Inserter for inserting an intrauterine device

Abstract

The present invention relates to an inserter for inserting a hormonal or copper intrauterine device (IUD) into the uterine cavity of a patient. The inserter according to the present invention comprises an insertion tube and a plunger having a surface optimized for the passage of the IUD removal strings. Abstract figure: Fig 1

Description

Title of the invention: Inserter for inserting an intrauterine device

[0001] The present invention relates to an inserter for inserting, into the cavity of the uterus of a patient, an intrauterine device (IUD) of the hormonal or copper type.

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

[0003] - either by pulling on the one or more threads attached to the IUD (said one or more threads 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 backwards which has the effect of sliding the tube backwards and releasing the IUD from the inserter tube. Once released from the insertion tube the horizontal branches of the IUD are found deployed, for example 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] For example, European patent EP 798 999 relates to an inserter which comprises a plunger, a handle attached to the plunger, one or more wires for removal of the IUD, a slot at the end of the handle for locking the one or more wires so that the IUD remains stationary relative to the plunger and the inserter tube around the plunger.

[0008] Document WO2010031899 describes for example an inserter provided with a handle which can have many shapes and is designed for easy handling of the inserter even using only one hand.

[0009] The pusher attached to the handle is advantageously hollow or has a groove extending axially, thus allowing the one or more wires to slide freely therein, without the risk of them becoming stuck between the pusher and the inserter tube. Before inserting the IUD into the uterine cavity, the one or more wires is (are) blocked in the locking device associated with the plunger. The one or more wires thus slide freely, and there is no risk of them getting stuck between the pusher and the tube. The one or more wires is (are) blocked inside the inserter handle and cannot be manipulated by a practitioner.

[0010] In general, the pushers have a round cross-section. However, there are other inserters comprising pushers sliding inside the inserter tube having a square or rectangular cross-section, for example those described in document EP0700275.

[0011] The inserters described in these documents therefore use either a mechanical locking system or a manual locking system for one or more threads which do not respond in a completely satisfactory manner to the problem of managing one or more IUD removal threads.

[0012] Therefore, there remains a need for an improved inserter.

[0013] An object of the invention is to provide a simple and easy-to-use "two-part" inserter for positioning an IUD in the uterus by providing in particular an inserter having an improved system for securing the management and positioning of the one or more wires inside the inserter tube.

[0014] A typical inserter for an intrauterine system according to the present invention comprises

[0015] - a tube having first and second ends and a longitudinal axis, the tube being capable of receiving a pusher which slides inside the tube along said longitudinal axis, the first distal end housing the IUD, the second proximal end being integral with an end piece serving both as a guide for the pusher and as a gripping handle,

[0016] - a removable pusher having a longitudinal axis substantially parallel to the long axis horizontal of the inserter tube,

[0017] -a preferably flat tip having a notch opening onto a longitudinal opening, said opening having a longitudinal axis parallel to the longitudinal axis of the inserter tube, said tip being integral with the proximal end of the inserter tube

[0018] -optionally, a removable ring sliding on the inserter tube.

[0019] According to a particular embodiment of the invention, the inserter for inserting into the cavity of the uterus of a patient, an intrauterine device (IUD) of the hormonal or copper coil type comprises

[0020] -a tube (1) having first and second ends and a longitudinal axis, the tube being adapted to receive a pusher which slides inside the tube along said longitudinal axis, the first distal end of the tube comprising the IUD (2) to be inserted, provided with one or more wire(s) (11) fixed to the base of the IUD, said one or more wire(s) slide freely in the tube; the second proximal end of the tube being secured to a tip (3) comprising a guide means (4) with a pusher,

[0021] - a removable pusher (5) having a longitudinal axis substantially parallel to the longitudinal axis of the inserter tube,

[0022] -a tip (3) having a guide means, for example a notch (4) opening onto a longitudinal opening, said opening having a longitudinal axis parallel to the longitudinal axis of the inserter tube, said tip being integral with the proximal end of the inserter tube, in which

[0023] the inserter pusher has a cross-section (along its longitudinal axis) of a shape filling less than 60% of the surface area of ​​the internal cross-section of the inserter tube (along its longitudinal axis).

[0024] A person skilled in the art understands that the shape of the pusher corresponds to that of its cross-section. The expression "cross-section of a shape of the pusher" used in the text is interchangeable with the expression "a shape of the pusher".

[0025] Pushers having a round, oval or square cross-section are excluded from the present invention.

[0026] According to another embodiment of the invention, the inserter tube is graduated.

[0027] According to another embodiment of the invention, the material of the tube is chosen from polyethylenes, polypropylenes, polyamides, butadiene styrene, mediprene, polyoxymethylene (polyacetal, POM); acrylonitrile butadiene styrene or other types of polymers.

[0028] According to another embodiment of the invention, the external surface of the pusher is graduated or has a marking to allow the practitioner to identify the expulsion of the IUD.

[0029] According to another embodiment of the invention, the pusher is provided with a handle or a gripping means (6) to facilitate its handling.

[0030] According to another embodiment of the invention, the pusher is a solid or hollow rod.

[0031] According to another embodiment of the invention, the pusher is composed of a material chosen from polyethylenes, polypropylenes, polyamides, butadiene styrene, mediprene, polyoxymethylene (polyacetal, POM); acrylonitrile butadiene styrene or other types of polymers.

[0032] According to another embodiment of the invention, the end piece is provided with a notch which is useful both for serving as a guide for inserting a pusher into the inserter tube and as a means for gripping the inserter tube.

[0033] It will be noted that the notch allowing the passage of the pusher and the orifice of the tube are coaxial to allow the insertion of the IUD into the uterus using the pusher.

[0034] The tip provided with a notch serving as a guide for the insertion of a pusher is advanced typically made of a material selected from polyethylenes, polypropylenes, polyamides, butadiene styrene, mediprene, polyoxymethylene (polyacetal, POM), acrylonitrile butadiene styrene or other types of polymers.

[0035] According to another characteristic of the invention, the pusher has a gripping means adapted for holding the pusher, said gripping means (6) being made up of a part made of plastic or other material, solid or hollow, extra-flat and wide, formed of a single part, or of two parts, molded or clipped, trapping the proximal end of the pusher.

[0036] According to another embodiment of the invention, the tip is glued, molded or overmolded.

[0037] According to another embodiment of the invention, a sliding 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 after hysterometry.

[0038] 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 cupric type having a cupric surface.

[0039] The aim of the present invention is to propose an IUD inserter of a particularly simple design and manufacture allowing an IUD to be introduced into the uterine cavity of a patient while securing the management of the one or more threads of the IUD located inside the inserter tube in an optimized space in order to avoid any winding or blocking of the one or more threads during the introduction of the pusher into the inserter tube and during its translation inside the tube at the time of ejection of the IUD into the uterine cavity.

[0040] This object is achieved according to the present invention by producing an inserter for inserting, into the uterine cavity of a patient, an IUD of a type known per se, comprising a pusher whose introduction into the inserter tube is facilitated by the presence of a pusher introduction guide facilitating the passage of the pusher into the inserter tube.

[0041] The guide in the form of a notch in the proximal part extends in the extension of the inserter tube.

[0042] 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 one or more IUD removal thread(s) is / are attached.

[0043] According to another embodiment of the invention, said zone of interaction of the pusher with the lower part of the IUD comprises a straight end.

[0044] According to one embodiment or use of the invention, the one or more wire(s) attached to the base of the IUD slide(s) freely inside the tube to exit the tip attached to the proximal end of the inserter tube.

[0045] According to one embodiment of the invention, the one or more wire(s) attached to the base of the IUD exit(s) the tube through the proximal end of the tube, via the tip.

[0046] According to another mode of use of the invention, the one or more wire(s) is(are) positioned in an “optimized space” (7) between the internal wall of the tube and a wall of the pusher having a cross section of polygonal or polyhedral shape, optionally having at least one concave or convex part, or of a shape formed of curves inscribed in a circle from a central point, called a rosette.

[0047] The expression "optimized space" (7) within the meaning of the present invention corresponds to a space defined between a straight, convex or concave wall (9) of a pusher according to the present invention, the cross-section of which has a diameter (a fictitious circle (10)) passing through the vertices of the polygonal or polyhedral shape, as shown in [Fig.2] and the internal wall of the inserter tube.

[0048] According to another embodiment of the invention, the pusher has a contact surface with the IUD such that one or more wires are positioned in at least one "optimized space", preferably one, two, three, four or more "optimized space(s)". Said one or more space(s) represent(s) at least 40% of the surface area of ​​the internal cross-section of the inserter tube.

[0049] According to another embodiment of the invention, the one or more wire(s) is(are) positioned in at least one "optimized space", preferably one, two, three, four or more "optimized space(s)". Said one or more space(s) represent(s) at least 40% of the surface area of ​​the internal cross-section of the inserter tube.

[0050] According to a preferred embodiment of the invention, said one or more spaces represent from 40% to 50%, from 50% to 60%, from 60% to 70%, or more of the surface area of ​​the internal cross-section of the inserter tube.

[0051] According to a preferred embodiment of the invention, the inserter pusher has a cross-section of a shape preferably filling from 10% to 20%, from 20% to 30%, from 30% to 40%, from 40% to 50%, or from 50% to less than 60% of the surface area of ​​the internal cross-section of the inserter tube.

[0052] According to a particular embodiment of the invention, the one or more thread(s) of the IUD is composed of one or two threads attached to the IUD.

[0053] According to a particular embodiment of the invention, the two wires are either in the same space, between the internal wall of the tube and a wall of the pusher, or in a different space, between the internal wall of the tube and two different walls of the pusher.

[0054] According to a particular embodiment of the invention, the pusher has a cross section of polygonal or polyhedral shape.

[0055] According to another particular embodiment of the invention, the pusher has a cross-section of polygonal star shape (or star shape).

[0056] According to another particular embodiment of the invention, the pusher has a star-shaped cross section comprising from 3 to 16 branches, in particular 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16 branches.

[0057] According to another particular embodiment of the invention, the star shape is regular or irregular; that is to say the branches of the star, defined by vertices and bases, have either identical or different sizes.

[0058] According to a particular embodiment of the invention, the cross section of the pusher corresponds to:

[0059] -a star with 3, 4, 5, 6, 7 or more branches, regular or irregular.

[0060] According to another particular embodiment of the invention, the pusher has a star-shaped cross-section comprising rounded tops and / or bases as shown in [Fig.2] or 4.

[0061] According to another particular embodiment of the invention, the pusher has a cross section of polygonal or polyhedral shape, having at least one concave or convex part.

[0062] According to another particular embodiment of the invention, the pusher has a cross-section of shape formed of curves inscribed in a circle from a central point, called a rosette.

[0063] According to a particular embodiment of the invention, the cross section of the pusher corresponds to:

[0064] - a rosette with 3, 4, 5, 6, 7 or more branches, regular or irregular.

[0065] According to another embodiment of the invention, the cross-section of the pusher corresponds to a combination of polygonal and / or polyhedral shapes and optionally at least one concave or convex wall as shown in [Fig.3],

[0066] According to another embodiment of the invention, the cross section of the pusher corresponds to a combination of star shapes (straight branch) and rosette shapes (branch formed of 2 lunules).

[0067] According to another embodiment of the invention, the pusher is a solid or hollow rod whose cross section has at least one straight, convex or concave edge.

[0068] According to another mode of use of the invention, the cross section of the pusher has a geometric shape of which all the walls are concave (for example the cross section of shape G) of [Fig.3].

[0069] According to another embodiment of the invention, the pusher has a polygonal or polyhedral cross-section along the entire length of the pusher.

[0070] For the purposes of the present invention, the term “clearance” between the inserter tube and the pusher refers to the space left between the tube and the pusher.

[0071] In particular, the clearance is determined as being the difference between the internal diameter of the lumen of the inserter tube and the diameter of the pusher.

[0072] The cross-section of the pusher being of prismatic, polygonal or polyhedral shape, the diameter d of the pusher corresponds to the diameter of a theoretical circle (10) passing through the vertices of the edges of the geometric shape of the cross-section of the pusher.

[0073] According to a particular embodiment of the invention, the clearance is from 0.1 to 3 mm, preferably from 0.1 to 1 mm. The clearance can be very small, of the order of one or a few tenths of a millimeter when the cross section of the pusher has a concave shape, for example 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 or 0.9 mm.

[0074] According to a particular embodiment of the invention, the cross-section of the inserter tube is generally circular, or oval.

[0075] According to a particular embodiment of the invention, the cross section of the pusher is capable of fitting into the cross section of the inserter tube.

[0076] 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.

[0077] 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.

[0078] When the inserter tube is positioned inside the uterine cavity, the practitioner can slightly withdraw the tube and slide the pusher into the inserter tube along its entire useful length, in order to push the IUD out of said tube.

[0079] Another embodiment of the invention relates to the use of an IUD inserter comprising a pusher having one or more spaces preventing one or more wires (11) attached to the IUD from becoming stuck when removing the insertion device.

[0080] Another embodiment of the invention relates to the use of an IUD inserter comprising a pusher having a polygonal or polyhedral cross-section, optionally having at least one concave or convex part, or a shape formed from curves inscribed in a circle from a central point, called a rosette.

[0081] Another embodiment of the invention relates to a use of an IUD inserter in which the one or more IUD withdrawal wire(s) slide(s) freely in at least one optimized space, preferably two, three, four or more "optimized space(s)". Said one or more space(s) represent(s) at least 40% of the internal cross-sectional area of ​​the inserter tube.

[0082] 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.

[0083] [Fig.l]

[0084] [Fig.l] is a schematic representation of an inserter according to the invention comprising a tube, a pusher and an IUD

[0085] [Fig.2]

[0086] [Fig.2] shows an inserter in which the pusher is introduced into the tube with a cross-sectional view along line AA representing a triangular cross-section of the pusher. Another view shows the space (7) allowing one or more wires (11) to slide freely. The one or more wires is shown split on the left in the same space and on the right in two different spaces.

[0087] [Fig.3]

[0088] [Fig.3] represents, in section, several cross sections of the pusher of various geometric shapes.

[0089] [Fig.4]

[0090] [Fig.4] shows, in section, a cross-section of the rounded star-shaped pusher.

[0091] [Fig.5]

[0092] [Fig.5] A is a 3D representation of an inserter according to the invention comprising a tube, a pusher and an IUD. [Fig.5] B is a 3D representation centered on a pusher inserted into the notch of the tip of a tube.

[0093] According to a first preferred embodiment of the present invention shown in Figures 1 to 3 and with particular reference to [Fig.2], an inserter according to the present invention comprises a guide means, for example a notch (4) and a pusher (5) capable of penetrating into the guide means at the notch and capable of sliding into the tube of the inserter to insert the IUD into the uterine cavity.

[0094] [Fig.3] shows cross-sections of the pusher of various shapes:

[0095] A) right triangle, B) star hexagon, C) right cross, D) inverted triangles, E) star pentagon or 5-pointed star, F) square sail, G) concave “square”, H) 4-pointed star.

[0096] According to a particular embodiment of the invention, the pushers are manufactured by molding or extrusion according to techniques known to those skilled in the art.

[0097] The operations necessary for inserting the IUD into a cavity will now be described. uterine using the inserter according to the present invention, although these operations are understandable to a person skilled in the art.

[0098] As noted above, first the practitioner determined the depth of the uterine cavity and then positioned a sliding stop ring on the inserter tube at the graduation corresponding to the measured depth of the uterine cavity. The practitioner pulls on the one or more threads to position the arms of the IUD inside the inserter tube.

[0099] It will be noted that in this position the IUD is in its starting position with the arms in the folded position in the inserter tube. It is necessary to leave the end of the arms flush above the inserter tube.

[0100] From this position, the practitioner inserts the pusher into the notch in the tip of the inserter tube and then slides the pusher into the tube along the one or more threads and pushes forward until the pusher meets the lower part of the IUD and then pushes it out of the tube into the cavity of a patient's uterus.

[0101] The insertion operation then ends with the removal of the inserter. The practitioner pulls the pusher towards him, then the inserter tube.

[0102] The particular shape of the cross-section of the pusher according to the present invention allows for optimized management of the one or more IUD withdrawal threads when the pusher is in the inserter tube; the one or more threads are neither blocked nor wound in the space between the lumen of the tube and the pusher. Withdrawing the inserter from the uterine cavity therefore allows for very easy release of the one or more threads from the inserter tube. The one or more threads are finally cut a few cm from the external orifice of the patient's cervix. Examples

[0103] Estimation of the surface area of ​​the “optimized spaces” based on the shape of the transverse cross-section of the pusher.

[0104] The state of the art describes pushers sliding inside the inserter tube which have round, square or rectangular cross sections.

[0105] To evaluate the surface area of ​​the “optimized spaces” it is possible to calculate the surface area of ​​each shape of the cross-section of the pusher.

[0106] -For example, for a disk of radius r, its area can be calculated using the following formula: ir x r2

[0107] Its filling proportion relative to the internal diameter of the inserter tube is generally greater than 90%.

[0108] -For example, for a square inscribed in a disk of radius R, the triangle ABE is an isosceles right triangle at E, the area of ​​the square is AB2= (^2 R)2

[0109] Its proportion to the area of ​​the disc is approximately 64%.

[0110] -For example, for an equilateral triangle inscribed in a circle of radius R, a triangle ABC has the following surface area: S= / 2 x BC x AE= / 2 x (V3 xR)x (3 / 2R).

[0111] Its proportion to the area of ​​the disc is approximately 41%.

[0112] -For example, for a 3-branch rosette, we draw an equilateral triangle (ACD) inscribed in the large disk (see [Fig.4]), and we draw arcs of circles with centers at these three points and passing through O, the center of the large circle. The grayed-out surface is composed of three branches (or leaves), each made up of two lunules of the same area, lunule which appears in question 5) a) of the crescent passing through the center. Each lunule has the area of ​​the circular sector (AOBA), with an angle of 60°, removed from that of the equilateral triangle (OAB).

[0113] We therefore have (60 / 360 ^)-(^3 / 4 r2). The three branches therefore have an area 6 times the area cited, therefore 6(jr / 6-V3 / 4)r2

[0114] Its proportion to the area of ​​the disc is approximately 17%.

[0115] The proportion of a 3-pointed star to the area of ​​the disk is the same order of magnitude.

[0116] The proportion of a rosette or a 4-pointed star to the area of ​​the disc is approximately 36%.

[0117] [Tableauxl] Section of section 1 * state: the Proportion ée 1SSOàCS 'the technique "optimized" for 1 the wires (in Gercle (disc) <10 Square Approximately 36 Section of shape according to the invention >4Ü Star or rosette with 3 branches Approximately

[0118] The proportion of the "optimized" space for the wires represents the ratio of the cross-sectional area of ​​the pusher shape to the area of ​​the circle corresponding to the cross-section of the inserter tube xlOO.

Claims

Claims

1. Inserter for inserting into the uterine cavity of a patient, an intrauterine device (IUD) of the hormonal or copper coil type which comprises - a tube (1) having a first and a second end and a longitudinal axis, the tube being adapted to receive a pusher which slides inside the tube along said longitudinal axis, in use the first distal end of the tube comprises the IUD (2) to be inserted, provided with one or more wires fixed to the base of the IUD, said one or more wires slide freely in the tube;the second proximal end of the tube is secured to a tip (3) comprising a guide means (4) for a pusher, - a removable pusher (5) having a longitudinal axis substantially parallel to the longitudinal axis of the inserter tube, - a tip (3) having a guide means, for example a notch (4) opening onto a longitudinal opening, said opening having a longitudinal axis parallel to the longitudinal axis of the inserter tube, said tip being secured to the proximal end of the inserter tube, characterized in that said pusher has a cross-section of a shape filling less than 60% of the surface of the internal cross-section of the inserter tube, and in that said pusher has a cross-section of a star shape with 3 regular branches.;

2. The inserter according to claim 1, characterized in that the inserter pusher has a cross-section of a shape preferably filling from 10% to 20%, from 20% to 30%, from 30% to 40%, from 40% to 50%, or from 50% to less than 60% of the surface area of ​​the internal cross-section of the inserter tube.

3. The inserter according to claim 1 or 2, characterized in that the tube (1) of the inserter is a graduated tube.

4. The inserter according to any one of claims 1 to 3, characterized in that the pusher (5) is a solid or hollow rod.

5. The inserter according to any one of claims 1 to 4, characterized in that the pusher (5) is composed of a material chosen from polyethylenes, polypropylenes, polyamides, butadiene styrene, mediprene, polyoxymethylene (polyacetal, POM), acrylonitrile butadiene styrene or other types of polymers.

6. The inserter according to claim 1, characterized in that the guide means of the tip (3) is a notch (4) opening onto a longitudinal opening, said opening having a longitudinal axis parallel to the longitudinal axis of the inserter tube.

7. The inserter according to claim 1, characterized in that the star shape comprises rounded tops and / or bases.

8. The inserter according to claim 1, characterized in that the clearance between said inserter tube and said pusher is from 0.1 to 3 mm, preferably from 0.1 to 1 mm.

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