Intravaginal device

Abstract

An intravaginal device having a hollow cylindrical body with an open end and a removal strip, wherein the body has features that hold the removal strip in a track. During the removal process of pulling the removal strip, the cross-sectional area of the device is reduced. A kit includes the device and an auxiliary rod that facilitates insertion and removal.

Description

[0001] Related applications

[0002] This application claims the benefit of U.S. Application No. 62 / 960,839, filed on January 14, 2020, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention relates to vaginal implants that help control stress urinary incontinence and / or pelvic organ prolapse. Background Technology

[0004] Stress urinary incontinence refers to leakage of urine caused by increased pressure on the bladder from activities such as coughing, sneezing, laughing, exercising, or lifting heavy objects. It is the most common cause of urinary incontinence in women and significantly impacts their quality of life.

[0005] Overactive bladder in women refers to a frequent and urgent need to urinate, which may occur suddenly. Even if the bladder is only partially full, there may be signals that the bladder needs to be emptied.

[0006] Incomplete bladder emptying refers to a condition where some urine remains in the bladder after urinating as much as possible. It can be caused by prolapse, which alters the position of the bladder relative to the urethra.

[0007] Pelvic organ prolapse is the descent of one or more of the pelvic structures (bladder, uterus, vagina, colon, rectum) from their normal anatomical position toward or through the vaginal opening. Pelvic organ prolapse can occur when the pelvic floor muscles and ligaments stretch and weaken and can no longer provide sufficient support for the pelvic structures. Pelvic organ prolapse may be associated with stress urinary incontinence.

[0008] While surgical options exist for treating stress urinary incontinence and pelvic organ prolapse, such as sling surgery and vaginal suspension, significant risks and complications may arise. Given these risks and complications, non-surgical methods are generally used to treat stress urinary incontinence and pelvic organ prolapse.

[0009] A device, namely a vaginal pessary, may be inserted into the vagina to help control stress urinary incontinence and / or support prolapsed structures. Various vaginal pessaries are known in the art, including but not limited to ring-shaped and shelf-type pessaries.

[0010] U.S. Patent No. 6,413,206B2 describes a vaginal implant that helps control urinary incontinence by engaging the anterior vaginal wall to support the vaginal wall and the urethra behind it. Summary of the Invention

[0011] The purpose of this invention is to provide a vaginal implant.

[0012] According to one aspect of the invention, a vaginal implant is provided, comprising a hollow cylindrical body with an end opening and a removal strip; the body having a first end and a second end, a front wall and a rear wall; the body having a first notch at the first end of the front wall and a second notch at the second end of the front wall, wherein the first notch and the second notch are linearly positioned and substantially located on the midline of the front wall and form a track for the removal strip; the rear wall includes a tongue-shaped extension and an opening substantially opposite the first notch, wherein the opening is adapted to receive the removal strip; wherein the removal strip passes through the first notch, the second notch and the opening, and the front wall and the rear wall are compressed together when force is applied to the removal strip.

[0013] According to another aspect of the invention, a vaginal implant is provided, comprising a hollow cylindrical body with an end opening and a removal strip; the body is formed of a non-absorbent flexible material; the body has a first end and a second end, an anterior wall and a posterior wall; the posterior wall includes a tongue-shaped extension; the body has a first notch at the first end of the anterior wall and a second notch at the second end of the anterior wall; the first and second notches are linearly positioned and substantially located on the midline of the anterior wall and form a track for the removal strip; the posterior wall further includes an opening adapted to receive the removal strip, and the opening is substantially opposite to the first notch; the removal strip is formed of a non-absorbent flexible material; wherein the removal strip passes through the first notch, the second notch and the opening, and when a force is applied to the removal strip, it compresses the anterior wall and the posterior wall together, thereby reducing the cross-sectional area of ​​the body.

[0014] According to another aspect of the invention, the use of the vaginal implant of the invention in helping to control female stress urinary incontinence is provided.

[0015] According to another aspect of the invention, the use of the vaginal implant of the invention in helping to control pelvic organ prolapse is provided.

[0016] According to another aspect of the invention, the use of the vaginal implant of the invention in helping to control rectal prolapse is provided.

[0017] According to another aspect of the present invention, a method for controlling female stress urinary incontinence is provided, comprising inserting the device of the present invention into the vagina.

[0018] According to another aspect of the present invention, a method for helping to control pelvic organ prolapse is provided, comprising inserting the device of the present invention into the vagina.

[0019] According to another aspect of the invention, a method for helping to control rectal prolapse is provided, comprising inserting the device of the invention into the vagina.

[0020] According to another aspect of the present invention, a method for controlling female overactive bladder is provided, comprising inserting the device of the present invention into the vagina.

[0021] According to another aspect of the present invention, a method for controlling incomplete bladder emptying in women is provided, comprising inserting the device of the present invention into the vagina.

[0022] According to another aspect of the invention, a kit is provided, which includes the vaginal implant of the invention, a removal strip, and an instruction manual.

[0023] According to another aspect of the invention, a kit is provided, which includes the vaginal implant of the invention, an auxiliary rod, a removal strip, and an instruction manual. Attached Figure Description

[0024] These and other features of the invention will become more apparent from the following detailed description with reference to the accompanying drawings.

[0025] Figure 1 A perspective view of a vaginal implant device according to an embodiment of the present invention is shown.

[0026] Figure 2 It shows Figure 1 The side view of the vaginal implant shown.

[0027] Figure 3 It shows Figure 1 The front view of the vaginal implant shown.

[0028] Figure 4 It shows Figure 1 A cross-sectional view of the bottom end of the vaginal implant shown.

[0029] Figure 5 A 3D view of an embodiment of a vaginal built-in device with a removal strip is shown.

[0030] Figure 6A It shows Figure 5 An alternative view of the vaginal implant shown.

[0031] Figure 6B It shows Figure 5 An alternative view of the vaginal implant shown.

[0032] Figure 7 It shows Figure 5 An alternative view of the vaginal implant shown.

[0033] Figure 8This is a line drawing of a hand holding the vaginal implant device according to an embodiment of the present invention.

[0034] Figure 9 This is a line drawing of the vaginal implant of this invention, which is being held and compressed.

[0035] Figure 10 This is a line drawing of the compressed vaginal implant device according to an embodiment of the present invention.

[0036] Figure 11 This is a line drawing of the compressed vaginal implant device according to an embodiment of the present invention.

[0037] Figure 12 This is a sagittal cross-sectional view of the abdomen of a female patient, showing the normal physiological functions of the bladder and urethra;

[0038] Figure 13 This is a sagittal cross-sectional view of the abdomen of an incontinent female patient with the bladder neck in a downward position; and

[0039] Figure 14 yes Figure 13 A sagittal cross-sectional view of the abdomen of a female patient, showing the device of this embodiment of the invention inserted.

[0040] Figure 15 yes Figure 14 A sagittal cross-sectional view of the abdomen of a female patient, illustrating the device of an embodiment of the invention being compressed for removal.

[0041] Figure 16A This is a line drawing of the vaginal implant device according to an embodiment of the present invention.

[0042] Figure 16B This is a line drawing of the vaginal implant device of an embodiment of the present invention being slightly compressed.

[0043] Figure 17A This is a line drawing of an auxiliary rod used during the insertion and removal of a vaginal implant and a vaginal implant according to an embodiment of the present invention.

[0044] Figure 17B This is a line drawing of an auxiliary rod used during the insertion and removal of a vaginal implant and a vaginal implant according to an embodiment of the present invention.

[0045] Figure 17C This is a line drawing of an auxiliary rod used during the insertion and removal of a vaginal implant and a vaginal implant according to an embodiment of the present invention.

[0046] Figure 18A This is a line drawing of the removal bar according to an embodiment of the present invention.

[0047] Figure 18B This is a line drawing of the removal bar according to an embodiment of the present invention.

[0048] Figure 18C This is a line drawing of the removal bar according to an embodiment of the present invention.

[0049] Figure 18D This is a line drawing of the removal bar according to an embodiment of the present invention. Detailed Implementation

[0050] The present invention provides a vaginal implant to help control stress urinary incontinence and / or overactive bladder and / or incomplete bladder emptying and / or support of pelvic organs in subjects who require it (e.g., subjects with or at risk of pelvic organ prolapse).

[0051] vaginal implant

[0052] The vaginal implant 1 of the present invention includes a body 2 for engaging with and supporting the vaginal wall, and a removal strip 4. See also Figures 1 to 18D .

[0053] The main body of the vaginal implant:

[0054] The main body 2 of the vaginal implant is formed of a non-absorbent (optionally, hydrophobic) and flexible material. By using a non-absorbent (optionally, hydrophobic) material, the risk of odor, bacterial growth, and toxic shock syndrome can be reduced. In some embodiments, the non-absorbent material is washable, therefore, in such embodiments, the device is reusable. In other embodiments, the device is disposable.

[0055] Exemplary non-absorbent flexible materials include, but are not limited to, thermoplastic elastomers, such as thermoplastic vulcanizates. In some embodiments, the body of the vaginal implant is made of non-hygroscopic thermoplastic vulcanizates. In a particular embodiment, the body is made of Santoprene. TM Manufactured. An exemplary level of Santoprene that can be used to manufacture the body described herein. TM Including Santoprene TM 8281-45MED.

[0056] The main body 2 of the vaginal implant is shaped to engage with the anterior vaginal wall, thereby supporting and elevating the anterior wall and urethra without closing the urethra or obstructing urination. The main body 2 further engages with the posterior vaginal wall. In one embodiment, the device applies pressure to the vulnerable vaginal wall, causing pelvic organs to be pushed into the vaginal cavity and create a bulge, which would otherwise occur without the device. In one embodiment, the orientation of the device in the vagina is adapted to support either the vulnerable anterior or posterior vaginal wall.

[0057] In some embodiments, the body 2 is a hollow cylindrical body (ring) with an open end, wherein the rear wall extends from the first end to form a substantially tongue-shaped extension. The tongue-shaped extension prevents the device from rotating and shifting during insertion. In some embodiments, the second end of the body is slightly inclined towards the rear of the body portion. In some embodiments, the inclination is between 1° and 5°. In a particular embodiment, the inclination is 4°.

[0058] In some embodiments, the body 2 includes one or more means for engaging with the removal strip. Non-limiting examples of means for engaging with the removal strip (4) include, but are not limited to, one or more notches (3), cuts, openings (5), and combinations thereof. In a particular embodiment, the body includes a first notch at a first end of the front wall and a second notch at a second end of the front wall; the first notch and the second notch are linearly positioned and substantially located on the centerline of the front wall and form a track for the removal portion; and the rear wall further includes an opening (5) adapted to receive the removal strip, and the opening is substantially opposite the first notch.

[0059] In some embodiments, the vaginal implant includes one or more regions, bends (6), to enhance the flexibility of the device. Regions enhancing flexibility may include, for example, areas with reduced thickness in the wall of the vaginal implant, including but not limited to grooves, holes, cutouts, or cuts in the wall of the vaginal implant. One or more bends may help prevent the vaginal implant from exerting excessive pressure on the urethra, thereby preventing the possibility of urinary obstruction. One or more regions may help the vaginal implant collapse or fold during insertion and removal from the vagina. In a particular embodiment, the device includes a bend on the inner anterior wall of the vaginal implant. In a more specific embodiment, the bend includes a shallow cut located on the inner anterior wall of the vaginal implant (see...). Figure 9 and Figure 16B In a particular embodiment, the depth of the cut on the front of the bridge interior ranges from approximately 2 mm to approximately 4 mm. In a particular embodiment, the cut depth depends on the size of the device. For example, a depth of 2 mm is used for small devices, 3 mm for medium-sized devices, and 4 mm for large devices. In a particular embodiment, the cut depth is approximately 3 mm.

[0060] Remove bar

[0061] The vaginal implant also includes a removal strip to help remove the vaginal implant. See also Figures 18A to 18D as well as Figures 5 to 7The removal strip 4 may include, for example, one or more bands, cords, and / or strips. In some embodiments, the removal strip is made of a non-absorbent material. In a particular embodiment, the removal strip is a removal band formed of a non-absorbent flexible material. Exemplary materials include, but are not limited to, silicon.

[0062] In some embodiments, pulling the removal strip 4 can reduce the cross-sectional area of ​​the vaginal implant. In a particular embodiment, the cross-sectional area is reduced by causing the anterior wall to collapse to the posterior wall, and vice versa. In some embodiments, the removal strip 4 is attached to the device body 2. In other embodiments, the removal strip 4 is associated with but not anchored to the body 2. For example, the removal strip 4 may wrap around / through the body 2. In some embodiments, the removal strip passes through one or more notches 3 and / or openings 5 ​​in the body 2, wherein the one or more notches 3 and / or openings 5 ​​are configured such that the cross-sectional area of ​​the body is reduced when a force is applied. In a particular embodiment, at least one end of the removal strip includes a stopper to prevent it from passing through one or more openings in the body. In a particular embodiment, one end of the removal strip 4 is inserted through an opening 14 in a second end of the removal strip, thereby forming a loop that can tighten when a downward force is applied to the first end, thereby reducing the cross-sectional area of ​​the body. In one embodiment, the removal strip 4 has openings 14 at both ends. The openings in each end may be the same or different sizes and / or shapes. For example, the opening in the first end can be configured to allow insertion of a tool to assist in the removal of the device, and the opening in the second end can be configured to allow the first end of the removal strip to be inserted through the opening in the second end, thus forming a ring. When removal is required, the first end of the removal strip extending from the vagina can be pulled out manually or by using a hook such as the hook end of an auxiliary rod. Once force is applied to the removal strip, the cross-sectional area of ​​the device's body decreases to facilitate removal. Alternatively, it can be removed by inserting an index finger into the front bridge of the device and pulling downwards.

[0063] In some embodiments where the removal strip 4 has openings at both ends, a hook can be inserted into the opening 14 at the first end of the removal strip that extends outside the vagina.

[0064] In some embodiments, the removal strip 4 is a removal band that is attached to and wrapped around the front axle within the recess 3 through the rear hole or opening 5. See also Figures 5 to 7 .

[0065] kit

[0066] In some embodiments, a kit is provided that includes the vaginal implant of the present invention, an auxiliary rod, and an instruction manual. In some embodiments, these instructions are provided via a website or digital resources.

[0067] An illustrative embodiment of the auxiliary rod 10 is in Figures 17A to 17C As shown in the diagram. In some embodiments, the assistive rod is an elongated member having a hook end 11 and a bowl end 12. The hook end can be used to facilitate the removal of the vaginal insertive device. In particular, the hook can be used to grasp the device by removing the band 4 or by passing through the body 2 of the device. In some embodiments, the bowl end 12 of the assistive rod is capable of holding the body of the vaginal insertive device in a collapsed position. When the device is in the collapsed position, it is easier to insert. Therefore, in some embodiments, the assistive rod can be used to facilitate the insertion of the vaginal insertive device. In some embodiments, the assistive rod includes a bar 13, which holds the vaginal insertive device in its collapsed position when it is located in the bowl end 12 of the assistive rod 10.

[0068] Methods and uses

[0069] Normal anatomical structure of the urinary system in female patients, such as Figure 12 As shown. In normal anatomy, the bladder 62 is positioned such that the bladder neck 64 is located above the pelvic floor 68. The upper portion 84 of the urethra 66 is located within the abdominal cavity 78, while the lower portion 86 of the urethra is located within the vaginal cavity 80. Because the upper portion 84 of the urethra 66 is located within the abdominal cavity 78, when dynamic abdominal pressure is applied, such as through movement or coughing, abdominal pressure is applied not only to the bladder 62 but also to the upper portion 83 of the urethra 66. This instantaneous pressure on the upper portion 84 of the urethra 66 balances the pressure applied to the bladder 62, thus helping to prevent urine leakage in the event of a sudden increase in bladder pressure.

[0070] Figure 13 The anatomical structure of the urinary system is shown in a female patient with incontinence. In such patients, the bladder neck is in a downward position, placing it at or below the pelvic floor 68. The entire urethra 66 is located within the vaginal cavity 80. In this situation, when dynamic abdominal pressure is applied, because the upper part 84 of the urethra 66 is no longer located within the abdominal cavity 78, no additional pressure is applied to the urethra 66 to counteract the momentary increase in bladder pressure. Therefore, urine leaks out when dynamic abdominal pressure is applied; this condition is called stress urinary incontinence.

[0071] When installed inside the vagina (see...) Figure 14 The device can correct improper urethral positioning. Specifically, the posterior wall of the main body abuts against the posterior vaginal wall, and the anterior wall displaces the anterior vaginal wall anteriorly and superiorly to support the urethra. This support stabilizes the hypermobile urethra, fixing the upper portion of the urethra within the abdominal cavity. Therefore, when dynamic abdominal pressure is applied, a portion of the pressure is applied to the upper urethra, providing additional force to counteract the transient increase in bladder pressure.

[0072] Therefore, in some embodiments, a method for controlling stress urinary incontinence is provided, the method comprising inserting the device of the present invention into the vagina of a subject in need.

[0073] The vaginal implant of the present invention provides support for the pelvic organs. Therefore, in some embodiments, it can be used to support the pelvic organs of a subject in need (e.g., a subject with pelvic organ prolapse or a subject at risk of pelvic organ prolapse). In some embodiments, the vaginal implant of the present invention helps prevent, treat, and slow the progression of prolapse. In some embodiments, the use of the vaginal implant alleviates one or more symptoms of pelvic organ prolapse.

[0074] Those skilled in the art will readily understand that the use of vaginal implants to support the pelvic organs in a subject with pelvic organ prolapse may depend on the severity of the prolapse. In some embodiments, the pelvic organ prolapse is stage 1. In some embodiments, the pelvic organ prolapse is stage 2.

[0075] Those skilled in the art will further understand that the use of vaginal implants to support pelvic organs in subjects with pelvic organ prolapse may depend on the type of pelvic organ prolapse. Types of pelvic organ prolapse include: cystocele (i.e., bladder prolapse into the vagina), urethrocele (i.e., urethral prolapse), uterine prolapse, vaginal fornix prolapse, enterocele (i.e., small bowel prolapse), and rectocele (i.e., posterior vaginal wall prolapse between the vagina and rectum).

[0076] In some embodiments, pelvic organ prolapse is selected from one or more of the following: cystocele, urethrocele, uterine prolapse, vaginal vault prolapse, enterocele, and rectocele.

[0077] In some embodiments, pelvic organ prolapse is cystocele.

[0078] In some embodiments, pelvic organ prolapse is urethral prolapse.

[0079] In some embodiments, pelvic organ prolapse is rectocele. When placed in the vagina, the posterior wall of the vaginal insert abuts against the posterior wall of the vagina and helps support the fragile or thin tissue walls separating the vagina and rectum. That is, the vaginal insert of the present invention applies pressure to the posterior wall of the vagina (and to the anterior wall between the urethra and the vagina). This posterior pressure helps to keep the colon aligned, allowing feces to pass through the rectum and out of the colon, and preventing feces from becoming trapped in the prolapsed pocket.

[0080] In some embodiments, a method is provided for supporting the pelvic organs of a subject with pelvic organ prolapse, the method comprising inserting the device of the present invention into the vagina of the subject in need. In some embodiments, the pelvic organ prolapse is stage 1 pelvic organ prolapse. In some embodiments, the pelvic organ prolapse is stage 2 pelvic organ prolapse.

[0081] In some embodiments, the vaginal implant of the present invention can be used in conjunction with pelvic floor therapy to treat pelvic organ prolapse and / or to help strengthen pelvic floor muscles through regular use. Pelvic floor therapy includes, but is not limited to, pelvic floor exercises.

[0082] Overactive bladder and incomplete bladder emptying may be due to pelvic organ prolapse. Therefore, in some embodiments, the vaginal implant of the present invention can be used as a method for controlling female overactive bladder and / or controlling female incomplete bladder emptying.

[0083] An exemplary, non-limiting method for manually inserting the device is described in detail below.

[0084] 1. Empty the bladder

[0085] 2. If necessary, before insertion, attach the removal strip through the rear hole and wrap it around the front wall (i.e., the front axle) within the recess. See also Figures 5 to 7 .

[0086] 3. Clean the device before and after each use, for example, by washing and rinsing it in warm water with unscented soap.

[0087] 4. The device can be inserted using various techniques similar to those used for inserting tampons. The user should relax and sit on the toilet with legs apart, or stand with one leg raised (resting against an object at knee height), squat, or lie down with legs apart.

[0088] 5. To facilitate insertion, the device can be moistened with warm water, or a very small amount of water-based lubricant can be used in case of vaginal dryness.

[0089] 6. Fold the device by compressing the central bridge (ring) with your index finger and pressing the two sides together. See also Figure 9 and Figure 10 .

[0090] 7. The anterior central bridge (ring) points away from the vaginal opening but upwards, with its longer posterior end facing the vaginal opening.

[0091] 8. Now gently insert the folded device inward and upward into the vaginal canal until the bridge (ring) is no longer outside the vaginal opening. The device should be positioned behind the pubic bone; you should feel it as it passes through.

[0092] An exemplary, non-limiting method of inserting an auxiliary rod into the device is described in detail below.

[0093] 1. Empty the bladder

[0094] 2. If necessary, before insertion, attach the removal strip through the rear hole and wrap it around the front wall (i.e., the front axle) within the recess. See also Figures 5 to 7 .

[0095] 3. Clean the device before and after each use, for example, by washing and rinsing it in warm water with unscented soap.

[0096] 4. The device can be inserted using various techniques similar to those used for inserting tampons. The user should relax and sit on the toilet with legs apart, or stand with one leg raised (resting against an object at knee height), squat, or lie down with legs apart.

[0097] 5. To facilitate insertion, the device can be moistened with warm water, or a very small amount of water-based lubricant can be used in case of vaginal dryness.

[0098] 6. Fold the device by compressing the central bridge (ring) with your index finger and pressing the two sides together. See also Figure 9 and Figure 10 .

[0099] 7. Place the device on the cup end of the auxiliary rod and hold it in its collapsed position. The anterior central bridge (ring) points away from the vaginal opening but upwards, with its longer rear end facing the vaginal opening.

[0100] 8. Now, gently insert the folded device, held in the auxiliary rod, inward and upward into the vaginal canal until the bridge (ring) is no longer outside the vaginal opening. The device should be positioned behind the pubic bone; you should feel it as it passes through. Once the device is in the correct position, tilt the rod upward to release the device from it, and then gently remove the rod from the vagina.

[0101] An exemplary, non-limiting method for manually removing the device is described in detail below.

[0102] 1. To remove the device, the user needs to adopt the same posture as when it was inserted.

[0103] 2. Gently pull down the removal strip, which will cause the device to fold / collapse again for easy removal.

[0104] 3. Once the device is close to the vaginal opening, the user can hook the side of the ring with their index finger and gently pull it down until the device is removed.

[0105] An exemplary, non-limiting method for removing the device using an auxiliary rod is described in detail below.

[0106] 1. To remove the device, the user needs to adopt the same posture as when it was inserted.

[0107] 2. The hook end of the auxiliary rod is used to pull the removal strip downwards by hooking it onto the opening on the removal strip or onto the device. The device will refold / collapse when the removal strip is pulled out.

[0108] 3. Once the device is close to the vaginal opening, you can use the hook end of the assist stick to hook the side of the ring and gently pull it down until the device is removed, or the user can use their index finger to hook the side of the ring and gently pull it down until the device is removed.

[0109] 4. You can use a small amount of sterile water-based lubricant or just water to moisten the inside of the vagina around the device and gently pull the removal strip. Alternatively, you can insert your finger or the hook end of an aid into the vagina to squeeze the rings of the device together, thereby releasing any vacuum that may have formed.

[0110] Equivalent content

[0111] Those skilled in the art will understand that this description is made with reference to certain embodiments, and other embodiments may be made that employ the principles of the invention that fall within the spirit and scope of the invention.

Claims

1. A vaginal implant (1), comprising: Hollow cylindrical body with open ends (2) and removal strip (4); The main body has a first end and a second end, a front wall and a rear wall; The main body has a first notch (3) at a first end of the front wall and a second notch (3) at a second end of the front wall, wherein the first notch and the second notch are positioned in a straight line and are substantially located at the center line of the front wall and form a track for the removal strip. The rear wall includes a tongue-shaped extension and an opening (5) substantially opposite the first notch, wherein the opening is adapted to receive the removal strip. The removal strip passes through the first notch, the second notch, and the opening, and when force is applied to the removal strip, the front wall and the rear wall are compressed together, thereby reducing the cross-sectional area of ​​the main body.

2. The vaginal implant (1) according to claim 1, wherein, The main body (2) comprises a non-absorbent flexible material.

3. The vaginal implant device (1) according to claim 2, wherein, The non-absorbent flexible materials include thermoplastic elastomers and thermoplastic vulcanized rubber.

4. The vaginal implant (1) according to claim 1, 2 or 3, wherein, The removal strip (4) comprises a non-absorbent flexible material.

5. The vaginal implant (1) according to claim 2, wherein the removal strip (4) comprises a non-absorbent flexible material, and when force is applied to the removal strip (4), the anterior wall and the posterior wall are compressed together, thereby reducing the cross-sectional area of ​​the body.

6. The vaginal implant (1) according to claim 1, wherein the first end of the removal strip (4) is inserted through the opening (14) of the second end of the removal strip (4) to form a ring, which can be tightened when a downward force is applied to the first end of the removal strip (4), thereby reducing the cross-sectional area of ​​the body (2).

7. The vaginal implant (1) according to claim 1, for helping to control female stress urinary incontinence.

8. The vaginal implant (1) according to claim 1, for helping to control pelvic organ prolapse.

9. The vaginal implant (1) according to claim 1, for helping to control cystocele, urethral prolapse, uterine prolapse, vaginal vault prolapse, enterocele, rectal prolapse or a combination thereof.

10. A kit comprising the vaginal implant (1) according to any one of claims 1 to 6 and instructions.

11. The kit of claim 10, further comprising an auxiliary rod (10).

12. The kit according to claim 11, wherein, The auxiliary rod (10) includes a hook (11).

13. The kit according to claim 11 or 12, wherein, The auxiliary rod (10) includes a bowl end (12) that holds the vaginal implant (1) in the collapsed position.

14. A vaginal implant device comprising: A hollow cylindrical body with an open end and a flexible removal strip, wherein the shape of the body is adapted to engage the anterior vaginal wall, thereby supporting and elevating the anterior vaginal wall to the urethra; The body is formed of a non-absorbent flexible material, and the body has a first end and a second end, a front wall and a rear wall, wherein the rear wall extends at the first end to form a tongue-shaped extension. The removal strip is disposed around the body or through one or more openings on the body, such that when force is applied to the removal strip, the front wall and the rear wall are compressed together, thereby reducing the cross-sectional area of ​​the body, and the removal strip is strip-shaped or rope-shaped.

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