Inserter for inserting an intrauterine device

Abstract

The present invention relates to an inserter for inserting, into the uterine cavity of a patient, an intrauterine device (IUD) of the hormonal or copper coil type. The inserter according to the present invention comprises a movable slider arranged in a longitudinal opening having lateral structural elements capable of sliding on lateral guides along the walls of the handle. Abstract figure: Fig 2

Description

Title of the invention: Inserter for inserting an intrauterine device

[0001] The present invention relates to an inserter for inserting, into the uterine cavity of a patient, preferably an intrauterine device (IUD) of the hormonal or copper coil type, or a device containing medicinal substances used for hormonal therapies, chemotherapies or any other substances or devices to be inserted into the uterine cavity as part of treatment or monitoring in a patient.

[0002] State-of-the-art inserters generally comprise as essential elements an insertion tube having a relatively narrow diameter and a rounded end, and a pusher also called a plunger or mandrel inside the inserter tube which allows the IUD to be ejected by pushing out of the tube, into the uterine cavity. Before the IUD is inserted into the uterine cavity of a patient, the IUD which is in an unfolded position in its packaging before use, is reinserted into the inserter tube to be in its folded form in the tube (the horizontal branches of the T-shaped IUD are folded inside the inserter tube in the axis of the tube)

[0003] - either by pulling on the thread attached to the IUD (said thread being intended for removing the IUD from the uterus),

[0004] - either by inserting the IUD into the inserter tube by means of a mechanism actuated by a slider.

[0005] Then, the inserter tube still including the IUD in the folded position inside the tube is introduced through the cervical canal into the uterus. When the insertion tube is correctly positioned, the IUD is released either by pushing a plunger towards the uterus, or by holding the plunger still and actuating a slider, in communication with the inserter tube, backwards which has the effect of sliding the inserter tube backwards and releasing the IUD from the inserter tube. Once released from the inserter tube the horizontal branches of the IUD are found deployed in a T shape, in the uterine cavity.

[0006] Most state-of-the-art inserters proceed in the manner described above to insert an IUD into a patient's uterine cavity.

[0007] Document WO2010031899 describes for example an inserter provided with a handle which can have many shapes and which is designed for easy handling of the inserter using only one hand.

[0008] The pusher attached to the handle is advantageously hollow or has a groove extending in the axial direction thus allowing the wire to slide freely therein.

[0009] The inserter of document WO2010031899 comprises a movable slider and locking means to keep the thread locked before insertion of the IUD or to release the thread when the slider is moved backward. Inserters having the locking means as described above may cause an audible disturbance to the patient when the slider activates the locking / unlocking mechanism of the inserter introduced into a patient's uterus.

[0010] Therefore, there continues to be a need for the implementation of novel IUD inserters that provide improved patient comfort and ease of use for the practitioner.

[0011] An object of the invention is therefore to provide a simple and easy-to-use “all-in-one” type inserter for positioning an IUD in the uterus, in particular by proposing an inserter whose implementation allows the positioning of an IUD in the uterus in a more satisfactory manner for the patient.

[0012] A typical inserter for an IUD according to the present invention comprises

[0013] -a handle, also called a grip comprising a longitudinal opening having a longitudinal axis parallel to the longitudinal axis of the inserter, and said handle being provided with a means which allows the exit of the wire attached to the base of the IUD, for example an orifice or a slot located at the proximal end of the handle. Said orifice or said slot allows the exit of the wire to be manipulated by the practitioner,

[0014] - a tube having a first and a second end and a longitudinal axis, the tube being capable of receiving a pusher inside the tube along said longitudinal axis, the first distal end housing the IUD, the second proximal end being secured to a movable slider,

[0015] - a movable slider-button arranged in said longitudinal opening having lateral structural elements capable of sliding on lateral guides along the walls of the handle,

[0016] - a stationary pusher, integral with the handle of the inserter, having a long axis horizontal substantially parallel to the longitudinal axis of the inserter tube,

[0017] -optionally, a removable ring sliding on the inserter tube.

[0018] According to a particular embodiment of the invention, the inserter (1) for inserting into the cavity of the uterus of a patient, preferably an intrauterine device (IUD) of the hormonal or copper coil type, or a device containing medicinal substances used for hormonal therapies, chemotherapies or any other substances or devices to be inserted into the uterine cavity as part of a treatment or monitoring in a patient, comprises

[0019] - a handle (2) positioned at the proximal end of the inserter, comprising:

[0020] -a longitudinal opening (3) having a longitudinal axis parallel to the longitudinal axis of the inserter,

[0021] -a proximal end (4), constituting a housing (5) provided with a means which allows the exit of the wire attached to the base of the IUD,

[0022] -a distal end (6), and

[0023] -two lateral guide supports (7) and (8) on either side of the longitudinal opening of the handle housing,

[0024] -a tube (9) comprising first and second ends and a longitudinal axis, the tube being adapted to receive a pusher inside the tube along said longitudinal axis, the first distal end being adapted to receive the IUD in its folded form, the second proximal end (11) being in communication with a movable slider button,

[0025] -a movable slider button (12) arranged in said longitudinal opening of the handle, adapted and configured to move in the longitudinal opening to manually control an axial movement of the tube,

[0026] - a stationary pusher (13), integral with the handle of the inserter, having a longitudinal axis substantially parallel or superimposed on the longitudinal axis of the inserter tube,

[0027] characterized in that the cursor button

[0028] comprises at least two, preferably two lateral structural elements (14) and (15) on either side of the slider button, parallel to the longitudinal axis of the slider button, connected by at least one connecting segment (16) or (17) to the slider button, and

[0029] said lateral structural elements each have at least one protruding element (18) whose shape is capable of coming into contact with a hollow part (19) present on at least one of the two lateral guide supports (7) or (8).

[0030] The invention therefore provides an easy-to-use insertion device. The slider button according to the invention is designed to allow its movement in a “smooth” and efficient manner in order to position an IUD in the uterus of a patient while limiting plastic noises, and avoiding vibrations from a thread locking / unlocking mechanism.

[0031] According to the present invention, the function of the two lateral structural elements (14) is to allow the sliding of the slider button along the longitudinal opening of the handle of the inserter comprising the lateral guide supports which act as a slide.

[0032] According to the present invention, at least one of the lateral structural elements of the slider button comprises a contact surface (10) with at least one of the lateral guide supports, which surface is substantially planar.

[0033] According to the present invention, the two lateral structural elements of the slider button each comprise a contact surface (10), with at least one of the lateral guide supports, which surface is substantially flat.

[0034] According to the present invention, a part or all of the surface of at least one of the lateral structural elements of the slider button is in contact with at least one of the lateral guide supports.

[0035] When only one part of a lateral structural element of the slider button is in contact with at least one of the lateral guide supports, this part comprises a free end of flat or preferably round, or concave shape (18).

[0036] According to a variant of the present invention, one or two of the lateral structural elements of the slider button is (are) not continuous when said structural element(s) is (are) connected by a single connecting segment (16) or (17) to the slider button. In this configuration, the lateral structural element has a free end comprising the projection-forming element (18). The lateral structural element as shown in [Fig.4] is not continuous (i.e. it is not connected by the two connecting segments) and comprises a contact surface (10) with the lateral guide support, which is substantially planar, interrupted at the level of the projection-forming element (18) of cylindrical shape. In this configuration, said structural element undergoes an upward deformation to more easily cross a hollow part and to slide freely along at least one of the lateral guide supports of the handle housing.

[0037] The deformation of the structural element is carried out in a perpendicular direction, preferably upwards, relative to the axis of movement of the cursor button.

[0038] Advantageously, the free end of the structural element lifts upwards in a direction perpendicular to the lateral guide support; this deformation allows the cursor to very easily cross the hollows arranged along the lateral guide support and produces an audible and / or tactile signal whose intensity is modulated according to the depth of the hollow, the flexibility of the free end of the structural element and possibly the nature of the material found in the hollows and on the element forming a projection of the free end of the structural element of the cursor button.

[0039] According to the present invention, each lateral structural element of the slider button is of the spring-leaf type.

[0040] According to the present invention, said lateral structural elements are capable of undergoing deformation in order to slide along the lateral guide supports (7) and (8) of the handle housing.

[0041] According to the present invention, the slider button comprises two lateral structural elements (14) and (15) on either side of the slider button, parallel to the side walls of the slider button, each connected by one or two connecting segment(s) (16) or (17) to the cursor button.

[0042] According to the present invention, the lateral guide supports (7) and (8) represent slides, slides, rails or simple flat surfaces capable of receiving the lateral structural elements of the slider, parallel to the slider and joined at least at one point to the body of the slider by a transverse element. These structural elements represent the sliding means of the slider along the lateral guide supports (7) and (8).

[0043] According to the present invention, the useful length of the lateral guide supports corresponds to the length allowing at least three protruding elements to be provided corresponding to the three positions of the slider button when using the inserter to insert into the cavity of the uterus of a patient, an intrauterine device (IUD) of the hormonal or copper coil type.

[0044] According to the present invention, the lateral guide support is preferably a flat surface whose width is substantially equal to that of the lateral structural element of the slider button.

[0045] The lateral guide supports (7) and (8) are further configured to comprise one or more hollow parts, preferably three hollow parts.

[0046] According to the present invention, each lateral guide support (7) or (8) has at least one hollow part, preferably two or three hollow parts.

[0047] Said hollow part represents a substantially concave part, a recess, a cavity, a notch or even a groove.

[0048] According to the present invention, the lateral structural elements each have a protruding element.

[0049] According to the present invention, the hollow portion is capable of receiving the protruding element in an imbricated manner.

[0050] The lateral guide supports (7) and (8) extend over part or the entire length of the longitudinal opening of the handle housing.

[0051] According to the present invention, the depth of the hollow is a few millimeters, preferably 2 to 7 mm or even 3 to 5 mm.

[0052] According to a variant of the present invention, the internal surface of the hollow is coated with a material different from that constituting the lateral guide support.

[0053] Advantageously, the protruding element is configured so as not to constrain the movement of the cursor button along the lateral guide supports (7) and (8) but on the contrary is configured to restore an audible signal and / or a variation in tactile perception when the thumb or another finger of the practitioner placed on the cursor button moves said cursor button and when the protruding element encounters a hollow part during the movement of the structural elements (14) and (15) along the lateral guide supports (7) and (8).

[0054] According to a variant of the present invention, the internal surface of the hollow is coated with a material making it possible to amplify the sound effect or the tactile effect when the protruding element encounters a hollow part during the movement of the structural elements (14) and (15) along the lateral guide supports (7) and (8).

[0055] According to the present invention, the inner surface of the recess is textured or ribbed to amplify the sound effect or the tactile effect of the passage of a structural element of the slider button.

[0056] According to a variant of the present invention, each lateral guide support (7) or (8) has three hollow parts corresponding to the three positions of use of the inserter.

[0057] According to the present invention, the hollow parts are present on at least one of the two lateral guide supports (7) or (8).

[0058] According to the present invention, the hollow parts are present on the two lateral guide supports (7) and (8).

[0059] According to the present invention, the lateral guide supports (7) and (8) are located either in the lower part (20) of the inserter handle, or in the upper part (21) of the inserter handle or preferably in both the lower and upper parts of the inserter handle (7), (7') and (8), (8').

[0060] According to the present invention, the recessed portions are located either in the lower portion (20) of the inserter handle, or in the upper portion (21) of the inserter handle, or preferably in both the lower and upper portions of the inserter handle (7), (7') and (8), (8').

[0061] According to the present invention, the lower part of the inserter handle is the part of the handle housing which contains the fixing means (22) of the pusher as shown in figure (2).

[0062] According to the present invention, the lower portion of the inserter handle may also be defined relative to the arrangement of the asymmetrically shaped slider button. The asymmetrically shaped slider button may have raised patterns on its upper surface actuated by the thumb or finger of the user.

[0063] According to the present invention, the space available for the lateral structural element of the slider button on the lateral guide supports is called "play" between the lateral guide supports (7) and (7') or (8), (8') present in the two lower and upper parts of the inserter handle.

[0064] This space must be calculated as precisely as possible in order to allow optimized sliding of the lateral structural element of the slider button.

[0065] According to a variant of the present invention, when the slider button is in an initial position most distal in the longitudinal opening of the handle, a stop means is provided to block the position 1 of the slider button. Said means stop is, for example, an adaptable and configurable stop to include a mechanical constraint, or a means to increase friction or prevent free sliding of a lateral structural element on a lateral guide support.

[0066] According to the present invention, it is possible to define three positions of the cursor button on the lateral guide supports, corresponding to the three steps implemented when using an inserter to insert, into the cavity of the uterus of a patient, an intrauterine device (IUD) of the hormonal or copper coil type.

[0067] In step 1 of the IUD insertion procedure, the cursor button is in a most distal starting position. This position 1 corresponds to the initial position in which the IUD is located inside the tube (after manipulation of the wire by the user to introduce the horizontal branches of the T-shaped IUD inside the inserter tube in the axis of the tube).

[0068] The protrusion-forming element (18) of the lateral structural element of the slider button is positioned in the first (most distal) recessed portion of at least one lateral guide support. The lateral structural element is in a substantially planar position, its surface is in contact with the surface of the lateral guide support.

[0069] In step 2, the user moves the cursor to a second position which corresponds to an intermediate position of the IUD, the horizontal branches of the IUD are deployed in a T shape and the body of the IUD is located in the inserter tube.

[0070] The movement of the slider button towards the rear of the handle allows the inserter tube to slide backwards; in fact, since the tube is secured to the slider button, the tube follows the same direction as the slider button when it is moved.

[0071] When the slider button is manually pulled backwards from position 1 to position 2, said structural element undergoes an upward deformation, in a direction perpendicular to the axis of movement of the slider button, to cross the recessed portion corresponding to position 1 and to slide freely along the lateral guide support, from the housing of the handle to the recessed portion in position 2.

[0072] The deformation of the structural element is carried out in a direction perpendicular to the movement of the cursor button.

[0073] Advantageously, the free end of the structural element lifts upwards; this deformation allows the cursor to very easily cross the hollow parts arranged along the lateral guide support(s) and produces an audible and / or tactile signal whose intensity is modulated according to the depth of the hollow part, the flexibility of the free end of the structural element and possibly the nature of the material found in the hollow parts and on the projection of the free end of the structural element of the cursor button.

[0074] In step 3, the user moves the cursor to a third position which corresponds to a position where the IUD is completely outside the tube.

[0075] According to a variant of the present invention, the external surface of the handle of the inserter has a visual marking, at the level of each hollow part, inside the handle.

[0076] According to another embodiment of the invention, the inserter tube is graduated.

[0077] According to another embodiment of the invention, the external surface of the pusher is graduated or has a marking.

[0078] According to another embodiment of the invention, the pusher is a solid or hollow rod, preferably of circular or oval section.

[0079] According to another embodiment of the invention, the pusher is formed by a rod whose distal end comprises a zone capable of interacting with the lower part of the IUD comprising an orifice in which the IUD removal thread is tied.

[0080] According to another embodiment of the invention, said zone of interaction of the pusher with the lower part of the IUD comprises a section forming a receptacle in the form of a recess in the solid rod of the pusher.

[0081] According to one embodiment or use of the invention, the wire fixed to the base of the IUD freely passes through the hollow tube along the pusher located inside said tube and exits at the proximal end of the tube of the inserter secured to the cursor and continues its path along the pusher then out of the housing of the handle of the inserter through a slot or an orifice.

[0082] According to another mode of use of the invention, the wire is positioned in a “space” between the internal wall of the tube and a wall of the pusher having a prismatic, polygonal or polyhedral section, and optionally having at least one concave or convex part.

[0083] According to another mode of use of the invention, the wire is housed in a protective tube positioned from the distal end of the slider button to the proximal end of the housing of the inserter handle at the level of the slot or the orifice.

[0084] According to a particular embodiment of the invention, the pusher has a prismatic, polygonal or polyhedral section.

[0085] According to another embodiment of the invention, the pusher is a solid or hollow rod whose section has at least one straight, convex or concave edge.

[0086] According to another embodiment of the invention, the pusher has a prismatic, polygonal or polyhedral section over the entire length of the pusher.

[0087] In addition, the inserter tube is provided with graduations to facilitate the positioning of the aforementioned sliding stop according to the depth of the uterine cavity measured by the practitioner, which allows the latter to visualize the insertion depth of the inserter.

[0088] The practitioner will be able to locate himself at the distance of the marking without using the stop.

[0089] Furthermore, preferably, the pusher comprises a useful length substantially equal to or less than the total length of the inserter itself, which makes it possible to prevent the pusher from protruding from the inserter tube.

[0090] According to another embodiment of the invention, a ring is positioned on a graduation of the inserter tube, said position being determined as a function of the depth of the patient's uterine cavity.

[0091] According to a particular embodiment of the invention, the IUD is either of the hormonal type comprising a reservoir containing a progestin or of the copper type having a copper surface.

[0092] Suitable materials for all of the features of the insertion device include biocompatible materials such as plastic or a thermoplastic polymer including, for example, polyethylene or polypropylene.

[0093] According to the present invention, the slider does not include any locking means, so that no pinion or rack mechanism interferes with the sliding of the slider button in the handle.

[0094] According to the present invention, the slider does not move inside an elongated guide but only along lateral guide supports such as the substantially flat slides.

[0095] Other characteristics, details and advantages of the present invention will become clear during the explanatory description which follows, given with reference to the schematic drawings illustrating several embodiments of the invention given solely by way of example and which therefore cannot in any way limit the scope of the present invention.

[0096] [Fig.l]

[0097] [Fig.l] is a 3D representation of the handle of an inserter according to the invention showing the upper part (21) of the housing of the handle, the longitudinal opening of the handle revealing the wire (23) (substantially) stretched along the pusher (13) and an asymmetrical button (12) representing the manipulable part of the cursor button. The button is shown in its initial position (at the distal end (6) of the handle) corresponding to step 1 of the procedure for inserting an IUD.

[0098] [Fig.2]

[0099] [Fig.2] is a 3D representation of the lower part (20) of a handle (2) of the inserter. A longitudinal opening (3) in the housing of the handle allows manual movement of the slider button. A slot (24) located in the housing (5) of the handle at the proximal end (4), allows the exit of the wire attached to the base of the IUD, said wire running along the pusher in the longitudinal opening.

[0100] Along the longitudinal opening, the ends of the handle housing have two lateral guide supports (7) and (8) representing slides provided with several hollow parts (19) or visible notches.

[0101] The tube (9) comprising a pusher inside the tube is fixed to the movable slider button (12) arranged in the longitudinal opening of the handle; its movement in the longitudinal opening makes it possible to manually control the axial movement of the tube along the stationary pusher, fixed to the housing of the handle in its proximal part.

[0102] The slider button comprises two lateral structural elements (14) and (15) on either side of the slider button, parallel to the side walls of the slider button, connected by two connecting segments (16) or (17) to the slider button. The two lateral structural elements rest on the two lateral guide supports (7) or (8).

[0103] [Fig.3]

[0104] [Fig.3] is a 3D representation of the lower part (20) of a handle (2) of the inserter.

[0105] [Fig. 3] shows a lateral structural element of the slider button provided with a protrusion-forming element (18) whose shape is adapted to come into close contact with a recessed portion (19) of the lateral guide support (7). The lateral structural element as shown in [Fig. 3] comprises a contact surface (16) with the lateral guide support which surface is substantially planar.

[0106] [Fig.4]

[0107] [Fig.4] is a 3D representation of the lower part (20) of a handle (2) of the inserter.

[0108] [Fig.4] shows a lateral structural element of the slider button provided with a protrusion-forming element (18) whose shape is capable of coming into close contact with a recessed portion (19) of the lateral guide support (7).

[0109] The protruding element has a cylindrical shape.

[0110] The lateral structural element as shown in [Fig.4] is not continuous and comprises a contact surface (10) with the lateral guide support, which surface is substantially planar and interrupted at the level of the cylindrically shaped projection-forming element (18). In this configuration, the lateral structural element has a free end comprising the projection-forming element (18) [YES] [Fig.5]

[0112] [Fig.5] is a sectional representation of the handle (2) of the inserter.

[0113] [Fig.4] shows a lateral structural element of the slider button provided with a protrusion-forming element (18) in close contact with a recessed portion (19) of the lateral guide support (7).

[0114] The cursor button is in a most distal starting position.

[0115] The protrusion-forming element (18) of the lateral structural element of the slider button is positioned in the first (most distal) recessed portion of the lateral guide support. The lateral structural element is then in a substantially planar position, its surface is in contact with the surface of the lateral guide support.

Claims

Claims

1. An inserter (1) for inserting into the uterine cavity of a patient, preferably an intrauterine device (IUD) of the hormonal or copper coil type, or a device containing medicinal substances used for hormonal therapies, chemotherapies or any other substances or devices to be inserted into the uterine cavity as part of treatment or monitoring in a patient comprising: - a handle (2) positioned at the proximal end of the inserter, comprising: • a longitudinal opening (3) having a longitudinal axis parallel to the longitudinal axis of the inserter, • a proximal end (4), constituting a housing (5) provided with a means which allows the exit of the wire attached to the base of the IUD, • a distal end (6), and • two lateral guide supports (7) and (8) on either side of the longitudinal opening of the handle housing, -a tube (9) comprising first and second ends and a longitudinal axis, the tube being adapted to receive a pusher inside the tube along said longitudinal axis, the first distal end (10) being adapted to receive the IUD in its folded form, the second proximal end (11) being in communication with a movable slider button, -a movable slider button (12) arranged in said longitudinal opening of the handle, adapted and configured to move in the longitudinal opening to manually control an axial movement of the tube, - a stationary pusher (13), integral with the handle of the inserter, having a longitudinal axis substantially parallel or superimposed on the longitudinal axis of the inserter tube, characterized in that the slider button comprises at least two, preferably two lateral structural elements (14) and (15) on either side of the slider button, parallel to the longitudinal axis of the slider button, connected by at least one connecting segment (16) or (17) to the slider button, and said lateral structural elements each have at least one protruding element (18) whose shape is capable of coming into contact with a hollow part (19) present on at least one of the two lateral guide supports (7) or (8).

2. The inserter according to claim 1, characterized in that at least one of the lateral structural elements of the slider button comprises a contact surface (16) or (17) with a lateral guide support, which surface is substantially planar.

3. The inserter according to claim 1 or 2, characterized in that a part or the whole of the surface of at least one of the lateral structural elements of the slider button is in contact with the lateral guide support.

4. The inserter according to any one of the preceding claims, characterized in that only one part of a lateral structural element of the slider button is in contact with the lateral guide support, said part comprises one end of a lateral structural element of flat or preferably round, or concave shape.

5. The inserter according to any one of the preceding claims, characterized in that one or two of the lateral structural elements of the slider button has(have) a free end comprising the projection-forming element (18).

6. The inserter according to any one of the preceding claims, characterized in that each lateral structural element of the slider button is of the spring-leaf type, capable of undergoing deformation to slide along the lateral guide supports (7) and (8) of the handle housing.

7. The inserter according to any one of the preceding claims, characterized in that the lateral guide supports (7) and (8) are configured to comprise one or more hollow parts, preferably three hollow parts.

8. The inserter according to any one of the preceding claims, characterized in that the protruding element is configured to restore an audible signal and / or a variation in tactile perception when the protruding element encounters a recessed portion during movement of the structural elements (14) and (15) along the lateral guide supports (7) and (8).

9. The inserter according to any one of the preceding claims, characterized in that the recessed parts are present on both side guide supports (7) or (8).

10. The inserter according to any one of the preceding claims, characterized in that the lateral guide supports (7) and (8) are located either in the lower part (20) of the inserter handle, or in the upper part (21) of the inserter handle or preferably in both the lower and upper parts of the inserter handle (7), (7') and (8), (8').

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