Gynaecological device for permanent tubal sterilization using a bendable radiofrequency applicator

Abstract

The invention relates to a single-use gynaecological device (1) for producing thermal lesions in the Fallopian tubes by application of radiofrequency in order to bring about permanent sterilization, said device (1) comprising an elongate tubular applicator (10) which extends along a longitudinal axis (XX') and is equipped with a manual gripping means (20) arranged near a proximal end (1a), and with an active segment, for emission of bipolar radiofrequency, arranged near a distal end (1b), said active segment for emission of bipolar radiofrequency being connected to a radiofrequency source (30), characterized in that the manual gripping means (20) has at least one manually movable mechanical bending actuator (50) for bending the distal end (1b) of the elongate tubular applicator (10), and a means (60) for blocking said bending once the latter has been determined with the aid of said mechanical bending actuator (50).

Description

Description Title of the invention: Gynecological medical device for permanent tubal sterilization using an incurable radiofrequency applicator Technical field of the invention

[0001] The present invention relates to a single-use gynecological medical device designed to produce thermal lesions in the intramyometrial portion of the fallopian tubes by applying radiofrequency energy. This thermal lesion is accompanied by tubal obstruction through thermofusion, thereby creating permanent tubal sterilization. Previous technique

[0002] Definitive medical tubal sterilization by action on the Fallopian tubes has existed for many years and most often requires a surgical procedure: laparoscopic or hysteroscopic.

[0003] A very common method of female sterilization is tubal ligation using titanium and silicone clips (such as the "Filshie Clip®") that are closed around each fallopian tube, near the uterus. Traditionally, this is a surgical procedure performed in an operating room under general anesthesia. It has also become possible to ligate or clip the fallopian tubes using a minimally invasive surgical procedure: laparoscopy or celioscopy. This involves inserting a trocar (a tubular instrument called a "trocar sleeve" or "laparoscopic cannula") into the abdominal wall. For this surgical procedure, two trocars are usually required, namely an umbilical trocar to introduce the laparoscope (camera) to provide visual feedback to the practitioner on the operation, and a midline suprapubic trocar to introduce a forceps applicator to position and tighten the clips.If exposure is difficult, another trocar may be inserted through the abdominal wall to allow the operator to better expose the fallopian tubes. Generally, when the first trocar is positioned, the abdominal cavity is pressurized (inflated with CO2) to distend it. abdominal wall and allow visualization of the organs and safe mobilization.

[0004] Laparoscopic surgery offers several advantages over traditional open surgery (laparotomy). The smaller incisions made during laparoscopic procedures are less painful for the patient, resulting in faster recovery and a quicker convalescence. This minimizes hospital stays. Furthermore, laparoscopic surgery is quicker and less expensive than conventional surgery for the same procedure.

[0005] A major disadvantage of laparoscopic surgery is that it must always be performed in a hospital operating room, even though it is most often done on an outpatient basis. It cannot be performed in doctors' offices. Although complications are rare, they expose the patient to the risks of general anesthesia and surgery (hematoma, infection, thromboembolic events, etc.). Finally, the costs of recovery and hospitalization are high for the healthcare system.

[0006] An alternative to this laparoscopic procedure was tubal sterilization by hysteroscopy (permanent and irreversible) using an innovative medical device (MD) developed by Bayer under the name Essure®. The procedure involves placing a micro-insert simultaneously in both fallopian tubes. This insert takes the form of a spiral (an expandable spring approximately 4 centimeters long) composed of a central stainless steel section, active polyethylene terephthalate (PET) fibers inside the device to block the fallopian tube, an external spring made of a nickel-titanium alloy (Nitinol) to hold the implant in place, two platinum guide rings, and a silver-tin solder joint.

[0007] The device was placed in the fallopian tubes by a gynecologist-obstetrician via the natural route (vagina and cervix). Once in place, the implant expanded and conformed to the The implant was designed to fit the contours of the inner wall of the fallopian tube. This technique was performed as "office surgery," meaning it did not require general anesthesia. Within three months of insertion, its presence caused tissue fibrosis around the implant, leading to permanent tubal obstruction. This reactive fibrosis was secondary to the reaction of the tubal tissues to the components of these implants. Tubal obstruction was confirmed by verifying the correct positioning of the device within the fallopian tubes three months after insertion, either through a plain abdominal X-ray or a 3D ultrasound.

[0008] The simplicity of the procedure and the effectiveness of the device had won over both professionals and patients. This technique had thus very quickly established itself as the new gold standard for permanent tubal sterilization.

[0009] However, this procedure, which has been used since the late 1990s, was responsible, in the immediate aftermath of insertion, for mild to moderate pelvic pain, even cramps, vaginal bleeding, and discomfort in the pelvis or back for a few hours to a few days following the procedure. Some women could also suffer from headaches, nausea and / or vomiting, or dizziness and / or fainting. Despite the absence of any known allergies to the components of the implants, some women experienced these symptoms becoming chronic or recurring over time.

[0010] According to the French National College of Gynecologists and Obstetricians (CNGOF), the efficacy and safety of such a procedure / device were called into question as early as 2012 with the National Agency for the Safety of Medicines and Health Products (ANSM) and the Ministry of Health, after more than 10 years of use in France. This concern intensified between 2015 and 2017 following reports of adverse and potentially debilitating events, including gynecological symptoms or more general, varied, and nonspecific symptoms. These included pain, allergies or hypersensitivity reactions to the various components, and disorders. Intestinal problems, neurosensory disorders, anxiety, depression, unusually severe fatigue, autoimmune diseases, thyroid disorders, lower limb weakness, and ear, nose, and throat problems were reported. Pelvic or general disorders often led patients to consult their doctor to consider removal (explantation) of the implanted device, which, in some exceptional cases, could migrate uncontrollably to other parts of the body, also raising concerns about the safety of the implant placement technique. This procedure was then performed under general anesthesia via laparoscopy. After removal of the affected implants, patients regained a quality of life similar to that before their implantation.

[0011] Therefore, women experiencing symptoms such as those described above should consult their doctor to rule out any underlying iatrogenic condition. In the absence of a precise diagnosis, the possibility of removal should be discussed between the woman and her doctor.

[0012] Finally, this device was withdrawn from sale in France on September 18, 2017 by decision of the Minister of Solidarity and Health, and then at the global level.

[0013] Various alternatives to surgical tubal ligation or the ESSURE® procedure described above exist and notably involve localized radiofrequency treatment to cause thermal lesions of the tissues at the entrance of the fallopian tubes in order to block them to prevent fertilization of the eggs by a spermatozoon in the tubes.

[0014] The so-called tubal thermofusion method sterilizes women by blocking the lumen of the fallopian tubes leading to the uterus. The thermal effect is accompanied by damage to the tubal ciliary epithelium and contraction of the peritubal muscles (myometrium), resulting in thermofusion of the tubal mucosa within a few days to a few weeks, leading to permanent tubal obstruction.

[0015] Thus, US patent 4057063A describes a device for sterilizing women by transuterine coagulation of the fallopian tubes comprising a The invention described in this document aims to provide a device for transuterine coagulation of the fallopian tubes, enabling sterilization to be performed very quickly and accurately without the use of a hysteroscope and therefore without anesthesia (local or general). To this end, the described device is characterized in that the probe consists of a flexible catheter having at one end a metallic portion that forms the active electrode and is electrically connected to a connection provided near the other end of the catheter.

[0016] US patent 3840016 relates to a bipolar electrocoagulation electrode for intrauterine sterilization of the fallopian tubes using limited thermal radiation to cauterize only the portion of tissue to be obstructed, without damaging surrounding tissue. To ensure proper catheter placement within the fallopian tubes, the patent utilizes a hysteroscope consisting of optics connected to a camera and a tubular stem with an operating channel for introducing the radiofrequency applicator under direct vision. The applicator is made of an insulated conductor, the distal end of which, protruding from the hysteroscope, incorporates a bipolar electrode (a heat-emitting section positioned between two insulated sections).This heat locally destroys the tissues of the fallopian tube over a short length and thickness, triggering an inflammatory response that leads to local scarring, which causes the walls of the fallopian tube to fuse. This gradual scarring (over a few weeks) then blocks the fallopian tube, resulting in permanent and irreversible sterilization of the patient.

[0017] US patent 5122137 relates to a radiofrequency medical device for heating a patient's tissues to induce thermofusion (cauterization), particularly in the intramyometrial portion of the fallopian tubes. The device comprises several radiofrequency conductors through which a radiofrequency current flows for cauterization. tissues. At least one of the conductors is a thermally conductive electrode that concentrates the radiofrequency current in a localized region of the tissue with which the electrode is in contact. A temperature sensor is carried by and is in thermally conductive contact with the thermally conductive electrode. The temperature sensor, positioned at the distal end of the electrode, detects the electrode's temperature and thus indirectly detects the temperature of the tissue in contact with the electrode. Finally, the sensor is connected via a feedback line to a control circuit that automatically modulates the radiofrequency power applied to the electrode based on the feedback signal received by the temperature sensor.The principle of radiofrequency ablation can be used for the percutaneous treatment of liver metastases or for the transrectal treatment of prostate tumors, for the percutaneous treatment of varicose veins in the lower limbs using the same thermofusion principle, or in gynecology for the percutaneous treatment of uterine fibroids. In this application to the fallopian tubes, instead of tubal ligation, in which an abdominal incision is usually made to access the tubes, the device is inserted transvaginally into the uterus and then into the fallopian tube using a hysteroscope to heat the tube wall to a controlled temperature. This causes injury to the fallopian tube, triggers a local inflammatory response, leading to local scarring of the tissues responsible for the obstruction of the fallopian tube and resulting in permanent and irreversible sterilization of the patient.

[0018] US patent US5303719 describes a surgical instrument for use in female sterilization procedures, comprising an elongated endoscope, also called a hysteroscope, with an operating channel through which an elongated, flexible endoscopic surgical instrument is inserted. In a female sterilization procedure, the endoscope is inserted through the patient's vagina, cervix, and uterus to the fallopian tube. This allows visualization of the fallopian tube ostia (the openings of the fallopian tubes into the uterine cavity). The endoscope includes a guide for this purpose. The surgical instrument consists of a fiber optic illumination system functionally connected to a cold light source, a fiber optic image guide functionally connected to an eyepiece or video monitor, and an auxiliary conduit extending longitudinally that can be connected to suction tubing or a vacuum generator. This auxiliary conduit, also called the operating channel, allows the introduction of the radiofrequency medical device. The surgical instrument is equipped at its distal end with an active operative component designed to destroy the cells of the tubal ciliated epithelium along the inner surface of the fallopian tube. The surgical instrument and / or endoscope are manipulated from outside the patient to move the operative component close enough to the tubal ostium to allow the introduction of the distal end of the radiofrequency probe (housing the radiofrequency conductors) into the intramyometrial portion of the fallopian tube.The surgical component is operationally connected, at a proximal end of the surgical instrument, to a power source that provides the component with the energy necessary to destroy organic tissue. This energy is delivered by a radiofrequency source, for example, a laser beam. The energy emitted by the source is transmitted along the fiber at a power sufficient to partially destroy a layer of tissue along the inner surface of the fallopian tube's opening. The beam energy is controlled by the generator so that heat diffusion is limited around the bipolar electrode (cauterization zone). Similarly, the portion of the surgical instrument inserted into the tube is controlled, thus limiting the risk of tearing or perforation of the tube. Consequently, the outer surface of the tube remains intact.According to one variant, the instrument comprises a tubular element and an electrical wire extending longitudinally through the tubular element from an electrical voltage source at a proximal end of the tubular element. A cauterizing contact is functionally connected to the wire at the distal end of the instrument. During traction of the tubular element in a proximal direction through the fallopian tube, the source... An electrical contact is operationally connected to transmit a cauterizing current to the inner surface of the fallopian tube, thereby destroying the cells of the tubal epithelium to allow the adhesion of this layer to itself and being responsible for obstructing the entrance of the tube, which results in definitive and irreversible sterilization of the patient.

[0019] US patent 4700701 relates to a fallopian tube sterilization device comprising a catheter with a free working end and an opposite control end. The catheter includes an outer sleeve and a concentric inner core. A thermoelectric cautery is mounted on the free end of the catheter and is electrically powered by a Peltier cell consisting of a bimetallic structure formed from a hollow cylindrical copper substrate. Insulated wires are electrically coupled to the Peltier cell and extend inside the catheter to a suitable electrical power source (preferably a direct current source) via a current regulator and a switch. The device operates by cryo-cauterization, for example at -40°C, so as to destroy a portion of the fallopian tube epithelium in contact with the surface of the Peltier cell.The next step involves activating the generator using a switch located on the instrument's handle. The thermal injury to the tissue triggers intense inflammation and scarring. The end result is the replacement of the tubal epithelium and the muscle fibers exposed by cauterization with scar tissue, leading to occlusion of the fallopian tube (where there was a hollow tube, there is now a solid column of fibrous tissue), resulting in the patient's permanent and irreversible sterilization.

[0020] US patent 5095917 relates to an irreversible sterilization method that combines the destruction of the fallopian tube epithelium by hyperthermia with the insertion of a biodegradable plug. As in the previous document, the destruction of the mucosa causes an inflammatory reaction, and the plug serves as a substrate to initiate the occlusion process. More specifically, the method This procedure includes the steps of destroying a superficial layer of the uterotubal junction and inserting agents to promote scar tissue growth at the point of destruction of the uterotubal junction. The sterilization instrument used comprises a hollow tube containing one or more stoppers made of biodegradable material, which may or may not contain a drug such as tetracycline hydrochloride to delay the breakdown of the initial clot and enhance scarification. The hollow tube is also equipped externally with copper wiring for connection to a high-frequency bipolar current generator via electrical cables. In operation, a bipolar coagulation current of approximately 5 watts for a duration of 5 to 15 seconds is sufficient to produce irreversible but shallow thermal damage to the tubal epithelium.After bipolar coagulation of the uterotubal junction, a piston is activated and the instrument is simultaneously withdrawn slightly, releasing a plug that is then positioned precisely over the damaged lining of the uterotubal junction. The application of bipolar electrical energy triggers an immediate inflammatory response. Part of this response is edema, or tissue swelling. This natural mechanism helps maintain the plug in place. Inflammatory cells leave the blood vessels and colonize the injured tissue. They first seal the area and then, along with other cells, repair the injury. The proliferation of fibroblasts (cells that form connective tissue) is part of this process. This proliferation process can be enhanced by certain medications, such as tetracycline hydrochloride, which is contained within the plug.Thanks to the presence of the plug, fibroblasts will colonize not only the damaged tissue but also the plug itself. Other cells, such as macrophages, will "clean" the area and contribute to the digestion of the material that makes up the plug. After a period of 3 to 6 weeks, the cells gradually disappear, leaving behind a dense structure of fibers called scar tissue, which will also include the area where the plug was located. was inserted. This process therefore results in an irreversible occlusion of the tubal lumen, thus rendering the patient sterile.

[0021] Finally, patent FR2748648 describes an apparatus and method for transcervical sterilization and embolization using a catheter, and more specifically a temperature-controlled bipolar radiofrequency catheter, as well as its use for creating thermal lesions in the fallopian tubes. The transcervical sterilization apparatus comprises an elongated catheter with a distal end and a connector on the opposite end, equipped with wires for connection to an electrosurgical generator that supplies radiofrequency energy, the quantity of which can be controlled. At least two bipolar electrodes, located around the distal end of the catheter, are spaced apart.A temperature (variation) sensor determines the state of the transmural formation of the thermal lesion generated between each of the bipolar electrodes to transmit a signal to the electro-surgical generator, during control, in order to control the application of radiofrequency energy to the inner wall of the Fallopian tube.

[0022] However, all these devices and procedures still have numerous drawbacks. In particular, they are unsuitable for treating both fallopian tubes quickly, precisely, and safely. They are not ergonomic or easy enough to handle to optimize and reduce the duration of the procedure.

[0023] Currently, there are no alternatives to hysteroscopic tubal ligation. Patients are therefore once again being offered laparoscopy for this procedure. This represents a step backward of more than twenty years in patient care. Presentation of the invention

[0024] The present invention aims to overcome these drawbacks with a completely innovative approach to offer a solution that is simple to implement, easy to use, can be handled by a single person, is very safe, fast, efficient, can be manufactured in large quantities, and is relatively inexpensive. costly and, most importantly, leaving no foreign bodies in the patient's body.

[0025] Accordingly, in a first aspect, the present invention relates to a single-use gynecological medical device intended to produce thermal lesions in the Fallopian tubes by applying bipolar radiofrequency to create permanent tubal sterilization, said device comprising a long, flexible tubular applicator extending along a longitudinal axis and equipped with a handle-type manual gripping means disposed near a proximal end and an active bipolar radiofrequency emission segment disposed near a distal end, said active radiofrequency emission segment being connected to a radiofrequency source, characterized in that the manual gripping means further comprises at least: - a manually operated mechanical bending actuator to bend the distal end of the long, tubular applicator, and - a means of locking said curvature once it has been determined using said mechanical bending actuator.

[0026] The device is intended to be used with an operating hysteroscope equipped with an operating channel; the curvature is only produced at the exit of the hysteroscope into the uterine cavity.

[0027] Thanks to this controlled curvature, the solution of the present invention allows for ideal insertion and positioning of the device in the entrance of the Fallopian tube (intramyometrial portion), and in particular of its active radiofrequency emission zone, and the possibility, thanks to the means of locking the curvature of the applicator, of positioning the device in the second Fallopian tube in an extremely rapid, precise and efficient manner to achieve its occlusion, all without having to make potentially tedious new adjustments to said curvature of the applicator.

[0028] The invention is implemented according to the embodiments and variants set out below, which are to be considered individually or in any technically feasible combination.

[0029] Advantageously, the tubular applicator includes a bendable area with a length of between approximately 2 and 10 centimeters from its distal end, preferably between approximately 4 and 8 centimeters.

[0030] This solution allows for a wide range of curvature (radius of curvature) and enables the best possible adaptation of the positioning of the active radiofrequency emission zone according to the morphology of the Fallopian tube.

[0031] Preferably, the maximum angle of curvature formed between the longitudinal axis of the long tubular applicator and a tangent to its distal end is between approximately 30° and 90°.

[0032] This solution allows the curvature of the distal end of the device to be varied so that it adapts to the maximum number of possible cases encountered according to the constraints of introducing the device, the shape of the uterine cavity and the entrance of the Fallopian tubes being treated and the practice of the specialist physician who may prefer to choose one curvature rather than another.

[0033] According to a preferred embodiment of the present invention, the curvature actuator is a rotary knob. This rotary knob may or may not be notched. The advantage of this notching is that it maintains the angle to facilitate contralateral treatment.

[0034] This highly ergonomic solution is simple to implement in the handle, easy to use, precise, and compact. It adapts to the usual practice of specialist physicians.

[0035] In particular, the bending actuator is a traction wheel that can be rotated in two opposite directions around a pivot.

[0036] This solution is particularly compact and intuitive to use.

[0037] According to a complementary aspect, the long tubular applicator contains at least one cable fixed on one side in the immediate vicinity of its distal end and on the other side to the traction wheel, said cable being able to slide a distance of a few millimeters inside the long tubular applicator, the rotation in one direction of said The tension knob causes a pull on the cable resulting in a bend in one direction of the distal end of the long tubular applicator as the knob is turned, and rotation in the opposite direction of the tension knob causes a pull on the cable resulting in a bend in a second, opposite direction of the distal end of the long tubular applicator as the knob is turned.

[0038] This solution is particularly compact, as it is fully integrated into the tubular applicator, efficient and fast, thanks to the direct and immediate action of the wheel on the cable, and guarantees optimal hygiene conditions since the control of the curvature of the distal end of the device is carried out at the level of its proximal end, located ex vivo.

[0039] The ergonomics of this solution allow it to be used with one hand.

[0040] According to one embodiment, the long tubular applicator contains at least two identical parallel cables fixed on one side in the immediate vicinity of its distal end and on the other side to two opposite fixing points of the traction wheel, the cables being able to slide over a distance of a few millimeters inside the long tubular applicator, the rotation in one direction of said traction wheel causing a traction of a first cable resulting in a curvature in a first direction of the distal end of the long tubular applicator as the wheel is turned, and the rotation in the opposite direction of said traction wheel causing a traction of the second cable resulting in a curvature in a second opposite direction of the distal end of the long tubular applicator as said wheel is turned.

[0041] This solution with dual parallel cables allows for more precise control of the device's curvature and the responsiveness of its control.

[0042] Preferably, the means of locking the bend is a push button linked to the bending actuator.

[0043] This solution is simple to implement, intuitive in terms of operation, very reliable technically and clinically proven.

[0044] According to a particularly interesting aspect of the present invention, the long tubular applicator comprises, from its distal end, an active radiofrequency emission segment measuring between approximately 4 and 10 millimeters and preferably between approximately 6 and 8 millimeters.

[0045] This solution allows for effective thermal treatment of the Fallopian tube which does not require extremely precise placement (below one millimeter) of the device as long as the active segment allows for the desired result of radiofrequency thermal lesions.

[0046] Preferably, the long, tubular applicator is traversed longitudinally by at least two separate conductive filaments, forming at their distal ends two radiofrequency electrodes axially separated from each other and positioned within the active radiofrequency emission segment. The electrode is said to be bipolar, thus providing maximum safety for the procedure.

[0047] This bipolar solution optimizes the thermal treatment of the Fallopian tube epithelium while ensuring maximum safety for the patient during the procedure.

[0048] Advantageously, each radiofrequency electrode has an axial length of between approximately 2 and 4 millimeters and preferably approximately equal to 3 millimeters.

[0049] Additionally, an electrically insulating segment is placed between the two radio frequency electrodes.

[0050] This solution limits the diffusion of the thermal effect in the vicinity of the electrode, thus creating a roughly "olive-shaped" thermal diffusion around the electrode.

[0051] In particular, the insulating segment has an axial length of approximately 1 millimeter.

[0052] According to another aspect of the present invention, the distal end of the long, tubular applicator comprises a round, atraumatic tip measuring between approximately 1 and 2 millimeters in length. This tip is also insulating and thus prevents distal diffusion of the thermal effect, thereby reducing the risk of collateral tissue damage.

[0053] This solution allows the practitioner to more easily position the device in the desired area, without risking damage to the tissues (vagina, uterus, fallopian tubes).

[0054] According to another characteristic, the tubular applicator includes a marker opaque to X-rays and / or ultrasound placed upstream of the active radiofrequency emission segment.

[0055] This solution allows for remote monitoring of the device's insertion and progression within the uterus and then into the proximal part of the fallopian tubes, verifying the precise positioning of the active radiofrequency emission zone to ensure the most accurate and effective heat treatment possible. This option is naturally only used in cases of anatomical variations and would require the procedure to be performed under fluoroscopy or ultrasound guidance.

[0056] According to a particular embodiment of the present invention, the manual gripping means is equipped with an indicator light showing the operation of the radio frequency source.

[0057] This solution allows the practitioner to know exactly when the radiofrequency emission occurs in order to control, in particular, the duration of exposure.

[0058] For a similar purpose, the manual gripping means is equipped with an on / off button (“switch”) for the radio frequency source.

[0059] According to an advantageous feature of the present invention, the manual gripping means incorporates the radio frequency source and a removable battery for powering the radio frequency source. This solution thus eliminates the need for an external RF generator.

[0060] This solution allows practitioners to have a completely autonomous, compact and easy-to-handle piece of equipment.

[0061] According to another aspect of the present invention, the device further comprises a stop means fixing the longitudinal position of the active radiofrequency emission segment once the distal end of the tubular applicator is implanted in the Fallopian tube in the desired position.

[0062] This solution guarantees efficient and highly precise positioning of the active radiofrequency emission zone, which prevents the practitioner from having to try several times or fumble around.

[0063] In particular, the stop means is an inflatable balloon mounted around the tubular applicator.

[0064] This solution allows for quick positioning without any risk of causing injury by inserting the applicator too far (too deep) into the Fallopian tube.

[0065] For the same reasons, and according to an alternative embodiment, the stopping means is a "stent" mounted in a substantially cylindrical sheath surrounding the tubular applicator, said stent being deployable in the manner of an umbrella to form a cone that narrows as one approaches the active radiofrequency emission segment.

[0066] According to a final variant, the stop means is a localized annular thickening of the insulating sheath of the applicator r with a width of about 1 to 2 mm for a thickness of about 0.5 mm. Brief description of the figures

[0067] Other advantages, purposes and features of the present invention will become apparent from the following description, given for explanatory purposes and in no way as a limitation, with reference to the accompanying drawings, in which:

[0068] [Fig. 1] Figure 1 is a schematic view illustrating a first embodiment of a single-use gynecological medical device according to the present invention and intended to produce thermal lesions in the Fallopian tubes by application of radiofrequency,

[0069] [Fig. 2] Figure 2 is a detailed view of a distal end of a long, tubular applicator of the medical device shown in Figure 1.

[0070] [Fig. 3] Figure 3 is a view of a first possible configuration of said distal end of Figure 2,

[0071] [Fig. 4] Figure 4 is a view of a second possible position configuration of said distal end of Figure 2,

[0072] [Fig. 5] Figure 5 is a view of a third possible configuration of said distal end of Figure 2,

[0073] [Fig. 6] Figure 6 is a perspective view of a manipulation handle of the medical device of the present invention,

[0074] [Fig. 7] Figure 7 is an exploded view of Figure 6,

[0075] [Fig. 8] Figure 8 is a longitudinal cross-sectional view of the handle shown in Figures 6 and 7.

[0076] [Fig. 9] Figure 9 is a detailed cross-sectional view of the distal end of the long, tubular applicator of the medical device of the present invention,

[0077] [Fig. 10] Figure 10 is a view similar to Figure 9 but in which an active segment of the distal end is in operation,

[0078] [Fig. 11] Figure 11 is a view illustrating the operation of the device according to the present invention,

[0079] [Fig. 12] Figure 12 is a cross-sectional view of a part of a woman's human body in which the device is shown in use.

[0080] [Fig. 13] Figure 5 is viewed similarly to Figure 13 in another stage of use,

[0081] [Fig. 14] Figure 14 is a variant embodiment of Figure 1 with an integrated battery,

[0082] [Fig. 15] Figure 15 is a detailed view of the distal end of the device fitted with a radially inflatable balloon,

[0083] [Fig. 16] Figure 16 is a view of a variant embodiment of Figure 14 in which the balloon is replaced by a radially expandable stent, and

[0084] [Fig. 17] Figure 17 is a view similar to Figure 16 in which the stent is radially expanded. Description of the implementation methods

[0085] A single-use gynecological medical device 1 conforming to the present invention is shown in Figure 1 in its inactive state before use in the human body of a woman.

[0086] This gynecological medical device 1, designed to produce thermal lesions in the Fallopian tubes by applying radiofrequency in order to create permanent sterilization, generally comprises: - a long, tubular applicator 10 essentially solid (it is not a hollow catheter for injecting a product) extending over approximately 400 millimeters along a longitudinal axis XX' and made of a flexible, biocompatible material, - a manual gripping means 20, of the ergonomic handling handle type formed of two plastic half-shells, disposed at a proximal end of the long tubular applicator 10, and - a bipolar radio frequency source 30 (for example 460kHz at 5W), external in this case (see Figure 14 for a fully integrated internal solution), connected to said handling handle 20 using, for example, a cable 25 of a known type, and

[0087] An 80 hysteroscope having an operating channel into which the long tubular applicator 10 is intended to be inserted.

[0088] The resulting assembly is particularly compact, lightweight and easy to handle.

[0089] The long tubular applicator 10 has, at a distal end 1b of the device 1, an active radiofrequency emission segment 40 connected to the radiofrequency source 30 and which will be described in more detail in relation to figures 9 and 10. Typically, the active radiofrequency emission segment 40 measures axially about 6 to 8 millimeters, for example about 7 millimeters.

[0090] In reality, "distal end 1b" means an entire area starting from an atraumatic rounded tip 11 of the long tubular applicator 10 and having a length (measured towards the handle 20) of between approximately 2 and 10 centimeters, preferably between approximately 4 and 8 centimeters.

[0091] The atraumatic tip 11 measures approximately 1 millimeter axially in length. This tip has two objectives: to facilitate access to the surgical site (non-traumatic passage of the applicator through the osmium). tubal by the practitioner and prevent the diffusion of the thermal effect beyond a certain point, the thermal effect occurring only between the two electrodes (described later) in an olive shape.

[0092] As can be seen in Figure 2, the long, tubular applicator 10 is initially straight in its resting position before insertion into the human body. However, it is made of a material and has an external diameter of approximately 1.5 millimeters, such that its distal end 1b can be bent over a distance of several centimeters from the rounded end 11 by means of a mechanical bending actuator 50, which is manually operated by a practitioner. A push-button type device 60 is also provided for locking this bend once it has been determined using the mechanical bending actuator 50 and will be described in more detail with reference to Figures 6 to 8.

[0093] As can be seen from figures 3 to 5, due to the flexibility of the long tubular applicator 10, the distal end 1b can, in use and thanks to the mechanical bending actuator 50, take on different curvatures (defined by their respective radii of curvature) and form an angle a, defined between the axis XX' and the tangent T at the distal end 1b, between approximately 30° and 90° depending on the configuration and conditions of use of the gynecological medical device 1.

[0094] Obtaining this curvature / angle a thus results both from the flexible structure of the tubular applicator 10, particularly at its distal end, and from the mechanical means of curvature described 50 below.

[0095] Thus, the mechanical bending means 50, as shown in Figures 6 to 8, comprises a movable part integrated into the operating handle 50, namely a rotating tension knob 51 mounted to rotate around a pivot 55 within a certain angular range (a few degrees on either side of a central inactive position, referred to as the "rest position"). For this purpose, the tension knob 51 has two lateral lugs 52 (left) and 53 (right) to facilitate manual manipulation with one hand (for example, with the thumb and forefinger). Small notches 54 (parallel grooves) may be provided on the lugs. lateral 52 and 53 to improve their grip (better adhesion thanks to this ribbed texture of type "grip") and make the practitioner's movement more precise, faster and more efficient.

[0096] The handling handle 20 also includes a trigger switch type button 56 (usable for example with the practitioner's thumb) to start or stop the radiofrequency source 30, as well as an indicator 57 (of the LED type for example) which acts as an indicator that the radiofrequency source 30 is active when the medical device 1 is used.

[0097] As can be seen in Figure 7, two cables 58 (left) and 59 (right), for example metallic (composite materials, for example based on carbon fiber or Kevlar, are conceivable for their lightness and strength) are attached to the tension wheel 51, on either side of its pivot 55, and pass through almost the entire tubular applicator 10 to be fixed at respective points 58b and 59b at the distal end 1b of the medical device 1.

[0098] Thus, as will be described later in more detail in relation to figures 12 and 13, the practitioner turning the tension wheel 51 in one direction (for example clockwise when looking at the handle 20 from above) while pushing the left lug 52 with his thumb (and incidentally pulling the right lug 53 with his index finger) will exert traction on the right cable 59, causing the progressive curvature of the distal end 1b of the tubular applicator to the left as the wheel 51 is turned.

[0099] A rotation of the tension wheel 51 in the opposite direction (counterclockwise) by pushing on the right lug 53 with the index finger (and incidentally by pulling the left lug 52 with the thumb) will exert a traction on the left cable 58 and cause the progressive curvature of the distal end 1b of the long tubular applicator 10 as the wheel 51 is turned.

[0100] The two tension bending cables 58 and 59 are preferably mounted to slide axially within the material forming the long tubular applicator 10, while being fixed close the atraumatic tip 11 at points 58b and 59b so that the traction effect causing the bending can occur.

[0101] In the right or left stop position of the lugs 52 and 53 against the half-shells of the handle 20, the curvature of the distal end 1b of the long tubular applicator 10 is maximum.

[0102] As can be seen in Figures 8 and 9, the distal end 1b of the tubular applicator has several distinct zones following each other axially from the atraumatic tip 11.

[0103] More specifically, an implantation zone 12 for the fixing points 58b and 59b of the tension bending cables 58 and 59 is provided and positioned as close as possible to the atraumatic tip 11, in order to optimize the bending of the long tubular applicator 10. Indeed, when the practitioner rotates the tension wheel 51 in one direction or the other, the cables 58 and 59 will exert their pulling force as far away as possible from the handling handle 20, which will optimize the formation of the radius of curvature of the long tubular applicator 10.

[0104] Following this implantation zone 12, measuring approximately 2 millimeters axially, is the active segment 40, which initially comprises a first electrode zone 13, measuring approximately 3 millimeters axially. It is in this first electrode zone 13 that a first attachment point 14b is located for a first copper filament 14 (left-hand filament), connected to the radio frequency source 30 via the handling handle 20. This first electrical filament 14 thus passes through the long, tubular applicator 10 and extends, within the latter, from its connection inside the handling handle 20 to its attachment point 14b.

[0105] Following this first electrode zone 13, an insulating segment 15, measuring approximately 1 millimeter axially in length, is provided. This segment 15 isolates the first electrode zone 13 from a second electrode zone 16, measuring approximately 3 millimeters axially in length. It is in this second electrode zone 16 that a second attachment point 17b is located for a second copper filament 17 (the right-hand filament), also connected to the radio frequency source 30 via the handling handle 20. This second filament electric 17 thus passes through the long tubular applicator 10 and extends, inside the latter, from its connection inside the handling handle 20 to its second fixing point 17b.

[0106] The two copper electrical filaments 14 and 17 are electrically insulated from each other. The active segment 40 thus measures approximately 7 millimeters in axial length.

[0107] Finally, a radio-opaque marker 18 measuring approximately 4 millimeters in axial length is provided upstream of the second electrode zone 16, at the entrance of the active segment 40. Black markers 19 are also shown (see figure 10) every centimeter on the outside of the long tubular applicator 10, over an axial distance of approximately 5 centimeters.

[0108] Figure 10 illustrates the operation of medical device 1 when the radio frequency source is switched on to send its bipolar signal into the active segment 40.

[0109] The principle of bipolar radiofrequency (RF) is to generate, through ionic agitation, a heat source resulting in controlled thermal ablation of tissues above 60°C. Obstruction of the tubal structure is achieved by tissue shrinkage as a consequence of the destruction of its collagenous (helical) structure. The thermal effect of bipolar radiofrequency on a small tubular space with a small internal diameter (< 15 mm), such as a fallopian tube, results in its permanent obstruction. Since heat dispersion remains limited to the electrodes, the risk of collateral damage to surrounding anatomical structures is virtually nil.

[0110] Figure 11 shows how the practitioner can, in a simple, efficient, precise and rapid manner, modify the curvature of the distal end 1b of the long tubular applicator 10 by a simple manual action on the notched tension rotary knob 51 of the ergonomic handling handle 20. Depending on the Fallopian tube he wishes to treat first, he will bend the distal end 1b of the long tubular applicator 10 more or less (between about 30° and 90° as seen previously) to the right or to the left.

[0111] Figures 12 and 13 illustrate the practical use of the medical device 1 of the present invention once the latter has been implanted inside the uterus U of a woman to render her sterile, using in particular an operative hysteroscope 80 having an operative channel in which the long tubular applicator 10 is inserted and slides longitudinally, it being understood that the curvature of the latter is imposed on the latter only at the exit of said hysteroscope.

[0112] In the present case, the curvature of the distal end 1b of the long tubular applicator 10 is oriented to the left using the notched button 51, which indicates that the practitioner will perform his gynecological medical procedure on the left Fallopian tube LFT (hysteroscope 80 inclined from right to left from its proximal end, as in figure 12).

[0113] Thus, once the medical device 1 is correctly positioned and the active segment 40 is placed at the desired location in the inlet (intramyometrium portion) of the Fallopian tube (TGF) (the radiopaque marker 18 and / or the graduations 19 can assist the practitioner in this positioning), the practitioner locks this curvature by pressing the pressure button 60. This prevents any unintentional rotation of the tension knob 51, and therefore any change in the curvature of the distal end 1b. The practitioner can then activate the bipolar radiofrequency source 30 by pressing the switch button 56 to send an electrical current through the copper filaments 14 and 17. This creates a localized (olive-shaped) temperature increase (>60°C) at the level of the active segment 40, which will cause thermal destruction (burning) of the mucosal tissue over a thin layer.The indicator light 57 remains lit throughout this phase to indicate to the practitioner that the bipolar radiofrequency source 30 is active.

[0114] Once the practitioner has determined that the thermal effect has lasted long enough and has been sufficiently effective, they release the switch button 56 so that the radio frequency source 30 no longer powers the copper filaments 14 and 17, thus stopping the heat. around the active segment 40. The practitioner can verify that the radiofrequency source 30 is no longer emitting a signal by observing that the indicator light 57 is off.

[0115] Thanks to device 1 of the present invention, the practitioner can unlock the pressure button 60, remove the distal end 1b of the long tubular applicator 10 from the entrance of the first left Fallopian tube TFG, pivot the hysteroscope 80 from left to right (see figure 13) and turn the wheel 51 in the opposite direction, namely clockwise, so as to curve the distal end 1b in the opposite direction (to the right) before inserting said distal end 1b into the entrance (intramyometrial portion) of the right Fallopian tube TFD.The practitioner can then perform the same procedure as for the first fallopian tube, namely, blocking the curvature of the distal end 1b of the tubular applicator 10 by pressing the pressure button 60, and activating the bipolar radiofrequency source 30 by pressing the switch button 56 to send an electrical current through the copper filaments 14 and 17. This will create a local temperature increase (>60°C) in the active segment 40, which will cause thermal destruction (burning) of the mucosal tissue of the second right fallopian tube (TFD) over a thin layer. The indicator light 57 also remains illuminated throughout this phase to indicate to the practitioner that the radiofrequency source 30 is active.

[0116] According to one variant, after acting on the left Fallopian tube TFG, the practitioner can move the tubular applicator 10 back inside the hysteroscope 80 to insert the entire distal end 1b into its working channel, reposition the hysteroscope opposite the second Fallopian tube TFD (figure 13) by tilting it from left to right (figure 13) before bringing out the distal end 1b of said tubular applicator 10 in order to give it the opposite curvature by acting on the notched wheel 51.

[0117] According to another alternative use, the practitioner can, after removing the curved distal end 1b from the entrance of the Fallopian tube From the left TFG, rotate the entire hysteroscope 80 and device 1 assembly 180° around its main axis in a single movement, and insert the distal end 1b, held curved out of the hysteroscope 80, into the entrance of the right TFD fallopian tube, while keeping the hysteroscope 80 inserted into the patient's body. This is made possible because the pressure button 60 remains engaged and maintains the curvature of the distal end 1b of the long tubular applicator 10.

[0118] In all cases, the practitioner does not need to remove the entire assembly consisting of the hysteroscope 80 and the medical device 1 from the patient's uterus U to move from one fallopian tube to the other. Thus, as previously mentioned, the practitioner can, in a single gynecological procedure, treat the second fallopian tube TFD in the same way as the first during a single, quick, and effective intervention.

[0119] It will be checked approximately 3 months after the procedure that intra-myometrial coagulation has taken place and that the Fallopian tubes are perfectly blocked, without any after-effects.

[0120] Thus, this solution does not require general anesthesia or an operating room, which significantly reduces the inconvenience, associated costs, and duration of the procedure. It does not cause tissue trauma because it does not use trocars. Access is via the natural openings (hysteroscope referenced as 80 in Figures 12 and 13), and there is no risk of migration of a micro-insert implanted in the fallopian tube since the device leaves no foreign bodies in the patient's body. Finally, there is no risk of the fallopian tubes becoming blocked again.

[0121] The invention is the first device to offer definitive tubal obstruction by thermofusion using a bipolar energy source, thus minimizing risks to the patient. A key advantage of this device is that it leaves no foreign body in the uterine tissues after thermofusion, as the medical device is completely removed. The device, designed for ease of use by a single operator, is quick, efficient, and requires a reproducible procedure.

[0122] The device also has the advantage of offering a non-invasive treatment, eliminating the need for long-term hormone use for contraception. It addresses a significant patient demand, as currently there are no alternatives to general anesthesia and laparoscopy. This device is of interest to a large market estimated at 650,000 permanent sterilizations in Europe, 900,000 in North America, and over 12 million in the rest of the world (Asia and Latin America).

[0123] According to an alternative embodiment illustrated in figures 15 to 17, the medical device 1 may include, at its incurvable distal end 1b, a stop means 90 fixing the longitudinal position of the active radiofrequency emission segment 40 once the distal end 1b of the long tubular applicator 10 is implanted in the entrance (intramyometrial portion) of the Fallopian tube in the desired position.

[0124] As illustrated by figure 15, this stop means 90 takes for example the form of an inflatable balloon 91 mounted around the tubular applicator 10 (a priori before the radio opaque witness 18).

[0125] Thus, when the long, tubular applicator 10 is inserted into the first right or left fallopian tube, and once the curvature is defined and the distal end 1b is positioned as desired, the balloon 91 is inflated (for example, by the passage of air inside the tubular applicator). This maintains the distal end 1b in position within the fallopian tube, and in particular the radiofrequency emission active segment 40, which must be positioned as precisely as possible to irradiate the selected areas. In one variant, the balloon is already inflated, thus eliminating the need for an inflation step.

[0126] In a second step, the bipolar radiofrequency source is activated using the switch button 56 of the handling handle 20 so as to emit a radiofrequency signal which will burn the surrounding tissues over a thin layer, as described previously in relation to Figures 12 and 13.

[0127] In a third step, the long, tubular applicator 10, equipped with its inflated balloon 91, is removed from the entrance of the fallopian tube The fallopian tube and the second fallopian tube can be treated as previously described.

[0128] Finally, in a fourth step, the tubular applicator 10 and the hysteroscope are completely removed from the uterus.

[0129] According to another embodiment illustrated by figures 16 and 17, the stop means 90 takes the form of a radially expandable stent 92 in the manner of an umbrella mounted around the tubular applicator 10 (a priori before the radio-opaque witness 18) and whose operation is similar to the balloon described previously.

[0130] Thus, during the insertion of the long, tubular applicator 10 into the first fallopian tube, and once the curvature of the distal end 1b is defined, the stent 92 is opened radially (Figure 17). This allows the distal end 1b to be held in position within the tube, and in particular the radiofrequency emission active segment 40, which must be positioned as precisely as possible to irradiate the selected areas. The stent 92 is folded radially (Figure 16) to return to its initial position once the first tube has been treated in order to treat the second, or it is folded once both tubes have been treated, so that the entire assembly consisting of the hysteroscope 80 and the tubular applicator 10 can be easily removed from the patient's uterus.

[0131] It must be clearly understood that the detailed description of the object of the invention, given solely as an illustration, does not in any way constitute a limitation, technical equivalents also being included within the scope of the present invention.

[0132] Thus, it might be possible to provide for only one cable wound around an axis of rotation of the movable wheel and which, by pulling in one direction or another, would curve the distal end of the tubular applicator 10.

[0133] The knob can take another form, or even be replaced by another means of pulling the cables.

Claims

Demands Claim 1. A single-use gynecological medical device (1) intended to produce thermal lesions in the Fallopian tubes (FTT, FTT) by application of bipolar radiofrequency to create permanent tubal sterilization, said device (1) comprising a long, flexible tubular applicator (10) extending along a longitudinal axis (XX') and equipped with a handle-type manual gripping means (20) disposed near a proximal end (1a) and an active bipolar radiofrequency emitting segment (40) disposed near a distal end (1b), said active radiofrequency emitting segment (40) being connected to a radiofrequency source (30), the manual gripping means (20) comprising at least: - a manually movable mechanical bending actuator (50) for bending the distal end (1b) of the long tubular applicator (10) and having the form of a traction wheel (50) that can be rotated in two opposite directions around a pivot (55), and - a means (60) for locking said curvature once it has been determined using said mechanical bending actuator (50), - the long tubular applicator (10) containing at least two identical parallel cables (58, 59) fixed on one side in the immediate vicinity of its distal end (1b) and on the other side to two opposite attachment points of the traction wheel (51), the cables (58, 59) being able to slide over a distance of a few millimeters inside the long tubular applicator (10), the rotation in one direction of said traction wheel (51) causing a traction of a first cable (58; 59) resulting in a curvature in a first direction of the distal end (1b) of the long tubular applicator (10) as the wheel (51) is turned, and the rotation in the opposite direction of said traction wheel (51) causing a traction of the second cable (59;58) resulting in a curvature in a second opposite direction of the distal end (1b) of the long tubular applicator (10) as said wheel (51) is turned, characterized in that:; - the long, tubular applicator (10) is traversed longitudinally by at least two separate conducting filaments (14, 17) forming respectively at their distal ends (14b, 17b) two radiofrequency electrodes (13, 16) axially separated from each other and arranged in the active radiofrequency emission segment (40), an electrically insulating segment (15) being arranged between the two radiofrequency electrodes (13, 16), - the distal end (1b) of the long tubular applicator (10) has a round, atraumatic tip (11), and - the distal ends (58b, 59b) of the cables (58, 59) are axially arranged closer to the atraumatic tip (11) than the distal ends (14b, 17b) of the conducting filaments (14, 17) forming attachment points of the latter. Claim 2. Device (1) according to claim 1, characterized in that the long tubular applicator (10) has a bendable area having a length of between approximately 2 and 10 centimeters from its distal end (1b), preferably between approximately 4 and 8 centimeters. Claim 3. Device (1) according to any one of the preceding claims, characterized in that the maximum angle of curvature formed between the longitudinal axis (XX') of the long tubular applicator (10) and a tangent (T) at its distal end (1b) is between approximately 30° and 90° Claim 4. Device (1) according to any one of the preceding claims, characterized in that the means for blocking the curvature (60) is a push button linked to the curvature actuator (50). Claim 5. Device (1) according to any one of the preceding claims, characterized in that the long tubular applicator (10) comprises, from its distal end (1b), an active radiofrequency emission segment (40) measuring between about 4 and 10 millimeters and preferably between about 6 and 8 millimeters. Claim 6. Device (1) according to any one of the preceding claims, characterized in that each radiofrequency electrode (13, 16) has an axial length of between approximately 2 and 4 millimeters and preferably approximately equal to 3 millimeters. Claim 7. Device (1) according to any one of the preceding claims, characterized in that the insulating segment (15) has an axial length approximately equal to 1 millimeter. Claim 8. Device (1) according to any one of the preceding claims, characterized in that the long tubular applicator (10) has an X-ray opaque marker (18) placed upstream of the active radiofrequency emission segment (40). Claim 9. Device (1) according to any one of the preceding claims, characterized in that the manual gripping means (20) is equipped with an indicator light (57) showing the operation of the radio frequency source. Claim 10. Device (1) according to any one of the preceding claims, characterized in that the manual gripping means (20) is equipped with a button (56) for activating / deactivating the radio frequency source (30). Claim 11. Device (1) according to any one of the preceding claims, characterized in that the manual gripping means (20) contains the radio frequency source (30) and a battery (90) for powering the radio frequency source (30). Claim 12. Device (1) according to any one of the preceding claims, characterized in that it further comprises a stop means (90) fixing the longitudinal position of the active radiofrequency emitting segment (40) once the distal end of the tubular applicator (10) has been implanted in the Fallopian tube in the desired position. Claim 13. Device according to claim 12, characterized in that the stop means (90) is an inflatable balloon (91) mounted around the tubular applicator (10). Claim 14. Device according to claim 12, characterized in that the stop means (90) is a stent (92) mounted in a substantially cylindrical sheath surrounding the tubular applicator (10), said stent being radially deployable in the manner of an umbrella to form a cone that narrows as one approaches the active radiofrequency emission segment (40). Claim 15. Assembly comprising a device (1) according to any one of the preceding claims and a hysteroscope (80) inside which the tubular applicator (10) is inserted and slides axially.

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