Apparatus for treating body tissue with ultrasound

Surgery – Instruments – Cutting – puncturing or piercing

Reexamination Certificate

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C606S170000

Reexamination Certificate

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06436114

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates to an apparatus for treating body tissue with ultrasound having a generator and means for transmitting ultrasound into the tissue as well as a hollow probe for removing the treated tissue.
Such an apparatus is described for example in the brochure “SONOTOM 110, Ultraschallaspirator”, 9/95, of the company Berchthold GmbH & Co, Medizin-Elektronik, Tuttlingen, Germany.
Ultrasound is not only used for diagnostic purposes for viewing body structures of varying density, it is also used for therapeutic purposes. Ultrasound is either applied externally to the skin or directly within the body at the tissue to be treated by means of corresponding laparoscopic instruments, optionally with endoscopic control.
As a result of the ultrasound treatment, the tissue is heated and caused to denaturate, the so-called (thermo) coagulation. Apart from heat development, ultrasound has a mechanical effect in the form of so-called cavitation. Sound waves propagate in a medium as periodic density fluctuations of the medium. A volume element of the medium is alternately compressed (higher pressure) and expanded (lower pressure). The lower pressure in a liquid, for example in the cytoplasma of the cells or in the tissue fluid can cause vapor bubble formation, which destroys the cells and tissue.
Such an ultrasound treatment is suited for disintegration or dissolution of soft tissue, for example fat tissue. Generally, ultrasound waves in the region of 26 kHz are employed. The coagulated and/or disintegrated tissue is suctioned into a tube-shaped hollow probe, where in addition a washing means for flushing purposes is normally also provided. The flushing fluid is passed through a hollow space between the probe and an outer shaft. The flushing fluid mixed with the cell or tissue residue is suctioned off through the hollow probe.
Such ultrasound treatments are particularly employed for the destruction of tumorous tissue. It is especially applied in liver surgery, because one can skeletonize, i.e. only tissue can be removed from an organ, for example the liver, without cutting or destroying blood vessels of the organ.
However, since ultrasound can only destroy extremely soft tissue in loose cell structures, an ultrasound treatment of more solid tissue and tumors or other hard tissue is not sufficient. Sharper cutting devices, scalpels, etc. are employed which additionally complicates the operation.
Other medical instruments such as surgical knives or scalpels employ ultrasound, which are set into vibration by means of ultrasound. Such an “ultrasound driven” surgical knife for laparoscopic application is disclosed in WO 93/14708. A knife is slidably arranged in the interior of a shaft, from which it is drawn out for the operation. Ultrasound energy is transmitted directly and exclusively to the knife, which is then excited to undergo vibration. A therapeutic application of ultrasound for tissue disintegration is not possible with this surgical cutting device. In addition, it is not possible to remove the cut tissue parts from the operation field. Furthermore, the device is limited to diameters larger than 1 cm.
A further development of this surgical knife is disclosed in U.S. Pat. No. 5,346,502, which is similar in that ultrasound is applied to the surgical knife for vibration. In this case, an outer diameter of the shaft of 5 mm is achieved. This instrument however is extremely complicated in manufacture, because the shaft is made of PTFE and must be subjected to several expansion and contraction processes. In addition, it is not possible to apply ultrasound to destroy soft tissue with this knife.
The German patent DE 40 42 435 C2 discloses an ultrasound treatment apparatus having a hand piece with an ultrasound oscillator and a plurality of probes connectable to the hand piece. Thus an ultrasound apparatus is provided, which is inexpensive with respect to purchase and maintenance costs and at the same time can be used for the most different applications.
The European patent application EP 0 384 672 A2 discloses an ultrasound probe by which the distal suction opening is variable in its form and size to achieve an optimal suction force for withdrawing treated tissue.
The European patent application EP 0 238 667 A1 discloses an ultrasound instrument whose distal end is formed in spoon shape. A central flushing channel supplies fluid to the spoonlike distal end.
The U.S. Pat. No. 5,188,102 describes a surgical knife driven by ultrasound to undergo vibration. A central flushing channel is provided by which a flushing fluid is fed to the distal end, particularly at an angle of 5° to 90° with respect to the cutting plane.
The U.S. Pat. No. 5,047,043 also describes a surgical knife driven by ultrasound, by which an endoscope is inserted to observe the distal end visually.
The European patent application EP 0 695 535 A1 describes a gripping instrument driven by ultrasound, which can grasp the tissue removed by ultrasound.
The U.S. Pat. No. 5,322,055 describes an apparatus driven by ultrasound, which is suitable for cutting and coagulating. A clamping device provided at the distal end, where the tissue to be coagulated is held between a moveable mouth portion and a stationary mouth portion.
In view of the above background art, an object of the present invention is to provide an improved apparatus for therapeutic treatment of body tissue with ultrasound, which apart from removing soft tissue structures also makes it possible to remove harder tissue structures with constructively simple means.
SUMMARY OF THE INVENTION
According to the present invention, an apparatus of the abovementioned type is provided, which has a cutting blade in the region of the distal end of the hollow probe and a grasping means having a first and a second jaw. In conventional ultrasound devices for therapeutic treatment, the hollow probe serves only to draw off and discharge the coagulated and fluidized cell and tissue components, optionally to further inject a flushing fluid into the operation area and to remove it again.
By providing a cutting blade at the distal end of the probe, i.e. at the probe tip which is open for suction purposes, a multifunctional medical instrument is provided in simple manner. The soft tissue components can be disintegrated and suctioned off and at the same time, more rigid tissue portions which are insensitive to ultrasound, can be cut out and also removed. The effect is exploited, that the end of the probe located in the operation area can be excited to undergo vibration, also in therapeutic ultrasound applications. The vibrating cutting blade has excellent cutting properties, even when the blade itself is comparatively blunt.
The function of destroying tissue in the present apparatus is further enhanced by the heat generation of the therapeutic ultrasound waves. Thus it is possible with a single instrument to simultaneously disintegrate tissue through ultrasound, to cut and/or scrape off with the cutting blade and also to coagulate, whereby the continuously loosened cell or tissue pieces are removed from the operation area.
It will be understood that the cutting blade can be used to separate hard or soft tissue components, for example to separate fat tissue from subcutaneous tissue. Under these circumstances, the apparatus of the present invention is used as a cutting and suction apparatus.
The provisions of the grasping means has the advantage that the present apparatus has two further functions, which are often needed in operations where tissue is to be removed. For example, vessels, nerves, etc. can be grasped and such tissue structures can be cut. When cutting arteries, it is advantageous that the heat generation caused by ultrasound also causes coagulation and therefore helps stop the bleeding.
The grasping and cutting function is necessary especially when solid tissue components are to be removed or to be cut and then removed. When the ultrasound is turned off, the present apparatus becomes a pinching or clamping means with the two jaws arranged at the dista

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