WO2010049176A1 - Medical device for treating tumor tissue - Google Patents

Medical device for treating tumor tissue Download PDF

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Publication number
WO2010049176A1
WO2010049176A1 PCT/EP2009/007798 EP2009007798W WO2010049176A1 WO 2010049176 A1 WO2010049176 A1 WO 2010049176A1 EP 2009007798 W EP2009007798 W EP 2009007798W WO 2010049176 A1 WO2010049176 A1 WO 2010049176A1
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WO
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Patent type
Prior art keywords
medical device
characterized
device according
surgical instrument
tissue
Prior art date
Application number
PCT/EP2009/007798
Other languages
German (de)
French (fr)
Inventor
Axel Erich Theuer
Original Assignee
Walter, Gerhard Franz
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/2202Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N7/02Localised ultrasound hyperthermia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N7/02Localised ultrasound hyperthermia
    • A61N7/022Localised ultrasound hyperthermia intracavitary
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0059Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0071Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a resistor, e.g. near the spot to be heated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12Devices for heating or cooling internal body cavities
    • A61F2007/126Devices for heating or cooling internal body cavities for invasive application, e.g. for introducing into blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N2007/0039Ultrasound therapy using microbubbles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N2007/0043Ultrasound therapy intra-cavitary

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

A medical device for the treatment of tumor tissue

description

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

The above-mentioned US 2002/0003385 Ai discloses a medical device for the selective destruction and removal of tissue with ultrahochfrequentem ultrasound. The known apparatus comprises an insertable into the body surgical instrument with a tubular housing, the surgical instrument may form the tip of a catheter. In the area of ​​the free end of the surgical instrument or of the housing, a piezoelectric element for generating the ultrasonic vibrations is arranged. The piezoelectric element is covered on the free end of the housing with a resilient material. The known apparatus further comprises an extracorporeally arranged frequency generator which is connected by cable to the piezoelectric element and the vibration signals to generate the ultrasonic vibration to the piezoelectric element electrically transmits.

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

The high frequencies in combination with the relatively high ultrasonic intensity or render effect, a transmission of the vibrations via the directly arranged in the region of the piezoelectric element area of ​​tissue, so that damage of healthy cells can not be ruled out in the known device. In particular, in the known device the risk that healthy, surrounding tissue is due to the high ultrasonic frequencies thermally damaged by heating. Thus, the surgical instrument according to the US 2002/0003385 Al acts essentially corresponding to an ultrasonic scalpel, thus tissue in the immediate area of ​​influence of the vibration-generating component, in particular of the piezoelectric element is destroyed. Therefore, an exact positioning of the instrument is required. With a deviation of the position of the tissue to be treated, there is the risk of damaging healthy tissue, since the ultrasonic vibrations generated equally act on healthy as on malignant or tissue to be treated.

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

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

The invention is based on the concept of a medical device for the treatment of tumor tissue comprising provide an insertable into a body surgical instrument with a biocompatible housing in which a vibration element is arranged which can be coupled for generating an ultrasonic vibration actuated, in particular with a frequency generator, wherein is the vibration member, a transfer area associated with the at least partly comprises a wall of the housing, which is arranged in use faces the tumor tissue to be treated, and the transfer area is adapted to transmit the ultrasonic vibration in the treated tumor tissue, in use, said transfer portion comprising at least a tempering device cooperates.

It has been shown that tumor cells, or in general tumor tissue compared to healthy cells have an altered vibration behavior. Tumor tissue and healthy tissue differs in particular in the respective resonant frequency. It was also recognized that the difference of the resonance frequencies can be significantly increased by the influence of heat. It is therefore proposed in the inventive medical device to combine the treatment with ultrasound and heat treatment.

Through the surgical instrument with the vibrating element, the tumor tissue to be treated is directly subjected to ultrasonic vibration. Preferably, a low-frequency ultrasonic vibration is used. The ultrasonic frequency range of the low-frequency oscillation can be used for example 0.5 KHz - 500 KHz, especially from 1 KHz - 300 KHz, especially from 20 KHz - 60 KHz, respectively.

The inventive device is operated at a relatively low ultrasound intensities, wherein a mechanical destruction of the tumor tissue, and in particular the initiation of natural destruction processes such as apoptosis are in the foreground.

The medical device according to the invention further, the ultrasonic vibration is introduced to the tissue to be treated over the in use has a communication area. The transmission range referred to in the invention the area that contacts the tissue to be treated in use, ie when positioning the surgical instrument within the body, is arranged on the tissue to be treated or. In particular, the transmission range is a part of the surgical instrument, which is located between the tissue to be treated and the vibration member.

Through the tempering, which cooperates with the transfer area, it is achieved that the tissue to be treated and the area of ​​tissue which comprises the tumor tissue to be treated, is heated. The heating is done specifically in the area of ​​tissue to be treated, ie essentially in the area where the ultrasonic vibration acts. The heating may be by direct contact with the heating device and / or be caused by the introduction of certain quantities of a heated treatment medium or generally a tempered liquid to the tissue to be treated. In this way, the selectivity of the destruction effects achieved by the ultrasonic vibration is increased in tumor tissue. Damage to the healthy tissue is avoided by selectively to the resonant frequency of tumor cells matched ultrasonic vibration. The tempering has a function to generate a temperature gradient between the tumor tissue and healthy tissue may be enhanced by cooling the healthy tissue. For example, by the selective heating in the area of tissue that comprises the tissue to be treated, ie, the effective range, a temperature of at most 42 0 C, especially at most 41 0 C, especially at most 40 0 C, is set.

Preferably, the temperature control device is disposed in the transfer region. The combination of the transfer area with the temperature control is achieved in that the heat energy generated by the tempering device acts substantially in the same area of ​​tissue, such as the data transmitted via the transmission range of ultrasonic vibrations. The efficiency of the treatment is thus increased.

The tempering may comprise at least one electrical heating spiral. Electrical heating coils have the advantage that the heat transfer is simple and easy to control in the tissue being treated. Furthermore, electric heating coils have a relatively small size and are suitable for installation in small surgical, in particular microsurgical instruments.

Alternatively or additionally, the temperature control can comprise at least one tubular conduit, in which a thermal treatment fluid is guided. The use of a tempering fluid and a temperature-controlled liquid has the advantage that the tissue to be treated not only heated, but can also be cooled as required. In particular, it is possible with the thermal treatment to keep the temperature in the area of ​​tissue to be treated essentially constant. In this way, temperature fluctuations in the treatment area be compensated which can be caused by the ultrasound treatment.

The tubular conduit can form a closed fluid circuit. This ensures that the thermal treatment does not interact with the tissue to be treated, or in general the body. In the closed fluid circuit, a relatively small amount of the tempering fluid is also required.

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

Temperature fluctuations, for example, cavitation effects are buffered particularly effective in this way, or compensated for, since the thermal treatment or the treatment medium, dissipating the additional thermal energy generated by the ultrasonic treatment, for example the Kavitationswärme from the treatment site. Suitable Temperierfluide or treatment media, for example, medical water, isotonic saline solution (NaCl 0.9%), but are not limited to these media or glucose solution. The use of such biocompatible tempering fluid or treatment medium has the additional advantage that tumor tissue to be treated, the liquid content is increased in the tumor cells by supplying the temperature control fluid for, whereby the selectivity is increased further, in the ultrasonic treatment. The increased liquid content, in particular water content, is thus additionally or alternatively to the temperature difference between tumor cells and healthy tissue improves the selective treatment of the tumor tissue and to avoid damage to the healthy tissue.

It is possible that the heating means comprises both an electrical heating coil, and a tubular conduit for conducting a thermal treatment fluid. The combination of an electrical heating element with a tubular conduit, in particular a tubular conduit having an opening for introduction of the temperature control fluid in the tumor tissue allows, on the one hand, the heat tumor tissue to be treated at the start of treatment with the help of the heating coil. On the other hand, that during the treatment a substantially constant temperature is maintained in the treatment area is made possible by the thermal treatment in the course of treatment.

In a preferred embodiment of the medical device according to the invention, the rocking member comprises at least one piezo element. The piezo element permits 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 construction is achieved with the annular or semi-annular piezoelectric element, that the ultrasonic vibration generated propagates targeted below a certain solid angle.

Preferably, the vibration element, in particular the ring-shaped piezoelectric element, arranged coaxially to a longitudinal axis of the surgical element.

The surgical instrument, in particular the housing may comprise at least one upper shell and at least one lower shell, which are hingedly or fixedly connected or bonded together. The two or more part construction allows simplified handling of the surgical instrument. Such a surgical instrument can be used for the treatment of tumor cells in blood vessels, for example, the instrument, the blood vessel can be positioned by the enclosing two or more part construction simple. The parts or part-shells may be loosely positioned to each other or be connected to one another.

The upper shell and the lower shell may be replaced by a clamping device can be tensioned against each other. 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 arranged within the upper shell and / or the lower shell vibration member may be substantially propagate without any loss in the upper shell and the lower shell.

In a preferred embodiment, the surgical instrument, in particular the housing, is formed sleeve-like or tubular, wherein the transmission region is arranged such that the ultrasonic vibration is transferred radially inwardly in use. In this way it is possible to treat a targeted tumor tissue and tumor cells in areas of the body that can be enclosed ring of the surgical instrument. For example, with the sleeve-like surgical instrument, in particular in connection with an articulated connection of the upper shell to the lower shell, or in general the two or more part construction of the surgical instrument, a treatment of tumor cells or metastases possible that occur in blood vessels. For this purpose, the surgical instrument may surround the blood vessel, the ultrasonic vibration is transmitted radially inwardly into the blood vessel or the blood stream. In general, with the tubular surgical instrument in the treatment of tumor cells of organs or generally to treatment sites possible, which are formed tube-like or cylindrical. Treatment is therefore not limited to blood vessels, but for example also includes the esophagus, the bronchi or intestine.

Preferably, the temperature control device is arranged in a wall of the surgical instrument. Preferably, an arrangement of the temperature control is such that the delivery of the required amounts of heat in the radial direction. For a radially inwardly directed heat emission, the temperature control is preferably arranged in a radially inner wall. For a radially outwardly directed heat emission to an arrangement of the temperature in a radially outer wall is advantageous. In this way, heat can be introduced into the tissue to be treated areas specifically for the treatment of tubular body areas.

In a further preferred embodiment the surgical instrument is spherical, wherein the transfer region comprises an outer wall of the spherical surgical instrument. The surgical instrument may also be cylindrical and have at least a substantially semicircular degree. The embodiments described allow an efficient treatment of tumor tissue in body cavities, being achieved in that the surgical instrument can be inserted easily and with little risk of injury in the body cavity. The frequency response comprises the outer wall of the surgical instrument, so that the ultrasonic vibration generated propagates substantially in all directions in space, or at least over a large solid angle. In this way a simultaneous treatment of a relatively large area of ​​tissue is possible, so that the treatment time is reduced.

The tempering may be disposed in the outer wall of the surgical instrument. Thus heating the tissue area is reached, which is applied to the ultrasonic vibration. The selectivity between normal cells and tumor cells is thereby increased.

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

Preferably, the vibration element, especially the vibration generating piezo element, arranged coaxially with the screw connection and surrounds the threaded annular. The vibration element or piezoelectric element is thus positioned between the upper shell and the lower shell and advantageously clamped by the screw to the upper shell and lower shell, so that the ultrasonic vibration produced is substantially loss-free transfer in the upper shell and the lower shell.

In a further preferred embodiment of the medical device of the invention, the surgical instrument comprises a sonotrode or Hohlsonotrode. The sonotrode may have a substantially kathenoidale form. The kathenoidale shape enables an improved transfer of the ultrasonic vibration in the tissue being treated. With the relatively narrow, kathenoidalen form it is also achieved that the surgical instrument for the treatment requires a relatively small infeed channel into the body. Therefore, the horn for minimally invasive surgical approaches is.

Preferably, the sonotrode has a Sonotrodenfuß in which the vibration member is arranged and a horn tip, in which the transmission portion is disposed. The arrangement of the vibration member in the Sonotrodenfuß is advantageous because the Sonotrodenfuß is preferably arranged in the treatment outside the body. This is to avoid that the vibration element that is acted upon by an electrical voltage, resulting in a malfunction of injury within the body. Rather, it is achieved by the shape of the sonotrode kathenoidale that the ultrasonic vibrations generated in Sonotrodenfuß be directed into the horn tip. The propagating in the axial direction of the sonotrode ultrasonic vibrations are amplified thereby, that the amplitude of the ultrasonic vibration is increased. The gain factor is dependent on the shape and length of the sonotrode. In the horn tip of the transmission portion is disposed. The ultrasonic vibration generated in the Sonotrodenfuß is thus led to the horn tip within the sonotrode, and exits from the surgical instrument in the area of ​​the horn tip. The treatment is therefore in the tissue area, which is arranged essentially directly to the horn tip. Preferably, in the sonotrode tip the tempering device is disposed. Thus, the temperature rise of the invention in the treatment area, ie in the area where the ultrasonic vibration acts achieved.

The sonotrode may be paraboloidal, hemispherical, or convex and configured such that the ultrasonic vibration is focusable. The intensified over the horn ultrasonic vibration can be used in this way specifically in individual tissue areas so that particularly small areas of tumor tissue can be treated. The focusing capability allows a particularly targeted treatment of tumor cells.

Further, the sonotrode can comprise a temperature and / or Beschieunigungssensor disposed in the horn tip. Preferably, the temperature and / or acceleration sensor are connected to a controller, which is further coupled to the temperature control and the vibration member and the frequency generator, so that the treatment parameters with respect to the ultrasonic frequency, the ultrasonic intensity, the pulse duration and the tissue temperature depending on the measured values ​​of the temperature - and / or acceleration sensor can be controlled. Here, the temperature sensor measures the tissue temperature in the treatment area, so that the temperature generated in the treatment area to control, particularly in connection with an automatic control is adjustable. The measured values ​​of the acceleration sensor are used to control the ultrasonic amplitudes, and actually produced in the sonotrode tip of the amplitude gain caused along the sonotrode, as well as to adjust the frequency generator such that the amplitudes of the forces acting on the tissue ultrasonic vibration can be tailored to the medical application. The adjustment can be performed automatically in connection with a controller.

The horn tip may have a supply port for the thermal treatment, especially a targeted heated treatment medium, and / or for active ingredients, especially sonosensitizer or microbubbles. Through the supply port in the horn tip, it is possible to incorporate the active ingredients directly and simultaneously with the treatment in the tissue being treated. The supply port may be connected to the tempering device, in particular a pipe for the thermal treatment. The supply port can also be associated with a separate supply line for a tempering or active ingredients, for example, a separate supply channel.

Preferably, the supply port is connected by a line with an active ingredient disposed in Sonotrodenfuß supply means. Such supply means may be a commercially available luer connector. Thus, the active ingredients such as other medicinally usual method using a syringe can be easily inserted into the tissue to be treated.

The invention is illustrated hereinafter by means of embodiments with reference to the accompanying diagrammatic drawings. therein

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

Figures 2a, 2b, 3 are respectively a longitudinal section of a surgical instrument according to another preferred embodiment.

4 is a cross-sectional view of a surgical instrument according to another preferred embodiment.

Figure 5 is a medical device of the invention according to a preferred embodiment with a longitudinal section through the surgical instrument. and

FIG. 6a, 6b a detailed view of the surgical instrument of FIG. 5.

Fig. 1 shows a surgical instrument 10 of a medical device for the treatment of tumor tissue with a tubular housing 11. The housing 11 comprises two half-shells, which are respectively a channel-shaped, ie have a semi-circular cross-section. The two half shells are hinged together. Other compounds, especially loose or fixed connections are possible. The articulated connection comprises a hinge or hinge 14, which extends in the axial direction along the surgical instrument 10th The hinge 14 can be arranged in an alternative embodiment also to an axial end of the half shells or of the surgical instrument 10 degrees. Opposite the hinge 14, a tensioning device 15 is also provided for connecting the two half-shells. The clamping device 15 may for example comprise a screw or snap connection. Other types of connections that allow a tightening of the two housing shells to one another, are conceivable. The housing above preferably forms a sleeve comprising a material that blocks a propagation of ultrasonic waves, or at least reduced.

Within the cylindrical housing, a vibration member is arranged at least 12th The vibration member 12 comprises two semi-annular segments which are assembled in use, so that they form a complete ring. The vibration members preferably comprise piezoelectric elements. The connecting surfaces of the two oscillation elements 12 are preferably at an angle with respect to the axis of rotation of the instrument, in particular perpendicularly arranged to the connection surfaces of the housing. 11 Further, cooling channels 16 are provided, which form a tempering device and extend substantially in the axial direction of the surgical instrument 10 degrees. The tempering or the tempering 16 may be generally disposed in a transfer region 13 in an inner wall or IIb. Through the cooling channels 16 may be a thermal treatment, in particular a temperature-controlled liquid can be guided. Alternatively or additionally to the cooling channels 16, a heating coil may further be provided at least, which perceives by an applied voltage a heating function. The tempering may include heating pads and an electric heating layer, for example an electrical resistance heater. The heating layer is preferably disposed on a radially outer or radially inner cylinder shell surface of the hollow cylindrical casing so that heat is dissipated radially in the direction of the treated tumor tissue. Other heating ramp rates are not excluded.

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

The medical device or the surgical instrument lu FIG. 1 is preferably used for the treatment of tumor tissue in tubular or hose-like body vessels, in particular in a blood vessel 40, are used. For this, the instrument 10 is placed in the context of surgery in the body. In the treatment of tumor cells, especially blood metastases in blood vessels 40 is made possible by the pivotal connection of the two housing shells, that the device can be positioned without damaging the blood vessel 40th The blood vessel 40 is enclosed by the surgical instrument 10 degrees. For this purpose, the surgical instrument 10 is preferably dimensioned such that the blood vessel 40 and the vessel wall abuts an inner wall IIb of the housing 11, particularly at the transfer region. 13 For the treatment of blood metastases the vibration elements are offset 12 in vibration, so that an ultrasonic vibration is generated, acting on the blood metastases or tumor cells and lead to destruction or to initiate an apoptotic process in the tumor cells. The ultrasonic propagation or the direction of the ultrasound propagation is affected by the material properties of the housing. 11 In the embodiment according to FIG. 1, the outer half shells of the housing 11 are made of a material that prevents propagation of the ultrasonic vibrations or limited. The transfer portion 13 is, however, adjusted such that the ultrasonic vibrations are transferred from the vibrating elements 12 in the tissue to be treated, in particular the blood vessel 40th For this purpose, the inner wall IIb of the housing 11, which forms the transfer region 13, for example, comprise titanium. An outer wall IIa of the housing 11 preferably comprises a biocompatible material.

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

The surgical instrument 10 of FIG. 2a comprises a housing 11 having an outer wall and an inner wall IIa IIb. Between the outer wall and the inner wall IIa IIb an oscillating element 12 is disposed. The housing 11 and the vibrator 12 are respectively formed of tubular or have a circular cross-section. The outer wall iia biidet the transmission portion 13, so that the ultrasonic vibrations generated by the vibrator 12 can spread radially outward. The outer wall IIa further comprises a tempering or cooling channels 16, in which heating coils are arranged. Alternatively, through the cooling channels 16, a thermal treatment, in particular a heated liquid, are passed. It is also possible that the inner wall IIb additionally comprises tempering sixteenth The temperature control allows tempering, that is, a heating and / or cooling of the tissue to be treated.

The cavity formed by the cylindrical surgical instrument 10 constitutes an active agent line 17. The active agent line 17 is provided with a supply means (not shown). The supply means preferably includes a connector for connecting a syringe, which is arranged in use outside the body. In this way, in tissue to be treated or into the treatment area, a thermal treatment or a selectively heated treatment medium, may be initiated with a drug. Such agents may, for example sonosensitizer or microbubbles. This selectivity can be increased between the tumor cells and healthy cells. The efficiency of the treatment is enhanced by the addition of Sonosensitizem and / or microbubbles. The housing 11 encloses the vibration member 12 completely, ie the outer wall IIa is connected to the axial ends of the surgical instrument 10 by a side wall 11c. 11c both the side of the outer wall IIa, IIb and the inner wall be associated, either comprise the same material as the outer wall or the inner wall IIa IIb. Other materials are also possible. Depending on the medical application so the side wall 11c can allow the spread of ultrasonic vibrations or limit the spread of the ultrasonic vibrations. It is possible that the side wall 11c, as shown in Fig. 2b, is hemispherically shaped. The hemispherical termination reduces the risk of injury when using the surgical instrument. Others, in particular the risk of injury-minimizing shapes of the side wall are iic possibIe.

The surgical instrument 10 further includes an acceleration sensor 18, which is preferably arranged in the transfer region. 13 The acceleration sensor

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

19, 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 are provided 19th

Fig. 3 shows another embodiment of the surgical instrument 10, wherein the structure is substantially the surgical instrument 10 of FIG. 2a corresponds to. The difference is that the surgical instrument 10 comprises according to Fig. 3 a plurality of vibration elements 12 which are annular. The housing 11 is substantially flexible, so that the vibration elements of annular construction 12, which are disposed axially spaced from each other can be arranged at an angle to each other, so that the surgical instrument 10 assumes a curved shape. Thus, the surgical instrument 10 has an increased flexibility and is suitable for positioning in body cavities that have a curvature. In addition, allows the arrangement of a plurality of spaced-apart vibrating elements 12 located between these radial openings which enable the supply of a tempering fluid and a selectively heated treatment medium, optionally with one or more active ingredients across 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 has two half-spheres, which are connected to a tensioning device 15, in particular a ball screw 15a, to each other. The ball screw 15a is disposed at substantially the center of the spherical surgical instrument 10th The ball screw I5A is enclosed by two vibration elements 12 which are annular. A different number of vibration elements 12 is possible. The housing 11 includes a temperature control or tempering 16, which are arranged in the half shells. The cooling channels 16 may be arranged in a half-shell or both shells. The surgical instrument of FIG. 4 consists of four cooling channels 16. A different number of cooling channels 16 is possible. The cooling channels 16 may include a thermal treatment. The tempering may also comprise at least a heating coil. A combination of the heating element with the temperature control channel 16 or other means or devices for heat transfer or generation are possible.

The clamping device 15, in particular the fitting screw 15 enables a solid connection of the two semi-spherical housing shells, in particular with the oscillating elements 12, so that an effective and efficient transfer of ultrasonic vibrations from the vibration elements 12 via the housing 11, in particular the transfer region 13, bounded by the housing 11 is formed, is in reaching tissue to be treated. The housing 11 preferably comprises half-shells made of titanium or stainless steel.

The device according to Figures 2a, 2b, 3 and 4 are preferably used for the treatment of tumor tissue in body cavities, especially in the gut. The ultrasonic propagation takes place in the radially outward direction. It is also possible that, by suitable choice of material the inner wall IIb or outer wall IIa in the cylindrical surgical instruments 10, the sound propagation, is performed according to figures 2a, 2b and 3 radially inwardly so that the cylindrical device can also be used to treat blood metastases. In this case, the surgical instrument as an interposition in a vessel such as a blood vessel 40, are used. This can for example take place in that the blood vessel 40 to be treated separately and the surgical instrument 10 is sewn between the open ends of the vessel by means of conventional vascular surgery technique.

In principle, the direction of ultrasound propagation can be affected by the fact that a wall of the housing 11 and another wall of which is at least relatively rigid flexible.

The transmission portion 13 preferably comprises a material having a high sound propagation speed, for example titanium or stainless steel.

The cylinder-shaped embodiments according to Figures 2a, 2b and 3 may further radially outwardly directed openings (not shown) or bushings have, so that the active ingredients from the drug line 17 can be introduced radially outwards into the tissue to be treated. The radially outwardly directed openings may also be connected to the tubular conduits and cooling channels 16, so that the thermal treatment or the heated treatment medium in the tissue to be treated can be initiated. The thermal treatment may include drugs.

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

A corresponding method of treatment comprises, for example, the following steps, without the invention being limited thereto: The with a colonoscope or generally coupled to a suitable supply means surgical instrument 10 is inserted into the bowel or other cavity. As the surgical instrument 10 is positioned at the treatment site is solved or the colonoscope endoscope and removed. The connection between the colonoscope and the surgical instrument 10 may be, for example, a screw connection or clamping connection, that generally comprise 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 is performed via cables 57 which are led out of the body to the outside. Since only the surgical instrument 10 remains within the body, the treatment can be carried out patient gently and continuously. Preferably, the treatment is carried out at regular time intervals, so that by Koppelbarkeit of the surgical instrument 10 with a colonoscope or generally endoscope, the number of endoscopic procedures is reduced, since the surgical instrument 10 remains between the treatment intervals within the body.

It is also conceivable, the surgical instrument 10 for the treatment of other hollow vessels of the body such as the esophagus, the urethra, the stomach, the pancreas, or to use of blood vessels, said coupling with respective feeding means, such as endoscopes and catheters, is to be applied accordingly.

For coupling the ultrasonic vibrations in the treatment into the fabric, it is contemplated within the scope of the method to provide a liquid, in particular water layer between the intestinal wall and the surgical instrument 10. Advantageously, the intestine is to rinse at least in the region of the treatment site with water or the treatment medium, in particular the thermal treatment. The water preferably has body temperature, ie from 37 to 38 0 C, to. By the tempering 30, is locally in the tissue to be treated that is within the operating range of the ultrasonic vibration, a temperature of 40 - 42 ° C generated. At these temperatures, the selectivity between tumor cells and healthy cells is increased without done damage to the healthy tissue. A further preferred embodiment of the medical device according to the invention, Fig. 5. Therein is shown a surgical instrument 10 that comprises a sonotrode 50th The horn 50 has a horn tip 51, a 52 and a Sonotrodenhals Sonotrodenfuß 53rd The sonotrode 50, and in particular the sonotrode tip 51 and the Sonotrodenhals 52 is rotationally symmetrical, in particular kathenoidal or paraboloidartig formed. Other geometrical shapes are possible, for example, the Sonotrodenhals 52 may have an oval cross-section instead of a circular cross-section. The sonotrode tip 51 may also be a concave shape, ie, a curved in the direction of curvature include Sonotrodenfußes 53 so that the ultrasonic vibrations are focused. The Sonotrodenfuß 53 comprises a counterweight 54, and a stereotactic Dreiachssteuerung (not dargesteiit). In Sonotrodenfuß 53 are also vibrating elements 12, in particular piezo rings arranged. The size of the piezo rings is substantially of the ultrasound to be generated frequency dependent. The vibration member 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 (not shown) connected in the sonotrode tip 51 to the tempering or the tempering 16, in particular electric heating elements. The sonotrode tip 51, in particular an acceleration sensor 18 disposed therein is connected to the amplitude control 23rd The amplitude controller 23 is further connected to the frequency generator 20 and the computer 22nd With the amplitude controller 23 acting in the region of the sonotrode tip 51 ultrasonic amplitudes are measured and evaluated by the computer 22nd On the basis of the measured values ​​is the ultrasonic frequency, which is generated in the frequency generator 20 is controlled.

By the geometrical shape of the sonotrode 50, the ultrasonic vibrations are, in particular the amplitudes which are generated by vibrating element 12, amplified when propagating in the direction of the horn tip 51st The amplified ultrasonic vibrations are transmitted by the sonotrode tip 51 and through the horn tip 51 formed by the transfer region. 13 By reinforcing the ultrasonic vibrations particularly efficient treatment is guaranteed.

As shown in FIGS. 6a, 6b can be seen in detail, the sonotrode tip 51 is in several parts, in particular two-piece, constructed. In particular, the sonotrode tip 51 includes an end piece 51a, which limits the axial free end of the sonotrode 50th In the end piece 51a are cooling channels 16, in particular heating coils are arranged. The heating coils and the cooling channels 16 form the temperature control together. For the connection of the temperature and of the heating elements with the temperature controller 24, the sonotrode 50 has a supply passage 55 extending from the end piece 51a of the sonotrode tip 51 to Sonotrodenfuß 53, in particular up to the vibration element 12th In the Versorgungskanai 55 a cable 57 is arranged, which forms the electrical connection between the heating elements 16 and the temperature control 24th Instead of the cable 57 also a heating line may be provided, if the tempering or the tempering

16 include a liquid temperature-regulating fluid. The supply channel 55 may further comprise an active agent line 17, which has a connection possibility or a feed in the range of Sonotrodenfußes 53 so that on the active line

17, a thermal treatment or a selectively heated treatment medium, optionally with additives, in particular Sonosensitizern or microbubbles, can be introduced into the tissue to be treated. For this purpose, the sonotrode tip 51, particularly the end piece 51a, openings which are connected with the active line 17th

The sonotrode tip 51, as shown in Fig. 6a, 6b, 51b comprise an intermediate piece that the sonotrode tip 51 is disposed between the Sonotrodenhals 52 and. The intermediate piece 51b is preferably bolted to the end piece 51a and the Sonotrodenhals 52 or glued together. Other types of connection are possible. Further, on the intermediate part 51b has a recess 56 in which an acceleration sensor is disposed 18th Another arrangement of the acceleration sensor 18 in the sonotrode tip 51 is possible. For example, the acceleration sensor 18 may include a sensor film, which is adhered to the horn tip 51st The intermediate piece 51b is preferably arranged between the end piece 51a and the Sonotrodenhals 52 clamped or clamped to the end piece 51a and the Sonotrodenhals 52 that an efficient propagation of the ultrasonic vibrations is provided in the direction of the end piece 51a. The Sonotrodenhals 52, the intermediate portion 51b and end portion 51a that can have different materials. Materials or materials which have a high sound propagation speed and biocompatibility, e.g., titanium or stainless steel are preferred.

The horn 50 is used for example for the treatment of tumor cells in the brain. The narrow, kathenoidale shape of the horn 50 is a relatively simple and prone low-risk treatment of brain tumors or metastases is possible. The horn is not limited to the treatment in the brain, but is also suitable for treating tumor cells in other organs, particularly the pancreas, breast, ureter or the coronary vessels. Definition of the ultrasonic vibration field, ie to the tissue area in which the ultrasonic waves are particularly efficient effect, narrow, preferably sonosensitizer or microbubbles are introduced into the tissue. The sonosensitizer can be selected tumor specific.

LIST OF REFERENCES

Surgical instrument 10

11 housing

IIa outer wall

IIb inner wall

11c side

12 vibrator

13 Frequency response

14 hinge

15 clamping device

15a Passschraube

16 temperature control channel

17 active line

18 Accelerometer

19 temperature sensor

20 frequency generator

21 amp

22 computers

23 amplitude control

24 temperature control

40 blood vessel

50 horn

51 horn tip

tail 51a

51b spacer

52 Sonotrodenhals

53 Sonotrodenfuß

54 Counterweight

55 supply channel

56 recess

57 cable

Claims

A medical device for the treatment of tumor tissue claims
1. A medical device for the treatment of tumor tissue comprising an insertable into a body surgical instrument (16) comprising a housing (11), in which a vibration element (12) is arranged, the operable for generating an ultrasonic vibration, in particular with a frequency generator (20) coupleable, wherein the vibration member (11), a transfer region (13) is associated, which at least partly a wall (IIa, IIb, Hc) of the housing (11), which is arranged to face the tumor tissue to be treated in use and the transfer region is adapted (13) to transmit, in use, the ultrasonic vibration in the treated tumor tissue, characterized in that the transfer area (13) cooperates with at least one tempering device.
2. Medical device according to claim 1, characterized in that
Tempering device is disposed in the transfer region (13).
3. Medical device according to claim 1 or 2, characterized in that the tempering comprises at least one electrical heating spiral.
4. Medical device according to claim 1 to 3 characterized in that the
Tempering device comprising at least one tubular conduit, in which a thermal treatment fluid is guided.
5. The medical device according to claim 4, characterized in that the tubular conduit forms a closed fluid circuit.
6. The medical device according to claim 4, characterized in that the tubular conduit has at least one opening, that the thermal treatment is so introduced into the tumor to be treated tissue.
7. The medical device according to at least one of claims 1 to 6, characterized in that the vibration element (12) comprises at least one piezo element.
δ. The medical device according to claim 7, characterized in that the
is formed piezoelectric element annular or semi-annular.
9. The medical device according to at least one of claims 1 to 8, characterized in that the Schwingungseiement (12), in particular the ring-shaped piezoelectric element, coaxially to a longitudinal axis of the surgical instrument (10) are arranged.
10. The 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 includes hingedly or fixedly connectable or connected together.
11. The medical device according to claim 10, characterized in that
The upper shell and the lower shell by a clamping means (15) are mutually tensioned.
12. The medical device of claim 10 or 11, characterized in that the surgical instrument (10), in particular the housing (11), sleeve-like and / or tubular in shape, wherein the transfer portion (13) is arranged such that in use, the ultrasonic vibration is transferred radially inwardly.
13. The medical device according to claim 12, characterized in that the
Tempering device is disposed in a wall (IIb) of the surgical instrument (10).
14. The medical device according to at least one of claims 1 to 13, characterized in that the surgical instrument (10) is spherically shaped, wherein the transmission portion (13) an outer wall (IIa) of the spherical surgical instrument (10).
15. The medical device according to claim 14, characterized in that
Tempering in the outer wall (IIa) is disposed the spherical surgical instrument.
16. The medical device according to at least one of claims 11 to 15, characterized in that the tensioning device (15) comprises a screw connection, in particular a Passschraubverbindung.
17. The medical device of claim 16, characterized in that the
Vibration element (12) is arranged coaxially to the screw connection and surrounds the threaded annular.
18. The medical device according to at least one of claims 1 to 17, characterized in that the surgical instrument (10) comprising a sonotrode (50) or Hohlsonotrode.
19. Medical device according to claim 18, characterized in that the sonotrode (50) has a substantially kathenoidale form.
20 has medical device of claim 18 or 19, characterized in that the sonotrode (50) has a Sonotrodenfuß (53) in which the oscillating element
(12) is arranged, and a horn tip (51) in which the transfer region
(13) is arranged.
21. The medical device according to claim 20, characterized in that
Tempering device is disposed in the horn tip (51).
22. The medical device of claim 20 or 21, characterized in that the sonotrode (51) is formed paraboloid, hemispherical, or convex in shape such that the ultrasonic vibration is focusable.
23. The 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 horn tip (51).
24. The medical device according to at least one of claims 20 to 23, characterized in that the horn tip (51) having a supply port for active substances, in particular sonosensitizer or microbubbles.
25. The medical device of claim 24, characterized in that the
Supply port disposed through a drug conduit (17) having a Sonotrodenfuß (53) supply means is connected.
PCT/EP2009/007798 2008-10-31 2009-10-30 Medical device for treating tumor tissue WO2010049176A1 (en)

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