Patent Application
20130171232
The invention is related to methods and articles for treating or ameliorating Parkinson's disease.
Parkinson's disease (PD or Parkinson's) is a degenerative disorder of the central nervous system and involves the malfunction and death of vital nerve cells in the brain, called neurons. Parkinson's primarily affects neurons in the area of the brain called the substantia nigra. Some of these dying neurons produce dopamine, a chemical that sends messages to the part of the brain that controls movement and coordination. As PD progresses, the amount of dopamine produced in the brain decreases, leaving a person unable to control movement normally.
Each person with Parkinson's will experience symptoms differently. For example, many people experience tremor as their primary symptom, while others may not have tremors, but may have problems with balance. Also, for some people the disease progresses quickly, and in others it does not.
By definition, Parkinson's is a progressive disease. Although some people with Parkinson's only have symptoms on one side of the body for many years, eventually the symptoms begin on the other side. Symptoms on the other side of the body often do not become as severe as symptoms on the initial side.
Symptoms of PD can be categorized into: primary motor symptoms; secondary motor symptoms; and nonmotor symptoms. These symptoms are well documented and within the general knowledge in the medical field.
Acupuncture has been documented to be effective in treating or managing PD with limited success. See, Shulman L M, et al., Acupuncture therapy for the symptoms of Parkinson's disease, in Mov Disord. 2002 July; 17(4):799-802; Jeon, S., et al., Proteomics 2008, 8, 4822-4832.
Acupuncture is a medical practice of traditional Chinese medicine. Traditional Chinese medicine focuses on interconnectedness and free flow of the biological system of a human being and believes any interference, e.g., blocking, with such a free flow biological system would result in a disorder of the biological system.
According to traditional Chinese medicine, blocking of the free flow of human biological system happens in certain places (points) in the human body and cause diseases to occur. A particular disorder corresponds to blocking of a particular point or set of points in the biological system. Stimulating one of these points can free up the flow of biological system of human being so as to treat or ameliorate a disease arising out of blocking of such point or set of points. According to this school of medicine, a method of therapeutics—acupuncture—was developed and practiced in China for thousands of years. The oldest medical book known, written in China 4000 years ago, describes the use of acupuncture to treat medical problems. The use of the treatment spread to other Asian countries and to other regions of the world, including to Europe by the 1700s. In the United States, acupuncture has been used for about 200 years.
Research on acupuncture began in the United States in 1976. Twenty years later, according to National Cancer Institute, the US Food and Drug Administration (FDA) approved the acupuncture needle as a medical device. Many illnesses are treated with acupuncture, but it is used mainly to control pain, including pain in cancer patients and to help control nausea and vomiting. Its primary use in cancer patients has been as an addition to conventional (standard) therapy.
The FDA approved acupuncture needles for use by licensed practitioners in 1996. The FDA requires that sterile, nontoxic needles be used and that they be labeled for single use by qualified practitioners only.
More than 40 states and the District of Columbia have laws regulating acupuncture practice. The National Certification Commission for Acupuncture and Oriental Medicine certifies practitioners of acupuncture and traditional Chinese medicine (TCM). Most states require this certification.
A common side effect of acupuncture is concern of infection caused by cross-contamination of acupuncture needles that may include viral or bacterial pathogens. Other concerns may arise out of patient's negative reactions against piercing of acupuncture needles or misapplication of such needles by a practitioner. Further, access to acupuncture by a practitioner is limited so as to limit the effect of acupuncture.
Therefore, there is a need for additional treatment regime for PD.
The embodiments described below address the above identified needs and issues.
In one aspect of the present invention, it is provided a composition for Parkinson's disease (PD), the composition comprises a heat generation component, the composition is formulated in a formulation for selective application to a set of acupoints or one or more acupoint(s) for Parkinson's disease (“acupoint(s) for PD”) in a patient, and the composition generates heat upon application to the acupoint(s) for PD for a sufficient period of time to generate an effect to ameliorate or treat PD.
In some embodiments of the composition, the set of acupoints comprises the tips of fingers (Shouzhijian) and toes, shenshu, taixi, and shenque acupoints of a PD patient.
In some embodiments of the composition, optionally in combination with any or all of the above various embodiments, the composition is capable of generating heat for at least 1 hour (e.g., 1 hour, 2 hours, 4 hours, 8 hours, or 10 hours) after application to the set of acupoints or one or more acupoint(s) for PD.
In some embodiments of the composition, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth component.
In some embodiments of the composition, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth magnetic powder, saussurea in volucrata, musk, sea otter, chuanwu, caowu, lilac, menthol, meiyao, wujiapi, and maqianzhi.
In some embodiments of the composition, optionally in combination with any or all of the above various embodiments, the formulation is a patch comprising a cover. In some embodiments, the cover is a plastic, rubber, or paper cover.
In another aspect of the present invention, it is provided a method of fabricating a composition, for Parkinson's disease (PD), comprising providing a heat generation component, and formulating the composition in a formulation for selective application to a set of acupoints or one or more acupoint(s) for Parkinson's disease (“acupoint(s) for PD”) in a patient. The composition generates heat upon application to the set of acupoints or one or more acupoint(s) for PD for a sufficient period of time to generate an effect to ameliorate or treat PD.
In some embodiments of the method, the set of acupoints comprises the tips of fingers (Shouzhijian) and toes, shenshu, taixi, and shenque acupoints of a PD patient.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the composition is capable of generating heat for at least 1 hour (e.g., 1 hour, 2 hours, 4 hours, 8 hours, or 10 hours) after application to the set of acupoints or one or more acupoint(s) for PD.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth component.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth magnetic powder, saussurea in volucrata, musk, sea otter, chuanwu, caowu, lilac, menthol, meiyao, wujiapi, and maqianzhi.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the formulation is a patch comprising a cover. In some embodiments, the cover is a plastic, rubber, or paper cover.
In a further embodiment of the present invention, it is provided a method of treating or ameliorating Parkinson's disease (PD), comprising applying a composition at least once per day to a set of acupoints or one or more acupoint(s) for Parkinson's disease (“acupoint(s) for PD”) in a PD patient, which composition comprising a heat generation component, wherein the composition is formulated in a formulation for selective application to the set of acupoints or one or more acupoint(s) for PD over the entire length of a prescribed treatment course, wherein the composition generates heat upon application to the set of acupoints or one or more acupoint(s) for PD for a sufficient period of time to generate an effect to ameliorate PD.
In some embodiments of the method, the set of acupoints comprises the tips of fingers (Shouzhijian) and toes, shenshu, taixi, and shenque acupoints of a PD patient.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the composition is capable of generating heat for at least 1 hour (e.g., 1 hour, 2 hours, 4 hours, 8 hours, or 10 hours) after application to the set of acupoints or one or more acupoint(s) for PD.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth component.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth magnetic powder, saussurea in volucrata, musk, sea otter, chuanwu, caowu, lilac, menthol, meiyao, wujiapi, and maqianzhi.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the formulation is a patch comprising a cover. In some embodiments of method, the cover is a plastic, rubber, or paper cover.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the treatment course lasts for about 1 month, 3 months, 6 months; or 12 months.
In one aspect of the present invention, it is provided a composition for Parkinson's disease (PD), the composition comprises a heat generation component, the composition is formulated in a formulation for selective application to a set of acupoints or one or more acupoint(s) for Parkinson's disease (“acupoint(s) for PD”) in a patient, and the composition generates heat upon application to the acupoint(s) for PD for a sufficient period of time to generate an effect to ameliorate or treat PD. As used herein, the term PD includes the disorder as diagnosed by general medical standards and symptoms of PD.
the set of acupoints comprises the tips of fingers (Shouzhijian) and toes, shenshu, taixi, and shenque acupoints of a PD patient (
In some embodiments, optionally in combination with any or all of the above various embodiments, the composition is capable of generating heat for at least 10 minutes, e.g., 20 minutes, 30 minutes, 60 minutes (1 hour), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, or 24 hrs. In some embodiments, the composition is capable of generating heat for at least 2 hours after application to the acupoint(s) for PD.
In some embodiments of the composition, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth component. Such rare earth component can be a rare earth magnetic powder (e.g., samarium-cobalt magnetic material or neodymium based magnetic material) or a rare earth oxide, which can be any oxide of a rare earth element. Rare earth elements include lanthanide series elements and actinide series elements. Lanthanide series elements are Lanthanum, Cerium, Praseodymium, Neodymium, Promethium, Samarium, Europium, Gadolinium, Terbium, Dysprosium, Holmium, Erbium, Thulium, Ytterbium, and Lutetium; Actinide series elements are Actinium, Thorium, Protactinium, Uranium, Neptunium, Plutonium, Americium, Curium, Berkelium, Californium, Einsteinium, Fermium, Mendelevium, Nobelium, and Lawrencium.
In some embodiments of the composition, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth magnetic powder, saussurea in volucrata, musk, sea otter, chuanwu, caowu, lilac, menthol, meiyao, wujiapi, and maqianzhi.
In some embodiments of the composition, optionally in combination with any or all of the above various embodiments, the formulation is a patch comprising a cover. In some embodiments, the cover can be e.g., a plastic, rubber, or paper cover.
In another aspect of the present invention, it is provided a method of fabricating a composition for Parkinson's disease (PD), comprising providing a heat generation component, and formulating the composition in a formulation for selective application to a set of acupoints or one or more acupoint(s) for Parkinson's disease (“acupoint(s) for PD”) in a patient. The composition generates heat upon application to the set of acupoints or one or more acupoint(s) for PD for a sufficient period of time to generate an effect to ameliorate or treat PD.
In some embodiments of the composition, the set of acupoints comprises the tips of fingers (Shouzhijian) and toes, shenshu, taixi, and shenque acupoints of a PD patient.
In some embodiments of the method, optionally in combination with any or all of the above various embodiments, the composition is capable of generating heat for at least 10 minutes, e.g., 20 minutes, 30 minutes, 60 minutes (1 hour), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 14 hours, or 24 hours. In some embodiments, the composition is capable of generating heat for at least 2 hours after application to the acupoint(s) for PD.
In some embodiments of the method, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth component. Such rare earth component can be a rare earth magnetic powder (e.g., samarium-cobalt magnetic material or neodymium based magnetic material) or a rare earth oxide, which can be any oxide of a rare earth element. Rare earth elements include lanthanide series elements and actinide series elements. Lanthanide series elements are Lanthanum, Cerium, Praseodymium, Neodymium, Promethium, Samarium, Europium, Gadolinium, Terbium, Dysprosium, Holmium, Erbium, Thulium, Ytterbium, and Lutetium; Actinide series elements are Actinium, Thorium, Protactinium, Uranium, Neptunium, Plutonium, Americium, Curium, Berkelium, Californium, Einsteinium, Fermium, Mendelevium, Nobelium, and Lawrencium.
In some embodiments of the method, optionally in combination with any or all of the above various embodiments, the formulation is a patch comprising a cover. In some embodiments, the cover can be e.g., a plastic, rubber, or paper cover.
In a further embodiment of the present invention, it is provided a method, of treating or ameliorating Parkinson's disease (PD), comprising applying a composition at least once per day to a set of acupoints or one or more acupoint(s) for Parkinson's disease (“acupoint(s) for PD”) in a PD patient, which composition comprising a heat generation component, wherein the composition is formulated in a formulation for selective application to the set of acupoints or one or more acupoint(s) for PD over the entire length of a prescribed treatment course, wherein the composition generates heat upon application to the set of acupoints or one or more acupoint(s) for PD for a sufficient period of time to generate an effect to ameliorate PD.
In some embodiments of the method, the composition is capable of generating heat for at least 10 minutes, e.g., 20 minutes, 30 minutes, 60 minutes (1 hour), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 15 hours or a day. In some embodiments, the composition is capable of generating heat for at least 2 hours after application to the acupoint(s) for PD. In some embodiments, the composition is capable of generating heat for at least 2 hours after application to the acupoint(s) for PD.
In some embodiments of the method, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth component. Such rare earth component can be a rare earth magnetic powder (e.g., samarium-cobalt magnetic material or neodymium based magnetic material) or a rare earth oxide, which can be any oxide of a rare earth element. Rare earth elements include lanthanide series elements and actinide series elements. Lanthanide series elements are Lanthanum, Cerium, Praseodymium, Neodymium, Promethium, Samarium, Europium, Gadolinium, Terbium, Dysprosium, Holmium, Erbium, Thulium, Ytterbium, and Lutetium; Actinide series elements are Actinium, Thorium, Protactinium, Uranium, Neptunium, Plutonium, Americium, Curium, Berkelium, Californium, Einsteinium, Fermium, Mendelevium, Nobelium, and Lawrencium.
In some embodiments of the method, optionally in combination with any or all of the above various embodiments, the heat generation component comprises a rare earth magnetic powder, saussurea in volucrata, musk, sea otter, chuanwu, caowu, lilac, menthol, meiyao, wujiapi, and maqianzhi.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the formulation is a patch comprising a cover. In some embodiments of method, the cover is a plastic, rubber, or paper cover.
In some embodiments of method, optionally in combination with any or all of the above various embodiments, the treatment course lasts for about 1 month, 3 months, 6 months, or 12 months.
As used herein, the term “heat generation component” can be any component capable generating heat upon exposure to moisture or air that provides a local temperature above body temperature (e.g., 37° C.) to about 50 μl Local temperature refers to the temperature of the skin area in contact with a composition disclosed herein, Such heat generation can last at least about 10 minutes, e.g., e.g., 20 minutes, 30 minutes, 60 minutes (1 hour), 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 14 hours, or 24 hours. An example of the heat generating component is a chemical composition commonly in baby products or winter comfort products. For example, in some embodiments, the heat generation component can comprise iron powder, activated carbon, and inorganic salt. In another embodiment, the heat generation component can comprise the heat generation component comprises a rare earth component. Such rare earth component can be a rare earth magnetic powder (e.g., samarium-cobalt magnetic material or neodymium based magnetic material) or a rare earth oxide, which can be any oxide of a rare earth element. Rare earth elements include lanthanide series elements and actinide series elements. Lanthanide series elements are Lanthanum, Cerium, Praseodymium, Neodymium, Promethium, Samarium, Europium, Gadolinium, Terbium, Dysprosium, Holmium, Erbium, Thulium, Ytterbium, and Lutetium; Actinide series elements are Actinium, Thorium, Protactinium, Uranium, Neptunium, Plutonium, Americium, Curium, Berkelium, Californium, Einsteinium, Fermium, Mendelevium, Nobelium, and Lawrencium.
As used herein, the term “a set of acupoints or one or more acupoint(s) for PD” shall mean any set of acupoints or one or more acupoint(s) identified as acupuncture target for treating or ameliorating PD. In some embodiments, the set of acupoints or one or more acupoint(s) shall include the set of acupoints comprises the tips of fingers (Shouzhijian) and toes, shenshu, taixi, and shenque acupoints of a PD patient (
Acupuncture, practiced for several thousand years in China (Veith I. The yellow emperor's classic of internal medicine. Williams & Wilkins: Baltimore; 1949. pp 58-76), is increasingly used worldwide in the treatment of many disorders. An accumulating body of evidence summarized in a NIH Consensus Statement on Acupuncture (NIH Consensus Development Panel. Acupuncture. JAMA 1998; 280: 1518-1524) confirms that acupuncture treatment has beneficial effects for conditions ranging from postoperative dental pain to chemotherapy-associated emesis. It is also effective as an adjunctive modality for joint and muscle pain, addictions, and asthma, for example.
In Traditional Chinese Medicine (TCM), life force or ‘Qi’ (‘chee’) is thought to circulate within energy pathways or ‘meridians’ longitudinally throughout the body. There are 14 major meridians, corresponding (loosely) to the Western definition of ‘organs.’ Acupoints are specific locations on the body considered to be connected to these energy meridians (NIH Consensus Development Panel. Acupuncture. JAMA 1998; 280: 1518-1524; Vickers A, Zollman C. ABC of complementary medicine: acupuncture. BMJ 1999; 319: 973-976; and Mitchell E R. Fighting drug abuse with acupuncture: the treatment that works. Pacific View Press: Berkeley, Calif.; 1995). During illness Qi is thought to be out of balance, and stimulation of acupoints corrects this imbalance. Theoretically, an ‘excess’ or ‘deficiency’ of Qi can be ‘normalized’ by the specific manner of point stimulation.
In terms of traditional medicine, it is believed that acupuncture works to alter central nervous system neurotransmitter levels by stimulating peripheral nerves at acupoints. These stimulated nerves then carry the signals centrally (Stux G, Pomeranz B. Basics of acupuncture, 4th ed. Springer-Verlag: Berlin; 1998; Mann F. Acupuncture: cure of many diseases. Butterworth-Heinemann Ltd.: Oxford; 1992), including to the spinal cord, pituitary, and midbrain. Activated centers can then release neurochemicals: endorphins, monoamines, and cortisol (Stux G, Pomeranz B. Basics of acupuncture, 4th edn. Springer-Verlag: Berlin; 1998).
A large number of acupoints (365 points have been identified in Chinese acupuncture maps) show concentrations of peripheral nerve junctions, referred to as ‘trigger points (Vickers A, Zollman C. ABC of complementary medicine: acupuncture. BMJ 1999; 319: 973-976). A variety of methods are used to stimulate acupoints (NIH Consensus Development Panel. Acupuncture. JAMA 1998; 280: 1518-1524; Stux G, Pomeranz B. Basics of acupuncture, 4th edn. Springer-Verlag: Berlin; 1998; Lao L. Acupuncture technique and devices. J Ahern Complem Med 1996; 2: 23-25). These include:
For providing treatment of Parkinson's disease using the device of the present invention, acupoints generally include the tips of fingers (Shouzhijian) and toes, shenshu, taixi, and shenque. These acupoints are fully described in the acupoints diagram generally available in the art. Please refer to
Acupuncture has been proven to be effective for treating or ameliorating Parkinson's disease. Research reports on the effect of Acupuncture on Parkinson's disease are found in, e.g., Lee M S, Shin B C, Kong J C, Ernst E. Effectiveness of acupuncture for Parkinson's disease: a systematic review. Mov Disord 2008; 23: 1505-1515; Chae, Hyejung Lee, Hackjin Kim, Chang-Hwan Kim, Dae-Il Chang, Kyung-Mi Kim, Hi-Joon Park. Parsing brain activity associated with acupuncture treatment in Parkinson's diseases (p NA) Movement Disorders, Published Online Jun. 16 2009 2:42 PM DOI: 10.1002/mds.22673; and Joh T H, Park H J, Kim S N, Lee H. Recent development of acupuncture on Parkinson's disease. Neurol Res. 2010 February; 32 Suppl 1:5-9.
For treating or ameliorating the Parkinson's disease of a particular patient, the acupoints include the above described set of acupoints and further, additional acupoints, which are generally known in the art.
The composition of invention can be formulated in any formulation suitable for topical, selective application to one or more Parkinson's acupoint(s). One example of the formulation is a paste. Another example is a patch. The patch can include having a cover or protective layer one side of which has a composition of invention placed thereonto. The cover can be plastic, paper, or a foil (e.g., aluminum containing foil). A thin film can be used to sandwich the composition with the cover so as to prevent the composition from exposure to moisture prior to application to Parkinson's acupoint(s) of a user. A person of ordinary skill in the art can readily formulate a composition of invention into any of such formulations.
A composition disclosed herein is formulated into a patch and applied to one or any of the acupoints for PD of a PD patient. The patch generates heat to cause the temperature of the one or more of the acupoints to have a temperature of about 50° C., which lasts several hours. The procedure is repeated over a course of 3 months. Improved limb control is observed by standard motion tests for PD.
While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications can be made without departing from this invention in its broader aspects. Therefore, the claims are to encompass within their scope all such changes and modifications as fall within the true spirit and scope of this invention.
This application is a continuation-in-part of U.S. application Ser. No. 13/471,138, filed on May 14, 2012. This application is also a continuation-in-part of U.S. application Ser. No. 13/341,877, filed on Dec. 30, 2011. The teachings in these applications are incorporated herein in their entirety by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13471138 | May 2012 | US |
| Child | 13527499 | US | |
| Parent | 13341877 | Dec 2011 | US |
| Child | 13471138 | US |
