WO2021175837A1 - Dispositif contre l'incontinence urinaire pour femmes - Google Patents

Dispositif contre l'incontinence urinaire pour femmes Download PDF

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Publication number
WO2021175837A1
WO2021175837A1 PCT/EP2021/055159 EP2021055159W WO2021175837A1 WO 2021175837 A1 WO2021175837 A1 WO 2021175837A1 EP 2021055159 W EP2021055159 W EP 2021055159W WO 2021175837 A1 WO2021175837 A1 WO 2021175837A1
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WO
WIPO (PCT)
Prior art keywords
elongated body
intravaginal device
pressure exerting
vagina
exerting portion
Prior art date
Application number
PCT/EP2021/055159
Other languages
English (en)
Inventor
Hedieh ASADI
Hasti ASADI
Gunvor Ekman Ordeberg
Original Assignee
Deodoc Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Deodoc Ab filed Critical Deodoc Ab
Publication of WO2021175837A1 publication Critical patent/WO2021175837A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/005—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra with pressure applied to urethra by an element placed in the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary

Definitions

  • the present invention relates to a urinary incontinence device for women, and in particular to a urinary incontinence device for stress induced incontinence, according to the preamble of the independent claim.
  • Urinary incontinence causes significant suffering for the individual and large costs to society, for example an estimated 2% of the total health care cost in Sweden. Urinary incontinence is classified by the WHO as a global public health disease. Still the current products and methods are insufficient to relieve leakage problems.
  • the urinary tract in women consists of two parts, the bladder, functioning as a reservoir, and the urethra.
  • the bladder functioning as a reservoir
  • the urethra Early on, studies concerning urine incontinence in women was focused on the function of the bladder. Later, attention was shifted to the urethra, as it has been shown through measurements of urethral pressure profiles that the main difference between continent and stress-incontinent women lies in the inability of the latter to withstand pressure due to weakened musculature surrounding the urethra ( U . Ulmsten, M. Asmussen and K. Lindstrom (1977) Urol. Int. 32:127-136 and L Henriksson, K.-E. Andersson & U. Ulmsten (1979) Scand. J. Urology and Nephrology, 13:1, 5-10).
  • US Patent 6,808,485 discloses a helically shaped device that conforms to the walls of the vagina.
  • US Patent 6,770,025 shows a molar shaped vaginal incontinence insert.
  • a number of different shapes of intravaginal devices have been proposed, for example in US2009/0203959, CA2371974A1, WO98/49980, and W02018/140192.
  • Other vaginal devices are also known for other purposes, such as for prolapse alleviation (US Patent 8,651,109) and strengthening the pelvic floor (US Patent Appln. 2010/0145137).
  • An object of the present invention is to provide an intravaginal device for stress induced urinary incontinence which is effective, easy to use and easy to manufacture.
  • a further object is to provide a intravaginal device which is easy to insert into position by the user, with high accuracy in correct placement in an effective and comfortable position in the vagina.
  • an intravaginal device for stress induced urinary incontinence comprises an elongated body adapted for insertion into a vagina, wherein the body is cup-shaped or cylindrical, or a combination thereof.
  • the elongated body has a proximal end and a distal end, wherein the distal end is adapted to be placed distally in the vagina and the proximal end is adapted to be placed closer to the opening of the vagina.
  • the elongated body is essentially hollow with an open end at the proximal end, has an outer surface being adapted to contact surrounding vaginal walls when inserted into a vagina, and comprises at least one circumferential pressure exerting portion around the circumference of the elongated body.
  • the circumferential pressure exerting portion comprises a strengthened circumferential portion of the body near the proximal end of the body, or at least in the proximal half of the elongated body.
  • Figure 1a and 1b shows perspective views of intravaginal devices from a proximal side direction.
  • Figure 2 shows a perspective view of the intravaginal device of Figure 1 from a a distal side direction.
  • Figure 3 shows a side view of the intravaginal device of Figure 1a.
  • Figure 4a and 4b show cross-sectional views of the intravaginal device of Figure 1a and figures 4c and 4d show cross-sectional views of the intravaginal device of Figure 1b.
  • Figure 5 shows another aspect of an intravaginal device.
  • Figure 6 shows further aspects of an intravaginal device.
  • Figure 7 shows a side view of another aspect of an intravaginal device.
  • FIGs 8a and 8b illustrates folding of an intravaginal device as shown in Figure 1b.
  • Figure 9 illustrates a cross-sectional view of a woman’s pelvic region before insertion of an intravaginal device.
  • Figure 10 illustrates the position of an intravaginal device within the vagina.
  • the present invention is based on the realization that there is a need for a effective, yet comfortable and easy-to-use device for those experiencing stress-induced incontinence.
  • the present disclosure provides an effective and easily used urine incontinence device which contributes to increased quality of life for the affected women. At the same time, the disclosed device is environmentally friendly and cost-effective for the patient, the healthcare system and the community.
  • proximal in view of a device, applies to a direction towards a user and/or towards the outside of the body, and the term “distal” applies to a direction away from a user and/or an insertion direction into a body.
  • an intravaginal device for stress induced urinary incontinence comprising an elongated body adapted for insertion into a vagina, wherein the body is cup-shaped, cylindrical or a combination thereof.
  • the body further comprises a proximal end and a distal end adapted to be placed distally in the vagina.
  • the distal end preferably has a smaller outer diameter than the proximal end, said diameter measured essentially perpendicular to a longitudinal axis of the body.
  • An outer surface of the body is adapted to contact surrounding vaginal walls when inserted into a vagina, and the body comprises at least one pressure exerting portion arranged along a circumference of the elongated body essentially in a plane being perpendicular to the longitudinal axis.
  • the at least one pressure exerting portion is adapted to radially exert pressure on the surrounding vaginal walls, and comprises a strengthened circumferential portion of the elongated body.
  • Figures 1a and 2 show one aspect of an intravaginal device 1 for stress induced incontinence from two different perpectives, wherein the device is seen from a proximal side view in Figure 1a and from a distal side view in Figure 2.
  • Figure 1b shows a similar device, wherein the device shown in Figure 1b has a shorter overall length than that of Figure 1a, as will be detailed further below.
  • Figure 3 shows a side view of the device of Figure 1a, with the longitudinal axis A illustrated.
  • the intravaginal device 1 comprises an elongated body 2 adapted for insertion into a vagina.
  • the body 2 of the device may be shaped as an elongated cup, with a narrower distal end 3 intended for distal insertion into a vagina.
  • the cup-shape has a distal convex outer surface, which is adapted to be inserted distally into the vagina, as will be described further below.
  • the body is elongated along the longitudinal axis A.
  • the body may be rounded at the distal end 3.
  • the diameter of the body gradually lessens towards the distal end 3, where the diameter is measured essentially perpendicular to the longitudinal axis of the body.
  • the proximal end 4 of the body is adapted to be placed towards the outer vaginal opening.
  • the elongated body 2 is essentially hollow with an open end at the proximal end 4.
  • the body 2 forms a solid cup-shape with a distal convex surface and without any throughgoing holes.
  • the body may be cylindrical or approximately cylindrical in shape.
  • the body 2 may also in some aspects, have an opening at the distal end, as shown in Figure 5, to allow discharge to pass through.
  • the body 2 may be generally cup-shaped with a distal convex surface and a cutaway top at the distal end 3.
  • the outer circumferential surface of the body 2 is adapted to contact surrounding vaginal walls when inserted into a vagina as will be detailed further below.
  • the body 2 preferably has an essentially circular cross-section.
  • the outer surface of the body 2 is continuous around the circumference of the body, as may be seen in e.g. Figures 1-3, 5, 6 and 7.
  • the outer surface of the body 2 is preferably a smooth and continuous surface also along essentially the majority of a longtitudinal length of the body 2.
  • the body 2 comprises at least one pressure exerting portion 5 around a circumference of the elongated body.
  • the pressure exerting portion 5 is preferably provided along a circumference in a plane essentially perpendicular to the longitudinal axis A of the body.
  • the intravaginal device is configured to have its largest outer diameter at the one or more pressure exerting portions 5, as seen in the Figures.
  • the body and pressure exerting portions are provided such that they are rotationally symmetrical, i.e. have the same outer profile irrespective of rotation around the longitudual axis A.
  • the at least one pressure exerting portion 5 is adapted to exert radial pressure on the surrounding vaginal walls, as will be described in more detail further below.Thus, the body and pressure exerting portion are adapted such that the latter exerts a higher radially directed force than other portions of the body. This results in a device, that when placed in the vagina, will exert pressure on the vaginal walls in a localized ring-shaped region.
  • the at least one pressure exerting portion 5 thus comprises a strengthened circumferential portion of the body.
  • the radial pressure exerting effect may be achieved by a number of manners. Some examples are shown in Figures 1-7, wherein one or several ring-shaped thicker layers of material are provided.
  • a pressure exerting portion may be made of a material that is stiffer and/or more rigid than the surrounding material, such that a higher radial force will be exerted at the pressure exerting portion than in other regions of the body 2.
  • the term strengthened portion or ring is occasionally used to mean pressure exerting portion.
  • the pressure exerting portion(s) are configured to apply pressure directed towards the urethra, concentrated to a region located approximately at a 20-30 mm depth into the vagina, which corresponds to the region of the urethra identified as most affected in incontinent women, and thus is a region most in need of support.
  • the pressure exerting portion forms a circumferential region around the body of the intravaginal device such that when placed in the vagina, the pressure exerting portion will through contact of mainly the wall opposing the wall directed towards the urethra, in combination with the round cross-sectional shape of the pressure exerting portion, exert pressure directed towards the urethra.
  • the at least one pressure exerting portion is ring-shaped around the circumference of the body.
  • a pressure exerting portion is preferably provided as a smooth continuous shape around the entire circumference of the body, which provides an evenly distributed pressure profile, and lessens the risk of irritation of the delicate vaginal walls.
  • a continuous pressure exerting portion i.e evenly distributed around the entire circumference, makes the device easy to apply, as it may be inserted in any rotational direction, in terms of rotation around the longituinal axis.
  • one pressure exerting portion in the form of a strengthened ring 5 is illustrated, however, it is conceivable to have one, two, three or multiple strengthened circumferential portions 5.
  • the ring(s) 5 are provided by strengthening a ring-shaped region in the body by providing thicker material in this region of the cup-shaped body, as seen in the cross-sectional views of e.g. Figures 4a-4d.
  • the pressure exerting portion 5 is provided as an integrated part of the elongated body 2 and thus comprising a thicker portion of wall material.
  • the body 2 and strengthened ring 5 are provided as a single integrated part, e.g.
  • a hollow cup or cylinder with an outer wall 11 having a first thickness ti in material at and/or near the distal end 3 and wherein the wall 11 has a second thickness t2 in material at a pressure exerting portion 5, i.e. at the strengthened ring, located in the more proximal part of the body.
  • the second thickness t2 in material is thus greater than the first thickness ti in material.
  • the thickness t2 of the material in the wall forming the pressure exerting portion 5, is preferably at least 1 ,5 times the thickness ti of the material forming the wall of the distal part of the body.
  • the thickness t2 of the material forming the pressure exerting portion 5, is at least 2, 3, 4, 5, 6, 7, 8, 9 or 10 times the thickness ti of the material forming the wall of the distal part of the body,
  • a further example, comprising multiple strengthened portions 5, is shown in Figure 6.
  • the multiple strengthened circumferential portions 5 are provided by strengthening several ring- shaped regions in the body by providing thicker material in this region of the cup-shaped body, as described above.
  • a thickness t2 of the material forming each of the pressure exerting portions 5, is preferably at least 1,5 times a thickness ti of the material forming wall of the distal part of the body.
  • An advantage of providing the intravaginal device 1 with integrated body 2 and pressure exerting portion(s) 5 is that the device may be molded in a single step, providing for easy manufacture. Furthermore, a continuous common outer surface of the body 2 and pressure exerting portion(s) 5 provides for a more comfortable device, without any parts that may chafe or irritate the delicate membranes if the vagina.
  • the outer circumference of the pressure exerting portion 5 coincides with the largest outer circumference of the body 2, i.e. forms the widest part of the body.
  • the rim 6 is preferably also provided as a thicker, strengthened portion. A strengthened rim 6 provides the advantage of helping to keep the device in place in the vagina near the opening.
  • At least one of the at least one pressure exerting portion 5 is provided adjacent or near the rim 6 at the proximal end of the elongated body. In some aspects, a midpoint of the at least one pressure exerting portion(s) 5 is provided approximately 5 to 20 mm from the edge of the proximal rim 6. In further aspects, the at least one pressure exerting portion 5 is provided in a proximal half of the elongated body.
  • the strengthened portion(s) 5 may be formed by providing thicker materal than material proximally and distally in the body, as is illustrated in the figures and described above.
  • the strengthened pressure exerting portion(s) 5 may be formed by adding a ring of another material inside or within the rings.
  • the pressure exerting portion(s) 5 may further be provided in another material, such as a less yielding material, than the surrounding material. Examples of materials for the intravaginal device will be discussed further below.
  • Figures 4a and 4b illustrate cross-sectional views along two planes through the longitudinal axis A of the device in Figure 3, wherein the two illustrated planes are perpendicular to each other.
  • Figures 4c and 4d show the corresponding views of an intravaginal device with a shorter length, e.g. that of Figure 1b.
  • the intravaginal device preferably comprises a removal member 7 adapted for gripping and removal of the intravaginal device from the vagina.
  • a removal member 7 is provided to extend in the proximal direction.
  • removal member 7 may be a U-shaped loop attached to at least two points of the proximal end 4 of the elongated body 2. Using such a loop, the intravaginal device may easily be removed by pulling on the loop using fingers.
  • a removal member may be another shape, such as an elongated removal member 7, an example of which is illustrated in Figure 7.
  • a removal member may be attached to an internal site of the body 2, e.g. at or near the internal side of the distal end 3, and extend to or proximally past the proximal rim 6 of the body.
  • the elongated removal member 7 extends at least 10-20 mm proximally of the proximal rim 6 of the body, such that it may be gripped by a user for removal of the device by pulling in a proximal direction.
  • the at least one pressure exerting portion 5 is adapted to exert pressure on the vaginal wall at a position approximately 20 to 30 mm from the outer vaginal opening.
  • the vagina 50 is arranged between the rectum 53 and the urethra 51.
  • the urethra 51 leads urine from the bladder 52.
  • the vagina 50 When relaxed, the vagina 50 is naturally compressed on itself, and the continence of the urethra 51 is controlled by surrounding musculature.
  • the intravaginal device 1 has a unique shape to ease insertion and retention into the vagina 50, the method of which will be further detailed below. It is designed to exert radial pressure, such that pressure is exerted in the region of the affected area (approximately 20-30 mm above the vaginal opening 54) where the weakened muscles surrounding the urethra are located.
  • the intravaginal device 1 When the intravaginal device 1 is inserted into the vagina 50, as seen in Figure 10, the urethra 51 is compressed and angled slightly upwards and forwards.
  • the pressure exerting portion 5 of the intravaginal device 1 is provided at the same height as the musculature where the urethra 51 is weakened, which prevents involuntary leakage. Thus, stress induced urinary leakage is prevented when the device is used.
  • the use of the intravaginal device 1 supports and strengthens the muscle area around the urethra providing support that prevents leakage effectively.
  • the shape and application method of the intravaginal device provides easy insertion and use of the device.
  • the intravaginal device 1 may be provided with folding regions 8.
  • these are seen as preformed folding lines, or indentations, on the inside surface of the wall 11 of the body 2, wherein the folding lines 8 extend from the proximal end 4 in a distal direction along approximately two thirds of the length of the body 2.
  • folding lines 8 assist a user in folding the device to a smaller diameter for insertion into the vagina.
  • an even and continuous surface is maintained on the outside of the wall of the body, which provides for a sleek and smooth profile, even when folded. Folding is achieved by hand by the user.
  • folding regions 8 may be provided in a number of alternative manners, as long as they provide regions or lines of preferential folding or compression when a user compresses the device by hand. Folding regions may be provided as lines or other dedicated regions of less thickness of the body of the device. In some aspects, one, two, three, four or multiple regions 8 may be provided in the body 2. Folding lines or regions may extend along e.g. a part of or essentially the entire length of the body 2.
  • the device When folding or compressing an intravaginal device 1, the device is compressed such that is obtains a smaller cross-sectional area and/or smaller circumference. In a folded or compressed state, the intravaginal device may easily be inserted into the vagina.
  • the user compresses the device into a folded state as described above and inserts it into the vagina.
  • the user applies it into her own vagina; however the device may also be applied by e.g. another person, such as a medical professional or caregiver.
  • the device Once the device is at a depth such that the pressure exerting portion is at approximately 20-30 mm, more preferably approximately 25 mm into the vagina, the user releases the compression of the device, such that it expands into its original shape, and is securely held in place as shown in Figure 10.
  • the disclosed method of insertion provides for an easy and user friendly way of insertion, mimimizing any discomfort and making it easy to place the device correctly in the vagina.
  • the intravaginal device When provided with a removal member 7, e.g. in the form of a loop 7 ( Figures 1-4) or elongated removal member 7 ( Figure 7), the intravaginal device is preferably arranged such that the distance D between the proximal end point 9 of the device and a midpoint 10 of the pressure exerting portion 5, as illustrated in Figure 3, is approximately 20-30 mm, more preferably approximately 25 mm.
  • the user may use the removal member as a distance guide, in that the device is placed within the vagina such that the proximal end point 9 is at or just within the vagina opening, as seen in Figure 10.
  • a shorter removal member 7 is provided, and in such cases, the device should be inserted such the proximal end point 9 is approximately 5 to 15 mm distally of the vagina opening. A shorter removal member 7 is sometimes preferred for better comfort of wearing the device.
  • a method for alleviating female urinary incontinence comprising the steps of providing an intravaginal device for stress induced urinary incontinence, the device comprising a cup-shaped and/or cylindrical elongated body, said body comprising at least one circumferentially pressure exerting portion arranged along a circumference of the elongated body, and instructing a user to compress said intravaginal device and insert the device into a vagina such that the pressure exerting portion is approximately 20 to 30 mm from the outer vaginal opening. Therafter the user may release the device and leave it in the vagina.
  • the flexible material and symmetrical shape, combined with the smooth outer surface, makes it easy even for an inexperienced user to place the device in a correct position.
  • Figure 3 also illustrates measurements of an intravaginal device as disclosed herein.
  • a total length of the device may be approximately between 40 mm and 100 mm, more preferably between 60 mm to 75 mm.
  • the body 2 of the intravaginal device 1 preferably has a length l_2 approximately between 30 and 80 mm, more preferably approximately between 45 mm and 65 mm, most preferably approximately between 50 mm and 60 mm .
  • the diameter d, at the widest point of the body, is preferably approximately between 20 mm and 50 mm, more preferably approximately between 30 mm and 40 mm.
  • the device may be provided in different sizes. In some aspects, the removal member is provided in different lengths.
  • the intravaginal device 1 is made out of any or a combination of suitable biocompatible materials such as silicones, polyurethanes, gels, plastics.
  • suitable biocompatible materials such as silicones, polyurethanes, gels, plastics.
  • the outer surface of the device becomes smooth and slippery in contact with the naturally moistened mucous membranes.
  • the outer surface of the intravaginal device 1 is adapted to have reduced friction when exposed to moisture, in order to make insertion smooth.
  • the intravaginal device is preferably made by molding, such as injection molding, extrusion or pressing. It is also conceivable that in the future other manufacturing methods may be used, such as 3D printing or other techniques.
  • the device is preferably molded in one unitary piece, including the body and removal member.
  • the material of the device is chosen such that it has enough stiffness and ability to maintain its shape in its manufactured shape to provide effective radial pressure at the pressure exerting portions. In addition, it must be flexilbe enough to be able to be folded by hand, and when released, resume its initial shape.
  • the intravaginal device 1 is preferably manufactured in a medical silicone material or thermoplastic elastomer (TPE) that is approved for intravaginal use.
  • TPE thermoplastic elastomer
  • Such material does not irritate or dry out the mucous membranes, and becomes smooth and slippery in contact with the naturally moistened mucous membranes. This is an advantage in comparison to known pelvic supporting products that are often made of foamed plastic and need to be soaked and shaped 8-10 times before being inserted into the vagina.
  • the disclosed material also helps to make the product more environmentally and climate friendly as it can be re-used and used for several years. For example, a user may use it for up to 12 hours or more at a time.
  • the device is preferably worn when the risk of stress induced incontinence is increased, such as during excersize or prolonged sessions where time for urinating is limited. Later in lafe, the urethra may become more stiff, and incontinence may be more frequent, wherein use of an incontinence device as disclosed herein alleviates such problems.
  • the device may also be sterilized if needed, such as by boiling or autoclaving.

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  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un dispositif intravaginal contre l'incontinence urinaire induite par le stress, comprenant un corps allongé adapté pour être inséré dans le vagin. Le corps présente la forme d'une coupe, d'un cylindre ou d'une combinaison de ces éléments, et comprend une extrémité proximale adaptée pour être placée à proximité ou au niveau de l'ouverture vaginale externe et une extrémité distale adaptée pour être placée dans le vagin, à distance de l'extrémité proximale. Une surface extérieure du corps est adaptée pour entrer en contact avec les parois vaginales environnantes lorsqu'il est inséré dans un vagin, et le corps comprend au moins une partie exerçant une pression autour de la circonférence du corps allongé et est adaptée pour exercer une pression sur les parois vaginales environnantes.
PCT/EP2021/055159 2020-03-03 2021-03-02 Dispositif contre l'incontinence urinaire pour femmes WO2021175837A1 (fr)

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SE2050237-3 2020-03-03

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