A pelvic support vaginal insert device

Abstract

A pelvic support vaginal insert device (100) for managing various pelvic floor disorders is disclosed. The said device (100) comprises of a spindle-shaped 5 collapsible body (110) which is configured to transform said device (100) from a compressed state to an expanded state and further comprises of a single or a plurality of spindle shaped structures (110a, 110b). The plurality of spindle shaped structures (110a, 110b) comprises a plurality of flexible curved arms (130) that protrudes inwards or outwards based on the said state of the body (110) 10 and has varying cross-sectional area at a plurality of critical points and is configured to provide joint-like deformation in the body (110). The said device (100) is configured to support the vaginal walls and urethra together when the body (110) is transformed into the expanded state. 15 Figure 1A Figure 1B

Description

“A PELVIC SUPPORT VAGINAL INSERT DEVICE”FIELD OF THE INVENTION:

[0001] The present invention relates to a pelvic support vaginal insert device. Particularly, the present invention relates to a pelvic support vaginal insert device for managing various pelvic floor disorders in humans. Particularly, the present invention relates to a pelvic support vaginal insert device for managing stress urinary incontinence (SUI) and pelvic organ prolapse.BACKGROUND OF THE INVENTION:

[0002] Pelvic floor disorders (such as urinary incontinence, pelvic organ prolapse, pelvic floor dysfunction, rectocele, overactive bladder, etc.) are widely seen in human females.

[0003] Incontinence may occur when the muscles of the urinary system malfunction or are weakened in a human female body. Specifically, urinary incontinence (UI) like stress urinary incontinence (SUI) is the involuntary loss of urine that occurs due to sudden increases in intra-abdominal pressure resulting from activities such as coughing, sneezing, lifting, straining, exercising and, in severe cases, by mere changing the body position. The cause of SUI is typically weakened pelvic floor muscles and / or the urethral sphincter in the human female body, often due to factors like pregnancy, childbirth, aging, obesity, or trauma.

[0004] About 50% of women with UI report SUI as the primary or sole symptom of incontinence. (Thom and Brown 1998; Nygaard et al. 2008). The gold standard for treatment for SUI is mid-urethral sling placement surgery, which supports the mid-urethral segment and reduces urethral hypermobility (Cox, Herschom, and Lee 2013). However, given the invasive nature of the intervention and several long term risks it possesses, it is not the preferred choice of treatment for women.

[0005] Apart from surgery, conventional methods like providing electric stimulation, injecting prosthetics or wearable devices into the pelvic region of the human female body, etc. is seen for treating SUI. However, traditional aforesaid prosthetics / wearable devices suffer from various shortcomings, such as difficulty in placement and removal which may attract a doctor’s or a caregiver’s supervision, gauging the optimal placement point in the body while deploying the device into a human vaginal tract, degree of flexibility offered by the device in its movement once deployed in the human body, device reusability, device cost, etc.

[0006] Moreover, the implication of such disorder includes loss of self-esteem, embarrassment, restriction of social and sexual activities, isolation, and depression and, in many instances, dependence on caregivers.

[0007] Hence, a need arises to offer a pelvic support vaginal insert device to mitigate above challenges while serving the primary purpose of supporting the pelvic organs and controlling the pelvic floor disorder(s) (like stress urinary incontinence (SUI)) simultaneously.OBJECTS OF THE INVENTION:

[0008] The object of the present invention is to provide a pelvic support vaginal insert device which controls, manages and / or treats the pelvic floor disorder, specifically stress urinary incontinence (SUI) and pelvic organ prolapse.

[0009] Yet another object of the present invention is to provide a pelvic support vaginal insert device which supports the vaginal walls and / or the mid-urethral region or supports a portion of a urethra through the vagina or supports an anterior vaginal wall and the urethra together for managing stress urinary incontinence, pelvic organ prolapse and / or pelvic floor dysfunction.

[0010] Yet another object of the present invention is to provide a pelvic support vaginal insert device which mimics a human joint and offers a human joint-like flexibility, elasticity and deformation.

[0011] Yet another object of the present invention is to provide a pelvic support vaginal insert device which is simple to use, reusable, sustainable and which requires minimal to nil assistance from a caregiver for deployment in a human body.SUMMARY OF THE INVENTION:

[0012] In an aspect, a pelvic support vaginal insert device for managing pelvic floor disorders, including SUI and pelvic organ prolapse is disclosed. The pelvic support vaginal insert device of the present invention comprises of a body which is configured to transform the pelvic support vaginal insert device from a compressed state to an expanded state. The body further comprises a spindle-shaped collapsible structure, wherein the spindle-shaped collapsible structure further comprises of a single or a plurality of spindle shaped structures. The plurality of spindle shaped structures comprises a plurality of flexible curved arms that protrudes inwards or outwards based on the said state of the body and have varying cross-sectional area at a plurality of critical points and are configured to provide joint-like deformation in the body. The pelvic support vaginal insert device is configured to support the vaginal walls and urethra together when the body is transformed into the expanded state.

[0013] In an aspect, the plurality of curved arms responds to forces differently depending on the direction applied and covers the plurality of critical points at any length of the plurality of curved arms.

[0014] In an aspect, the plurality of critical points is located at middle and at extreme ends of each of the plurality of the flexible curved arms.

[0015] In an aspect, the plurality of flexible curved arms having variable cross-sectional area is configured to resist the undesired deformation of said device caused to a user activity.

[0016] In an aspect, the plurality of curved arms includes gaps between each arm for facilitating the plurality of curved arms to collapse and expand.

[0017] In an aspect, the plurality of curved arms has variable thickness at critical points for enabling said arms to bend into the gaps and collapse into a smaller shape.

[0018] In an aspect, the pelvic support vaginal insert device further comprises a top ring and a bottom ring at the extreme ends of the body for repositioning and / or removal of the said device from the body.

[0019] In an aspect, ends of the plurality of flexible curved arms of the upper spindle part are attached to the top ring and to the middle ring. Further, the ends of the plurality of flexible curved arms of the lower spindle part are attached to the bottom ring and to the middle ring.

[0020] In an aspect, size of the upper spindle part is greater than the size of the lower spindle part or identical.

[0021] In an aspect, the middle ring and the bottom ring together define a vertical hollow chamber which coincides with a central vertical axis of the body.

[0022] In an aspect, the pelvic support vaginal insert device is symmetrical along the central vertical axis.

[0023] In an aspect, an applicator is inserted into the vertical hollow chamber of the body, wherein the applicator is configured to hold the pelvic support vaginalinsert device in the compressed state, to insert the said device into a vaginal canal by exerting a force which is parallel to the central vertical axis and to detach once said device is inserted into the vaginal canal.

[0024] In an aspect, a string is attached to the bottom ring of the pelvic support vaginal insert device, wherein the string is configured to measure depth of placement of said device into the vaginal canal and to pull said device for removing said device from the vaginal canal.

[0025] In an aspect, the pelvic support vaginal insert device is configured to support an anterior vaginal wall and the urethra together and / or is configured to support a mid-urethral region.

[0026] In an aspect, the pelvic support vaginal insert device is configured to support the posterior urethral region along the entire length of the urethra.

[0027] In an aspect, the pelvic support vaginal insert device is configured to support the vaginal walls and / or apex together or is configured to support all the regions of the vaginal canal.

[0028] In an aspect, the pelvic support vaginal insert device manages both urinary incontinence (like SUI) and pelvic organ prolapse simultaneously as the said device supports vaginal wall and urethra together thus assists in mitigating said medical conditions in one go.

[0029] In an aspect, a method for managing pelvic floor disorders is disclosed. Said method comprises steps of inserting an applicator into a hollow chamber of a pelvic support vaginal insert device for adapting said device in a compressed state, inserting said device in the compressed state from a vaginal canal so as to reach a mid-urethral region of a human body, and removing the applicator from the hollow chamber in such a way that the pelvic support vaginal insert deviceswitches to an expanded state and wherein said device bulges and supports a urethra from the vaginal canal in the human body in the expanded state.BRIEF DESCRIPTION OF DRAWINGS:

[0030] Figure 1A shows a photographic image whereas Figure IB shows a schematic diagram of the pelvic support vaginal insert device in a compressed state, according to an embodiment of the present invention.

[0031] Figure 2B shows a photographic image whereas Figure 2B shows a schematic diagram of the pelvic support vaginal insert device in an expanded state, according to an embodiment of the present invention.

[0032] Figure 3 illustrates an engineering drawing of the pelvic support vaginal insert device where multiple views like a top view, a bottom view, a front view and a perspective view of the pelvic support vaginal insert device of the present invention is depicted.

[0033] Figure 4A illustrates an applicator assembly for the pelvic support vaginal insert device, Figure 4B illustrates a housing of the applicator assembly, Figure 4C illustrates a plunger for the housing, Figure 4D illustrates a scenario where the plunger is gradually inserted into the housing of the applicator assembly, Figure 4E illustrates a scenario where the plunger is completely inserted into the housing of the applicator assembly, Figure 4F illustrates a view when the housing of the applicator assembly is loaded into the pelvic support vaginal insert device and simultaneously the plunger is also gradually inserted into the housing .to cause the pelvic support vaginal insert device to compress and Figure 4G illustrates a view when the plunger is completely inserted into the housing of the applicator assembly which causes the pelvic support vaginal insert device to expand, according to an embodiment of the present invention.

[0034] Figure 5 illustrates an idle / rest state of the pelvic support vaginal insert device, according to an embodiment of the present invention.

[0035] Figure 6 illustrates a curved arm of a spindle part of the present pelvic support vaginal insert device possessing varying thickness as well as application of an axial force and perpendicular force on said curved arm.

[0036] Figure 7A (a) illustrates a top view with cutting plane lines SI, S2 and S3 at critical points A, B and C respectively whereas Figure 7A (b) illustrates various width of the curved arm of the upper spindle part of the present pelvic support vaginal insert device in the top view, Figure 7B (a) illustrates a lateral view whereas Figure 7B (b) illustrates various width of the curved arm of the lower spindle part of the present pelvic support vaginal insert device in the lateral view and Figure 7C illustrates an isometric view of the present pelvic support vaginal insert device of the present invention.

[0037] Figure 8 A illustrates a cross-sectional area of the curved arm when the section of pelvic support vaginal insert device is sliced with a cutting plane line S 1 at a critical point A, Figure 8B illustrates a cross-sectional area of the curved arm when the section of pelvic support vaginal insert device is sliced with a cutting plane line S2 at a critical point B and Figure 8C and 8D illustrates a cross-sectional area of the curved arm when the section of pelvic support vaginal insert device is sliced with a cutting plane line S3 at a critical point C of the present invention.

[0038] Figure 9A illustrates a state-of-the-art tape (sling) implanted into a human body and Figure 9B illustrates deployment of the present pelvic support vaginal insert device of the present invention.DETAILED DESCRIPTION OF THE INVENTION:

[0039] List of reference numerals:

[0040] The term “applicator” and “applicator assembly” may be interpreted synonymously, if the context allows.

[0041] The term “stress” may be interpreted as the force per unit area within a curved arm of a spindle part.

[0042] The term “strain” may be interpreted as the change in length of a curved arm divided by the original length of the same curved arm.

[0043] The term “young’s modulus” may be interpreted as the measure of the material's stiffness or the measure of resistance offered by the material to deformation.

[0044] The term “body” of the present pelvic support vaginal insert device may also be interpreted as a spindle-shaped collapsible structure having single or a plurality of spindle shaped structures (like the upper spindle part and the lower spindle part) which is depicted, for instance, in Figures 1A, IB, 2A and 2B. Alternately, the term “body” may also be used interchangeably or interpretedsynonymously with the phrase “spindle-shaped collapsible structure” throughout the disclosure, wherever the context allows.

[0045] The present invention provides a simple, user-friendly support to the pelvic organs for managing pelvic floor disorders. To achieve so, the present invention provides a pelvic support vaginal insert device for supporting the vaginal walls for immediate and sustained control of symptoms. That is, the present device provides support to a portion of the urethra through the vagina by making the most of the anatomical proximity of the two organs i.e. urethra and vagina. The present pelvic support vaginal insert device aims to support the mid-urethral segment for reducing urine leakages in case of incontinence.

[0046] The present device may be flexible and exhibits a human joint-like movement once inserted in the human body by being collapsible or expandable at multiple points in the structure. The present invention offers a solution for treating, controlling and / or managing pelvic floor disorders like SUI where a user may insert the pelvic support vaginal insert device by its own by seeking minimal to nil assistance from a medical practitioner, doctor and / or a caregiver.

[0047] The present device also provides strong resistance to the unwanted deformation (caused by a force called perpendicular force generated by the body) while maintaining the configuration intact when deployed into the human body. The varying cross-sectional area (or varying thickness) of the curved arms of the present device offers said resistance due to the application of linear (or axial force) while inserting the device. When placed in the human vagina, the device supports the urethra without deformation even in the presence of perpendicular forces. Further, the curved arms are adaptable in shape (like straightened or bulged) while placing and retrieving the device and also bend in certain parts while staying strong to ensure efficacy.

[0048] The present pelvic support vaginal insert device may be construed as an implant (or a removable implant) or a prosthetic injected / inserted into a human body, particularly, into a human female body via a vaginal tract for treating, controlling and / or managing various pelvic floor disorders.

[0049] The present pelvic support vaginal insert device may also be construed as a vaginal insert device designed to support the mid-urethral segment.

[0050] In an embodiment, a pelvic support vaginal insert device for managing pelvic floor disorders, including SUI and pelvic organ prolapse is disclosed. The pelvic support vaginal insert device of the present invention comprises of a body which is configured to transform the pelvic support vaginal insert device from a compressed state to an expanded state. The body further comprises a spindle-shaped collapsible structure, wherein the spindle-shaped collapsible structure further comprises of a single or a plurality of spindle shaped structures. The plurality of spindle shaped structures comprises a plurality of flexible curved arms that protrudes inwards or outwards based on the said state of the body and have varying cross-sectional area at a plurality of critical points and are configured to provide joint-like deformation in the body. The pelvic support vaginal insert device is configured to support the vaginal walls and urethra together when the body is transformed into the expanded state.

[0051] In the same embodiment, a pelvic support vaginal insert device is disclosed for the present invention for managing various pelvic floor disorders, including stress urinary incontinence and pelvic organ prolapse. The pelvic support vaginal insert device comprises of a body which is configured to transform the pelvic support vaginal insert device from a compressed state to an expanded state. The body further comprises an upper spindle part and a lower spindle part. The upper spindle part and the lower spindle part further comprises a plurality of flexible curved arms of varying thickness that protrudes inwards or outwards based on the said state of the body and having varying cross-sectionalarea at a plurality of critical points and configured to provide joint-like deformation. The pelvic support vaginal insert device is configured to support the vaginal walls and urethra together when the body is transformed into the expanded state. Further, the upper spindle part and the lower spindle part are linked via a middle ring.

[0052] In an embodiment, the plurality of curved arms responds to forces differently depending on the direction applied and covers the plurality of critical points at any length of the plurality of curved arms

[0053] In an embodiment, the plurality of critical points is located at middle and at extreme ends of each of the plurality of the flexible curved arms.

[0054] In an embodiment, the plurality of flexible curved arms having variable cross-sectional area is configured to resist the undesired deformation of said device caused to a user activity.

[0055] In an embodiment, the plurality of curved arms includes gaps between each arm for facilitating the plurality of curved arms to collapse and expand.

[0056] In an embodiment, the plurality of curved arms has variable thickness at critical points for enabling said arms to bend into the gaps and collapse into a smaller shape.

[0057] In an embodiment, the pelvic support vaginal insert device further comprises a top ring and a bottom ring at the extreme ends of the body for repositioning and / or removal of the said device from the body.

[0058] In an embodiment, ends of the plurality of flexible curved arms of the upper spindle part are attached to the top ring and to the middle ring. Further, theends of the plurality of flexible curved arms of the lower spindle part are attached to the bottom ring and to the middle ring.

[0059] In an embodiment, size of the upper spindle part is greater than the size of the lower spindle part or both upper and lower spindle part are identical.

[0060] In an embodiment, the middle ring and the bottom ring together define a vertical hollow chamber which coincides with a central vertical axis of the body.

[0061] In an embodiment, the pelvic support vaginal insert device is symmetrical along the central vertical axis.

[0062] In an embodiment, an applicator is inserted into the vertical hollow chamber of the body, wherein the applicator is configured to hold the pelvic support vaginal insert device in the compressed state, to insert the said device into a vaginal canal by exerting a force which is parallel to the central vertical axis and to detach once said device is inserted into the vaginal canal.

[0063] In an embodiment, a string is attached to the bottom ring of the pelvic support vaginal insert device, wherein the string is configured to measure depth of placement of said device into the vaginal canal and to pull said device for removing said device from the vaginal canal.

[0064] In an embodiment, the pelvic support vaginal insert device is configured to support an anterior vaginal wall and the urethra together and / or is configured to support a mid-urethral region.

[0065] In an embodiment, the pelvic support vaginal insert device is configured to support the posterior urethral region along the entire length of the urethra.

[0066] In an embodiment, the pelvic support vaginal insert device is configured to support the vaginal walls and / or apex together or is configured to support all the regions of the vaginal canal.

[0067] In an embodiment, the present pelvic support vaginal insert device (100, 200) manages both urinary incontinence (like SUI) and pelvic organ prolapse simultaneously as the said device (100, 200) supports vaginal wall and urethra together thus assists in mitigating said medical conditions in one go.

[0068] In an embodiment, a method for managing pelvic floor disorders is disclosed. Said method comprises steps of inserting an applicator into a hollow chamber of a pelvic support vaginal insert device for adapting said device in a compressed state, inserting said device in the compressed state from a vaginal canal so as to reach a mid-urethral region of a human body, and removing the applicator from the hollow chamber in such a way that the pelvic support vaginal insert device switches to an expanded state and wherein said device bulges and supports a urethra from the vaginal canal in the human body in the expanded state.

[0069] Figure 1A shows a photographic image of the pelvic support vaginal insert device in the compressed state. Further, Figure IB shows a schematic diagram of the pelvic support vaginal insert device in the compressed state, according to an embodiment of the present invention.

[0070] The pelvic support vaginal insert device (100) of the present invention, as shown in Figure 1A and IB, comprises of a body (110) further comprising an upper spindle part (110a) and a lower spindle part (110b), a plurality of curved arms (130), a string (140), an applicator (150), a middle ring (170) and a hollow chamber (190). Further, there may be a top ring (180a) and a bottom ring (180b) at the top and bottom end of the body (110) respectively for repositioning and / or removal of the said device (100, 200) from the body.

[0071] The body (110) may be a spindle-shaped collapsible structure which tapers longitudinally along a central vertical axis (120) as well as horizontally along the horizontal plane (160). The body (110) may comprise of a single or a plurality of spindle shaped structures (110a, 110b). The upper spindle part (110a) and the lower spindle part (110b) of the body (110) may be coupled linearly or in series back-to-back via a middle ring (170) along the central vertical axis (120). Such configuration may prevent rotational displacement (in the axis perpendicular to the central vertical axis (120)). By maintaining a consistent orientation within the vaginal canal, the dual-spindle configuration may ensure continuous support along the length of the human urethra. The further technical benefits of deploying spindle-shaped body (110) are provided in the subsequent paragraphs of the written description.

[0072] The body (110) may be further adapted to operate in two states, namely, in a compressed state and in an expanded state.

[0073] Each spindle part (110a, 110b) may have a plurality of curved arms (130) which has varying thickness along its length. The plurality of curved arms (130) may be bulged or protrudes outwards. The plurality of curved arms (130) of the upper spindle part (110a) may be attached between the middle ring (170) and a top ring (180a). Similarly, the plurality of curved arms (130) of the lower spindle part (110b) may be attached between the middle ring (170) and the bottom ring (180b). Further, the plurality of curved arms (130) may be spaced evenly around the central vertical axis (120). The plurality of curved arms (130) is configured to flatten side-to-side to enable deformation along the central vertical axis (120) and / or perpendicular to it along the horizontal plane (160) and at specific points across the aforesaid device (100). Each arm of the plurality of curved arms (130) may be adapted to bend inward and outward in a radial pattern, thus creating distinct configurations once said device (100) is inserted into a human body.

[0074] Figure 1A and IB shows four curved arms in each of the upper spindle part (110a) and the lower spindle part (110b). However, it may be appreciated that the number of curved arms in each of the upper spindle part (110a) and the lower plurality of curved arms (130) may vary according to specific requirements for offering increased stability and versatility without affecting the overall aesthetic and structural integrity of the aforesaid device (100). Further, Figure 1A and IB shows two spindle parts, namely the upper spindle part (110a) and the lower spindle part (110b). However, it may be appreciated that the number of the spindle parts may also vary for meeting the requirements of customization, appearance and / or functionality of the aforesaid device (100).

[0075] The body (110) may be reusable and configured to be re-elongated multiple times for each insertion. Such body (110) may also be designed to be used multiple times, allowing for efficient and cost-effective utilization of the pelvic support vaginal insert device (100).

[0076] The upper spindle part (110a) and the lower spindle part (110b) may be of same size or the upper spindle part (110a) may be comparatively large as compared to the lower spindle part (110b) or vice-versa. Therefore, the pelvic support vaginal insert device (100) may be symmetrical along the central vertical axis (120). Further, the upper spindle part (110a) and the lower spindle part (110b) may be permanently attached or detachably attached to each other.

[0077] As discussed above, the upper spindle part (110a) may be comparatively large as compared to the lower spindle part (110b) for offering maximum expansion once the pelvic support vaginal insert device (100) is inserted in the body for supporting the vaginal walls and adjacent urethra.

[0078] The middle ring (170) and the bottom ring (180b) may have a circular cross-sectional area where the diameter of the middle ring (170) and the diameter of the bottom ring (180b) may be same. Alternately, the diameter of the middlering (170) may be comparatively large as compared to the diameter of the bottom ring ( 180b) or vice versa.

[0079] The plurality of curved arms (130) of the upper spindle part (110a) may terminate at the top ring (180a). The bottom portion of the plurality of curved arms (130) of the upper spindle part (110a) and the top portion of the plurality of curved arms (130) of the lower spindle part (110b) may be connected with the middle ring (170). The middle ring (170) brings stability at the central structure of the said device (100) and confers rotational stability to external forces applied at an angle to either one of the spindle bulges. Further, the bottom ring (180b) may connect the base of the plurality of curved arms (130) of the lower spindle part (110b), ensuring structural integrity and balance. The middle ring (170) may define a hollow chamber (190) (or a hollow space) in the said device (100) for inserting the applicator (150) as explained below. Alternately, the middle ring (170) and bottom ring (180b) together may define the hollow chamber (190) in the said device (100) for inserting the applicator (150). The hollow chamber (190) may coincide or may be parallel to the central vertical axis (120, 220) of the body (110, 210).

[0080] The plurality of curved arms (130) are adapted to exert a force against the vaginal wall providing support to the mid-urethral segment when the pelvic support vaginal insert device (100) is inserted in the human body. Further, the plurality of curved arms (130) is also configured to provide joint-like flexibility and deformation when the said device (130) is inserted in the human body and enable the body (110) to switch from the compressed state (or collapsed state) to the expanded state (or wide state). The plurality of curved arms (130) may include gaps between each arm for facilitating the plurality of curved arms (130) to collapse. Further, the plurality of curved arms (130) may also have variable thickness at critical points, enabling said arms (130) to bend into the gaps and collapse into a smaller shape. Such variable thickness aids in fine-tuning the pressure which different parts of the device (100) can withstand withoutdeformation. Also, the points present at the critical points may tend to suffer high chances of deformation, hence, the plurality of curved arms (130) having maximum thickness may be present at the critical points to resist undesired deformation of the device due to physical activity of an user (which is explained in subsequent paragraphs).

[0081] The plurality of curved arms (130) with variable thickness stretches the device comfortably and reduces the curvature while inserting under the influence of the axial force. At the same time, the plurality of curved arms (130) resists a perpendicular force aimed at reducing curvature due to the increased thickness at the point of force application explained in detail in subsequent paragraphs. The plurality of curved arms (130) response is governed by the interplay between the force magnitude, material properties, and the geometry of the variable crosssections.

[0082] The pelvic support vaginal insert device (100) may be characterized by a varying thickness (or varying cross-sectional area) along the length of the curved arms (130). Such feature of varying thickness may impart flexibility and reinforcement for the aforesaid device (100). Also, the said device (100) provides joint-like flexibility and deformation while being a single piece unit.

[0083] The plurality of curved arms (130) may further provide the hollow chamber (190) along the central vertical axis (120) such a way that an applicator (150) may be inserted externally by a user to the pelvic support vaginal insert device (100). The applicator (150) may facilitate insertion of the said device (100) into a human vagina. The applicator (150) may be designed to hold the said device (100) in the elongated state thus allowing the said device (100) to remain narrow and sleek during insertion. The applicator (150) may also be detached from the said device (100) once it has been inserted into the human vagina. Such feature may allow convenient removal of the applicator (150) with no interference in the operation of the said device (100). By enabling the separation of theapplicator (150) from the said device (100) once deployed in the human body, the present invention enhances the overall usability of the said device (100) within the internal human vaginal environment. The applicator (150) may also assist in locking the plurality of curved arms (130), creating a compact and streamlined structure by applying a linear force (or an axial force) which is parallel to the central vertical axis (120).

[0084] Further, the hollow chamber (190) may provide a space for inserting the applicator (150) so as to provide axial lengthening of said device (100) for switching between the two configurations - a compressed state (or collapsed state) and an expanded state (or wide state).

[0085] Further, a string (140) may be coupled to the bottom ring (180b) of the pelvic support vaginal insert device (100). The string (140) may be used to measure depth of placement and later for pulling out the said device (100) during removal. During pulling the said device (100) out, the aforesaid device (100) may stretch along the central vertical axis (120) and put the said device (100) to the compressed state during removal, thus facilitating easy insertion and removal in compressed state. While deploying the device (100) in the human vagina, the aforesaid device (100) in a compressed state may be loaded with the help of the applicator (150) and the string (140) may be used to remove the aforesaid device (100) from the body.

[0086] Optionally, while deploying said device (100) into the human body (or vagina), the string (140) may be pulled to load the aforesaid device (100) in a compressed state with the applicator (150) (similar to a slingshot) and the string (140) may then be released with the applicator (150) for loading the aforesaid device (100) into the body.

[0087] As shown in Figure IB, the string (140) may be a u-shaped thread. Alternately, the string (140) may also be a simple, straight thread attached to thebotom ring (180b) of the pelvic support vaginal insert device (100) for easy retrieval of said device (100) from the human body. Further, the string (140) may be made from materials like elastic, coton, plastic, and the like.

[0088] The body (110) along with the rings (170, 180a, 180b) of the present pelvic support vaginal insert device (100) may be fabricated using any elastic and / or flexible material like a medical -grade silicone material. Such in-built properties of the aforesaid elastic and / or flexible material may help in bending (or controlling) the said device (100) without requiring any external or a specialised control system while inserting and / or once the said device (100) is inserted into the human body.

[0089] When the pelvic support vaginal insert device (100) is idle or in its rest state, the said device (100) may bend outward forming two-spindled bulges. The idle / rest state may be construed as the said device (100) having no applicator inserted and at the same time said device (100) being non-compressed. The natural (or by default) tendency of the said device (100) lies to be in the idle / rest state (as depicted in Figure 5).

[0090] When the plurality of curved arms (130) of the pelvic support vaginal insert device (100) collapses inwards or protrudes inwards, the said device (100) may form a tight, substantially straight-armed structure, as shown in Figure 1A and IB switching from the spindle-shaped bulge configuration (as depicted in Figure 5).

[0091] On the contrary, when the plurality of curved arms (130) of the pelvic support vaginal insert device (100) protrudes outwards, the said device (100) may shrink longitudinally (or vertically) and expand horizontally as shown in Figure 2A and 2B.

[0092] Figure 2A shows a photographic image whereas Figure 2B shows a schematic diagram of the pelvic support vaginal insert device in the expanded state, according to an embodiment of the present invention. The components of the pelvic support vaginal insert device (200) for Figure 2A and 2B, like the body (210), upper spindle part (210a), lower spindle part (210b), plurality of curved arms (230), string (240), applicator (250), middle ring (270), top ring (280a), bottom ring (280b) and hollow chamber (290) including their function, remains the same as explained above for Figure 1A and IB.

[0093] When the pelvic support vaginal insert device (200) switches to the expanded state as shown in Figure 2A and 2B, the plurality of curved arms (230) of the pelvic support vaginal insert device (200) protrudes outwards. Such protrusion may cause the said device (200) to shrink longitudinally (or vertically) and expand horizontally.

[0094] The present pelvic support vaginal insert device (100, 200) operates in two states / configurations, namely, in the compressed state and in the expanded state. The working of the present pelvic support vaginal insert device (100, 200) is explained in the subsequent paragraphs.

[0095] The applicator (150, 250) may be inserted into the hollow chamber (190, 290) of the said device (100, 200) which elongates the spindle-shaped structure. Such elongated structure brings the said device (100, 200) in the compressed state / configuration such a way that the upper spindle part (110a, 210a) portion is intended to enter first into the human body (or vagina) followed with the lower spindle part (110a, 210a). The extent of insertion may be such that the said device (100, 200) is positioned below the bladder neck and urethra so as to ensure that the circumferential support aligns with the anterior vaginal wall.

[0096] The said device (100, 200) is placed with its central vertical axis (120, 220) aligned along the vaginal canal so as to ensure that the symmetrical designprovides equal support to the vaginal walls and maintains proper orientation. The applicator is then inserted into the hollow chamber (190, 290) to cause the device (100, 200) to expand (or enter into the expanded state) where the plurality of arms (130, 230) bulge outwards away from the central vertical axis (120, 220) and the device (100, 200) shrinks vertically.

[0097] The plurality of curved arms (130, 230) offers support to the interior pelvic organs once said device (100,200) is inserted. The dual-spindle configuration of the said device (100, 200) offers stability by preventing rotation, misalignment and / or displacement of the said device (100, 200) once deployed into the human body. The plurality of curved arms (130, 230) provides circumferential support along the vaginal walls thereby reducing the likelihood of localized pressure points which could bring discomfort or tissue irritation. The flexible material of the body (110, 210) adjusts the said device (100, 200) into the user’s abdominal region ensuring consistent support without excessive pressure on the vaginal walls when the user engages in any type of physical activity.

[0098] For effectively managing the SUI, the said device (100, 200) applies gentle upward pressure to the urethra through the anterior vaginal wall. Such pressure supports the urethral closure mechanism thus preventing involuntary urine leakage caused by increased intra-abdominal pressure. The said device’s (100, 200) elasticity ensures that while the device (100, 200) provides adequate support to prevent urine leakage, the device (100, 200) remains soft enough to allow voluntary urination by accommodating voluntary detrusor muscle contraction.

[0099] For effectively managing the pelvic organ prolapse, the said device (100, 200) stabilizes and supports the bladder and / or pelvic organs that may have descended into the vaginal canal. For achieving so, the dual spindle design along with the plurality of curved arms (130, 230) ensures multi-point support whichredistributes the load of the prolapsed organ and relieves the pressure on the vaginal walls.

[0100] The present pelvic support vaginal insert device (100, 200) may support reduced health care attention for inserting said device (100, 200) into the body due to simple steps of deployment thus reducing the need for frequent clinic visits. Alternately, the said device (100, 200) may also support a dual approach, allowing users to transition between self-management and caregivers’ assistance as required for deploying said device (100, 200) into the human body.

[0101] The present device (100, 200) may be reused for up to a month, thus providing long-term support and convenience for patients dealing with multiple pelvic floor disorders.

[0102] The present device (100, 200) may be removed once a week for cleaning and may undergo a resting period of 12 hours. This ensures that the device (100, 200) remains hygienic and effective for continued use. Such aforesaid cleaning may be done with the help of a mild soap and water for ensuring that the device (100, 200) is free from debris, contaminants and / or pathogens before reinsertion and for maintaining proper hygiene.

[0103] Figure 3 illustrates a top view, a bottom view, a front view and a perspective view of the pelvic support vaginal insert device showing dimensions of all the components of the pelvic support vaginal insert device.

[0104] The present pelvic insert support device may also be available in various sizes like XS (X-Small), S (Small), M (Medium), L (Large) and XL (X-Large) depending on the user’s physical requirement. Accordingly, the size of the upper spindle part, lower spindle part, bottom ring and middle ring may vary for XS, S, M, L and XL sizes. The detail dimensions are provided in Figure 3.

[0105] The following table shows the various sizes of the pelvic insert support device along with the dimensions:

[0106] Figure 4A illustrates an applicator assembly of the pelvic support vaginal insert device (100, 200), according to an embodiment of the present invention. The applicator (150, 250) of Figure 1A and 2A is explained in more detail in the subsequent paragraphs with respect to Figures 4A to 4G.

[0107] The applicator assembly (400) as depicted in Figure 4A comprises of a housing (410) and a plunger (420). The housing (410) and the plunger (420) of the applicator assembly (400) is illustrated in Figure 4B and Figure 4C respectively.

[0108] The housing (410) of the applicator assembly (400) comprises of a hollow cylindrical vertical rod (410a), a thumb rest (410b) and a plurality of grooves / ridges / protrusions (410c) as depicted in Figure 4B.

[0109] The thumb rest (410b) may be fixed to the base of the hollow cylindrical vertical rod (410a). Further, the hollow cylindrical vertical rod (410a) may have a plurality of grooves / ridges / protrusions (410c) present on the outer surface of said vertical rod (410a). For instance, Figure 4B shows an array of grooves / ridges / protrusions (410c) positioned in a circular fashion on the outer surface of said vertical rod (410a).

[0110] Figure 4C shows a plunger (420) for the housing (410) of the applicator assembly (400). The plunger (420) may be inserted into the hollow cylindrical vertical rod (410a) of the housing (410) for pushing the pelvic support vaginal insert device (100, 200) into the human body. While performing said insertion, the rod of the plunger (420a) may gradually enter into the hollow cylindrical vertical rod (410a) and eventually, the base of plunger (420b) may contact the thumb rest (410b) or the end of the housing (410).

[0111] Figure 4D and 4E shows the interaction of the plunger (420) with the housing (410) of the applicator assembly (400). Figure 4D illustrates a scenario where the plunger (420) is gradually inserted into the housing (410) of the applicator assembly (400). Whereas, Figure 4E illustrates the scenario where the plunger (420) is completely inserted into the housing (410) of the applicator assembly (400).

[0112] Figure 4F illustrates a view when the housing (410) of the applicator assembly (400) is loaded into the pelvic support vaginal insert device (100, 200) and simultaneously the plunger (420) is also gradually inserted into the housing. (410) to cause the pelvic support vaginal insert device (100, 200) to compress (or enter into the compressed state).

[0113] Figure 4G illustrates a view when the plunger (420) is completely inserted into the housing (410) of the applicator assembly (400) which causes the pelvic support vaginal insert device (100, 200) to expand (or enter into the expanded or wide state).

[0114] While inserting the pelvic support vaginal insert device (100, 200) into the human body, the said device (100, 200) is held in place due to the plurality of grooves (410c) (as shown in Figure 4F). The axial force, while loading the applicator (400), stretches said device (100, 200) out to reach the sleek / elongated shape (or compressed state). As the plunger (420) is graduallypushed, the device overcomes the ridges and the plunger (420) reaches the closed end (as shown in Figure 4G) for attaining the active position for providing pelvic support inside the vagina. As the axial force causing the deformation of the said device is released, the device (100, 200) attains the rest / idle state.

[0115] Figure 6 illustrates a curved arm of a spindle part of the pelvic support vaginal insert device, according to an embodiment of the present invention. Specifically, Figure 6 illustrates the curved arm possessing varying thickness throughout the curved arm. The maximum thickness (T2) of the curved arm is observed at the bulged end (or middle portion) and at each of the extreme ends of the curved arm whereas the minimum thickness (Tl) of the curved arm is observed at the region between the bulged end (or middle portion) and at each of the extreme ends of the curved arm.

[0116] Further, Figure 6 also illustrates the application of an axial force (Al, A2) and perpendicular force (P) on the curved arm. The axial force Al and A2 may be realized as the force applied by a user during insertion and retrieval of the pelvic support vaginal insert device that causes said device to stretch and bulge. Further, perpendicular force P may be realized as the undesired force acted on the curved arm once the said device is inserted into the human body. Such undesired force may be caused due to user activity like coughing, sneezing, lifting, straining, exercising and, in cases, by changing the user body position.

[0117] To elaborate further, the axial force (Al, A2) may be a force applied along the length of the curved arm and perpendicular to the curvature of the said device.

[0118] The response of the curved arm under axial force and perpendicular force is provided as below:

[0119] Axial Force:

[0120] Even Stress Distribution: When an axial force is applied, the stress is distributed evenly along the curved arm’s length. The thicker sections at the points of maximum and minimum curvature provide more resistance to stretching, while the thinner sections in between offer less resistance to the axial force.

[0121] Comfortable Stretching: The curved arm stretches comfortably under the axial force where the thicker sections experience less strain (stretching) compared to the thinner sections, allowing for a more uniform elongation of the curved arm.

[0122] Reduced Curvature: As the curved arm stretches, the initial curvature becomes less pronounced as the axial force tends to straighten the curved arm.

[0123] Perpendicular Force:

[0124] Uneven Stress Distribution: When a perpendicular force is applied inward at the point of curvature (as shown in Figure 6), the stress distribution will be uneven. The area where the perpendicular force is applied will experience the highest stress, while other areas will experience less stress.

[0125] Limited Curvature Reduction: Due to the increased thickness at the point of force application, the curved arm resists the perpendicular force effectively. In other words, the curvature of the device does not reduce significantly compared to a curved arm with uniform thickness.

[0126] The thicker sections of the curved arm provide greater resistance to deformation compared to the thinner sections. Such difference in resistance plays a crucial role in how the curved arm responds to the forces (particularly to the perpendicular force P).

[0127] Further, the force distribution also plays a crucial role in stress distribution. The axial force leads to a more even stress distribution, while the perpendicular force results in a more localized stress concentration.

[0128] Figure 7A (a) illustrates atop view with cutting plane lines SI, S2 and S3 at critical points A, B and C respectively whereas Figure 7A (b) illustrates various width of the curved arm of the upper spindle part of the present pelvic support vaginal insert device. Different sectional views of the present pelvic support device may be obtained by slicing said device at critical points A, B and C by cutting sectional lines SI, S2 and S3 respectively (which will be explained in subsequent paragraphs). Further, the varying width of the curved arm of the upper spindle part, for instance, may range from 10.0 mm to 13.6 mm as depicted in Figure 7A (b).

[0129] Figure 7B (a) illustrates a lateral view whereas Figure 7B (b) illustrates various width of the curved arm of the lower spindle part of the present pelvic support vaginal insert device. The varying width of the curved arm of the lower spindle part, for instance, may range from 6.5 mm to 12 mm as depicted in Figure 7B (b). Further, Figure 7C illustrates an isometric view of the present pelvic support vaginal insert device.

[0130] Figure 8A illustrates a cross-sectional area of the curved arm when the section of pelvic support vaginal insert device is sliced with a cutting plane line SI at a critical point A. The cross-sectional area at SI is high for said device (for instance, 31.53 mm2for the upper spindle part with perimeter 27.27 mm and 22.57 mm2for the lower spindle part with perimeter 23.77 mm).

[0131] Figure 8B illustrates a cross-sectional area of the curved arm when the section of pelvic support vaginal insert device is sliced with a cutting plane line S2 at a critical point B. The cross-sectional area at SI is low for said device(for instance, 18.81 mm2for the upper spindle part with perimeter 25.1 mm and 12.26 mm2for the lower spindle part with perimeter 19.44 mm).

[0132] Figure 8C illustrates a cross-sectional area of the curved arm when the section of pelvic support vaginal insert device is sliced with a cutting plane line S3 at a critical point C. The cross-sectional area at S3 is high for said device. For instance, the cross-sectional area at the cutting plane line S3 may be higher than the cross-sectional area obtained at the cutting plane line SI as shown in Figure 8C and 8D (For instance, 47.21 mm2for the upper spindle part with perimeter 34.84 mm and 24.52 mm2for the lower spindle part with perimeter 24.71 mm).

[0133] The present pelvic support vaginal insert device supports the mid-urethral segment non-surgically. Figure 9A and 9B depicts the cross-sectional view of a human pelvic region showing urethra. Instead of implanting a permanent tape (sling) around the mid-urethra as shown in Figure 9A via a surgery as discussed in the background section, the said device of the present invention supports the mid-urethra region through pressure being delivered from the anterior vaginal wall as shown in Figure 9B.

[0134] Though the present invention aims to treat, manage and / or control pelvic floor disorders like SUI with the help of the pelvic support vaginal insert device, it is appreciated that other pelvic floor disorders like pelvic organ prolapse, other pelvic floor dysfunctions and the like may also be treated, managed and / or controlled with the assistance of the pelvic support vaginal insert device (100, 200) as envisaged in the present invention.

[0135] The technical benefit of deploying spindle shaped body (110, 210) in the pelvic support vaginal insert device (100, 200) of the present invention are provided below:

[0136] The use of interconnected spindles in a linear arrangement ensures longitudinal support across the urethra and stabilizes the device (100, 200) within the vaginal canal. Further, the spindle shaped body (110, 210) prevents misalignment and provides multi-point support along the urethra, increasing therapeutic efficacy.

[0137] The spindle-shaped design ensures symmetrical pressure distribution along the vaginal walls, providing consistent support across the urethra and anterior vaginal wall. Such symmetry reduces the likelihood of uneven pressure or tissue irritation, improving both efficacy and patient comfort.

[0138] The spindle shape allows the device (100, 200) to elongate longitudinally while reducing its diameter, facilitating seamless insertion and removal from the vaginal canal. Such dynamic behaviour is achieved without the need for joints or additional mechanisms, simplifying both use and manufacturing.

[0139] The symmetrical spindle geometry inherently resists rotation or misalignment within the vaginal canal, ensuring that the device (100, 200) maintains its correct orientation for effective support. This prevents the device (100, 200) from becoming ineffective due to positional changes.

[0140] The spindle design provides support at multiple points along the length of the urethra, as opposed to localized pressure in single-point designs. This multi-point support improves urethral closure and enhances the management of SUI.

[0141] The spindle-shaped body (110, 210) dynamically conforms to the anatomical variations of different users, providing a personalized fit. Such adaptability ensures that the device is effective for a broader range of patients.

[0142] The inherent structure of the spindle shape prevents collapse or deformation during deployment and use, ensuring consistent support over extended periods. Such feature increases reliability and patient confidence in the device (100, 200).

[0143] The spindle shape ensures minimal contact pressure at insertion points, reducing discomfort during insertion or removal. The smooth, curved spindle design further minimizes the risk of irritation or trauma to the vaginal tissues.

[0144] The spindle shape is intuitive to use and aligns naturally with the vaginal canal, minimizing the risk of improper placement. Such feature is particularly advantageous for patients managing the device (100, 200) at their home.

[0145] The spindle body is designed to work seamlessly with an applicator (150, 250) that stretches the device (100, 200) during insertion. Such feature ensures precise placement of the device (100, 200) without the need of any surgery or any caregiver’s assistance and allows the device (100, 200) to expand to its functional state after deployment.

[0146] Further, the present pelvic support vaginal insert device (100, 200) provides following technical advantages:

[0147] The present pelvic support vaginal insert device (100, 200) provides a solution for managing pelvic floor disorders including stress urinary incontinence without the need for invasive or surgical procedures.

[0148] The material properties of the present pelvic support vaginal insert device (100, 200) strikes a balance between rigidity and flexibility for meeting thedual purpose of providing sub-urethral support and allowing voluntary urination without any obstruction.

[0149] The unique geometry of the present pelvic support vaginal insert device (100, 200) mimics like a body part with joints that allows said device to compress during insertion and expand when deployed which in turn offers to support the pelvic organs while in use.

[0150] The present pelvic support vaginal insert device (100, 200) enables self-implantation in the user’s body without the need for a medical professional while using the device at the user’s home.

[0151] The present pelvic support vaginal insert device (100, 200) is reusable offering an effective, cost-effective, and a sustainable solution.

[0152] The present pelvic support vaginal insert device (100, 200) is easy to use and does not require assembling of parts while deploying.

[0153] The present pelvic support vaginal insert device (100, 200) need not be removed from the human body while urination.

[0154] The present pelvic support vaginal insert device (100, 200) may also be benefitted for subjects having medical condition of both urinary incontinence (like SUI) and pelvic organ prolapse as the said device (100, 200) supports vaginal wall and urethra together thus assists in mitigating said medical conditions in one go.

[0155] The invention is described herein in detail with the help of figures appended at the end of the specification. The figures illustrate the preferred embodiment as well as other embodiments that define the scope of the present invention. However, it may be understood that the figures presented herein areintended to exemplify the scope of the invention only. The person skilled in art may note that by no means the figures limit the scope of the invention. Any variation in the drawings by any other person will be falling in the scope of the present invention.

[0156] The foregoing descriptions are merely specific embodiments of the present invention, but are not intended to limit the protection scope of the present invention. Any variation or replacement readily figured out by a person skilled in the art within the technical scope disclosed in the present invention shall fall within the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

We claim:

1. A pelvic support vaginal insert device (100, 200) for managing pelvic floor disorders, said device (100,200) comprises:a body (110, 210) configured to transform the pelvic support vaginal insert device (100, 200) from a compressed state to an expanded state, wherein the body (110, 210) further comprises a spindle-shaped collapsible structure (110, 210), wherein the spindle-shaped collapsible structure (110, 210) comprises of a single or a plurality of spindle shaped structures (110a, 210a, 110b, 210b), wherein the plurality of spindle shaped structures (110a, 210a, 110b, 210b) comprises a plurality of flexible curved arms (130, 230) that protrudes inwards or outwards based on the said state of the body (110, 210) and having varying cross-sectional area at a plurality of critical points and configured to provide joint-like deformation in the body (110, 210), andwherein the pelvic support vaginal insert device (100, 200) is configured to support the vaginal walls and urethra together when the body (110, 210) is transformed into the expanded state.

2. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein the plurality of curved arms (130, 230) responds to forces differently depending on the direction applied and covers the plurality of critical points at any length of the plurality of curved arms (130, 230).

3. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein the plurality of critical points are located at middle and at extreme ends of each of the plurality of the flexible curved arms (130, 230).

4. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein the pelvic floor disorders are at least one of stress urinary incontinence, pelvic organ prolapse and pelvic floor dysfunction.

5. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein the plurality of flexible curved arms (130, 230) having variable cross-sectional area is configured to resist the undesired deformation of said device (100, 200) caused to a user activity.

6. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein the plurality of curved arms (130, 230) includes gaps between each arm for facilitating the plurality of curved arms (130, 230) to compress and expand.

7. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein the plurality of curved arms (130, 230) has variable thickness at the plurality of critical points for enabling said arms (130, 230) to bend into the gaps and compress into a smaller shape.

8. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein said device (100, 200) further comprises a top ring (180a, 280a) and a bottom ring (180b, 280b) at the extreme ends of the body (110, 210) for repositioning and / or removal of the said device (100, 200) from the body.

9. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein ends of the plurality of flexible curved arms (130, 230) of the upper spindle part (110a, 210a) are attached to the top ring (180a, 280a) and to the middle ring (170, 270).

10. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein ends of the plurality of flexible curved arms (130, 230) of the lower spindle part (110b, 210b) are attached to the middle ring (170, 270) and to the bottom ring (180b, 280b).

11. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein size of the upper spindle part (110a, 210a) is greater than the size of the lower spindle part (110b, 210b).

12. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein said device (100, 200) comprises the middle ring (170, 270) and the bottom ring (180b, 280b) which together defines a vertical hollow chamber (190, 290) which is parallel to a central vertical axis (120, 220) of the body (110, 210).

13. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein said device (100, 200) is symmetrical along the central vertical axis (120, 220).

14. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein said device (100, 200) further comprises an applicator (150, 250) for inserting into the vertical hollow chamber (190, 290).

15. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein said device (100, 200) comprises a string (140, 240) attached to the bottom ring (180b, 280b) of said device (100, 200).

16. The pelvic support vaginal insert device (100, 200) as claimed in claim 13, wherein the applicator (150, 250) is configured to:hold the said device (100, 200) in the compressed state,insert the said device (100, 200) into the vaginal canal by exerting a force which is parallel to the central vertical axis (120, 220), anddetach once said device (100, 200) is inserted into the vaginal canal.

17. The pelvic support vaginal insert device (100, 200) as claimed in claim 14, wherein the string (140, 240) is configured to:measure depth of placement of said device (100, 200) into the vaginal canal, andpull said device (100, 200) for removing said device (100, 200) from the vaginal canal.

18. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein said device (100, 200) is configured to support an anterior vaginal wall and the urethra together or is configured to support a mid-urethral region of a human body.

19. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein said device (100, 200) is configured to support the posterior urethral region along the entire length of the urethra.

20. The pelvic support vaginal insert device (100, 200) as claimed in claim 1, wherein said device (100, 200) is configured to support the vaginal walls and / or apex together or is configured to support all the regions of the vaginal canal.

21. A method for managing pelvic floor disorders, said method comprising:inserting an applicator (140, 240) into a hollow chamber (190, 290) of a pelvic support vaginal insert device (100, 200) for adapting said device (100, 200) in a compressed state;inserting said device (100, 200) in the compressed state from a vaginal canal so as to reach a mid-urethral region of a human body; andremoving the applicator (140, 240) from the hollow chamber (190, 290) in such a way that the pelvic support vaginal insert device (100, 200) switches to an expanded state, wherein said device (100, 200) bulges and supports a urethra from the vaginal canal in the human body.

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