Patent Description:
For example, many gynecological procedures, such as intra uterine contraception device (IUCD) insertion and removal, uterine tissue swabs for diagnostic purposes, cervix dilatation for uterine cavity curettage and/or for hysteroscopy, and measuring uterine cavity size during surgery, require an instrument to be inserted into the uterine cavity through the cervical canal.

In most anatomical cases, however, the cervical canal is typically angled with respect to the vaginal canal. Thus, prior to being able to perform the gynecological procedure, the cervical canal must be straightened in order to be able to insert an instrument into the uterine cavity.

Thus, for instance, grasping and manipulating the cervix of a patient is essential for performing many gynecological procedures, such as those described above. Hence, prior to performing the procedures, users open the vagina by means of a speculum in order to view the cervix of the patient. Then, the user inserts a grasping device in order to grasp the cervix and straighten the cervical canal to allow an instrument to be inserted into the uterine cavity.

One such grasping device is referred to as a tenaculum. Tenaculums typically have sharp-pointed hooks attached to a scissor-like handle. The cervix is grasped by the ends of the hooks by actuating the scissor-like handle to generate a clamping force. However, this form of grasping device can often be uncomfortable to the patient and can cause pain, bleeding and damage to the tissue of the cervix.

Thus, in recent years the use of vacuum-based grasping devices has been proposed in order to provide a gentler and more comfortable means for grasping the cervix of a patient. For instance, <CIT>discloses a grasping device comprising a suction head and a handle part connected to each other by a suction tube. The handle part comprises a vacuum pump with a vacuum chamber and a piston having a piston head movably arranged within the vacuum chamber. The vacuum pump further comprises a spring which is compressible by a compressing means and a button for releasing the compression of the spring. Once the suction head is properly placed, the user pushes the button to release the spring in order to generate a vacuum in the vacuum chamber and to grip the cervix.

Moreover, <CIT> discloses a gynecological device comprising a body part having a vacuum chamber and a rod member having a channel extending from a distal end to a proximal end. The gynecological device further comprises a cervix head arranged at the distal end of the rod member and a sealing mechanism configured to switch between an ambient state and a vacuum state. The sealing mechanism comprises a sleeve element which is axially movable relative to the vacuum chamber to switch the sealing mechanism between the ambient state and the vacuum state. The rod member is displaceable relative to the body member, thereby also axially displacing the sleeve element within the sleeve element to a first position to create a vacuum in the vacuum chamber. The sleeve element is moved further axially to a second position in order to transfer the vacuum from the vacuum chamber to the rod member and thus to the cervix head to grip the cervix.

However, the above-described vacuum-based grasping devices include a plurality of moving parts and are difficult to operate.

Moreover, the operation of known vacuum-based grasping devices can still provide discomfort to the patient. Since the vacuum generating mechanism is often operated as the gynecological device is engaged with the cervix of the patient, the complicated vacuum-generating mechanisms involving a plurality of moving parts can cause forces, such as thrusting forces, to be unintentionally transferred to the cervix by the grasping device as the vacuum mechanism is being activated, potentially causing pain and damage to the tissue of the cervix.

Furthermore, the complicated build of the known vacuum-based grasping devices limits the cost-efficiency of the manufacturing of such grasping devices.

Therefore, it is an object of the invention to provide a gynecological device for cervix handling with an improved means for providing a vacuum for gripping the cervix.

According to a first aspect, this object is achieved by a handheld gynecological device for cervix handling comprising a body member defining a vacuum chamber and having a proximal end and a distal end.

Within the context of the present disclosure, the term "distal" and "distally" is to be understood as referring to a direction away from a user of the device, i.e. a practitioner, and the term "proximal" and "proximally" is to be understood as referring to a direction towards the user of the device. Thus, the distal end of the body member is arranged further from the user than the proximal end of the body member.

The body member may have a wall defining at least a portion of the vacuum chamber. Preferably, the body member is made of a plastic material, which may be transparent. Preferably, the body member may comprise openings at its distal and its proximal end, preferably formed in the wall of the body member.

Furthermore, the body member preferably has a substantially hollow cylindrical shape with a substantially annular-shaped cross-section. Alternatively, the body member may have a cross-sectional shape that is hollow and polygonal, such as a hollow shape with a quadrilateral or pentagonal cross-section. The hollow shape of the body member preferably at least partially forms the vacuum chamber.

The body member may be elongate, having a length preferably ranging from <NUM> to <NUM>, more preferably from <NUM> to <NUM> and having an outer diameter preferably less than <NUM>, more preferably less than <NUM>.

The body member may be of a one-piece construction. However, alternatively, the body member may be constructed of a plurality of different parts that are connected to each other.

The handheld gynecological device further comprises a piston member being at least partially received in the vacuum chamber and configured such that at least a portion of the piston member is displaceable in the vacuum chamber from a first position to a second position for creating a vacuum in the vacuum chamber. Preferably, the piston member can be displaced axially from the first position to the second position along a longitudinal axis of the body member. The piston may be configured to be manually operable by the user of the device. The piston could also be referred to as a "plunger" in the context of the present disclosure.

The piston member may have a wall defining an outer surface of the piston member. Furthermore, the piston member may be hollow such that the wall may also define an inner surface of the piston member.

The piston member preferably is substantially hollow cylindrical with a substantially annular-shaped cross-section in at least a section of the piston member.

Preferably, the shape and dimensions of the piston member, such as its outer diameter, may be configured such that the piston member can be slidably displaced within the vacuum chamber to generate a vacuum in the vacuum chamber.

Thus, when the piston member is in the first position, e.g. when the piston member is inserted at the furthest possible distal position in the vacuum chamber, a large section of the piston member, preferably at least <NUM>%, more preferably at least <NUM>% of a total length of the piston member, may be arranged in the vacuum chamber. However, in the first position, a section of the piston member may extend through an opening at the proximal end of the body member out of the vacuum chamber. The section extending through the opening in the first position may provide a gripping portion, for instance for a user to grip and pull the piston member such that the piston member can be axially displaced relative to the body member towards the second position.

The gripping portion may comprise a feature which facilitates gripping by the user. For instance, the gripping portion may have a flared form, such as a bell mouth shape, to prevent the piston member from slipping out of the hand of the user or to at least reduce slipping. Moreover, the gripping portion may alternatively or additionally have a roughened or gnarled surface to prevent the piston member from slipping out of the hand of the user or to at least reduce slipping.

Alternatively or additionally, the body member may have a gripping feature, preferably arranged on an outer surface of the body member to facilitate gripping and pulling the piston member such that piston member is axially displaced relative to the body member. For instance, the body member may comprise a handle attached to the outer surface of the body member and extending radially therefrom. Preferably, the handle extends circumferentially around at least a portion of the body member, preferably around the entire circumference of the body member. Alternatively or additionally, the outer surface of the body member may have a roughened or gnarled portion to prevent the body member from slipping out of the hand of the user when gripping and pulling the piston member.

Alternatively or additionally, the piston member may be displaced from the first position to the second position by means of a mechanical element, such as a spring or an electric motor. Thus, for instance, the mechanical element may be actuated by a piston member actuating element which may in turn be activated by the user. Thus, the user may activate the piston member actuating element, for instance a button, which actuates the mechanical element which in turn displaces the piston member from the first position to the second position to generate a vacuum in the vacuum chamber.

The piston member may comprise a sealing structure on at least a portion of a section of the piston member which is arranged in the vacuum chamber when the piston member is in the first position and in the second position. The sealing structure can be arranged in a groove or slot formed around a circumference of the outer surface of the wall of the piston member.

Thus, by displacing the piston member from the first position to the second position relative to the body member, for instance by gripping and pulling the piston member axially along the longitudinal axis of the body member, the air mass in the vacuum chamber can be expanded, thus generating a vacuum within the vacuum chamber.

The handheld gynecological device further comprises a rod member having a proximal end and a distal end. The rod member defines a lumen and is configured to be coupled to the body member.

The rod member may have a wall defining an outer surface and an inner surface, the inner surface preferably defining the lumen of the rod member. The rod member preferably has a substantially hollow cylindrical shape with a substantially annular-shaped cross-section. Alternatively, the rod member may have a cross-sectional shape that is hollow and polygonal, such as a hollow shape with a quadrilateral or pentagonal cross section.

The rod member preferably has openings at its proximal end and/or distal end.

The rod member preferably has a total length ranging from <NUM> to <NUM>, more preferably from <NUM> to <NUM>, most preferably from <NUM> to <NUM>. Preferably, the rod member has an outer diameter of less than <NUM>, more preferably of less than <NUM>.

Furthermore, the rod member preferably is substantially rigid to prevent or at least limit bending of the rod member when grasping and manipulating the cervix of a patient.

The handheld gynecological device further comprises a suction head configured to engage at least a portion of a cervix of a patient. The suction head is fluidly connected to a distal end of the rod member and has a cross-section that is larger than a cross-section of the rod member. The suction head may be C-shaped. The suction head may be integrally formed (e.g., integrally moulded) with the rod member.

The suction head may comprise a wall, preferably extending around at least a portion of a circumference of the suction head and preferably defining a suction lumen. The wall may be concave with respect to the distal direction. Thus, the suction lumen preferably is open in the distal direction. The suction lumen preferably is fluidly connected to the lumen of the rod member.

The wall preferably defines an engaging surface configured to engage at least a portion of the cervix of a patient. Preferably, the suction head comprises a sealing element arranged on at least a portion of the engaging surface such that the sealing element may provide a substantially air-tight seal between the suction head and the portion of the cervix the handheld gynecological device is to be applied to.

Preferably, the position of the rod member along the longitudinal axis of the body member is fixed relative to the body member when the rod member is coupled to the body member. In other words, the rod member cannot be moved relative to the body member along the longitudinal axis of the body member. For example, the rod member and the body member may be manufactured as a single integral part. Alternatively or additionally, a separate connecting member may be arranged between the rod member and the body member which can provide a connection between the rod member and the body member. The rod member may be fixed relative to the body member such that also a rotational movement of the rod member relative to the body member is prevented (e.g., a rotational movement about the longitudinal axis of the rod member and/or about the longitudinal axis of the body member). However, if desired, the rod member and the body member may also be movable with respect to each other, for example movable with respect to each other along the longitudinal axis of the body member and/or rotatable with respect to each other (e.g., rotatable about the longitudinal axis of the rod member and/or about the longitudinal axis of the body member).

Preferably, the device further comprises an actuating mechanism with an actuating member. The actuating member preferably is coupled to the body member and/or the rod member. This preferably is achieved by movably mounting the actuating member to the body member and/or the rod member, for instance by configuring the body member and/or the rod member to receive at least a portion of the actuating member in at least a portion thereof. Alternatively or additionally, the actuating member may be configured such that a portion of the body member and/or the rod member may be received in at least a portion of the actuating member to couple the actuating member to the body member and/or the rod member.

Alternatively, a separate connecting element, to which the actuating member is preferably releasably and/or movably attached, may be arranged between and connected to the rod member and/or the body member.

The actuating member is configured to be switched from a disconnected position, in which the vacuum chamber of the body member is fluidly disconnected from the lumen of the rod member, to a connected position, in which the vacuum chamber of the body member is fluidly connected to the lumen of the rod member.

Thus, the actuating member may provide a mechanism for transferring the vacuum generated in the vacuum chamber by the piston member to the lumen of the rod unit and thus to the suction head. This allows the user to generate a vacuum in the vacuum chamber by displacing the piston member from the first position to the second position in the vacuum chamber prior to placing the suction head onto at least a portion of the cervix of the patient. Thereafter, the suction head can be placed onto at least a portion of the cervix. Thereupon, a vacuum can be provided at the suction head via the lumen of the rod member by switching the actuating member from the disconnected position to the connected position to allow the user to grasp and/or manipulate the cervix of the patient. Thus, at the point of application, i.e. when the suction head is engaged with at least a portion of a cervix of a patient, a vacuum can be generated at the suction head by simply switching the actuating member from the disconnected position to the connected position. Since the rod member is fixed relative to the body member, the rod member and the body member do not have to be moved relative to one another during operation of the actuating member.

For one, this enhances the comfort of the patient during the medical procedure since the suction head can be securely engaged to the cervix of the patient while reducing the risk of movement of the suction head relative to the cervix, for instance caused by relative movement between the body member and the rod member.

Furthermore, this eliminates the need for a plurality of moving parts and facilitates the operation of the device for the user, which enables a more efficient performance of the procedure and a more comfortable experience for the patient.

Moreover, the simple build of the device increases the cost-efficiency of the manufacturing of the device.

Preferably, the device is configured such that the actuating member is retained in the connected position and/or in the disconnected position. In other words, the device preferably switches only from the connected position to the disconnected position and/or from the disconnected position to the connected position upon a force applied onto the actuating member, in particular upon a manual force applied by the user.

The actuating member may comprise at least one sealing element configured and arranged to seal the vacuum chamber from the lumen of the rod member when the actuating member is in the disconnected position. The at least one sealing element may further be configured and arranged to allow fluid connection between the lumen of the rod member and the vacuum chamber of the body member when the actuating member is in the connected position.

The sealing element may prevent or at least reduce air from entering the vacuum chamber and/or the lumen of the rod member (in particular, at the proximal end of the rod member) from the environment when the actuating member is in the connected position to help maintain a vacuum.

The actuating member preferably is switched from the disconnected position to the connected position by displacing the actuating member relative to the body member and/or the rod member. For instance, the actuating member may be displaced by rotating and/or translationally moving the actuating member relative to the body member and/or the rod member.

In the case of a rotational movement of the actuating member, the rotational movement may be a rotation about the longitudinal axis of the body member and/or about the longitudinal axis of the rod member. Alternatively, the rotational movement of the actuating member may be about an axis which does not coincide with the longitudinal axis of the body member and/or the rod member, such as about an axis which extends at an angle to the longitudinal axis of the body member and/or the rod member, preferably about an axis which is perpendicular to the longitudinal axis of the body member and/or the longitudinal axis of the rod member.

In the case of a translational movement of the actuating member, the translational movement may be a movement along the longitudinal axis of the body member and/or along the longitudinal axis of the rod member. Alternatively, the translational movement of the actuating member may be a movement in a direction which extends at an angle to the longitudinal axis of the body member and/or the longitudinal axis of the rod member, preferably in a direction which is perpendicular to the longitudinal axis of the body member and/or the longitudinal axis of the rod member.

Preferably, only a rotational movement or only a translational movement of the actuating member is performed in order to switch the device from the connected to the disconnected position, and/or vice-versa. However, the actuating member may also be switched from the disconnected position to the connected position by a combined rotational and translational movement. For instance, the actuating member may first be rotationally displaced and then translationally displaced, or vice versa, from the disconnected position to the connected position.

Preferably, the actuating member comprises a channel. Preferably, at least a portion of the channel preferably extends substantially longitudinally with respect to the longitudinal axis of the rod member and/or the longitudinal axis of the body member. Alternatively or additionally, at least a portion of the channel may extend at an angle to the longitudinal axis of the rod member and/or the body member, preferably substantially transversely with respect to the longitudinal axis of the rod member and/or the longitudinal axis of the body member.

The channel may comprise a plurality of channel segments, for instance one channel segment may extend in a first direction, preferably substantially longitudinally with respect to the longitudinal axis of the rod member and/or of the body member, and a second channel segment fluidly connected to the first channel segment may extend in a second direction, preferably substantially transversely with respect to the longitudinal axis of the rod member and/or of the body member.

The channel may comprise a plurality of channel sections which are not fluidly connected with each other, at least when the actuating member is in the disconnected position. In this case, the plurality of channel sections may also each comprise a plurality of channel segments. For instance, each channel section may comprise one channel segment which extends in a first direction, preferably substantially longitudinally with respect to the longitudinal axis of the rod member and/or of the body member, and a second channel segment fluidly connected to the first channel segment that may extend in a second direction, preferably substantially transversely with respect to the longitudinal axis of the rod member and/or of the body member. Moreover, it may be the case that only one of the plurality of channel sections comprises a plurality of channel segments while the other channel section or channel sections comprise(s) only one channel segment extending substantially in one direction.

The channel and/or channel segments and/or channel sections may have a substantially constant cross-sectional shape and/or cross-sectional dimension along its extension in the actuating member. Preferably, the cross-sectional shape is circular or semi-circular. However, the channel and/or channel segments and/or channel sections may have a varying cross-sectional shape and/or dimension along at least a portion of their extension in the actuating member. For instance, the channel and/or channel segments and/or channel sections may have a tapered form along at least a portion of its/their extension in the actuating member. Thus, for instance, the dimension of the channel and/or channel segments and/or channel sections may increase and/or decrease along at least a portion of its/their extension in the actuating member.

The actuating member preferably is switchable from the disconnected position to the connected position by being displaced relative to the body member and the rod member such that, in the disconnected position, the channel of the actuating member may be sealed from the vacuum chamber and/or the lumen of the rod member, and, in the connected position, the channel can fluidly connect the vacuum chamber of the body member to the lumen of the rod member.

Thus, the channel of the actuating member may provide a fluid connection to fluidly connect the lumen of the rod member to the vacuum chamber of the body member. Thus, by displacing the actuating member, the channel of the actuating member may also be displaced, thereby selectively fluidly connecting and disconnecting the lumen of the rod member to/from the vacuum chamber of the body member.

In order to seal the channel of the actuating member from the vacuum chamber and/or the lumen of the rod member in the disconnected position, the body member and/or the rod member and/or the actuating member may comprise at least one sealing element which prevents or at least reduces gas transfer between the vacuum chamber and/or the lumen of the rod member.

In one preferred embodiment, the vacuum chamber may be fluidly connectable to the lumen of the rod member by displacing the actuating member axially along the longitudinal axis of the rod member and/or the longitudinal axis of the body member.

Preferably, the vacuum chamber is fluidly connectable to the lumen of the rod member by displacing the actuating member along the longitudinal axis of the rod member and/or the longitudinal axis of the body member in a distal direction, i.e. away from the user. This may make the operation of the handheld gynecological device more intuitive since when the user would like to transfer the vacuum generated in the vacuum chamber to the lumen of the rod member by fluidly connecting the vacuum chamber to the lumen of the rod member, the user would also displace the actuating member in the same direction as the vacuum is to be transferred, i.e. in a distal direction extending from the vacuum chamber to the rod unit.

Moreover, a distal movement may avoid the user from inadvertently applying a pulling force to the device.

The longitudinal axis of the body member and the longitudinal axis of the rod member may extend parallel to each other. Preferably, the longitudinal axis of the body member and the longitudinal axis of the rod member are coincident. In both cases, the actuating member can be displaced axially along the longitudinal axis of the rod member and the longitudinal axis of the body member.

However, it is also possible that the longitudinal axis of the body member and the longitudinal axis of the rod member extend at an angle to each other. In this case, the actuating member can be displaced axially along either the longitudinal axis of the rod member or the longitudinal axis of the body member.

In one embodiment, the actuating mechanism may comprise a static member along which at least a portion of the actuating member is slidably arranged. Thus, the static member may provide a mounting and/or a guiding for the actuating member in order to displace the actuating member from the disconnected position to the connected position. Furthermore, the static member may also function as the connecting member that connects the body member to the rod member. As such the static member may fixe the position of the rod member relative to the body member, as discussed above.

Preferably, the static member comprises at least one channel formed therein. For instance, the static member may provide a flow channel that is fluidly connectable to the channel of the actuating member in order to fluidly connect the lumen of the rod member to the vacuum chamber of the body member.

At least a portion of the at least one channel formed in the static member preferably extends substantially longitudinally with respect to the longitudinal axis of the rod member and/or the longitudinal axis of the body member. Alternatively or additionally, at least a portion of the channel may extend at an angle to the longitudinal axis of the rod member and/or the longitudinal axis of the body member, preferably substantially transversely with respect to the longitudinal axis of the rod member and/or of the body member.

Moreover, the channel of the static member may comprise a plurality of channel segments, for instance one channel segment may extend in a first direction, preferably substantially longitudinally with respect to the longitudinal axis of the rod member and/or the body member, and a second channel segment fluidly connected to the first channel segment may extend in a second direction, preferably substantially transversely with respect to the longitudinal axis of the rod member and/or the body member.

Furthermore, the channel may comprise a plurality of channel sections which are not fluidly connected with each other, at least when the actuating member is in the disconnected position. In this case, the plurality of channel sections may also each comprise a plurality of channel segments. For instance, each channel section may comprise one channel segment which extends in a first direction, preferably substantially longitudinally with respect to the longitudinal axis of the rod member and/or the longitudinal axis of the body member, and a second channel segment fluidly connected to the first channel segment, which may extend in a second direction, preferably substantially transversely with respect to the longitudinal axis of the rod member and/or the longitudinal axis of the body member. Moreover, it may be the case that only one of the plurality of channel sections comprises a plurality of channel segments while the other channel section or channel sections comprise(s) only one channel segment extending substantially in one direction.

The channel and/or channel segments and/or channel sections may have a substantially constant cross-sectional shape and/or cross-sectional dimension along its/their extension in the actuating member. Preferably, the cross-sectional shape is circular or semi-circular. However, the channel and/or channel segments and/or channel sections may have a varying cross-sectional shape and/or dimension along at least a portion of its/their extension in the actuating member. For instance, the channel and/or channel segments and/or channel sections may have a tapered form along at least a portion of its/their extension in the actuating member. Thus, for instance, the dimension of the channel and/or channel segments and/or channel sections may increase and/or decrease along at least a portion of its/their extension in the actuating member.

Preferably, the channel of the static member is fluidly connectable to the channel formed in the actuating member by sliding the actuating member along the static member.

Preferably, the actuating member can be slid substantially along the longitudinal axis of the rod member and/or the longitudinal axis of the body member along the static member to fluidly connect the channel of the static member to the channel formed in the actuating member.

Thus, by sliding the actuating member substantially along the longitudinal axis of the rod member and/or the longitudinal axis of the body member along the static member, the vacuum chamber can be fluidly connected to the lumen of the rod member and thus to the suction head by fluidly connecting the channel of the static member to the channel formed in the actuating member.

The static member and/or the actuating member may comprise at least one sealing element to prevent or at least reduce a fluid connection between the lumen of the rod member and the vacuum chamber of the body member when the actuating member is in the disconnected position. The sealing element may also prevent or at least reduce air from entering the vacuum chamber and/or the lumen of the rod member (in particular, at the proximal end of the rod member) from the environment when the actuating member is in the connected position to help maintain a vacuum.

Alternatively or additionally, the rod member and/or the body member may comprise at least one sealing element to prevent or at least reduce a fluid connection between the lumen of the rod member and the vacuum chamber of the body member when the actuating member is in the disconnected position. The sealing element may also prevent or at least reduce air from entering the vacuum chamber and/or the lumen of the rod member from the environment when the actuating member is in the connected position to help maintain a vacuum.

The actuating member may be slidably attached to the static member. Alternatively or additionally, the actuating member may be slidably attached to the body member and/or the rod member.

The actuating member preferably has at least one protrusion arranged on at least a portion of an outer surface of the actuating member and extending therefrom to facilitate gripping and sliding of the actuating member by the user.

In one embodiment, the vacuum chamber may be fluidly connectable to the lumen of the rod member by rotating the actuating member relative to the rod member and/or the body member.

Preferably, the vacuum chamber is fluidly connectable to the lumen of the rod member by rotating the actuating member relative to the rod member and/or the body member about the longitudinal axis of the rod member and/or the longitudinal axis of the body member.

Thus, for instance, a channel formed in the actuating member may be rotatably displaced by rotating the actuating member such that the vacuum chamber can be fluidly connected to the lumen of the rod member, and thus to the suction head, by the channel formed in the actuating member. This provides an efficient and reliable means for switching the actuating member from the disconnected to the connected position and/or vice versa. In particular, the actuation by rotation of the actuating member about the longitudinal axis of the rod member and/or the longitudinal axis of the body member minimizes thrust forces along the longitudinal axis of the rod member and/or the longitudinal axis of the body member, thus reducing the risk of discomfort that may be caused to the patient by excessive thrust forces.

Alternatively, the rotational movement of the actuating member may be about an axis which does not coincide with the longitudinal axis of the body member and/or the longitudinal axis of the rod member, such as about an axis which extends at an angle to the longitudinal axis of the body member and/or of the rod member, preferably about an axis which is perpendicular to the longitudinal axis of the body member and/or of the rod member.

Also in this embodiment, the actuating mechanism may comprise a static member having a channel formed in at least a portion thereof. The channel of the static member and the channel of the actuating member preferably are arranged offset relative to each other in the disconnected position. The channel of the static member and the channel of the actuating member preferably are fluidly connectable by rotating the actuating member relative to the rod member and/or the body member.

The term "offset" is to be understood as being arranged apart from one another such that a fluid connection is prevented. Thus, when the channel of the static member and the channel of the actuating member are arranged offset relative to each other in the disconnected position, the channel of the static member and the channel of the actuating member are spaced apart
from one another such that the fluid path between the channel of the static member and the channel of the actuating member is interrupted. For instance, the channel of the static member and the channel of the actuating member may be positioned at different distances from the longitudinal axis of the rod member and/or the longitudinal axis of the body member to provide an offset. Alternatively or additionally, such offset may be provided by positioning the channel of the static member and the channel of the actuating member at different rotational positions around the longitudinal axis of the rod member and/or the longitudinal axis of the body member.

Thus, when the channel of the static member and the channel of the actuating member are arranged offset relative to each other in the disconnected position, a fluid connection between the channel of the static member and the channel of the actuating member is prevented. Thus, the vacuum chamber and the lumen of the rod member are also fluidly disconnected in this disconnected position.

By rotating the actuating member relative to the rod member and/or the body member, the channel of the static member and the channel of the actuating member can be fluidly connected, for instance by substantially aligning the channel of the static member with the channel of the actuating member. The vacuum chamber may thereby be connected to the lumen of the rod member. When connected, the channel of the static member and the channel of the actuating member may be coaxial.

This provides a simple and reliable fluid connection to connect the vacuum chamber to the lumen of the rod member to provide a vacuum at the suction head of the handheld gynecological device to efficiently and reliably grasp a portion of a cervix of a patient.

Preferably, the channel of the static member and the channel of the actuating member is fluidly connectable by rotating the actuating member relative to the rod member and/or the body member about an axis that is parallel to the longitudinal axis of the rod member and/or to the longitudinal axis of the body member. This axis may coincide with the longitudinal axis of the rod member and/or with the longitudinal axis of the body member. Alternatively, the rotational movement of the actuating member may be about an axis which is not parallel with the longitudinal axis of the body member and/or the rod member, such as about an axis which extends at an angle to the longitudinal axis of the body member and/or to the longitudinal axis of the rod member, preferably about an axis which is perpendicular to the longitudinal axis of the body member and/or the rod member.

Preferably, the channel of the static member and/or the channel of the actuating member are arranged offset relative to the longitudinal axis of the rod member and/or the longitudinal axis of the body member. Thus, the channel of the static member and/or the channel of the actuating member may be arranged at a distance from the longitudinal axis of the rod member and/or the longitudinal axis of the body member.

Thus, for instance by rotating the actuating member relative to the rod member and/or the body member, preferably about a longitudinal axis of the rod member and/or about a longitudinal axis of the body member, the channel of the static member and the channel of the actuating member may be brought into fluid connection to fluidly connect the vacuum chamber with the lumen of the rod member and thus the suction head when the actuating member is in the connected position.

In one embodiment, the vacuum chamber may be fluidly connectable to the lumen of the rod member by displacing the actuating member relative to the rod member and the body member substantially perpendicular to a longitudinal axis of the rod member and/or a longitudinal axis of the body member.

In particular, the actuation by displacing the actuating member substantially perpendicular to the longitudinal axis of the rod member and/or the longitudinal axis of the body member also minimizes thrust forces along the longitudinal axis of the rod member and/or the longitudinal axis of the body member, thus reducing discomfort caused to the patient by excessive thrust forces.

For example, the actuating mechanism may comprise a static member having a channel formed in at least a portion thereof. The channel of the static member and the channel of the actuating member may be arranged offset relative to each other in the disconnected position. The channel of the static member and the channel of the actuating member may be fluidly connectable by displacing the actuating member relative to the rod member and/or the body member substantially perpendicular to a longitudinal axis of the rod member and/or a longitudinal axis of the body member. Thus, by displacing the actuating member relative to the rod member and/or the body member substantially perpendicular to a longitudinal axis of the rod member and/or a longitudinal axis of the body member the channel of the static member and the channel of the actuating member may be brought into fluid connection to fluidly connect the vacuum chamber with the lumen of the rod member and thus the suction head when the actuating member is in the connected position.

Preferably, the channel of the static member and/or the channel of the actuating member can be arranged offset relative to the longitudinal axis of the rod member and/or the longitudinal axis of the body member.

According to a further aspect of the present disclosure, the handheld gynecological device comprises a locking mechanism configured to maintain the piston member in the second position. The locking mechanism may thus provide a locking element to lock the piston member in the second position once the piston member has been displaced from the first position to the second position to generate a vacuum in the vacuum chamber. Hence, the piston member is prevented from returning to the first position by the locking mechanism.

Such locking mechanism allows the user to generate the vacuum in the vacuum chamber by pulling the piston member relative to the body member, thereby displacing the piston member from the first position to the second position, and locking the piston member in the second position by the locking mechanism. Then, the user can place the suction head of the handheld gynecological device onto a portion of the cervix of a patient. The cervix of the patient can then be grasped and manipulated, for example by switching the actuating member from the disconnected position to the connected position, thereby transferring the vacuum in the vacuum chamber to the lumen of the rod member and thus to the suction head.

It is understood that the locking mechanism disclosed herein is not dependent on the actuating mechanism also disclosed herein or the position of the rod member relative to the body member being fixed. Thus, the locking mechanism may be implemented in the handheld gynecological device without the presence of the actuating mechanism and vice versa. Thus, for instance, the locking mechanism may be combined with any type of actuating mechanism, including actuating mechanisms not disclosed herein, and may even be provided without any actuating mechanism at all.

In other words, such locking mechanism may be implemented in conjunction with any of the devices described above, in particular in conjunction with any of the more specific features for switching the device from the connected to the disconnected position. However, such locking mechanism may also be implemented independently in any handheld gynecological device comprising a body member defining a vacuum chamber and having a proximal end and a distal end, a piston member being at least partially received in the vacuum chamber and configured such that at least a portion of the piston member is displaceable in the vacuum chamber from a first position to a second position for creating a vacuum in the vacuum chamber, and a rod member having a proximal end and a distal end, wherein the rod member preferably is coupled to the body member, and a suction head configured to engage at least a portion of a cervix of a patient, the suction head being coupled to the distal end of the rod member and having a cross-section that is larger than a cross-section of the rod member.

Preferably, the locking mechanism comprises at least one slot formed in the piston member or the body member. The locking mechanism may further comprise at least one engaging element formed on or attached to the other of the piston member and the body member. Preferably, the engaging element is movably received in the slot.

Thus, the slot and the engaging element may engage with each other in order to guide the piston member from the first position to the second position and/or lock the piston member in the second position.

The piston member and the body member may also each have at least one slot formed therein and may each comprise at least one engaging element formed on or attached thereto. The respective slot formed on one of the piston member and the body member may cooperate with the respective engaging element formed on or attached to the other of the piston member and the body member.

The slot may completely penetrate the entire thickness of a wall of the piston member or the body member at least in a section of the slot. Alternatively or additionally, a section of the slot may penetrate only a portion of the thickness of the wall of the piston member or the body member such that the respective section of the slot is formed as a recess in the respective wall.

Preferably, the slot may comprise a guiding section configured to guide the engaging element when moving the piston member between the first position and the second position. The guiding section may thus allow a guided movement of the piston member from the first position to the second position. This facilitates the movement of the piston member to generate the vacuum in the vacuum chamber since the user does not actively have to guide the piston member from the first position to the second position and thus facilitates engaging the locking mechanism in the second position. Thus, the guiding section guides the piston member from the first position to the second position to ensure the locking mechanism may be securely engaged in the second position.

This provides a reliable and efficient vacuum generating process to enhance the safety, efficiency and patient comfort of the medical procedure.

Preferably, the guiding section extends substantially parallel to a longitudinal axis of the body member. Thus, the piston member may be guided from the first position to the second member in a substantially translational movement, i.e. without any substantial rotation of the piston member. Alternatively or additionally, the guiding section may extend, at least along a portion thereof, in a substantially helical manner.

The locking mechanism may comprise a locking structure providing a stop for the engaging element to maintain the piston member in the second position. The locking structure providing the stop may provide a surface which the engaging element can engage with to prevent the piston member from returning to the first position once the piston member has been displaced to the second position.

Preferably, the locking structure may be formed as a locking section of the slot. The locking section preferably provides an undercut. For example, the locking section preferably extends substantially transversely to the guiding section of the slot and/or in a circumferential direction. The locking structure and the guiding section may be formed as a continuous slot. This enables the piston member to be guided from the first position to the second position. Thereafter, the piston member may be further displaced, for instance by rotating the piston member, in order to engage the engaging element with the locking structure to maintain the piston member in the second position. In other words, the locking section may be formed as a bayonet mount.

Preferably, the locking mechanism is actuated to maintain the piston member in the second position by rotating the piston member relative to the body member to engage the engaging element with the locking structure once the piston member is in the second position.

Thus, once the piston member has been displaced from the first position to the second position, for instance by pulling the piston member substantially longitudinally manually by the user, the piston member can be fixed in the second position by rotating the piston member relative to the body member. By rotating the piston member relative to the body member, the engaging element and the locking structure are thus displaced relative to one another from a disengaged state to an engaged state. In the engaged state, the engaging element and the locking structure prevent the piston member from returning to the first position.

Alternatively or additionally, the engaging element may be insertable into at least a portion of the locking structure in a self-activating manner to engage the engaging element with the locking structure when the piston member is brought to the second position.

For instance, the engaging element and/or the locking structure may be deflectable relative to each other. For instance, as the piston is being displaced to the second position, the engaging element and the locking structure may be configured to contact each other prior to reaching the second position. As a result of a force acting on the engaging element and/or the locking structure resulting from the engaging element contacting the locking structure, the engaging element and/or the locking structure may be deflected and/or biased to allow the engaging element to pass the locking structure. Once the piston member is in the second position, the engaging element and/or the locking structure may at least partially return to its or their original, i.e. non-deflected, position and may retain the piston member in the second position by engagement of the engaging member and the locking structure. Thus, the engaging element may be insertable into at least a portion of the locking structure in a self-activating manner, i.e. without having to actively, for instance by a force exerted by the user, manoeuvre the engaging element to circumvent the locking structure or vice versa.

As opposed to a rigid, i.e. non-deflectable, engaging element and locking structure, in which case the engaging element would have to bypassed by actively moving the piston member or the body member, for instance by means of a force exerted by the user on the piston member or the body member, such an additional movement can be omitted if the engaging element and/or the locking structure are configured to be deflectable. This may be helpful for further reducing the forces exerted on the patient after grasping the cervix, for example rotational forces.

The deflectable engaging element and/or locking structure may be realized, for instance, by configuring the material of the engaging element and/or the locking structure to allow the engaging element and/or the locking structure to bend or deform otherwise. For instance, a protruding tab or arm may be provided.

Alternatively or additionally, the engaging element and/or the locking structure may be provided with a spring, which may allow the engaging element and/or the locking structure to be deflected by compression of the spring as the engaging element and the locking structure contact each other prior to the piston member reaching the second position. Once the piston member is in the second position, the engaging element and/or the locking structure can at least partially return to its or their original, i.e. non-deflected, position by the spring force acting on the engaging element and/or the locking structure.

In other words, the locking mechanism may comprise an undercut (which may be formed, for example, by a recess, an opening, or a protrusion) provided on a first one of the body member and the piston member. The engaging element provided on the other one of the body member or the piston member may be configured to snap into the undercut (e.g., the recess or opening) to lock the relative position of the two members (in particular, to lock the relative position of the two members once sufficient vacuum has been generated in the vacuum chamber). The engaging element may be a deflectable arm, e.g. a cantilever arm, which can be resiliently biased.

Preferably, the engaging element and/or the locking structure are deflectable in a direction that is oblique or substantially perpendicular to a longitudinal axis of the rod member while the piston member is being moved between the first position and the second position.

The handheld gynecological device may further comprise a disengaging actuator that is configured to exert a force on the engaging element. The disengaging actuator preferably is configured to disengage the engaging element from the locking structure, preferably by exerting a force on the disengaging actuator, thereby deflecting the engaging element. The disengaging actuator may thus provide a means for the user to release the locking mechanism such that the piston member may be returned to the first position, for instance after completion of the medical procedure.

Preferably, the engaging element may be deflected in a direction oblique or substantially perpendicular to a longitudinal axis of the rod member to disengage the engaging element.

Alternatively, for example when a bayonet mount is used, the engaging element may be disengagable from the locking structure by rotating the piston member relative to the body member when the piston member is in the second position.

If desired, the locking mechanism may comprise at least two slots formed in the piston member or the body member and preferably at least two engaging elements formed on the other one of the piston member and the body member. This provides for a better guidance of the members when moving them relative to each other. The at least two slots and the at least two engaging elements may be arranged diametrically opposed to each other.

The locking mechanism may also comprise more than two slots, for instance three, four, five or six slots, which may be distributed around the circumference of the piston member or the body member. In this case, preferably the other one of the piston member and the body member comprises the same amount of engaging elements as the number of slots provided, wherein each engaging element may be receivable by one of the slots.

Alternatively, the locking mechanism may comprise more engaging elements than slots, so that at least one of the plurality of slots may be configured to receive at least two or more engaging elements.

Preferably, the rod member is substantially rigid. Substantially rigid is to be understood as providing sufficient stiffness of the rod member such that the rod member does not bend or is otherwise deformed, or is only minimally bent or otherwise deformed, when manipulating the cervix.

Preferably, the longitudinal axis of the rod member and the longitudinal axis of the body member are parallel or coincide with each other.

Preferably, the rod member and/or the body member is substantially hollow cylindrical.

Preferably, the gynecological device has a total length extending in the direction of the longitudinal axis of the rod member. Preferably, when the piston member is in the second position, the total length is <NUM> or less. More preferably, the total length is <NUM> or less. More preferably, the total length is <NUM> or less.

Preferably, the rod member is <NUM> long or more, more preferably <NUM> long or more, or <NUM> or more. Preferably, the rod member is <NUM> long or less, preferably <NUM> long or less. For example, the length of the rod member may be about <NUM>. Such lengths are favourable for inserting the rod member through the vagina of the patient to engage with at least a portion of the cervix while allowing the user to operate the gynecological device, such as by actuating the actuating member.

Thus, depending on the required length of the gynecological device, for instance due to the varying anatomy of patients, the user can adapt the gynecological device according to the situation.

Preferably, the piston member has a total length extending in the direction of the longitudinal axis of the rod member of <NUM> or less, more preferably of <NUM> or less, most preferably of <NUM> or less.

Preferably, the lumen of the rod member is at ambient pressure when the actuating member is in the disconnected position. For example, the handheld gynecological device may further comprise an ambient opening fluidly connected to an ambient environment outside of the gynecological device. Preferably, the lumen of the rod member is fluidly connected to the ambient opening when the actuating member is in the disconnected position. Preferably, the lumen of the rod member can be fluidly disconnected from the ambient opening when the actuating member is in the connected position.

By configuring the handheld gynecological device such that the lumen of the rod member may be fluidly connected to the ambient environment when the actuating member is in the disconnected position and fluidly disconnected from the ambient environment when the actuating member is in the connected position, the vacuum in the lumen of the rod member, and thus the suction, can be released. This allows a simple and comfortable disengagement of the device from the cervix of the patient when the actuating member is switched to the disconnected position. This further enhances the ease of operation of the gynecological device and the safety and comfort of the patient during performance of the medical procedure.

Embodiments of the present invention are further elucidated below with reference to the figures.

<FIG> shows a handheld gynecological device <NUM> for cervix handling comprising a body member <NUM> having a wall <NUM> defining a vacuum chamber <NUM> and having a proximal end <NUM> and a distal end <NUM>. The body member <NUM> further comprises an opening <NUM> at its proximal end <NUM> and an opening <NUM> at its distal end <NUM>.

The handheld gynecological device <NUM> further comprises a rod member <NUM> having a wall <NUM> defining a lumen <NUM> and further having a proximal end <NUM> and a distal end <NUM>.

The handheld gynecological device <NUM> also comprises a piston member <NUM> having a proximal end <NUM> and a distal end <NUM> and being partially received in the vacuum chamber <NUM> of the body member <NUM> such that the proximal end <NUM> of the piston member <NUM> extends out of the vacuum chamber <NUM> through the opening <NUM> of the body member <NUM>.

At the proximal end <NUM>, the piston member <NUM> comprises a gripping section <NUM> having a flared form, similar to a bell mouth, to facilitate gripping the piston member <NUM> by a user. The piston member <NUM> further comprises a sealing element <NUM> arranged in a recess <NUM> formed at the distal end <NUM> of the piston member <NUM>.

The piston member <NUM> is partially received in the vacuum chamber <NUM> of the body member <NUM> such that the piston member <NUM> can be displaced axially along a longitudinal axis of the body member <NUM> from a first position to a second position to generate a vacuum in the vacuum chamber <NUM>.

In the embodiment shown in <FIG>, the longitudinal axis of the body member is coincident with a longitudinal axis of the rod member <NUM>. Thus, in this case, the piston member <NUM> can be displaced axially along the longitudinal axis of the body member <NUM> and the longitudinal axis of the rod member <NUM>. However, it is also feasible that the longitudinal axis of the body member <NUM> is not coincident with the longitudinal axis of the rod member <NUM>. For instance, the longitudinal axis of the body member <NUM> may extend at an angle to the longitudinal axis of the rod member <NUM>. Thus, in this case, the piston member <NUM> can be displaced axially along a longitudinal axis of the body member <NUM>.

<FIG> shows the piston member <NUM> in the first position, i.e. when the piston member <NUM> is inserted at the furthest possible distal position in the vacuum chamber <NUM>. To generate a vacuum in the vacuum chamber <NUM>, the user can grasp the piston member <NUM> at the gripping section <NUM> and exert a pulling force in a proximal direction to axially move the piston member <NUM> to the second position, i.e. when the piston member <NUM> is at its fully or nearly fully extended position in the proximal direction.

As <FIG> further shows, the handheld gynecological device <NUM> further comprises a suction head <NUM> coupled to the distal end <NUM> of the rod member <NUM>. The suction head <NUM> comprises a suction head wall <NUM> defining a suction head lumen <NUM> and an engaging surface <NUM> configured to engage at least a portion of a cervix of a patient. The suction head <NUM> further comprises a sealing element <NUM> attached to the engaging surface <NUM> to provide a substantially fluid-tight seal between the suction head <NUM> and the portion of the cervix the suction head <NUM> is applied to. The suction head lumen <NUM> is in fluid communication with the lumen <NUM> of the rod member <NUM>.

The suction head <NUM> may be substantially C-shaped, when viewed in a proximal direction. Moreover, the engaging surface <NUM> is not arranged in a single plane. Instead, a plurality of sections of the engaging surface <NUM> are each arranged on different planes. This facilitates engaging the cervix of a patient.

Moreover, the suction head <NUM> has a cross-section that is larger than a cross-section of the rod member <NUM>, wherein the cross-section is determined based on a cross-sectional view substantially perpendicular to the longitudinal axis of the rod member <NUM>. The larger cross-section is provided by the suction head lumen <NUM> being larger than the lumen <NUM> of the rod member <NUM>. This facilitates gripping and manipulating of the cervix of a patient by providing a larger engagement surface.

The handheld gynecological device <NUM> further comprises an actuating mechanism <NUM> having an actuating member <NUM> and a static member <NUM>. The actuating mechanism <NUM> is shown in more detail in <FIG> and <FIG>.

Furthermore, the handheld gynecological device <NUM> comprises a locking mechanism <NUM> comprising a slot <NUM> formed in the piston member <NUM> and an engaging element <NUM> fixed to the wall <NUM> of the body member <NUM>. The engaging element <NUM> is thereby partially received in an opening formed in the wall <NUM> of the body member <NUM>. Alternatively, the engaging element <NUM> may be formed integrally with the wall <NUM> of the body member <NUM>. The engaging element <NUM> is slidably received in the slot <NUM>.

The slot <NUM> comprises a guiding section <NUM> extending substantially parallel to the longitudinal axis of the body member <NUM> and configured to guide the engaging element <NUM> as the piston member <NUM> is moved between the first position and the second position. The slot <NUM> further comprises a locking section <NUM> providing a locking structure <NUM> providing a stop or undercut for the engaging element <NUM> to maintain the piston member <NUM> in the second position. The locking section <NUM> may extend substantially transversely to the guiding section <NUM> along a portion of the circumference of the piston member <NUM>.

In order to fix the piston member <NUM> in the second position by the locking mechanism <NUM>, the piston member <NUM> is first displaced from the first position to the second position by exerting a pulling force, for instance by manually pulling on the piston member <NUM> or by actuating a mechanical element, such as a spring or an electric motor. The engaging element <NUM> is thereby guided in the guiding section <NUM> of the slot <NUM>. Once the piston member <NUM> is in the second position, the piston member <NUM> can be rotated about an axis, which in the case of the embodiment shown in <FIG> coincides with the longitudinal axis of the body member <NUM>.

By rotating the piston member <NUM>, the engaging element <NUM> is received in the locking section <NUM> of the slot <NUM>. Once the engaging element <NUM> is received in the locking section <NUM> of the slot <NUM>, the locking structure <NUM> prevents the piston member <NUM> from returning to the first position, thus maintaining the piston member <NUM> in the second position.

To return the piston member <NUM> to the first position, the piston member <NUM> can be rotated in a direction opposite to the direction in which the piston member <NUM> was rotated to insert the engaging element <NUM> in the locking section <NUM> of the slot <NUM>. Thus, the engaging element <NUM> is released from the locking section <NUM> of the slot <NUM> and the piston member <NUM> can be returned to the first position.

As shown in <FIG> and <FIG>, the actuating member <NUM> is slidably attached to the static member <NUM> such that the actuating member <NUM> can be slid along the static member <NUM> to switch the actuating member <NUM> between a disconnected position and a connected position.

The handheld gynecological device <NUM> further comprises a connecting element <NUM> which mechanically connects the rod member <NUM> to the body member <NUM> via the static member <NUM>.

However, the connecting element <NUM> may be omitted. In this case, the rod member <NUM> and the connecting element <NUM> may be a single integral part. In this case, the body member <NUM> may be mechanically connected directly to the rod member <NUM> or it may be formed integrally therewith.

The rod member <NUM> is configured to be connected to the body member <NUM>. For example, the rod member <NUM> and the body member <NUM> may be connected to each other by a material bond, such as by using an adhesive or by using hot air welding, ultrasonic welding, or laser welding to weld the rod member <NUM> to the body member <NUM>. Other types of permanent or detachable connections may also be used.

The actuating member <NUM> comprises an inner section <NUM> and an outer section <NUM>. The inner section <NUM> is partially received within a portion of the wall <NUM> of the body member <NUM>, whereas the outer section <NUM> is arranged outside of the wall <NUM> of the body member <NUM>. The inner section <NUM> and the outer section <NUM> are connected to each other by a connection structure (not shown in <FIG> and <FIG>). Preferably, the connecting structure extends through slots formed in the wall <NUM> of the body member <NUM> so that the actuating member <NUM> can be slid along the wall <NUM> of the body member <NUM>. The inner and outer sections <NUM>, <NUM> may be integrally formed with each other.

The outer section <NUM> of the actuating member <NUM> provides a gripping portion having one or more (e.g., two) protrusions <NUM> extending from the outer surface of the outer section <NUM> to facilitate gripping the outer section <NUM> and axially displacing the actuating member <NUM> between the disconnected and the connected positions. The protrusions <NUM> each extend around a portion of the circumference of the outer section <NUM>. Alternatively, the outer section <NUM> may have a single protrusion <NUM> extending around a portion of the circumference of the outer section <NUM> or around the entire circumference of the outer section <NUM>.

The inner section <NUM> comprises a channel <NUM> formed substantially in the center of the inner section <NUM>. The channel <NUM> has a section <NUM> with an enlarged diameter compared with other sections of the channel <NUM>. The inner section <NUM> further comprises two sealing elements <NUM> that may be arranged in recesses formed in the inner section <NUM> on opposite sides of the section <NUM>.

The static member <NUM> comprises a channel <NUM> having two channel sections <NUM>, <NUM> fluidly separated from each other by a separation element <NUM>. Each channel section <NUM>, <NUM> comprises two channel segments <NUM>, <NUM> and <NUM>, <NUM>. The channel sections <NUM>, <NUM> extend substantially axially along the longitudinal axes of the body member <NUM> and/or the rod member <NUM>, whereas the channel sections <NUM>, <NUM> extend substantially perpendicular to the longitudinal axes of the body member <NUM> and/or the rod member <NUM>. The channel segments <NUM> and <NUM> are fluidly connected to each other and the channel segments <NUM> and <NUM> are fluidly connected to each other.

<FIG> shows the actuating member <NUM> in the disconnected position. In this position, the channel sections <NUM>, <NUM> are not connected to each other via the section <NUM>. Thus, the channel sections <NUM>, <NUM> are fluidly disconnected.

The sealing elements <NUM> preferably provide a seal proximally and distally of the channel <NUM>. In this manner, the channel <NUM> is sealed from the surrounding environment when the actuating member <NUM> is in the disconnected position. Meanwhile, the proximal aperture of the channel <NUM> is located distally of the distal one of the sealing elements <NUM>. Therefore, the channel <NUM> is not fluidly connected with the channel <NUM>. Rather, the channel <NUM> (and thus the lumen <NUM> of the rod member <NUM>) is connected with the surrounding environment.

By axially displacing the outer section <NUM>, and thus the inner section <NUM> as well, from the disconnected position to the connected position in the distal direction, the section <NUM> with an enlarged diameter is displaced axially, in the illustrative example of <FIG>, distally. In the connected position, as shown in <FIG>, the section <NUM> with an enlarged diameter at least partially overlaps with the channel sections <NUM>, <NUM>, thus fluidly connecting said channel sections <NUM>, <NUM> with each other. In this connected position, the vacuum chamber <NUM> is fluidly connected to the lumen <NUM> of the rod member <NUM> and thus to the suction head <NUM>.

Thus, in the connected position, the vacuum generated in the vacuum chamber <NUM> by the piston member <NUM> can be transferred to the lumen <NUM> of the rod member <NUM> and thus to the suction head <NUM> by the actuating mechanism <NUM> to provide a vacuum to grasp and manipulate the cervix of the patient at the suction head <NUM>.

Since the sealing elements <NUM> are attached to the inner section <NUM> on opposite sides of the section <NUM>, the sealing elements <NUM> are also displaced along with the inner section <NUM>. Thus, in the connected position, the sealing elements <NUM> are arranged to prevent air from entering into the channels <NUM>, <NUM> from the environment in order to maintain the vacuum.

<FIG> and <FIG> show a handheld gynecological device <NUM> according to an alternative embodiment. The embodiment shown in <FIG> and <FIG> differs from the embodiment shown in <FIG> mainly in the configuration of the actuating mechanism, which is referenced by the reference sign <NUM> in <FIG> and <FIG>.

As may be seen in greater detail in <FIG>, an actuating member <NUM> comprises a channel <NUM>, which may have a tapered form, extending through the actuating member <NUM>. The channel <NUM> tapers towards the center of the extension of the channel <NUM> in a distal direction, i.e. the cross-section of the channel <NUM> is continuously reduced. In the remaining extension of the channel <NUM>, the cross-section of the channel <NUM> is continuously increased in a distal direction.

In the embodiment shown in <FIG> and <FIG>, a static member <NUM> connects the body member <NUM> to the rod member <NUM>. Furthermore, the static member <NUM> comprises a channel <NUM> formed in a section thereof.

As opposed to the embodiment shown in <FIG>, in which the opening <NUM> formed at the distal end of the body member <NUM> is arranged centrally, i.e. substantially along the longitudinal axis of the body member <NUM>, the opening <NUM> formed at the distal end of the body member <NUM> in the embodiment according to <FIG> and <FIG> is arranged decentrally, i.e. outside of the longitudinal axis of the body member <NUM>, substantially aligned with the channel <NUM> formed in the static member <NUM>.

According to the embodiment shown in <FIG> and <FIG>, the actuating member <NUM> comprises a sealing element <NUM> arranged in a recess formed in the actuating member <NUM>. Furthermore, the body member <NUM> also comprises a sealing element <NUM> arranged in a recess formed at the distal end <NUM> of the body member <NUM>. The sealing elements <NUM> are arranged and configured to prevent air from entering into the device <NUM> from the environment through channels <NUM>, <NUM> or through opening <NUM> in order to maintain the vacuum.

In the connected position, which is shown in <FIG> and <FIG>, the channel <NUM> of the actuating member <NUM>, the channel <NUM> formed in the static member <NUM> and the opening <NUM> of the body member <NUM> are fluidly connected to each other to provide a fluid connection between the vacuum chamber <NUM> and the lumen <NUM> of the rod member <NUM> and thus to the suction head <NUM>.

In the embodiment shown in <FIG> and <FIG>, the channel <NUM> of the actuating member <NUM>, the channel <NUM> formed in the static member and the opening <NUM> of the body member <NUM> are substantially aligned with each other in the connected position, as shown in <FIG> and <FIG>. However, it is also feasible to fluidly connect the channel <NUM> of the actuating member <NUM>, the channel <NUM> formed in the static member and the opening <NUM> of the body member <NUM> without configuring said channels <NUM>, <NUM> and said opening <NUM> to be aligned with each other in the connected position. For instance, the opening <NUM> and the channel <NUM> may be offset from each other, i.e. not aligned, and the channel <NUM> may extend at an angle to the longitudinal axis of the body member <NUM> to fluidly connect the opening <NUM> and the channel <NUM> in the connected position to provide a fluid connection between the vacuum chamber <NUM> and the lumen <NUM> of the rod member <NUM> and thus to the suction head <NUM>.

It will also be appreciated that a de-central arrangement of the opening <NUM> and/or of the channel <NUM> may be favourable for the construction of the actuating member <NUM>. However, it will be appreciated that also a central arrangement is possible.

To switch the actuating member <NUM> from the disconnected position to the connected position, the actuating member <NUM> is rotated substantially about the longitudinal axis of the body member <NUM> and/or the rod member <NUM>. The channel <NUM> formed in the actuating member <NUM> is thereby also rotated substantially about the longitudinal axis of the body member <NUM> and/or the rod member <NUM>. Thus, as the channel <NUM> formed in the actuating member <NUM> fluidly connects the opening <NUM> of the body member <NUM> and the channel <NUM> formed in the static member <NUM>, the actuating member <NUM> and the channel <NUM> is rotated substantially about the longitudinal axis of the body member <NUM> and/or the rod member <NUM> to fluidly connect the opening <NUM> of the body member <NUM> and the channel <NUM> formed in the static member <NUM>.

As the actuating member <NUM> is rotated substantially about the longitudinal axis of the body member <NUM> and/or the rod member <NUM> from the connected position back to the disconnected position, the channel <NUM> formed in the actuating member <NUM> is also rotated such that the channel <NUM> is no longer in fluid connection with the opening <NUM> of the body member <NUM> and the channel <NUM> formed in the static member <NUM>. In this position, the channel <NUM> and the channel <NUM> are arranged offset relative to each other and relative to the longitudinal axis of the rod member <NUM> and the longitudinal axis of the body member <NUM>.

Thus, in the disconnected position, the vacuum chamber <NUM> and the lumen <NUM> of the rod member <NUM> are not fluidly connected via the opening <NUM> of the body member <NUM>, the channel <NUM> of the actuating member <NUM> and the channel <NUM> formed in the static member <NUM>.

<FIG> and <FIG> show an alternative embodiment of the handheld gynecological device <NUM>. The embodiment shown in <FIG> and <FIG> differs from the embodiments shown in <FIG> and <FIG> and <FIG> mainly in the configuration of the actuating mechanism, which is referenced to by the reference sign <NUM> in <FIG> and <FIG>.

As may be seen in greater detail in <FIG>, the actuating member <NUM> comprises a channel <NUM> extending through the actuating member <NUM>. The channel may have a tapered form in the distal direction.

In the embodiment shown in <FIG> and <FIG>, the static member <NUM> connects the body member <NUM> to the rod member <NUM>. Furthermore, the static member <NUM> comprises a channel <NUM> formed in a section thereof.

In the disconnected position, which is shown in <FIG> and <FIG>, the channel <NUM> of the actuating member <NUM>, the channel <NUM> formed in the static member <NUM> and the opening <NUM> of the body member <NUM> are fluidly connected to each other to provide a fluid connection between the vacuum chamber <NUM> and the lumen <NUM> of the rod member <NUM> and thus to the suction head <NUM>.

In the embodiment shown in <FIG> and <FIG>, the channel <NUM> of the actuating member <NUM>, the channel <NUM> formed in the static member and the opening <NUM> of the body member <NUM> are substantially aligned with each other in the connected position, as shown in <FIG> and <FIG>. However, it is also feasible to fluidly connect the channel <NUM> of the actuating member <NUM>, the channel <NUM> formed in the static member and the opening <NUM> of the body member <NUM> without configuring said channels to be aligned with each other in the connected position. For instance, the opening <NUM> and the channel <NUM> may be offset from each other, i.e. not aligned, and the channel <NUM> may extend at an angle to the longitudinal axis of the body member <NUM> to fluidly connect the opening <NUM> and the channel <NUM> in the connected position to provide a fluid connection between the vacuum chamber <NUM> and the lumen <NUM> of the rod member <NUM> and thus to the suction head <NUM>.

To switch the actuating member <NUM> form the disconnected position to the connected position, the actuating member <NUM> is displaced substantially perpendicular to the longitudinal axis of the body member <NUM> and/or the rod member <NUM>. The channel <NUM> formed in the actuating member <NUM> is thereby also displaced substantially perpendicular to the longitudinal axis of the body member <NUM> and/or the rod member <NUM>.

Thus, as the channel <NUM> formed in the actuating member <NUM> fluidly connects the opening <NUM> of the body member <NUM> and the channel <NUM> formed in the static member <NUM>, the actuating member <NUM> and the channel <NUM> is displaced substantially perpendicular to the longitudinal axis of the body member <NUM> and/or the rod member <NUM> to fluidly connect the opening <NUM> of the body member <NUM> and the channel <NUM> formed in the static member <NUM>.

As the actuating member <NUM> is displaced substantially perpendicular to the longitudinal axis of the body member <NUM> and/or the rod member <NUM> from the connected position back to the disconnected position, the channel <NUM> formed in the actuating member <NUM> is displaced such that the channel is no longer in fluid connection with the opening <NUM> of the body member <NUM> and the channel <NUM> formed in the static member <NUM>. In this position, the channel <NUM> is arranged offset relative to the channel <NUM> and to the opening <NUM>. Thus, in the disconnected position, the vacuum chamber <NUM> and the lumen <NUM> of the rod member <NUM> are not fluidly connected via the opening <NUM> of the body member <NUM>, the channel <NUM> of the actuating member <NUM> and the channel <NUM> formed in the static member <NUM>.

More generally speaking, in the embodiments of <FIG>, the connected position is achieved by having a first portion of the channel <NUM>, <NUM>, <NUM> in the actuating member <NUM>, <NUM>, <NUM> (e.g., a proximal portion or opening of the channel <NUM>, <NUM>, <NUM>) at least partially overlap with a channel that is in fluid connection with the vacuum chamber <NUM> (in the exemplary embodiment of <FIG>, with the opening <NUM>, <NUM>; in <FIG> with the channel <NUM>) and having a second portion of the channel <NUM>, <NUM>, <NUM> in the connecting member <NUM>, <NUM>, <NUM> (e.g., a distal portion or opening of the channel <NUM>, <NUM>, <NUM>) at least partially overlap with a channel that is in fluid connection with the suction head <NUM> (e.g., with the lumen <NUM> of the rod member <NUM> or with a channel <NUM>, <NUM>, <NUM> that is fluidly connected with said lumen <NUM> of the rod member <NUM>). In the connected position, as shown in <FIG>, a first seal member <NUM> preferably is arranged around the first portion and a second seal member <NUM> preferably is arranged around the second portion of the channel <NUM>, <NUM>, thus preventing ambient air from entering where the channels overlap. However, the sealing may also be achieved in a different manner (see, for example, <FIG>).

The disconnected position is preferably achieved by avoiding the above-mentioned overlap of the first and/or second portion of the channel <NUM>, <NUM>, <NUM> with the channel fluidly coupled to the vacuum chamber <NUM> and/or the channel fluidly coupled to the suction head <NUM>, respectively (see, for example <FIG>). In the disconnected position, one of the seal members <NUM> may be arranged around the channel fluidly coupled to the vacuum chamber <NUM> and seal against a surface of the actuating member <NUM>, <NUM>, <NUM>, thus preventing ambient air from entering the vacuum chamber <NUM>. The channel that is fluidly coupled with the suction head <NUM> may be connected to the surrounding environment to release vacuum provided therein, e.g. by arranging the second seal member <NUM> such that it is moved away from this channel (see, for example, <FIG>) and/or by providing a further pressure relief channel (not shown) in the actuating member <NUM>, <NUM> that is fluidly connected with the suction head <NUM> when the actuating mechanism is moved into the disconnected position.

In the embodiment of <FIG> and <FIG>, the actuating member <NUM> is rotated to move the channel <NUM> between the connected and disconnected positions (in the example shown, the rotation occurs around the longitudinal axis of the rod member <NUM> and/or of the body member <NUM>, but also another axis may be chosen). In the embodiments of <FIG>, <FIG> and <FIG>, the actuating member <NUM>, <NUM> is slid to move the channel <NUM>, <NUM> between the connected and disconnected positions.

<FIG> show alternative embodiments of a locking mechanism <NUM>, <NUM> of a handheld gynecological device <NUM>, <NUM>. The devices <NUM>, <NUM> may include any of the actuating mechanism discussed above with reference to <FIG>.

As may be seen from the Figures, the gynecological device <NUM>, <NUM> comprises two slots arranged diametrically opposite from each other. The gynecological device <NUM>, <NUM> thus also comprises two engaging elements <NUM>, which are however not visible due to the cross-sectional view of <FIG>. Thus, the locking mechanism <NUM>, <NUM> is described in the following based on the visible portion of the locking mechanism <NUM>, <NUM> in <FIG> and <FIG>. The skilled reader will appreciate that one, two, or more slots and one, two, or more respective engaging elements may be employed in accordance with the principles disclosed herein.

In <FIG>, the locking mechanism <NUM> comprises a guiding section <NUM> similar or identical to the guiding section <NUM> shown in the embodiments of <FIG>. Also similar to the embodiments of <FIG>, the engaging element <NUM> may be at least partially received in an opening <NUM> formed in the wall <NUM> of the body member <NUM>, with a portion of the engaging element <NUM> extending into an interior of the body member <NUM>.

The embodiment according to <FIG> differs from the embodiments shown in <FIG> mainly in the configuration of the locking section, denoted as <NUM> in <FIG>.

Instead of providing a locking section extending substantially transversely to the guiding section <NUM> along a portion of the circumference of the piston member, as shown in embodiments of <FIG>, the embodiment according to <FIG> comprises a deflectable locking structure <NUM> formed on the piston member <NUM> which is engagable with the engaging element <NUM>.

As the piston member <NUM> is being displaced to the second position, the engaging element <NUM> and the deflectable locking structure <NUM> contact each other prior to reaching the second position. The force acting on the engaging element <NUM> and the deflectable locking structure <NUM> effected by the engaging element <NUM> contacting with the deflectable locking structure <NUM> causes the locking structure <NUM> to be deflected substantially perpendicular to the longitudinal axis of the body member <NUM> to allow the deflectable locking structure <NUM> to pass the engaging element <NUM>.

Once the piston member <NUM> is in the second position, the deflectable locking structure <NUM> can at least partially return to its original, i.e. non-deflected, position and can retain the piston member <NUM> in the second position by engagement of the engaging member <NUM> and the deflectable locking structure <NUM>. The engaging element <NUM> may thus be received in a locking section <NUM> in a self-activating manner, i.e. without having to actively, for instance by a force exerted by the user, manoeuvre the engaging element <NUM> to circumvent the locking structure, such as by rotating the piston member as described in connection with the embodiments shown in <FIG>.

In <FIG> and <FIG>, the deflectable locking structure <NUM> is configured as an arm or protrusion extending from a portion of the piston member <NUM> in a distal direction. The deflectable locking structure <NUM> is dimensioned such to allow deflection of the deflectable locking structure <NUM> without breaking the deflectable locking structure <NUM> or substantially permanently deforming the deflectable locking structure <NUM>. However, the engaging element <NUM> may alternatively or additionally also be configured as a deflectable part.

For instance, the engaging element <NUM> may also be configured to allow deflection of the engaging element <NUM> without breaking the engaging element <NUM> or substantially permanently deforming it.

Moreover, the engaging element <NUM> and/or the deflectable locking structure <NUM> may be provided with an additional biasing element, such as a spring, to allow the engaging element <NUM> and/or the deflectable locking structure <NUM> to be deflected by compression of the detent element, for instance by compression of the spring, as the engaging element <NUM> and the deflectable locking structure <NUM> contact each other prior to reaching the second position. Once the piston member <NUM> is in the second position, the engaging element <NUM> and/or the deflectable locking structure <NUM> may at least partially return to its original, i.e. non-deflected position, by a restoring force provided by the biasing element, such as a spring force provided by the compressed spring, and acting on the engaging element <NUM> and/or the deflectable locking structure <NUM>.

To return the piston member <NUM> to the first position, the slot <NUM> may comprise a manoeuvring section <NUM>, only rudimentarily shown in <FIG>. To allow the engaging element <NUM> to pass the deflectable locking structure <NUM>, the piston member <NUM> can be rotated about the longitudinal axis of the body member <NUM> such that the engaging element <NUM> is received in the manoeuvring section <NUM>. The manoeuvring section <NUM> allows the engaging element <NUM> to bypass the deflectable locking structure <NUM> to allow the piston member <NUM> to return to the first position.

Once the engaging element <NUM> has bypassed the deflectable locking structure <NUM>, the engaging element <NUM> may be received in the guiding section <NUM> to allow the piston member <NUM> to be guided back to the first position.

<FIG> show an alternative embodiment of a locking mechanism <NUM>. According to <FIG>, the locking mechanism <NUM> comprises a disengaging actuator <NUM>. The disengaging actuator <NUM> may, for manufacturing purposes, be connected to the engaging element <NUM> via a connection element <NUM>. The disengaging actuator <NUM> may extend through an opening <NUM> formed in the wall <NUM> of the body member <NUM>. Furthermore, the disengaging actuator <NUM> may further comprise a projection <NUM> configured to engage with the deflectable locking structure <NUM>.

Thus, in order to release the locking mechanism <NUM> to allow the piston member <NUM> to be returned to the first position, the user can actuate the disengaging actuator <NUM> by exerting a pushing force thereupon. The projection <NUM> thereby engages the deflectable locking structure <NUM>, deflecting the deflectable locking structure <NUM> perpendicular to the longitudinal axis of the body member <NUM>. Thus, this allows the engaging element <NUM> to pass the deflectable locking structure <NUM> to enable the piston member <NUM> to return to the first position.

It is understood that the locking mechanisms <NUM>, <NUM> shown in <FIG> may be combined with any of the actuating mechanisms <NUM>, <NUM>, <NUM> shown in <FIG>.

However, the locking mechanisms <NUM>, <NUM>, <NUM> disclosed herein may also be implemented in a gynecological device independently from the actuating mechanisms disclosed herein. Instead, the locking mechanisms <NUM>, <NUM>, <NUM> may be combined with actuating mechanisms not disclosed herein or without an actuating mechanism altogether.

Claim 1:
A handheld gynecological device (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) for cervix handling, comprising:
- a body member (<NUM>) defining a vacuum chamber (<NUM>) and having a proximal end (<NUM>) and a distal end (<NUM>);
- a piston member (<NUM>; <NUM>) being at least partially received in the vacuum chamber (<NUM>) and configured such that at least a portion of the piston member (<NUM>; <NUM>) is displaceable in the vacuum chamber (<NUM>) from a first position to a second position for creating a vacuum in the vacuum chamber (<NUM>);
- an actuating mechanism (<NUM>; <NUM>; <NUM>) having an actuating member (<NUM>; <NUM>; <NUM>);
- a rod member (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>), the rod member (<NUM>) defining a lumen (<NUM>) and being configured to be coupled to the body member (<NUM>); and
- a suction head (<NUM>) configured to engage at least a portion of a cervix of a patient, the suction head (<NUM>) being fluidly connected to the distal end (<NUM>) of the rod member (<NUM>) and having a cross-section that is larger than a cross-section of the rod member (<NUM>);
wherein the position of the rod member (<NUM>) along the longitudinal axis of the body member is fixed relative to the body member (<NUM>) when the rod member (<NUM>) is coupled to the body member (<NUM>); and
wherein the actuating member (<NUM>; <NUM>; <NUM>) is coupled to the body member (<NUM>) and/or the rod member (<NUM>) characterized in that the actuating member (<NUM>; <NUM>; <NUM>) is configured to be switched from a disconnected position, in which the vacuum chamber (<NUM>) of the body member (<NUM>) is fluidly disconnected from the lumen (<NUM>) of the rod member (<NUM>), to a connected position, in which the vacuum chamber (<NUM>) of the body member (<NUM>) is fluidly connected to the lumen (<NUM>) of the rod member (<NUM>).