JPH04276250A - Female incontinence controller - Google Patents

Abstract

PURPOSE: To prevent woman from making incontinence caused by stress. CONSTITUTION: Higher pressure in the urethra than in the bladder is kept regardless of change in internal abdominal pressure when the internal abdominal pressure suddenly increases by such a physical motion as cough, sneeze and laugh. A device 22 has a structure wherein an annular expandable main body part which can be inserted into a vagina and a means through which an opening 32 passes and expands and shrinks the main body part and additionally contains two projections and has a pipe 44 extending from the main body and a valve 46 in the pipe.

Description

[Detailed description of the invention]

0001

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device used for controlling bladder stress incontinence in women. More specifically, the entire device is inserted into the vagina. By supporting the vaginal tissue on either side of the urethra, the device allows tissue to be pulled across the urethra when viewed from the abdominal cavity during increases in intra-abdominal pressure. The tension allows the tissue to provide more pulsatile pressure so that the intra-abdominal pressure is more fully transmitted to the tensioned tissue. The above-mentioned tissues contained in the urethra will then be affected by the increase in intra-abdominal pressure. This serves to prevent the resting pressure difference between the upper urethra and the bladder from being compressed during coughing or other activities that cause a sudden increase in intra-abdominal pressure.

[0002] If a patient's urine is controlled during rest, the problem is how to change the intra-abdominal pressure.

0003

BACKGROUND OF THE INVENTION Female urinary incontinence is a common problem and may even be a serious social problem. Frequent incontinence of urine irritates the skin and is embarrassing for women. Much incontinence, characterized by the passing of urine during coughing, sneezing, laughing, and physical activity, is stress-related. Often problems only occur if internal intra-abdominal pressure increases too much. In other cases, incontinence occurs with minimal stress, especially when standing.

The only way to deal with urinary incontinence is to apply absorbent pads to the genital area. However, these pads have limited capacity to absorb urine, limited odor binding, and a high potential for skin infection and irritation.

[0005] It is desirable to be able to control stress incontinence, and we must consider how this can be done. Urinary control is achieved by higher pressure in the urethra than in the bladder. Resting pressure is higher in the upper third of the urethra than in the bladder due to the tension of the circular smooth muscle system of the urethra, which acts as a sphincter. The internal abdominal pressure that increases during coughing generally increases pressure equally in the upper urethra and in the bladder. Therefore, the pressure remains higher in the upper part of the urethra than in the bladder, allowing the patient to control his urine. As we grow older, the tissue atrophies, and the sudden pressure on the abdomen, as a result of childbirth, becomes compromised so that it is no longer able to reach the urethra to reach the bladder. At that time, the pressure difference between the bladder and urethra becomes zero. At this time, there is nothing to prevent urine from leaking, resulting in incontinence.

[0006] Conventionally, stress incontinence was treated as described in US Pat. No. 4,1
Kennedy stitch described in column 1, line 44 et seq. of No. 39,006.
) was controlled by the application of Kennedy stich does not provide the necessary support of the anterior wall of the vagina, which support is reduced in muscle tone, tissue atrophy, and in many cases
Lost due to birth injuries. Rather, Kennedy Stitch reduces the width of the urethra and makes incontinence less likely.

It is said that urinary incontinence can be controlled by a device that changes the angular relationship between the bladder and the urethra. Thus, the urethrovesical angle, the angle between the urethra and the base of the bladder,
It has been found that greater sharpness often reduces urinary incontinence. Edwards
No. 3,705,575 and Cory
U.S. Pat. No. 4,139,006 to ey) is based on this principle. Edwards discloses an incontinence device that changes the urethrovesical angle. The device includes a first member that fits within the vagina and applies pressure to the urethra and a second member that is adapted to attach to the pubic bone of the woman's body. However, this device is not comfortable to wear and will cause irritation to the vaginal mucous membranes. Additionally, the device cannot be inflated and expanded to a suitable size for support when just inserted into the portal.

Corey US Pat. No. 4,
No. 139,006 discloses a device that is fully inserted into the vagina to alter the surface of the anterior wall of the vagina. and,
The midsection of the urethra close to these points toward the pubic bone and reduces the urethrovesical angle to restore the patient's natural control of urine flow from the bladder to the urethral entrance. but,
The device doesn't just rest at the entrance to the vagina, and it doesn't inflate, so it doesn't expand to the right size for support.

Another incontinence device is the Habib
), US Pat. No. 3,554,184. Incontinence devices are made of silicone rubber and are designed to be inserted into the vaginal opening. The patient must wear a belt, connected to a member, the latter large enough to block the flow of urine, and inserted through the urethra against the front wall of the vagina. In addition to having to wear an uncomfortable belt, the device is placed partially inside the vagina and irritates the labia.

Bonner US Pat. No. 3,
No. 646,929 discloses a female incontinence device consisting of a flat support inserted into the vagina. A flexible septum is coupled to the brace and inflated and spread upwardly against the anterior wall of the vagina to apply pressure and block the urethra. But this device blocks all urine from the bladder. Therefore, when the patient urinates, the device must be deflected and then replaced after urination.

[0011] As mentioned above, surgically another solution is available. Many surgical procedures for stress incontinence control improve upper urethral support. It is rather more exposed to changes in intra-abdominal pressure. After the treatment, when the pressure in the abdominal cavity increases due to stress such as coughing, it is transmitted not only to the bladder but also to the upper urethra with almost the same strength. Thus, a higher pressure is maintained in the urethra than in the bladder, regardless of intra-abdominal pressure changes. Manipulation of the Bonney, a finger-like support on either side of the upper urethra, is often attempted by physicians before surgery. If such support inhibits cough incontinence, the patient would be a suitable candidate for the procedure, but surgery is often performed without consideration of the patient's age or medical condition.

Accordingly, it would be desirable to develop an incontinence control device that overcomes the problems of the prior art as disclosed herein. Surgery is also performed at the same time, or permanently if the patient cannot tolerate surgery. Bonne
This device can permanently provide support similar to that provided by the doctor's hand when the operation in y) is performed.

[0013]

SUMMARY OF THE INVENTION A first object of the present invention is to provide an inflatable device that can be inserted completely into the vagina to control stress incontinence in women. The device prevents incontinence by improving the transmission of intra-abdominal pressure to the upper urethra during stress situations such as coughing, sneezing, laughing and physical movements.

Another object of the invention is to provide such a device which does not put permanent pressure on the urethra and does not need to be removed during urination.

Another object of the invention is to provide a device that provides support on both sides of the upper urethra.

Another object of the invention is to provide a device which is adjustable by expansion and which increases both in capacity and size when inserted, and decreases during actual insertion or removal.

Another object of the present invention is to provide such a device that maintains a certain shape when uninflated and is rigid so that it can be rolled out.

Another object of the invention is that the invention is easy to insert;
It is an object of the present invention to provide a device that causes minimal discomfort and irritation to patients.

Another object of the invention is to provide a device configured to permit urinary drainage from the neck of the vagina into the entrance.

Another object of the invention is to provide a device for preventing uterine and vaginal prolapse.

[0021] This device of the invention is not intended to affect the urethrovesical angle, nor does it exert pressure that sticks to the urethra. However, it increases the transmission of internal abdominal pressure to the upper urethra. More particularly, the present invention provides a means for increasing the pressure on the anterior wall of the vagina so that, during a cough, the pressure suddenly increases, this stress increase in pressure is transmitted to the anterior wall of the vagina, which provides adequate support for the urethra. It is operated by properly supporting the The circular muscle can maintain a higher urethral pressure than the bladder. In other words, just as the pressure in the urethra is higher than the bladder and incontinence does not occur, when abdominal pressure increases, not only the bladder but also the urethra can maintain high pressure. By having such an effect, the closing pressure (herein referred to as the maximum pressure difference between the urethra and the bladder) remains clear regardless of changes in the internal abdominal pressure, and incontinence is prevented.

Female incontinence devices are inserted into the vagina to control stress incontinence in women. The device consists of an annular or oval inflatable body portion and two sides of the upper urethra, such that when a sudden increase in intra-abdominal pressure occurs, the tissue between the supporting protrusions stretches and applies opposing pressure. Contains two projections to support the vaginal tissue. The urethra between the support points is more rapidly exposed to increased internal intra-abdominal pressure, so closure pressure remains evident. The body portion has means for deflection and expansion.

[0023] Because every human body is different, each of Applicant's designs will be manufactured differently. Intermediate sizes are obtained by varying the inflation pressure. The device can be successfully inserted into the vagina if it is biased. Inside the vagina, it is partially expanded and positioned. Once the device is placed in the correct position with the fingers, inflation is complete, as described above. The effectiveness of the device can be tested by patients themselves. When your bladder is full, urine won't leak even if you laugh hard. If complete control is not possible, adjust the position of the device and the inflation pressure used. To keep the device in the best possible position, the outer surface should be roughened to reduce movement of the device and vaginal walls.

Applicants have designed a hammock-shaped support provided by two projections and an intermediate tissue. The urethra is at rest in this hammock, which causes an increase in the intra-abdominal pressure leading to it. Preferably, the support provided by the two projections is modified. This is possible when the protrusion has a thickness less than the thickness of the wall of the body portion. During expansion, when pressure is increased, the two projections become larger than the body. In other words, the protrusion will have the following shape: It has a rough surfaced body and a shape that allows it to contact the walls of the vagina so as to limit the relative movement of the body when inside the vagina. Holes run through them to reduce the overall volume of the device, allowing the passage of urine and restricting relative movement of the body when in the vagina. The expansion and deflection of the body portion includes a tube extending from the body portion and a contained valve contained within the tube or contained within the body for regulating the inflow and outflow of air. Due to the bias of the device, the attendant or the patient himself can open the valve by pushing with his finger.

[0025] The device is specifically shaped like a ring used for prolapse of the uterus or vagina. There are significant differences from the applicant's design. It has projections that support the anterior wall of the vagina on either side of the urethra.

The foregoing will become apparent to those skilled in the art from the more detailed drawings and description below.

[0027]

SUMMARY OF THE INVENTION The present device controls incontinence in women. The device is inserted completely into the vagina to support the vaginal tissue on either side of the upper urethra. When a sudden increase in intra-abdominal pressure occurs, the tissue between the supporting protrusions stretches into a hammock-like shape and applies opposing pressure. This transmits internal abdominal pressure to the upper urethra. That is, to ensure that the closing pressure (maximum pressure difference between the urethra and the bladder) remains clear and prevents incontinence, regardless of changes in intra-abdominal pressure.

[0028] The support on both sides of the urethra causes the tissue between the supports to act like a hammock, and when a sudden increase in internal abdominal pressure occurs due to coughing, sneezing, laughing, or physical movements,
Create pressure against the organization. In this way, the urethra rests in a hammock. Affected by a sudden increase in intra-abdominal pressure, resulting in higher pressure than in the bladder. Closing pressure remains clear and incontinence is controlled.

FIG. 1 shows the sagittal organs of the female pelvis that are contacted by the device of the invention. The related organs are the vagina 10, the uterus 12, the vaginal cervix 14 at the lower end of the uterus 12, the entrance to the vagina 10, the vaginal cervix 14 at the lower end of the uterus 12, the bladder 16, and the urethra 1.
It is 8. The bladder 16 stores urine and discharges it through the urethra through the urethral entrance 20. When a sudden increase in intra-abdominal pressure occurs, such as during coughing, sneezing, laughing and physical movements, the pressure within the bladder 16 is completely affected by the increased pressure. In women who exhibit stress incontinence, the increase in internal abdominal pressure is not completely transmitted to the urethra. At the peak of stress, the pressure is not as high in the urethra 18 as it normally is in the bladder 16. Additionally, there is nothing to prevent urine from exiting through the urethral entrance 20. The present invention aims to improve this situation. It improves the transmission of intra-abdominal pressure and maintains a higher pressure than the bladder despite changes in intra-abdominal pressure. Illustrated in FIGS. 2-4 is the device 22 of the present invention, a donut or ring, annular, oval body 24. The body 24 is defined by a roughened, axially extending outer surface 28 and an inner surface 30. Inner surface 30 is defined by the outer diameter of open portion 32 passing through body 24 . The opening part 32 is the uterus 12
through the secretions from the vagina 10. The protruding portion indicated at 36 contacts the body 24 and forms entirely part of the body 24 and has two front protrusions 34 on the outer surface 28 . Here, the protrusion 34 completely constitutes a part of the main body 24, but it may be attached so as to be separable from the main body 24. When the device 22 is inserted into the vagina, the protrusion 34 is inserted into the urethra 18.
Provides tissue support for the anterior vaginal wall 38 (FIG. 4) on either side of the vagina.

[0030] The projections 34 form a U-shaped surface 40. The protrusion 34, the contour of the U-shaped surface 40 and the entire body 24
The outer circumference of the can be made to suit and suit the woman's anatomy. The device 22 is made of a flexible and resilient material, and is molded into a smooth unit like an elastomer. Device 2
2 is folded upon insertion into the vagina 10 and provides the required support of the tissue of the anterior vaginal wall 38 during normal physical movements. When the device is installed, gaps 42 are created between the protrusions 34, as shown in FIG. In FIG. 3, the expansion means 4
3 is provided. The inflation means 43 is operated by a syringe or pump (not shown) and includes a tube 44 and a one-way ball valve 46 connected to the body 24 at the circumferential surface 30.
have. Tube 44 is placed outside the vagina for easy manipulation. Then it will have a helical 'memory', i.e. it will be made of elastic material. At rest, it forms a spiral close to the body 24 within the vagina. A valve 46 at the end of tube 44 can be pulled through the inlet. When the valve is loosened after inflation or deflation, the tube returns into the vagina. In other words, once the device 22 is inflated, the tube 44, which is naturally of a length that readily allows expansion, may be cut with scissors. For deflation, the valve 46 is opened by an attendant or by the patient's own finger pressure. It is also possible to replace the valve arrangement without departing from the invention. Main body 2
4 can be replaced with anything that can expand or contract.

The device is inserted into the vagina 10 so that the projections 34 are on both sides of the urethra 18 and no pressure is applied to the urethra 18. The protrusion 34 is supported to connect to the anterior vaginal wall tissue between the urethra and the vaginal mucosa. This tissue acts like a hammock and provides pulse pressure to the increasing internal abdominal pressure. Furthermore, the protrusions 34 leave the device 22 in a suitable position for many physical operations, thereby increasing the likelihood of natural attachment to the vaginal walls.

In FIG. 2, device 22 is inserted into vagina 10 by a patient in a doctor's office or at home. First, the physician or patient grasps the body 24 of the device 22 and compresses it sagittally along the major diameter of the body portion, causing the device to contract and assume the shape of a spherical section. When the doctor or nurse introduces the fully folded device to reach the posterior fornix, the indentation of the section should be facing the patient. Insert as shown. As the device 22 approaches the proper position, the device 22 partially inflates, the projections 34 secure against the sides of the vagina, and the rings settle on the pubic arch and levator muscles. When the correct position is established, the device 22 inflates further until leakage stops during coughing, sneezing, laughing, and the like. The diameter of the device 22 is between 50 and 95 mm in the normal state and in the inflated state. The supportive pressure exerted on the vagina laterally adjacent to both sides of the urethra 18 allows the tissue 42 between the urethra 18 and the vaginal mucosa to act like a hammock, as shown in FIG. When the intra-abdominal pressure suddenly rises due to coughing, sneezing, laughing, or physical movements, the tissue provides pulse pressure. In this way, intra-abdominal pressure is transmitted to the upper urethra such that the closing pressure remains distinct despite changes in intra-abdominal pressure, to prevent incontinence. The patient can then participate even in formal situations where the risk of unexpected urine leakage due to the increase in intra-abdominal pressure caused by stress activities is unacceptable, and the device remains in the patient even when urinating. .

[0033] The equipment for cleaning can be removed at the end of the day and kept for more than a month, like any other demolition equipment.

What has been described above is one embodiment, and various modifications can be made by those skilled in the art without changing the spirit of the present invention.

[Brief explanation of the drawing]

FIG. 1 is a cross-sectional view showing the sagittal portion of a female pelvis.

FIG. 2 is a sectional view showing the sagittal portion of a woman's pelvis when the device of the present invention is inserted into the vagina.

FIG. 3 is a plan view showing the device of the present invention in an expanded state.

FIG. 4 is a sectional view taken along line 4-4 in FIG. 2;

[Explanation of symbols]

10...Vagina, 18...Urethra, 22...Apparatus, 34...Protrusion, 44
...Tube, 46...Valve.

Claims

[Claims] 1. An annular inflatable body portion insertable into the vagina, a body portion whose outer surface contacts the vagina so that relative movement of the body portion with respect to the vagina when inflated is restricted; contains two protrusions that form a U-shaped surface, and the protrusions stretch the tissue between them, causing a sudden increase in intra-abdominal pressure such as during coughing, sneezing, laughing, and physical movements. It supports the anterior vagina to transmit internal abdominal pressure to the upper urethra so that the urethral pressure becomes higher than the bladder pressure and prevents incontinence regardless of pressure changes, and the main body part is supported appropriately against the anterior vaginal wall. A female incontinence control device that can be removably inserted into the vagina to support both sides of the urethra, having means for expanding and contracting. 2. The female incontinence control device of claim 1, wherein the outer circumferential surface of the body portion is roughened and abuts the vaginal wall to limit relative movement of the body portion when placed within the vagina. 3. The inflating and deflating means has a valve attached to and extending from the body portion and housed therein for regulating the flow of air to and from the body. A female incontinence control device according to claim 1, comprising a tube. 4. The female incontinence control device of claim 3, wherein said valve is a one-way ball valve. 5. The female incontinence control device of claim 4, wherein the one-way ball valve is opened by finger pressure. 6. The female incontinence control device of claim 1, wherein said protrusion is generally parallel to the larger diameter. 7. The female incontinence control device of claim 1, wherein the body portion is designed such that the two protrusions immediately spread beyond the body during inflation. 8. The female incontinence control device of claim 7, wherein the two protrusions have a wall thickness less than or equal to that of the body portion. 9. The body portion includes two projections extending therefrom to support vaginal tissue on either side of the urethra;
When the tissue between the protrusions is stretched and the internal abdominal pressure suddenly increases due to coughing, sneezing, laughing, physical movements, etc., the urethral pressure becomes higher than the bladder pressure regardless of the change in the internal abdominal pressure. providing an annular or oval inflatable body portion removably insertable into the vagina that supports the anterior vagina to transmit internal abdominal pressure to the upper urethra to prevent incontinence; into the urethra to reach the posterior fornix, the protrusions are positioned on both sides of the urethra, the device is rested on the pubic arch and levator muscles, and the body part is placed under the sudden internal abdominal pressure. A control method for preventing incontinence in women by inflating the urethra to prevent urine from leaking from the urethral entrance.