Surgery: kinesitherapy – Kinesitherapy – Ultrasonic
Reexamination Certificate
2000-08-04
2002-09-17
Lateef, Marvin M. (Department: 3737)
Surgery: kinesitherapy
Kinesitherapy
Ultrasonic
C604S022000, C600S439000
Reexamination Certificate
active
06450979
ABSTRACT:
TECHNOLOGICAL FIELD
The present invention belongs to the field of equipment for reduction and prevention of obesity, and improvement of obesity for health and beauty, especially relating to ultrasound equipment for medical treatment and prevention of obesity and improvement of obesity for health and beauty.
BACKGROUND ART
Recently adult (including Mammalian) diseases such as diabetes mellitus, hypertension, and vascular degeneration of brain and viscera have become serious problems. Their greatest origin is obesity.
For improvement of obesity, it is known scientifically that suppression of caloric intake and exercise are effective. Administration of appetite suppressers and digestion/intake suppressers in addition to thermo-metabolism enhancers are under study and some of them are approved by the Government.
As for exercise, persons tend to undertake dieting, walking, physical exercise, dancing, swimming, cycling, etc, due to a shortage of exercise resulting from sedentary occupations and the popularization of automobiles. However, it is a big problem that maintaining an exercise program is very difficult without ample time and strong will. Therefore, a method for reducing obesity comfortably and effectively is desired.
There are some aesthetic salons in the market which are announcing fat reduction by ultrasound as a variation of folk medicine. But such techniques have no scientific evidence, the used frequency of all the equipment is 1 MHz, and there is no display of acoustic intensity, but only an electric input power per transducer unit area. For example, the book titled “Wrinkles Stretched in only 5 min.” by Masuda, published on Aug. 25, 1996 by Success Marketing Co. Ltd. discloses an ultrasound treatment method using an ultrasound applicator for beauty, increased blood flow and lymphoid flow, by the effect of thermo-heating and massage, for enhancing beauty of the skin. Such thermo-heating brings the fat to an easily decomposable state and massage further promotes such decomposing. Stimulation, by ultrasound, of the sensitive spot known as “tubo in acupuncture and moxibustion is also disclosed. In the aforesaid book, 1-10 MHz for medical treatment and 1 MHz for beauty enhancement are disclosed. In relation to the sonicating acoustic power density, or intensity, the following facts are disclosed: The safety limit defined by the Society for Ultrasound for Medicine and Biology is 1000 mW/cm
2
for continuous wave (CW) sonication and 240 mW/cm
2
(SPTA) for pulse wave (PW) sonication. For beauty enhancing applications, the intensity used was 1500-2000 mW/cm
2
for thick muscles, 1000-1500 mW/cm
2
for thin muscles, 500 mW/cm
2
for the face in CW sonication and 120 mW/cm
2
for the face in PW sonication. And their level is half of the aforesaid safety limit.
However, the intensity used for the thick and thin muscles disclosed above clearly exceeds the safety limit of 1000 mW/cm
2
for CW, so the disclosed intensity must be the electric power per transducer unit area. If we assume they are of electric power intensity, then an electric intensity of 1500-2000 mW/cm
2
corresponds to 500-700 mW/cm
2
of acoustic intensity, as the electric to acoustic conversion efficiency of the transducer is usually 30% and coincides with the description that they are half the safety limit. In another chapter it is disclosed that a scientific experiment on reduction of fat was carried out and the reduction was effective, and a reduction amount is reported. Although a scientific description of the sonication conditions such as intensity is not shown, it is reasonably presumed in context with the nearby sentences that 1 MHz of the equipment for beauty enhancement was used, and that its acoustic intensity was less than 700 mW/cm
2
again considering the aforesaid electric to acoustic conversion efficiency.
Concerning patent applications, Tokukai Hei-4-89058 (Yahmann Co) discloses an equipment for beauty using a frequency of 1-3 MHz and an intensity of 100-500 mW/cm
2
. Tokukai Hei 3-123559 (Yahmann Co.) discloses a fat reducing effect which is introduced by muscle shrinkage and an improvement in blood /lymphoid liquid flow. In the detailed explanation of this specification, a frequency of 20-50 KHz, and an intensity of 100-500 mW/cm
2
is disclosed, but there is no disclosure of any scientific reason why these values are specified, nor any scientific data explaining what the specified values are based on. Further, no commercialized product has yet appeared on the market.
The specified values 20-50 KHz at 100-500 mW/cm
2
and 1-3 MHz at 100-500 mW/cm
2
in the prior art, do not have any scientifically provable data attesting to their effectiveness. Further, the reasons why these values are specified, taking safety into consideration, have not been described. According to the experiments carried out and described later by the inventor, these values are inadequate.
An object of the present invention is to clarify the effective frequency and intensity, including safety considerations, for lipolysis of living bodies, as well as providing equipment for performing lipolysis of a living body safely and effectively using ultrasound sonication.
DISCLOSURE OF INVENTION
In a living body, fat is synthesized by lipo-synthesizing enzymes in the adipocyte from glucose and free fat acid, and forms an oil droplet. As for humans, adipocyte of adults is mostly white adipocyte. So, hereafter, adipocyte shall be taken to imply white adipocyte. Adipocyte is slender and 20 &mgr;m in length at birth but grows to a 100 &mgr;m (sometimes 200 &mgr;m) diameter sphere in accordance with fat accumulation.
The accumulation of fat in adults is caused by the growth of each adipocyte rather than an increase in their number. In a grown adipocyte, the oil droplet is covered by a water based cell liquid layer, the thickness of which is much less than the diameter of the oil droplet itself.
In the cell liquid, there is enclosed an endoplasmic reticulum, which includes a lipolytic enzyme referred to as hormone sensitive lipase (HSL), which decomposes the fat into glycerol and fatty acid. Meanwhile., the fat oil droplet surface is covered with a flowable molecular layer of phospholipid and is protected from contact with the lipolytic enzyme located on the endoplasmic reticulum surface.
In the fat of the living body, the phospholipid layer partly disappears when hormones, such as epinephrine (adrenaline) released from adorenal modula or norepinephrine (noradorenarine) released from sympathetic nerve, are introduced. Then the oil drop makes contact directly with the endoplasmic reticulum and lipolysis starts. Fat is resolved into glycerol and free fatty acid, and the resolved products exit from the cell into the blood and are finally burned or consumed by exercise etc. The remaining final products are discharged from the body as CO
2
and H
2
O in expiration and/or urine.
It is known that ultrasound sonication on a living body has effects such as the promotion of enzyme reactions, emulsification, thermogenic effects, expansion of capillary blood vessels, and enhancement of metabolism. In the present invention, the increase of peripheral blood flow by expansion of the capillary blood vessels as a result of sonication is the same as in the prior art equipment used for health and beauty. However, the inventors have doubts about the lack of scientific evidence for the effectiveness of such conventional equipment for health and beauty and the frequencies used for them. As predicted from the aforesaid biochemical mechanisms of lipolysis, there must be an effective frequency less than 1 MHz, and the effectiveness must be frequency dependent, for such mechanisms as the stimulation of sympathetic nerves, the release of hormones at their ends, and activation and fluidization of the phospholipid layer. The inventors have confirmed the effective frequency and its intensity experimentally to examine this prediction. The present invention is based on the fact that the results obtained by such experimentation are quite different from the descriptions in
Kino Masato
Miwa Hirohide
Guss Paul A.
Lateef Marvin M.
Lin Jeoyuh
Miwa Science Laboratory Inc.
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