Organ Prolapse Correction Device

Abstract

The present invention relates to a device for correcting prolapse, which is composed of a single part (1) in which a head (2) having an approximately dome-shaped upper end (21), two arms (3) branching opposite to each other, and a connecting strap (4) can be distinguished, the device takes, by default, an elastically deformable, approximately isosceles triangular expanded position (A) when the connecting strap (4) is pulled by hand in the opposite direction to the head (2), the device can be placed in a compressed position (B1) which facilitates the placement of the device inside the vagina or the removal of the device from inside the vagina, when the pulling of the connecting strap (4) is stopped, the arms (3) react with a restoring force which exerts pressure against the vaginal wall, the part (1) is fixed under pressure inside the vagina, and the device takes the activated position (B2).

Description

[Technical field]

[0001] The present invention relates to a prolapse correction device, and more particularly to a prolapse correction device for permanently or temporarily reducing a patient's pelvic organ prolapse while functional testing is being performed prior to surgical correction. [Background technology]

[0002] The problem of prolapse of the pelvic organs (bladder, uterus, rectum) through the vaginal opening is known to the current state of the art. When prolapse reaches a significant size, it often becomes a problem that requires a surgical solution.

[0003] In these cases, functional testing is usually performed before planning any therapeutic intervention to eliminate occult stress urinary incontinence.

[0004] This type of examination simulates the position of the pelvic organs after surgical correction and forces the appearance of stress urinary incontinence during bladder filling. If stress urinary incontinence occurs, it is surgically corrected at the same time as the prolapse. It also examines the emptying of the bladder in its new position.

[0005] It is known to use pessaries and vaginal packing to resolve pelvic organ prolapse.

[0006] Pessaries are designed for permanent correction of pelvic organ prolapse in patients awaiting intervention or in whom surgery is inoperable. Pessaries come in a variety of different sizes and are replaced every six months, during which they require only periodic cleaning. They must be sterilized and multiple sets must be prepared for temporary use on different patients. During attempts to demonstrate stress urinary incontinence, the pessary may become dislodged if not properly adjusted in size.

[0007] As for vaginal packing, it is simply gauze rolled up and then shaped into an arrow shape. Given the material used, vaginal packing has two drawbacks: insertion can cause discomfort and even pain, and it does not maintain its shape inside the vagina.

[0008] From the patent document EP 3487428, various devices are known that replace or supplement the posterior support of the urethra, which may help to prevent the involuntary flow of urine through the urethra. In a variant, the device has a shape similar to a crossbow and is equipped with a thread-like element, or thread, for tightening the bow, which may have a simple arch shape or be configured in a double S-shape. The device has an edge, requires assembly of several parts, and has a kind of handle or pole for holding the thread together, providing a loop for the user to pull.

[0009] From the patent document US Patent No. 6,460,542, a device for controlling urinary incontinence is known. This device is made in a single piece that is placed in the vagina, but is not suitable for correcting prolapse, especially in cases of severe prolapse, since the device does not remain locked sufficiently in the vagina and cannot support the pressure exerted by the offset organs, leading to the device being expelled. Furthermore, the placement of the device requires that a part of the device is pinched and elastically deformed by fingers during placement, and that the fingers are inserted into the vagina together with the device.

[0010] The main object of the present invention is to provide an alternative to known devices.

[0011] It is also desirable for the device to enable both the patient and the specialist applying the device to relieve a patient's pelvic organ prolapse in a simple, safe and comfortable manner. Summary of the Invention [Problem to be solved by the invention]

[0012] The proposed device for correcting organ prolapse is the device described in claim 1.

[0013] The device consists of a single elastically deformable part adapted to be positioned and remain within the patient's vagina.

[0014] Essentially, the device is characterized in that the part has a head having a generally dome-shaped upper end and two arms beginning below the head and branching out opposite each other, each arm having a proximal end for attachment to the head, a central portion and a distal end, the part further has a connecting strap extending between the two arms and connecting the two arms at their distal ends, the device defaulting to an extended position in the shape of a generally isosceles triangle, with the head at the apex, the arms being the sides of the triangle and the connecting strap being the base of the triangle.

[0015] The feature of this part is that when the connecting strap is pulled by hand in the direction away from the head and at the same time pressure is applied by a human finger to the lower end of the head provided for this purpose, the part is elastically deformed, the arms approach each other and the device can be placed in a compressed position in which operations for inserting the device into the vagina or for removing it from the vagina can be easily performed.

[0016] Also, a feature of this part is that when pulling on the connecting strap is released after inserting the part inside the vagina, the part will attempt to return to its expanded position and the arms will react with a restoring force by exerting pressure against the walls of the vagina, and the part will be secured under pressure inside the vagina, i.e., the device will assume its operative position when seated inside the vagina.

[0017] In the context of the present invention, the term elasticity refers to the physical and mechanical property of certain materials undergoing reversible deformation when subjected to external forces and returning to their original shape when these external forces are removed.

[0018] In a variant of the invention, the upper end of the head is in the form of a hemispherical cap having a radius of 8 to 12 mm.

[0019] In a variant of the invention, the lower end of the head is a protrusion located between the arms, in the shadow of the upper end and extending in the opposite direction to the upper end without exceeding the gauge of the upper end.

[0020] The length dimension of the lower end is less than the height dimension of the part, and as will be explained below, an ideal compromise exists that allows the part to be pushed safely without the need to insert an index finger deeply into the vagina, saves on material costs, and eliminates any elements or parts that may cause discomfort when the part is placed inside the vagina.

[0021] In a variant of the invention, the lower end extends below the upper end by a length of 15 to 20 mm.

[0022] The lower end may have a concave surface at its distal end intended to support a human finger.

[0023] The lower end may be generally frusto-conical in shape narrowing towards its distal end.

[0024] In a variation of the invention, the proximal end of the arm begins below the upper end of the head and extends tangentially to the upper end, the central portion has a slight S-shaped contour that gives the arm a slight outward arch, and the distal end is rounded to seamlessly join with the connecting strap, which also arches slightly towards the outside of the part.

[0025] Preferably, the assembly of the head and arm parts is symmetrical about mutually orthogonal first and second planes of symmetry, while the connecting strap is not symmetrical about the first plane of symmetry but is slightly offset to one side of the first plane of symmetry, all to facilitate handling of the device during vaginal insertion and removal operations, as will be explained in more detail below.

[0026] In particular variants, the connecting straps are also narrowed along their central portions.

[0027] The narrowed portion of the connecting strap can be realised in the form of a recess formed in a lateral edge of the connecting strap, oriented towards the inside of the part.

[0028] Preferably, the outer surfaces of the arms are curved, concave relative to the free space defined between said arms, to minimize discomfort while supported on the soft tissue inside the vagina.

[0029] In a variant of the invention, in each of the transition areas between the arms and the connecting straps, the material of the parts is reduced, the presence of which is intended to provide a hinge effect that facilitates deformation of the parts, which also contributes to facilitating the handling of the device during insertion and removal from the vagina.

[0030] Preferably, the height dimension of the approximately isosceles triangle shape of the part is 60 to 70 mm, more preferably 64 to 66 mm, and the width dimension of the approximately isosceles triangle shape of the part is 80 to 90 mm, more preferably 84.5 to 86.5 mm.

[0031] The part defines two lower support zones in the correct placement position within the vagina. The actual extent of these support zones varies from patient to patient and with the degree of compression the part assumes when placed, but typically covers 7-10% of the extension to each side of the base of the isosceles triangle. Preferably, the height of the part from these lower support zones to the tip of the head is 63-67 mm.

[0032] The absolute dimensions stated have a margin of ±5%. [Brief description of the drawings]

[0033] [Figure 1] FIG. 2 is a front view of the device according to the invention; [Diagram 2] FIG. 2 is a bottom view of the device according to the invention. [Diagram 3] 2 is a cross-sectional view taken along the cutting plane AA shown in FIG. [Figure 4] FIG. 1 is a schematic diagram intended to show how the device can be handled. [Diagram 5] FIG. 1 is a schematic diagram intended to show how the device can be handled. [Figure 6] FIG. 1 is a schematic diagram of a typical cystocele condition. [Figure 7A] FIG. 7 is a schematic diagram showing the device in an operative position inside the vagina to correct the condition of FIG. 6. [Figure 7B] FIG. 7 is a schematic diagram showing the device in an operative position inside the vagina to correct the condition of FIG. 6. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] A device according to the present invention is illustrated in FIGS.

[0035] The device consists of a single elastically deformable part 1. Suitable biocompatible materials for the manufacture of part 1, designed to be manufacturable according to conventional injection molding techniques, are synthetic resins such as silicones, or various plastic materials such as polyolefins, urethanes, ABS, thermoplastic elastomers, or combinations of materials that provide the necessary restoring forces for the part to fit snugly inside the vagina, all as will be explained in more detail below.

[0036] With reference to FIG. 1, the part 1 has an approximately isosceles triangular shape, at its apex is a head 2, in this example in the form of a hemispherical cap of radius R, having a generally dome-shaped upper end 21, and two equal and opposite arms 3 starting from below the head 2 and extending divergently from one another to define the sides of said approximately isosceles triangular shape.

[0037] Each arm 3 has a proximal end 31 for attachment to the head 2 , a central portion 33 , and a distal end 32 .

[0038] The proximal end 31 begins and extends tangentially to the upper end 21 of the head 2, the central portion 33 defines a slight S-shaped contour giving the arm 3 a slight outward arch (bulging outward), and the distal end 32 is rounded to seamlessly connect with the connection strap 4 which connects to the arm 3 near its distal end 32 and defines the base of an approximately isosceles triangle.

[0039] The connection strap 4 is also slightly isosceles shaped (dished) towards the outside of the part 1, making it possible to distinguish two opposing ends 41 of the connection strap 4 and a central tensioning portion by means of which the connection strap 4 is attached to the distal end 32 of the arm 3.

[0040] It should be noted that part 1 has a smooth surface on the outside and, as already mentioned, the attachment between arms 3 and connecting strap 4 is uninterrupted, i.e. the outer surface of part 1 at each of the transition areas 300 between arms 3 and connecting strap 4 (which are the highest points of the base of the approximately triangular shape of the part) are all rounded, since these are the anchoring points of part 1 inside the vagina. Similarly, the outer surfaces of arms 3 are curved (widening outwards) which are concave with respect to the free space defined between said arms 3, so that the support of arms 3 on the soft tissue inner wall of the vagina is not uncomfortable.

[0041] Figure 1 shows the part 1 in a position with the head 2 facing up and the connecting strap 4 below, which is the same orientation that the part 1 will have in use.

[0042] Part 1 has a certain symmetry. In particular, in the exemplary variant, head 2 and arm 3 of part 1 have symmetry with respect to two orthogonal planes that intersect and coincide with an imaginary straight line that is coincident with the bisector of the angle subtended by arm 3 and that is coaxial with the axis of the hemispherical cap of the upper end 21 of head 2.

[0043] FIG. 1 shows, among other things, the symmetry that the head 2 and the arm 3 have with respect to a first plane of symmetry y1 perpendicular to the plane of the paper on which FIG. 1 is drawn, along which the aforementioned imaginary straight line is drawn.

[0044] FIG. 2 is a bottom view of the part 1 and shows, among other things, the symmetry that the head 2 and the arm 3 have with respect to a second plane of symmetry y2 perpendicular to the first plane of symmetry y1 and to the plane of the paper of FIG. 2, and also shows an imaginary straight line.

[0045] FIG. 3 is a cross-sectional view of the part 1 according to the section plane AA shown in FIG. 1, which coincides with the first plane of symmetry y1.

[0046] 1 and 2 is the natural shape of the part 1. This position is called the extended position A.

[0047] To place the part 1 in the vagina and perform its purpose, it is in particular configured so that its arms 3 can approach each other and it is elastically deformed until it assumes a compressed position B1, in which it is inserted into the vagina by means of its head 2, the hemispherical cap shape of its upper end 21 facilitating this insertion operation.

[0048] This deformation can be done by hand without the use of any auxiliary tools. Moreover, this operation can be performed without the need to place fingers on the arm 3 from the outside in order to manually grip the part 1, and without the need to insert fingers into the vagina.

[0049] For this purpose, the head 2 has a lower end 22 which is particularly suitable and sized to support a finger, such as the index finger, which can be pressed against as if drawing a bow using the fingers of the other hand while pulling the connecting strap 4 in the opposite direction for the above purpose.

[0050] 4 and 5 are sketches each intended to illustrate this procedure, moving part 1 from the extended position A of FIG. 4 until part 1 assumes the compressed position B1 of FIG.

[0051] As regards the lower end 22 of the head 2 mentioned above, in this example, the lower end 22 does not extend beyond the thickness of the upper end 21, i.e. the lower end 22 is hidden behind the hemispherical cap and between the arms 3. In the variant of the drawing, this lower end 22 has at its distal end a concave surface 22a intended to support the index finger precisely, the lower end 22 being approximately frustoconical in shape, narrowing towards its distal end.

[0052] To further facilitate the manipulation for positioning the device, the connecting strap 4 has been specially designed to leave more space for the index finger pressing from below on the head 2 of the part 1. As can be seen from figures 2 and 3, the connecting strap 4 is narrower than the arm 3, is slightly offset to one side of the second plane of symmetry y2, and has a slight recess 42a in its central tensioning part 42, at the edge oriented towards the inside of the part 1. The collection of such features facilitates the deformation of the part 1 by concentrating less material in the attachment areas between the connecting strap 4 and the arm 3, these areas exerting a kind of hinge or joint effect, while leaving this part of the part 1 empty, leaving more space for the passage of the index finger to support it under the head 2 of the part 1.

[0053] Once part 1 is correctly positioned inside the vagina, the finger can be removed from the part allowing it to return to its natural (default) position, and arm 3 will react with a restoring force by exerting pressure against the inner wall of the vagina, part 1 will remain fixed under pressure inside the vagina and the device will assume the activated position B2 (see FIG. 7A).

[0054] 6 is a schematic diagram intended to illustrate a typical cystocele condition, in which the supporting tissues around the bladder 55 and vaginal wall weaken and stretch, causing the bladder 55 and vaginal wall to collapse into the vaginal canal 33.

[0055] Figures 7A and 7B show part 1 in operative position B2 to correct this condition. It can be seen how the head 2 of the device rests on the cervix or cervical canal. The lateral arms 3 are supported on the lateral vaginal wall on the outside of the lateral arms 3, on the anterior vaginal wall on which the bladder 55 rests on the upper side of the lateral arms 3, and on the posterior vaginal wall on which the rectum 66 is supported on the lower side of the lateral arms 3, all of which provide support to keep the uterus in position 11 and provide support for the rectum and bladder, so that uterine prolapse, rectocele and cystocele are corrected.

[0056] It is conceivable to provide a set of different sizes of parts 1 depending on the morphology or vaginal shape of each patient. However, in contrast to conventional pessaries, which have up to 10 or more sizes, the specific configuration of parts 1 allows for finding a suitable ratio or design such that parts 1 are universal and do not require multiple sizes.

[0057] Thus, for example, the height dimension h (see FIG. 3) of part 1 is preferably 60-70 mm, and particularly noteworthy is height h1=65±2 mm (see FIG. 1), in combination with a preferred width dimension z (see FIG. 1) of part 1 of 80-90 mm, and particularly noteworthy is width z=85.6 mm.

[0058] The height dimension h1 is the height from the tip of the head 2 to the furthest height of the lower support area 44 of the part 1 when placed in the vagina, which corresponds to the end transition area between the arms and the connecting straps (see also FIG. 7A). This support area covers about 7-10% of the width of said base of the triangular shape of the part 1 on each side of the base.

[0059] It can be observed that the minimum width dimension is greater than the maximum height dimension, which in these preferred cases results in part 1 having a flat shape, i.e. wider than it is tall.

[0060] For the head 2, a hemispherical cap shape is selected for its upper end 21, with a radius R between 9 and 11 mm, and particularly noteworthy is radius R=10 mm.

[0061] For the lower end 22 of the head 2, an ideal compromise exists, allowing the part 1 to be pushed in safely without the need to insert the index finger too deeply into the vagina, saving on material costs and omitting elements or parts that may cause discomfort when placing the part 1. In the variants illustrating the invention, possible lengths l for the lower end 22 (see FIG. 3) are between 20 and 17 mm, with a particular noteworthy length l=18.5 mm.

Claims

1. 1. A prolapse correction device including a single elastically deformable part configured to be positioned and retained within a patient's vagina, the single elastically deformable part having a head with a generally dome-shaped upper end and two arms beginning below the head and branching out opposite each other, each arm having a proximal end for attachment to the head, a central portion, and a distal end; the single elastically deformable part further includes a connecting strap extending between the two arms and connecting the two arms at the distal ends of the two arms; the device defaults to an extended position that is approximately an isosceles triangle shape, with the head at the apex, the arms at the sides of the triangle, and the connecting straps at the base of the triangle; the arms of the single elastically deformable part are movable toward each other; when the connecting strap is manually pulled in a direction opposite to the head and simultaneously pressure is applied by a person's finger to a lower end of the head provided for this purpose, the single elastically deformable part is elastically deformed, the device can be placed in a compressed position that allows easy manipulation to insert the device into or remove the device from the vagina; When the pulling on the connecting strap is released after the part is inserted inside the vagina, the single elastically deformable part attempts to return to its expanded position, and the arms react with a corresponding restoring force sufficient to exert pressure against the walls of the vagina, such that the device assumes an operative position when the single elastically deformable part is fitted inside the vagina.

2. The device of claim 1, wherein the upper end of the head is in the shape of a hemispherical cap having a radius of 8 to 12 mm.

3. the head having a lower end that is a protrusion positioned between the arms; The device of claim 1 , wherein the lower end is in the shadow of the upper end and extends in the opposite direction from the upper end without exceeding the size of the upper end.

4. The device of claim 3, wherein the lower end extends below the upper end by a length of 15 to 20 mm.

5. 4. The device of claim 3, wherein the lower end has a concave surface at a distal end thereof intended to support a human finger.

6. The device of claim 3 , wherein the lower end is generally frustoconical in shape narrowing toward the distal end of the lower end.

7. the proximal end of the arm originates below the upper end of the head and extends tangentially to the upper end; the central portion defines a slight S-shape that causes the arms to arch slightly outward; 2. The device of claim 1, wherein the distal end is rounded to seamlessly connect with the connecting strap, the connecting strap also being slightly arched toward the outside of the single elastically deformable piece and having a concave surface directed toward the inside of the single elastically deformable piece.

8. an assembly of the head and the arm of the single elastically deformable part is symmetrical with respect to a first plane of symmetry and a second plane of symmetry that are orthogonal to each other; 2. The device of claim 1, wherein the connecting strap is not symmetrical with respect to the first plane of symmetry, but is slightly offset to one side of the first plane of symmetry.

9. The device of claim 1 , wherein the connection strap narrows along a central tension portion of the connection strap.

10. The device of claim 9 , wherein the narrowed portion of the connection strap is in the form of a recess formed in a lateral edge of the connection strap.

11. The device of claim 1 , wherein the outer surfaces of the arms are curved concavely relative to the free space defined between the arms.

12. In each transition region between the arm and the connecting strap, the material of the single elastically deformable part is reduced, The device of claim 1 , wherein the presence of the transition region is intended to provide a hinge effect that facilitates deformation of the single elastically deformable part.

13. The height dimension of the approximately isosceles triangle shape of the single elastically deformable part is 60 to 70 mm, The device according to any one of claims 1 to 12, wherein the width dimension of the substantially isosceles triangular shape of the single elastically deformable part is 80 to 90 mm.

14. the height of the lower support of the single elastically deformable part, understood as the height of the approximately isosceles triangle shape from the lower support area corresponding to the end transition area between the arm and the connecting strap to the tip of the head, is between 63 and 67 mm; 14. The device of claim 13, wherein the lower support region covers 7-10% of the width of the base of the triangular shape of the single elastically deformable part from both two sides of the base.

15. A device as described in claim 13, wherein the width dimension of the approximately isosceles triangle shape is 84.5 to 86.5 mm.

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