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EP-4248910-B1 - PROLAPSE CORRECTIVE DEVICE

EP4248910B1EP 4248910 B1EP4248910 B1EP 4248910B1EP-4248910-B1

Inventors

  • Llopis Manzanera, Juan

Dates

Publication Date
20260506
Application Date
20220324

Claims (15)

  1. A prolapse corrective device, made up of a single elastically deformable piece (1) suitable for being located and remaining in the vagina of a patient, wherein - the piece (1) has a head (2) with an upper ending (21) and a lower ending (22), the upper ending (21) being in the general shape of a dome, below which two arms (3) originate and extend, opposing and diverging from each other, each arm (3) having a proximal end (31), for attaching to the head (2), a central portion (33) and a distal end (32), the piece further having a connecting strap (4) that extends between and that connects the two arms (3) at the distal ends (32) thereof, the device adopting an expanded position (A) by default in the general shape of a dished isosceles triangle wherein the head (2) is at the vertex, the arms (3) are the sides of the triangle and the connecting strap (4) is the base of the triangle, - wherein the arms (3) of the piece (1) are approachable each other, the piece (1) configured for being elastically deformed, when the connecting strap (4) is manually pulled in a direction opposite to the head (2) and a pressure by a human finger is simultaneously applied on the lower ending (22) of which said head (2) is provided for this purpose, the device being able to be arranged in a compressed position (B1) that facilitates being able to perform a manoeuvre to insert the device inside a vagina or to remove the device from inside a vagina, - the arms (3) configured for responding with a corresponding restoring force, enough to exert pressure against the walls of the vagina as the piece (1) tends to recover the expanded position (A) thereof when in use the pulling of the connecting strap (4) stops after inserting the piece into the vagina, the piece (1) being hold under pressure inside the vagina, the device adopting an operative position (B2).
  2. The device according to claim 1, characterised in that the upper ending (21) of the head is in the shape of a hemispherical cap with a radius comprised between 8 and 12 mm.
  3. The device according to claims 1 or 2, characterised in that the lower ending (22) of the head is a protrusion located between the arms (3), which extends in the opposite direction to the upper ending (21), in the shadow and without exceeding the gauge of the aforementioned upper ending (21), such that said lower ending (22) is hidden behind the upper ending (21) of the head (2) in the general shape of a dome.
  4. The device according to the preceding claim, characterised in that the lower ending (22) extends a length (l), below the upper ending (21), of between 15 to 20 mm.
  5. The device according to the preceding claim, characterised in that the lower ending (22) has, at the distal end thereof, a concave surface (22a) intended for a human finger to be supported.
  6. The device according to any one of claims 3 to 5, characterised in that the lower ending (22) is generally frustoconical in shape, narrowing towards the distal end thereof.
  7. The device according to any one of the preceding claims, characterised in that the proximal ends (31) of the arms (3) originate below the upper ending (21) of the head and extend tangentially thereto; the central portions (33) follow a S-shaped profile that equips the arms (3) with a outward arch; and the distal ends (32) are rounded to link, without interruption, with the connecting strap (4), also arched towards the outside of the piece (1), with a concavity directed towards the inside of the piece.
  8. The device according to any one of the preceding claims, characterised in that the assembly of the head (2) and the arms (3) of the piece (1) is symmetrical with respect to a first and a second plane of symmetry (y1, y2) orthogonal to each other; while the connecting strap (4) is not symmetrical with respect to the first plane of symmetry (y1), being slightly offset to one side of said first plane of symmetry (y1).
  9. The device according to the preceding claim, characterised in that the connecting strap narrows along a central pulling portion (42) thereof.
  10. The device according to the preceding claim, characterised in that the narrowness of the connecting strap (4) is in the form of an indentation (42a) formed on a lateral edge thereof.
  11. The device according to any one of the preceding claims, characterised in that the outer surface of the arms (3) is a curved surface, concave with respect to the free space defined between said arms (3).
  12. The device according to any one of the preceding claims, characterised in that in each transition area (300) between the arms (3) and the connecting strap (4) there is a reduction in material in the piece (1), with the purpose of having this transition area (300) deploying a hinge effect that facilitates the deformation of the piece (1).
  13. The device according to any one of the preceding claims, characterised in that - the height dimension (h) of the generally dished triangle shape that the piece (1) has is comprised between 60 and 70 mm, and in that - the width dimension (z) of the generally dished triangle shape that the piece (1) has is comprised between 80 and 90 mm.
  14. - The device according to claim 13, characterised in that the end transition area between each arm and the connecting strap determine respective lower support areas (44), the aforementioned support areas covering each between 7 to 10% of the width of the base of the triangle shape of the piece (1) from either of the two sides of said base; and in that the height dimension (h1) considered as being the vertical distance from the lowermost part of the lower support areas (44) to the tip of the head (2), is between 63 to 67 mm.
  15. The device according to claims 13 or 14, characterised in that the width dimension (z) is between 84.5 and 86.5 mm.

Description

Technical field of the invention The invention relates to a prolapse corrective device, especially for reducing the pelvic organ prolapse of a patient, either permanently or temporarily during the performance of a functional study prior to surgical correction. Background of the invention The problem of prolapse or the exit of any pelvic organ (bladder, uterus or rectum) through the vaginal orifice is known in the current state of the art. When a pelvic organ prolapse acquires a significant size, it becomes a problem that requires a solution, often surgical. In such cases, functional studies are usually performed before planning the intervention, to rule out concealed stress urinary incontinence. During this type of study, a simulation of the arrangement that the pelvic organs will have after surgical correction is practiced, and the appearance of stress urinary incontinence is forced during the filling of the bladder. If stress urinary incontinence occurs, it is surgically corrected at the same time as the pelvic organ prolapse. The emptying of the bladder in the new placement thereof is also investigated. The use of pessaries and vaginal packing to solve pelvic organ prolapse is known. Pessaries are designed for correcting pelvic organ prolapse in a sustained manner in patients awaiting intervention or inoperable patients. They come in different sizes and are changed every six months. During that time they only require regular cleaning. For its temporary use in different patients, sterilisation and the availability of several sets are required. During attempts to demonstrate stress urinary incontinence they may fall out if the size is not properly adjusted. As far as the packing is concerned, it is nothing more than a rolled gauze, which is then shaped into an arrow. Given the material used, it has two drawbacks: insertion can be uncomfortable and even painful, and it does not maintain its shape inside the vagina. From patent document EP 3487428 various devices are known to replace or supplement a support of the rear side of the urethra that can help 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 filiform element, a thread, to tighten the bow which can have a simple arch shape or be configured in the shape of a double S. The device has edges, it requires several portions to be assembled and has a kind of handle or pole to gather the thread and offer the user a loop to pull therefrom. From patent document US 6460542 a device for controlling urinary incontinence is known. The device is made of a single piece that is placed in the vagina, but it is not suitable for correcting prolapse, especially if it is of a high degree, because it does not remain sufficiently locked in the vagina to support the pressure exerted by the offset organs, which causes ejection of the device. In addition, its placement requires portions of the device to be pinched with the fingers to deform it elastically during the placement thereof, the fingers having to be inserted together with the device into the vagina. The patent documents WO 2018/140192, US 2021/0282961 and US 2009/0266367 describe respective devices for supporting a prolapsed organ able to adopt a compact and an expanded configurations, respectively suitable for insertion into a vagina and for remaining coupled therein stretching at least a portion of a prolapsed vagina wall, thereby substantially alleviating prolapse of at least one pelvic organ. WO2018/140192 describes devices comprising a body to be inserted into a vagina, the body comprising a longitudinal axis, a proximal insertion portion, a plurality of legs, and a distal retrieval portion. The plurality of legs may each comprise a proximal end, a distal end, and a longitudinal axis. The proximal end of each leg may be coupled to the insertion portion and the distal ends of the plurality of legs may be coupled to one another. Each leg may curve radially outward along its longitudinal axis between its proximal and distal ends. The longitudinal axis of each of the plurality of legs may be substantially parallel to the longitudinal axis of the body. It is the main objective of the present invention to provide an alternative to the known devices. It is also desirable that the device enables the pelvic organ prolapse of a patient to be reduced in a simple, safe and comfortable way for both the patient and the specialist applying it. Explanation of the invention The proposed prolapse correction device is a device according to claim 1. The device is made up of a single elastically deformable piece suitable for being located and remaining in the vagina of a patient. In essence, the device is characterised in that the piece has a head with an upper ending in the general shape of a dome, below which two arms originate and extend opposing and diverging from each other, each arm having a proximal end, for attaching to the head, a ce