WO2016005824A1

WO2016005824A1 - Intra-urethral device for the treatment of urinary incontinence of females

Info

Publication number: WO2016005824A1
Application number: PCT/IB2015/050018
Authority: WO
Inventors: Saliya Ovitigala OVITIGALAGE
Original assignee: Ovitigalage Saliya Ovitigala
Priority date: 2014-07-09
Filing date: 2015-01-02
Publication date: 2016-01-14

Abstract

Devices and methods for treating female urinary incontinence. The intra-urethral device consists of a hemispherical container (cup) (5) inclusive of a valve (10) at the bottom of it, the 'urine flow control valve unit', which could be located in the level of the bladder neck of a female patient, a short silicon cylindrical tube (7) with a narrow diameter. The container (cup) is fixed to the proximal end of the short cylindrical tube while three tape (8) are fixed to the distal end of it at equal distances on the bottom of the tube, the extended tapes have holes (9) on them at the end of the tapes at equal distances.

Description

FIELD OF THE INVENTION

The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to intraurethral devices and methods for controlling urine flow.

BACKGROUND OF THE INVENTION 1.0 Introduction

Female urinary incontinence is a common medical condition, having widespread economic and social consequences. The difficulty and awkwardness associated with urinary

incontinence often causes the affected person to limit her social activities.

There are two common types of urinary incontinence: stress incontinence and urge incontinence. Stress Urinary Incontinence (SUI) is a common type of bladder control problem in women. It is characterized by uncontrollable leakage of urine with increased abdominal pressure. SUI is triggered by events such as coughing and laughing. This situation occurs when abdominal pressure or "stress" is placed on the weakened urethral sphincter or pelvic floor muscles. Therefore, damaged pelvic nerves, from obstetrical trauma for example, can affect the activity of the sphincter and pelvic floor muscles and also cause SUI.

The other type is Urge Urinary Incontinence (UUI) is most often caused by overactive bladder. In a situation of exert pressure on the abdominal muscles viz. overactive bladder is one that contracts without warning, leading to symptoms of urinary urgency and frequency. UUI is urine loss as the result of these symptoms. SUI is not accompanied by the sensation of a sudden urge to urinate. The cause for SUI is different from that for UUI. Some people have both SUI and UUI, known as mixed incontinence.

2.0 Prevalence

SUI is the most common type of incontinence in women younger than 60 years and accounts for at least half of incontinence in all women around the globe. This condition often goes undiagnosed and many women believe that it is normal result of aging.

3.0 Management

3.1 Incontinence Absorbents

In some cases, pads or diapers are used to absorb the uncontrolled seepage of urine. These absorbent items must be changed frequently, creating an ongoing economic burden. The wearing of absorbent undergarments may also restrict the type or style of clothing which the patient may wear. Moreover skin irritation and other hygienic difficulties often result from the enduring presence of captured urine against tender urogenital tissues.

3.2 Urethral Inserts / Non-Surgical Procedures

Bladder control problems are difficult to manage. Although medical devices do not cure bladder control problems, they can be used to manage urinary incontinence. Accordingly, incontinence products are used to eliminate urine leakage or for better control for urge to urinate falls into two groups. One group consists of internal and external devices that keep urine leaking out of the bladder. The other group includes various nerve stimulation devices, pelvic muscle exercises, medications, injection therapies and radio frequency energy treatments that are used over time strengthens the muscles that supports the pelvic organs and help maintain continence. However the methods used in the latter group is quite expensive and time consuming.

3.4 Conclusion

Stress incontinence is very common in women and can significantly impact a woman's life. If SUI is niggling situation for females, it should be encouraging to note that there are non-surgical treatment options that can greatly improve their quality of life. While exploring such options, special attention should be given for each option opportunity for success. While seeking treatment, women may also consider management better option, such as urethral inserts.

WAY FORWARD

Perspective of a new concept for an additional method of treating urinary incontinence is the use of bladder flow control devices, sometimes referred to as artificial sphincters or prosthetic urethral valves. A bladder flow control device may be positioned in the urethra of a patient to control the flow of urine out of the bladder. It is desirable for the placement of the bladder flow control apparatus in the urethra to be performed easily and non-surgically. Once the bladder flow control device is placed, it is desirable that it be safely and securely retained in the urethra.

Optimally, the device surfaces which contact the human body, will be formed of biocompatible materials, to lessen chances of inflammation in patients.

DESCRIPTION OF THE MODALITY

1. The intra-urethral device in accordance to the present invention is the hemispherical container (cup) and the short silicon cylindrical tube with a narrow diameter as the base of the container that consists of the 'urine flow control valve unit'. The container (cup) is fixed to the proximal end of the short cylindrical tube while three tape that will be fixed to the distal end of it at equal distances on the bottom of the tube. This intra-urethral device is mentioned as the distal member, will be placed inside in a collapsible state inside a narrow cylindrical plastic tube.

The distal member is having a proximal portion inside the plastic tube and that is firmly placed with an insertion tool being the plunger with its distal tip is positioned beyond the distal end of the said plastic tube. It is of the exact shape of a syringe. The distal member at the proximal end of the plastic cylindrical tube consists of the hemispherical container in a collapsible position which is pre-inserted to the said tube. The proximal end of the plastic tube is closed with a plastic cap which could be removed at the time insertion procedures are about to commence and at the distal end of the plastic tube the plunger is firmly placed beside the distal member having drawn the tapes that are extended from the distal member through the holes of the polymer tip of the plunger. Both ends of the plastic tube are firmly closed and the distal member is not exposed to the environment. The plastic tube and the buttons will be supplied in sterile packaging. . The insertion tool includes a plunger having a distal end and a proximal end. The distal end of the plunger is adaptable to selectively form the distal member with its polymer tip at its proximal end to control push /pull mechanism of the plastic cylindrical tube. The plunger of the insertion tool provides a convenient location to grasp the assembly. The use of an insertion tool minimizes the risk of infection by minimizing human contact with the intraurethral device. , The cylindrical plastic tube that includes the distal member is taken out from the sealed packaging and the cap on the proximal end of it will be removed before the procedures of insertion of the intra-urethral device commences. The proximal portion of the distal member is moveable within the tube. The distal member has to be placed close to the distal end of the tube just before insertion the intraurethral device to the patient. The distal member will be pushed forward gently by moving the plunger along side of the tube by its distal tip. The procedure of insertion the intra- urethral device will be supported by ultra sound scan that is will be performed simultaneously and the container is gradually placed in the level of the bladder neck of the female patient. After placing the proximal retainer on the floor level of the bladder, the tube is gently drawn out of the urethra and the container is well sealed in the bladder with the three extended three tapes hanging out. Afterwards, the piece of the button with the crown will be placed to the outer edge of the urethra, by inserting the crown to the urethra and softly drawing the extended plastic tapes of the container that is placed in the bladder neck passing through the centre circular opening. The button will be steady in the urethra with crown well placed within it. The other piece of the button that has the three button- holes will be set into the button with the crown that is already placed in the outer edge of the patient's urethra. The extended three plastic tapes will be drawn gently through the holes until they are firmly extended and holes of the plastic tapes will be placed on top of the studs of the button already in place in the urethra and will be locked tightly with the button holes of the other piece of button. Excess portions of plastic tapes are visible from the button outer edge will be sliced out of it. The container on the floor of the bladder and the button on the edge of the urethra are very firmly placed and aligned to the passage with no movement. The button will never loosen as it is tightly locked and the container is very well placed on the bladder neck with no movement as it is tightly drawn by the plastic tapes to the button.

7. The valve of the container is kept sealed properly while the bladder is filled with urine and is well rested upon the inner wall of the bladder. When the bladder is full and with the urge to urinate the pressure is applied by strain and the bladder squeezes and with the pressure the valve will be opened and the urine releases through the urethra. The valve will be opened only with the strain by the woman. It is assured that this device will not not have a leakage. The valve of the device could resist the maximum voiding pressure in the bladder of 50cm/ H2O. Urinary incontinence in female will be investigated by performing uro-dynamic tests prior to the procedure of insertion of the urethra device in order to find the maximal voiding pressure.

8. Closing /opening functions of the urine flow control valve unit will continue for a considerable period of time as it is made out of superior quality silicon and the container will also function without any stress cracking of the superior quality inner lining material that will not react with urine. The five /six ridges in the container will keep it very firmly throughout the recommended life time of the apparatus. Valve too is made out of superior material possibly out of silicon and t is guaranteed for long life without leakage.

The procedure in removing the container placed in the floor of the bladder after having it for a considerable period of time with the physician's advice is quite simple. It could be taken out from the urethra by pulling from the button placed at the bottom edge of the urethra when the bladder is empty. The container will be formed to a collapsible position and could be pulled out of the urethra without a damaging the bladder or urethra due o the flexibility of silicon and inner lining materials of the intra-urethral device.

DESCRIPTION OF THE DRAWINGS

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention.

Fig I - It shows the side view of the button with two pieces and one having a crown and a brim on it while the other one is plane with a brim. The circumferences of the two brims are identical.

No.l depicts the button with the crown and the brim.

No.2. depicts the button- hole punch on the surface of the plane button. There are two more such holes placed at equal measurements on the surface of the brim of the plane button facing the bottom of the button with the crown.

No.3 depicts the side view of the plane button and the surface of the brim is visible.

Note: The circumference of the brims of Nos. 1 and 3 are exactly the same.

This figure illustrates how best the two pieces of button seal with the circular opening at the centre of the buttons. It shows the button from another side view.

No.4 depicts the button- stud on the brim and the other two button- studs too are visible which are placed exactly at a equal measurement on the brim. Centre circular openings too could be seen. The button with the crown has a smaller centre circular opening than that of the plane button.

This figure illustrates how best the two pieces of the button could seal and the flow of urine in between though the centre openings. It shows clearly the un-deformed container which will be placed on the floor of the bladder.

No. 5 depicts the container looks like a cup which will be made of a material that will withstand the harsh and corrosive environment of the human body.

No.6 A ridge made out of very firm fibre substance that will keep the container in the bladder fully opened without sagging. The ridge too will have to be made of a material that will withstand for the rugged and corrosive environment in the body.

No.7 depicts the cylindrical base of the cup of which the container (cup) and the valve at the bottom is held. The base is also made out of a rigid material that will withstand the above stated environment in the body.

No.8 The plastic tape fixed to the base of the container (cup). There altogether three such plastic tapes extended downwards from other sides of the cylindrical base leaving equal gaps in between them.

No.9 depicts the holes on all plastic tapes that will be fastened to the buttons.

The figure illustrates the configuration of the intra-urethral device viz container with the valve that is placed on the bladder neck of the patient and the plastic tapes are fixed the container. It shows the top view of the container when it is positioned at the bottom of the bladder of the female patient.

No.10 The stop valve at the right at the bottom of the container

The figure illustrates as to how the urine is stored in the container and the mechanism of the flow of the urine when required by the patient. The stop valve will be opened with the pressure made by the patient by straining when needed to urinate. The valve is sealed properly and no leakage is guaranteed as the valve is made out of tough material that could resists more than the maximum voiding pressure in the bladder of a normal female. V - It depicts the short cylindrical tube and the plunger with a polymer tip at the proximal end of it.

No.ll depicts the small cylindrical tube used for the intra -urethral device where the container in a collapsible is placed.

No.12 depicts the plunger that contains the polymer tip on the proximal end. The plunger could be moved firmly through the small cylindrical tube by the pull- push mechanism.

It depicts the intra- urethral device with the container as the distal member in a collapsible just before insertion to the urethra of the female.

No.13 depicts the polymer piston like tip of the plunger with three holes on the surface of it.

The figure illustrates how the plunger is drawn downwards to demonstrate as to how the plastic tapes are drawn through the three holes on the surface of the polymer tip of the plunger. The plunger will be pushed upwards in the small cylindrical tube to make a projection of the deformed container inside the bladder when the urethral device is inserted to the urethra of the female with the aid of ultra sound scanning.

VII- It depicts the plunger and its polymer tip that works like a piston inside the small cylindrical tube. One hole/ opening could be seen on one side of the polymer tip where the plastic tape is drawn through it. There are similar two holes on other sides from which the other two plastic tapes are drawn.

No.14 - Depicts a hole on one side of the surface of the polymer it of the plunger from which the plastic tape of the container is drawn for the purpose of locking. VIII -The figure illustrates as to how the intra-urethra device is positioned in the urethra after the insertion and the bladder full with urine.

BIBILOGRAPHY

Scholarly references after the invention for the treatment of incontinence of female patients.

(i) WO 0211810;

(ii) US 5352182;

(iii) EP 0444831;

(iv) WO 2006093621 ;

(v) US 4155364;

(vi) US 5749826;

(vii) US 3372695;

(viii) US 5112306;

(ix) WO 9533420;

(x) US 5713829;

(xi) WO 2013/041111;

(xii) US 6171230;

(xiii) US 5234409; and

(xiv) JPH 03118059

Claims

CLAIMS What is claimed is:

1.0 The methodology of treating incontinence in female patients comprising the steps of :

1.1 Insertion of the intra-urethral device to the urethra

1.2 The use of ultra sound scanning for the procedure 1.1

1.3 Placing the hemispherical container in the level of the bladder neck of the patient.

1.4 Gently drawing out intra-urethral device

1.5 Placing the button on the outer surface of the urethra to make the hemispherical container and the button sealed.

1.6 Valve at the bottom of the container is opened when the patient needs to urinate with the pressure applied by her.

1.7 Container in a deformed position but slightly opened after the bladder is emptied.

1.8 Container opens gradually with filing of urine to the container and when the

bladder is full the container is rested upon the inner wall of the bladder.

1.9 In the event a new container is needed to be replaced after considerable period of time, replacement procedures of the container in the bladder.

1.10 The difficulty and the awkwardness with the urinary incontinence has ceased and getting back to social activities.

2.0 The configuration of intra-urethral devices used for the Claim No. 1.0.

3.0 The apparatus used for intra-urethral device in accordance to Claim No. 2.0 includes a short cylindrical tube with a narrow diameter that has proximal and distal ends.

4.0 An apparatus according to Claim No. 3.0 the deformed hemispherical container which is sealed to three tapes at its base inserted in the short cylindrical tube as mentioned in No.3.0 above

diameter.

5.0 An apparatus according to Claim No.4.0 with the push-pull mechanism by a plunger inserted at the distal end of the tube to push the deformed hemispherical container inside the short cylindrical tube that could be moved tightly within extending a projection of the hemispherical container.

6.0 An apparatus according to Claim No.5.0 the deformed hemispherical container is supplied for the said purpose in sterile packaging. This will avert the risk of vulnerability to infection.

7.0 A tool according to Claim No.7.0 the plastic tapes that are sealed to the base of the

hemispherical container is slightly longer than the tube contains several holes with equal measurements at the end in order to keep the hemispherical container firmly and lock the tapes to the button s at the outer end of urethra. The plastic tapes are drawn through the three holes on the surface of the polymer tip of the plunger in order to pull the cylindrical tube safely out from the female urethra after insertion of the container on the neck of the bladder and to draw the tapes neatly out of the urethra to fix them to the button.

An apparatus according to Claim No.7.0 the button has two components. One side has a circular opening at the middle and has three pins at the outer layer and the other button has a circular opening at the middle and three tiny spikes to fit in the pins in its outer layer.