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    • 专利摘要:
    The invention relates to an electrosurgical device (1) with an HF power source with HF voltage for electrosurgery and a circuit for applying the RF voltage to an electrode end (4) in electrosurgical operation on a patient, wherein the circuit is adapted to in a dissection mode, to provide RF voltage automatically in the form of pulses that automatically have a defined duration. This device can be used for bladder examination and radical en bloc removal of a large tumor by means of an active resection electrode loop and an optical resectoscope, wherein the bladder wall layers below the tumor base within the intact tissue margin under step-by-step coagulation and Dissection of the tumor nutrient vessels and the inter-tissue fibers can be prepared with pulsatile turn-on of the electrosurgical device in monopolar dissection mode.
    公开号:CH709074B1
    申请号:CH00567/15
    申请日:2012-10-25
    公开日:2017-07-31
    发明作者:Masansky Igor
    申请人:Masansky Igor；
    IPC主号:
    专利说明:

    Description [0001] The present invention relates to an apparatus for performing operations.
    As a PCT application, the present invention also relates to a method of performing an operation even for the countries where permissible.
    In onco-urology, a situation may occur where a tumor is in the bladder of a patient. It may be necessary to remove this tumor for therapeutic or diagnostic purposes. In this case, it is preferable to do so using minimally invasive surgical treatment.
    In particular, superficial bladder tumors and superficial muscle invasive tumors should be treated by a transurethral resection technique.
    At the same time, transurethral resection of a bladder tumor, TURBT, serves as a diagnostic method to evaluate the histo-pathological nature and stage of the disease, and it can be performed for palliative and hemostatic purposes.
    Three electrical TURBT techniques are currently in use, the choice being made depending on the size of the tumor and the location, see R. Hofmann, "Endoscopic Urology Atlas and Textbook", Springer Verlag, 1st edition 2005, p. 124 -133.
    Known transurethral resection techniques include laser and electrovaporation of bladder tumors, as well as radio frequency current-based TURBT.
    However, laser and electrovaporation of bladder tumors are not in general use as they provide no means for obtaining pathology specimens, which prevents the accurate diagnosis of choosing appropriate postoperative treatment according to a medical monitoring protocol.
    Thus, high frequency current based TURBT is often preferred.
    As far as traditional resection of parts or ablation is performed en bloc by HF transurethral resection, the RF current-based transurethral resection method requires a video resectoscope optical resectoscope, an 90 ° active angled resection loop electrode, and high frequency current (FIG. electrical resection). Continuous or cyclic bladder perfusion with sterile conductive solution throughout the resection procedure is required. The degree of bladder filling and, correspondingly, the bladder wall thickness is controlled at the perfusion rate.
    There are high-frequency surgical instruments for cutting and coagulation, which are equipped with a means for automatic regulation of the high-frequency voltage, a means for automatic regulation of the arc intensity and a means for automatically regulating the peak power - the PPS (Power Peak System) , During surgery with the device, the electrode is in an aqueous medium, e.g. in the method of transurethral resection of the bladder tumor. It should be understood that when reference is made to the manual adjustment of these parameters, the automatic and / or automatic sequencing control will also be included in this disclosure.
    With these devices according to the prior art small tumors - and only those - can be removed by horizontal resection. The tumor is resected layer by layer, starting from its top to its bottom. This technique is unacceptable for high-vascular tumors as it causes excessive tissue bleeding, significantly affecting visualization in the course of surgery.
    [0013] Reference is made in its entirety to the TURBT technique, as published by Russian Patent # 2 417 775 on 05.10.2011, and this is also considered to be the closest prior art to the technique described herein. The known method involves the en bloc resection of tumors of the bladder less than 1 cm in size by means of a single backward movement of the loop electrode, the support of the resectate from the branches of the frame through the end of the loop and subsequent evacuation of the tissue fragments by the resectator. frame tube.
    The disadvantage of this technique is the limitation with respect to the size of the tumors.
    It is not possible to remove bladder tumors en bloc regardless of their size, location and degree of bladder wall invasion.
    Therefore, things are different for large tumors (more than 4 cm in diameter), which infiltrate the muscle layer of the bladder wall.
    In the overwhelming majority of conventional cases, TUR of such tumors is not radical and patients often have to undergo cystectomy.
    Therefore, in the case of bladder cancer, the conventional TUR techniques have certain disadvantages and limitations, namely violation of the ablastic principle (that is, the tumor is removed by fragmentation without defunctionalizing nutrient vessels) resulting in tumor spread or early relapse can.
    Another disadvantage is increased tumor tissue bleeding, which impairs visualization during surgery.
    In addition, there is an increased risk of bladder wall perforation since in the procedure the resection loop has been advanced deep into the tissues, i. outside visual control.
    In addition, when the tumor is located on the lateral bladder wall, TURBT is practically not feasible without prior endotracheal anesthesia and muscle relaxation due to the risk of surgery-induced obturator nerve syndrome.
    Finally, TUR of high vascularized large tumors requires longer high flow perfusion with sterile solution to ensure constant visual control over the bladder wall and residual tumor, which is jeopardized by excessive tissue bleeding. This in turn significantly increases intravesical pressure and thus increases the risk of urinary bladder wall perforation and extravasation.
    Thus, while there exist techniques and instruments for the removal of a tumor that is small, i. E. Tumors of up to 1 cm in diameter and superficial within the bladder mucosa, the idea to remove bladder tumors en bloc, has challenged the worldwide urological community for decades.
    It would be helpful to allow better treatment of patients with bladder tumors. In particular, it would be helpful to facilitate a tumor removal procedure for a surgeon treating a patient with a large bladder tumor.
    The object of the present invention is to provide an electrosurgical device with which an electrosurgical procedure on a patient can be facilitated, in particular an electrosurgical removal of large bladder tumors.
    It will be seen below that, using novel surgical techniques, vertical or radial resection can be used to remove large tumors, including solid bladder tumors.
    In order to perform the new method of surgery, improved electrosurgical devices are disclosed.
    It is believed, however, that before describing this novel electrosurgical device, for better understanding of the benefits of the new device, the surgical procedure for which it is intended should be described.
    The medical treatment to be carried out using the present invention should be in accordance with the ablastic principle.
    By preserving the anatomical structures in the course of the TURB, it is possible to eradicate the bladder tumor en bloc independently of its size, location and the extent of the bladder wall invasion.
    In accordance with the surgical procedure disclosed herein, a way out of the problem of removing large tumors by analysis and taking into account the peculiarities of bladder wall anatomy has been found.
    The bladder wall has a total thickness of 4-5 mm and consists of several layers, namely mucous membrane, submucosa, inner, middle and outer muscle layers and tunica adventitia.
    The most important thing is that all layers rather loosely adhere to each other and move against each other within certain limits, which allows a continuous change of the two physiological processes: filling and emptying the bladder with constant changes in its volume.
    This anatomical structure is exploited in isolation of the tumor-penetrated layers of the bladder wall en bloc within a particular site and separation from the intact layers (more or less, as layer by layer of an onion is peeled) according to the new method described, without allowing perforations or tearing of the bladder.
    In view of this, during the course of the surgical procedure, short turn-on pulses of a monopolar dissection mode can be used for the preparation of the tumor wall affected by the bladder wall.
    In particular, the target set for the TURBT technique, including bladder examination and radical en bloc removal of the tumor with a resection electrode loop of an optical resectoscope, is achieved by careful dissection of the bladder wall layers beneath the tumor base within the intact tissue margin. This is done by step-by-step coagulation and dissection of the tumor nutrient vessels as well as the interstitial fibers by pulsing the electrosurgical device in monopolar dissection mode.
    Thereafter, the tissues produced are displaced by short movements of the cool resection loop, while the tip of the resectoscope tube supports them (see Fig. 2).
    Specifically, it is proposed that the resection be performed starting from the intact bladder wall at the tumor base until the outer muscle layer is reached.
    For this purpose, a resectoscope is used under the tumor base in the space between the layers of the wall as needed, depending on the depth of tumor invasion in the bladder wall, wherein the insertion is such that there are no visible signs of the tumor.
    Then, advancing on the tumor, a step-by-step removal of subsequent portions of its tissue regions is performed, strictly down the sagittal plane, until the previous level of resection is achieved.
    Numerous damaged vessels along the resection margin are coagulated from time to time as practical and necessary.
    During the surgical procedure, single exophytic papillary tumors of small size (less than 1 cm in diameter) may also be resected with a loop motion made on the tumor base, as long as the bladder submucosa is captured by the snare ,
    In all of the above methods, the loop is pulled further in the process of resection and embedded in the layer of the resectate, with simultaneous switching on of the electrosurgical device in use for a fairly long interval, that is usually more than 2 seconds and in monopolar dissection mode.
    Thus, according to the method proposed herein, bladder tumors are removed en bloc as a whole with the surrounding intact bladder wall.
    The method is advantageous in that during the operation only small Zwischengewebefasern and the main vessels leading to the tumor, must be separated.
    Before dissecting the blood vessels, they are coagulated with a forced coagulation mode (FORCED COAG) of an electrosurgical device.
    This mode is used to prevent bleeding; when this mode is activated, the tissue is not cut but closed, as the temperature becomes very high at the point of its contact with the loop electrode.
    This mode can also be used in the form of interrupted pulses; but in this case this is not essential.
    The most important parameters of this mode may e.g. as follows: RF voltage is pulse modulated AC voltage with a nominal frequency of 1 MHz and a maximum peak value of up to 2600 V, the nominal RF power being 120 watts.
    The experienced surgeon knows how and when these values should be used or changed.
    Accordingly, it has been found that it is both sufficient and preferable to switch on the monopolar resection mode only for a very brief instant, usually a fraction of a second.
    Thereby, the process of mobilization of the tumor becomes short, practically bloodless and safe for the remaining intact bladder wall, which is not affected by the tumor.
    The proposed new surgical procedure has several significant advantages compared with the conventional techniques.
    In particular, the ablastic principle is met, that is, the malignant tumor is removed en bloc with surrounding and the underlying tissue, and its comminution is not carried out sooner than the nutrient vessels are completely separated.
    Further, preventive coagulation of the major nutrient vessels in the bladder wall helps to minimize bleeding during the course of the operation.
    Then the risk of bladder wall perforation is minimized, thanks to visual control of the active electrode movements in the resection course.
    In addition, even when large tumors located on lateral walls of the bladder sidewalls (within the obturator nerve projection) are removed, there is no indication of endotracheal anesthesia with complete muscle relaxation.
    In addition, TUR is performed on low flow perfusion, which reduces the risk of bladder wall perforation and extravasation of urine and saves significant amounts of perfusate.
    While the method may be performed by a power-on pedal of an RF power generator very frequently and by short-pressing for the above-mentioned mode, this requires considerable skill and is tiring for the surgeon.
    Thus, while it is possible to learn this, the ability to regulate the length of the power-on pulses of the resection mode by varying the frequency by pressing the foot pedal of the device is comparable to the ability to master the Russian tap dance and time and possibly require special training in a clinical setting to use this technique with hands-on experience.
    In order to provide an easy way to perform the new method of operation, it is now proposed to change the RF current generator so that the application of RF energy is easier.
    To this end, the proposed novel surgical procedure discloses an electrosurgical device comprising an RF power source with RF energy for electrosurgery and circuitry for applying the application of RF energy to an electrosurgical electrode tip to a patient control, wherein the circuit means is adapted to automatically apply the RF energy when in a dissection mode at the electrode end in the form of pulses so that the pulses are automatically of a defined length.
    It is to be understood that a device with a circuit which will automatically generate pulses will make it possible in a very simple manner to ensure that it is sufficient to switch on only the monopolar resection mode, without the need for any special skills other than that an otherwise experienced surgeon.
    By using such a device, the process of dissection of the tumor becomes short, practically bloodless, and safe for the remaining intact bladder wall unaffected by the tumor.
    None of the other functionalities of a known device must be changed.
    Thus, each surgeon urologist will be able to adjust the mode of operation of the RF current generator of the present invention in accordance with tumor spread and personal experience, giving him the opportunity to perform the surgical procedure safely and with always invariably perfect results.
    Therefore, while it is of course possible to learn to regulate the length of the switch-on pulses of the resection mode by changing the frequency of pressing the foot pedal of the device (as the inventor has done), it will no longer be necessary. mastering the difficult practice that was not as simple as mastering the art of Russian tap dance and time and, most likely, requiring special training in a clinical setting with hands-on experience with this technique.
    It is apparent that the disclosed device is particularly useful for bladder tumor removal.
    Depending on the intended use, in particular for the removal of bladder tumors, in a preferred embodiment the device according to the present invention may further comprise a device for continuous or cyclic low flow bladder perfusion with sterile conductive solution during the course of the operation, without overfilling the bladder over its physiological volume.
    It is advantageous if the electrode to which the RF energy is applied is an active resection electrode loop with 0-45 ° bending angle.
    Also in a preferred embodiment, the device can be further provided with an optical resectoscope as per se known, so that the visual control of the surgical site, preferably at the minimum possible focus distance, is possible.
    It will be understood that a surgical procedure system of the present invention may be preferably adapted for use with a rotatable tissue morcellator.
    Preferably, in the device according to the present invention, the circuit means is adapted to automatically apply in dissection mode RF energy in the form of pulses to the electrode end for durations of the pulses of between 0.1 and 2 seconds.
    Preferably, in the device according to the present invention, means are provided for selecting a length of the automatically generated RF pulses in the dissection mode, the means preferably allowing a choice of the length of the pulses between 0.1 and 2 seconds, and / or wherein the duration of the pulses can be selected between 0.1 and 1 second.
    The use of pulses up to 2 seconds will allow the use of lower power and / or treatment of larger areas and / or with larger electrodes, while very short pulses will allow the treatment of small structures.
    Further reduction of pulse lengths is generally not beneficial in adult patients and therefore will not be preferred.
    It should be noted that it is possible to use single shot activation for the circuit, whereby the application of a pulse of RF energy to the electrode per activation, e.g. Triggering a pulse occurs each time a manual or footswitch is depressed while not allowing any further trip before releasing the switch and pressing the switch again.
    However, it is also possible to allow other types of activation as an alternative and / or in addition to the one-shot mode.
    For example, it would be possible to generate pulse trains having a particular, preferably adjustable pulse repetition rate for a duration that a switch is actuated, e.g. a number of e.g. to 3 or 5 or 10 pulses per interval of e.g. 5-10 sec., As long as a foot pedal or the like is pressed continuously.
    This allows a slow movement of the resection electrode over an area where, for example, coagulation of a number of vessels is necessary and / or when a recession must be particularly slow.
    It would also be possible to apply a burst having a selectable maximum total number of pulses, preferably again at a predetermined, preferably adjustable repetition rate, wherein the maximum number of pulses in such a burst is not exceeded, even if a switch such as manual or foot switch, is pressed for a long time.
    Also, the repetition rate and / or the energy of a pulse and / or the length of the automatically generated pulses could be made dependent on the strength with which a pedal switch or the like is kicked or manually depressed.
    It is noted that there are a large number of possibilities to implement circuits that provide these functionalities.
    In particular, these functionalities can be implemented with analog and / or digital electronics.
    Preferably, with the device of the present invention, RF energy in dissection mode is applied to the electrode as monopolar energy for dissection.
    Preferably, with the device according to the present invention, the RF energy in dissection mode is provided as monopolar energy for dissecting at a frequency between 300 and 450 kHz. If the current frequency is above 450 kHz, not only would special equipment be required, but it would also manifest an effect called tissue vaporization effect.
    While there are also special surgical techniques that rely on this effect, they are rarely practiced because of the marked electrical damage to the normal tissue adjacent to the tumor during the course of the intervention.
    Thus, it is preferred for the present invention to have RF energy at a frequency of less than 450 kHz. For example, it has been found that a BOWA ARC 3.00 HF current generator manufactured in Germany can be used with an output current frequency of 330 kHz for performing the new surgical procedure without the new device of the present invention.
    It is considered sufficient, and therefore preferred, for the device of the present invention to provide a maximum output power for monopolar dissection of 300 watts, and preferably the output power is adjustable.
    Furthermore, in the device according to the present invention, the RF voltage in the dissection mode is preferably an unmodulated sinusoidal AC voltage.
    It is also preferable that the maximum RF voltage in the dissection mode is less than 600V, preferably equal to or less than 570V.
    Also, in a particularly preferred embodiment in the device according to the present invention, the circuit is further suitable, RF energy for blood vessel coagulation with a nominal frequency of> 500 kHz, preferably 800-1500 kHz, and an RF power of less to create as 200 watts.
    A typical and thus preferred RF frequency will be 1 MHz. This mode allows to prevent bleeding.
    When this mode is activated, the tissue will not be cut but rather sealed as the temperature becomes very high at the point of its contact with the loop electrode.
    This mode may also be used in the form of interrupted pulses as described above in connection with the monopolar dissection mode; but in this case this is not essential.
    In a practical embodiment, it has been found that, as the most important parameters, this mode can be applied as follows; however, it is to be understood that these parameters are not intended to limit or limit the scope of the invention, and that a skilled enough surgeon will know how and when to use values other than these: a pulse modulated RF alternating voltage with a nominal one RF frequency of 1 MHz, a maximum peak of up to 2600 V and a nominal RF power of 120 watts.
    In this way, prior to dissection, the blood vessels can be more easily coagulated using a forced coagulation mode.
    It should be noted that the surgery device can make use of (at least) two regulators at the output of the RF current, and preferably, with a regulator of the monopolar dissection and a regulator serving the coagulation mode.
    It has been stated above for the monopolar dissection control that preferably the length of the automatic turn-on pulse (s) and e.g. the length of the interval between the pulses should be controlled.
    It should be noted that in a particularly preferred embodiment, corresponding adaptations will also be possible for the coagulation mode.
    These at least two regulators can help to keep the required parameters within the given mass without special efforts on the part of the surgeon.
    The electrosurgical device of the invention will not require to change or abandon other key features of known electrosurgical devices, such as safety measures, patient end combination with optical instruments, light, etc.
    Nevertheless, any surgeon urologist will still be able to easily adjust the mode of operation of the HF current generator according to the tumor spread and his personal experience, allowing him to perform the surgical procedure safely and with always perfect results.
    The present invention will now be described without limitation to the specific embodiment and thus by way of example only, with reference to the drawings. What is shown in the drawing is
    Fig. 1, the electrosurgical device according to the invention;
    FIG. 2 is an illustration of the surgical procedure performed with the electrode of the device of FIG. 1. FIG.
    Referring to Fig. 1, an electrosurgical device 1 comprises an RF power source 2 which provides RF energy for a dissection step during electrosurgical intervention, and a circuit 3 for applying RF energy to an electrode end 4 which is used in the electrosurgical operation of a patient is used.
    In this electrosurgical apparatus 1, the circuit 3 is designed to automatically apply, in a dissection mode, the RF energy for separation to an electrode end 4 in the form of pulses, so that the pulses automatically have a defined length.
    The electrosurgical device 1, aside from referring to the circuits and devices described herein, is adapted conventionally and for bladder surgery in a manner known per se to those skilled in the art.
    For this purpose, the electrode end 4 is part of a surgical intervention end, which is a resectoscope, which is constructed in a conventional manner and allows to see the surgical site during surgery.
    It is also adapted for continuous or cyclic low flow bladder perfusion with sterile conductive solution and / or spinal anesthesia.
    Corresponding controls are provided, cf. Reference 5.
    The electrode 4 itself is preferably constructed as a loop electrode with a suitable angle.
    The control circuit 3 is adapted to set a pulse duration t per pulse, as indicated by arrow 3a; set a repetition rate (or the time interval between the pulses) as indicated by the arrow 3b, between a single-shot mode, a burst mode and a mode of repeating the pulses for an infinite time as long as an activation signal is received, as selected by the Arrow 3c indicated; adjust the RF output power as indicated by the arrow 3d; and the RF frequency for the dissection as indicated by the arrow 3e.
    The electrosurgical device 1 is further provided with a blood coagulation RF power source 6 whose output power source can be adjusted via a controller 7 as indicated by the arrow in box 7.
    A selection as to whether RF power from the coagulation current source or the dissection current source is turned on to the electrode end 4 may be made by a footswitch 8 having two regions for activation, with either one (and only one at a time) of the Power sources is activated.
    For the sake of completeness, it should be noted that the coagulation current source and the dissecting current source need not necessarily be different; instead, it would be possible to operate the same power source in different ways to provide energy for both dissection and coagulation.
    The electrosurgical device 1 is further provided with a foot pedal switch 8 with a number of different pedals, here two pedals 8a and 8b.
    By stepping on pedal 8a, the pulse or pulses from the RF dissection power part 2 are switched to electrode 4 in an interface 9.
    These pulses are generated according to the setting with the operating elements 3a-3e, and therefore have corresponding power, frequency, duration, repetition rate and are selected in one of single-shot mode, burst mode or continuous pulse generation mode.
    By stepping on pedal 8b, the coagulation power set by controller 6 is applied to electrode 4.
    A controller detects if both pedals are activated simultaneously. In this case, a warning signal is generated, but no electrical power to the electrode 4th
    The device according to the present invention is useful in a surgical procedure performed as follows: The target set for the TURBT technique and the examination of the bladder and the radical en bloc removal Tumor resection using the active resection electrode-loop of the optical resectoscope with active resection loop electrode is achieved by careful preparation of the bladder wall layers beneath the tumor base within the intact tissue margin.
    Here, the step-by-step coagulation and dissection of the tumor nutrient vessels and the inter-tissue fibers is carried out by pulsing the electrosurgical device using the monopolar dissection mode.
    Thereafter, the prepared tissues are pushed away by brief movements of the cool resection loop while the tip of the resectoscope tube supports them.
    The duration of the individual switch-on pulses of the surgical device in use, which is operated in the monopolar dissection mode, is set in such a way that the circuit 3 does not exceed one second per pulse.
    Using the device according to the present invention, there is no need for the surgeon to constantly control the duration and frequency of the pulses, turning on the resection mode of the high frequency surgery device by changing the frequency and time of pressing of the foot pedal of an electrosurgical device used in bladder wall preparation and tumor removal procedures.
    Instead, the relevant parameters may be adjusted in advance, and then the surgical device can be easily triggered with the pedal 8.
    The use of the proposed mode of operation of the high frequency electrosurgical device of the present invention thus allows any urologist - even with limited experience in transurethral surgery, bladder tumors safely en bloc and completely independent of their location, size or depth of bladder wall invasion remove.
    Preparatory coagulation of the bladder mucosa and vessels passing through the mucosa around the tumor base is performed as specifically recommended, with subsequent dissection of the bladder wall deep down into the external muscle layer along the outline drawn by the coagulation procedure is preferably not more than 1.5 cm from the tumor base depending on the size of the focus.
    [0130] The preparation is carried out by activation impulses of the electrosurgical unit using the monopolar dissection mode.
    This method uses the standard active resection electrode loop (at 0-45 ° bend angle) and operating at the minimum possible focus distance of the optical resectoscope.
    This method allows the use of continuous or cyclic low flow bladder perfusion with sterile conductive solution and spinal anesthesia instead of general anesthesia with muscle relaxation.
    This process is performed in the following order of its steps.
    The alleged TURBT method requires the use of an optical resectoscope with video system, active standard RF resection loop with 0-45 ° bending angle and high frequency current (electrical resection).
    During the resection procedure, continuous or cyclic blister perfusion with sterile conductive solution must be provided.
    In order to ensure bleeding control, low flow perfusion may be used.
    After examination of the bladder: coagulation of the bladder mucosa and its vessels around the visible tumor base at a distance of not more than 1.5 cm thereof, depending on the size of the focus.
    In the next step, the mucosa, the submucosa and the internal muscle layer are prepared in the previously coagulated area.
    The prepared tissues are displaced through the resection loop; slight stress generated by the latter is sufficient because bladder wall layers tend to be loosely bound together. This is shown in FIG. 2.
    From this step, the surgeon will take care to prevent over-inflation of the bladder with the surgical solution.
    Meanwhile, the tip of the resectoscope tube is advanced into the defect, which now appears in the bladder wall, and light pulling on the prepared tissue en bloc is applied in the direction of the resection.
    At this stage, the edge of the tumor or the inflammatory involvement of the bladder wall can be clearly seen, allowing immediate choice of the layer for further treatment.
    The layer of the preparation depends on the tumor extent and the depth of penetration.
    Light pull is usually sufficient to separate the tissue within the working layer, except for blood vessels that approach the tumor and separate muscle fibers that are interwoven between the external and internal muscle layers.
    These elements are coagulated step-by-step and prepared with the resection loop by automatically generated pulses as pedals 8a or 8b are stepped on.
    The surgery device is set to not exceed a pulse duration of 1 second in the monopolar dissection mode.
    On the one hand, this allows for easy control of bleeding in the course of surgery, as the tumor's major nutrient vessels are coagulated and dissected into smaller branches upstream of their division. On the other hand, even without drug-induced muscle relaxation, the patient does not suffer from clinically significant obturator nerve syndrome and concomitant complications.
    In addition, the proposed short-pulse turn-on of the resection mode precludes the significant rectification of a portion of the high-frequency alternating current that otherwise occurs due to the arc that arises between the active electrode and the tissue in the process of preparation, which in turn more or less strongly modulated current components that are capable of causing pronounced irritation of such irritable tissue such as muscles and nerves.
    The clinical significance of this effect is that pulsed turn-on of the high-frequency surgical device in the resection mode in the course of transurethral resection of the bladder tumor using the above-described technique in use could only cause minimal stimulation of the obturator nerve , which manifests itself in only minor twitching of the ipsilateral lower extremity, but can completely exclude bladder wall perforation.
    By this effect, the intervention can be performed in all cases, regardless of tumor size or site under spinal anesthesia, which is particularly important in the elderly and weak patients.
    When the surgeon gets deeper below the tumor base, he will simultaneously perform the step-by-step coagulation and dissection of the mucous and submucosal cells on either side of the tumor along the resection edge described above until the removed tissues are completely separated en bloc from the bladder wall are.
    The sophisticated technique makes it possible to perform the resection under complete visual control over the entire procedure.
    Virtually complete absence of tissue bleeding throughout the operation, step-by-step tissue dissection only at the edge of contact with the resection loop, and small focus distance operation (with minimal loop dilation) contribute to this.
    The new surgical procedure for which the electrosurgical device is intended is intended for a variety of patients.
    This will be exemplified with reference to the following cases. Then, case histories will illustrate the feasibility of the new technology and the achievement of the goals set.
    Case 1 Patient Y, age 78, was due to complaints of obstructed urine flow and occasional lumped hematuria over the past 3 months in the Department of Oncological Surgery III of the Minsk Municipal Health Center for Clinical Oncology (MMHG-CO). admitted.
    The condition of the patient at admission was satisfactory, he was fully conscious, with normal color of the skin, without edema or dilation of the peripheral lymph nodes.
    His hemodynamic parameters were in the normal range, blood pressure 130/80 mm / Hg. No palpable masses could be detected on physical examination.
    The patient was struggling to defecate, and blood could be detected in his urine with the naked eye.
    The examination and laboratory test results were as follows: ECG: sinus rhythm, HR-76 bpm, the electrical heart axis was in normal position.
    Chest x-ray: residual post-tuberculosis changes, emphysema and pneumosclerosis. Abdominal ultrasound findings: unremarkable, no metastases found.
    The kidneys: unremarkable.
    The bladder contained 200 ml of urine; a hyperechogenic tissue mass 55 x 47 mm in size was recognized on the left side of the bladder wall.
    The prostate was not enlarged, 32 x 35 x 33 mm.
    Renographical radionuclide study: significantly impaired secretory and excretory function of the right kidney; markedly impaired secretory and excretory function of the left kidney (parenchyma type of the curve).
    Blood count: RBC - 3.36 x 10 <12>, HG - 99 g / l, color index - 0.88, PLT - 305 x 10 <12>, WBC - 4.8 x 109, eosinophilia phil cells - 1%, chopsticks - 2% , segmented neutrophils - 69%, lymphocytes - 19%, monocytes - 9%, ESR - 36 mm / h.
    Biochemical blood test: total protein - 80.1 g / l, urea - 5.6 qnol / l, total bilirubin -9.0 dmol / l, glucose - 4.7 Πτηοΐ / Ι.
    Urine analysis: reddish, muddy, specific gravity - 1010, alkaline reaction, protein content 1.05 g / l, RBC cover all fields of vision.
    The patient was scheduled for surgery.
    Under spinal anesthesia, the 24-CH resectoscope tube was passed lightly through the urethra. Under visual control, the resectoscope was inserted into the bladder.
    The bladder capacity was 400 ml.
    The examination showed that the prostate was not enlarged.
    The mucosa was of trabecular construction with patchy sites of inflammation and consistently pronounced vascular injection.
    Both ureteral openings were unremarkable.
    A villous solid mass of 55 mm diameter on a broad base was placed on the left sidewall, passing over the rear wall of the bladder.
    The tumor was bleeding continuously.
    The bladder cavity was rinsed to remove about 30 ml of fresh and old blood clots. No other pathological changes were revealed.
    The en bloc resection of the remaining lateral and posterior bladder wall with the tumor was performed with precision electrical heat preparation deep down to the external muscle layer.
    Control of bleeding was safe throughout the surgery.
    Bubble wall integrity was checked.
    The resected tissue pieces were fragmented in the bladder space for subsequent evacuation.
    The bladder cavity was rinsed to remove the resected tissue fragments.
    Resection margin biopsy and residual bleeding testing was performed. Urethral Foley catheter CH 20 was placed in the bladder for urinary diversion.
    On bimanual palpation, the bladder felt soft, with no noticeable masses. The prostate felt atrophic and of elastic consistency.
    Macro-preparation: 1. Tumor small, villous structure, 5.5 cm diameter with base and surrounding mucosa, fragmented. 2. Resection margin sample.
    Pathology Report # 2009 / 41.114-214: papillary urothelial carcinoma with invasion of subepithelial connective tissue, pT1G2, cut margin negative on tumor growth.
    The postoperative period was uneventful.
    The catheter was removed on the 2nd day after surgery.
    Normal emptying restored.
    Hemo-gram: RBC - 4.18 x 10 <12>, HG - 123 g / l, color index - 0.82, PLT-275X10 <12>, WBC - 8.4 x 109, eosinophils - 1%, sticks -3 %, segmented neutral -72%, lymphocytes - 11%, monocytes -12%, ESR-41 mm / h.
    Biochemical blood test: total protein - 78.0 g / l, urea - 3.8 mol / l, total bilirubin - 9.8 dmol / l, glucose-4.6 dmol / l.
    Urinalysis: light yellow, slightly soiled, specific gravity - 1006, alkaline response, protein content-0.075 g / L, squamous epithelium, 1-2 per field of view; WBC - 2-3 per field of view; RBC -18.10 per field of view.
    On the 8th day after the operation, the patient was discharged in a satisfactory condition by an ambulance urologist, and urotropic antimicrobial agents for oral administration for 10 days were recommended for further treatment.
    [0179] Follow-up at 3 months was recommended.
    At postoperative control at 3 months, the condition of the patient was satisfactory. Urine cytology test negative for tumor cells.
    Abdominal ultrasound findings: unremarkable, no metastases found.
    Kidney ultrasound image: unremarkable.
    The bladder contained 200 ml of urine and was round with a pronounced uniform outline.
    The bladder wall thickness did not exceed 0.4 cm.
    No additional masses were found.
    The prostate was not enlarged.
    Case 2 Patient K., aged 53, was admitted as an emergency in the Department of Oncosurgery III of the Minsk Municipal Health Center for Clinical Oncology (MMHCCO) for lumped hematuria and obstructed urinary flow.
    The patient's condition at admission was satisfactory, he was fully conscious, with pale skin color, no edema, or enlargement of the peripheral lymph nodes. His hemodynamic parameters were in the normal range, blood pressure 130/80 mm / Hg. No palpable masses could be detected by physical examination. The patient was struggling to empty himself, and blood could be traced in his urine with the naked eye.
    The examination and laboratory test results were as follows: ECG: sinus rhythm, HR-88 bpm. Thorax X-ray examination: inconspicuous.
    Abdominal ultrasound findings: unremarkable, no metastases found.
    The kidneys: unremarkable.
    The bladder contained 300 ml of urine: a hyperechogenic tissue mass 58 x 48 x 42 mm in size on a broad base was detected on the left bladder wall.
    Hyperechogenic masses not attached to the bladder wall (blood clots) were seen in the bladder cavity.
    Enlarged lymph nodes up to 14 mm in diameter were recorded along the iliac vessels on the left side. The left ureter was expanded to 0.8 mm in diameter along its entire length. Pelvic computed tomography: CT image of an invasive tumor of the left bladder wall, metastasis of iliac lymph nodes on the left side, osteoblastic metastases in the pelvic and sacral bones.
    Blood count: RBC - 4.94 x 10 <12>, HG - 113 g / l, color index - 0.80, PLT - 183 x 10 <12>, WBC - 5.3 x 109, eosinophils - 1%, rods - 3%, segmented neutral - 67%, lymphocytes - 23%, monocytes - 7%, erythrocyte sedimentation rate -20 mm / h.
    Biochemical blood test: total protein - 81.3 g / l, urea-5.9 lmol / l, total bilirubin - 14.8 dmol / l, glucose - 5.2 mmol / l.
    Urinalysis: brown color, specific gravity -1017, acid reaction, protein content - 0.45 g / l, squamous epithelium, 1-2 per field of vision; Leukocytes - 3-6 per field of view; RBC - in large quantities.
    The patient was placed in surgery for emergency surgical intervention because of increasing gross hematuria.
    Under spinal anesthesia, a 24-CH resectoscope tube was lightly inserted through the urethra and the reconcerectoscope was visually inspected into the bladder.
    Bladder capacity was 300 ml.
    Examination of the bladder showed slightly enlarged prostate, the bladder cavity contained up to 60 cc of amount of floating blood clots which were removed.
    The mucosa was of trabecular structure with spotty foci of inflammation and marked vascular injection. The right ureteral opening was unremarkable.
    A small villous mass of 55 mm diameter on a broad base, which included the left ureteral orifice, was placed on the left sidewall.
    The tumor was bleeding continuously.
    Signs of tumor invasion were detected: several dilated and tortuous vessels around the broad tumor base, the latter completely immobile.
    On the anterior wall of the bladder neck, another tumor-like structure 0.6 cm in diameter was detected on a narrow base.
    No other pathological changes were revealed.
    The en bloc resection of the left lateral bladder wall with the tumor was performed under precision electrical heat preparation deep down into the paravalent fat layer.
    In doing so, the intramural part of the ureter was mobilized and cut 0.8 cm above the visual tumor margin.
    An endo-soft radiopaque double pigtail stent CH 7.5 from Cook Medical was placed in the left kidney.
    Bleeding control was safe throughout the operation.
    The bladder wall integrity was checked.
    The resected tissue pieces were fragmented into the bladder space for subsequent evacuation.
    The tumor on the anterior side was resected first.
    The bladder cavity was rinsed to remove the resected tissue fragments. Biopsy resection margin and residual hemorrhage testing was performed.
    Urethral Foley catheter CH 22 was placed in the bladder for urine.
    On bimanual palpation, the bladder felt soft and mobile.
    The prostate felt slightly enlarged and of elastic consistency.
    1. Macro-preparation: Turner of small villous structure, 5.5 cm in diameter, with base and surrounding mucosa, fragmented.
    [0196] 2. Resection margin sample.
    [0197] Pathology Report: Transitional cell carcinoma with muscle layer attack, pT2bG2 contains cut-edge, fat and muscle tissue negative for tumor growth.
    The postoperative phase was uneventful.
    The catheter was removed on the 3rd day after surgery.
    Normal emptying was restored.
    The blood count was within normal limits; Urinalysis: light yellow, slightly soiled, specific gravity - 1020, acid reaction, protein content - 0.12 g / l, squamous epithelium: 1-2 per field of vision; WBC: 2-4 per field of view; RBC: 20-40 per field of view.
    On the 10th day after the operation, the patient was discharged in a satisfactory condition, with his further course of treatment including chemotherapy.
    The patient was scheduled for re-hospitalization 6 months after surgery.
    [0198] No complaints were presented.
    The condition of the patient at inpatient admission was satisfactory, he was in full consciousness, with pale pink color of the skin, without edema or dilation of the peripheral lymph nodes.
    His hemodynamic parameters were in the normal range, blood pressure 130/80 mm / Hg. No palpable masses could be detected during physical examination.
    The patient had no trouble emptying and his urine was clear.
    The study and laboratory test results were as follows: ECG: sinus bradicardia, HR-65 bpm.
    Regarding mucosa, overall normal structure was found with patchy sites of inflammation.
    The post-resection scar was 2.8 x 2.5 mm in size, with focal spots of the loose mucosa surrounded by bullous edema, to the left of the bladder wall adjacent to the bladder neck.
    The left ureteral opening was patulous, tumor-free and contains the stent.
    There were no other pathological formations in the bladder.
    Biopsy of the post-resection scar on the left bladder wall was performed.
    The residual bleeding was checked.
    The stent was removed with tweezers and a CH-18 urethral catheter inserted into the urethra. Macro-preparation: Small bladder wall fragments were taken from the post-resection scar on the left bladder wall.
    [0207] Pathology Report: Fragments of fibrous tissue with mild inflammation and residual epithelial lining residuals.
    [0208] The postoperative phase was uneventful.
    The catheter was removed on the 1st day after surgery.
    Normal emptying was restored.
    Conclusion: The condition of the patient is satisfactory.
    In the first case, the bladder was obtained and the patient defecated naturally.
    In the second case, complete removal of the tumor has allowed control of gross hematuria and deblocking of the left kidney, which in turn has created conditions for full chemotherapy with a positive effect.
    The immediate oncological result was good.
    权利要求:
    Claims (10)
    [1]
    [0212] What is considered novel and inventive with respect to the method of surgical practice in the countries, where applicable but not expected to be the subject of a search of the PCT application at the time of filing, is: [0213] ] A. TURBT technique for bladder exploration and radical en bloc removal of a tumor using the active resection electrode loop of an optical resectoscope with the bladder wall layers beneath the tumor base within the intact tissue area using step-by-step techniques. Coagulation and dissection of the tumor nutrient vessels and the inter-tissue fibers is prepared by pulsing the electrosurgical device in use in monopolar dissection mode; B. the TURBT technique of A, wherein after the electrosurgical device has been applied, the prepared tissues pass through short movements of a preferably cold or inactive Resektionssch be pushed away while the tip of the resectoscope tube supports them. C. The TURBT technique as described in A or B, wherein the duration of each turn-on pulse of the electrosurgical unit in use, operating in monopolar dissection mode, does not exceed 1 second. D. The TURBT technique as described in one of AC, wherein preliminary coagulation of the bladder mucosa and / or the vessels passing through the mucosa around the visible tumor base, with subsequent separation from the bladder wall deep to the outer muscle layer along the Outline is performed by the coagulation process, wherein the preparation by means of pulse curves on the surgery device, which is used in the monopolar dissection mode is performed. E. The TURBT technique of one of A-D, wherein preliminary coagulation of the bladder mucosa and preparation of the bladder wall and vessels therein are performed no further than 1.5 cm from the tumor base depending on the size of the focus. F. The TURBT technique of any one of A-E, wherein a standard active resection electrode loop of 0-45 ° bending angle is used. G. The TURBT technique of one of A-F performed with the minimum possible focal distance of the optical resectoscope. H. TURBT technique of any one of A-G, wherein a continuous or cyclic low-flow bladder perfusion with sterile conductive solution is performed in the course of the operation without over-inflation of the bladder over its physiological volume. I. The TURBT technique of one of A-H wherein the radical en bloc removal of the tumor is independent of the size of the tumor, the location and the depth of the bladder wall invasion. J. The TURBT technique of one of Al, wherein surgery under spinal anesthesia is performed regardless of tumor size, location and depth of bladder wall invasion so that risks of clinically significant obturator nerve syndrome are minimized and general anesthesia with muscle relaxation is not is required. K. The TURBT technique of one of AJ, wherein after the en bloc resectate lump is completely separated from the bladder wall, a rotatable tissue morcellator for evacuating the resected en bloc tissue lump of greater than 5 cm diameter is used and wherein tumor fragments are removed via the optical resectoscope tube. Claims 1. An electrosurgical device having an RF power source configured to provide RF voltage for electrosurgery on an electrode loop in a dissection mode, and circuitry for applying RF voltage to the electrode loop during a time period electrosurgical operation of a patient, characterized in that the circuitry is adapted to apply the RF voltage in the dissection mode to the electrode loop automatically in the form of pulses of a defined duration.
    [2]
    2. Device according to claim 1, wherein the circuit arrangement is designed such that the pulses in the dissection mode have pulse durations between 0.1 and 2 seconds.
    [3]
    A device according to claim 2, comprising means for selecting the duration of the automatically generated pulses in the dissection mode, wherein the means is arranged to allow a choice of pulse durations between 0.1 and 2 seconds, and / or a choice of Pulse durations between 0.1 and 1 second.
    [4]
    4. Apparatus according to claim 3, which is adapted to apply the RF voltage with a high frequency between 300 and 450 kHz in the dissection mode to the electrode loop.
    [5]
    5. Device according to one of claims 1 to 4, which is adapted to apply a maximum output power for the dissection of 300 watts.
    [6]
    6. Device according to one of claims 1 to 5, which is adapted to apply an unmodulated sine voltage to the electrode loop in the dissection mode.
    [7]
    7. Device according to one of claims 1 to 6, which is adapted to apply in Dissektionsmodus a maximum RF voltage below 600 V, preferably equal to or less than 570 V.
    [8]
    8. Device according to one of claims 1 to 7, which is further configured so that for the coagulation of blood vessels an RF voltage with a nominal frequency of> 500 kHz, preferably 800-1500 kHz, and at an RF power of less than 200 watts can be created.
    [9]
    9. Device according to one of claims 1 to 8 with an electrode loop with 0-45 ° bending angle for the active resection.
    [10]
    10. Device according to one of claims 1 to 9, comprising an optical resectoscope to allow a visual inspection of the operation site, preferably in the minimum possible focal distance of the resectoscope,
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    同族专利:
    公开号 | 公开日
    WO2014064480A1|2014-05-01|
    US20150289928A1|2015-10-15|
    US10292762B2|2019-05-21|
    引用文献:
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    法律状态:
    2016-07-15| PFA| Name/firm changed|Owner name: IGOR MASANSKY, US Free format text: FORMER OWNER: IGOR MASANSKY, US |
    优先权:
    申请号 | 申请日 | 专利标题
    PCT/IB2012/002145|WO2014064480A1|2012-10-25|2012-10-25|Electrosurgical device and its use for removing large bladder tumors|
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