Surgery – Instruments – Electrical application
Reexamination Certificate
2001-02-20
2002-09-03
Cohen, Lee (Department: 3739)
Surgery
Instruments
Electrical application
C606S049000, C219S121360, C219S121540
Reexamination Certificate
active
06443948
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device for stopping a bleeding in living tissue in humans and animals by forming a necrotic layer in the tissue, the device comprising a means for generating a dynamic plasma flow of such a character that it is capable of wholly or partially penetrating an outer, porous layer of the necrotic layer.
The invention also relates to a method for use of such a device.
TECHNICAL BACKGROUND
One way of stopping bleedings in connection with surgery is by forming a necrotic layer (death of living tissue) on the bleeding tissue. Today a plurality of methods are available to form such a layer, inter alia, treatments with a plasma jet, laser irradiation, or electrosurgery. A common feature of all these methods is that a bleeding tissue is supplied with energy, forming a necrotic layer on the surface of the wound, which stops the bleeding. The necrotic layer usually consists of several layers. On the outside a porous necrotic layer forms, where the fluid component of the tissue has been vaporised by the supplied energy. The inner boundary of the porous layer thus constitutes the fluid limit of the tissue. Underneath this layer proteins in the tissue are denatured because of a rise in temperature, whereby a compact necrotic layer forms. The two layers together form the necrotic layer which stops the bleeding.
In order to stop the bleeding efficiently the necrotic layer has to be formed at a higher speed than the flow rate of the blood out of the tissue. At the same time the effect adjacent to the surface of the tissue must not be too great since the outer, porous layer is sublimed at temperatures that are too high. The problem is made worse by the low heat conductivity of the porous layer.
A device which utilises a plasma jet to form the necrotic layer is known from SE 503 334. The device which is described in this publication has the advantage of providing a dynamic plasma flow, the character of which is such that it is capable of penetrating an upper porous necrotic layer, such that when the plasma jet is directed towards a tissue, a great part of the flow energy is conducted to the fluid limit of the tissue.
The above device operates well to stop small to middle-sized bleedings. Bleedings from blood-vessels with a diameter of 3 and 4 mm for arteries and veins, respectively, can be successfully stopped. However, in connection with very heavy bleedings, such as from thick blood vessels within, for instance, the liver, the blood stopping capacity is insufficient.
Another known technique for stopping bleedings by forming a necrotic layer on the tissue is the electrosurgical technique, which is shown in, for instance, U.S. Pat. No. 4,781,175. Here electric high-frequency energy is conducted from an electrosurgical generator through a circuit comprising a gas jet, which is directed towards the tissue, the patient, and a diathermic plate connected to the patient. The electric energy is conducted to the tissue by the gas jet in the form of a diffuse current. This causes necrosis on the surface of the tissue. The formed necrotic layer is compact and relatively thin, and therefore, this technique can only be used in connection with small, capillary bleedings.
In order to stop a more extensive bleeding a larger amount of electric energy is required. As the amount of energy from the generator thus increases, electric arcs and sparks between the surgical instrument and the tissue appear. During the use of large amounts of energy a necrotic layer is formed, which consists of both a compact and a porous layer. Because of the influence of the sparks and the electric arcs, the porous layer is, however, formed with depressions and is more porous, and thus also brittler than desired. Moreover, in the formation of electric sparks there is a rectification of the alternating current, a rectified current passing through the patient. This current causes an unintentional excitation of nerves and muscles. This excitation can be injurious in connection with, for instance, heart diseases. Another disadvantage is that relatively high voltages (2000 V) are required to obtain a satisfying effect.
The use of the method is limited to middle-sized bleedings owing to, inter alia, the previously mentioned problem caused by the insufficient heat conductivity and sublimation of the porous layer. Neither does the necrotic layer form so quickly that a bleeding from, for instance, a thick blood-vessel can be stopped.
SUMMARY OF THE INVENTION
The object of the present invention is to provide a device, which allows a better and quicker stopping of a bleeding. In particular, it should be possible to stop heavy bleedings from relatively thick blood-vessels. At the same time the patient should not risk being exposed to potentially injurious, rectified currents.
According to the invention, this object is achieved by means of a device which comprises a means for generating a dynamic plasma flow of such a character that it is capable of wholly or partially penetrating an outer, porous layer of the necrotic layer. The device is characterized in that an electrosurgical generator is arranged to transfer electric energy to the fluid limit of the tissue through a circuit, which comprises the plasma flow and the tissue.
The above device is used according to the inventive method, which comprises the steps of generating the plasma flow and directing it towards a bleeding tissue, whereby a necrotic layer comprising a porous and a compact layer forms in the bleeding tissue. Electric high-frequency energy is transferred to the tissue through an electric circuit which comprises the plasma jet and the tissue, the electric energy being conducted through the plasma jet to the fluid limit of the tissue for increasing the thickness of the compact necrotic layer.
The dynamic, hot plasma flow quickly forms a necrotic layer on the tissue. The formed outer, porous necrotic layer has no depressions. Furthermore, the plasma flow is a nearly ideal conductor for the electric energy, which owing to the penetrating effect of the plasma is conducted directly to the fluid limit of the tissue, where it quickly causes an increase of the compact layer in the necrotic layer. The voltage in the electrosurgical generator can be low (<200 V), and neither sparks nor electric arcs appear. Thus there will be no difficulties in rectifying the alternating current from the generator.
Preferably, one of the poles of the electrosurgical generator is connected to an electrode in the plasmagenerating means and its other pole to a diathermic plate to be connected to the patient.
Advantageously, an electric switch is arranged for manually switching on and off the electrosurgical generator. It is then possible to use a method where electric high-frequency energy is supplied instantaneously to stop especially heavy bleedings in the tissue, for instance, in thick blood-vessels. In this case the electrosurgical function is used only when necessary. The plasma function is sufficient on most of the wound surfaces. Thus, the device and the method will be flexible and easy to use in connection with different types of surgery.
Preferably, the outer casing of the plasmagenerating means is an electrically non-conductive body. Otherwise, further insulation is required to prevent the casing from being conductive when the electrosurgical generator is switched on.
REFERENCES:
patent: 4781175 (1988-11-01), McGreevy et al.
patent: 4901720 (1990-02-01), Bertrand
patent: 5843079 (1998-12-01), Suslov
patent: 503 334 (1996-05-01), None
Cohen Lee
Nikval International AB
Pillsbury & Winthrop LLP
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