plaguing. NS was always accompanied by large amount of proteinuria (>_3.5g/24h), hypoproteinemia (serum albumin<30g/L), hyperlipemia and explicit edema. All patients were classified into certain types according to the 1985 national conference on diseases of glomerulus (Nanjing). Some underwent renal biopsy for pathological classification. The group treated with the rehabilitation chips included:
20 patients with ordinary type of CGN, 12 patients with type of flare in course of chronic plaguing, 5 patients having striking hypertension. The group treated with medication included: 18 patients with ordinary type of CGN; 12 patients with type of flare in course of chronic plaguing, 4 patients with striking hypertension, and 13 patients with NS.

For the group treated with the rehabilitation chips, the chips were placed at the following acupuncture points: Shenshu, Pangguangshu, Sanjiaoshu, Guanyuan, Qihai, SanYinjiao, Shuitong, Shenjue, HuiYin, and Qugu. The treatment was administered for one hour in each session of therapy. Each session of therapy used 4-5 acupuncture points.
The acupuncture points were alternately varied during treatment. The treatment was conducted once daily and ten sessions constituted one therapeutic course. The patients in this group were also administered with routine treatment, of taking inosine 0.2g, three times daily, Liuweidihuang concoction (add or remove some constituents according to need); dihydrochlorothiazide was used to treat edema and to remove retention of water;
and nifepine and captopril were used to relieve hypertension. The secondl group only received the routine treatment.
The tests for observing the effectiveness of the treatment included: routine urine test, quantitative measurement of protein in 24h urine, 0213-MG, urine 32 -MG, blood routine test, blood creatinine, blood urea nitrogen, complement, Ig and renogram.

The effectiveness of the treatment was determined based on the observation of the following findings after the therapy: observational measurement of urinary protein was negative, quantitative measurement of protein in 24h urine was <150mg, normal renal function, and normal immunity test. Lowering of blood pressure, decreasing of urine protein and improvement of renal function were not discussed in determining the effectiveness.

After subjecting to 1-3 therapeutic courses using the rehabilitation chip, protein disappeared in urine of 39(75%) patients. 17 out of 20 patients with ordinary type CGN
showed effectiveness, 9 out of 12 patients with type of flare in course of chronic plaguing showed effectiveness, one out of 5 patients with striking hypertension showed effectiveness, 12 out of 15 patients with NS showed effectiveness. While in the other group treated with medication, protein disappeared in urine of 16 (34%) patients. 4 out of 18 patients with ordinary type CGN showed effectiveness, 4 out of 12 patients with type of flare in course of chronic plaguing showed effectiveness, none of 4 patients with striking hypertension showed effectiveness, 8 out of 13 patients with NS
showed effectiveness. Biopsy of patients treated with the chip showed mostly minute lesions, mild proliferation of mesenteric tissue, and membranate nephrosis. All patients showed effectiveness had normal value of Cr, Bun, C3 and renogram showed favorable profile.
Effectiveness rate between the two groups differed significantly with u>2.58, P<0.05 which indicated that the group treated with the chip plus medication, the result was superior to the group of patients treated with only medication. Due to the scarcity of patients having biopsy, it was unable to obtain the relationship between pathological type and effectiveness. However, aftermath of protein in urine was related to pathological classification.

IX. This clinical trial was conducted at the Linli Hospital for Traditional Chinese Medicine in China for treatment of 56 patients having trigeminal neuralgia.

56 patients with trigeminal neuralgia were treated, in which 20 were men, 36 were women. The oldest was 78 years old; the youngest was 35.5 patients suffered pain in first branch, 15 in second branches and 16 in third branches. 20 were compounded.
The shortest disease course was one month and the longest was 10 years. 48 patients were primary and 8 were secondary. 3 suffered cholesteatoma, 5 suffered eye-branch residual pain due to infection of herpes zoster virus.

For the patients in the first branch the chips were located at primary acupuncture points Yuyao and Xiaguan, matched with Yangbai, Shangxing, Hegu, and Neiting.
For the second and third branches the chips were located at Sibai, Xiaguan, Dicang, Jiachengjiang, Hegu, and Neiting. For lesion on head and face, acupuncture points located on the side feeling the pain were used, and Hegu and Neiting were used alternately. The treatment was stopped for 3-5 days between two therapeutic courses.

The following criteria were used to denote the result of the treatment:
Cured: pain in the face completely disappeared.

Obvious effectiveness: pain in the face became dramatically infrequent.
Alleviated: pain in the face became alleviated and infrequent.
No effect: pain in the face remained unchanged in severity and frequency after the therapy.

In the treatment, 38 patients originally orally taking carbamazepine and stopped taking it for poor effect. They were stopped from taking carbamazepine during the therapeutic course with the chip. 18 patients who had not been taking carbamazepine were administered carbamazepine 0.1 g bid during their therapeutic course with the chip.
The numbers of least sessions for using the chip were 6 times and the most numbers were 20 times. 42 patients were clinically cured, accounting for 75%; 9 patients showed obvious effectiveness, accounting for 16.1 %; 5 patients alleviated, accounting for 8.9%;
all of the chip-treated patients showed effectiveness from the treatment; and the general effectiveness rate was 100%. 42 patients did not relapse within half a year following the treatment, 11 patients relapsed within 3-4 months, but only with mild symptoms, and the symptoms disappeared for another 5-10 sessions of therapy with the chip. 3 patients with cholesteatoma were referred to other hospital for operation with no available follow-up result.

X. The following clinical trial was conducted at the 302 Hospital of anshun in China for treatment of 120 patients suffering from headache.

Of the 120 patients, 39 were men and 81 were women. The youngest patient was 20 years old and the oldest was 70. The shortest disease course was 5 hours and the longest was 20 years.

In the treatment the chips were located at the primary acupuncture points Fengchi, and Baihui, matched with other acupuncture points according to various different syndrome. The patients were clinically classified as: (1) Affection due to external wind in which headache occurred upon encountering wind and the pain was striking. They were treated with the chips located at Fengfu, Lieque, Waiguan, and Heger (2) Liver-Yang with pain on one side of the head and which may be at the top of the head.
They were treated with the chips located at Sishencong, Taichong and Shuiquan. (3) Stasis of blood with refractory and pricking pain. They were located with the chips located at SanYinjiao and Ashixue.

The following criteria were used to denote the effectiveness of the treatment:
Cure: pain disappeared completely and did not relapse within half a year, Obvious effectiveness: pain was obviously alleviated and became less frequent;

Some certain effectiveness: pain was alleviated and became less frequent; and No effect: pain remained unchanged.

The result of the trial therapy showed that among the 120 patients, 96 patients were cured, accounting for 80%; 18 patients showed obvious effectiveness, accounting for 15%; 6 patients showed some certain effectiveness, accounting for 5%. The effectiveness rate was 100%.

XI. This clinical trial was conducted at the No.l Hospital for Traditional Chinese Medicine of Changde City in China for the treatment of 80 patients suffering from gastric or duodenal ulcer.

All 80 patients met the criteria as having gastric or duodenal ulcer. They were randomly separated into two groups. The first group consisted of 50 patients in which 35 were men and 15 were women, and the ages ranged between 24-62, with an average age of 35.5 11.3. The disease courses varied between 0.5-20 years with an average of 6.4 2.8. 19 patients were suffering from gastric ulcer, 26 patients were suffering from duodenal ulcer, 5 patients were suffering from compound ulcer, 44 patients had negative occult blood in stool, 4 patients had weak positive result and 2 had positive result. The second group consisted of 30 patients in which 18 were men and 12 were women.
The ages were in the range of between 20-68 with an average age of 34.4 12.4. The disease courses were between 4 months to 18 years with the average length of 6.5 3.0 years. 10 patients were suffering from gastric ulcer, 13 patients were suffering fromduodenal ulcer, 7 patients were suffering from compound ulcer, 25 patients had negative occult blood in stool, 3 patients had weak positive result and 2 had positive result. The differences between the two groups were non-significant according to X2 (P>0.05, were comparable to one another.

The first group was treated with the chips located at Zusanli, Neiguan, and Gongsun; and the second group was treated with the chips located at Zhongwan, Pishu, and Weishu. The location LiangQiu was added in case of stomach pain; and the locations at the upper and lower Zhongwan were added in case of cold in stomach; the location Tianshu was added in case of flatulence; the location Taichong was added in case of acid regurgitation; the location Zhigou was added in case of constipation; the location Shenmen was added in case of insomnia; the location Qihai was added in case of fatigue.

The two groups of acupuncture points were applied alternately once daily. The treatment administered for 2 months.
For the second group, the acupuncture points were same as those of the first group except for additionally using supplementing or dispelling maneuver. For mild bleeding ulcers (mild), some medications could additionally be used.

The parameters for observation included ulcer lesion observed in gastroscopy, and some physical symptoms of abdominal pain, and acid regurgitation.

The Standard for Determining Effectiveness over Diseases Treated with Traditional Chinese Medicine issued in 1994 by State Administration of Traditional Chinese Medicine of PR China was used to determine the following criteria of effectiveness of the treatment:

Clinically cured: ulcer lesion heals found by gastroscopy, symptoms disappeared;
Obvious effectiveness: ulcer lesion shrank or less found by gastroscopy, symptoms disappear or become alleviated;

Alleviated: lesion did not shrink, but congestion and edema in membrane of stomach became alleviated, and symptoms became alleviated;

No effect: ulcer remained unchanged i.e. lesion and symptoms remained unchanged.

The results are tabulated in the following two tables.

Table 1 Comparison between the two groups in effectiveness main Number Cure Obvious Alleviated No General symptoms of patient effectiveness effect effectiveness rate (%) Treatment 50 14 11 21 4 92.01 group Control 30 6 6 13 5 83.3 group Table 2 Comparison between the two groups for the length of treatment time required to show effectiveness Group Number of patient Therapeutic course Treatment 14 2 5 5 2 group Control 6 0 0 2 4 group XII. The following clinical trial was conducted at the Hospital of Jinshi county in China for the treatment of vascular headache.

120 patients participated in the trial in which 35 were men and 85 were women.
The youngest was 18 years old and the oldest was 76. The longest therapeutic course lasted 10 years and the shortest course was one day.

The acupuncture points used in the treatment were classified into four groups.
The first group included Yintang, Yongquan, and Hegu; the second group included Yintang, Fengchi, and Zhongwan; the third group included Neiguan, Yifeng, and TaiYang.
For headache in the entire head, acupuncture points along hairline were added. The fourth group included Fengchi, Neiguan, TaiYang, and Shuaigu.

The therapeutic effect was evaluated after every two therapeutic courses.

The following criteria were used in determining the effectiveness of the treatment:
Clinically cured: pain disappeared and normal life was restored, and pain did not relapse within half a year afterward;
Obvious effectiveness: pain disappeared and normal life was restored, but relapses occurred within half a year afterward;

Some certain effectiveness: pain was alleviated, but became deteriorated with tiredness and fretfulness, and relapses sometimes occurred;

No effect: pain remained unchanged.

The result of the therapy was that 120 patients were cured; 20 patients showed obvious effectiveness; 20 patients showed some certain effectiveness; 12 patients showed no effect. The general effectiveness rate was as high as 97.5%.

XIII. This clinical trial was conducted in Duan Changjiu in China with 48 patients suffering from bronchial asthma.

Among the 48 patients, 20 were men and 28 were women. The youngest was 6 years old and the oldest was 65. The longest therapeutic course lasted 27 years and the shortest course was 6 months. 36 patients had phlegm-hot, 12 were had wind-cold.

This disease was mostly due to wax of evil and wane of genuine according to traditional Chinese medicine, with excess of viscera at the onset, displaying either cold or hot feature. Symptoms can be short breath and choked chest, wheeze, loud speaking and powerful pulse. For those who displayed cold features, their sputum was cold and thin and was complicated by coldness signs; for those who displayed hot features, they had more expiration and less inspiration, exacerbated by motion, short breath, fatigue, gloomy complexion and weak pulse. Protracted period of such disease course could hurt spleen and kidney and could be complicated with deficiency in the functions of both the spleen and kidney.
In the treatment, the chips were located at acupuncture points Neiguan, Tiantu, Dingchuan, Shanzhong, Feishu, Chize, Zusanli, Yuji, Yezui, and Lieque. 4 to 5 of these acupuncture points were used alternately in the treatment.

The following criteria were used to denote the effectiveness of the treatment:
Obvious effectiveness: symptoms were removed without relapse within half a year, or occasionally relapse very slightly, and could survive without anti-asthma medications.

Alleviated: symptoms were obviously alleviated, and could return to normal life although the symptoms could still occur occasionally, and anti-asthma medications was reduced dramatically.

No effect: symptoms remained unchanged after three therapeutic courses.
The result of the treatment was that 15 patients showed obvious effectiveness, accounting for 315; 30 patients showed some certain effectiveness, accounting for 63%; 3 patients showed no effect, accounting for 6%; general effectiveness rate was 94%.

The following table shows the effectiveness of the types of asthma treated with acupuncture Main Number Obvious Alleviated No General symptoms of patient effectiveness effect effectiveness rate (0/u) Treatment 36 12(33) 23(64) 1(3) 97 group Control 12 3(25) 7(58) 2(17) 83 group Comparing to other procedures of CAM (Complementary and alternative medicines), the chip of the present invention is more effective in providing treatment of various diseases and additionally it can provide the following advantages:

1. Without using needle and medications, and it is thus free from any side or toxic effect. It is superior to invasive procedures, and meets the requirements for non-deleteriousness and environment-friendliness.

2. Without using electricity and mechanic parts, and it is thus free from damage and requirement of maintenance. It is therefore better than electromechanical devices.

3. It can be used easily and is very accessible for self administering and household use. It does not require a special practitioner to operate, and thus is not subject to poor effect due to inappropriate practice.

4. It is economical and cheap to use since the chip can be used personally and it can endure repeated uses as many as tens of thousand of times, with the cost of only several cents for each session of therapy.

Claims (3)

1. A non-invasive acupuncture device in the form of a solid chip comprising:
a polar tourmaline powder selected from the group consisting of iron tourmaline, magnesium tourmaline, iron and magnesium tourmaline, and lithium tourmaline;
an infrared refractive material selected from the group consisting of oxide crystal sapphire, and magnesium oxide;
a pliable magnetic material selected from the group consisting of iron oxide, and iron trioxide;
a photo-catalytic material selected from the group consisting of titanic oxide, zinc oxide, tin oxide, and tungsten oxide;
a composite oxide selected from the group consisting of CeO2, Ce2O3, La2O3 and Nd2O3, and calcium oxide;
an adhesive material selected from the group consisting of stearic acid, polyvinyl chloride, pine resin, flax oil and castor oil; and an inclusive compound material selected from the group consisting of methyl celluslose, liquid paraffin wax, colophon, and polyvinyl chloride.
2. A non-invasive acupuncture device in the form of a solid chip having a mixture comprising:
20 to 40% by weight of a polar tourmaline powder selected from the group consisting of iron tourmaline, magnesium tourmaline, iron and magnesium tourmaline, and lithium tourmaline;
30 to 50% by weight of an infrared refractive material selected from the group consisting of A12O3 and MgO;
to 10% by weight of a pliable magnetic material selected from the group consisting of FeO and Fe2O3;
1 to 5% by weight of photo-catalytic material selected from the group consisting of TiO2, ZnO, SnO and WO;
1 to 5% by weight of a composite salt selected from the group consisting of CeO2, Ce2O3, La2O3, and Nd2O3;

to 10% by weight of calcium oxide;
2 to 5% by weight of an adhesive material selected from the group consisting of stearic acid, polyvinyl chloride, pine resin, flax oil, and caster oil; and 1 to 5% by weight of an inclusion compound material selected from the group consisting of methyl cellulose, liquid paraffin wax, colophon, and polyvinyl chloride.
3. A non-invasive acupuncture device according to Claim 2 wherein said composite salt is further selected from the group consisting of LaPO4, NdPO4, Ce(NO3) 3, and La(NO3).
CA2529239A 2005-11-03 2005-11-23 Non-invasive acupuncture device Expired - Fee Related CA2529239C (en)

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EP06705333A EP1945171B1 (en) 2005-11-03 2006-03-16 A medical device's manufacture and usage in alternative medicine for rehabilitation treatment of chronic diseases
KR1020087010112A KR100961595B1 (en) 2005-11-03 2006-03-16 A chip for use in alternative medical treatment and method of manufacturing the same
PCT/CA2006/000392 WO2007051278A1 (en) 2005-11-03 2006-03-16 A medical device's manufacture and usage in alternative medicine for rehabilitation treatment of chronic diseases
US11/377,858 US8936815B2 (en) 2005-11-03 2006-03-17 Device for external use in alternative medicine applications

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