Apparatus and method for treating body tissue, in particular...

Surgery – Means for introducing or removing material from body for... – With means for cutting – scarifying – or vibrating tissue

Reexamination Certificate

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C604S020000, C604S890100, C604S290000, C601S002000

Reexamination Certificate

active

06500141

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates to an apparatus for treating body tissue, particularly soft surface tissue, with ultrasound. The apparatus comprises an ultrasound generation unit and an applicator with which ultrasound can be emitted from an applicator surface facing the body surface from the outside through the body surface into the body tissue.
The invention further relates to a method for treating body tissue, in particular soft surface tissue, with ultrasound. An apparatus as mentioned at the outset is known from the U.S. company brochure of Wells Johnson Company, Tucson, Ariz., U.S.A, entitled “Introducing SILBERG E.U.S.™ External Ultrasonic System”.
The use of ultrasound for healing purposes has increased in importance. Depending on the therapy, ultrasound is applied in the form of continuous or pulsed ultrasound wave fields.
Ultrasound has been successfully employed in so-called exterior shock wave therapy as well as ultrasound wave therapy for treating stones in the kidneys, urethra, gall and the like. An apparatus for treating body stones, a so-called lithotriptor, is known for example from the Swiss company brochure of Storz Medical AG, Kreuzlingen, Switzerland, entitled “STORZ MODULITH®-Systeme für die extrakorporale Lithotripsie”. Short ultrasound pulses generated with this lithotriptor externally, i.e. outside of the body, are coupled into the body and focused on the stones in the body. The stones are localized beforehand by ultrasound imaging devices or X-ray systems.
Developments are being made in the external treatment of tumors in which special ultrasound applicators generate ultrasound waves which are transmitted to the tumor from the outside. By special control of the time the ultrasound acts on the tumor, an overheating of the tumorous tissue results and leads to its destruction.
It is not only the thermal effect of ultrasound which leads to dissolution of the cell structure, but also the pure mechanical effect in the form of cavitation. Sound waves propagate in a medium in the form of periodically varying density fluctuations of the medium. A volume element of the medium is alternately compressed (higher pressure) and expanded (lower pressure). The lower pressure can lead to vapor bubble formation in the fluid, for example in cell fluid, where in the end, the cell walls and/or the cell structure is destroyed.
It has been shown that this effect of ultrasound is suitable for disintegration or dissolution of soft tissue, for example fat tissue. The apparatus disclosed in the above-mentioned U.S. company brochure is employed for removing fat tissue close to the surface. The known apparatus comprises an applicator with which ultrasound is coupled from the outside through the body surface into the lower lying soft tissue.
A drawback of the known apparatus is the difficulty in achieving a uniform coupling of the applicator over its entire active surface to the tissue to be treated. When this is not the case, not only is the applied ultrasound energy not optimally utilized, an increased heat development also occurs.
A further drawback of the known apparatus is that it is not possible to control the depth effect of ultrasound, i.e. The penetration depth of the active ultrasound or its focus. When applying the applicator, a compression or a displacement of the underlying tissue can result, such that the individual tissue layers no longer have their original thickness or disposition. Without depth control, it is not possible to couple the ultrasound properly to the body tissue to be treated. There is also the danger that tissue which is not to be treated could be damaged.
Another apparatus of the present type for treating body tissue with ultrasound is disclosed in U.S. Pat. No. 5,618,275. The apparatus comprises an applicator having a housing in which an ultrasound transducer is embedded. A collar is provided on the housing on the side facing the body surface, which together with the housing forms a chamber of predetermined volume. A substance to be applied to the body surface is held in the chamber between the body surface and the applicator surface, such that the substance cannot be released from the chamber formed by the collar. The collar is formed of rubber or the like to be flexible. The therapeutic substance held by the collar between the applicator surface and the body surface more easily penetrates the tissue by means of the ultrasound treatment.
An object of the present invention is to provide an improved apparatus of the above-mentioned type, where ultrasound can be specifically coupled to the body tissue to be treated and where depth control of the ultrasound therapy can be achieved.
SUMMARY OF THE INVENTION
According to the present invention, an apparatus for treating body tissue, in particular superficial soft tissue, with ultrasound, is provided, comprising: an ultrasonic generation unit; an applicator having an applicator surface facing the body surface from which said ultrasound can be irradiated through said body surface into said body tissue, wherein a suction apparatus is provided for taking in said body surface against said applicator surface.
The present invention further provides a method for treating body tissue, in particular superficial soft tissue, with ultrasound, comprising the steps of: providing an ultrasonic generation unit and an applicator having an applicator surface; taking in said body surface against said applicator surface and irradiating said ultrasound from said applicator surface from outside through a body surface into said body tissue.
By taking in the body surface against the applicator surface, the underlying body tissue is drawn against the applicator, whereby a fixation of the tissue to the applicator is achieved. Through this fixation, the ultrasound can be optimally coupled into the tissue over its surface for the purposes of therapy. The treatment region in the body in terms of distance is fixed by sucking in the tissue. Thus ultrasound can be specifically applied to the body tissue in controlled manner because the distance between the emission point of ultrasound from the applicator and the body tissue is defined.
A sucking in of the body surface and thus the underlying tissue to be treated has the advantage over pressing the applicator onto the body surface in that the soft tissue underlying the surface is not displaced laterally or pushed outwardly. Thus the amount of soft tissue in the region of the applicator is not reduced, but on the contrary, it is drawn into the coupling region of the ultrasound.
In a preferred embodiment of the present invention, the suction apparatus is formed as a suction cup.
This can be realized by providing the applicator with at least one suction cup or forming the applicator itself as a suction cup in order to fix the tissue to the applicator. An embodiment of the applicator formed as a suction cup can be achieved by providing a lip structure at the edge of the applicator, which is flexible and elastic. When pressing the applicator onto the body surface, the lips produce a corresponding counter-force, whereby the body surface is drawn onto the applicator surface. Further, the lips must be configured such that they form a seal with the body surface either alone or together with a sealing substance, whereby the applicator itself should also be sealed.
In a further preferred embodiment, the applicator comprises at least one suction channel opening into the applicator surface, which is connected to an external suction device.
With this measure, a vacuum can be easily generated between the body surface and the applicator surface. A vacuum pressure is applied by the external suction apparatus to the suction channel joining into the applicator surface, whereby the body surface is sucked onto the applicator surface. The suction of the body surface can be further improved by providing a plurality of suction channels joining into the applicator surface. If only one suction channel is provided, it is advantageous to provide it approximately at the center of the applicator su

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