Surgery – Miscellaneous – Methods
Reexamination Certificate
1998-11-02
2002-03-12
Nguyen, Dinh X. (Department: 3738)
Surgery
Miscellaneous
Methods
Reexamination Certificate
active
06354297
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed toward a method and device for destroying unwanted fat cells by induction of programmed cell death (apoptosis). In particular it relates to a method and device that places substances such as Ultra Violet light (UV) and other chemical substances which induce programmed cell death (suicide cell self destruction) in direct contact with fat cells lying underneath the skin.
BACKGROUND OF THE INVENTION
The desire of individuals to lose weight and specifically, to lose fatty tissue, has become nearly an obsession in the United States and many other countries. Any simple and safe method toward achieving a slim figure is in great demand. Methods for losing weight include hundreds of advised diets, machines and methods for exercise, various psychiatric techniques involving alteration in mental attitudes, and a variety of surgical techniques. Liposuction has created an entirely new surgical cosmetic industry, but carries a small but significant risk and often leaves the patient with an unsightly cosmetic result due to the inflammatory reaction surrounding where the fatty tissue has been removed by a technique which produces a severe tissue reaction.
Obesity is a serious public health hazard, second in importance only to tobacco. Approximately ⅓ of Americans are seriously overweight according to life insurance data. In approximately 12 million Americans, obesity significantly contributes toward the cause and complications of serious disease. Such conditions include heart and lung disease, many types of cancer, diabetes, high blood pressure, and peripheral arterial disease. This is in addition to how obesity becomes a cosmetic problem. Being overly fat limits both length of life and its quality.
A multi-billion dollar industry has developed in an effort to control weight. The many varied and expensive techniques employed speak to the relative ineffectiveness of the many techniques that have been tried to get rid of excess fat.
Obesity has recently been recognized as a public health hazard of epidemic proportions by the World Health Organization. One of three Americans between the ages of 20-74 are obese (Body Mass Index >30 Kg/m
2
body surface). This amounts to 58 million people. The number of obese adults has increased dramatically. In 1980 25% of US adults were obese. The equivalent figure was 33% in 1990. In Europe the equivalent figure is about 40%.
Obesity significantly contributes to the dangers of other diseases in approximately half of those who exceed the threshold description of obesity. For example, 19% of the cost of management of heart disease can be ascribed to obesity. Obesity is also recognized as a co-morbid factor for obese patients suffering from degenerative arthritis, peripheral vascular disease, and many forms of pulmonary disease such as emphysema. The expenditure for products, goods, and services in the management of obesity is estimated to be $33 billion per year. This is 3%-4% of total health care expenditure per year and exceeds that expended for AIDS and cancer.
Obesity is such a prevalent, important and distressing problem that its many methods for suggested management are too well known to deserve more than listing. They include diets that exclude fats and high caloric elements, food supplements, appetite suppressants, exercise machines and regimes, biofeedback and other psychotherapeutic techniques, and a variety of operative techniques. Operations include a number of methods for decreasing the capacity the stomach, gastric by-pass operations, methods to shorten the small intestinal absorption surface, excision of the unwanted fat (lipectomy) and techniques of liposuction. Liposuction is performed approximately 51,000 times each year in the US. The maximum amount of fat that can safely be removed is approximately 2 Kg. Being an operative technique for removing fat, in this case by suction, it inevitably excites an inflammatory response at the operative site, which results not only in post operative inflammation but in subsequent uneven and unsightly scarring beneath the skin where the fat has been removed. Numerous patents involve devices and techniques of liposuction. For example, U.S. Pat. No. 5,527,273 to Manna et al. discloses an ultrasonic lipectomy probed; U.S. Pat. Nos. 5,642,270 and 5,644,585 to Mitchell et al. disclose the use of a yag laser to ablate tissue; and U.S. Pat. No. 5,143,063 to Fellner discloses the use of heat to non-invasively destroy adipose tissue. Such methods which destroy cells by heat, laser or ultrasound or by liposuction of direct trauma, are relatively crude in that they involve rough manipulation of body tissue fat cells and therefore incite severe local inflammatory reaction. This results in scarring and other immediate and longer term pathologic reactions. Such adverse reactions add to the probability of immediate complications (morbidity and sometimes even mortality) and to a poor subsequent cosmetic result at the site of the inflammatory response.
In every person hundreds of thousands of old or damaged cells die each day by the process of apoptosis and are replaced in the ebb and flow of maintaining a constant number of living cells in the body. Old and damaged cells die in response to a signal triggered on the cell surface for the targeted cell to self destruct (commit suicide). A popular synonym for this process is programmed cell death. Such cell turnover occurs without causing tissue reaction. Apoptosis is the body's mechanism for cell disposal which maintains a balance between the removal of old cells and their replacement by new cells. Some cell types are quickly replaced. Others, including brain, nerve and to a lesser degree fat cells, lack in varying degrees the potential for self renewal. Fat cells promptly increase or decrease in individual cell size in response to overeating or diet, but have at best limited self renewal potential.
The signal triggering cell surface receptors that induce cell suicide are highly specific for each cell type. Within the past two decades there has been intense study of factors which stimulate apoptosis, particularly as they provide a potential for destruction of cancer cells. Each cell type has its own specific receptor which can be activated or blocked.
Cell self destruction by apoptosis must be differentiated from destruction by outside forces such as direct injury, infection, or heat-each of which produces cell destruction which results in cell necrosis and scarring. Apoptosis can be differentiated from necrosis by microscopic and specific chemical analytic methods. Necrosis results in the familiar signs of inflammation including swelling, redness, pain and tenderness. Apoptosis does not stimulate such reactions. The cells shrivel up, break into pieces and the contents are quietly removed by methods that do not induce inflammation.
Therefore, a need exists for a method and a device to eliminate undesirable adipose tissue in a safe, inexpensive and efficient manner without inciting violent local tissue reaction such as occurs following liposuction removal of fat cells, or by their destruction by heat, laser, ultrasound or other similar methods. There is also a need for a method and device that can destroy undesired fat cells by stimulating apoptotic events in fat cells, thus ridding a patient of undesired fat without the harmful reactions experienced by present fat-removal techniques and procedures.
SUMMARY OF THE INVENTION
The device and technique of the present invention does not incite the above described deleterious reactions. Instead, apoptosis is triggered by activation of a signal mechanism on the surface of a cell which commands the cell to self destruct. An important mechanism in apoptosis involves cutting off the energy supply to cell function. The present invention is a new method for ridding the body of excess unwanted body fat using a temporarily implanted device placed adjacent to the targeted fatty areas. The device delivers chemical or light signals to the fat cells to self destruct by a reco
Nguyen Dinh X.
Sheridan & Ross P.C.
The Uniformed Services University of the Health Sciences
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