AU2011100113B4 - An electrode for subcutaneous electrolipolysis - Google Patents

Description

An electrode for subcutaneous electrolipolysis Introduction Lipolysis is a natural biochemical process by which triglyceride stored in animal or human fat cells is reduced to glycerol and free fatty acids, with a consequential reduction of fat cell volume. It can be stimulated either by cold temperature (cryolipolysis) or by applying electrical currents through the subcutaneous fat cell layer (electrolipolysis). Medically, electrolipolysis is carried out using acupuncture needles as electrodes. These are placed into the subcutaneous fat layer parallel to the skin and a pulsed electric current is then applied through them (Nguyen, 1996, Bachelier et al., 1996). Needles, rather than pads are used for electrolipolysis due to the inability of surface pads to deliver enough concentrated current around the fat cells to stimulate lipolysis (RconSult-Medberaad, 1998). The drawbacks of using acupuncture needles for electrolipolysis include the requirement of a Medical practitioner with experience in needle insertion, patient discomfort, pain, bruising and patient compliance. The development of the Multiple Needle Electrode (Australian patent applications 1995023409) has overcome some of these drawbacks. These include, reducing pain and technical difficulty related to needle insertion and obtaining optimum penetration depth into the subcutaneous fat layer. The Multiple Needle Electrode (MNE) is a long flexible electrode with a conductive stem and multiple fine needles protruding perpendicularly from this stem. These fine needles are then pressed into the skin before attaching the conductive stem supporting the needles to a pulsed electric generator (medical device).This new electrode has similar discharging effectiveness as the acupuncture needles, demonstrated with subcutaneous voltage maps across similar spaced oppositely charged electrodes implanted in a woman's abdomen (Barnett R.W 1994). Commercial application of electrolipolysis involves one hour treatments on a weekly basis for six weeks, and has shown effective in reducing the appearance of cellulite and anthropometric measurements, in over 100,000 women (Bachelier et al., 1996). This treatment time, using histological and cytological evaluation, is effective in reducing fat cell volume and biochemical changes consistent with an increase in lipolysis (Nguyen et al., 1996, Bachelier et al., 1996 and D.E.Tulhurst (Guys Hospital London)). Further research by Ignjatovic et al., 1995, has demonstrated that extension of the treatment time for electrolipolysis, results in a proportional increase in lipolysis and fat cell volume reduction. These Monash University studies, using the abdominal fat layer of the Wistar rat, showed that 3 or 6 hours of continuous electrolipolysis, resulted in a cytological reduction of fat cell volume by 11% and 25% respectively. The ability to quantitatively increase lipolysis by extending electrolipolysis treatment time offers new use possibilities, particularly in reducing localised fat deposits. However, existing electrode technology does not allow for economical or patient compliant treatment options beyond one hour.

What is the invention? The MNE claims to have a flexible conductive stem, allowing it to be curved around the contours of the skin, however, it is not designed to allow the patient to have electrolipolysis treatment whilst ambulant for extended periods of time. Such an electrode design transmits mechanical forces from one needle to the next along the stem, effectively causing pain or dislodgement of the electrodes from the subcutaneous layer when there is movement of the patient. The subcutaneous lipolysis electrode (FLE) that is described in this provisional patent is designed to improve upon the MNE and allow long term electrolipolysis treatment to be carried out on a fully ambulant patient doing normal daily duties. Aims of the invention The invention is tailored to deliver electrolipolysis whilst the patient is ambulant and doing normal daily duties. This involves: 1. A miniaturised portable electrical apparatus carried by the patient to deliver electrical information to the new electrode invention referred to as the subcutaneous lipolysis electrode (SLE). This will allow the patient to carry out normal duties whilst having the electrolipolysis treatment. 2. The treatment time can be comfortably increased in order to achieve greater amounts of lipolysis (i.e. 1 to 12 hours instead of 1 hour). As a consequence, the treatment results improve several folds within a shorter time frame. Treatment results include a reduction of fat cell volume, anthropometric measurements, as well as an increase in biochemical indicators of lipolysis. 3. The SLE that will be in this provisional patent application, will differ to the MNE in that the conductive stem is not only flexible, it can extend, conduct, contract and move so that any two needles attached to this stem float independently when placed in the subcutaneous layer without transmitting force to each other as they move with the body. 4. Increasing lipolysis by increasing treatment time gives electrolipolysis further opportunity in cosmetic medicine as a treatment for reducing greater volumes of localised fat bulk or cellulite in men and women. The invention description In the simplest description, SLE aims to transfer electrical information generated from an attached medical device to the subcutaneous tissue beneath the skin. The information is conducted along a stem that has 2 or more invasive conductive needle electrodes attached. These needles are attached so that electrical information is transmitted evenly through all needle electrodes within the subcutaneous layer. The needle electrodes are pressed perpendicularly through the skin and can be engineered to penetrate to any required depth by adjusting the length of the needle. These needles electrodes may contain an adhesive tape or the like that will allow then to adhere onto the skin once inserted into the subcutaneous layer.

A unique feature of this SLE is the capacity of each of these electrically in series invasive electrodes to remain attached to the skin and to each other, whilst also allowing total independent mechanical movement of each of the invasive electrodes. In effect, the SLE claims it will allow the information generated by a medical device that attaches to the SLE to reach the subcutaneous tissue whilst allowing full ambulation of the subject wearing the electrodes. The electrical stimulator in the broad sense will be small enough to be portable and used by a patient during normal daily activity. It can mimic the specifications of existing electrolipolysis generators i.e. 15Hz, 2-4mA or 150uA, rectangular wave and biphasic as an example only. It may also have capacity to produce frequency specific micro-currents for use in health or pain control. It could be single use or reusable. The exclusive features of the FSE are as follows: 1. A series of invasive electrodes on a single flexible, expandable conductive stem. The conductive stem allows stretching, compression and all other movements necessary so that movement of any needle on the SLE will not transmit enough mechanical force to affect the positioning of any of the other placed needle electrodes. In addition to this, the conducting stem will allow electrical information to reach each electrode. The number of electrodes on each conductive stem is two or more. 2. Said differently, the conductive stem between each invasive electrode is designed to allow full and independent articulation between invasive electrodes. This allows invasive electrodes to be attached and embedded into the skin and subcutaneous tissue, whilst subjects remains fully ambulant and are treated by an electronic medical device. 3. Each invasive electrode penetrates through the skin layer and can be of any length. The length of the needle governs the depth of penetration which can be modified if required. 4. The diameter of the needle electrodes can vary and the needle can be solid or hollow. 5. Each electrode on the common conductive stem is in series and can conduct electrical information (from a medical device) and distribute this beneath the skin evenly (subcutaneous voltage map), or if required, on the skin simultaneously. 6. Each SLE is either an anode or cathode. 7. The SLE will allow electrical conductive coupling to a medical electronic device. 8. The head of each invasive needle electrode can be insulated at the point of contact with the skin in order to eliminate short circuiting with the skin. 9. Each of the invasive needle electrodes can have if required, adhesive tape that will hold the needle electrode in place on the skin during treatment. 10. The medical device will be small enough for the patient to carry around unnoticed. 11. The medical device will have programmable control of variables that will be necessary for a prescription treatment for electrolipolysis. 12. The SLE will be packaged and be available sterile for easy application. Uses of the invention This SLE has immediate application in electrolipolysis, pain control, lymphatic drainage and wound healing although other applications will become available.

. The SLE wll remain securely embedded into the subcutaneous layer and remain securely in place during routine daily activity. 2. The SLE wil allow long or short durations of electrolipolysis treatment to be carried out whilst the patient is normally ambulant. 3. The SLE quantitatively delivers more lipolysis than other prior art whilst a patient is ambulant. 4. The SLE expands the dinical applications of electrolipolysis for use in reducing larger localised fat deposit. 5. The SLE can reduce cellulite more effectively than traditional electrolipolysis using either acupuncture needle electrodes or MNE. 3

Claims (5)

1. A conductive device for delivering an electrical current into subcutaneous tissue comprising (i) a stem and (ii) two or more invasive electrodes, the stem and electrodes configured to allow (a) independent articulation between the stem and one of the two or more invasive electrodes and/or (b) independent articulation between the two or more invasive electrodes.

2. A conductive device according to claim 1 wherein the stem is conductive

3. A conductive device according to claim 1 or claim 2 wherein the two or more invasive electrodes comprise insulation at the point of contact with the skin.

4. A method for delivering an electrical current to subject in need thereof, the method comprising the step of applying a conductive device according to anyone of claims 1 to 3 to the subject; the method optionally comprising the step of using an adhesive to hold the conductive device in place on the skin to allow ambulation in the subject.

5. A method according to claim 4 wherein the electrical current is delivered for a period of more than 1 hour. 6