WO2010049176A1

WO2010049176A1 - Medical device for treating tumor tissue

Info

Publication number: WO2010049176A1
Application number: PCT/EP2009/007798
Authority: WO
Inventors: Axel Erich Theuer
Original assignee: Walter, Gerhard Franz
Priority date: 2008-10-31
Filing date: 2009-10-30
Publication date: 2010-05-06
Also published as: DE102008054083A1

Abstract

The invention relates to a medical device for treating tumor tissue, comprising a surgical instrument (16) that can be inserted into a body and has a housing (11) in which an oscillating element (12) is arranged, which can be actuated so as to generate an ultrasound oscillation, and in particular can be coupled to a frequency generator (20). A transmission region (13) is associated with the oscillating element (11), said region comprising at least in some areas a wall (11a, 11b, 11c) of the housing (11) that faces the tumor tissue to be treated during use. The transmission region (13) is designed such that during use the ultrasound oscillations are transmitted into the tumor tissue to be treated. The invention is characterized in that the transmission region (13) interacts with at least one temperature control device.

Description

Medical device for the treatment of tumor tissue

description

The invention relates to a medical device for the treatment of tumor tissue according to claim 1. Such a medical device is known for example from US 2002/0003385 Al.

The aforementioned US 2002/0003385 Ai discloses a medical device for the selective destruction and removal of tissue with ultra-high-frequency ultrasound. The known device comprises a surgical instrument insertable into the body with a tubular housing, wherein the surgical instrument can form the tip of a catheter. In the region of the free end of the surgical instrument or the housing, a piezoelectric element for generating the ultrasonic vibrations is arranged. The piezo element is covered at the free end of the housing with an elastic material. The known device further comprises an extracorporeally arranged frequency generator, which is connected by cables to the piezoelectric element and electrically transmits the vibration signals for generating the ultrasonic vibration to the piezoelectric element.

The known device is used for removing or destroying unwanted body tissue, for example fat cells, prostate tissue or cancer cells. For this purpose, the tip of the surgical instrument is brought with the vibration element to the tissue to be treated, so that the flexible material at the free end of the instrument is flush with the tissue to be removed. In use of the known device, a high-frequency ultrasonic vibration is generated with the frequency generator and the piezoelectric element at the tip of the catheter. The high-frequency vibrations, ie oscillations of at least 50 MHz, preferably 90-100 MHz, are transmitted to the tissue directly adjacent to the catheter tip. The high ultrasonic frequencies cause a swing of the The catheter tip adjacent cell membranes so that they break, causing the cells arranged directly in the region of the catheter tip are destroyed. The penetration depth of the high-frequency ultrasonic vibrations is less than one millimeter due to the short wavelength. In order to achieve sufficiently high oscillation amplitudes in the cell membranes so that the cell membranes burst open, it is provided in the known device to provide an ultrasound intensity of at least 100 mW / cm ² .

The high frequencies in combination with the relatively high ultrasound intensities or powers cause transmission of the vibrations beyond the tissue area arranged directly in the region of the piezoelectric element, so that in the known device damage to healthy cells can not be ruled out. In particular, there is the risk in the known device that healthy, surrounding tissue is thermally damaged due to the high ultrasonic frequencies due to heating. The surgical instrument according to US 2002/0003385 A1 thus essentially acts in accordance with an ultrasound scalpel, with which tissue in the immediate region of action of the vibration-generating component, in particular the piezoelectric element, is destroyed. Therefore, an exact positioning of the instrument is required. In the event of a deviation from the position of the tissue to be treated, there is a risk of damaging healthy tissue, since the generated ultrasonic vibrations act equally on healthy as well as on malignant or treated tissue.

The invention is therefore based on the object to provide a medical device for the treatment of tumor tissue, which allows safe and easy handling and with the damage to healthy tissue is avoided.

According to the invention the object is achieved by the subject matter of patent claim 1.

The invention is based on the idea to provide a medical device for the treatment of tumor tissue comprising a body-insertable surgical instrument with a biocompatible housing in which a Vibration element is arranged, which can be actuated to generate an ultrasonic vibration, in particular with a frequency generator is coupled, wherein the vibration element is associated with a transmission region which at least partially comprises a wall of the housing, which is arranged in use facing the tumor tissue to be treated, and adjusted the transmission range is to transfer in use the ultrasonic vibration in the tumor tissue to be treated, wherein the transmission area cooperates with at least one tempering device.

It has been shown that tumor cells or tumor tissue in general have a changed vibration behavior compared to healthy cells. Tumor tissue and healthy tissue differ in particular in the respective resonance frequency. It has also been recognized that the difference in resonance frequencies can be significantly increased by the influence of heat. Therefore, it is proposed in the medical device according to the invention to combine the ultrasonic treatment with a heat treatment.

By the surgical instrument with the vibration element, the tumor tissue to be treated is directly applied with an ultrasonic vibration. Preferably, a low-frequency ultrasonic vibration is used. The ultrasonic frequency range of the low-frequency oscillation used can be, for example, 0.5 kHz-500 kHz, in particular 1 kHz-300 kHz, in particular 20 kHz-60 kHz.

The device according to the invention is operated with relatively low ultrasound intensities, wherein a mechanical destruction of the tumor tissue and in particular the initiation of natural destruction processes, for example apoptosis, are in the foreground.

The medical device according to the invention further comprises a transmission region, via which the ultrasound vibration is introduced to the tissue to be treated during use. In the context of the invention, the transmission region refers to the region which is in use, ie when positioning the surgical device Instrument within the body, is arranged on the tissue to be treated or touches the tissue to be treated. In particular, the transfer area constitutes a part of the surgical instrument which is arranged between the tissue to be treated and the oscillation element.

The tempering device, which cooperates with the transfer region, ensures that the tissue to be treated or the tissue area which comprises the tumor tissue to be treated is heated. The heating takes place deliberately in the region of the tissue to be treated, ie essentially in the region in which the ultrasonic vibration also acts. The heating can be effected by direct contact with the heating device and / or by introducing certain amounts of a heated treatment medium or generally a tempered liquid into the tissue to be treated. In this way, the selectivity of the destruction effects achieved in the tumor tissue by the ultrasonic vibration is increased. Damage to the healthy tissue is avoided by the ultrasonic oscillation which is selectively matched to the resonance frequency of the tumor cells. The tempering device has the function of creating a temperature gradient between the tumor tissue and the healthy tissue, which can be enhanced by cooling the healthy tissue. For example, by the targeted heating in the tissue area, which includes the tissue to be treated, ie the effective range, a temperature of at most 42 ⁰ C, in particular at most 41 ⁰ C, in particular at most 40 ⁰ C set.

Preferably, the tempering is arranged in the transmission area. The combination of the transmission range with the tempering device ensures that the heat energy generated by the tempering device acts essentially in the same tissue area as the ultrasonic vibrations transmitted over the transmission range. The efficiency of the treatment is thus increased.

The tempering device may comprise at least one electric heating coil. Electric heating coils have the advantage that the heat transfer into the tissue to be treated is easy and easy to control. Furthermore, electrical Heizspiralen a relatively small size and are suitable for installation in small surgical, especially microsurgical, instruments.

Alternatively or additionally, the tempering device may comprise at least one tubular conduit in which a tempering fluid is guided. The use of a tempering fluid or a temperature-controlled liquid has the advantage that the tissue to be treated can not only be heated, but if necessary can also be cooled. In particular, it is possible with the tempering fluid to keep the temperature in the tissue area to be treated substantially constant. In this way, temperature fluctuations in the treatment area can be compensated, which can be caused by the ultrasonic treatment.

The tubular conduit may form a closed fluid circuit. This ensures that the tempering fluid does not interact with the tissue to be treated or generally the body. Furthermore, in the case of the closed fluid circuit, a relatively small amount of the tempering fluid is required.

Alternatively, the tubular conduit may have at least one opening, so that the tempering fluid or treatment medium can be introduced into the tumor tissue to be treated. For a particularly targeted temperature of the tumor tissue to be treated is possible. The direct contact of the tempering fluid or treatment medium with the tumor tissue to be treated enables a particularly efficient transfer of heat. ultrasound induced

Temperature fluctuations, such as cavitation effects, are particularly effectively buffered or compensated in this way, since the tempering fluid or the treatment medium dissipates the heat generated by the ultrasonic treatment additional heat energy, for example, the Kavitationswärme from the treatment. Suitable tempering fluids or treatment media are, for example, medicinal water, isotonic saline solution (NaCl 0.9%) or glucose solution, without being limited to these media. The use of such a biocompatible tempering fluid or treatment medium has the further advantage that the liquid content in the tumor cells is increased by the supply of the tempering fluid to the tumor tissue to be treated, whereby the selectivity in the ultrasound treatment is further increased. Due to the increased liquid content, in particular water content, therefore, in addition to or as an alternative to the temperature difference between tumor cells and healthy tissue, the selective treatment of the tumor tissue is improved and damage to the healthy tissue is avoided.

It is possible that the heating device has both an electric heating coil, as well as a tubular conduit for guiding a tempering fluid. The combination of an electric heating coil with a tubular conduit, in particular a tubular conduit having an opening for introducing the tempering fluid into the tumor tissue, on the one hand enables the tumor tissue to be treated to be heated at the beginning of the treatment by means of the heating coil. On the other hand, it is made possible by the tempering fluid in the further course of the treatment that during treatment a substantially constant temperature is maintained in the treatment area.

In a preferred embodiment of the medical device according to the invention, the vibration element comprises at least one piezoelectric element. The piezoelectric element allows a compact design and good controllability of the therapeutically effective ultrasonic vibration.

The piezoelectric element may be annular or semi-annular. In addition to the compact design is achieved with the annular or semi-annular piezoelectric element, that the generated ultrasonic vibration propagates selectively under a certain solid angle.

Preferably, the vibration element, in particular the annular piezoelectric element, is arranged coaxially to a longitudinal axis of the surgical element.

The surgical instrument, in particular the housing, can comprise at least one upper shell and at least one lower shell, which can be connected or connected to one another in an articulated or fixed manner. The two- or multi-part design allows for simplified handling of the surgical instrument. Such a surgical instrument, for example, for the treatment of Tumor cells are used in blood vessels, the instrument can be positioned by the two- or multi-part structure simply surrounding the blood vessel. The parts or partial shells can be loosely positioned relative to each other or connectable to each other.

The upper shell and the lower shell can be tensioned against each other by a clamping device. In this way, a particularly good contact between the upper shell and the lower shell is produced, so that the ultrasonic vibration generated by the vibration element disposed within the upper shell and / or the lower shell can propagate substantially lossless over the upper shell and the lower shell.

In a preferred embodiment, the surgical instrument, in particular the housing, is cuff-shaped or tubular, wherein the transmission region is arranged such that, in use, the ultrasonic vibration is transferable radially inwardly. In this way, it is possible to specifically treat tumor tissue or tumor cells in body regions that can be enclosed in a ring shape by the surgical instrument. For example, with the sleeve-like surgical instrument, in particular in conjunction with an articulated connection of the upper shell to the lower shell or generally the two- or multi-part structure of the surgical instrument, a treatment of tumor cells or metastases occur that occur in blood vessels. For this purpose, the surgical instrument can enclose the blood vessel, wherein the ultrasound oscillation is transmitted radially inward into the blood vessel or the bloodstream. In general, with the tubular surgical instrument, it is possible to treat tumor cells on organs or, in general, on treatment sites which are tubular or cylindrical in shape. The treatment is therefore not limited to blood vessels, but includes, for example, the esophagus, the bronchi or intestinal sections.

Preferably, the tempering device is arranged in a wall of the surgical instrument. An arrangement of the tempering device is preferably such that the delivery of the required amounts of heat takes place in the radial direction. For a radially inward heat dissipation, the tempering device is preferably arranged in a radially inner wall. For a radially outwardly directed heat output, an arrangement of the tempering device in a radially outer wall is advantageous. In this way, in the treatment of tubular body areas targeted heat can be introduced into the tissue areas to be treated.

In a further preferred embodiment, the surgical instrument is spherical, wherein the transmission region comprises an outer wall of the spherical surgical instrument. The surgical instrument may also be cylindrical and have at least one substantially semicircular termination. The described forms enable efficient treatment of tumor tissue in body cavities, thereby achieving that the surgical instrument can be easily and with minimal risk of injury introduced into the body cavity. The transmission region comprises the outer wall of the surgical instrument, so that the generated ultrasonic vibration propagates substantially in all spatial directions or at least over a large solid angle. In this way, a simultaneous treatment of a relatively large tissue area is made possible, so that the treatment time is reduced.

The tempering device can be arranged in the outer wall of the surgical instrument. Thus, a heating of the tissue area is achieved, which is acted upon by the ultrasonic vibration. The selectivity between healthy cells and tumor cells is thereby increased.

The tensioning device for tensioning the upper shell against the lower shell or generally the parts of the surgical instrument to be connected may comprise a screw connection, in particular a fitting screw connection. For example, clamping screws can be used for the screw connection.

Preferably, the vibration element, in particular the vibration-generating piezoelectric element, is arranged coaxially to the screw connection and surrounds the Screw connection annular. The vibration element or piezoelectric element is thus arranged between the upper shell and the lower shell and advantageously braced by the screw connection with the upper shell and the lower shell, so that the generated ultrasonic vibration is transmitted substantially lossless in the upper shell and the lower shell.

In a further preferred embodiment of the medical device according to the invention, the surgical instrument comprises a sonotrode or hollow sonotrode. The sonotrode may have a substantially cathenoidal shape. The catenary shape allows for improved transmission of the ultrasonic vibration into the tissue to be treated. With the relatively narrow, cathenoidal shape is also achieved that the surgical instrument for treatment requires a relatively small import channel into the body. Therefore, the sonotrode is suitable for minimally invasive surgical approaches.

Preferably, the sonotrode has a Sonotrodenfuß in which the vibration element is arranged and a sonotrode tip, in which the transmission region is arranged. The arrangement of the vibration element in the Sonotrodenfuß is advantageous because the Sonotrodenfuß is preferably arranged outside the body during the treatment. This avoids that the vibrating element, which is subjected to an electrical voltage, leads to injuries within the body in case of malfunction. Rather, it is achieved by the kathhenoidale form of the sonotrode that the ultrasonic vibrations generated in Sonotrodenfuß are conducted into the sonotrode tip. The ultrasonic vibrations propagating in the axial direction of the sonotrode are thereby amplified, ie the amplitude of the ultrasonic vibration is increased. The amplification factor depends on the shape and length of the sonotrode. In the sonotrode tip of the transmission area is arranged. The ultrasonic vibration generated in the sonotrode is thus guided to the tip of the sonotrode within the sonotrode and exits the surgical instrument in the area of the sonotrode tip. The treatment thus takes place in the tissue area which is arranged substantially directly on the sonotrode tip. The tempering device is preferably arranged in the sonotrode tip. Thus, the temperature increase according to the invention in the treatment area, ie in the area in which the ultrasonic vibration acts reached.

The sonotrode tip may be paraboloidal, hemispherical, or convex such that the ultrasonic vibration is focusable. The ultrasound vibration amplified via the sonotrode can thus be used selectively in individual tissue areas, so that particularly small areas can be treated with tumor tissue. The focusability allows a particularly targeted treatment of tumor cells.

Furthermore, the sonotrode may comprise a temperature and / or Beschieunigungssensor disposed in the sonotrode tip. Preferably, the temperature and / or acceleration sensor are connected to a controller, which is further coupled to the tempering device and the vibration element or the frequency generator, so that the treatment parameters with respect to the ultrasonic frequency, the ultrasound intensity, the pulse duration and the tissue temperature in dependence of the measured values of the temperature - And / or acceleration sensor are controllable. In this case, the temperature sensor measures the tissue temperature in the treatment area, so that the temperature generated in the treatment area controllable, especially in conjunction with an automatic control is adjustable. The measured values of the acceleration sensor serve to control the ultrasonic amplitudes actually generated in the region of the sonotrode tip and the amplitude amplification effected along the sonotrode and to set the frequency generator, so that the amplitudes of the ultrasonic vibration acting on the tissue can be adapted to the medical application. The adaptation can take place automatically in connection with a control.

The sonotrode tip can have a supply opening for the tempering fluid, in particular a specifically heated treatment medium, and / or for active ingredients, in particular sonosensitizers or microbubbles. Through the supply opening in the sonotrode tip, it is possible, the active ingredients directly and simultaneously with the To bring treatment in the tissue to be treated. The supply opening may be connected to the tempering device, in particular a line for the tempering fluid. The feed opening can also be assigned to a separate feed line for a tempering fluid or active substances, for example a separate supply channel.

Preferably, the feed opening is connected by an active ingredient line with a arranged in Sonotrodenfuß supply device. Such a feeder may be a commercially available luer connector. As a result, the active substances, as in other medically customary methods, can easily be introduced into the tissue to be treated with the aid of a syringe.

The invention is explained in more detail below on the basis of embodiments with reference to the accompanying schematic drawings. Show in it

1 is a perspective view of a surgical instrument according to a preferred embodiment of the medical device according to the invention;

2a, 2b, 3 each show a longitudinal section through a surgical instrument according to a further preferred embodiment;

4 shows a cross section through a surgical instrument according to a further preferred embodiment;

5 shows a medical device according to the invention according to a preferred embodiment with a longitudinal section through the surgical instrument; and

6a, 6b a detail view of the surgical instrument according to FIG. 5.

1 shows a surgical instrument 10 of a medical device for treating tumor tissue, with a tubular housing 11. The housing 11 comprises two half-shells, which are each channel-shaped, ie have a semicircular cross-section. The two half-shells are hinged together. Other compounds, in particular loose or solid compounds are possible. The hinged connection includes a hinge 14 that extends in the axial direction along the surgical instrument 10. The hinge 14 can also be arranged at an axial end of the half-shells or the surgical instrument 10 in an alternative embodiment. Opposite the joint 14, a clamping device 15 is also provided for connecting the two half-shells. The tensioning device 15 may comprise, for example, a screw or snap connection. Other types of connection, which allow a distortion of the two housing shells together, are conceivable. The housing ü preferably forms a sleeve which has a material which blocks or at least reduces a propagation of ultrasonic waves.

Within the cylindrical housing at least one vibration element 12 is arranged. The vibrating element 12 comprises two semi-annular segments which in use are assembled so as to form a complete ring. The vibration elements preferably comprise piezo elements. The connecting surfaces of the two vibration elements 12 are preferably arranged at an angle with respect to the axis of rotation of the instrument, in particular perpendicular to the connecting surfaces of the housing 11. Furthermore, temperature control channels 16 are provided which form a tempering device and extend substantially in the axial direction of the surgical instrument 10. The tempering device or the tempering channels 16 can also be arranged in an inner wall IIb or generally in a transfer area 13. Through the tempering channels 16, a tempering fluid, in particular a tempered liquid, be performed. As an alternative or in addition to the temperature control channels 16, at least one heating coil can furthermore be provided, which performs a heating function by means of an applied voltage. The tempering device may also comprise heating mats or an electrical heating layer, for example an electrical resistance heater. The heating layer is preferably arranged on a radially outer or radially inner cylinder jacket surface of the hollow cylindrical housing, so that a Heat is released radially in the direction of the tumor tissue to be treated. Other heating variants are not excluded.

On a radially inwardly facing side of the vibration elements 12, the transmission region 13 is arranged. The transfer area 13 forms part of the housing 11, i. the transfer region 13 comprises a wall of the housing 11, which in use faces the tissue to be treated. The transfer region 13 comprises a biocompatible material that allows transmission of the ultrasonic vibrations from the vibratory elements 12 into the tissue to be treated.

The medical device or the surgical instrument 1 according to FIG. 1 is preferably used for the treatment of tumor tissue in tubular or tubular body vessels, in particular in a blood vessel 40. For this purpose, the surgical instrument 10 is placed in the body during a surgical procedure. In the treatment of tumor cells, in particular blood metastases, in blood vessels 40, the articulated connection of the two housing shells allows the device to be positioned without damaging the blood vessel 40. The blood vessel 40 is enclosed by the surgical instrument 10. For this purpose, the surgical instrument 10 is preferably dimensioned such that the blood vessel 40 or the vessel wall rests against an inner wall IIb of the housing 11, in particular on the transfer region 13. For the treatment of the blood metastases, the vibration elements 12 are vibrated, so that an ultrasonic vibration is generated which acts on the blood metastases or tumor cells and leads to destruction or initiation of an apoptotic process in the tumor cells. The ultrasonic propagation or direction of the ultrasonic propagation is influenced by the material properties of the housing 11. In the embodiment of FIG. 1, the outer half shells of the housing 11 are made of a material which prevents or limits a propagation of the ultrasonic vibrations. By contrast, the transmission region 13 is adapted such that the ultrasonic vibrations are transmitted from the vibration elements 12 into the tissue to be treated, in particular the blood vessel 40. For this purpose, the inner wall IIb of the housing 11, the Transmission area 13 forms, for example, titanium include. An outer wall IIa of the housing 11 preferably comprises a biocompatible material.

It is possible that the device according to FIG. 1 comprises more than two vibration elements 12 or more than two segments of the vibration elements 12. It is also possible that the housing 10 has more than two housing shells.

The surgical instrument 10 according to FIG. 2a comprises a housing 11 with an outer wall IIa and an inner wall IIb. Between the outer wall IIa and the inner wall IIb, a vibration element 12 is arranged. The housing 11 and the vibration element 12 are each tubular or have a circular cross-section. The outer wall iia biases the transmission region 13, so that the ultrasonic vibrations generated by the vibration element 12 can propagate radially outward. The outer wall IIa further comprises a tempering or tempering 16, in which heating spirals are arranged. Alternatively, a tempering fluid, in particular a heated fluid, can be passed through the temperature control channels 16. It is also possible that the inner wall IIb additionally comprises tempering channels 16. The tempering device allows tempering, i. heating and / or cooling the tissue to be treated.

The cavity formed by the cylindrical surgical instrument 10 forms a drug line 17. The drug line 17 is connected to a supply device (not shown). The delivery device preferably comprises a connector for connecting a syringe, which in use is located outside the body. In this way, a tempering fluid or a specifically heated treatment medium, optionally with an active substance, can be introduced into the tissue to be treated or into the treatment area. Such agents may be, for example, sonosensitizers or microbubbles. Thereby, the selectivity between the tumor cells and healthy cells can be increased. The efficiency of the treatment is increased by the addition of sonosensitizers and / or microbubbles. The housing 11 completely surrounds the vibration element 12, ie the outer wall IIa is connected at the axial ends of the surgical instrument 10 by a side wall 11c. The side wall 11c may be associated with both the outer wall IIa, and the inner wall IIb, ie either have the same material as the outer wall IIa or the inner wall IIb. Other materials are also possible. Depending on the medical purpose, therefore, the side wall 11c may allow propagation of the ultrasonic vibrations or limit the propagation of the ultrasonic vibrations. It is possible that the side wall 11c, as shown in Fig. 2b, is formed hemispherical. The hemispherical termination reduces the risk of injury when using the surgical instrument. Other, in particular the risk of injury minimizing forms of the side wall iic are possible.

The surgical instrument 10 also has an acceleration sensor 18, which is preferably arranged in the transmission region 13. The acceleration sensor

18 allows a measurement of the ultrasonic amplitudes that act on the tissue to be treated. Preferably, the acceleration sensor 18 is formed like a film and connected to the outer wall IIa of the housing 11, in particular glued. The acceleration sensor 18 can also be arranged within the outer wall IIa. Furthermore, the surgical instrument 10 has a temperature sensor

19, which measures the temperature in the tissue to be treated. The temperature sensor 19 is also preferably connected to the outer wall IIa. It is possible that a plurality of acceleration sensors 18 and temperature sensors 19 are provided.

FIG. 3 shows a further exemplary embodiment of the surgical instrument 10, the structure essentially corresponding to the surgical instrument 10 according to FIG. 2 a. The difference is that the surgical instrument 10 according to FIG. 3 comprises a plurality of vibration elements 12, which are of annular design. The housing 11 is substantially flexible, so that the ring-shaped vibration elements 12, which are arranged spaced apart in the axial direction, can be arranged at an angle to each other, so that the surgical instrument 10 assumes a curved shape. The surgical instrument 10 has Thus, increased flexibility and is suitable for positioning in body cavities, which have a curvature. In addition, the spaced-apart arrangement of a plurality of vibration elements 12 between them allows radial openings, which allow the supply of a tempering fluid or a specifically heated treatment medium, optionally with one or more active ingredients over the entire length of the device.

It is also possible that the surgical instrument 10, as shown in Fig. 4, is spherical. In this case, the housing 11 on two hemispheres, which are connected to a clamping device 15, in particular a dowel screw 15 a, with each other. The dowel screw 15 a is disposed substantially at the center of the spherical surgical instrument 10. The dowel screw i5a is surrounded by two vibration elements 12, which are annular. Another number of vibration elements 12 is possible. The housing 11 comprises a tempering or tempering 16, which are arranged in the half-shells. The tempering channels 16 can be arranged in a half shell or both half shells. The surgical instrument according to FIG. 4 comprises four tempering channels 16. A different number of tempering channels 16 is possible. The temperature control channels 16 may comprise a tempering fluid. The tempering device may also have at least one heating coil. A combination of the heating coil with the tempering 16 or other means or devices for heat transfer or generation are possible.

The tensioning device 15, in particular the dowel 15 a allows a firm connection of the two hemispherical housing shells, in particular with the vibration elements 12, so that an effective or efficient transmission of the ultrasonic vibrations of the vibration elements 12 via the housing 11, in particular the transmission area 13, by the Housing 11 is formed, is achieved in the tissue to be treated. The housing 11 preferably comprises half shells made of titanium or stainless steel.

The device according to FIGS. 2 a, 2 b, 3 and 4 are preferably used for treating tumor tissue in body cavities, in particular in the intestine. there the ultrasonic propagation takes place in the radial direction to the outside. It is also possible that by suitable choice of material of the inner wall IIb or outer wall IIa in the cylindrical surgical instruments 10 according to Figures 2a, 2b and 3, the sound propagation takes place radially inwards, so that the cylindrical device can also be used for the treatment of blood metastases. In this case, the surgical instrument can be used as an interponate in a vessel, for example a blood vessel 40. This can be done, for example, by separating the blood vessel 40 to be treated and sewn the surgical instrument 10 between the open vessel ends by conventional vascular surgical technique.

In principle, the direction of the ultrasonic propagation can be influenced by the fact that at least one wall of the housing 11 is relatively rigid and another wall is flexible.

The transfer region 13 preferably comprises a material with a high sound propagation speed, for example titanium or stainless steel.

The cylindrical embodiments according to FIGS. 2 a, 2 b and 3 can furthermore have radially outwardly directed openings (not shown) or bushings, so that the active substances from the active substance line 17 can be introduced radially outwards into the tissue to be treated. The radially outwardly directed openings can also be connected to the tubular conduits or tempering channels 16 so that the tempering fluid or the heated treatment medium can be introduced into the tissue to be treated. The tempering fluid may comprise active ingredients.

The surgical instrument 10 for the treatment of tumor tissue in the intestine can be coupled to a colonoscope or general endoscope, so that the surgical instrument 10 can be easily brought to the treatment site.

An appropriate treatment method includes, for example, the following steps without limiting the invention thereto: The surgical instrument 10 coupled to a colonoscope or generally to a suitable delivery device is inserted into the intestine or other cavity. Once the surgical instrument 10 is positioned at the treatment site, the colonoscope or endoscope is released and removed. The connection between the colonoscope and the surgical instrument 10 may comprise, for example, a screw connection or clamping connection, ie in general a positive or frictional connection. A magnetic coupling is also possible. Other types of connections are not excluded. The power supply of the surgical instrument 10 via cables 57, which are guided out of the body to the outside. Since only the surgical instrument 10 remains within the body, the therapy can be performed patient-friendly and continuously. Preferably, the therapy is carried out at regular time intervals, so that the number of endoscopic interventions is reduced by the coupling of the surgical instrument 10 with a colonoscope or general endoscope, since the surgical instrument 10 remains between the treatment intervals in the body.

It is also conceivable to use the surgical instrument 10 for the treatment of other hollow vessels of the body, for example the esophagus, the urethra, the stomach, the pancreas or blood vessels, wherein the coupling with corresponding supply devices, such as endoscopes or catheters, is to be used accordingly.

In order to couple the ultrasonic vibrations in the treatment in the tissue, it is provided in the context of the method, between the intestinal wall and the surgical instrument 10, a liquid, in particular water layer to provide. Advantageously, the intestine is rinsed with water or the treatment medium, in particular the tempering fluid, at least in the area of the treatment site. The water preferably has body temperature, ie 37-38 ⁰ C on. The tempering device 30 generates a temperature of 40-42 ° C. locally in the tissue to be treated, ie in the effective range of the ultrasonic oscillation. At these temperatures, the selectivity between tumor cells and healthy cells is increased without damaging the healthy tissue. FIG. 5 shows a further preferred embodiment of the medical device according to the invention. The sonotrode 50 has a sonotrode tip 51, a sonotrode neck 52 and a sonotrode 53. The sonotrode 50, in particular the sonotrode tip 51 and the sonotrode neck 52, is of rotationally symmetrical design, in particular cathenoidal or paraboloid-like. Other geometric shapes are possible, for example, the sonotrode neck 52 may have an oval cross section instead of a circular cross section. The sonotrode tip 51 may also be concave-shaped, ie comprise a curvature curved in the direction of the sonotrode base 53, so that the ultrasonic vibrations can be focused. The sonotrode 53 includes a counterweight 54 and a stereotactic triaxial control (not shown). In Sonotrodenfuß 53 also vibration elements 12, in particular piezores are arranged. The size of the piezor rings is essentially dependent on the ultrasonic frequency to be generated. The vibrating element 12 is electrically coupled to an amplifier 21 which is connected to the frequency generator 21 and amplifies the ultrasonic signal generated therein. The medical device further comprises a computer 22, an amplitude controller 23 and a temperature controller 24. The temperature controller 24 is connected to the tempering device or the temperature control channels 16, in particular electrical heating coils (not shown) in the sonotrode tip 51. The sonotrode tip 51, in particular an acceleration sensor 18 arranged therein, is connected to the amplitude control 23. The amplitude controller 23 is further connected to the frequency generator 20 and the computer 22. With the amplitude control 23, the ultrasonic amplitudes acting in the region of the sonotrode tip 51 are measured and evaluated by the computer 22. Based on the measured values, the ultrasonic frequency generated in the frequency generator 20 is controlled.

Due to the geometric shape of the sonotrode 50, the ultrasonic vibrations, in particular the amplitudes generated by the vibration element 12, are amplified when propagated in the direction of the sonotrode tip 51. The amplified ultrasonic vibrations are transmitted from the sonotrode tip 51 or via the transmission region 13 formed by the sonotrode tip 51. By the Reinforcement of the ultrasonic vibrations ensures a particularly efficient treatment.

As can be seen in detail in FIGS. 6a, 6b, the sonotrode tip 51 is constructed in several parts, in particular in two parts. In particular, the sonotrode tip 51 comprises an end piece 51 a, which delimits the axial, free end of the sonotrode 50. Tempering channels 16, in particular heating spirals, are arranged in the end piece 51a. The heating coils and the temperature control channels 16 together form the tempering device. To connect the tempering or the heating coils with the temperature control 24, the sonotrode 50 has a supply channel 55 which extends from the end piece 51a of the sonotrode tip 51 to the sonotrode 53, in particular to the vibration element 12. In the supply channel 55, a cable 57 is arranged, which forms the electrical connection between the heating coil 16 and the temperature control 24. Instead of the cable 57 may also be provided a heating line when the temperature control or the Temperierkanäle

16 comprise a liquid tempering fluid. The supply channel 55 may further comprise an active substance line 17, which has a connection possibility or a feed in the area of the sonotrode base 53, so that via the active substance line

17, a tempering fluid or a specifically heated treatment medium, optionally with active ingredients, in particular sonosensitizers or microbubbles, can be introduced into the tissue to be treated. For this purpose, the sonotrode tip 51, in particular the end piece 51a, has openings which are connected to the active substance line 17.

The sonotrode tip 51 can, as shown in FIGS. 6a, 6b, comprise an intermediate piece 51b, which is arranged between the sonotrode neck 52 and the sonotrode tip 51. The intermediate piece 51b is preferably screwed or glued to the end piece 51a and the sonotrode neck 52. Other connection types are possible. Furthermore, the intermediate piece 51b has a recess 56 in which an acceleration sensor 18 is arranged. Another arrangement of the acceleration sensor 18 in the sonotrode tip 51 is possible. For example, the acceleration sensor 18 may comprise a sensor film which is glued to the sonotrode tip 51. The intermediate piece 51b is preferably such clamped between the end piece 51a and the sonotrode neck 52 and clamped with the end piece 51a and the sonotrode neck 52, that an efficient propagation of the ultrasonic vibrations in the direction of the end piece 51a is made possible. The sonotrode neck 52, the intermediate piece 51b and the end piece 51a may have different materials. Preference is given to materials or materials which have a high sound propagation speed and biocompatibility, for example titanium or stainless steel.

The sonotrode 50 is used for example for the treatment of tumor cells in the brain. The narrow, cathenoidal shape of the sonotrode 50 allows a relatively simple and low-risk treatment of brain tumors or metastases. The sonotrode is not limited to treatment in the brain, but is also suitable for the treatment of tumor cells in other body organs, in particular in the pancreas, the breast, the ureter or the coronary vessels. To delineate the ultrasound vibration field, ie in order to limit the tissue area in which the ultrasound waves are particularly efficiently effective, preferably sonosensitizers or microbubbles are introduced into the tissue. The Sonosensitizer can be selected tumor specific.

LIST OF REFERENCES

10 surgical instrument

11 housing

IIa outer wall

IIb inner wall

11c side wall

12 vibration element

13 transmission range

14 hinge

15 clamping device

15a dowel screw

16 tempering channel

17 active ingredient line

18 acceleration sensor

19 temperature sensor

20 frequency generator

21 amplifiers

22 computers

23 amplitude control

24 temperature control

40 blood vessel

50 sonotrode

51 sonotrode tip

51a tail

51b intermediate piece

52 sonotrode neck

53 Sonotrodenfoot

54 counterweight

55 supply channel

56 recess

57 cables

Claims

Medical device for the treatment of tumor tissue claims

A medical device for the treatment of tumor tissue comprising a surgical instrument (16) insertable into a body having a housing (11) in which a vibration element (12) is arranged which is operable to generate an ultrasonic vibration, in particular a frequency generator (20). can be coupled, wherein the vibration element (11) is associated with a transmission region (13) which at least partially comprises a wall (IIa, IIb, Hc) of the housing (11), which is arranged in use facing the tumor tissue to be treated, and the transmission area (13) is adapted, in use, to transmit the ultrasonic vibration into the tumor tissue to be treated, characterized in that the transmission region (13) cooperates with at least one tempering device.

2. Medical device according to claim 1, characterized in that the

Tempering device in the transmission area (13) is arranged.

3. Medical device according to claim 1 or 2, characterized in that the tempering device comprises at least one electric heating coil.

4. Medical device according to claim 1 to 3, characterized in that the

Tempering device comprises at least one tubular conduit in which a tempering fluid is guided.

5. A medical device according to claim 4, characterized in that the tubular conduit forms a closed fluid circuit.

6. A medical device according to claim 4, characterized in that the tubular conduit has at least one opening such that the tempering fluid can be introduced into the tumor tissue to be treated.

7. Medical device according to at least one of claims 1 to 6, characterized in that the vibration element (12) comprises at least one piezoelectric element.

δ. Medical device according to claim 7, characterized in that the

Piezoelectric element is annular or semi-annular.

9. Medical device according to at least one of claims 1 to 8, characterized in that the Schwingungseiement (12), in particular the annular piezoelectric element, are arranged coaxially to a longitudinal axis of the surgical instrument (10).

10. Medical device according to at least one of claims 1 to 9, characterized in that the surgical instrument (10), in particular the housing (11), at least one upper shell and at least one lower shell comprises, which are articulated or firmly connected or connected to each other.

11. Medical device according to claim 10, characterized in that the

Upper shell and the lower shell by a clamping device (15) are mutually clamped.

12. A medical device according to claim 10 or 11, characterized in that the surgical instrument (10), in particular the housing (11), is cuff-shaped and / or tubular, wherein the transmission region (13) is arranged such that in use Ultrasonic vibration is transferable radially inwardly.

13. A medical device according to claim 12, characterized in that the

Tempering device in a wall (IIb) of the surgical instrument (10) is arranged.

14. Medical device according to at least one of claims 1 to 13, characterized in that the surgical instrument (10) is spherical, wherein the transmission region (13) comprises an outer wall (IIa) of the spherical, surgical instrument (10).

15. A medical device according to claim 14, characterized in that the

Tempering device in the outer wall (IIa) of the spherical, surgical instrument is arranged.

16. Medical device according to at least one of claims 11 to 15, characterized in that the clamping device (15) comprises a screw connection, in particular a Passschraubverbindung.

17. Medical device according to claim 16, characterized in that the

Vibration element (12) is arranged coaxially to the screw and surrounds the screw annular.

18. Medical device according to at least one of claims 1 to 17, characterized in that the surgical instrument (10) comprises a sonotrode (50) or hollow sonotrode.

19. A medical device according to claim 18, characterized in that the sonotrode (50) has a substantially kathenoidale shape.

20. Medical device according to claim 18 or 19, characterized in that the sonotrode (50) has a Sonotrodenfuß (53), in which the vibration element

(12), and a sonotrode tip (51) in which the transmission region

(13) is arranged.

21. A medical device according to claim 20, characterized in that the

Tempering device in the sonotrode tip (51) is arranged.

22. Medical device according to claim 20 or 21, characterized in that the sonotrode tip (51) is paraboloidal, hemispherical or convex in shape such that the ultrasonic vibration can be focused.

23. Medical device according to at least one of claims 20 to 22, characterized in that the sonotrode (50) comprises a temperature sensor (19) and / or acceleration sensor (18) which is arranged in the sonotrode tip (51).

24. Medical device according to at least one of claims 20 to 23, characterized in that the sonotrode tip (51) has a supply opening for active substances, in particular sonosensitizers or microbubbles.

25. Medical device according to claim 24, characterized in that the

Supply opening is connected by an active ingredient line (17) with a feed device arranged in the sonotrode base (53).