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Technical Study CAVITATION

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Technical Study

CAVITATION

NOVACAV Technical Study

2

Chapter I

CONTENTS

INTRODUCTION

WHAT IS CAVITATION? 4CORPORA’S NEW CAVITATION 4ACTION AGAINST FAT 4

ULTRASOUND APPLIED TO CAVITATION

TYPES OF ULTRASOUND 7ORIGIN OF THE APPLIED TECHNOLOGY 8PHYSICAL PRINCIPLE 8CHEMICAL PRINCIPLE 10

CAVITATION APPLIED TO THE FIELD OF AESTHETICS

EFFECTS OF CAVITATION ON ADIPOSE TISSUE AND ON THE TREATED AREA 13PHYSIOLOGY OF THE ADIPOCYTE – TRIGLYCERIDES 13EFFECTS OF ULTRASOUND ON FAT 15

APPLIED CAVITATION

METHOD OF APPLICATION 18TREATMENT PROTOCOLS 18METHOD OF APPLICATION 18CONSIDERATIONS 20CAVITATION EFFECTS 21EXTERNAL REMODELLING OF THE BODY 22ACTION AGAINST LOCALISED ADIPOSITY AND CELLULITE 22CORRECT DIET 22VISIBLE RESULTS IN A VERY SHORT TIME 22COMPLEMENTARY TREATMENT 23SECONDARY EFFECTS 23CONTRAINDICATIONS 23

4

INTRODUCTION

WHAT IS CAVITATION?Cavitation, used both in cosmetology and in aesthetic medicine and surgery, is an innovative technique mainly for reducing localised adiposity and cellulite in a non-surgical manner, which uses low frequency ultrasound (from 30 to 70 KHz). It is a safe, efficient method, which is non-invasive, causes no pain or collateral effects, consisting of diluting fat through movement, safely, with no anaesthetic or recovery time required.

CORPORA’S NEW CAVITATIONCORPORA has developed an innovative technique which allows you achieve fast, definitive results with no secondary affects or nuisance. This technology has been applied to the NOVACAV equipment with surprising results for its application in a context of absolute safety.

This new CORPORA CAVITATION lets you shape the body, freeing it from those localised fat deposits or structures against which it is so difficult to act.

Currently, it is the only comparable alternative to surgery or liposuction. It is painless, non-invasive and has no side effects.

CAVITATION produces a phenomenon in which gas bubbles form. These con-tract and expand inside a liquid subject to an intense, low-frequency ultrasonic (LFU) field.

ACTION AGAINST FATCavitation acts against the adipose tissues, causing the fatty material to frag-ment and subsequently diffuse the lipidic matrix, which will later be dissolved into the interstitial fluid. Emulsification of the lipidic content favours its metabolic assimilation. This fluid is conducted through the vascular and lymphatic syste-ms towards the liver. Once there, it is processed normally by the organism.

Chapter I

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Chapter I

NOVACAV Technical Study

1. Prior to starting the treatment. Basic structure of the fatty tissue.

2. During treatment. After 5 minutes.

3. Liquidising of the basic fat cells can be seen.

4. Liquid fat produced from breakage of the fat cell membranes and micro-vessels undamaged by the effects of cavitation.

Representation of the cavitation process on fatty tissue

1. 2.

3. 4.

6

The ultrasound used in medical therapy and in aesthetic treatments is represen-ted by a mechanical vibration (mechanical energy waves) which are propagated through an elastic conductor medium, liquid or solid (for example, body tissue), as a longitudinal wave that alternatively produces compression (high pressure) and rarefaction (low pressure), producing elastic oscillations in its molecules of a sinusoidal type in relation to the original position of balance.

Propagation of sound can be represented in the shape of a sinusoidal wave, the variables of which are: 1) pressure (P), 2) wave length (λ), 3) frequency (f), 4) period (T) and 5) speed (c).

The intensity (W/cm) is proportional to the square of the frequency and to the vibration amplitude; this means, increasing the frequency, the radiation intensity can be extremely high, even if the vibration amplitude is low.

One characteristic that should often be taken into account in the study of ultra-sound effects is the absorption coefficient α. The value of α can vary according to the state of aggregation of the medium in which wave propagation occurs (normally high) and is proportional to the square of the frequency.

The frequency of ultrasound waves is greater than 20,000 Hz (or 20 Khz) and ultrasound waves are not audible to the human ear. The human ear’s capacity to capture sound lies between 20 and 20,000 Hz because the organ of Corti in the inner ear does not contain appropriate receptors for sound waves outside this frequency, such as ultrasound waves. This also explains why in rare cases, some patients are particularly “sensitive” (possibly due to a hyper-specialisation of the auditory nerve receptors) during the application of frequencies employed in cavitation (30-70 KHz). They perceive an annoying whistle.

Chapter II

Representation of an acoustic wave

ULTRASOUND APPLIED TO CAVITATION

Pre

ssur

eP

ress

ure

Higher Frequency

Lower Frequency

Period

Compression

Rarefaction

Time

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TYPES OF ULTRASOUND

We can schematically divide ultrasound (US) into:

1. Ultra-low frequency US (20-100 KHz) used mainly in the industrial sector (for example for cleaning metals or glass), and also nowadays in the medical envi-ronment of cavitation.

2. Low-frequency US (100 KHz-1 MHz), used in medicine in physical therapy for its significant therapeutic effects on tissues.

3. High-frequency US (1-10 MHz) employed in the medical environment in do-ppler sonographies.

The speed of the sound varies in the different biological mediums yet its avera-ge value is 1,540 m/s (constant) for many soft human tissues. The speed of sound (c) can be calculated by multiplying the wave length by the frequency (f). Therefore high-frequency sound has a short wavelength and vice versa. For example, for a 2 MHz frequency, the ultrasonic wave length will be 0.77 mm and for a 15 MHz one the wave length would be 0.10 mm.

Chapter II

Speed of sound transmission in the different human organs in relation to air

NOVACAV Technical Study

Medium Ultrasound speed (m/sec.)

Air 300

Lung 500

Fat 1,450

Muscle 1,580

Liver 1,550

Brain 1,560

Brain 1,560

Soft tissue 1,540

Bone 4,000

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ORIGIN OF THE APPLIED TECHNOLOGY

Until very recently, physical aesthetic therapy and surgery exclusively used ultrasound fre-quencies of 1 or 3 MHz, the effects of which were based on delivering ultrasonic energy to the

tissues (thermal, mechanical, chemical, neuronal, conventional cavitation).

The novelty, both in medicine and aesthetic surgery, and in exclusively aes-thetic treatment, a product of recent scientific research, is to use ultra-low frequency ultrasound systems (25-70 KHz) to generate a particular effect on tissues: CAVITATION, which is the consequence of alternating compression and rarefaction (see Figure 1) of the substances subject to this ultrasound, with an effect like turbulence similar to that of water close to boiling point, capable of destroying the adipose cells using mechanical energy, without damaging the structures that surround them (skin, vascular and lymphatic epithelia and their content, muscles and nerves), as these structures have a different susceptibility to ultrasound.

PHYSICAL PRINCIPLE

Acoustic cavitation is the physical principle that manifests when a liquid is subjected to a sufficiently intense sound or ultrasound (frequencies from 20 KHz upwards). If the intensity of the sonar field is high enough, this can cause the formation, growth and rapid rarefaction or implosion of gas bubbles (char-ged with energy) in the liquid, micro-bubbles of gas that increase their volume until their energy is greater than that exercised by the external pressure pushing against them.

Chapter II

Showing a sound wave applied to liquid inside a tissue.

1 Generation of bubbles

2 Bursting of micro bubbles

3 Fats are lique-fied/emulsified

Fat Cells

Bubbles

The number and size of bubbles increase.

The bursting of the bubbles releases huge amounts of energy, which breaks the cell wall of fat cells.

Complex fatty acids are broken down into simpler fatty acids.

Cavitation

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This occurs due to the local drop in pressure with a value lower than the gas pressure on the liquid itself, which therefore undergoes a change of state from liquid to gas, forming cavities containing gas.

The imploding (burst) bubbles (the hot spot) generate a “localised heat” and a “pressure impulse” (shockwaves greater than 1 atmosphere) associated to “high chemical energy” (with division of the long molecules into chain, ionisation and, consequently, the formation of free radicals) (Atchley AA - Crum LA).

The HOT SPOT phenomenon determines the boiling of water and of the fluids present in adipose cells (adipocytes) and their consequent explosion (lipo-clasy). Furthermore, it disintegrates the “partition” tissue present in the hypo-dermis, for the presence of what is called the “limit stratum”, or the plane of separation between two tissues of different density where, due to the pheno-mena of refraction and reflection, the biological effects of the US are amplified and cumulative.

The limit stratum is represented by the interface of adipose and fibrous tissues, which is why in the inter-adipose collagen partitions the maximum scope of ultrasound action is observed. The liquid content of the interstitial spaces needs successive, careful drainage (manual, instrumental, or both). Such an effect determines a significant local vibration that favours an increase in local blood micro-circulation.

Chapter II

Blood micro-circulation

Muscle fibre (cell)

Precapi l lar y sphincter

True capillaries

Arteriole

Metarteriole

Drainage duct

Venule

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Chapter II

CHEMICAL PRINCIPLE

The chemical effect of ultrasound on a liquid solution has been studied for se-veral years. The first products generated were molecular hydrogen (H2) and hydrogen peroxide (H2O2). High-energy intermediate products are also gene-rated.

In studies performed on organic liquids it has been seen that the total gas pres-sure is low, enough to allow the implosion effect of the bubbles. Almost all the organic liquids generate free radicals (Suslick KS).

Evolution of the cavitation bubbles

A) Creation of bubbles; B) Increase in size; C) Implosion of the bubble; D) Hot spot: by imploding, suddenly bursting, the cavitation bubbles create vibration pressure impulse characterised by extremely high temperatures, pressures and changes of heat in fractions of time around the length of a micro-second. The hot spot impulse develops from the principle of an adipocyte structure, also managing to break the cell wall of the adipocytes, thereby causing a resulting reduction in permanent fat.

SUMMARY

Cavitation is therefore a phenomenon that consists in the formation of gaseous zones (cavities or bubbles) inside a fluid, which are charged with energy, in-crease in size and finally burst.

The cavitation phenomenon can be evaluated by employing the cavitation num-ber defined through the following equation:

Where Pa, Ps and Pv are the pressure applied, the hydrostatic and the gas pressure; d is density and V is speed, always referring to liquid.That is, the tendency for a liquid to “cavitate” is directly proportional to the pres-sures applied, and inversely proportional to its density and speed in movement.

Pa + Ps + Pvn = ----------------- (d/2) x V2

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Chapter II

Schematic representation of the formation of gas micro-bubbles From: High intensity focused ultrasound in the treatment of solid tumours. James E. Kennedy. Nature reviews. Cancer 5, 321-327 (April 2005).

Liquids irradiated using ultrasound can produce bubbles. These bubbles osci-llate, progressively growing in size during the expansion phase of the sound probe and are restricted during the compression phase. Under such suitable conditions, these bubbles can undergo a violent collapse that leads to extre-mely high pressures and temperatures. This process is called cavitation.

From: “The Chemistry of Ultrasound” by Kenneth S. Suslick from The Yearbook of Scien-ce & the Future 1994; Encyclopaedia Britannica: Chicago, 1994; pp 138-155.

Propagation direction of the ultrasound wave through the tissue

Time

Hot Spot

Flat presentation of Ultrasound

Pre

sión

acú

stic

a

Changing of bubble size in the wave cycle

Aco

ustic

p

ress

ure

Compression

Expansion

Bub

ble

radi

us

Time

Hot spotFormation

Shock wave

Implosion

Growth

Fast cooling

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Chapter III

Cavitation has an application in the sphere of aesthetic cosmetology with the maximum safety, so much so, that applied to human tissue it is sufficiently powerful to damage the cells of adipose tissue, but not sufficient for the micro-bubble created to be charged with so much energy as to damage tissues, or-gans, muscles and blood vessels.

Cavitation enables micro-bubbles (or cavities) to be generated in the fatty mass and adipocytes. The continual formation and bursting of these bubbles close to the cell walls, facilitates break-down of the fat molecule by bombarding it from all direc-tions (three dimensional cavitation), liquidising it and encouraging evacuation without damaging the cell membranes.

In relation to the value of the density, so that cavitation occurs in the tissues, an intensity 1,000 times greater than that necessary for liquids is required. In any case, one should consider that the human body consists of 60% water (although the adipose tissue only contains 18%). Therefore, the presence of water in the tissue and application of ultrasound determines the cavitation of the liquid, formation of micro-bubbles, their bursting and damage to the biological material surrounding them. Likewise, the most delicate structures, such as endothelial cells and adipose cells, will damage more easily than the more resistant structures such as connec-tive tissue, bone and so on.

The operational frequencies used (from 30 to 42 KHz) can be regulated by con-tinuous emission or modulated, achieving a deeper or more superficial effect.

Ratio between power and depth of action of CAVITATION

CAVITATION APPLIED TO THE FIELD OF AESTHETICS

Depth of the adipose tissue (cm)

Power (%) Effects on tissue

0,8-1,3 20% Lipolysis

1,3-1,8 30%

1,8-2,3 40%

2,3-2,8 50%

2,8-3,2 60%

3,2-3,6 70%

3,6-4,0 80% Attention

4,0-4,5 90% Attention

4,5-5 99% (2W) Attention

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Chapter III

Cavitation, applied correctly at a suitable power, is highly selective with respect to adipose tissue and any other organ or tissue that could be affected. It elimi-nates the adipose cells permanently in a painless, non-invasive manner. Due to the fact the effect is localised at a specific depth (the subcutaneous adipose stratum) the tissues surrounding it are not damaged.

By passing the probe head over the treatment area, the low-frequency ultra-sound produces focused “cavitation”, attacking the adipose tissue and causing gas bubbles to form in the treatment area at the level of the adipose stratum. The bubbles increase in volume causing the mechanical breakage of the adi-pocyte cellular membranes, releasing this material into the interstitial fluid of the triglyceride cells (which occupy up to 75% of adiposity volume). These will be eliminated from the body through a natural metabolic process (physiological cleansing or purifying organs: liver, lymphatic system and venous system); and utilised partially by the energy metabolism in the 4-5 days following treatment. Lipiduria (presence of lipids in urine) occurs above all in the first 24 hours and peaks around the 18th hour.

PHYSIOLOGY OF THE ADIPOCYTE – TRIGLYCERIDES

Concerning the intra-adipocyte vacuole containing triglycerides, this can vary from normal content of 65-85 micrograms up to 200 micrograms or more in obesity.

EFFECTS OF CAVITATION ON ADIPOSE TISSUE AND ON THE TREATED AREA

Representation of an adipose cell

The excess fat is stored in the adipocyte vessel which grows even larger

Fat reservoir

Nucleus

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A triglyceride molecule is formed of three fatty acids joined to a glycerol molecule. When they are outside of the adipocyte cells, the triglycerides are normally “packa-ged” in lipo-proteiaceous particles (a combination of apolipoproteins and lipids, cholesterol, triglycerides and cholesterol esters). A series of metabolic and physio-logical channels regulate the route of molecules that are insoluble in cholesterol water and triglycerides through the circulatory system and its fluids toward the in-terstitial spaces.

Formation of a triglyceride: combination of three fatty acids with a glycerol molecule

Glycerol is soluble in water and needs no “carrier” molecules or accompaniment to pass the interstitial fluids into the circulatory system. After cavitation no significant increase in the levels of glycerol in plasma has been found in patients treated.

Triglyceride. Three-dimensional representation

Triglyceride

Glycerine

Fatty acids

Chapter III

Glycerol

Triglyceride

Three fatty acids

Nucleus

Fat

Cell membrane

Adipose tissue

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However, the fatty acids are not very soluble in water and these molecules are transported by albumin (present in the interstitial fluid and in circulation), which has the capacity to join two or three free fatty acid molecules per molecule and trans-port them to the liver. The liver makes no distinction between fatty acids originating from adipocytes destroyed through the cavitation process and those absorbed by the adipocytes themselves by physiological necessity, or those produced by a meal eaten several hours before treatment. Many triglycerides released after cavitation through adipo-se lysis are eliminated by the kidneys, and a percentage of these reach the liver where they combine to form lipoproteins, or rather macromolecules in which the fats produced through lysis combine with a protein.

According to academic work published it can be sustained that the triglycerides are created immediately (within around 4 hours) by the lipoprotein lipase (LPL), an en-zyme that exists in the capillary endothelia, close to the adipocytes.

“In vitro” studies have demonstrated that the triglycerides present as an emulsion and not in lipoprotein particles, as they travel through the arteries and the interstitial space, are quickly hydrolysed by the LPL in glycerol and free fatty acids.In conclusion, after cavitation the triglycerides released by adipocyte lysis and its derivatives are processed normally through metabolic pathways.

In any case, because the oestrogen hormones decrease the LPL activity, consumption of these substances should be avoided or reduced several days prior to cavitation treatment and for at least 5 days following each session.

EFFECTS OF ULTRASOUND ON FAT

In practice, low-frequency ultrasound has three main effects on fat:

1. Depolymerisation or molecular dislocation of triglycerides and/or the increa-se in fluidity: lipolysis or the expulsion of fatty acids from adipocyte cells. Ac-tion due to permanent cavitation and an increase in the cellular permeability of the adiposity.

2. Lysis of the adiposity (rupture).

3. Defibrosis through a mechanical defibrinating action on the tissue mass pre-sent in the hypodermis.

Chapter III

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Chapter III

Monitoring the effect of cavitation on human tissue using an electronic microscope

1) Basic structure of the adipose tissue before using the NOVACAV ULTRASONIC CAVITATION equipment.

2) Immediately after the start of treatment. 3) During treatment (after 5 minutes). 4) Liquefaction of fat cells through the action of cavitation. 5) Micro-capillaries and liquefied fat undamaged by the effect of cavitation. 6) Emulsification.

From: Dr Pedro Lapuente: “monitoring met een elektronishe microscoop van cavitatie effect in menselijk weefsel”. Bologna, 15 August 2006. Universidad de Zaragoza, Spain.

TEMPORAL SEQUENCE OF THE ACTION OF ULTRASONIC CAVITATION ON ADIPOCYTES

1. 40 seconds after the start of treatment, an increase in the number and size of cavitation bubbles occurs.

2. After 1 minute of treatment an exponential increase of the number of bubbles is observed.

3. After 2 minutes of treatment, coinciding with a large number of imploding (burs-ting) bubbles, the destruction of adipose cells commences.

4. After 3 minutes of treatment an increase in the area of destruction of the adipose tissue is observed.

5. After 4 minutes, the emulsification and rupture of triglycerides contained in the adipocytes reaches its peak.

6. The emulsification increases the surface-volume ratio favouring the absorption of lipids and the action of lipolytic enzymes that act on the surface of lipid droplets.

1.

2.

3.

4.

5.

6.

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Chapter IV

DEFINING AREAS TO BE TREATED:

Applying CAVITATION is recommended in all areas where there is excess fat, excluding the face, neck and female breasts.

Areas to treat:

• buttocks• legs• ankles• arms• abdomen• knee (medial region) • thighs• lumbosacral region

APPLIED CAVITATION

RECOMMENDATIONS FOR APPLYING CAVITATION

1. Treatment of Cellulite (Edematous-fibrosclerotic panniculopathy, or EFP). Best results are obtained by treating adipose areas that are not overly extensive.

2. Localised adiposity, or rather, the presence of a tissue that is particularl rich in adipose cells compared to other body zones.

3. Localised fat is responsible for points of low aesthetic value such as enlarged stomach, thighs or hip areas. In such cases, part of the body’s fat is concen-trated in specific regions that become preferential for storing excess lipids.

4. Post-liposuction imperfections with remodelling after surgical liposuction.5. Pre-liposuction treatment (assisted liposuction).6. Body remodelling.7. Re-absorption of the lipomas; treatment preceding surgical extirpation for the

purpose of reducing the size of the lipoma, encouraging less obvious scar formation (Chimenti S.).

Do not treat the following areas:

• armpit• popliteal zone (behind the knee)• groin• hands and feet• neck• face and head in general• area of the sexual organs

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Chapter IV

METHOD OF APPLICATION TREATMENT PROTOCOLS

The areas to be treated displaying adipose accumulation are subjected to 7-10 treatments carried out a week apart to obtain the desired result, with a reduc-tion of 4-5 cm per patient.

Patients are evaluated each time they attend the treatment, standing and always in the same posture, marking the treatable area so that it corresponds to the size and shape of the lipodystrophy. Therefore, ultrasound is administered using the NOVACAV equipment and suitably cold-sterilised probe, with a power inten-sity of 2-3 W/cm2 in continuous emission.

The choice of emission frequency of the probe will naturally depend on the depth of action desired:

• extremely superficial action, 1.5 - 2.5 cm• deep action, 3.5 - 4 cm or more

The depth of cavitation action is directly proportional to the ultrasound power (W/cm2); so the higher the power, the greater the result of adipocyte destruc-tion.

The pressure applied by the probe on skin must be around 1-3 Kg/cm2 and probes must perform a circular movement around the treatable area until this turns visibly “softer”, which occurs after around 15-30 minutes of treatment.

Probes a re manufactured in a manner guaranteeing an excellent thermal dis-persion with no risk of transducers overheating.

METHOD OF APPLICATION

An aesthetic cavitation session follows the main steps below:

1. Define and evaluate the treatment areas.

2. Provide and request the patient to sign a document of informed consent (see annex 1) regarding treatment before beginning cavitation sessions.

3. Define the areas to be treated using a black dermal pencil; outlining the areas to be treated symmetrically on each side of the body.

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4. Take a photographic record before, during and after treatment (frontal full-body shot, right-side, left-side and rear).

5. Use the conductor gel in suitable amounts, ensuring that there is always a layer between the probe head and the patient’s skin.

6. Maximum 15-minute session per area according to its size (this can be re-peated if you are treating large areas), but under no circumstances must you surpass 60 minutes total of treatment. The sessions must be carried out wee-kly with 1-3 monitoring and maintenance sessions every 6 months.

It is essential to recommend that the patient drinks at least 1.5 – 2 litres of water a day from the week before the session, to stimulate the liver and kidneys’ cleansing actions.

Best results are obtained on patients who require lipodystrophy remodelling of thighs, trochanteric regions and abdomen, who have toned, elastic skin and consistent, compact adipose tissue. although other areas can also be treated, such as the insides of thighs, knee, ankle and the pectoral region in men affec-ted with pseudo-gynecomastia.

In general, on average according to the subject treated, after the initial cavitation session around 1.5 - 2 cm of circumference is eliminated from the trochanteric, peritrochanteric regions, abdomen, thigh and inner thigh areas and 0.3 – 1 cm around the inner knee, ankle and arm.One should pay particular attention to the correct placing of the probe head. It should not be aimed at pubic regions, hypogastric, kidney or osseous regions. It would be ideal to take the folded adiposity area between the practitioner’s fingers so that the ultrasound waves penetrate the tissue almost horizontally without damaging deeper structures.

Ensure the surface of the head is always in perfect contact with the patient’s skin to avoid defects in applying the treatment.

Chapter IV

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Manually folded skin tissue for improved cavitation

Treatment is painless and non-invasive, although in all cases, after the first application, a mild to moderate edema can appear in the treated area, which could last on average 7 to 10 days. On first examination, the patient may not notice the immediate reduction of fatty mass yet it will be notable once the ede-ma has been reabsorbed.

Lipoclastic treatment is considered definitive in the areas of direct application yet it should be considered repeatable over time, once the remaining adipo-cytes have increased in volume due to external factors.

Sometimes, particularly predisposed subjects could notice a light whistle pro-duced by the equipment. This should not lead to suspension of treatment, ex-cept when such a whistle becomes unbearable and causes a headache. In any case, it is an exceptional event since normally the frequency perceived by the human ear is between 50 Hz and 16-20 Khz, while low-frequency ultrasound has a frequency value above 16-20 Khz.

CONSIDERATIONS

Treatment, in healthy subjects, generally follows a protocol of one session per week.

It is always advisable to engage in supporting physical activity, (so that the ATP produced by the lipid catabolism is used by the muscle and not in triglyceride biosynthesis), including a drainage treatment around 2-3 days later (with pres-sotherapy or lymphatic drainage).

Chapter IV

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Chapter IV

The released fat, above all in certain quantities, can be eliminated with difficulty. So it is useful on one hand to monitor cavitation power and, on the other, en-courage expulsion using suitable, periodic drainage massages. Keeping to a diet rich in vegetables and drinking a lot of water will enable the adipose waste and toxins in general to be easily eliminated from the organism, because these open the body’s natural “taps”.

It is fundamental to monitor the strength of the ultrasound waves because un-suitable treatment levels could lead to a degeneration of the adipose tissue with damage to the treated area and the appearance of pockmarks. It is possible, if the sessions are numerous or scheduled too close together, for skin erythema or even ulcers to develop.

Each treatment must be administered under suitable criteria, which is why ultra-sound application with cavitation effects should not be applied, for example, to anyone with metabolic problems (hypertriglyceridemia, hypercholesterolemia), vascular problems, who suffers from diabetes, hepatopathies, nephropathies and pregnancy.

CAVITATION EFFECTS

1. Lipoclasy and progressive remodelling of the silhouette

2. Reduction of the “orange peel” look of skin and elimination of the cellulite’s adipose fibrous nodules

3. Oxygenation and revascularisation of asphyctic skin.

4. Drainage of retained liquids

5. Reactivation of the peripheral circulation.

6. Absorption of revitalising or lipolitic active principles

7. Improvement in tissue tone and elasticity. In effect, ultrasound induces a dis-tension of tissues which become more elastic thanks to reactivation of the micro-circulation and stimulation of the fibroblasts (that is the typical and most numerous cells in connective tissue, capable of producing the components of the extra-cellular matrix: collagen, glycosaminoglycan, elastic and reticular fibres and glycoproteins). These cells are therefore highly important in rege-nerating tissues.

Clearly the effects depend on the entity and size of the treatable areas. In our experience optimum treatment constitutes one session every 7–10 days for a total of 7–10 sessions, with the possibility of cycle repetitions whenever necessary.

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Chapter IV

EXTERNAL REMODELLING OF THE BODY ACTION AGAINST LOCALISED ADIPOSITY AND CELLULITE

In general, whatever the area to be treated, the following procedure type is re-commended:

• Choose the area according to the protocol set on the equipment• The treatment time per area should be approximately 20 minutes, moving the

probe head slowly over the treatable area.• Total treatment time should not surpass 60 minutes per session.• A session once per week is recommended, for 7-10 treatments.• As maintenance treatment, 1-3 sessions are recommended every 6 months.

CORRECT DIET

It is highly important to keep to a suitable diet, extremely low in fat.

Lipolitic treatment causes fragmentation of the adipose cell membranes and releases fat into the interstitial fluid.

When the fat cell membrane is destroyed, the triglycerides are released into the interstitial fluid. Glycerol, soluble in water, is absorbed by the circulation system. Fatty acids, which are by nature hydrophobic, are conducted by transport or carrier proteins, predominantly albumins, to the liver where they are metaboli-sed.After carrying out treatment it is recommendable to perform lymphatic drainage or else apply pressotherapy. You should keep to a very low-fat diet at least during the following five days, to allow the liver to metabolise these fatty acids released by the Novacav treatment.

• In the case of sedentary, totally inactive patients, it is essential to advise them to engage in at least 30 minutes of exercise a day. (Nordic walking, strolling, swimming, stretching).

• Patients are recommended to drink a lot of water before and after each treatment.

VISIBLE RESULTS IN A VERY SHORT TIME

The results can be seen after the first treatment.Depending on the area to be treated, the reduction can be 1 to 5 centimetres in diameter.A minimum loss of 2 centimetres is guaranteed.In certain cases of patients responding extremely well to treatment, reductions of up to 7 centimetres have been recorded in a single session.

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COMPLEMENTARY TREATMENT

It is always recommended to complement CAVITATION treatment with treat-ments help to achieve the desired results.

• Cavitation: You destroy fat using ultrasound. Apply NOVACAV conductor gel containing active, anti-cellulite ingredients to tone your body.

• Electroporation: Using magnetic fields, this process opens pores and introduces reducing, or draining agents.

• Pressotherapy: Using pressure sleeves, this increases drainage, naturally helping to eliminate the destroyed fat.

• Vibrating platform: Among other benefits it helps to reaffirm and tone the treated area.

SECONDARY EFFECTS

If the application protocol is followed and the correct parameters set, with the exclusion criteria for the patients described in previous paragraphs, the colla-teral effects will be non-existent or else minimal.

In any case, the episodes leading to mild edemas can be verifi ed (which can last 7-15 days) or bruising on the treated area, in more sensitive patients with greater application frequency of treatment.

CONTRAINDICATIONS

• kidney failure• hepatic insuffi ciency or bladder infl ammation• active vascular pathologies: thrombosis and thrombophlebitis• venous insuffi ciency in lower extremities• patients being treated with anticoagulants• those carrying pacemakers or other implanted electronic systems• possible or confi rmed pregnancy• extremely obese patients or those with active diseases, especially with car-

diac problems• arterial hypertension• epileptic patients• diabetes mellitus• patients with metal prostheses and other means of magnetisable synthesis;

due to its greater absorption compared to the surrounding tissue, can over-heat and deteriorate. Overheating can cause an alteration in the means of synthesis and of the prostheses themselves. Due to the heat they can easily deform. Furthermore, overheating can cause damage to the surrounding soft tissue, causing serious regressive processes in tissues. Lastly, means of metal synthesis and articulated, metal prostheses can have their structure negatively affected by ultrasound vibrations.

• dyslipidemia (hypertriglyceridemia, hypercholesterolemia) • patients with transplants

Chapter IV

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Chapter V

TEST OF EFFICACY 1

The study was carried out on 20 patients (10 men and 10 women) aged from 25 to 45, who displayed different pathologies, such as localised fat, overweig-ht and associated cellulite. The god health of each subject treated was checked and no pathologies of the liver were detected nor any circulation problems.

Using NOVACAV latest generation cavitation equipment, 15 sessions were conducted using low-frequency ultrasound at a range of 38 KHz (+15%). Maxi-mum operational power used was 3W/cm2. Two emission types were applied, continuous (2W/cm2) and alternate (3W/cm2), according to the characteristics of the adipose tissue treated, using variable application times as necessary on each subject. NOVACAV enables the professional practitioner to adjust emission settings according to need.

APPLIED PROTOCOL

The operational protocol used was the following:

1. An anamnesis was performed on the participating persons to obtain general

information on their state of health. Photos of patients’ initial states were taken.

2. The skin fold was measured.

3. The perimeter was measured using a metal tape measure, using the anthro-

pometric method.

4. NOVACAV Professional Gel was applied to the area to be treated.

5. A 20-minute session of NOVACAV was applied to each treatment area.

6. A 20-minute massage was administered to encourage lymphatic drainage.

7. 8 sessions were conducted.

For the purpose of monitoring the evolution of each patient studied, 4 prior measurements were taken, before the first session with NOVACAV.

ADVERSE REACTIONS

Of 160 applications of treatment administered, two different types of reaction were observed, similar to a folliculitis. One, of a general type (3 cases), and the other more defined and limited to a highly specific area (6 cases). Both disap-peared approximately one hour after finishing the treatment, without any further effects being observed.

TEST OF EFFICACY