Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-06-25
2002-08-20
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C514S718000
Reexamination Certificate
active
06436448
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a novel method for the treatment of lymphedema and in reducing weight gain associated with lymphedema.
BACKGROUND OF THE INVENTION
The lymphatic system is a complex structure organized like the blood system in that it includes a system of numerous tiny vessels connected to a network of larger vessels, and through which system and network a liquid medium containing solutes and particulates is transferred. A healthy lymphatic system continuously drains lymphatic fluid, consisting of a mixture of lymph, water, proteins and other matter, away from various interstitial areas of the body and back into the blood system. Lymph is the clear, liquid medium or solvent of the lymphatic system.
In contrast to the blood system, which utilizes the heart to pump blood throughout the body, the lymph fluid is pumped through the lymphatic system and away from various body areas by both the action of adjacent muscle tissue and the contraction of the larger lymphatic vessels. Foreign matter is filtered out of the lymph fluid as the fluid passes through bundles of lymph nodes during its course through the lymphatic system. The lymph nodes also monitor the contents of the lymph fluid to determine if any appropriate immune reactions should be initiated by the host's immune system. The lymphatic vessels are not interconnected in the same manner as blood vessels, but rather form a set of coordinated structures including the initial lymphatic sinuses which drain into the lymphatic capillaries and subsequently to the collecting lymphatics which drain into the lymphatic trunks and the thoracic duct which ultimately drains into the blood system after the filtration.
Lymphedema or “high protein edema” is a deficiency, blocking or dysfimction of the lymphatic system that limits the flow of lymph fluid from a body area. Any sustained accumulation of proteins delivered to the body tissue by the blood capillaries, and not removed by the lymphatic system, will cause an accumulation of high protein fluid in the interstitial areas of the body tissues resulting in lymphedema or “high protein edema”.
Fibromyalgia patients and some normal people develop lymphedema commonly labeled as “subjective swelling” of unknown etiology. Though often dismissed as subjective, many of these patients have overt swelling on their body that is not amenable to conventional medical treatment—i.e. diuresis through diuretics. These swellings often complicate many of the fibromyalgia patients' daily living which includes swelling of the upper and lower extremities, faces and jaws and trunks. In the more severe cases, the lymphedema may result in swelling of the lung tissues causing shortness of breath and complicating the oxygen transfer process within the lung linings. It may also cause swelling of the heart lining causing pericardial effusion and impede the pumping mechanism of the heart.
In addition to these troublesome swellings, excessive fluid retention within the tissues also impacts the ability of many of these patients to recover from skin and superficial injuries and infections. The fluid retention also increases the risks associated with surgery because effusion of fluid into an incision site complicates the recovery process. As these patients age and the disease progresses, the normal healing process of their bodies (particularly the extremities) is impeded by the swelling, which results in pooling of the fluid to the extremities. This swelling and pooling of fluid on the extremities puts compressive pressure on the blood vessels and impedes the blood flow in the extremities, which further reduces the circulation and slows the healing process.
Conventional treatment techniques for lymphedema include the use of manual lymph drainage techniques, compression techniques, electrical stimulation of the lymph vessels and exercise.
SUMMARY OF THE INVENTION
The present invention is based upon the recognition that a relationship exists between the porosity (altered permeability or changed selectivity) of a person's gastrointestinal tract (“GI tract”) and its diseased ability to absorb partially-digested food (macronutrients, in the form of partially digested proteins or large clumps of amino acid) to the accumulation of high protein fluid in a patient's tissues resulting in weight gain and lymphedema.
Accordingly the ideal treatment for this type of lymphedema comprises: (1) restoring the selectivity or altered permeability of the mucosa within the linings of the GI tract, thus, reducing its ability to absorb partially digested proteins; and (2) treating the previously accumulated high protein edema or lymphedema.
In accordance with one aspect of the invention it has been surprisingly found that guaifenesin is useful in reducing the accumulation of fluid in a patient's tissue and in the treatment of lymphedema.
In one method of the invention, the accumulation of fluids in the tissue of a patient having such accumulation is reduced by administering to the patient a therapeutically effective amount of guaifenesin or one of its pharmaceutically acceptable derivatives. In one embodiment of the method, the amount administered is about 600 mg to about 4000 mg per day.
In one preferred embodiment of the invention, the guaifenesin or its pharmaceutically acceptable derivative is administered to the patient in two different dosage forms, one dosage form being a short acting form and the other being a long acting form. The short acting dosage is preferably about 200-600 mgs and the long acting form is preferably about 200-600 mgs. The two forms are desirably administered to the patient once or twice a day so that a sustained level of guaifenesin or its pharmaceutically acceptable derivative may be obtained in the blood stream sufficient for the lymphatic diuresis to occur.
In other embodiments of the invention, the guaifenesin or its pharmaceutically acceptable derivative may be administered to the patient in more than one dose of a short acting dosage form or in different combinations of short acting doses with long acting doses. Some reduction of fluid accumulation will be seen with the administration of guaifenesin in the amounts described herein in most patients, however, the dosage regime should be optimized for each patient.
Another embodiment of the invention is a method for inducing weight loss in patients having accumulated fluid in their tissue comprising administering an effective amount of guaifenesin or one of its pharmaceutically acceptable derivatives to a patient to cause a reduction in the amount of the accumulated fluid and weight loss.
Yet another embodiment of the invention is a method for treating and preventing lymphedema comprising the steps of: a) using guaifenesin or one of its pharmaceutically acceptable derivatives to reduce accumulated high protein fluid in a patient; b) including in the patient's diet, enzyme supplements chosen to increase the ability of the patient's gastrointestinal tract to digest food; and c) administering to the patient an effective amount of relaxin and its related hormones to induce production of new collagen to repair the mucosa and restore the selectivity of the gastrointestinal tract.
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Website http://public.csusm.edu/public/guests
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Website http://public.csusm.edu/public/guests
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Website http:
Fredrikson & Byron , P.A.
Henley III Raymond
Sky BioHealth Solutions, Inc.
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