Gynecological devices

Abstract

The present invention relates to a gynecological device (1), comprising: a body portion (2) having a vacuum cavity (3); a rod unit (4) having a distal end, a proximal end and a channel (41) extending between the distal end and the proximal end; a cervical head (5) arranged at the distal end of the rod unit (4); and a sealing mechanism (6) configured to switch between an ambient state and a vacuum state. The rod unit (4) extends to the vacuum cavity (3) of the body portion (2) so that the proximal end of the rod unit (4) is located in the vacuum cavity (3) of the body portion (2). The cervical head (5) is configured to engage a section of the cervix from the vaginal side. When in the ambient state of the sealing mechanism (6), the vacuum cavity (3) of the body portion (2) is sealed, and the channel (41) of the rod unit (4) is open to the outside (7) of the gynecological device (1). In the vacuum state of the sealing mechanism (6), the channel (41) of the rod unit (4) is open to the vacuum chamber (3) of the body portion (2) and is sealed to the exterior (7) of the gynecological device (1).

Description

Technical Field

[0001] The present invention relates to a gynaecological device according to the preamble of independent claim 1 and more particularly to a gynaecological device for cervical treatment.

[0002] Such devices may be used to grasp and / or manipulate the cervix, for example in conjunction with the insertion or removal procedure of an intrauterine contraceptive device. Background Art

[0003] Grasping the cervix is ​​essential during many very common gynecological procedures, among which the following can be mentioned by way of example: IUCD (intrauterine contraceptive device) insertion and removal; uterine tissue swabs (endometrium) for diagnostic purposes; cervical dilatation for uterine cavity curettage; cervical dilatation for hysteroscopy (intrauterine camera); measurement of the uterine cavity size during surgery; hysterosalpingography (imaging procedure of the uterine cavity and fallopian tubes for fertility examinations).

[0004] In order to perform the above process, the physician uses a speculum to open the vagina and observe the cervix before inserting the gripping hook. The gripping hook is a forceps with two overlapping sharp hooks. After being inserted into the vagina, the gripping hook allows the outer part of the cervix to be grasped. Then, the physician pulls the gripping hook claws along the axis of the vagina. According to the natural anatomical configuration, the cervix is ​​angled relative to the vaginal cavity. By applying traction, the physician corrects the anatomical flexion angle or kink between the cervical axis and the body axis (uterus). Such corrections of about 60° require entering the uterine cavity through the cervical canal. This angle modification minimizes the risk of uterine perforation during the insertion of the instrument into the uterine cavity.

[0005] However, conventional holding hooks include teeth or prongs that can easily tear and / or puncture tissue during use.

[0006] US 2012 / 0283595 A1 proposes an alternative gripper hook that uses evenly distributed negative pressure. However, such solutions use a closed suction section whose form makes the central tunnel too narrow and does not allow all instruments to enter or exit, thereby hindering the correct performance of some gynecological surgical procedures. In addition, cervical dilation is limited by the fixed central tunnel diameter.

[0007] GB 2 485 967 proposes an obstetric vacuum extractor, which includes a cylinder, a cup-shaped member connected to the cylinder, and a piston movable in the cylinder to empty the cup-shaped member; wherein the piston is movable in the cylinder by a handle, and the handle is connected to the piston by an extendable biasing element, thereby allowing relative movement of the handle relative to the piston.

[0008] However, none of the devices of the prior art achieves gentle, non-traumatic treatment of the cervix by reliable, uncomplicated technical means while ensuring a perfect and effective grip of the cervix.

[0009] WO 2016 / 092458 A1 discloses a device for medical use, comprising an improved suction pad technology in tight fluid connection with a vacuum system via a hollow rod. The vacuum system can be configured according to two different embodiments, which respectively include a vacuum pump or a vacuum reserve source enclosed by a pierceable element designed to cooperate with a hollow needle.

[0010] However, it would be beneficial to incorporate yet another alternative way to use vacuum to treat the cervix in a gynecological device that is even more direct and reliable than in prior art applications. In fact, it would be preferred to simplify the fluid mechanics involved even further. Furthermore, it would be desirable to enable an operator of a gynecological device to quickly and easily (even repeatedly or cyclically) implement the steps of establishing, activating, deactivating and / or re-establishing a vacuum in order to perform cervical treatment via a connected suction module. By repeatedly establishing the desired vacuum conditions depending on the treatment scenario, providing the opportunity to repeat the cervical treatment procedures until the desired effect is achieved allows these procedures to be perfectly completed by using the same device.

[0011] Therefore, there is a need for a gynecological device that allows cervical manipulation in a safe and effective manner without the aid of hazardous parts and relying on economical, reliable technology. There is also a need for a gynecological device that, while being disposable and advantageously not requiring sterilization, allows cervical manipulation to be performed in multiple attempts until the perfect completion of the surgical procedure. Summary of the invention

[0012] According to the invention, this need is solved by a gynecological device as defined by the features of independent claim 1. Preferred embodiments are subject matter of the dependent claims.

[0013] Specifically, the present invention relates to a gynecological device, which includes: a main body portion having a vacuum cavity; a rod unit having a distal end, a proximal end and a channel extending between the distal end and the proximal end; a cervical head arranged at the distal end of the rod unit; and a sealing mechanism configured to switch between an ambient state and a vacuum state.

[0014] The body portion may protect the mechanical system formed by the rod unit and the sealing mechanism, and may ensure the airtightness of the vacuum chamber.The body portion is preferably configured to allow a firm grip of the gynecological device during manipulation thereof by an operator or physician.

[0015] The rod unit extends to the vacuum cavity of the body portion so that the proximal end of the rod unit is located in the vacuum cavity of the body portion. By extending into the vacuum cavity, the rod unit can be securely connected to the body portion. Specifically, such an arrangement allows an actuatable pressure connection to be provided between the vacuum cavity and the channel of the rod unit.

[0016] The term "distal" as used herein relates to a direction towards the front end of a gynecological device or towards the end that will be oriented or directed towards a patient in use. In particular, the front end of the device may be formed by the cervical head, and more particularly, by the edge of the cervical head. Similarly, the term "proximal" as used herein relates to a direction opposite to the distal, i.e., a direction towards the rear end of the device or towards the end that will be oriented away from the patient towards a physician operating the device in use.

[0017] The cervical head is configured to engage a segment of the cervix from the vaginal side. The cervical head may have a cavity with an edge. Advantageously, the cavity may be in fluid connection with the channel of the rod unit. The edge of the cavity may form the distal end of the device and may be formed so that it substantially corresponds to the shape of the cervix. In particular, the edge may be a C-shaped closed loop as viewed from the distal side. Like this, the cervical head may be positioned close to the cervix around the external orifice opening so that this opening is still accessible.

[0018] In the environmental state of the sealing mechanism, the vacuum cavity of the main body part is sealed and the channel of the rod unit is open to the outside of the gynecological device, while in the vacuum state of the sealing mechanism, the channel of the rod unit is open to the vacuum cavity of the main body part and is sealed to the outside of the gynecological device.

[0019] The term "external" used in conjunction with a gynecological device relates to the space outside or surrounding the device. Thus, in order to be connected to the outside, an element may be in direct or indirect contact or connection with the outside. Typically, there is an ambient or atmospheric pressure outside or around the device, so that when open to the outside, any underpressure or overpressure in the channel or vacuum chamber is eliminated.

[0020] The term "open" in relation to the vacuum chamber, the passage and the exterior relates to being in connection so that pressure differences can be compensated. Specifically, openness can be in fluid or air connection.

[0021] By being equipped with a sealing mechanism as described above, the gynecological device can be actively switched between the ambient state and the vacuum state. This arrangement enables the device to generate a vacuum inside the vacuum chamber (i.e., be in the ambient state), then allows the device to become capable of applying a vacuum at the cervical head (i.e., be in the vacuum state) when placed via the vagina to the cervix, and further become capable of releasing the cervical head from the cervix (i.e., be in the ambient state again) by eliminating the vacuum in the cervical head. This allows a very delicate and convenient operation of the device, in particular for grasping and pulling the cervix in gynecological applications and also in multiple successive stages, where the surgical procedure is gradually refined until the desired completion.

[0022] The arrangement of the gynecological device according to the present invention allows the entire device to be provided as a disposable. In particular, the design of the device allows the use of processes and materials in manufacturing so that the gynecological device can be provided at a relatively low cost. This allows for a single-use or less-use application of the device.

[0023] Furthermore, the arrangement of the gynecological device according to the present invention allows some components to be provided for multiple or permanent use, and other components to be provided for single or less frequent use. In particular, the gynecological device may be arranged such that the cervical head is replaceable, and other components such as the body portion, the rod unit, etc. form a reusable instrument. Like this, the cervical head may be discarded after use, while the main part of the device may be reused. Such a replaceable cervical head also allows the device to be effectively adapted to given needs and anatomical conditions.

[0024] Preferably, the sealing mechanism comprises a sleeve element arranged in the vacuum chamber of the body part, through which the rod unit extends. The sleeve element can be made axially movable relative to the vacuum chamber and relative to the rod unit. The term "axially movable" used in this connection can relate to movement along the axis of the rod unit or along the axis of the entire complete device. Therefore, the rod unit and / or the gynecological device can have a central and straight axis that is advantageous for such movement.

[0025] Thus, the sleeve element allows to effectively realize the switching between the ambient state and the vacuum state. In particular, by moving the sleeve along the axis, these two states can be effectively and reversibly realized. For example, the sleeve can slide along the axis on the rod unit and / or in the vacuum chamber, so that the switching movement is well guided and predefined.

[0026] Preferably, the sleeve element of the sealing mechanism has an internal sealing member which seals the sleeve element and the rod unit towards each other.

[0027] Furthermore, preferably, the sleeve element of the sealing mechanism has an external sealing member which seals the sleeve element and the vacuum chamber of the body portion toward each other.

[0028] Preferably, a first friction force between the inner sealing member of the sleeve element of the sealing mechanism and the rod unit is less than a second friction force between the outer sealing member of the sleeve element of the sealing mechanism and the vacuum chamber. To achieve this, a friction reducing substance such as silicone oil may be provided between the inner sealing member of the sleeve element of the sealing mechanism and the rod unit. For example, such a substance may be sprayed into the sleeve element. An axial movement of the rod unit in a direction towards the distal or front end of the gynecological device (i.e., towards the end that will be directed or guided towards the patient in use) corresponds to a traction of the cervical head, for example, applied by an operator by pulling. This displacement in combination with the above-mentioned friction force arrangement allows an initial vacuum to be established in the vacuum chamber of the body portion. More precisely, it inspires and enables the establishment of two different chambers in the body portion at two corresponding pressure differences, one of which is the vacuum chamber. The vacuum chamber may be arranged proximally relative to a different, more distal chamber in the body portion, which chamber is instead maintained at a higher pressure (e.g., corresponding to ambient pressure or atmospheric pressure). The traction of the cervical head may cause translation of the rod unit within the body portion and relative to the sealing mechanism. During this phase, the sealing mechanism may remain stationary due to the higher second friction between the outer sealing member of the sleeve element of the sealing mechanism and the vacuum cavity (or in other words, the wall of the body portion). Thus, the friction arrangement of the inner and outer sealing members of the sleeve element as explained above is functional for initial vacuum generation and establishment of a vacuum cavity within the body portion.

[0029] For this purpose, preferably, the inner sealing member and the outer sealing member of the sleeve element of the sealing mechanism are axially offset from each other.

[0030] Preferably, the inner sealing member of the sleeve element of the sealing mechanism is closer to the distal end of the rod unit than the outer sealing member of the sleeve element of the sealing mechanism.

[0031] After the initial creation of vacuum within the vacuum chamber, further application of traction on the cervical head, for example by pulling, carries the stem unit and the sleeve element of the sealing mechanism together until vacuum creation is complete at ambient conditions of the sealing mechanism.

[0032] As described above, when a vacuum is generated in the vacuum chamber, under the environmental state of the sealing mechanism, the sleeve element preferably moves axially in a first position, in which the internal sealing element seals the channel of the rod unit and the vacuum chamber of the main body portion toward each other, and the external sealing element seals the vacuum chamber of the main body portion toward the outside of the gynecological device.

[0033] On the other hand, when the vacuum of the vacuum cavity is activated (i.e., in the vacuum state of the sealing mechanism), the sleeve element preferably moves axially in a second position, for example, more distal than the first position, in which the inner sealing element seals the channel of the rod unit toward the outside of the gynecological device, and the outer sealing element seals the vacuum cavity of the body portion toward the outside of the gynecological device. Thus, vacuum can be transmitted from the vacuum cavity through the channel of the rod unit all the way to the cervical head for optimal cervical grasping and handling.

[0034] Preferably, in order to switch from the first position of the ambient state to the second position of the vacuum state, the sleeve element comprises an activation portion extending to the exterior of the body portion.

[0035] The rod unit may basically include a portion of an elongated shape. Thus, this portion may be a column having a circular, elliptical or polygonal cross section. Moreover, it may be substantially straight. The elongated portion of the rod unit may be further equipped with additional elements at its circumference, such as reinforcing elements, guiding elements, etc. Preferably, the rod unit has a protrusion, which is configured to abut the sleeve element when the rod unit moves through the sleeve element in the distal direction along its axis. The protrusion of the rod unit may be positioned so that the rod unit can be moved to a predetermined extent through the sleeve element along its axis. Specifically, this predetermined degree of axial movement can allow the provision of moving the internal sealing element and the external sealing element so as to change the sealing mechanism from the ambient state to the vacuum state, and vice versa.

[0036] Preferably, the rod unit has a lateral through hole open to the channel of the rod unit. Such lateral through holes may further cooperate with the inner sealing element and the outer sealing element to change the sealing mechanism from the ambient state to the vacuum state and vice versa. That is, the relative position of the seal and the through hole may be calibrated in the following manner: in the ambient state, the through hole is in fluid communication with the outside of the gynecological device; and in the vacuum state, the through hole is in fluid communication with the vacuum chamber.

[0037] The gynecological device according to the invention may comprise a cap closing the passage of the rod unit at the proximal end of the rod unit. The cap is preferably sized not to fit into the sleeve element of the sealing mechanism. Thus, the cap may abut the sleeve element such that it prevents the rod unit from being fully withdrawn from the sleeve element.

[0038] Preferably, a locking mechanism is provided, which is configured to switch between a released state in which the rod unit is axially movable relative to the vacuum chamber and a locked state in which the rod unit is prevented from moving into the ambient state. This prevention of movement of the rod unit in the locked state can be implemented, for example, by the rod unit being axially immovable relative to the vacuum chamber. Such a locking mechanism advantageously prevents the rod unit from being sucked back into its initial position by the vacuum established in the vacuum chamber. In fact, vacuum generation implies a changed force distribution in the body portion, which would otherwise pull the rod unit back into its initial position in the proximal direction.

[0039] More specifically, in the released state of the locking mechanism, the rod unit is preferably axially movable relative to the vacuum lumen of the body portion such that a vacuum is generated inside the vacuum lumen when the rod unit is moved distally relative to the vacuum lumen.

[0040] The locking mechanism may be configured such that pivoting the lever unit about its longitudinal axis in one direction switches the locking mechanism into the locked state, whereas pivoting the lever unit about its axis in another opposite direction switches the locking mechanism into the released state.

[0041] The locking mechanism may comprise a recess integral with the rod unit, the recess being configured to engage with a corresponding element of the gynaecological device (eg a female element on a front cap closing the body portion).

[0042] Preferably, the gynaecological device is configured to open the through hole to the vacuum chamber when in the locked state.As such, a vacuum may be activated (ie, applied through the through hole, the channel and the cervical head).

[0043] Thus, the gynecological device is preferably configured to open the through hole by applying a thrust to the cervical head. Moreover, preferably, when in a released state, the through hole is open to the vacuum chamber. Such a configuration allows for convenient application of vacuum once the cervical head is properly positioned. Moreover, such a configuration also allows for providing the device with a relatively small number of parts, since no manual activation parts are required.

[0044] Preferably, the gynecological device can be arranged in a pre-operational state, in which the rod unit is moved maximally into the vacuum chamber of the body portion in the proximal direction. In such a pre-operational state, the device can be relatively compact, thereby facilitating supply and storage. Further, in this state, the rod unit can be protected inside the body portion, so that the risk of damaging the relatively sensitive rod unit can be minimized.

[0045] Preferably, the vacuum lumen of the body portion has a main section and a proximal section, wherein the main section has a first diameter and the proximal section has a second diameter greater than the first diameter. By way of example, the proximal section of the vacuum lumen may be established within a rear cap portion configured to proximally enclose the body portion. The larger diameter of the rear cap may make it easier for an operator to grip the device, for example during traction of the cervical head.

[0046] In the above arrangement where the vacuum cavity has a narrower main section and a larger proximal section, the outer sealing member is compressed when positioned in the main section of the vacuum cavity of the body portion, while the outer sealing member is not compressed when positioned in the proximal section of the vacuum cavity of the body portion. Like this, when the device is stored and supplied, the outer sealing member can remain expanded in the larger proximal section of the vacuum cavity, so that its durability can be increased.

[0047] In order to ensure that the second friction force between the outer sealing member of the sleeve element of the sealing mechanism and the vacuum chamber is greater than the first friction force between the inner sealing member of the sleeve element of the sealing mechanism and the rod unit, an inclined transition section can be established between the proximal section of the vacuum chamber of the body part and the main section of the vacuum chamber of the body part, and the inclined transition section has a diameter that decreases from the second diameter to the first diameter. Such an inclined transition section (for example, in the form of an inclined plane) gradually transitions from a larger second diameter to a reduced first diameter. Different inclinations can be designed to achieve different friction forces. Alternatively, the transition section between the proximal section of the vacuum chamber of the body part and the main section of the vacuum chamber of the body part can be obtained by limiting the radius on the inner diameter edge of the main section. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In the following, the gynecological device according to the present invention is described in more detail by means of exemplary embodiments and with reference to the accompanying drawings, in which:

[0049] FIG1 shows a schematic cross-sectional view of a first embodiment of a gynecological device according to the present invention;

[0050] FIG2 shows two schematic cross-sectional views of the gynecological device of FIG1 , in order to illustrate its general functional principle;

[0051] FIG3 shows four schematic cross-sectional views of the gynecological device of FIG1 , in order to illustrate its complete functional cycle;

[0052] FIG. 3A shows four further schematic diagrams of partial cuts of the gynecological device of FIG. 3 , wherein the first two schematic cross-sectional views of FIG. 3 are further divided into intermediate sub-steps;

[0053] 4 shows a first side view and a front cross-sectional view and a second side view and a front cross-sectional view of an embodiment of a locking mechanism of the rod unit of the gynecological device of FIG. 1 , in a released and locked state of the locking mechanism, respectively;

[0054] FIG5 shows an embodiment of an activation portion of a sleeve element of the sealing mechanism of the gynecological device of FIG1 ;

[0055] 6 illustrates the step of establishing a vacuum in the gynecological device of FIG. 1 by traction of the cervical head thereof and translation of the rod unit in the distal direction out of the body portion of the gynecological device;

[0056] FIG. 7 shows a step of locking the rod unit of the gynecological device of FIG. 6 by rotating the cervical head;

[0057] FIG8 shows the step of activating the vacuum established in the gynecological device of FIG6 by sliding the activation portion of FIG5 laterally;

[0058] FIG. 9 illustrates the step of deactivating the vacuum established in the gynecological device of FIG. 6 by sliding the activation portion of FIG. 5 proximally;

[0059] 10 shows the step of ending the cervical head treatment process by the gynecological device of FIG. 6 by unlocking the lever unit by reverse rotation of the cervical head and by pushing the lever unit back in the proximal direction inside the body portion of the gynecological device;

[0060] FIG. 11 shows the steps of establishing a new vacuum in the gynecological device of FIG. 6 by repeating cervical head traction and translation of the rod unit and then locking the rod unit similar to the steps of FIG. 7 ;

[0061] Fig. 12 shows four schematic cross-sectional views of a second embodiment of a gynecological device according to the invention, illustrating its complete functional cycle. DETAILED DESCRIPTION

[0062] In the following description, some terms are used for convenience reasons and are not intended to limit the present invention. The terms "right", "left", "up", "down", "below" and "above" refer to the directions in the figure. The terminology includes the terms and their derivatives and terms with similar meanings that are clearly mentioned. Moreover, spatial relative terms such as "below", "below", "lower", "above", "upper", "near side", "distal side" can be used to describe the relationship between an element or feature and another element or feature, as shown in the figure. These spatial relative terms are intended to cover the different positions and orientations of the device in use or operation except the position and orientation shown in the figure. For example, if the device in the figure is turned over, the element described as "below" or "below" of other elements or features will be "above" or "above" of these other elements or features. Therefore, the exemplary term "below" can cover both the position and orientation of the upper and lower parts. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein are interpreted accordingly. Similarly, the description of movement along and around different axes includes different special device positions and orientations.

[0063] In order to avoid repetition in the drawings and descriptions of various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omitting an aspect from the description or drawings does not mean that the aspect is missing from the embodiment incorporating the aspect. On the contrary, for clarity and to avoid preamble description, the aspect may have been omitted. In this context, the following applies to the remainder of this description: If, in order to clarify the drawings, a figure contains reference numerals that are not explained in the directly associated part of the description, it refers to the previous or following description part. Further, for clarity, if all features of a part are not provided with reference numerals in the drawings, reference is made to other drawings showing the same part. The same numbers in two or more figures represent the same or similar elements.

[0064] 1 , a first embodiment of a gynecological device 1 according to the present invention comprises a body portion 2 having a vacuum chamber 3. A vacuum can be generated in the vacuum chamber 3 during operation of the device 1. The gynecological device 1 further comprises a rod unit 4 having a distal end, a proximal end and a channel 41 extending between the distal end and the proximal end. The rod unit 4 extends to the vacuum chamber 3 of the body portion 2 so that the proximal end of the rod unit is located in the vacuum chamber 3. The rod unit 4 is substantially cylindrical and has a straight shape. In this context, the term "substantially cylindrical" also covers some deviations from a geometric cylindrical shape. Specifically, it also covers a column provided with additional elements (such as, for example, a reinforcing element or a guiding element as can be seen in FIG. 7 ). The channel 41 is straight along the rod unit 4. The rod unit 4 is designed to resist mechanical stresses applied during manipulation of the cervix by an operator using the device 1.

[0065] The cervical head 5 configured to engage a section of the cervix from the vaginal side and conform to the anatomical structure of the cervix is ​​arranged at the distal end of the rod unit 4 in such a manner that the cervical head 5 is in fluid communication with the channel 41. Thus, the rod unit 4 ensures that the vacuum established in the vacuum chamber 3 inside the body portion 2 can be transferred to the cervical head 5 contacting the cervix.

[0066] The body portion 2 of the gynecological device 1 further comprises a rear cap 22, which closes the substantially tubular body portion 2 and ensures airtightness at the rear end of the body portion 2 proximally. The rear cap 22 is also configured to be easily grasped by an operator or physician when using the device 1. For this purpose, for example, the rear cap 22 may have a larger diameter than the rest of the body portion 2. Additionally or alternatively, the rear cap 22 may be provided with a wing-like structure or an extended finger-like flange structure to facilitate traction (if necessary).

[0067] The rod unit 4 can be extracted by means of a translational movement and repositioned inside the body part 2. The body part 2 further comprises a front cap 21 which partially closes the front end of the device 1 distally. The front cap 21 cooperates with the rod unit 4, thereby guiding the translational movement of the rod unit 4 once extended and eventually locking the position of the rod unit 4.

[0068] The sealing mechanism 6 is configured to switch between an ambient state and a vacuum state. As illustrated in FIG2 , in the ambient state of the sealing mechanism 6, the vacuum chamber 3 is sealed and the channel 41 of the rod unit 4 is open to the exterior 7 of the gynecological device 1. Conversely, in the vacuum state of the sealing mechanism 6, the channel 41 of the rod unit 4 is open to the vacuum chamber 3 of the body portion 2 and is sealed to the exterior 7 of the gynecological device 1.

[0069] In order to alternatively connect the channel 41 of the rod unit 4 with the outside 7 or with the vacuum chamber 3, the rod unit 4 is provided with a lateral through hole 42 open to the channel 41. Like this, the pressure in the channel 41 is equal to the pressure of the outside 7 when in the ambient state or equal to the pressure of the vacuum chamber when in the vacuum state, respectively.

[0070] A cap 12 , which may be in the form of a piston head, closes the passage 41 of the rod unit 4 at its proximal end.

[0071] The sealing mechanism 6 comprises a sleeve element 8 arranged in the vacuum chamber 3 of the body part 2. The rod unit 4 extends through the sleeve element 8. The sleeve element 8 is axially movable relative to the vacuum chamber 3 and relative to the rod unit 4 along the axis AA of the rod unit 4. In this case, the axis AA substantially coincides with the axis of the entire gynecological device 1.

[0072] The cap 12 is sized not to fit into the sleeve element 8 of the sealing mechanism 6 , thereby preventing the rod unit 4 from being decoupled from the sleeve element 8 .

[0073] Thus, as shown in FIG. 2 and in more detail in FIG. 3 , the axial movement of the sleeve element 8 allows a reversible switching between an ambient state of the sealing mechanism 6 for generating a vacuum in the vacuum chamber 3 and a vacuum state of the sealing mechanism 6 for transferring the generated vacuum to the cervical head 5. As the volume of the chamber 3 in the vacuum chamber 3 gradually increases, the vacuum increases accordingly and the remaining internal volume of the body portion 2 decreases. Basically, vacuum generation means that a vacuum chamber 3 is formed proximally within the volume of the body portion 2, while a separate remaining chamber 33 is correspondingly defined laterally. In the ambient state and vacuum state as defined, the remaining chamber 33 remains open to the exterior 7 of the gynecological device 1.

[0074] In FIG3 , the passage from the initial configuration of the gynecological device 1 just out of the package before the traction of the cervical head 5 at point I to the completion of the cervical head treatment process at point IV and the subsequent release of the vacuum generated in the device is shown. The configurations at points II and III of FIG3 correspond substantially to the environmental state and vacuum state of FIG2 as described above, respectively. The configuration of the gynecological device 1 just out of the package can also be designated as a pre-operational state. In the pre-operational state, for compactness during transportation and storage and for the protection of more delicate mechanisms, the rod unit 4 is moved to the maximum extent in the proximal direction into the vacuum chamber 3 of the body part.

[0075] Figure 3 also indicates further elements of the sealing mechanism 6 which may facilitate a fast switching between ambient and vacuum conditions.In fact, the sleeve element 8 of the sealing mechanism 6 has an internal sealing member 9 which seals the sleeve element 8 and the rod unit 4 towards each other.

[0076] Furthermore, the sleeve element 8 of the sealing mechanism 6 has an outer sealing member 10 which seals the sleeve element 8 and the vacuum chamber 3 of the body part 2 or, in general, the inner wall of the body part 2 towards each other.

[0077] The inner sealing member 9 and the outer sealing member 10 of the sleeve element 8 of the sealing mechanism 6 are axially offset from each other along the axis (AA). That is, the inner sealing member 9 of the sleeve element 8 of the sealing mechanism 6 is closer to the distal end of the rod unit 4 than the outer sealing member 10 of the sleeve element 8 of the sealing mechanism 6. This arrangement of the sealing members 9, 10 in combination with the displacement of the rod unit 4 and the resulting positioning of the lateral through hole 42 and the calibrated axial movement of the sleeve element 8 allows the above-mentioned environmental state and vacuum state to be accurately achieved, as depicted at points II and III in Figure 3.

[0078] At point II in Figure 3, it is shown how the sleeve element 8 moves axially in the first position under the environmental state of the sealing mechanism 6, in which the internal sealing element 9 seals the channel 41 of the rod unit 4 and the vacuum chamber 3 of the main body part 2 toward each other, while the external sealing element 10 seals the vacuum chamber 3 of the main body part 2 toward the outside 7 of the gynecological device 1.

[0079] At point III in Figure 3, it is shown how the sleeve element 8 moves axially in the second position under the vacuum state of the sealing mechanism 6, in which the internal sealing element 9 seals the channel 41 of the rod unit 4 toward the outside 7 of the gynecological device 1, and the external sealing element 10 seals the vacuum cavity 3 of the main body part 2 toward the outside 7 of the gynecological device 1.

[0080] To bring the sleeve element 8 from the first position at point II to the second position at point III of FIG. 3 , the sleeve element 8 is slid forward substantially so that the lateral through hole 42 is between the inner sealing element 9 and the outer sealing element 10. Then, at point III, the vacuum previously established in the cavity 3 at point II is activated, thereby reaching the cervical head 5. At this stage, the operator can hold, pull and manipulate the cervix.

[0081] By sliding the sleeve element 8 backwards at point IV of Figure 3, the lateral through hole 42 is brought back to a position relative to the seals 9, 10 equal to the position occupied at point II, thereby substantially opening the passage 41 of the rod unit 4 to the exterior 7. At point IV of Figure 3, the vacuum is released from the interior of the cervical head 5 and the rod unit 4, bringing them into pressure equilibrium with the remaining cavity 33 open to the exterior 7 (i.e. to atmospheric pressure).

[0082] A first friction force between the inner sealing member 9 of the sleeve element 8 of the sealing mechanism 6 and the rod unit 4 is smaller than a second friction force between the outer sealing member 10 of the sleeve element 8 of the sealing mechanism 6 and the vacuum chamber 3 .

[0083] The above friction force distribution allows the device 1 to be brought from point I in Figure 3 and the initial position of the device 1 just out of the package depicted at the beginning of the sequence in Figure 3A to the formation of the vacuum cavity 3, while laterally defining a separate residual cavity 33 within the volume of the main body part 2.

[0084] FIG3A indicates the intermediate steps included between the above-mentioned initial position (or pre-operation state) of the package and the environmental state at point II of FIG3. First, by pulling the cervical head 5 and the rod unit 4, both the rod unit 4 and the sealing mechanism 6 move together in the rear cap 22 until the narrower section of the body part 2. Subsequently, due to the above different friction forces, the sealing mechanism 6 does not move and only the rod unit 4 translates, thereby allowing the establishment of two separate chambers 3 (containing vacuum) and 33 (open to the outside 7 of the device 1). By further pulling, the sealing mechanism 6 and the rod unit 4 move again as a whole to increase the volume of the vacuum chamber 3 and generate the required vacuum.

[0085] As can be understood from the fourth cross-sectional view of Figure 3A and from the enlarged detail of the second cross-sectional view in Figure 3A, due to the design of the rear cap 22 relative to the rest of the main body portion 2, the vacuum chamber 3 of the main body portion 2 is changed to have a main section 31 and a proximal section 32, wherein the main section 31 has a first diameter d and the proximal section 32 has a second diameter D that is larger than the first diameter d.

[0086] As a result of the above design, the external sealing member 10 becomes compressed when positioned in the main section 31 of the vacuum cavity 3 of the body portion 2, and conversely, the external sealing member 10 is not compressed when positioned in the proximal section 32 of the vacuum cavity 3 of the body portion 2. Thus, stress on the external sealing member 10 is avoided when not required (i.e., during storage), thereby ensuring that the seal will, on the other hand, perform properly when the device 1 is in use.

[0087] In addition, in order to ensure that the friction force on the outer sealing member 10 is greater than the friction force on the inner sealing member 9 for the purpose of initial vacuum, cavity 3 formation and separation from the remaining cavity 33, not only the geometry of the sealing member 10 can be intentionally selected, but also an inclined transition section can be established between the proximal section 32 of the vacuum cavity 3 of the body part 2 and the main section 31 of the vacuum cavity 3 of the body part 2. Therefore, the diameter of the inner wall of the body part 2 is reduced from the second diameter D to the first diameter d. For the above inclined surface of the inclined transition section, several geometries and angles are possible, which are calibrated to obtain different friction forces. Alternatively, the radius on the inner diameter edge of the main section 31 can also be established to establish a friction force change.

[0088] In order to slide the sleeve element 8 forward in the distal direction from the first position at point II of FIG. 3 to the second position at point III of FIG. 3 , the sleeve element 8 is provided with an activation portion 11 (e.g., in the form of a slider) extending to the outside of the body portion 2, as shown in FIG. 5 . The slider 11 can be guided by a front cap 21 on which the slider slides. Further, the front cap 21 can be provided with a clip 21* designed to snap fit with the slider 11 so that the slider 11 is mechanically locked in a position that allows the vacuum state to be established and maintained during the cervical operation. A pair of depressible clips 21* can be provided on opposite sides of the front cap 21, which are designed to be pressed simultaneously by the operator to allow the slider 11 to be slid back in the proximal direction once the cervical operation process is over and it is desired to release or deactivate the vacuum.

[0089] In Fig. 5, it is shown how the rod unit 4 has a protrusion 43, which is configured to abut the sleeve element 8 when the rod unit 4 is moved in the distal direction along its axis AA through the sleeve element 8. In particular, when the rod unit 4 is fully moved in the distal direction along its axis AA, the sleeve element 8 abuts against the front cap 21. This abutment ensures that the user turns the rod unit 4 90° in the correct position and locks the position, as described below.

[0090] The protrusion 43 of the rod unit 4 is positioned so that the rod unit 4 is movable to a predetermined extent through the sleeve element 8 along its axis AA.

[0091] In Fig. 4, there is shown a locking mechanism for the rod unit 4. The locking mechanism is configured to switch between a released state (represented at point I in Fig. 4, where the rod unit 4 is axially movable relative to the vacuum chamber 3) and a locked state (represented at point II in Fig. 4, where the rod unit 4 is axially immovable relative to the vacuum chamber).

[0092] The locking mechanism is established by the cooperation of the protrusion 44 on the rod unit 4, which is free to slide in the front cap 21 when in the released state, and conversely engages in a corresponding concave depression of the front cap 21 when in the locked state (thereby preventing the rod unit 4 from translating in the distal or proximal direction). Thus, in the locked state, when the vacuum is activated, the rod unit 4 remains fixed and, due to the force exerted by the vacuum established in the vacuum chamber 3, the rod unit does not translate back to its initial position as it would otherwise tend to do.

[0093] The locking mechanism established by the protrusion 44 and the corresponding concave depression in the front cap 21 is configured so that pivoting the rod unit 4 about its longitudinal axis AA in one direction switches the locking mechanism into a locked state, while pivoting the rod unit 4 about its axis in the other opposite direction switches the locking mechanism into a released state.

[0094] 6 to 11 show the successive steps of a cycle of using the gynaecological device 1 .

[0095] FIG. 6 shows the step of establishing a vacuum in the gynecological device 1 by traction of the cervical head 5 and translation of the rod unit 4 out of the body portion 2 in the distal direction.

[0096] FIG. 7 shows the step of locking the rod unit 4 of the gynecological device 1 by rotation of the cervical head 5 so that the protrusion 44 engages with the concave depression of the front cap 21 .

[0097] FIG. 8 shows the step of activating the vacuum created in the gynecological device 1 by sliding the activation part or slider 11 laterally.

[0098] FIG. 9 shows the step after using the gynecological device 1 for aligning the cervix and thus completing a cervical manipulation, namely deactivating the vacuum established in the device 1 by sliding the activation part or movable member 11 proximally.

[0099] 10 shows the steps of ending the cervical head treatment process by the gynecological device 1 by unlocking the lever unit 4 by reverse rotation of the cervical head 5 and by pushing the lever unit 4 back inside the body part 2 of the gynecological device 1 in the proximal direction.

[0100] Figure 11 shows the steps of establishing a new vacuum in the gynecological device 1 by repeating the cervical head traction and translation of the rod unit and then locking the rod unit similar to the steps of Figure 7. The same device 1 allows a new procedure to be performed on the cervix in case a revision or repetition of the first operation is required or another operation should be performed.

[0101] In FIG. 12 , a second embodiment of a gynecological device 1 ′ according to the present invention is shown. The gynecological device 1 ′ is widely implemented similarly to the gynecological device 1 shown in the previous figures, so that reference is made to the above description for aspects not explicitly mentioned in the following description. The gynecological device 1 ′ comprises a cylindrical body portion 20 having a vacuum chamber 30, a rod unit 40 having a distal end, a proximal end, and a channel 410 extending between the distal end and the proximal end. The rod unit 40 extends to the vacuum chamber 30 so that the proximal end of the rod unit 40 is located in the vacuum chamber 30. The rod unit 40 is substantially cylindrical and has a straight shape. The channel 410 is straight along the rod unit 40. The proximal end of the rod unit is equipped with a cap 120, which closes the channel 410 of the rod unit 40 at its proximal end. The cap 120 is equipped with a sealing member 100 that seals the rod unit to the wall of the vacuum chamber 30.

[0102] The cervical head 50 designed to engage a section of the cervix from the vaginal side and conform to its anatomical structure is arranged at the distal end of the rod unit 40 to be in fluid communication with the channel 410. The rod unit is further equipped with a lateral through hole 420 radially opening the channel 410 near the cap 120.

[0103] The body portion 20 of the gynecological device 1 ' comprises a releasable elastic rear cap 60 that tightly closes the rear end of the body portion 20. The body portion 20 further comprises a front cap that closes the front end distally. The front cap cooperates with the rod unit 40 to guide the translational movement of the rod unit 40. The sealing mechanism is configured to switch between an ambient state and a vacuum state, as described below.

[0104] Depicted at I in FIG. 12 , the gynecological device 1 ′ is in an initial position or pre-operation state when it can be delivered to a physician for use. The rod unit 40 is arranged in the rightmost position so that its cap 120 abuts against the elastic rear cap 60. In this position, the through hole 420 of the rod unit 40 is covered and sealed by the sealing member 100. In the initial position, the gynecological device 1 ′ is in a released vacuum state, wherein the rod unit 40 is axially movable relative to the vacuum chamber 30.

[0105] As depicted at II in Figure 12, in order to generate a vacuum inside the vacuum chamber 30, the rod unit 40 is moved distally to the far left. As a result, the cap 120 displaces the sealing member 100 toward the distal end of the body portion 20. The sealing member 100 still seals the rod unit 40 to the wall of the vacuum chamber, and covers and seals the through hole 420. In this position, the rod unit 40 is rotated 90° around its longitudinal axis so that it is axially locked, that is, it is not displaceable in the axial direction. The gynecological device 1' is now in a closed vacuum position. In the closed vacuum position, the gynecological device 1' is in a locked vacuum state, in which the rod unit 40 cannot move to the environmental state of the gynecological device 1'. Specifically, the locked state prevents the rod unit 40 from being sucked into the vacuum chamber 30 due to the negative pressure in the vacuum chamber and thereby moving axially to the right.

[0106] As depicted at III in FIG. 12 , the cervical head 50 is located on the vaginal side of the cervix. At the same time, a thrust is applied axially to the rod unit 40 so that it is slightly displaced to the right. As a result, the through holes 420 are moved relative to the sealing member 100 so that they are open toward the interior of the vacuum chamber 30. A vacuum is applied to the cervix through the passage 410, and the cervix is ​​sucked and securely held at the cervical head 50. The gynecological device 1 'is now in an open vacuum position, wherein the gynecological device 1 'is still in a locked vacuum state.

[0107] As depicted at IV in Fig. 12, to release the cervix, the elastic rear portion 60 is removed, so that the outer portion 70 is in fluid communication with the cervix via the vacuum chamber 30 and the channel 410 of the rod unit. Thus, the vacuum is eliminated and the gynecological device 1' can be conveniently removed from the cervix. The gynecological device 1' is now in the end position in the ambient state.

[0108] The drawings that describe and show aspects and embodiments of the present invention should not be considered as limiting the claims of the protected present invention. In other words, although the present invention has been shown and described in detail in the drawings and the foregoing description, such showing and description should be considered illustrative or exemplary, rather than restrictive. Various mechanical, composition, structure, electrical and operational changes can be made without departing from the spirit and scope of this description and claims. In some instances, in order not to obscure the present invention, known circuits, structures and techniques are not shown in detail. Therefore, it will be understood that within the scope and spirit of the appended claims, those of ordinary skill in the art can make changes and modifications. Specifically, the present invention covers further embodiments with any combination of features from the different embodiments described above and below.

[0109] The present disclosure also covers all other features shown in the drawings, although they may not be described individually in the preceding or following description. Moreover, individual alternatives of the embodiments described in the drawings and the description as well as individual alternatives of their features may be abandoned from the subject matter of the present invention or from the disclosed subject matter. The present disclosure includes subject matter consisting of the features defined in the claims or in the exemplary embodiments as well as subject matter comprising said features.

[0110] Furthermore, in the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may perform the functions of several features recited in the claims. The sole fact that certain measures are recited in mutually different dependent claims does not indicate that the combination of these measures cannot be used advantageously. The terms "substantially", "about", "approximately", etc. related to attributes or values ​​also precisely define the attributes or precisely define the values ​​accordingly. In the context of a given numerical value or range, the term "about" refers to a value or range within 20%, 10%, 5% or 2% of a given value or range, for example. The parts described as being connected or connected may be directly connected electrically or mechanically, or they may be indirectly connected via one or more intermediate parts. Any figure marks in the claims should not be interpreted as limiting the scope.

Claims

1. A gynecological device (1; 1'), comprising a body portion (2; 20), the body portion having a vacuum chamber (3; 30), a rod unit (4; 40) having a distal end, a proximal end, and a channel (41; 410) extending between the distal end and the proximal end, a cervical head (5; 50) arranged at the distal end of the rod unit (4; 40), and A sealing mechanism (6; 100) configured to switch between an ambient state and a vacuum state, wherein The rod unit (4; 40) extends to the vacuum chamber (3; 30) of the body portion (2; 20), so that the proximal end of the rod unit (4; 40) is located in the vacuum chamber (3; 30) of the body portion (2; 20), The cervical head (5; 50) is configured to engage a section of the cervix from the vaginal side, In the environmental state of the sealing mechanism (6; 100), the vacuum chamber (3; 30) of the body portion (2; 20) is sealed, and the channel (41; 410) of the rod unit (4; 40) is open to the outside (7; 70) of the gynecological device (1; 1'), and In the vacuum state of the sealing mechanism (6; 100), the channel (41; 410) of the rod unit (4; 40) is open to the vacuum chamber (3; 30) of the body part (2; 20) and is sealed to the exterior (7; 70) of the gynecological device (1; 1'), The rod unit (4; 40) has a lateral through hole (42; 420) open to the channel (41; 410) of the rod unit (4; 40), wherein in the ambient state, the through hole (42; 420) is connected to the external fluid of the gynecological device (1; 1'); and in the vacuum state, the through hole (42; 420) is connected to the vacuum chamber (3; 30) fluid.

2. The gynecological device (1; 1') according to claim 1, wherein The sealing mechanism (6; 100) comprises a sleeve element (8) arranged in the vacuum chamber (3; 30) of the body portion (2; 20), The rod unit (4; 40) extends through the sleeve element (8), and The sleeve element (8) is axially movable relative to the vacuum chamber (3; 30) and relative to the rod unit (4; 40) along an axis (AA) of the rod unit (4; 40) and / or the gynecological device (1; 1').

3. The gynecological device (1; 1') according to claim 2, wherein the sleeve element (8) of the sealing mechanism (6; 100) has an internal sealing member (9) which seals the sleeve element (8) and the rod unit (4; 40) towards each other.

4. A gynecological device (1; 1') according to claim 2 or 3, wherein the sleeve element (8) of the sealing mechanism (6; 100) has an external sealing member (10) which seals the sleeve element (8) and the vacuum chamber (3; 30) of the body part (2; 20) towards each other.

5. A gynecological device (1; 1') according to claim 3, wherein the sleeve element (8) of the sealing mechanism (6; 100) has an external sealing member (10), which seals the sleeve element (8) and the vacuum chamber (3; 30) of the body part (2; 20) toward each other, and wherein a first friction force between the internal sealing member (9) of the sleeve element (8) of the sealing mechanism (6; 100) and the rod unit (4; 40) is smaller than a second friction force between the external sealing member (10) of the sleeve element (8) of the sealing mechanism (6; 100) and the vacuum chamber (3; 30).

6. A gynecological device (1; 1') according to claim 3 or claim 5, wherein the sleeve element (8) of the sealing mechanism (6; 100) has an external sealing member (10), which seals the sleeve element (8) and the vacuum chamber (3; 30) of the body part (2; 20) towards each other, and wherein the internal sealing member (9) and the external sealing member (10) of the sleeve element (8) of the sealing mechanism (6; 100) are axially offset from each other along the axis (AA).

7. The gynecological device (1; 1') according to claim 6, wherein the inner sealing member (9) of the sleeve element (8) of the sealing mechanism (6; 100) is closer to the distal end of the rod unit (4; 40) than the outer sealing member (10) of the sleeve element (8) of the sealing mechanism (6; 100).

8. A gynecological device (1; 1') according to claim 3, wherein the sleeve element (8) of the sealing mechanism (6; 100) has an external sealing member (10), which seals the sleeve element (8) and the vacuum chamber (3; 30) of the main body part (2; 20) towards each other, and wherein in the environmental state of the sealing mechanism (6; 100), the sleeve element (8) moves axially in a first position, in which the internal sealing member (9) seals the channel (41; 410) of the rod unit (4; 40) and the vacuum chamber (3; 30) of the main body part (2; 20) towards each other, and the external sealing member (10) seals the vacuum chamber (3; 30) of the main body part (2; 20) towards the outside (7; 70) of the gynecological device (1; 1').

9. A gynecological device (1; 1') according to claim 3, wherein the sleeve element (8) of the sealing mechanism (6; 100) has an external sealing member (10), which seals the sleeve element (8) and the vacuum chamber (3; 30) of the main body part (2; 20) toward each other, and wherein in the vacuum state of the sealing mechanism (6; 100), the sleeve element (8) moves axially in a second position, in which the internal sealing member (9) seals the channel (41; 410) of the rod unit (4; 40) toward the outside (7; 70) of the gynecological device (1; 1'), and the external sealing member (10) seals the vacuum chamber (3; 30) of the main body part (2; 20) toward the outside (7; 70) of the gynecological device (1; 1').

10. The gynecological device (1; 1') according to claim 2 or 3, wherein the sleeve element (8) comprises an activation portion (11) extending to the outside of the body portion (2; 20).

11. The gynecological device (1; 1') according to claim 2 or 3, wherein the rod unit (4; 40) has a protrusion (43) which is configured to abut the sleeve element (8) when the rod unit (4; 40) moves through the sleeve element (8) in the distal direction along its axis (AA).

12. The gynecological device (1; 1') according to claim 11, wherein the protrusion (43) of the rod unit (4; 40) is positioned so that the rod unit (4; 40) is movable to a predetermined extent along its axis (AA) through the sleeve element (8).

13. The gynecological device (1; 1') according to claim 1 or 2, comprising a cap (12) closing the channel (41; 410) of the rod unit (4; 40) at the proximal end of the rod unit (4; 40).

14. The gynecological device (1; 1') according to claim 2, comprising a cap (12) closing the channel (41; 410) of the rod unit (4; 40) at the proximal end of the rod unit (4; 40), and wherein the cap (12) is sized not to fit into the sleeve element (8) of the sealing mechanism (6; 100).

15. The gynecological device (1; 1') according to claim 1 or 2, comprises a locking mechanism (44, 21), which is configured to switch between a release state and a locked state, in which the rod unit (4; 40) is axially movable relative to the vacuum chamber (3; 30) of the body part (2; 20), and in which the locking mechanism prevents the rod unit (4; 40) from moving into the ambient state.

16. The gynecological device (1; 1') according to claim 15, wherein In the released state of the locking mechanism (44, 21), the rod unit (4; 40) is axially movable relative to the vacuum chamber (3; 30) of the body portion (2; 20), so that when the rod unit (4; 40) generates a vacuum inside the vacuum chamber (3; 30) when it moves distally relative to the vacuum chamber (3; 30).

17. The gynecological device (1; 1') according to claim 15, wherein the locking mechanism (44, 21) is configured such that pivoting the rod unit (4; 40) about its longitudinal axis (AA) in one direction switches the locking mechanism (44, 21) into the locked state, and pivoting the rod unit (4; 40) about its axis (AA) in another opposite direction switches the locking mechanism (44, 21) into the released state.

18. The gynecological device (1; 1') according to claim 15, wherein the rod unit (4; 40) has a lateral through hole (42; 420) open to the channel (41; 410) of the rod unit (4; 40), and wherein the gynecological device (1) is configured to open the through hole (42; 420) to the vacuum chamber (3; 30) when in the locked state.

19. The gynecological device (1; 1') according to claim 18, being configured to open the through hole by applying a pushing force to the cervical head (5; 50).

20. The gynecological device (1; 1') according to claim 18 or 19, wherein the through hole (42; 420) is open to the vacuum chamber (3; 30) when in the released state.

21. The gynecological device (1; 1') according to claim 1 or 2, wherein the gynecological device is configured to be arranged in a pre-operational state, in which the rod unit (4; 40) is moved to the maximum extent in the proximal direction into the vacuum chamber (3; 30) of the body part (2; 20).

22. The gynecological device (1; 1') according to claim 21, wherein the vacuum cavity (3; 30) of the body portion (2; 20) has a main section (31) and a proximal section (32), wherein the main section (31) has a first diameter (d) and the proximal section (32) has a second diameter (D) greater than the first diameter (d).

23. A gynecological device (1; 1') according to claim 22, wherein the sleeve element (8) of the sealing mechanism (6; 100) has an external sealing member (10), which seals the sleeve element (8) and the vacuum cavity (3; 30) of the main body part (2; 20) toward each other, and wherein the external sealing member (10) is compressed when positioned in the main section (31) of the vacuum cavity (3; 30) of the main body part (2; 20), and the external sealing member (10) is not compressed when positioned in the proximal section (32) of the vacuum cavity (3; 30) of the main body part (2; 20).

24. A gynecological device (1; 1') according to claim 22 or 23, wherein in an inclined transition section between the proximal section (32) of the vacuum cavity (3; 30) of the body part (2; 20) and the main section (31) of the vacuum cavity (3; 30) of the body part (2; 20), the diameter decreases from the second diameter (D) to the first diameter (d).

25. The gynecological device (1; 1') according to claim 3, wherein a friction reducing substance is arranged between the inner sealing member of the sleeve element of the sealing mechanism and the rod unit.

26. The gynecological device of claim 25, wherein the friction reducing substance comprises silicone oil.

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