This invention relates to a method and apparatus for destroying human fat cells and tissue safely and expeditiously directly inside the body or externally through the skin for ultimate removal or other liposculpturing treatment.

Current plastic surgery techniques for treating obesity of physical appearance requires elimination of human fat cells and tissue. With liposuction, surgical incisions are made and areas of fatty tissue are cut away with surgical instruments and removed with suction devices. Such operations can be traumatic and dangerous if not performed properly.

The present invention provides a novel technique for destroying fat cells and fat tissue areas directly inside the body or externally through the skin, significantly reducing surgical trauma by use of ultrasonic energy. With an ultrasonic probe disposed externally of the body, cavitation can be induced in adjacent fat cells beneath the skin destroying fat tissue without any incision. A small incision may be made and a liposuction device used for sucking out the destroyed fat tissues. Alternatively direct fat cell contact with a long titanium ultrasonic probe through a small incision may be employed to destroy the fat cells. Fat cells and tissue adjacent the probe end can be destroyed.

The use of the present method and apparatus greatly reduces the surgical trauma and risks presently experienced in liposuction and liposculpturing techniques while reducing the time of the procedures.

A method and apparatus for destruction of human fat cells and tissue using ultrasonic energy application either directly within the body or externally through the patients skin. The method broadly encompasses selecting the area of treatment, positioning an ultrasonic probe at the desired treatment location and applying ultrasonic energy to the human fat cells and tissues to be destroyed. The removal of the destroyed fat cells may be done through a small incision

SUBSTITUTE SHEET

with a liposuction device which sucks out the residual oils and residual fat tissue from the area subjected to ultrasonic energy between 20,000 Hz and 3,000,000 Hz.

For ultrasonic application externally through the skin, a plate-shaped ultrasonic probe of a predetermined size having a smooth, polished surface and centre connector coupled to the ultrasonic generator is utilized. A gel is applied to the outer skin of the patient in the probe contact area. Fat cells below the skin receiving the ultrasonic energy burst due to the application of ultrasonic energy causing their destruction. The probe may be applied with a slow circular motion around the body area to be treated. After the ultrasonic external treatment is finished, if desired although not mandatory, a small incision may be made in the patient's skin and a liposuction device inserted there through which sucks out the destroyed fat cells, tissue and oils and any residual cell material.

Alternatively, the fat cells may be destroyed internally. A long, narrow ultrasonic probe (preferably made of titanium) is connected to an ultrasonic generator. The narrow probe is inserted through a small incision in the patient's skin in the treatment area and the ultrasonic energy applied, thus destroying and bursting fat cells and tissue immediately surrounding the blunt end of the probe. For fat cell removal, liposuction with a suction device is performed through the incision to remove the oil, dead cells and tissue although this is unnecessary as the destroyed material will be reabsorbed by the body.

With the use of the present method and apparatus, fat cells and fat tissues are quickly and efficiently destroyed without surgical trauma to the patient currently experienced with liposuction surgical techniques. In addition, the patient may be treated either externally with the external surgical probe or internally through a small incision using the elongated blunt tip probe, both probes providing ultrasonic energy directed to the fat cells to be treated.

The total time period of ultrasonic energy application will be normally less than one minute for the internal

SUBSTITUTE SHEET

device, and quite longer (up to 15 minutes) for the external probe.

The technique and instruments provided are not only useful for abdominal areas of patients but can also be directed to other specific areas such as knees or saddle bags and buttocks in which autogolous collagen may be used for remodelling and in which the destroyed fat tissue materials may be allowed to reabsorb into the body and not be removed by suction after the ultrasonic exposure of the areas.

It is an object of this invention to provide a method for destroying fat cells and fatty tissue especially for liposculpturing also without using surgical trauma and surgical removal of the fat and cells and tissue.

It is another object of this invention to provide a method and apparatus for destroying human fat cells and tissue safely and efficiently.

Yet still another object of this invention is to provide a method and apparatus for performing liposculpturing and lipotripsion for treating human fat cells and tissue which includes internal or external ultrasonic application respectively.

In accordance with these and other objects which will be apparent hereinafter, the instant invention will now be described with particular reference to the accompanying drawings.

Figure 1 shows a perspective view of an apparatus used in the present invention which includes either an external probe or internal probe connected to the ultrasonic generator.

Figure 2 shows a side elevational view of the external probe used with the present invention.

Figure 3 shows a front elevational view with the probe used with the external application of the present invention.

Figure 4 shows a perspective view of the external probe used with the present invention.

_S U _BS TITUTESHEET

Figure 5 shows a perspective view of an internal probe for internal application of ultrasonic energy in accordance with the present invention.

The method in accordance with the invention is accomplished by locating the fat cell and tissue area to be treated and applying ultrasonic energy to a limited, defined area of human fat cells and tissue, with either a flat ultrasonic probe externally through the skin or with a narrow internal probe typically for the ultimate removal of the destroyed fat cells and tissue or for liposculpturing. The method involves the application of ultrasonic energy in the range of 20,000 Hz to 3,000,000 Hz with the use of specially designed probes for internal or external use. The fat cells are destroyed by the bursting of the cells releasing oil and residual tissue, all of which can be removed by suction quickly and efficiently, or can be left in the body for a progressive reabsorption.

To carry out the method described above, a device as shown in Figure 1 may be used comprising an ultrasonic generating system 18 connected to a standard AC power supply that includes a foot switch 22 connected by wires 20 into the generator 18 for controlling the application of the energy. Also attached to the power supply and generator 18 is a convertor 16 that is used to attach either a probe 10 which is used for external application of ultrasonic energy through the skin of the patient or probe 12 which with a small incision can be inserted into a patient for internal ultrasonic application. Such a device as the VIBRACELL VC 50 is manufactured by Sonics and Materials, Inc., of Danbury, Connecticut.

Referring now to Figures 2, 3 and 4 the external probe is shown comprised of a metal circular disk of an ultrasonic transmitting material (preferably titanium) which is perfectly smooth and polished on outside face 10a and which includes a connector 10c that connects to the converter of the ultrasonic generator and a central flange lOd that transmits the energy into the disk from the converter connection. The probe diameter may be a desired, preferably

SUBSTITUTESHEET

8 to 10 cm. The connector 10c includes a threaded connector to converter 16 shown in Figure 1 for the application of ultrasonic energy from 20,000 to 3,000,000 Hz. The probe 10 in conjunction with a gel applied on the skin of the patient can then be slowly moved in a circular motion on the skin around the area of fat cells below the skin which are to be destroyed by the ultrasonic energy. It is believed that cavitation in the fat cells is produced through the skin of the patient and the fat cells burst under the action of the ultrasonic energy. After the ultrasonic energy application is completed, destroying a reasonable number of fat tissue and fat cells desired beneath the skin, the residual is progressively reabsorbed by the body. The device is especially useful for treating small areas such as knees or saddle bags.

To employ the method with an internal ultrasonic application, and referring to Figure 5, an elongated titanium probe 12 is utilised which includes a thin cylindrical shaft portion 12a terminating in a blunt tip 12b from which the ultrasonic energy is transmitted. A threaded connector 12c connects the probe to the convertor 16 of Figure 1 of the ultrasonic energy generator. The probe 12 shown in Figure and shaft portion 12a is circular in cross section and includes an enlarged cylindrical portion 12d which connects the shaft 12a to the connector 12c. The length of the shaft may be between 10 and 30 centimetres and the diameter between 2 and 6 millimetres. To utilize the probe 12 shown in Figure 5 for internal use, a small incision is made in the patient in the desired area for the fat tissue and cell destruction. The probe 12 is inserted through the small incision under the skin into the area of the fat cells to be destroyed. Ultrasonic energy is then applied through the actuation of foot switch 22 shown in Figure 1 so that ultrasonic energy emerges from the blunt tip end and is concentrated in the area for the fat tissue destruction. After the ultrasonic treatment, a small liposuction device may be inserted in the treated area to remove the fat cell oil and dead cells or in some situations

SUB _S T _I TUTESHEET

the oil and fat cells may be left in place for natural reabsorption. In some cases the injection of autogolous collagen for remodelling a treated area may be applied.

Through the use of the present method, fat cells and tissue may be precisely and safely destroyed to permit removal or regeneration and liposculpturing in desired areas of the human body eliminating traumatic and dangerous cutting surgical techniques previously used. The invention also provides equipment for performing both external and internal ultrasonic destruction of fat cells and tissue in predetermined areas quickly and safely.

The instant invention has been shown and described herein in what it is considered to be the most practical and preferred embodiment. It is recognised, however, that departures may be made therefrom within the scope of the invention and that obvious modifications will occur to a person skilled in the art.

SUBSTITUTESHEET