DE68929556T2 - Device with a cooling device for the surgical treatment of tissues with hyperthermia, preferably the prostate - Google Patents

Description

FIELD OF THE INVENTION

The The invention relates to a device for surgical treatment of tissues by hyperthermia, preferably the prostate, with a cooling device.

BACKGROUND OF THE INVENTION

The EP-A-0248758 describes a microwave applicator introduced into the rectum by hyperthermia for the treatment of the prostate. The microwave applicator is by a laterally projecting balloon 7 within the rectum, meaning that special protection of the rectum is required. For heating the prostate is preferably a device 52 provided for reflecting the emitted microwaves, which are then on the side of the body opening opposite the balloon 7 be concentrated. In the microwave-emitting rectal applicator are channels 28 for circulating a cooling liquid, which is in 2 to 4 is shown.

The coolant protects the rectal walls in contact with the microwave antenna from damage. In addition, the presence of the reflection means 52 absolutely necessary to prevent emission of the antenna in all directions, if the radiation must be directed only to the prostate tissue.

In other words, the EP-A-0248758 a device for the surgical treatment of tissues by hyperthermia, preferably the prostate, comprising: a heating device for inducing hyperthermia with an emission probe adapted to be inserted into a body cavity and having a front end and a rear end, wherein the emission probe has a microwave antenna device located in the center or in the vicinity of the front end, and the microwave antenna device is connected to an external microwave generating device (MWG), an inflatable balloon device to the microwave antenna device below the balloon device ends in positional locking and an inflator for optionally inflating the balloon device, and wherein the external microwave generating device (MWG) comprises means for generating microwaves by the probe at a frequency and power that are effective Ge tissue to a predetermined temperature for a time sufficient to treat the tissues by hyperthermia.

The EP-A-0246176 describes a catheter having an antenna equipped with a temperature sensor which is inserted through the bladder into the urethra to the position of the above-mentioned EP-A-0248758 to locate and determine the described microwave applicator.

From a practical point of view, the design of the in the EP-A-0248758 for introduction into the rectum, inasmuch as the application lacks accuracy because the prostate is irradiated remotely.

Farther it is essential in this process, the emission of microwaves in all directions to prevent what an emission antenna is having includes very special design, with a reflection device for aligning the radiated microwaves in one direction only, namely to Prostate, is equipped.

Finally is it is unquestionably quite difficult with such a device, though not impossible, the sphincter to protect and more generally to protect the surrounding tissues. This is especially true in Case of blistering.

The EP-A-0105677 describes such a microwave hyperthermia antenna device designed for insertion into the tract or lumen, in which device the antenna assembly is placed in a supple polymer thin film without any means to protect the delicate tissues from the heat.

The WO-A-81/03616 (Bircher) again describes a microwave antenna system for hyperthermia therapy that is inserted into a body cavity and used in the treatment of cancer and the like. Ä. Is used. Typical examples of insertion openings are the mouth and the upper throat.

Of the The introductory part of this patent cites J. Microwave Power 14 (2): 167-171 (1969) in terms of an applicator used to irradiate the prostate is introduced through the rectum. It is stated that the Radiation treatment involves burning the tissues that are close lie the electrode.

According to this Document is the characteristic of this treatment in that she is performed at a lower frequency and at a higher wavelength, to penetrate the tissues down to depths of 5 to 6 cm too improve. Such a deep penetration allows the extensive irradiation greater Tumors in the intestine or similar

In "Proceedings of the 13th Annual Northeast Bioengineering Conference, Philadelphia, 12-13. Ryan "is the pretreatment of patients suffering from biliary obstruction due to cancer, described by microwave-induced hyperthermia, by inserting a catheter into the common bile duct to allow invasive drainage.

How out 5 As a result, tests were conducted on the same antenna in different media. In tests B and D, the medium was saline, and the Discussion section emphasizes that when the medium changes from air to such a conducting medium as saline or bile medium, the performances drop dramatically, which rather prevents the expert from getting a To use saline in microwave-induced hyperthermia.

A presentation by Biffi Gentili, Borrani et al., Two-element radiating system for endocavitary hyperthermia, Hyperthermic Oncology 1988, Kyoto, Japan, August 29th - 3. September 1988, discloses simulations of SAR distributions for a two-element endocavity radiation system. The system has two dipole antennas located in the urethra and in the Rectum at a distance of 4 cm. The SAR distribution is calculated and compared under the following operating conditions: a) only the rectal dipole is fed; b) both antennas are with fed with the same input voltage; both dipole antennas are with fed different input voltages.

The Conclusion this presentation is that that Two-antenna system for Provides a better SAR distribution in the area in which the hyperthermia treatment is applied.

In Medical Tribune, Vol. 29, No. 9, March 31, 1988, Transurethral hypothermia for BPH: Trial's goal is to top 80% success, is an applicator for heating the Prostate revealed in a transurethral approach. The applicator is made up of three microwave antennas and a thermometry sensor, on the outside surface of a Foley catheter are attached.

T. Harada et al., Microwave surgical treatment of disease of prostate, Urology, Vol. XXVI No. 6, December 1985 disclose an applicator for transurethral microwave treatment of the prostate. The probe is made of a coaxial cable, the probe tip with a Antenna is provided. Reports are made on tests on ham slices as prostate tissue dummies, animal experiments and clinical trials.

SUMMARY OF THE INVENTION

Consequently The invention is based on the object, this new technical Problem by providing a solution to overcome, which is a more accurate surgical treatment of tissues by hyperthermia, in particular the prostate, allows while the sensitive tissues except those due to hyperthermia too treated efficiently protected become.

The Invention is defined by the features of the claims.

Therefore it is clear that with the device according to the invention the emission probe device through the natural urethra channel directly positioned in the prostate, causing damage to the sphincter prevented.

Further It is due to the radiation-reflecting shielding device according to a preferred embodiment the invention possible the bladder as well as the rectal walls to protect efficiently. Possible is an emission probe device emitting in all directions to use, but of course is it possible according to the invention and in some cases advantageous to use a probe device, preferably emitted in a certain direction.

Understandably Therefore, all the decisive technical advantages, by the expert are not expected and listed above, obtained according to the invention, what is the reason for that? proposed device extremely versatile and for the Doctor is very easy to handle.

BRIEF DESCRIPTION OF THE DRAWINGS

The Invention will become apparent from the following description of several embodiments a Vorrich device according to the invention for the surgical treatment of tissues by hyperthermia, d. H. for the treatment of the prostate, better understood, with reference to the accompanying drawings is taken. Show it:

1 a schematic partial sectional view of the entire inventive device for the surgical treatment of prostate tissues to be destroyed by hyperthermia, which has a emitting Urethralsondeneinrichtung and an echographic detecting rectal probe device, both of which are connected to a central control device;

2 a partial longitudinal axial sectional view through the main part of the emitting Urethralsondeneinrichtung;

2a a cross section on the line IIa-IIa of 2 ;

3 a side perspective view of the emitting Urethralsondeneinrichtung according to 1 and 2 with the balloon deflated;

4 an embodiment variant of the emitting Urethralsondeneinrichtung invention, showing a longitudinal axial section through a second embodiment of the cooling device;

5 a further embodiment variant of the structure of the structure of the emitting urethral probe device, which shows an axial cross-section through a further embodiment of the cooling device;

6 another variant of the cooling device in one 5 similar view;

7 Yet another embodiment variant of the cooling device in one 5 similar view.

FURTHER DESCRIPTION PREFERRED EMBODIMENTS

With special reference to 1 is a device according to the invention with the general reference number 10 for the surgical treatment of tissues 12 through hyperthermia, ie

the prostate 14 that showed the kind of a heating device 16 for inducing hyperthermia, consisting of an in 2 clearly shown microwave generating device 18 consisting in a longitudinal axial section in 2 shown emission probe device with the general reference number 20 placed, which is suitable for insertion into a body cavity.

In the device for destruction of the prostate shown herein 14 by hyperthermia is the emission probe device 20 According to the invention, a urethral probe device.

The device according to a preferred embodiment of the invention is characterized in that it further comprises a thermal protector 22 . 30 to protect sensitive tissues other than the tissue to be destroyed 12 ie the prostate 14 , wherein the device comprises means comprising a radiation-reflecting screen 22 . 30 forms.

According to a preferred embodiment of the invention, the device forming the radiation-reflecting screen comprises a radiation-reflecting liquid medium, preferably an electrically conductive medium, which can reflect the microwaves emitted by the emission probe device 20 emitted with the microwave emission device 18 Is provided.

According to a specific variant of the embodiment, the radiation-reflecting conductive solution is directly into the bubble 24 injected by the patient. In this case the solution is preferably hypertonic. For example, it may be a solution with a high ion concentration, e.g. B. by using NaCl. Generally, suitable conductive solutions are saturated ionic solutions, e.g. B. NaCl or nitrate solutions, the solutions are obvious to the expert.

According to another preferred embodiment is a part 22 the shielding device is placed in the amount of an organ to be protected, in particular the bladder. According to a preferred embodiment, the device forming a protective screen for the bladder has a balloon 26 , the front end 20a the probe device 20 is provided. The balloon 26 is with a facility 28 equipped for its filling, preferably with a radiation-reflecting conductive solution 23 , Normally, the filling device has an inner channel 29 on that turns into a hose 30 extends to the outside. The radiation-reflective conductive solution may be identical to the aforementioned one and based on saturated NaCl solution.

The emission probe device according to the invention has a cooling device 32 on that in the probe device 20 for lowering the temperature of the outer wall of the probe device 20 ie the walls of the urethra 34 is installed. For example, there is the cooling device 32 from at least two lines, an inlet line 36 or an outlet conduit 38 containing the cooling medium and at the front of the probe device 20 over a connecting line 37 communicate with each other, what is in 2 is clearly shown. The wires 36 . 38 communicate with hoses 40 . 42 , a supply hose or a drain hose for the cooling medium, which may be water.

According to a preferred embodiment of the invention, the emitting urethral probe device is 20 with a device 44 for detecting the temperature on or within the urethral probe device 20 fitted. Advantageously, the temperature sensor 44 a fiber optic thermometer 46 on, wherein the optical fibers through a Wärmeisoliereinrichtung 48 from the rest of the probe device and in particular the cooling circuit 36 . 38 according to 2a and 3 are isolated. The thermometer has a plurality of fiber strands extending in the longitudinal direction of the probe device 20 placed so radially and / or longitudinally offset that they the temperature at various NEN radial and / or longitudinal positions detect the probe device.

The thermometer 46 and the associated insulation device 48 can in a longitudinal slot 50 be arranged in the outer surface 21 the probe device 20 is provided.

It should be noted that the front end 20a the probe device 20 should be advantageously rounded to the insertion of the probe device 20 through the urethra and up to the level of the bladder 24 to make things easier 1 evident.

The microwave generating device 16 according to 2 and 3 a metallic cable 52 on that with the probe device 20 coaxial and with an insulating cover 54 Covered over part of its length is the cable 52 at least one microwave emitting non-isolated part 52a which is preferably located at an intermediate or distal height of the emission probe device, which 2 and 3 clearly show. Preferably, the free end of the cable ends 52a forming a microwave emitting antenna, under the balloon 26 which forms the bubble guard. The cable 52 forms an emission antenna, the z. B. may be 20 to 40 mm long and radiates in all directions about its axis, ie over 360 °.

The through the uninsulated part of the cable 52 formed emission antenna 52a is connected to a symbolized by the abbreviation MWG microwave generating device, the z. B. at about 915 MHz and emitted with a power that is adjustable to 50 W or even 100 W.

According to a variant of this embodiment, the emission antenna may be more complex and shielding sections along the uninsulated part of the cable 52 whereby certain parts of the prostate should preferably be heated.

2a shows an axial cross section through the emission probe device 20 and illustrates the shape and position of each of the elements forming the probe assembly. From this drawing shows that the cooling medium, for. As water containing lines 36 . 38 are formed by wide openings extending over a circular arc of the probe device 20 extend, which has a substantially circular or slightly ovoid cross-section for easy passage through the urethra. It can be observed that according to the in 2a shown embodiment of the temperature sensor 44 and the balloon 26 dining channel 29 lie substantially in the same plane, the axis of the probe device and thus the cable 52 passes through, whereas the lines containing the cooling medium 36 . 38 are arranged symmetrically to the plane of symmetry.

Other variants of the structure of Urethralsondeneinrichtung 20 are in 4 to 7 in which the same reference numbers, increased by 100, are used to designate identical parts or parts having the same function.

In the embodiment according to 4 has the general reference number 120 designated Urethralsondeneinrichtung an annular channel 136 on top of that with the probe setup 120 is coaxial and with a disc-shaped common channel 137 communicates up to a central line 138 ranges into which the microwave emitting device 18 is introduced.

In 5 A further embodiment of the internal structure of the probe device is shown, whose general reference number has been increased by 200 in this case, giving the reference number 220 wearing. As shown occupies the cooling medium supplying the inlet pipe 236 an annular sector of the probe device 220 while the heated cooling medium laxative outlet 238 occupied a complementary annular sector, both ring sectors 236 . 238 through cross sections 239 . 241 are separated longitudinally. The emission device 218 is with regard to the probe device 220 always placed axially. Further shows 5 The administration 229 containing the inflation medium, e.g. B. an electrically conductive liquid, the balloon feeds, at the front end of the probe device 220 is provided, as well as the temperature sensor 244 ,

6 Figure 11 illustrates another embodiment in which the parts that are identical or have the same function continue to carry the same reference numbers increased by 100. According to 6 are four cooling medium supplying inlet pipes 336 provided, wherein the lines annular sectors of the probe device 320 from the scope 321 until the central longitudinal opening 353 in which the microwave emitting device 318 is introduced. The remaining sectors have corresponding ring lines 338 for discharging the cooling medium, wherein a conduit 329 also to inflate the balloon and a slot 350 for housing the temperature sensor 344 are provided.

In 7 Yet another variant of the construction of the probe device is shown, the reference number has been increased by another 100, bringing them 420 reads. Here are also four cooling medium inlet sectors 436 provided, wherein the sectors have rounded edges, so that the other sectors 438 are substantially cross-shaped, wherein the remaining cooling medium Auslaßsektoren communicate with each other or can not communicate. The emission device 418 is also on the axis of the probe device 428 placed.

The device according to a preferred embodiment of the invention further comprises a device 80 for controlling the positioning of the urethral sounding device 20 on, with the device 80 preferably in the rectal probe device 82 is installed. Preferably, the control device 80 through an echographic probe 82 formed by the rectal type. The echographic probe with an echoograph is advantageous 84 connected, which is equipped with a screen.

In an embodiment variant, the echographic probe may be provided with a central control device 86 which centrally summarizes all information and can automatically control the microwave generating device MWG as a function of the registered temperature data and any data that may be programmed by the physician 1 becomes understandable.

The central control device 86 , z. As a computer o. Ä., Receives all temperature data, which are summarized centrally in a thermometry device, and the temperature data from the cooling device, the cooling means of the emission probe device 20 fed; In addition, it issues the commands necessary for the microwave generating device (MWG) as well as the cooling device. According to an embodiment variant, it may also receive the data received from the echographic probe 82 based on the position of the emission probe device 20 in relation to the prostate.

An interstitial thermometer 100 may also be provided under echographic control in the prostate 14 is introduced, so that it is possible to detect the temperature to which the prostate gland is necessary to perform biopsies 14 through the probe device 20 emitted microwaves was heated. Of course, such temperature data is important to determine the power commands given to the microwave generator MWG by the controller 86 be granted.

According to the invention, the tissue protection device can also be attached to the rectal probe device 82 attached part 90 to protect the rectal wall from high temperatures. According to a particularly advantageous embodiment, the attached to the rectal probe device Schirmbildungsein direction 90 via an inflatable element 92 making a balloon surrounding the rectal tube 82 at its front end 82a is attached, wherein the element is preferably a radiation-reflecting liquid medium 94 over a hose 96 is fed, preferably with that for inflating the balloon 26 the urethral probe device used is identical. A temperature sensor 98 can inside the balloon 92 to detect the temperature at the level of the prostate 14 be provided rectal wall, wherein the registered by the sensor temperature data to the thermometry device and the central control device 86 , z. As a computer o. Ä., To be sent.

According to a further embodiment of the invention, the shielding device may comprise at least one wire parallel to the central electric field, the wire being in the rectal probe device 82 preferably integrated and longitudinally thereto in the direction of the emission probe device 20 is placed.

There may also be a device to protect the sphincter 15 be provided by a balloon system that the probe device 20 similar to the balloon 26 the system also passes through the feeder 30 can be fed.

It is clear that it is possible according to the invention, the prostate 14 to treat hyperthermia efficiently and generally to destroy tissue through hyperthermia.

With the echographic probe 82 that with an echoograph 84 connected to the screen, the exact position of the emission probe device can be 20 inside the prostate 14 extremely easy to control by the echo image of the emission probe device 20 on the screen 84 is monitored. The doctor sees that the emission probe device in the prostate 14 is precisely positioned, it can control the operation of the control device 86 to manually trigger the hyperthermia treatment, taking the temperature inside the prostate 14 as well as in the surrounding tissues and especially in the rectum by the various temperature sensors, eg. B. 98 . 100 , is controlled.

With the device it is also possible other tissues than the prostate through various other protective devices 22 . 90 to protect effectively. Due to the presence of the cooling device according to the invention 32 prevents burns that occur on the walls, with the probe device 20 in contact, especially the walls of the urethra 34 ,

Claims (19)

Device for the surgical treatment of prostate tissue by hyperthermia with a rectal probe ( 82 ) connected to a temperature sensing device ( 98 ), and a urethral probe ( 20 ) suitable to be inserted into the urethra, the urethral probe being a leading end ( 20a ) and a posterior end, the urethral probe ( 20 ) a microwave antenna device ( 18 ) in the urethral probe ( 20 ) and between the front and the rear end in the vicinity of the front end ( 20a ), the microwave antenna device ( 18 ) is connected to an external microwave generating device (MWG) having means for generating microwaves at a frequency and power effective for hyperthermia treatment, wherein the urethral probe ( 20 ) a cooling device ( 32 ) for cooling the surface of the urethral probe ( 20 ) in order to prevent burns on the urethral wall ( 34 ) that are associated with the urethral probe ( 20 ), and wherein the urethral probe has the only microwave antenna device of the device. Device according to claim 1, wherein the cooling device ( 32 ) from at least two lines ( 36 . 38 ) containing a cooling medium and at the anterior end of the urethral probe ( 20 ) communicate with each other. Apparatus according to claim 1 or 2 with a balloon ( 26 ) and a filling device ( 28 . 29 . 30 ) for filling the balloon ( 26 ), the balloon ( 26 ) so at the front end ( 20a ) that he is in the bladder ( 24 ) is placed when the microwave antenna device ( 18 ) in front of the prostate to be treated ( 14 ) is placed. Apparatus according to claim 1, 2 or 3, characterized in that a further temperature detection device ( 44 ) on or in the urethral probe and optionally in the balloon ( 26 ) is provided. Device according to one of claims 1 to 4, characterized in that the microwave radiating antenna device ( 18 ) a metallic cable ( 52 ) coaxial with the urethral probe ( 20 ) and an insulating sleeve ( 54 ) is covered over part of its length, the radiation part ( 52a ) is not isolated. Device according to one of claims 1 to 5, characterized in that it comprises a control device ( 80 ) for controlling the positioning of the urethral probe ( 20 ) having. Apparatus according to claim 6, wherein the control device ( 80 ) into the rectal tube ( 82 ) is installed. Device according to one of claims 1 to 7, characterized in that an immobilization device ( 92 ) for immobilizing the rectal probe ( 82 ) in axial position, but preferably to allow rotation of the rectal probe ( 82 ) is provided about its axis. Apparatus according to claim 8, characterized in that the immobilization device comprises a balloon ( 92 ), z. Latex having the rectal probe ( 82 ) and in which the rectal probe ( 82 ) is easily orientable from the outside. Device according to one of claims 1 to 9, characterized in that the rectal temperature detecting device ( 98 ) on or in the rectal tube ( 82 ) is provided. Apparatus according to claim 4, characterized in that the further temperature detection device ( 44 ) has a fiber optic thermometer which is separated from the cooling device ( 32 ), preferably with several fiber strands extending in the longitudinal direction of the urethral probe ( 20 ) are arranged radially and / or longitudinally offset to the temperature at different radial and / or longitudinal positions of the urethral probe ( 20 ) to detect. Device according to one of claims 1 to 11, characterized in that further comprises a heat protection device ( 22 . 90 ) for the thermal protection of sensitive tissues with the exception of the tissue to be treated ( 12 ) having a device comprising a radiation-reflecting screen ( 22 . 90 ). Device according to Claim 12, characterized in that the device which forms a radiation-reflecting screen is a radiation-reflecting liquid medium ( 23 . 94 ), which preferably comprises an electrically conductive liquid which reflects the microwaves. Apparatus according to claim 12, characterized in that the screen-forming device comprises at least one wire which is parallel to the central electric field and preferably with the rectal probe ( 82 ) connected is. Device according to one of claims 1 to 14, characterized that the external microwave generator (M.W. G.) microwaves with a frequency of about 900 MHz and one to 100 watts adjustable Power generated. Device according to claim 5, characterized in that that the Microwave Antenna Microwaves in all directions radiates. Apparatus according to claim 7, characterized in that the control device ( 80 ) is formed by an echographic probe connected to a shielded echo 84 ) connected is. Device according to one of Claims 4 to 17, characterized in that it comprises a central control device ( 86 ), all Informatio central, including all temperature data gathered centrally in a thermometry device, and can automatically control the microwave generator device (MWG) as a function of the registered temperature data and any data that may have been programmed. Device according to claims 17 and 18, characterized in that the central control device ( 86 ) receives the data from the echographic probe ( 82 ) relative to the position of the urethral probe ( 20 ) in relation to the prostate.