Patent Application
20060241672
This invention relates to medical apparatuses and methods for treatment of dermatological conditions, specifically for treatment of the edematous-fibrosclerotic panniculopathy, commonly known as cellulite.
Description of the Prior Art
Numerous treatments have been devised for the dermatological condition edematous-fibrosclerotic panniculopathy, commonly known as cellulite.
Some of these treatments have a scientific base, some have a pseudo-scientific, empiric base.
The edematous-fibrosclerotic panniculopathy commonly named cellulite, a non medical term coined in Europe, is a disorder of the skin and subcutaneous tissue. The edematous-fibrosclerotic panniculopathy is due to the formation of an abnormal fibrous network in the hypoderm. The abnormal fibrous network encapsulates conglomerates of fat cells causing a subcutaneous architectural disruption which results in a dimples and nodules appearance of the skin, known as orange peel skin. Strands of fibrous tissue connect the skin to deeper tissue layers and also separate compartments that contain conglomerates of fat cells. Cellulite affects more commonly the hips, thighs, glutei, abdominal wall and upper arms. Women are commonly more affected than men. Researchers agree that most of cellulite “cures” have been ineffective. Recent researches have confirmed that cellulite is product of faulty anatomy, genes and hormones.
Anticellulite products with unsubstantiated claims of successful treatment of the condition include creams and gels, brushes, rollers, body wraps toning lotions, electrical stimulation devices, vibrating machines, inflatable hip-high pressurized boots, hormone or enzymes injections and many others.
More recently, radio frequency and laser devices, cold-laser massage devices, combined radio frequency/infrared devices, fat melting injections, targeted liposuction, tissue fillers have been used for the treatment of cellulite with minimal or marginal success, eventually with only transitory improvements.
A more recently devised surgical procedure called skin subcision has shown some promising results. The procedure consists of cutting the cellulitic fibrous bands, the tethers which cause the depression in the skin with a special needle having surgical scalpel-like tip. The dimples, freed from their fibrous attachments, pop up and the skin is able to regain the even, pre-cellulitic aspect. Regretfully, the procedure is not void of complications. Pain, bruises, hemosiderosis have been associated with the procedure as reported in the International Journal of Dermatology, Volume 39 Issue 7, Page 539, July 2000.
With the present invention, applicants propose a simple medical-surgical device having the scientific prerequisites of being capable of detaching the fibrous attachments that connect the skin to the deeper layers and cause the typical dimples of a cellulitic skin, via blunt dissection, rather than via sharp dissection as currently in use. Detachment of such fibrous attachments resolves the skin dimples, restituting normal appearance to the skin, minimizing complications more likely to develop with sharp dissection.
The device is composed of a needle having an expandable balloon in proximity of the tip, connected to a syringe provided with a handle.
The operator inserts the needle into the skin, inflates the balloon, grossly shaped as a donut. The balloon once inflated has the double function of dissecting by outward radial expansion the fibrous bands network and of serving as anchoring device for skin traction purposes. The operator gently pulls up the needle acting upon the syringe handle connected to the needle carrying the expanded balloon. In doing so the operator elevates the skin, stretching it to the point of rupture the cellulitic fibrous bands which cause the dimpling of the skin.
The detachment of the fibrous bands occur by blunt dissection. It is expected that the extensible surrounding blood vessels are just stretched and not severed as in the above mentioned sharp subcision technique. Surrounding structures will be less traumatized being not sharply cut as in the sharp subcision technique. It is reasonable to say that less trauma to the tissue is expected to occur with greater patient comfort and with expectation of lesser complications.
It is an object of the present invention to provide a simple, rapidly deployable medical device for the treatment of cellulite, the treatment being based on solid anatomic-pathological foundations.
It is an object of the present invention to provide the consumer with a simple minimally invasive effective, rapidly deployable means and method for improving cosmetic appearance of the skin affected by cellulite.
It is an object of the present invention to provide a safe, simple and effective apparatus and method to target and to induce mechanical lysis of the fibrous bands which are at the core of the formation and persistence of the cellulite in body areas of patient's concern.
It is an object of the present invention to provide the operator with an alternative improved apparatus and method of an already proven effective method of cellulite treatment i.e. skin subcision the dissection of the cellulitic fibrous bands. The proposed device dissects the fibrous tissue by blunt, not sharp, dissection, causing less trauma, less bleeding, ultimately less inflammatory reaction in the subcutaneous tissue.
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Needle 2 can be formed with different sizes balloons allowing variable radial balloon expansions.
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The operator can repeat the procedure by inserting the needle into each cellulitic skin dimple 21′. By operating the device as described, the operator can eliminate, one by one, every skin dimple, restituting normal appearance to the skin.
