WO2018172692A1 - Device for dilating the uterine cervical canal - Google Patents

Device for dilating the uterine cervical canal Download PDF

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Publication number
WO2018172692A1
WO2018172692A1 PCT/FR2018/050675 FR2018050675W WO2018172692A1 WO 2018172692 A1 WO2018172692 A1 WO 2018172692A1 FR 2018050675 W FR2018050675 W FR 2018050675W WO 2018172692 A1 WO2018172692 A1 WO 2018172692A1
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WO
WIPO (PCT)
Prior art keywords
dilator
rod
support
cervical canal
protective tube
Prior art date
Application number
PCT/FR2018/050675
Other languages
French (fr)
Inventor
Aleksandra PETRICEVIC
Original Assignee
Petricevic Aleksandra
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Petricevic Aleksandra filed Critical Petricevic Aleksandra
Priority to EP18715215.2A priority Critical patent/EP3599985A1/en
Publication of WO2018172692A1 publication Critical patent/WO2018172692A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/303Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the vagina, i.e. vaginoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/0125Endoscope within endoscope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/32Devices for opening or enlarging the visual field, e.g. of a tube of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies

Definitions

  • the present invention relates to an uterine cervical canal dilatation device and an associated speculum for dilating the cervix, facilitating examinations, diagnostics and surgical procedures within the uterus.
  • This disposable medical device belongs to the field of application of medicine and medical instruments.
  • This medical device is used for interventions in gynecology, specifically to expand the cervical canal, examine and pass instruments for all examinations and surgical procedures performed in the uterine cavity. It allows you to safely expand or dilate the cervical canal.
  • Hegar candles have been around since 1879 and have never been upgraded or replaced. They are in the form of metal or plastic spacers. After grasping the cervix with forceps and pulling it outward, the practitioner introduces Hegar's first candle by pushing hard to spread the cervical canal. It begins with a small diameter, then introduces the following candles usually numbered 2 to 12 mmm one after the other. The first candles are the most dangerous because, because of their small size, they often cause lacerations or perforations of the cervical canal, leading to risks of internal bleeding. This is why these high-risk acts are performed in the operating room and involve costly surgical procedures.
  • the invention of this medical device solves the manufacturing problems usually encountered in the design of medical devices for gynecological examinations and procedures. By its simplicity of operation and use, it also allows the dilation and protection of the cervical canal by avoiding all possibilities of damaging, lacerating or perforating the collagenous tissues and muscle fibers that surround the cervical canal in women.
  • the invention relates to a device for dilatation of the uterine cervical canal, comprising:
  • a dilator rod mounted in translation in the support
  • the dilator rod thus makes it possible to dilate the cervical canal during its translation inside the extensible protective tube, the latter making it possible to protect the uterine cervical canal from friction of the dilator shaft in translation.
  • the tubular portion of the dilator sleeve holds the fin guide and the expandable protective tube apart and forms a protective channel to prevent contact and damage to the cervical canal during the passage of diagnostic and surgical instruments.
  • the dilator rod comprises at one end a guide rod connected by a series of portions of different sizes to a tube of the dilator rod, the size of the portions decreasing from the tube to the guide rod, for example from 12 to 2 mm, the guide rod having a diameter substantially equal to 2 mm.
  • the dilatation of the uterine cervical canal is obtained gradually, between 2 and 12 mm.
  • the tube of the dilator rod comprises a slot in which slides a transverse guide rod, the support having hooks adapted to engage with the transverse guide rod on each side of said tube of the dilator rod.
  • the support comprises a narrowing portion forming an end stop in translation of the dilator rod in the support, the displacement in translation being for example substantially equal to 50 mm.
  • the tubular portion of the dilator bushing is secured to a conical portion abutting in the narrowing portion of the support at the end of travel in translation of the dilator rod.
  • the conical portion of the dilator bushing comprises two windows in which are adapted to be introduced respectively two protrusions of the dilator rod during a withdrawal, by the dilator rod, the dilator sleeve out of the finned guide housed in the extensible protective tube.
  • the fin guide comprises several fins, and for example five fins, mounted on a conical portion of the fin guide, and movable between a rest position, in which the fins are collected and held tight inside the tube. extensible protector, and an expansion position, wherein the fins, after separation by the dilator rod, are held apart by the expansion sleeve inside the expandable protective tube.
  • the fins have on an external part excrescences, and for example three excrescences per fin, cooperating in the expansion position with a widened cylindrical portion of the extensible protective tube.
  • the excrescences cooperating with a widened cylindrical portion of the expandable protective tube allow the practitioner, by changing the position of the dilator after positioning and dilation of the uterine cervical canal, to adjust the position of the uterus and thereby facilitate the endoscopic vision of the uterus. uterine cavity.
  • the invention relates to a vaginal speculum comprising an extended body of a handle, forming a housing for supporting a uterine cervical canal dilation device as described above.
  • the body of the vaginal speculum comprises an upper spoon and a lower spoon mounted on a conical ring, the ends of the lower and upper spoons respectively clipping in two grooves engraved on the support of the dilator device of the uterine cervical canal.
  • vaginal speculum has similar features and advantages to those described above with reference to the cervical cervical canal dilatation device.
  • the invention relates to a disposable medical device which is integrated with a speculum of new design and in which is fixed the extensible protective tube support, allowing expansion from 2 to 12 mm safely.
  • This extensible protective tube covers the cervical canal to prevent any traumatic contact on the walls during the passage of hysteroscopic instruments and surgery, also avoiding any contribution of vaginal bacteria in the uterus.
  • This medical disposable device is composed of the various elements presented above to ensure the aforementioned advantages.
  • the selling price of this device will be positioned so that it does not exceed half the cost price of a sterilization of the instruments it replaces: metal speculum, set of Hegar candles, stainless steel clip.
  • the dilatation is done inside an extensible protective tube protecting the cervical canal from friction causing wounds and bleeding during the dilatation.
  • This device by its invention and its easy use, allows all gynecologists to practice cervical dilatation.
  • the speculum to dilate the cervical canal completely solves the problem of cervical dilation by avoiding any contact and damage or injury of the tissues of the wall of the cervical canal. It also prevents the perforation of the uterine walls.
  • this device While facilitating interventions within the uterine cavity, this device is designed for single use.
  • this medical device is designed to be integrated with a vaginal speculum. Thanks to the extendable protective tube deposited on the walls of the canal, it creates a protective tunnel between the entrance of the vagina and the uterine cavity thus preventing any contribution of vaginal bacteria brought by the instruments used.
  • the dilation is effected by the pressure exerted on the dilator stem by the thumb of the practitioner that he will have previously inserted into the ring at the back of the dilator shaft.
  • the dilator shaft penetrates and dilates the cervical canal.
  • Plastic fins placed between the expandable protective tube and the dilator shaft separate the extensible protective tube to prevent contact, frontal resistance and friction of the dilator shaft on the wall of the cervical canal. This same action simultaneously deposits the plastic dilator sleeve that will shroud the cervical canal and protect it during the entire duration of the procedure. This dilator sleeve keeps spread the extensible protective tube and forms a tunnel that will also allow the practitioner to remove the dilator rod.
  • this dilator sleeve is removed using the same dilator rod by turning a quarter turn on the right and pulling on the back to remove it. This will result in lowering the pressure of the cervical muscles and thus allow to remove the entire complete device with ease and security.
  • the penetration of the dilator rod is limited to a maximum of 50 mm by a stop formed by a narrowing of a conical portion located inside the support of the extensible protective tube.
  • the average length of the cervical canal varies between 25 and 35 mm.
  • the end of the penetrating portion of the dilator shaft is round and flexible and will therefore bend if there is contact with the walls of the uterine cavity to prevent laceration and / or perforation.
  • One of the main advantages of this invention is its ease of use and application.
  • the semi-rigid end (diameter 2 mm) of the dilator shaft is presented on the opening of the cervical canal (naturally open between 3.5 and 4.5 mm) and penetrates without effort and resistance in the cervical canal by pressing on the back of the support.
  • the extensible protective tube is placed in the cervical canal.
  • the practitioner, pushing on the ring of the dilator shaft dilates the cervical canal and positions the dilator sleeve inside the extensible protective tube allowing access of the intervention instruments in the uterine cavity. Then he removes the dilator rod and can begin his intervention.
  • FIG 1 shows the shape of the speculum to facilitate diagnostic examinations and surgical procedures inside the uterus, seen in perspective;
  • FIG 2 shows the speculum to facilitate the diagnostic examinations and surgical interventions inside the uterus, seen in profile;
  • FIG. 3 shows the speculum assembled by medical plastic elements
  • FIG 4 shows the entire support of the expansion device
  • FIG. 5 shows the dilator sleeve which will be positioned by the dilator rod inside the support of the extensible protective tube and introduced into the cervical canal, forming in the same cervical canal a protection tunnel during the intervention;
  • FIG. 6 shows the assembly of the dilator rod with the pusher ring to effect and facilitate the expansion
  • FIG. 7 shows the finned guide which is positioned at the outlet of the support of the extensible protective tube which will be placed on top of it. This set allows easy penetration of the dilator shaft into the cervical canal without contact or friction with the walls of the cervical canal;
  • FIG. 8 shows the extensible protective tube made of medical plastic which expands during the passage of the dilator shaft;
  • FIG 9 shows the locking ring with the threads inside to lock on the end of the support the fin guide and the extensible protective tube;
  • FIG. 10 shows an upper view of the assembly of the extensible protective tube under which the finned guide is located. This assembly is fixed by the locking ring on the end of the support inside which is already positioned the dilator shaft, ready to be activated to expand the cervical canal and position the dilator sleeve.
  • Figure 1 shows the shape of the disposable medical speculum instrument to facilitate diagnostic examinations and surgical procedures inside the uterus, packaged in sterile pouch ready for use.
  • body of speculum 1 of new form composed of its upper spoon 12 with the reduced end 121 and its lower spoon 13 with the reduced end 131 and the conical ring 14 which gives the conical rear shape of the body of speculum 1 extended handle 2, built with a rear tilt 21.
  • the support 3 will be introduced, by its rear part, through the speculum 1.
  • the extensible protective tube 8 At the end of the support 3 are already fixed the extensible protective tube 8, the finned guide 7 with the fins 71 by means of the ring 9.
  • the latter comprises in its interior the screw threads 91 which are screwed on the no screws 34 of the support 3.
  • the protection and expansion assembly, as well as the expansion sleeve 5 are ready to be introduced by simply pushing on the rear ring 61 of the dilator rod 6 until abutting on the depth limiter created by the conical narrowing portion 33 of the support 3 which at the same time limits the penetration of the sleeve 5 and the dilator rod 6.
  • Figure 2 shows the profile view of the disposable medical device, speculum to facilitate diagnostic examinations and surgical procedures inside the uterus.
  • the end of the instrument On the top is visible the end of the instrument with the assembly of the finned guide 7 and fins 71 of the previous Figure 1, on which is fixed the entire extensible protective tube 8, which has in its middle a enlarged cylindrical portion 87.
  • This expandable protective tube 8 expands from 2 to more than 12 millimeters.
  • the entire speculum is made of medical plastic shown in FIG. 3, where the body of the speculum 1, which narrows forwards and divides into an upper spoon 12 with its slightly inclined and narrowed end 121, is seen. and a symmetrical lower spoon 13 with its slightly inclined and narrowed end 131.
  • the rear of the body of the speculum 1 is presented in the form of a conical ring 14, continuing by a handle 2 slightly inclined towards the rear and having a depression, or reservation, on the rear part 21. In this depression it is possible to integrate the assembly 25 with directional light, and possibility of positioning a lighting source 26 shown in Figure 3a. It is possible to bring a strong cold directing light 27 which will propagate inside the speculum to illuminate the entrance of the cervical canal to facilitate the introduction into the extensible protective tube 8 of the various instruments used during the treatment. intervention.
  • FIG. 4 shows the support 3 in which will be positioned on the front part: the finned guide 7 with over the extensible tube 8.
  • the finned guide 7 and the extensible tube 8 are locked by the locking ring 9.
  • protective sleeve 5 and the dilator rod 6 will be positioned inside and behind the support 3, ready to be introduced inside the fin guide 7.
  • the action of pushing on the rod 6 will allow its front end 68 consisting of a series of portions to progressively remove the fins 71 and the extensible tube 8 which will exert a lateral force on the walls of the cervical canal and, thus, dilate it.
  • the support 3 is designed as an assembly with two right-hand and 32-left side arms, which extend through wide conical terminations 31 1 and 321.
  • hooks 312 and 322 for receiving the left and right portions of the handle of the transverse guide rod 64 of the guide rod 69.
  • the side openings 31 and 32 are integrally designed with a narrowing portion front conical 33 on which are engraved upper grooves 35 and lower 36 in which will be clipped the ends 121 and 131 of the speculum.
  • the portion 34 has a thread that corresponds to the internal screw thread 91 of the locking ring 9.
  • the end of the support 3 terminates in the form of a conical ring 37.
  • FIG. 5 shows the dilator bushing 5 which will be positioned at the center of the support 3 and whose end will be slightly inserted into the rear part of the extensible protective tube 8, the finned guide 7 and the fins 71.
  • This dilator sleeve 5 has in its conical rear portion 51 two transverse windows upper 52 and lower 53 (not visible in the image), in which will be introduced the two protrusions 651 on the left and 652 on the right (not visible on the dilator rod 6 ).
  • the conical portion 51 continues in the tubular portion 54, which constitutes the protective tunnel of the cervical canal during the procedure and which keeps apart, the finned guide 7 and the expandable tube 8.
  • Figure 6 shows the dilator rod 6 with the ring 61 at its rear end.
  • the hollow portion is in the form of a hollow tube 62.
  • the upper portion 621 of the slot 63 is fixed on the ring 61.
  • the lower part 622 of the slot 63 is also fixed on the ring 61.
  • the handle of the transverse guide rod 64 slides along this opening on which is fixed the end of the guide rod 69.
  • protuberances 632 and 631 (not visible in the diagram) behind which the rod transverse guide 64 will stay hooked and withdraw at the same time
  • the tube 62 represents the thickest part of the dilator rod 6 and its end 66 abuts against the narrowing portion 33, acting as a depth limiter.
  • the tube 62 narrows through the conical portion 66 and extends through the tube 67 of the dilator shaft 6, and terminates with a series of different sized portions 68, acting as dilator beads.
  • the series of portions 68 will be positioned at the outlet 37 of the support 3 and will be in contact with the inner portion of the fins 71 covered with the tube 8, and ready to spread laterally by the thrust on the dilator rod 6.
  • the rod 6, after spacing the fins and the tube 8, will introduce the end of the sleeve 5 to the entrance of the uterus.
  • the series of portions 68 of the rod 6 will be 15 mm inside the uterus and in front of the socket 5.
  • FIG. 7 shows the assembly of the finned guide 7 with at its end the narrowed end 74 to facilitate their positioning in the extensible protective tube 8.
  • This assembly is made of elastic medical plastic which is positioned on the cylindrical end 37 of the support 3 of the extensible protective tube 8 and the finned guide 7.
  • This assembly in which the tube 67 and the series of portions 68 of the dilator rod 6 are introduced, is intended to facilitate the introduction of the extensible protective tube 8, whose role is to isolate the walls of the cervical canal from the friction made by the ends 67 and 68 of the dilator rod 6.
  • the portion 72 (similar to a tube in FIG. 7) corresponds to the joining of the fins 71 assembled and kept tight 8.
  • the portion 70 has a conical shape, its end has 5 independent fins 71 to the end 74. These fins are joined inside the extensible protective tube 8 and form the tube 72. fins have on their outer part three protrusions 73 each whose role is to allow, after expansion and positioning of the expandable protective tube 8, traction of the uterus towards the outside of the vagina so that it takes an ideal position and facilitate endoscopic vision of the uterine cavity.
  • the tube 72 is thus the continuity of the five fins 71 which, between the conical portion 70 and the tube 72, have three hinged tabs each allowing their adaptation to the inner shapes 82, 83 and 84 of the tube 8.
  • the expansion is effected by the series of portions 68 by sliding inside the fins 71 which separate the tube 8.
  • the fins 71 of the same material as the rod 6, facilitate the sliding (plastic against plastic) of the rod 6 and laterally separate the tube 8 by preventing it from exiting forward. This action greatly reduces the force exerted to perform the dilation of the cervical canal.
  • Figure 8 shows the extensible protective tube 8 made of medical plastic and consisting of nine segments.
  • the segment 81 is the widest of all, it is positioned on the fin guide 7, the fins 71 and over the conical hollow portion 70.
  • the conical portion of the segment 81 narrows to reach the segment 82 which narrows him even to the segment 83 and continues to the portion 85 of the expandable protective tube 8 which has the shape of a cylindrical tube and which, in its middle, has an enlarged cylindrical portion 87, a space of about 1 mm which will leave room for the protrusions 73.
  • the conical widening 86 of the extensible protective tube 8 which continues on 15 mm on the central segment 87 and ends with a conical narrowing 88 to its end cylindrical 89.
  • FIG. 9 shows the locking ring having a cylindrical portion 92 which extends towards the conical portion 93 of the locking ring 9.
  • FIG. 10 shows the view over the entire support 3 with the extensible protective tube 8 inside which is the finned guide 7 and the fins 71 which are assembled and locked with the aid of the ring 9 on the end of the support 3, in which is located the dilator sleeve 5 inside which is positioned the guide rod 69 which has the role of introducing into the cervical canal the expandable protective tube 8 with the guide with fins 7 and the fins 71.
  • the handle of the transverse guide rod 64 locks the assembly on the back of the support 3 with the help of the protuberances 312 and 322.
  • the support 3, the guide rod 69, the expandable protective tube 8, the fin guide 7 and the fins 71 form an assembly whose end is introduced into the cervical canal ready to receive the end of the dilator rod 6 having the role of expanding the fins 7 and the extensible protective tube 8 and position, in same time, the dilator sleeve 5 which will create the protection tunnel during the intervention.
  • the guide rod 69, located inside the dilator rod 6, and the dilator rod 6 will be removed at the same time leaving the free passage for the instruments.
  • the dilator sleeve 5 will be easily removed from the cervical canal by re-introducing the dilator shaft 6 and turning it slightly to the right. Once hooked on the windows 52 and 53 located on the conical rear portion of the sleeve 5. It will be sufficient to pull the dilator rod 6 back, which will have the effect of narrowing the finned guide 7 and the fins 71, as well as the extensible protective tube 8 and thus allow the entire device to be removed from the cervical canal and the vagina. This device will then be deposited in the medical waste container.
  • the gynecologist takes the sterile speculum packaging to dilate the cervix, facilitate diagnostic examinations and surgical procedures inside the uterus.
  • this main packaging will be packaged separately, on the one hand, the body of speculum 1 with handle 2 made of medical plastic.
  • the dilator rod 6 in which will already be positioned the guide rod 69 and the dilator sleeve 5. This assembly will be positioned in the support 3, and hooked with the aid of the transverse guide rod 64 in the protrusions 312 and 322.
  • the fin guide 7 and the fins 71 also made of medical plastic, covered with extensible protective tube 8 made of medical materials.
  • the assembly will be locked by the locking ring 9 on the conical end 37 of the support 3.
  • To use the gynecologist takes the spoons 12 and 13 between the thumb and index finger folded to bring the ends 121 and 131 to introduce the speculum into the vagina by pushing it forward. Once the speculum is introduced into the vagina, it automatically deviates. Then it positions the lamp (FIG 3a) by housing it in the rear hollow portion of the handle 21 and adjusts the light flux 27. This light input will allow it to direct the entire support 3 and position the front part in the opening of the cervical canal.
  • the gynecologist pushes with his thumb on the tapered rear part of the support 3 and pushes it completely into the conical rear part of the body of the speculum 1, which guarantees that the Guide rod 69 will completely introduce into the cervical canal to the entrance of the uterus the extensible protective tube assembly 8, the finned guide 7 and the fins 71.
  • the gynecologist will introduce his thumb in the ring 61 positioned on the rear of the dilator shaft 6, and will perform a progressive push before abutting against the limiter or portion of narrowing 33 Then, pulling the ring 61 back, the gynecologist effortlessly removes the dilator rod 6 at the same time as the guide rod 69, which has the effect of clearing the passage for the various instruments to the uterine cavity through the extensible protective tube 8.
  • the gynecologist again introduces the dilator rod 6 to abut against the conical portion of the sleeve 5, he slightly rotates the rod 6 on the right to pick the windows 52 and 53 with the excrescences 651 and 652. Then the gynecologist removes the assembly with the sleeve 5 and releases the tension exerted on the finned guide 7, the fins 71, and the extensible protective tube 8. This allows to remove effortlessly the entire device with all its integrated elements that will be deposited in a medical waste container.

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Abstract

A device for dilating the uterine cervical canal comprises: - a support (3); - a dilator rod (6) mounted in translation in said support (3); - an extensible protective tube fixed to an end of the support (3); - a winged guide (7) housed in the extensible protective tube and fixed to the end of the support (3); and – a dilator bushing mounted on the dilator rod (6), the dilator rod (6) being adapted to move apart the wings of said winged guide (7) inside the extensible protective tube and to introduce a tubular portion of said dilator bushing inside the winged guide (7) housed in the extensible protective tube. Use to dilate the neck of the uterus and to facilitate examinations, diagnoses and surgical interventions inside the uterus.

Description

Dispositif de dilatation de canal cervical utérin  Uterine cervical canal dilatation device
La présente invention concerne un dispositif de dilatation de canal cervical utérin et un spéculum associé pour dilater le col de l'utérus, faciliter les examens, les diagnostiques et les interventions chirurgicales à l'intérieur de l'utérus. The present invention relates to an uterine cervical canal dilatation device and an associated speculum for dilating the cervix, facilitating examinations, diagnostics and surgical procedures within the uterus.
DOMAINE TECHNIQUE  TECHNICAL AREA
Ce dispositif médical à usage unique appartient au domaine d'application de la médecine et des instruments médicaux.  This disposable medical device belongs to the field of application of medicine and medical instruments.
Ce dispositif médical est utilisé pour les interventions en gynécologie, plus précisément pour élargir le canal cervical, examiner et passer des instruments pour tous les examens et interventions chirurgicales pratiquées dans la cavité utérine. Il permet, en toute sécurité, d'élargir ou de dilater le canal cervical.  This medical device is used for interventions in gynecology, specifically to expand the cervical canal, examine and pass instruments for all examinations and surgical procedures performed in the uterine cavity. It allows you to safely expand or dilate the cervical canal.
ETAT DE LA TECHNIQUE  STATE OF THE ART
Les bougies de Hegar existent depuis 1879 et n'ont jamais été améliorées ou remplacées. Elles se présentent sous la forme d'écarteurs métalliques ou plastiques. Après avoir appréhendé le col de l'utérus avec des pinces et l'avoir tiré vers l'extérieur, le praticien introduit la première bougie de Hegar en exerçant une forte poussée pour écarter le canal cervical. Il commence par un petit diamètre, puis introduit les bougies suivantes généralement numérotées de 2 à 12 mmm les unes après les autres. Les premières bougies sont les plus dangereuses car, de par leur petite taille elles occasionnent fréquemment des lacérations ou perforations du canal cervical, entraînant des risques d'hémorragie interne. C'est pourquoi ces actes à haut risque se pratiquent en bloc opératoire et entraînent des interventions chirurgicales coûteuses.  Hegar candles have been around since 1879 and have never been upgraded or replaced. They are in the form of metal or plastic spacers. After grasping the cervix with forceps and pulling it outward, the practitioner introduces Hegar's first candle by pushing hard to spread the cervical canal. It begins with a small diameter, then introduces the following candles usually numbered 2 to 12 mmm one after the other. The first candles are the most dangerous because, because of their small size, they often cause lacerations or perforations of the cervical canal, leading to risks of internal bleeding. This is why these high-risk acts are performed in the operating room and involve costly surgical procedures.
L'inconvénient majeur de ce type de dilatation est manifestement l'extrême force qui doit être appliquée pour faire pénétrer l'instrument dans le canal cervical, muscle le plus puissant du corps de la femme. La poussée exercée est alors de 7 à 10 kg. D'où le risque de perforation qui représente 2% à 3% des interventions chirurgicales en gynécologie (source : Ministère de la Santé français). The major disadvantage of this type of dilatation is obviously the extreme force that must be applied to penetrate the instrument into the cervical canal, the most powerful muscle of the woman's body. The thrust exerted is then 7 to 10 kg. Hence the risk of perforation which represents 2% to 3% of surgical procedures in gynecology (source: French Ministry of Health).
La résistance frontale rencontrée, et les frottements exercés sur les parois du canal cervical endommagent les tissus et provoquent des saignements abondants, occasionnant des dommages irréversibles. Ces agressions répétées affaiblissent les muscles entourant le canal cervical qui, par la suite, ne pourront plus maintenir l'utérus fermé jusqu'au terme d'une grossesse à venir, obligeant le gynécologue à poser un anneau autour du canal cervical.  The frontal resistance encountered and the friction exerted on the walls of the cervical canal damage the tissues and cause heavy bleeding, causing irreversible damage. Repeated aggression weakens the muscles surrounding the cervical canal, which can not keep the uterus closed until the end of a future pregnancy, forcing the gynecologist to place a ring around the cervical canal.
De par de fréquentes erreurs de manipulation durant les cycles de stérilisation, l'utilisation de ces instruments métalliques ne garantit pas une stérilisation efficace et sure à 100%.  Due to frequent handling errors during sterilization cycles, the use of these metal instruments does not guarantee effective and 100% safe sterilization.
Depuis quelques années différentes technologies ont vu le jour, offrant des solutions de dilatation par des sondes d'écartement latérales, exercées par pression pneumatique ou hydraulique jusqu'à un écartement pré déterminé sans possibilité de choix du diamètre de dilatation qui varie suivant les interventions (entre 6 et 12 mm). La fiabilité de ces produits n'a pas été démontrée.  In recent years various technologies have emerged, offering expansion solutions by lateral spacing probes, exerted by pneumatic or hydraulic pressure to a pre-determined spacing without the possibility of choice of the diameter of expansion which varies according to the interventions ( between 6 and 12 mm). The reliability of these products has not been demonstrated.
PROBLÈMES TECHNIQUES  TECHNICAL PROBLEMS
L'invention de ce dispositif médical permet de résoudre les problèmes de fabrication habituellement rencontrés lors de la conception de dispositifs médicaux servant aux examens et interventions gynécologiques. Par sa simplicité de fonctionnement et d'utilisation, il permet également la dilatation et la protection du canal cervical en évitant toutes possibilités d'endommager, lacérer ou perforer, les tissus collagènes et les fibres musculaires qui entourent le canal cervical chez la femme.  The invention of this medical device solves the manufacturing problems usually encountered in the design of medical devices for gynecological examinations and procedures. By its simplicity of operation and use, it also allows the dilation and protection of the cervical canal by avoiding all possibilities of damaging, lacerating or perforating the collagenous tissues and muscle fibers that surround the cervical canal in women.
Selon un premier aspect, l'invention concerne un dispositif de dilatation de canal cervical utérin, comprenant :  According to a first aspect, the invention relates to a device for dilatation of the uterine cervical canal, comprising:
- un support ;  - a support ;
- une tige dilatatrice montée en translation dans le support ; a dilator rod mounted in translation in the support;
- un tube protecteur extensible fixé à une extrémité du support ; - un guide à ailettes logé dans le tube protecteur extensible et fixé à l'extrémité du support ; et an extensible protective tube attached to one end of the support; - A finned guide housed in the extensible protective tube and fixed to the end of the support; and
- une douille dilatatrice montée sur la tige dilatatrice, la tige dilatatrice étant adaptée à écarter les ailettes du guide à ailettes à l'intérieur du tube protecteur extensible et à introduire une portion tubulaire de la douille dilatatrice à l'intérieur du guide à ailettes logé dans le tube protecteur extensible.  - A dilator bushing mounted on the dilator rod, the dilator rod being adapted to move the fins of the fin guide inside the expandable protective tube and to introduce a tubular portion of the dilator sleeve inside the finned guide housed in the extensible protective tube.
La tige dilatatrice permet ainsi de dilater le canal cervical lors de sa translation à l'intérieur du tube protecteur extensible, celui-ci permettant de protéger le canal cervical utérin des frottements de la tige dilatatrice en translation.  The dilator rod thus makes it possible to dilate the cervical canal during its translation inside the extensible protective tube, the latter making it possible to protect the uterine cervical canal from friction of the dilator shaft in translation.
La portion tubulaire de la douille dilatatrice maintient écartée le guide à ailettes et le tube protecteur extensible et forme un canal protecteur pour éviter tout contact et endommagement du canal cervical lors du passage des instruments de diagnostic et de chirurgie.  The tubular portion of the dilator sleeve holds the fin guide and the expandable protective tube apart and forms a protective channel to prevent contact and damage to the cervical canal during the passage of diagnostic and surgical instruments.
Selon une caractéristique avantageuse, la tige dilatatrice comprend à une extrémité une tige guide raccordée par une série de portions de tailles différentes à un tube de la tige dilatatrice, la taille des portions diminuant du tube vers la tige guide, par exemple de 12 à 2 mm, la tige guide ayant un diamètre sensiblement égal à 2 mm.  According to an advantageous characteristic, the dilator rod comprises at one end a guide rod connected by a series of portions of different sizes to a tube of the dilator rod, the size of the portions decreasing from the tube to the guide rod, for example from 12 to 2 mm, the guide rod having a diameter substantially equal to 2 mm.
La dilatation du canal cervical utérin est obtenue progressivement, entre 2 et 12 mm.  The dilatation of the uterine cervical canal is obtained gradually, between 2 and 12 mm.
En pratique, le tube de la tige dilatatrice comporte une fente dans laquelle coulisse une tige guide transversale, le support comportant des crochets adaptés à venir en prise avec la tige guide transversale de chaque côté dudit tube de la tige dilatatrice.  In practice, the tube of the dilator rod comprises a slot in which slides a transverse guide rod, the support having hooks adapted to engage with the transverse guide rod on each side of said tube of the dilator rod.
La translation de la tige dilatatrice est ainsi guidée dans le support. Selon une caractéristique de mise en œuvre, le support comprend une portion de rétrécissement formant butée de fin de course en translation de la tige dilatatrice dans le support, la course en translation étant par exemple sensiblement égale à 50 mm. En pratique, la portion tubulaire de la douille dilatatrice est solidaire d'une partie conique venant en butée dans la portion de rétrécissement du support en fin de course en translation de la tige dilatatrice. The translation of the dilator rod is thus guided in the support. According to an implementation characteristic, the support comprises a narrowing portion forming an end stop in translation of the dilator rod in the support, the displacement in translation being for example substantially equal to 50 mm. In practice, the tubular portion of the dilator bushing is secured to a conical portion abutting in the narrowing portion of the support at the end of travel in translation of the dilator rod.
Selon une autre caractéristique, la partie conique de la douille dilatatrice comporte deux fenêtres dans lesquelles sont adaptées à être introduites respectivement deux excroissances de la tige dilatatrice lors d'un retrait, par la tige dilatatrice, de la douille dilatatrice hors du guide à ailettes logé dans le tube protecteur extensible.  According to another characteristic, the conical portion of the dilator bushing comprises two windows in which are adapted to be introduced respectively two protrusions of the dilator rod during a withdrawal, by the dilator rod, the dilator sleeve out of the finned guide housed in the extensible protective tube.
En pratique, le guide à ailettes comprend plusieurs ailettes, et par exemple cinq ailettes, montées sur une partie conique du guide à ailettes, et mobiles entre une position de repos, dans laquelle les ailettes sont rassemblées et maintenues serrées à l'intérieur du tube protecteur extensible, et une position de dilatation, dans laquelle les ailettes, après écartement par la tige dilatatrice, sont maintenues écartées par la douille dilatatrice à l'intérieur du tube protecteur extensible.  In practice, the fin guide comprises several fins, and for example five fins, mounted on a conical portion of the fin guide, and movable between a rest position, in which the fins are collected and held tight inside the tube. extensible protector, and an expansion position, wherein the fins, after separation by the dilator rod, are held apart by the expansion sleeve inside the expandable protective tube.
Selon une caractéristique de mise en œuvre, les ailettes possèdent sur une partie externe des excroissances, et par exemple trois excroissances par ailette, coopérant dans la position de dilatation avec une portion cylindrique élargie du tube protecteur extensible.  According to an implementation characteristic, the fins have on an external part excrescences, and for example three excrescences per fin, cooperating in the expansion position with a widened cylindrical portion of the extensible protective tube.
Les excroissances coopérant avec une portion cylindrique élargie du tube protecteur extensible permettent au praticien, en modifiant la position du dispositif de dilatation après positionnement et dilatation du canal cervical utérin, d'ajuster la position de l'utérus et faciliter ainsi la vision endoscopique de la cavité utérine.  The excrescences cooperating with a widened cylindrical portion of the expandable protective tube allow the practitioner, by changing the position of the dilator after positioning and dilation of the uterine cervical canal, to adjust the position of the uterus and thereby facilitate the endoscopic vision of the uterus. uterine cavity.
Selon un second aspect, l'invention concerne un spéculum vaginal comprenant un corps prolongé d'un manche, formant un logement pour le support d'un dispositif de dilatation de canal cervical utérin tel que décrit précédemment.  According to a second aspect, the invention relates to a vaginal speculum comprising an extended body of a handle, forming a housing for supporting a uterine cervical canal dilation device as described above.
En pratique, le corps du spéculum vaginal comprend une cuillère supérieure et une cuillère inférieure montées sur une bague conique, les extrémités des cuillères inférieure et supérieure se clipsant respectivement dans deux sillons gravés sur le support du dispositif de dilatation du canal cervical utérin. In practice, the body of the vaginal speculum comprises an upper spoon and a lower spoon mounted on a conical ring, the ends of the lower and upper spoons respectively clipping in two grooves engraved on the support of the dilator device of the uterine cervical canal.
Le spéculum vaginal présente des caractéristiques et avantages analogues à ceux décrits précédemment en référence au dispositif de dilatation de canal cervical utérin.  The vaginal speculum has similar features and advantages to those described above with reference to the cervical cervical canal dilatation device.
Dans son principe, l'invention concerne un dispositif médical à usage unique qui est intégré à un spéculum de nouvelle conception et dans lequel est fixé le support de tube protecteur extensible, permettant une dilatation allant de 2 à 12 mm en toute sécurité. Ce tube protecteur extensible vient gainer le canal cervical afin d'éviter tout contact traumatisant sur les parois lors du passage des instruments d'hystéroscopies et de chirurgie en évitant, également, tout apport de bactéries vaginales dans l'utérus.  In principle, the invention relates to a disposable medical device which is integrated with a speculum of new design and in which is fixed the extensible protective tube support, allowing expansion from 2 to 12 mm safely. This extensible protective tube covers the cervical canal to prevent any traumatic contact on the walls during the passage of hysteroscopic instruments and surgery, also avoiding any contribution of vaginal bacteria in the uterus.
Ce dispositif médical à usage unique est composé des différents éléments présentés ci-dessus afin d'assurer les avantages précités.  This medical disposable device is composed of the various elements presented above to ensure the aforementioned advantages.
II sera livré dans un emballage plastique et stérile. Après utilisation il sera déposé dans les containers pour déchets médicaux.  It will be delivered in a plastic and sterile packaging. After use it will be placed in medical waste containers.
En réglant les problèmes déjà connus et les manques de solution mis à disposition jusqu'à ce jour, tels que les matériaux nocifs ou allergisants au contact du corps humain, son application permet également au gynécologue de pratiquer l'acte sans stress ni risques, et surtout sans stress et douleurs pour la patiente. Sa facilité et sa sécurité d'utilisation permettent de pratiquer certaines interventions directement dans les cabinets gynécologiques sans avoir systématiquement recours à une anesthésie générale en bloc opératoire avec ses effets secondaires. Il convient donc de prendre en compte la réduction des coûts des interventions par rapport à ceux d'un bloc opératoire et de l'anesthésie pratiquée.  By solving the problems already known and the lack of solutions made available to date, such as harmful or allergenic materials in contact with the human body, its application also allows the gynecologist to practice the act without stress or risk, and especially without stress and pain for the patient. Its ease and its safety of use make it possible to practice some interventions directly in the gynecological cabinets without systematically having recourse to a general anesthesia in operating theater with its side effects. It is therefore necessary to take into account the reduction of the costs of the operations compared to those of an operating theater and the anesthesia practiced.
Il est parfaitement connu qu'environ un gynécologue sur deux ne pratique jamais la dilatation cervicale au regard des risques encourus. Dorénavant c'est l'intégralité des praticiens qui pourra accéder à cet acte sans avoir systématiquement recours au bloc opératoire et ses effets collatéraux, tant en terme de coûts que de sécurité pour le praticien et la patiente. De plus la sécurité et la facilité de mise en œuvre du dispositif permettent un gain de temps conséquent par rapport à toutes les autres formes de dilatation. It is well known that about one out of two gynecologists never practice cervical dilatation with regard to the risks involved. From now on it is the totality of the practitioners who will be able to accede to this act without having systematically recourse to the operating room and its collateral effects, as well in terms of costs as of security for the practitioner and the patient. In addition, the safety and ease of implementation of the device allow a significant time saving compared to all other forms of expansion.
Le prix de vente de ce dispositif sera positionné de façon à ce qu'il ne dépasse pas la moitié du prix de revient d'une stérilisation des instruments qu'il remplace : spéculum métallique, set de bougies de Hegar, pince inox.  The selling price of this device will be positioned so that it does not exceed half the cost price of a sterilization of the instruments it replaces: metal speculum, set of Hegar candles, stainless steel clip.
Les autres avantages de cette invention sont les suivants : 1 ) L'ensemble de ce dispositif est livré stérile en emballage plastique pour usage unique.  The other advantages of this invention are as follows: 1) The whole of this device is delivered sterile in plastic packaging for single use.
2) La dilatation se fait à l'intérieur d'un tube protecteur extensible protégeant le canal cervical de frottements provoquant blessures et saignements lors de la dilatation.  2) The dilatation is done inside an extensible protective tube protecting the cervical canal from friction causing wounds and bleeding during the dilatation.
3) La dilatation sure et indolore peut se pratiquer avec anesthésie locale.  3) Safe and painless dilatation can be done with local anesthesia.
4) Une fois la dilatation effectuée il reste un tunnel protecteur protégeant le canal au passage des instruments traumatisants et supprimant le risque d'importation de bactéries vaginales.  4) Once the dilation has been completed, there remains a protective tunnel protecting the canal from traumatic instruments and eliminating the risk of importing vaginal bacteria.
5) Du fait de l'absence de risques de blessures et de douleurs, certaines interventions peuvent être pratiquées directement dans les cabinets de gynécologie.  5) Because of the risk of injury and pain, certain procedures can be performed directly in gynecology practices.
6) Le prix de ce dispositif ne dépassera pas la moitié du prix de la stérilisation des instruments qu'il remplace.  6) The price of this device will not exceed half the price of the sterilization of the instruments it replaces.
7) Ce dispositif, de par son invention et son utilisation facile, permet à tous les gynécologues de pratiquer la dilatation cervicale.  7) This device, by its invention and its easy use, allows all gynecologists to practice cervical dilatation.
Grâce aux éléments qui le composent, le spéculum pour dilater le canal cervical permet de résoudre totalement le problème de dilatation cervicale en évitant tout contact et dommages ou blessures des tissus de la paroi du canal cervical. Il empêche également la perforation des parois utérines.  Thanks to the elements that compose it, the speculum to dilate the cervical canal completely solves the problem of cervical dilation by avoiding any contact and damage or injury of the tissues of the wall of the cervical canal. It also prevents the perforation of the uterine walls.
Tout en facilitant les interventions à l'intérieur de la cavité utérine, ce dispositif est conçu pour un usage unique.  While facilitating interventions within the uterine cavity, this device is designed for single use.
Une des valeurs ajoutées de ce dispositif médical est qu'il est conçu pour être intégré à un spéculum vaginal. Grâce au tube protecteur extensible déposé sur les parois du canal, il crée un tunnel de protection entre l'entrée du vagin et la cavité utérine empêchant, ainsi, tout apport de bactéries vaginales apportées par les instruments utilisés. One of the added values of this medical device is that it is designed to be integrated with a vaginal speculum. Thanks to the extendable protective tube deposited on the walls of the canal, it creates a protective tunnel between the entrance of the vagina and the uterine cavity thus preventing any contribution of vaginal bacteria brought by the instruments used.
Ces éléments protecteurs de la paroi du canal cervical sont fixés ensemble sur l'extrémité du support du dispositif de dilatation intégré dans le spéculum vaginal.  These protective elements of the wall of the cervical canal are fixed together on the end of the support of the dilation device integrated in the vaginal speculum.
La dilatation s'effectue par la pression exercée sur la tige dilatatrice par le pouce du praticien qu'il aura préalablement inséré dans l'anneau à l'arrière de la tige dilatatrice. La tige dilatatrice pénètre et dilate le canal cervical. Des ailettes plastiques placées entre le tube protecteur extensible et la tige dilatatrice écartent le tube protecteur extensible afin d'éviter tout contact, résistance frontale et frottements de la tige dilatatrice sur la paroi du canal cervical. Cette même action dépose en même temps la douille dilatatrice en plastique qui va gainer le canal cervical et le protéger durant toute la durée de l'intervention. Cette douille dilatatrice maintient écarté le tube protecteur extensible et forme un tunnel qui permettra également au praticien de retirer la tige dilatatrice. Il pourra ainsi effectuer l'intervention prévue. A la fin de l'intervention, cette douille dilatatrice s'enlève à l'aide de la même tige dilatatrice en effectuant un quart de tour sur la droite et en tirant sur l'arrière pour l'enlever. Ceci aura pour conséquence de faire baisser la pression des muscles cervicaux et permettre ainsi de retirer l'ensemble du dispositif complet en toute facilité et sécurité.  The dilation is effected by the pressure exerted on the dilator stem by the thumb of the practitioner that he will have previously inserted into the ring at the back of the dilator shaft. The dilator shaft penetrates and dilates the cervical canal. Plastic fins placed between the expandable protective tube and the dilator shaft separate the extensible protective tube to prevent contact, frontal resistance and friction of the dilator shaft on the wall of the cervical canal. This same action simultaneously deposits the plastic dilator sleeve that will shroud the cervical canal and protect it during the entire duration of the procedure. This dilator sleeve keeps spread the extensible protective tube and forms a tunnel that will also allow the practitioner to remove the dilator rod. He will be able to carry out the planned intervention. At the end of the procedure, this dilator sleeve is removed using the same dilator rod by turning a quarter turn on the right and pulling on the back to remove it. This will result in lowering the pressure of the cervical muscles and thus allow to remove the entire complete device with ease and security.
La pénétration de la tige dilatatrice est limitée à 50 mm maximum par une butée formée par un rétrécissement d'une portion conique situé à l'intérieur du support du tube protecteur extensible. La longueur moyenne du canal cervical varie entre 25 et 35 mm. Par sécurité, l'extrémité de la partie pénétrante de la tige dilatatrice est ronde et souple et va donc se courber si il y a contact avec les parois de la cavité utérine afin d'éviter toute lacération et/ou perforation.  The penetration of the dilator rod is limited to a maximum of 50 mm by a stop formed by a narrowing of a conical portion located inside the support of the extensible protective tube. The average length of the cervical canal varies between 25 and 35 mm. For safety, the end of the penetrating portion of the dilator shaft is round and flexible and will therefore bend if there is contact with the walls of the uterine cavity to prevent laceration and / or perforation.
Un des principaux avantages de cette invention est sa facilité d'utilisation et d'application. Après l'introduction du spéculum dans le vagin, à travers lequel le gynécologue introduit l'ensemble support-tube protecteur extensible, l'extrémité semi-rigide (diamètre de 2 mm) de la tige dilatatrice est présentée sur l'ouverture du canal cervical (naturellement ouvert entre 3,5 et 4,5 mm) et pénètre sans effort et résistance dans le canal cervical en appuyant sur l'arrière du support. De cette manière le tube protecteur extensible est placé dans le canal cervical. Le praticien, en poussant sur l'anneau de la tige dilatatrice, dilate le canal cervical et positionne la douille dilatatrice à l'intérieur du tube protecteur extensible permettant l'accès des instruments d'intervention dans la cavité utérine. Ensuite il retire la tige dilatatrice et peut commencer son intervention. One of the main advantages of this invention is its ease of use and application. After the introduction of the speculum into the vagina, through which the gynecologist introduces the support-tube assembly extensible, the semi-rigid end (diameter 2 mm) of the dilator shaft is presented on the opening of the cervical canal (naturally open between 3.5 and 4.5 mm) and penetrates without effort and resistance in the cervical canal by pressing on the back of the support. In this way the extensible protective tube is placed in the cervical canal. The practitioner, pushing on the ring of the dilator shaft, dilates the cervical canal and positions the dilator sleeve inside the extensible protective tube allowing access of the intervention instruments in the uterine cavity. Then he removes the dilator rod and can begin his intervention.
BREVE DESCRIPTION DES ILLUSTRATIONS  BRIEF DESCRIPTION OF THE ILLUSTRATIONS
Dans le but de faciliter la compréhension de l'invention, les détails d'un exemple de mise en œuvre de l'invention sont montrés par des illustrations suivantes :  In order to facilitate understanding of the invention, the details of an exemplary implementation of the invention are shown by the following illustrations:
- FIG 1 : montre la forme du spéculum pour faciliter les examens diagnostiques et interventions chirurgicales à l'intérieur de l'utérus, vue en perspective ;  - FIG 1: shows the shape of the speculum to facilitate diagnostic examinations and surgical procedures inside the uterus, seen in perspective;
- FIG 2 : montre le spéculum pour faciliter les examens diagnostiques et interventions chirurgicales à l'intérieur de l'utérus, vue de profil ;  - FIG 2: shows the speculum to facilitate the diagnostic examinations and surgical interventions inside the uterus, seen in profile;
- FIG 3 : montre le spéculum assemblé par des éléments en plastique médical ;  FIG. 3 shows the speculum assembled by medical plastic elements;
- FIG 4 : montre l'ensemble du support du dispositif de dilatation ; FIG 4 shows the entire support of the expansion device;
- FIG 5 : montre la douille dilatatrice qui sera positionnée par la tige dilatatrice à l'intérieur du support du tube protecteur extensible et introduite dans le canal cervical, formant dans ce même canal cervical un tunnel de protection durant l'intervention ; FIG. 5 shows the dilator sleeve which will be positioned by the dilator rod inside the support of the extensible protective tube and introduced into the cervical canal, forming in the same cervical canal a protection tunnel during the intervention;
- FIG 6 : montre l'ensemble de la tige dilatatrice avec l'anneau poussoir pour effectuer et faciliter la dilatation ;  FIG. 6 shows the assembly of the dilator rod with the pusher ring to effect and facilitate the expansion;
- FIG 7 : montre le guide à ailettes qui se positionne à la sortie du support du tube protecteur extensible qui va se placer par-dessus. Cet ensemble permet une pénétration facile de la tige dilatatrice à l'intérieur du canal cervical sans contact ni frottement avec les parois du canal cervical ; - FIG 8 : montre le tube protecteur extensible en plastique médical qui se dilate lors du passage de la tige dilatatrice ; FIG. 7 shows the finned guide which is positioned at the outlet of the support of the extensible protective tube which will be placed on top of it. This set allows easy penetration of the dilator shaft into the cervical canal without contact or friction with the walls of the cervical canal; FIG. 8 shows the extensible protective tube made of medical plastic which expands during the passage of the dilator shaft;
- FIG 9 : montre la bague de verrouillage avec les pas de vis à l'intérieur pour verrouiller sur l'extrémité du support le guide à ailettes et le tube protecteur extensible ; et  - FIG 9: shows the locking ring with the threads inside to lock on the end of the support the fin guide and the extensible protective tube; and
- FIG 10 : montre une vue supérieure de l'ensemble du tube protecteur extensible sous lequel se trouve le guide à ailettes. Cet ensemble est fixé par la bague de verrouillage sur l'extrémité du support à l'intérieur duquel est déjà positionnée la tige dilatatrice, prête à être activée pour dilater le canal cervical et positionner la douille dilatatrice.  FIG. 10 shows an upper view of the assembly of the extensible protective tube under which the finned guide is located. This assembly is fixed by the locking ring on the end of the support inside which is already positioned the dilator shaft, ready to be activated to expand the cervical canal and position the dilator sleeve.
DESCRIPTION DE L'INVENTION  DESCRIPTION OF THE INVENTION
La figure 1 montre la forme de l'instrument médical à usage unique du spéculum pour faciliter les examens diagnostiques et interventions chirurgicales à l'intérieur de l'utérus, emballé en sachet stérile prêt à être utilisé. Sur la figure 1 on voit le corps du spéculum 1 de forme nouvelle composé de sa cuillère supérieure 12 avec l'extrémité réduite 121 et de sa cuillère inférieure 13 avec l'extrémité réduite 131 et la bague conique 14 qui donne la forme arrière conique du corps du spéculum 1 prolongé du manche 2, construit avec une inclinaison arrière 21 . Une fois le spéculum positionné dans le vagin, le support 3 sera introduit, par sa partie arrière, à travers le spéculum 1 . A l'extrémité du support 3, sont déjà fixés le tube protecteur extensible 8, le guide à ailettes 7 avec les ailettes 71 au moyen de la bague 9. Celle-ci comporte en son intérieur les pas de vis 91 qui se vissent sur les pas de vis 34 du support 3. De cette manière l'ensemble de protection et de dilatation, ainsi que la douille dilatatrice 5, sont prêts à être introduit par simple poussée sur l'anneau arrière 61 de la tige dilatatrice 6 jusqu'à buter sur le limiteur de profondeur créé par la portion de rétrécissement conique 33 du support 3 qui limite en même temps la pénétration de la douille 5 et de la tige dilatatrice 6.  Figure 1 shows the shape of the disposable medical speculum instrument to facilitate diagnostic examinations and surgical procedures inside the uterus, packaged in sterile pouch ready for use. In Figure 1 we see the body of speculum 1 of new form composed of its upper spoon 12 with the reduced end 121 and its lower spoon 13 with the reduced end 131 and the conical ring 14 which gives the conical rear shape of the body of speculum 1 extended handle 2, built with a rear tilt 21. Once the speculum is positioned in the vagina, the support 3 will be introduced, by its rear part, through the speculum 1. At the end of the support 3 are already fixed the extensible protective tube 8, the finned guide 7 with the fins 71 by means of the ring 9. The latter comprises in its interior the screw threads 91 which are screwed on the no screws 34 of the support 3. In this way the protection and expansion assembly, as well as the expansion sleeve 5, are ready to be introduced by simply pushing on the rear ring 61 of the dilator rod 6 until abutting on the depth limiter created by the conical narrowing portion 33 of the support 3 which at the same time limits the penetration of the sleeve 5 and the dilator rod 6.
Cet ensemble se positionnera ainsi en toute sécurité, dans le canal cervical. A l'intérieur de la tige dilatatrice 6 est déjà positionnée la tige guide 69 ayant pour rôle d'introduire le tube protecteur extensible 8, le guide à ailettes 7 et les ailettes 71 dans le canal cervical et, également, grâce à sa tige guide transversale 64, accrocher la tige dilatatrice 6 sur les crochets 312 et 322 pour permettre à la tige dilatatrice 6 de glisser dans l'axe de travail. Une fois la dilatation réalisée et la douille dilatatrice 5 positionnée dans le canal cervical il suffira de tirer sur l'anneau arrière 61 de la tige dilatatrice 6 pour la retirer, en même temps que la tige guide 69, du support 3. De cette manière on laisse le passage libre pour les instruments prévus pour l'intervention. This set will thus be positioned safely in the cervical canal. Inside the dilator rod 6 is already positioned the guide rod 69 having the role of introducing the expandable protective tube 8, the finned guide 7 and the fins 71 into the cervical canal and, also, thanks to its guide rod transverse 64, hook the dilator rod 6 on the hooks 312 and 322 to allow the dilator rod 6 to slide in the working axis. Once dilation is achieved and the dilator sleeve 5 positioned in the cervical canal, it will suffice to pull on the rear ring 61 of the dilator rod 6 to remove it, together with the guide rod 69, from the support 3. In this way the free passage is left for the instruments provided for the intervention.
La figure 2 montre la vue de profil de l'instrument médical à usage unique, spéculum pour faciliter les examens diagnostiques et interventions chirurgicales à l'intérieur de l'utérus. Sur le dessus on aperçoit l'extrémité de l'instrument avec l'ensemble du guide à ailettes 7 et des ailettes 71 de la précédente figure 1 , sur lequel est fixé l'ensemble du tube protecteur extensible 8, lequel possède en son milieu une portion cylindrique élargie 87. Ce tube protecteur extensible 8 se dilate de 2 à plus de 12 millimètres.  Figure 2 shows the profile view of the disposable medical device, speculum to facilitate diagnostic examinations and surgical procedures inside the uterus. On the top is visible the end of the instrument with the assembly of the finned guide 7 and fins 71 of the previous Figure 1, on which is fixed the entire extensible protective tube 8, which has in its middle a enlarged cylindrical portion 87. This expandable protective tube 8 expands from 2 to more than 12 millimeters.
L'ensemble de ce spéculum est fabriqué avec du plastique médical présenté sur la figure 3, ou on voit le corps du spéculum 1 qui se rétrécie vers l'avant et se divise en une cuillère supérieure 12 avec son extrémité légèrement inclinée et rétrécie 121 , et une cuillère inférieure symétrique 13 avec son extrémité légèrement inclinée et rétrécie 131 . L'arrière du corps du spéculum 1 est présenté sous forme d'une bague conique 14, continuant par un manche 2 légèrement incliné vers l'arrière et possédant un enfoncement, ou réservation, sur la partie arrière 21 . Dans cet enfoncement il est possible d'intégrer l'ensemble 25 avec lumière directionnelle, et possibilité de positionner une source d'éclairage 26 représentée par l'illustration 3a. Il est possible d'y apporter une forte lumière froide dirigeable 27 qui se propagera à l'intérieur du spéculum jusqu'à éclairer l'entrée du canal cervical pour faciliter l'introduction dans le tube protecteur extensible 8 des différents instruments utilisés pendant l'intervention.  The entire speculum is made of medical plastic shown in FIG. 3, where the body of the speculum 1, which narrows forwards and divides into an upper spoon 12 with its slightly inclined and narrowed end 121, is seen. and a symmetrical lower spoon 13 with its slightly inclined and narrowed end 131. The rear of the body of the speculum 1 is presented in the form of a conical ring 14, continuing by a handle 2 slightly inclined towards the rear and having a depression, or reservation, on the rear part 21. In this depression it is possible to integrate the assembly 25 with directional light, and possibility of positioning a lighting source 26 shown in Figure 3a. It is possible to bring a strong cold directing light 27 which will propagate inside the speculum to illuminate the entrance of the cervical canal to facilitate the introduction into the extensible protective tube 8 of the various instruments used during the treatment. intervention.
La figure 4 montre le support 3 dans lequel seront positionnés sur la partie avant : le guide à ailettes 7 avec par-dessus le tube extensible 8. Le guide à ailettes 7 et le tube extensible 8 sont verrouillés par la bague de verrouillage 9. La douille protectrice 5 et la tige dilatatrice 6 seront positionnées à l'intérieur et à l'arrière du support 3, prêtes à être introduites à l'intérieur du guide à ailettes 7. L'action de pousser sur la tige 6 va permettre à son extrémité avant 68 constituée d'une série de portions d'écarter progressivement les ailettes 71 et le tube extensible 8 qui vont exercer une force latérale sur les parois du canal cervical et, ainsi, le dilater. Le support 3 est conçu comme un ensemble avec deux bras latéraux 31 à droite et 32 à gauche, lesquels se prolongent par des terminaisons coniques larges 31 1 et 321 . Dans la partie intérieure de ces terminaisons sont positionnés des crochets 312 et 322 pour recevoir les parties gauche et droite de la poignée de la tige guide transversale 64 de la tige guide 69. Les ouvertures latérales 31 et 32 sont intégralement conçues avec une portion de rétrécissement conique avant 33 sur laquelle sont gravées des sillons supérieur 35 et inférieur 36 dans lesquels vont se clipser les extrémités 121 et 131 du spéculum. La partie 34 possède un pas de vis qui correspond au pas de vis intérieur 91 de la bague de verrouillage 9. L'extrémité du support 3 se termine sous forme d'une bague conique 37. FIG. 4 shows the support 3 in which will be positioned on the front part: the finned guide 7 with over the extensible tube 8. The finned guide 7 and the extensible tube 8 are locked by the locking ring 9. protective sleeve 5 and the dilator rod 6 will be positioned inside and behind the support 3, ready to be introduced inside the fin guide 7. The action of pushing on the rod 6 will allow its front end 68 consisting of a series of portions to progressively remove the fins 71 and the extensible tube 8 which will exert a lateral force on the walls of the cervical canal and, thus, dilate it. The support 3 is designed as an assembly with two right-hand and 32-left side arms, which extend through wide conical terminations 31 1 and 321. In the inner part of these terminations are positioned hooks 312 and 322 for receiving the left and right portions of the handle of the transverse guide rod 64 of the guide rod 69. The side openings 31 and 32 are integrally designed with a narrowing portion front conical 33 on which are engraved upper grooves 35 and lower 36 in which will be clipped the ends 121 and 131 of the speculum. The portion 34 has a thread that corresponds to the internal screw thread 91 of the locking ring 9. The end of the support 3 terminates in the form of a conical ring 37.
La figure 5 montre la douille dilatatrice 5 qui sera positionnée au centre du support 3 et dont l'extrémité sera légèrement introduite dans la partie arrière du tube protecteur extensible 8, du guide à ailettes 7 et des ailettes 71 . Cette douille dilatatrice 5 possède dans sa partie arrière conique 51 deux fenêtres transversales supérieure 52 et inférieure 53 (non visible sur l'image), dans lesquelles seront introduites les deux excroissances 651 à gauche et 652 à droite (non visible sur la tige dilatatrice 6). La partie conique 51 se poursuit dans la portion tubulaire 54, lequel constitue le tunnel protecteur du canal cervical durant l'intervention et qui maintient écartés, le guide à ailettes 7 et le tube extensible 8.  FIG. 5 shows the dilator bushing 5 which will be positioned at the center of the support 3 and whose end will be slightly inserted into the rear part of the extensible protective tube 8, the finned guide 7 and the fins 71. This dilator sleeve 5 has in its conical rear portion 51 two transverse windows upper 52 and lower 53 (not visible in the image), in which will be introduced the two protrusions 651 on the left and 652 on the right (not visible on the dilator rod 6 ). The conical portion 51 continues in the tubular portion 54, which constitutes the protective tunnel of the cervical canal during the procedure and which keeps apart, the finned guide 7 and the expandable tube 8.
La figure 6 montre la tige dilatatrice 6 avec l'anneau 61 à son extrémité arrière. La partie creuse se présente sous la forme d'un tube évidé 62. La partie supérieure 621 de la fente 63 est fixée sur l'anneau 61 . La partie inférieure 622 de la fente 63 est également fixée sur l'anneau 61 . La poignée de la tige guide transversale 64 glisse le long de cette ouverture sur laquelle est fixée l'extrémité de la tige guide 69. Au milieu de cette ouverture se trouvent des excroissances 632 et 631 (non visibles sur le schéma) derrière lesquelles la tige guide transversale 64 va rester accrochée et se retirer en même temps que la tige dilatatrice 6. Le tube 62 représente la partie la plus épaisse de la tige dilatatrice 6 et son extrémité 66 vient buter contre la portion de rétrécissement 33, agissant comme limiteur de profondeur. A l'autre extrémité du tube 62 de la tige dilatatrice 6, à gauche et à droite et de manière symétrique, sont positionnés deux excroissances 651 (non visible) et 652, lesquelles, vont accrocher les fenêtres 52 et 53 pour extraire la douille dilatatrice 5 à la fin de l'intervention, ce qui aura pour effet de libérer la pression latérale exercée sur les parois du canal cervical. Cette action va également permettre au guide à ailettes 7 et au tube 8 de retrouver leur position initiale afin d'extraire le dispositif complet. Le tube 62 se rétrécit par la partie conique 66 et se prolonge par le tube 67 de la tige dilatatrice 6, et se termine par une série de portions de tailles différentes 68, agissant comme des billes dilatatrices. Figure 6 shows the dilator rod 6 with the ring 61 at its rear end. The hollow portion is in the form of a hollow tube 62. The upper portion 621 of the slot 63 is fixed on the ring 61. The lower part 622 of the slot 63 is also fixed on the ring 61. The handle of the transverse guide rod 64 slides along this opening on which is fixed the end of the guide rod 69. In the middle of this opening are protuberances 632 and 631 (not visible in the diagram) behind which the rod transverse guide 64 will stay hooked and withdraw at the same time The tube 62 represents the thickest part of the dilator rod 6 and its end 66 abuts against the narrowing portion 33, acting as a depth limiter. At the other end of the tube 62 of the dilator rod 6, left and right and symmetrically, are positioned two protuberances 651 (not visible) and 652, which will hang the windows 52 and 53 to extract the dilator sleeve 5 at the end of the procedure, which will have the effect of releasing the lateral pressure exerted on the walls of the cervical canal. This action will also allow the finned guide 7 and the tube 8 to return to their original position in order to extract the complete device. The tube 62 narrows through the conical portion 66 and extends through the tube 67 of the dilator shaft 6, and terminates with a series of different sized portions 68, acting as dilator beads.
La série de portions 68 sera positionnée à la sortie 37 du support 3 et se trouvera au contact de la parte intérieure des ailettes 71 recouvertes du tube 8, et prête à les écarter latéralement par la poussée sur la tige dilatatrice 6.  The series of portions 68 will be positioned at the outlet 37 of the support 3 and will be in contact with the inner portion of the fins 71 covered with the tube 8, and ready to spread laterally by the thrust on the dilator rod 6.
La tige 6, après écartement des ailettes et du tube 8, va introduire l'extrémité de la douille 5 jusqu'à l'entrée de l'utérus.  The rod 6, after spacing the fins and the tube 8, will introduce the end of the sleeve 5 to the entrance of the uterus.
La série de portions 68 de la tige 6 va se trouver 15 mm à l'intérieur de l'utérus et en avant de la douille 5.  The series of portions 68 of the rod 6 will be 15 mm inside the uterus and in front of the socket 5.
En tirant sur l'anneau 61 le praticien retire la tige 6 et la tige guide By pulling on the ring 61 the practitioner removes the rod 6 and the guide rod
69, ce qui aura pour effet de libérer le tunnel à l'intérieur de la douille 5 qui restera ainsi positionné durant toute l'intervention. 69, which will have the effect of releasing the tunnel inside the sleeve 5 which will remain well positioned throughout the intervention.
La figure 7 montre l'ensemble du guide à ailettes 7 avec à son extrémité la terminaison rétrécie 74 afin de faciliter leur positionnement dans le tube protecteur extensible 8. Cet ensemble est fabriqué en plastique médical élastique qui se positionne sur l'extrémité cylindrique 37 du support 3 du tube protecteur extensible 8 et du guide à ailettes 7. Cet ensemble, dans lequel s'introduisent le tube 67 et la série de portions 68 de la tige dilatatrice 6, a vocation à faciliter l'introduction du tube protecteur extensible 8, dont le rôle est d'isoler les parois du canal cervical des frottements effectués par les extrémités 67 et 68 de la tige dilatatrice 6. La partie 72 (semblable à un tube à la figure 7) correspond à la réunion des 5 ailettes 71 rassemblées et maintenues serrées par le tube 8. La partie 70 a une forme conique, son extrémité possède 5 ailettes indépendantes 71 jusqu'à l'extrémité 74. Ces 5 ailettes sont réunies à l'intérieur du tube protecteur extensible 8 et forment le tube 72. Les 5 ailettes possèdent sur leur partie externe trois excroissances 73 chacune dont le rôle est de permettre, après dilatation et positionnement du tube protecteur extensible 8, la traction de l'utérus vers l'extérieur du vagin afin qu'il prenne une position idéale et faciliter ainsi la vision endoscopique de la cavité utérine. FIG. 7 shows the assembly of the finned guide 7 with at its end the narrowed end 74 to facilitate their positioning in the extensible protective tube 8. This assembly is made of elastic medical plastic which is positioned on the cylindrical end 37 of the support 3 of the extensible protective tube 8 and the finned guide 7. This assembly, in which the tube 67 and the series of portions 68 of the dilator rod 6 are introduced, is intended to facilitate the introduction of the extensible protective tube 8, whose role is to isolate the walls of the cervical canal from the friction made by the ends 67 and 68 of the dilator rod 6. The portion 72 (similar to a tube in FIG. 7) corresponds to the joining of the fins 71 assembled and kept tight 8. The portion 70 has a conical shape, its end has 5 independent fins 71 to the end 74. These fins are joined inside the extensible protective tube 8 and form the tube 72. fins have on their outer part three protrusions 73 each whose role is to allow, after expansion and positioning of the expandable protective tube 8, traction of the uterus towards the outside of the vagina so that it takes an ideal position and facilitate endoscopic vision of the uterine cavity.
Le tube 72 est ainsi la continuité des cinq ailettes 71 qui, entre la partie conique 70 et le tube 72, possèdent trois languettes articulées chacune permettant leur adaptation aux formes intérieures 82, 83 et 84 du tube 8.  The tube 72 is thus the continuity of the five fins 71 which, between the conical portion 70 and the tube 72, have three hinged tabs each allowing their adaptation to the inner shapes 82, 83 and 84 of the tube 8.
La dilatation est effectuée par la série de portions 68 en glissant à l'intérieur des ailettes 71 qui écartent le tube 8.  The expansion is effected by the series of portions 68 by sliding inside the fins 71 which separate the tube 8.
Les ailettes 71 , du même matériau que la tige 6, facilitent le glissement (plastique contre plastique) de la tige 6 et écartent latéralement le tube 8 en l'empêchant de s'extraire vers l'avant. Cette action réduit considérablement la force exercée pour effectuer la dilatation du canal cervical.  The fins 71, of the same material as the rod 6, facilitate the sliding (plastic against plastic) of the rod 6 and laterally separate the tube 8 by preventing it from exiting forward. This action greatly reduces the force exerted to perform the dilation of the cervical canal.
La figure 8 montre le tube protecteur extensible 8 fabriqué en plastique médical et constitué de neuf segments. Le segment 81 est le plus large de tous, il se positionne sur le guide à ailettes 7, les ailettes 71 et par- dessus la partie creuse conique 70. La partie conique du segment 81 se rétrécie pour arriver au segment 82 qui se rétrécie lui-même jusqu'au segment 83 et continue jusqu'à la partie 85 du tube protecteur extensible 8 qui a la forme d'un tube cylindrique et qui, en son milieu, possède une portion cylindrique élargie 87, espace d'environ 1 mm qui va laisser de la place aux excroissances 73. Suite à cela se forme le début de l'élargissement conique 86 du tube protecteur extensible 8 qui continue sur 15 mm sur le segment central 87 et se termine par un rétrécissement conique 88 jusqu'à son extrémité cylindrique 89.  Figure 8 shows the extensible protective tube 8 made of medical plastic and consisting of nine segments. The segment 81 is the widest of all, it is positioned on the fin guide 7, the fins 71 and over the conical hollow portion 70. The conical portion of the segment 81 narrows to reach the segment 82 which narrows him even to the segment 83 and continues to the portion 85 of the expandable protective tube 8 which has the shape of a cylindrical tube and which, in its middle, has an enlarged cylindrical portion 87, a space of about 1 mm which will leave room for the protrusions 73. Following this is formed the beginning of the conical widening 86 of the extensible protective tube 8 which continues on 15 mm on the central segment 87 and ends with a conical narrowing 88 to its end cylindrical 89.
La figure 9 montre la bague de verrouillage ayant une partie cylindrique 92 qui se prolonge vers la partie conique 93 de la bague de verrouillage 9. A l'intérieur se trouve le pas de vis 91 qui correspond avec le pas de vis 34 du support 3 pour, en vissant, verrouiller le tube protecteur extensible 8, le guide à ailettes 7 et les ailettes 71 sur l'extrémité du support 3. La figure 10 montre la vue par-dessus de l'ensemble du support 3 avec le tube protecteur extensible 8 à l'intérieur duquel se trouve le guide à ailettes 7 et les ailettes 71 qui sont assemblés et verrouillés à l'aide de la bague de verrouillage 9 sur l'extrémité du support 3, dans lequel se trouve la douille dilatatrice 5 à l'intérieur de laquelle est positionné la tige guide 69 qui a pour rôle d'introduire dans le canal cervical le tube protecteur extensible 8 avec le guide à ailettes 7 et les ailettes 71 . Puis la poignée de la tige guide transversale 64 verrouille l'ensemble sur l'arrière du support 3 avec l'aide des excroissances 312 et 322. De ce fait le support 3, la tige-guide 69, le tube protecteur extensible 8, le guide à ailettes 7 et les ailettes 71 , forment un ensemble dont l'extrémité est introduite dans le canal cervical prêt à recevoir le bout de la tige dilatatrice 6 ayant pour rôle de dilater les ailettes 7 et le tube protecteur extensible 8 et positionner, en même temps, la douille dilatatrice 5 qui va créer le tunnel de protection durant l'intervention. La tige-guide 69, située à l'intérieur de la tige dilatatrice 6, et la tige dilatatrice 6 seront retirées toutes les deux en même temps en laissant le passage libre pour les instruments. La douille dilatatrice 5 sera facilement enlevée du canal cervical en introduisant à nouveau la tige dilatatrice 6 et en la tournant légèrement à droite. Une fois accrochée sur les fenêtres 52 et 53 situées sur la partie arrière conique de la douille 5. Il suffira de tirer la tige dilatatrice 6 en arrière, ce qui aura pour effet de rétrécir le guide à ailettes 7 et les ailettes 71 , ainsi que le tube protecteur extensible 8 et permettre ainsi de retirer l'intégralité du dispositif du canal cervical et du vagin. Ce dispositif sera ensuite déposé dans le container des déchets médicaux. FIG. 9 shows the locking ring having a cylindrical portion 92 which extends towards the conical portion 93 of the locking ring 9. Inside there is the thread 91 which corresponds with the thread 34 of the support 3 for screwing, locking the extensible protective tube 8, the finned guide 7 and the fins 71 on the end of the support 3. FIG. 10 shows the view over the entire support 3 with the extensible protective tube 8 inside which is the finned guide 7 and the fins 71 which are assembled and locked with the aid of the ring 9 on the end of the support 3, in which is located the dilator sleeve 5 inside which is positioned the guide rod 69 which has the role of introducing into the cervical canal the expandable protective tube 8 with the guide with fins 7 and the fins 71. Then the handle of the transverse guide rod 64 locks the assembly on the back of the support 3 with the help of the protuberances 312 and 322. Thus the support 3, the guide rod 69, the expandable protective tube 8, the fin guide 7 and the fins 71, form an assembly whose end is introduced into the cervical canal ready to receive the end of the dilator rod 6 having the role of expanding the fins 7 and the extensible protective tube 8 and position, in same time, the dilator sleeve 5 which will create the protection tunnel during the intervention. The guide rod 69, located inside the dilator rod 6, and the dilator rod 6 will be removed at the same time leaving the free passage for the instruments. The dilator sleeve 5 will be easily removed from the cervical canal by re-introducing the dilator shaft 6 and turning it slightly to the right. Once hooked on the windows 52 and 53 located on the conical rear portion of the sleeve 5. It will be sufficient to pull the dilator rod 6 back, which will have the effect of narrowing the finned guide 7 and the fins 71, as well as the extensible protective tube 8 and thus allow the entire device to be removed from the cervical canal and the vagina. This device will then be deposited in the medical waste container.
Pour mieux comprendre le fonctionnement de cette invention nous allons décrire la manière dont le gynécologue va utiliser ce dispositif dans son cabinet. Après préparation de la patiente et son positionnement sur la table d'examen, le gynécologue prend l'emballage stérile du spéculum pour dilater le col de l'utérus, faciliter les examens diagnostiques et les interventions chirurgicales à l'intérieur de l'utérus. Dans cet emballage principal seront emballés séparément, d'une part, le corps du spéculum 1 avec le manche 2 fabriqués en plastique médical. D'autre part, préalablement montés dans un autre sachet la tige dilatatrice 6 dans laquelle seront déjà positionnées la tige- guide 69 et la douille dilatatrice 5. Cet ensemble sera positionné dans le support 3, et accroché à l'aide de la tige guide transversale 64 dans les excroissances 312 et 322. Sur l'extrémité avant du support 3 seront déjà positionnés le guide à ailettes 7 et les ailettes 71 , également fabriqués en plastique médical, recouvert du tube protecteur extensible 8 fabriqué en matériaux médical. L'ensemble sera verrouillé par la bague de verrouillage 9 sur l'extrémité conique 37 du support 3. Pour l'utiliser le gynécologue prend les cuillères 12 et 13 entre le pouce et l'index plié afin de rapprocher les extrémités 121 et 131 pour introduire le spéculum dans le vagin en le poussant en avant. Une fois le spéculum introduit dans le vagin il s'écarte automatiquement. Ensuite il positionne la lampe (FIG 3a) en la logeant dans la partie creuse arrière du manche 21 et il règle le flux de lumière 27. Cet apport de lumière lui permettra de diriger l'ensemble du support 3 et positionner la partie avant dans l'ouverture du canal cervical. En tenant avec quatre doigts placés devant le manche 2 du spéculum, le gynécologue exerce une poussée avec son pouce sur la partie arrière conique du support 3 et l'enfonce complètement dans la partie arrière conique du corps du spéculum 1 , ce qui garantit que la tige-guide 69 introduira complètement dans le canal cervical jusqu'à l'entrée de l'utérus l'ensemble tube protecteur extensible 8, le guide à ailettes 7 et les ailettes 71 . Ensuite pour effectuer la dilatation cervicale et positionner la douille dilatatrice 5, le gynécologue introduira son pouce dans l'anneau 61 positionné sur l'arrière de la tige dilatatrice 6, et effectuera une poussée progressive avant de buter contre le limiteur ou portion de rétrécissement 33. Ensuite, en tirant l'anneau 61 en arrière, le gynécologue retire sans effort la tige dilatatrice 6 en même temps que la tige-guide 69, ce qui a pour effet de dégager le passage pour les différents instruments vers la cavité utérine à travers le tube protecteur extensible 8. A la fin de l'intervention le gynécologue introduit de nouveau la tige dilatatrice 6 jusqu'à buter contre la partie conique de la douille 5, il tourne légèrement la tige 6 sur la droite pour crocheter les fenêtres 52 et 53 à l'aide des excroissances 651 et 652. Puis le gynécologue retire l'ensemble avec la douille 5 et libère la tension exercée sur le guide à ailettes 7, les ailettes 71 , et le tube protecteur extensible 8. Ceci permet de retirer sans effort l'ensemble du dispositif avec tous ses éléments intégrés qui sera déposé dans un container de déchets médicaux. To better understand how this invention works we will describe how the gynecologist will use this device in his office. After preparing the patient and positioning her on the examination table, the gynecologist takes the sterile speculum packaging to dilate the cervix, facilitate diagnostic examinations and surgical procedures inside the uterus. In this main packaging will be packaged separately, on the one hand, the body of speculum 1 with handle 2 made of medical plastic. On the other hand, previously mounted in a another bag the dilator rod 6 in which will already be positioned the guide rod 69 and the dilator sleeve 5. This assembly will be positioned in the support 3, and hooked with the aid of the transverse guide rod 64 in the protrusions 312 and 322. On the front end of the support 3 will already be positioned the fin guide 7 and the fins 71, also made of medical plastic, covered with extensible protective tube 8 made of medical materials. The assembly will be locked by the locking ring 9 on the conical end 37 of the support 3. To use the gynecologist takes the spoons 12 and 13 between the thumb and index finger folded to bring the ends 121 and 131 to introduce the speculum into the vagina by pushing it forward. Once the speculum is introduced into the vagina, it automatically deviates. Then it positions the lamp (FIG 3a) by housing it in the rear hollow portion of the handle 21 and adjusts the light flux 27. This light input will allow it to direct the entire support 3 and position the front part in the opening of the cervical canal. Holding with four fingers placed in front of the handle 2 of the speculum, the gynecologist pushes with his thumb on the tapered rear part of the support 3 and pushes it completely into the conical rear part of the body of the speculum 1, which guarantees that the Guide rod 69 will completely introduce into the cervical canal to the entrance of the uterus the extensible protective tube assembly 8, the finned guide 7 and the fins 71. Then to perform the cervical dilation and position the dilator sleeve 5, the gynecologist will introduce his thumb in the ring 61 positioned on the rear of the dilator shaft 6, and will perform a progressive push before abutting against the limiter or portion of narrowing 33 Then, pulling the ring 61 back, the gynecologist effortlessly removes the dilator rod 6 at the same time as the guide rod 69, which has the effect of clearing the passage for the various instruments to the uterine cavity through the extensible protective tube 8. At the end of the procedure the gynecologist again introduces the dilator rod 6 to abut against the conical portion of the sleeve 5, he slightly rotates the rod 6 on the right to pick the windows 52 and 53 with the excrescences 651 and 652. Then the gynecologist removes the assembly with the sleeve 5 and releases the tension exerted on the finned guide 7, the fins 71, and the extensible protective tube 8. This allows to remove effortlessly the entire device with all its integrated elements that will be deposited in a medical waste container.

Claims

REVENDICATIONS
1 . Dispositif de dilatation de canal cervical utérin, caractérisé en ce qu'il comprend : 1. Device for dilatation of the uterine cervical canal, characterized in that it comprises:
- un support (3) ;  a support (3);
- une tige dilatatrice (6) montée en translation dans ledit support (3) ; - a dilator rod (6) mounted in translation in said support (3);
- un tube protecteur extensible (8) fixé à une extrémité (37) du support (3) ; an extensible protective tube (8) fixed at one end (37) of the support (3);
- un guide à ailettes (7) logé dans le tube protecteur extensible (8) et fixé à ladite extrémité (37) du support (3); et  - a finned guide (7) housed in the extensible protective tube (8) and fixed to said end (37) of the support (3); and
- une douille dilatatrice (5) montée sur la tige dilatatrice (6), ladite tige dilatatrice (6) étant adaptée à écarter les ailettes (71 ) dudit guide à ailettes (7) à l'intérieur du tube protecteur extensible (8) et à introduire une portion tubulaire (54) de ladite douille dilatatrice (5) à l'intérieur du guide à ailettes (7) logé dans le tube protecteur extensible (8).  - a dilator bushing (5) mounted on the dilator rod (6), said dilator rod (6) being adapted to move the fins (71) of said fin guide (7) inside the extensible protective tube (8) and introducing a tubular portion (54) of said dilator sleeve (5) into the fin guide (7) housed in the expandable protective tube (8).
2. Dispositif de dilatation de canal cervical utérin conforme à la revendication 1 , caractérisé en ce que la tige dilatatrice (6) comprend à une extrémité une tige guide (69) raccordée par une série de portions (68) de tailles différentes à un tube (62, 67) de ladite tige dilatatrice (6), la taille desdites portions (68) diminuant dudit tube (62, 67) vers ladite tige guide (69), par exemple de 12 à 2 mm, ladite tige guide ayant un diamètre sensiblement égal à 2 mm.  2. A cervical canal dilatation device according to claim 1, characterized in that the dilator rod (6) comprises at one end a guide rod (69) connected by a series of portions (68) of different sizes to a tube (62, 67) of said dilator shaft (6), the size of said portions (68) decreasing from said tube (62, 67) to said guide rod (69), for example from 12 to 2 mm, said guide rod having a diameter substantially equal to 2 mm.
3. Dispositif de dilatation de canal cervical utérin conforme à la revendication 2, caractérisé en ce que le tube (62) de ladite tige dilatatrice (6) comporte une fente (63) dans laquelle coulisse une tige guide transversale (64), le support (3) comportant des crochets (312, 322) adaptés à venir en prise avec ladite tige guide transversale (64) de chaque côté dudit tube (62) de la tige dilatatrice (6).  3. Uterine cervical canal dilatation device according to claim 2, characterized in that the tube (62) of said dilator shaft (6) comprises a slot (63) in which slides a transverse guide rod (64), the support (3) having hooks (312, 322) adapted to engage said transverse guide rod (64) on each side of said tube (62) of the dilator shaft (6).
4. Dispositif de dilatation de canal cervical utérin conforme à l'une des revendications 1 à 3, caractérisé en ce que le support (3) comprend une portion de rétrécissement (33) formant butée de fin de course en translation de la tige dilatatrice (6) dans le support, ladite course en translation étant par exemple sensiblement égale à 50 mm. 4. Uterine cervical canal dilation device according to one of claims 1 to 3, characterized in that the support (3) comprises a narrowing portion (33) forming a limit stop in translation of the dilator rod (6) in the support, said displacement in translation being for example substantially equal to 50 mm.
5. Dispositif de dilatation de canal cervical utérin conforme à la revendication 4, caractérisé en ce que la portion tubulaire (54) de la douille dilatatrice (5) est solidaire d'une partie conique (51 ) venant en butée dans ladite portion de rétrécissement (33) du support (3) en fin de course en translation de la tige dilatatrice (6).  5. Uterine cervical canal dilatation device according to claim 4, characterized in that the tubular portion (54) of the dilator sleeve (5) is integral with a conical portion (51) abutting in said narrowing portion (33) of the support (3) at the end of travel in translation of the dilator rod (6).
6. Dispositif de dilatation de canal cervical utérin conforme à la revendication 5, caractérisé en ce que ladite partie conique (51 ) de la douille dilatatrice (5) comporte deux fenêtres (52, 53) dans lesquelles sont adaptées à être introduites respectivement deux excroissances (651 , 652) de la tige dilatatrice (6) lors d'un retrait, par ladite tige dilatatrice (6), de ladite douille dilatatrice (5) hors du guide à ailettes (7) logé dans le tube protecteur extensible (8).  6. Uterine cervical canal dilatation device according to claim 5, characterized in that said conical portion (51) of the dilator sleeve (5) comprises two windows (52, 53) in which are adapted to be introduced respectively two excrescences (651, 652) of the dilator rod (6) during a withdrawal, by said dilator rod (6), of said expansion sleeve (5) out of the fin guide (7) housed in the expandable protective tube (8) .
7. Dispositif de dilatation de canal cervical utérin conforme à l'une des revendications 1 à 6, caractérisé en ce que le guide à ailettes (7) comprend plusieurs ailettes (71 ), et par exemple cinq ailettes (71 ), montées sur une partie conique (70) du guide à ailettes (7), et mobiles entre une position de repos, dans laquelle les ailettes (71 ) sont rassemblées et maintenues serrées à l'intérieur du tube protecteur extensible (8), et une position de dilatation, dans laquelle les ailettes (71 ), après écartement par la tige dilatatrice (6), sont maintenues écartées par la douille dilatatrice (5) à l'intérieur du tube protecteur extensible (8).  Uterine cervical canal dilatation device according to one of Claims 1 to 6, characterized in that the fin guide (7) comprises a plurality of vanes (71), for example five vanes (71), mounted on a conical portion (70) of the fin guide (7), and movable between a rest position, wherein the fins (71) are gathered and held tight within the expandable protective tube (8), and an expansion position , in which the fins (71), after separation by the dilator rod (6), are kept apart by the expansion sleeve (5) inside the extensible protective tube (8).
8. Dispositif de dilatation de canal cervical utérin conforme à la revendication 7, caractérisé en ce que les ailettes (71 ) possèdent sur une partie externe des excroissances (73), et par exemple trois excroissances par ailette (71 ), coopérant dans ladite position de dilatation avec une portion cylindrique élargie (87) du tube protecteur extensible (8).  8. Uterine cervical canal dilatation device according to claim 7, characterized in that the fins (71) have on an outer part projections (73), and for example three excrescences per fin (71) cooperating in said position. for expanding with an enlarged cylindrical portion (87) of the expandable protective tube (8).
9. Spéculum vaginal comprenant un corps (12,13, 14) prolongé d'un manche (2), caractérisé en ce que le corps (12, 13, 14) forme un logement pour le support (3) d'un dispositif de dilatation de canal cervical utérin conforme à l'une des revendications 1 à 8. 9. Vaginal speculum comprising a body (12, 13, 14) extended by a handle (2), characterized in that the body (12, 13, 14) forms a housing for the support (3) of a device Cervical canal dilation according to one of Claims 1 to 8.
10. Spéculum vaginal conforme à la revendication 9, caractérisé en ce que le corps comprend une cuillère supérieure (12) et une cuillère inférieure (13) montées sur une bague conique (14), les extrémités (121 , 131 ) desdites cuillères inférieure (12) et supérieure (13) se clipsant respectivement dans deux sillons (35, 36) gravés sur le support (3) du dispositif de dilatation de canal cervical utérin. Vaginal speculum according to claim 9, characterized in that the body comprises an upper spoon (12) and a lower spoon (13) mounted on a conical ring (14), the ends (121, 131) of said lower spoons ( 12) and upper (13) clipping respectively in two grooves (35, 36) etched on the support (3) of the uterine cervical canal dilation device.
PCT/FR2018/050675 2017-03-21 2018-03-20 Device for dilating the uterine cervical canal WO2018172692A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP18715215.2A EP3599985A1 (en) 2017-03-21 2018-03-20 Device for dilating the uterine cervical canal

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1752324 2017-03-21
FR1752324A FR3064171B1 (en) 2017-03-21 2017-03-21 UTERIN CERVICAL CHANNEL EXPANSION DEVICE

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FR (1) FR3064171B1 (en)
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CN109770907A (en) * 2018-12-29 2019-05-21 付帅 A kind of syringe-type cervical dilatation size measuring instrument
CN111387928A (en) * 2020-03-28 2020-07-10 杨庆军 Gynecological vaginal dilator
CN113289220A (en) * 2021-07-07 2021-08-24 孙井兰 A expand palace appearance for treating gynaecology and obstetrics's uterus disease

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Publication number Priority date Publication date Assignee Title
EP0010650A1 (en) * 1978-10-10 1980-05-14 BioNexus, Inc. Instrument for dispensing material into the Fallopian tubes
US5769880A (en) * 1996-04-12 1998-06-23 Novacept Moisture transport system for contact electrocoagulation
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US20130041398A1 (en) * 2011-08-08 2013-02-14 James Goddard Dilator

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109770907A (en) * 2018-12-29 2019-05-21 付帅 A kind of syringe-type cervical dilatation size measuring instrument
CN111387928A (en) * 2020-03-28 2020-07-10 杨庆军 Gynecological vaginal dilator
CN113289220A (en) * 2021-07-07 2021-08-24 孙井兰 A expand palace appearance for treating gynaecology and obstetrics's uterus disease

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Publication number Publication date
EP3599985A1 (en) 2020-02-05
FR3064171A1 (en) 2018-09-28
FR3064171B1 (en) 2019-06-07

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