WO1995029732A1

WO1995029732A1 - Multiple needle electrode

Info

Publication number: WO1995029732A1
Application number: PCT/AU1995/000258
Authority: WO
Inventors: Peter Hatziorfanos; Ambrosios Kambouris
Original assignee: Peter Hatziorfanos; Ambrosios Kambouris
Priority date: 1994-05-03
Filing date: 1995-05-03
Publication date: 1995-11-09
Also published as: AUPM540394A0

Abstract

A multiple needle electrode for use in the treatment of subcutaneous cellulite. The electrode comprises an electrode terminal (11) attached to an insulated, flexible conductive stem (10) to the underside of which stem are attached a multiplicity of fine acupuncture type needles (20). These needles are sufficiently long to penetrate the dermis but not sufficiently long to penetrate subcutaneous muscle.

Description

MULTIPLE NEEDLE ELECTRODE

This invention relates to an improved electrode for use in the removal of subcutaneous cellulite such electrode use being a method of therapeutic treatment of a cosmetic nature.

The "mattress" or "orange peel" effect of subcutaneous cellulite is a complaint suffered by a significant proportion of the adult population, especially women. It has been found to have initial onset in puberty, at the beginning of oral contraceptive use and/or during pregnancy. Dietary factors and the effects of the hormone oestrogen have been cited as some of the contributory causes of cellulite.

The demand for aesthetically pleasing, cellulite-free legs and thighs has created vast commercial interest. Treatments such as massage, water blasting, icy bandaging, clay masking and creams for topical application have been developed with varying success in reduction of cellulite, as have surgical bindings such as liposuction.

Electrotherapy first became widely used during the 1930*s. Pulsed magnetic fields have also been used to accelerate wound healing and in a variety of disorders such as soft tissue damage and calcification. Recently a method was developed for cellulite reduction, known as cellulolipolysis. This treatment has been extensively tested on 50,000 women in France, and has undergone evaluation in trials in the U.K.

The effect of the treatment has been to significantly reduce the mattress effect on the skin of cellulite sufferers as well as reduce the circumference of their hips, thighs and knees.

This procedure involves three main steps:

Firstly evaluating and adjusting electrolyte and water levels in the client's body.

- Secondly providing dietary advice as a means of reducing and preventing further cellulite formation.

- Thirdly the insertion of 15 cm long and 0.3 mm diameter electrodes at an angle 3 mm beneath the skin and applying computer generated currents primed according to levels of urinary creatinine, sodium and potassium as well as urinary volume, ascertained in a 24 hour urine specimen test.

Cellulolipolysis has been shown to have several drawbacks including:

The requirement that it is administered by persons with medical expertise because of the length and manner of insertion of the electrode; Slow and painful needle insertion, which can result in bruising of the surrounding tissues; Low client acceptance and compliance because of the problems of electrode insertion and resultant pain and bruising;

Restriction of treatment to the abdomen, buttocks and thighs.

Basically the use of such long electrodes is problematic in that they are inserted into the shallow undulating layer of subcutaneous tissue and often are grounded by accidental insertion into the underlying muscle layer.

Because of this grounding, the effect of electrolysis from this electrode is reduced to a small area near the insertion point of the electrode. Additionally the underlying muscles are caused to contract which can cause some discomfort.

Even in the absence of such grounding the distribution of the electric field along the electrode is far from uniform.

It is an object of the present invention to overcome the above drawbacks and inherent difficulties of carrying out subcutaneous electrolysis which occur when such electrodes as are described above are used. The invention in its broadest sense includes an electrode for use in subcutaneous electrolysis having more than one needle capable of penetrating human skin.

This electrode to be used in the process of the removal of subcutaneous cellulite is a multiple needle electrode. The required number of such electrodes are inserted for a short time into any skin which covering the layer of subcutaneous cellulite to be treated.

During this time pulses of electrical current are caused to flow from the electrode into the subcutaneous layer providing stimulation which, if delivered for short periods but over a number of weeks, causes significant cellulite reduction to the area of the body where the stimulation is administered.

In a preferred embodiment of the invention, the multiple needle electrode comprises an electrode terminal attached to a flexible conductive stem which can vary in length according to the size of the area of cellulite which is undergoing treatment. The conductive stem is flexible so that it can wrap around the area of the body concerned and follow the body's contours.

In order that the invention may be more readily understood the preferred embodiment of it will be described in terms of the accompanying drawings: Fig. 1 shows a schematic drawing of the multiple needle electrode as viewed from one side.

Fig. 2 shows a diagram of the conventional long electrode passing through the skin.

The preferred embodiment of the electrode shown in Figure 1 shows a conductive stem (10), surrounded by an insulating layer, which has attached to it several needles (20) which in this preferred embodiment are six in number and are approximately 5 mm long and about 0.1 mm in diameter placed at intervals of about 30 mm along the length of the conductive stem (10).

In contrast the conventional long needle (30) is shown in Figure 2 penetrating for a length of approximately 150 mm at a shallow angle through the epidermis (31) and below the dermis (32) into the subcutaneous fat layer (33).

The needles (20) used are acupuncture quality stainless steel and the conductive stem (10) is a tin/copper mix however any material which is flexible and highly conductive could be used.

In this preferred embodiment there is a connection point (11) to a power source in the middle of the electrode stem (10). The precise location of this connection point is not germane to this invention.

In this embodiment the choice of needle (20) length was chosen so that it would penetrate the dermis but not contact subcutaneous muscle.

The spacing of the needles at 30mm apart has been chosen here to provide for an overlap in the discharge fields from each needle when a current of between 20 ma and 40 ma is applied to the stem of the electrode usually in a pulsed form of oscillation.

The aim of the electrode is to produce as uniform an electrical stimulation as possible along its extent.

The exact size and separation of the needles used on the electrode therefore is not germane to this invention as the length and separation of the needles used would be based on considerations such as the depth of the subcutaneous fat layer to be penetrated and other factors such as skin resistance and the voltage or current required.

Thus although specific sizes and spacings have been specified for the components of the multiple needle electrode these may be varied without departing from the spirit of the invention. Preferably the level of subcutaneous stimulation which should be applied should be sufficiently high that the person to whom the stimulation is being applied can sense that the stimulation is occurring.

The electrode stem (10) is attached to a power source such that a low voltage current can be applied which travels along the flexible conductive stem, which is strapped or otherwise attached to the cellulite affected skin, and down each of the 5mm needles (20) placed along the conductive stem.

The needles penetrate only the corium layer of subcutaneous tissue and there is no danger of contact by the needles with the underlying muscle layer. A comparison with one of the long electrodes (30) used previously is shown in Figure 2. Clearly a multiplicity of fine needles (20) would be more comfortable when inserted through the skin than a single large electrode of the order of 15 cm in length.

It is postulated that a local polarisation of charge may occur when a pulse of electrical current travels through the subcutaneous layer of skin. It is further postulated that this charge polarisation stimulates the break down of fat cells in the subcutaneous fat layer, thus commencing the effect that this cosmetic treatment is designed to achieve. Whilst we have described herein the preferred embodiment of the invention, it is to be understood that variations can be made in all aspects of the invention without departing from the spirit and scope of the invention.

Claims

I claim:

1. An electrode for use in subcutaneous electrolysis having more than one needle capable of penetrating human skin.

2. An electrode as claimed in claim 1 in which the electrode comprises a conductive stem, to the underside of which needles are attached, said conductive stem having a connection point to a power source.

3. An electrode as claimed in claim 2 having a multiplicity of needles attached to the underside of said conductive stem.

4. An electrode as claimed in claim 2 and claim 3 in which the needles are spaced equidistantly along the conductive stem.

5. An electrode as claimed in claim 2 in which the power source is either a voltage source or a current source.

6. An electrode as claimed in claim 5 in which the power source is pulsed.

7. An electrode as claimed in claim 2 in which the conductive stem connection point is located at the mid point of the conductive stem.

8. An electrode as claimed in claim 2 in which the conductive stem is flexible.

9. An electrode as claimed in claim 2 in which the flexible conductive stem is encased in an insulating material.