WO1992022341A1

WO1992022341A1 - A valve actuated catheter for urinary incontinence and retention

Info

Publication number: WO1992022341A1
Application number: PCT/IT1991/000051
Authority: WO
Inventors: Luigi Gigante
Original assignee: Luigi Gigante
Priority date: 1991-06-18
Filing date: 1991-06-18
Publication date: 1992-12-23

Abstract

There is described herein a valve operated catheter for urinary incontinence and retention. The catheter is essentially comprised of a substantially tubular member (10) of elastic material, adapted to be endourethrally set in place on the patient. A first end portion (12) thereof is adapted to be received within the bladder and it is substantially spiral shaped while inside the opposite end thereof there is provided a normally closed valve (20) which may be opened when manually operated upon by the patient through compression, allowing the urines to be evacuated. The inventive catheter has the purpose of preventing unintentional leaking of urines being sufficient, for said purpose, that the valve mentioned above be not operated. In addition it may apparently be used also in cases of urine retention.

Description

" A VALVE ACTUATED CATHETER FOR URINARY INCONTINENCE

AND RETENTION " This invention concerns a valve actuated catheter for

urinary incontinence and retention. Catheters for the therapy of the above pathologies are

already known, but they have a number of drawbacks which make them difficult if not sometimes impossible to be

used.

A catheter which is presently used in the majority of ' circumstances is essentially comprised of a substantial¬ ly tubular body, adapted to be inserted in the patient's urethra, and provided at one end thereof with a balloon suitable to be housed within the bladder, while the

opposite end, located outside the patient's urethra, is connected to a urine collection bag.

The above catheter has a first important drawback, which

is particularly dangerous during long-term catheterizat-

ions, where the balloon inserted within the bladder may cause irritations or traumas thereof.

A further drawback is the fact that, due to any occas¬

ional pull exerted on the catheter by the patient him¬

self, the above balloon may be the cause of possibly

important damages to the bladder as well as to the

bladder neck and to the urethra.

A further typical drawback of the above catheter already known results from the need to use the urine collection

bag which has to be constantly carried along by the pat¬ ient and which provides an obvious inconvenience. Another drawback of the conventional catheter results from the fact that it cannot be used in all those cases where bladder rehabilitation is required through the so-called "vesical exercise". The conventional catheters already on the market leave the bladder always empty thereby preventing the contracting and releasing funct- ional activity pertaining to the bladder.

There has now been contrived, and it is the subject of this invention, a catheter for urinary incontinence and retention which enables all the drawbacks of the

conventional catheters to be overcome . The features as well as the advantages of the catheter

of this invention will become apparent from the follow¬

ing detailed description of a non limiting embodiment

thereof, made in reference to the attached Figures wherein:

Figure 1 is a plan view of the catheter according to this invention;

Figure 2 is a view of the catheter according to section

II-II of Figure 1 ;

Figure 3 is a view of the catheter according to section

III-III of Figure 2, with the incorporated valve in the closed position;

Figure 4 is a view of the catheter still according to section III-III of Figure 2, with the incorporated valve in

the open condition for urine ejection. Referring now in particular to Figures 1 and 2, the catheter of this invention is essentially comprised of a substantially tubular duct 10 made of any elastic mater¬ ial, for instance a siliconated material which is adapted to be inserted and fitted within the patient's

urethra by means of a mandrel.

Substantially tubular body 10 has a generally circular cross section and has a standardized length, while the

diameter thereof follows the usual Cherier scale number¬ ing system. A first end portion of the inventive catheter, shown in general at 12, set to be fitted within the patient's bladder, includes a length 14 of said tubular member

comprising body 10 which is bent substantially according

to a spiral curve. Also length 14 is made of the

same material as the body 10 and therefore of an elastic material so that portion 12, which in the

rest position keeps its spiral shape, is elastically

deformable without the necessity of a high strength.

As many be seen in particular from Fig. 2 spirally curved portion 1 of the inventive catheter is provid¬ e_d, in the _longitudinal direction thereof, with a

continuous slit 16 through which the urines present within the bladder may freely flow towards the inside of portion 14 and then into the catheter. As a varia¬ tion the continuous slit 16 may be substituted by a number of openings having the same function. Still referring to Figure 2 it may be noticed that, at the end of portion 14 of the inventive catheter there is

provided, on the inside, a capsule 18 holding a substance having a disinfecting or antibacterial action of the type adapted to release said substance continuous¬ ly in time within the bladder.

Still referring in particular to Figure 2, but with re- ference to Figures 3 and 4 as well, it may be noticed

that at the distal end, or end portion of the catheter, there is located in a special seat a valve 20 having a

double function of preventing unintentional leaking of urines and of restoring the outflow thereof in case of

retention, through manual compression on said valve.

Valve 20, which is made of an elastic material such as

for instance the same material of tubular duct 10, has a

passage 22 which is closed in the rest position shown in

Figure 3, while it is open in the operative condition shown in Figure 4.

Opening of passage 22 is performed by the patient him- self through a compressive.action as shown schemat¬ ically by arrows F in Figure 4. Said action will be continued during the whole period of time necessary to evacuate the urines, i.e. until the patient gets reliev₇

ed of the corresponding stimulation.

As it may be noticed in particular in Figures 1 and 2,

the catheter end, in particular the end of tubular duct 10, is provided with a rearward folded portion, or "cap" 23, said portion being shaped in such a way as to comprise a stop member adapted to prevent the catheter from sliding inside the urethra.

According tc a further feature of the catheter of this invention cap portion 23 is provided, in a suitable position, with a contoured projection 24 the patient can use as a reference member for directing the pressure act¬ ion he will have to perform on the valve to obtain eject¬

ion of the urines. As it is apparent from the attached

drawing ,contoured portion 24 is located above passage 22

which extends vertically thereunder. From the above, the advantages obtained using the

catheter of this invention should be apparent, and they

will be shortly summarized in the following.

Provision of end portion 12 comprised of elastically

deformable spiral stretch 14 makes it possible to obtain three important advantages..

The first one is that the catheter is made self-stabiliz¬ ing. The second of said advantages is the fact that the length of tubular duct 10 received within the urethra may be modified according to need, by simply inserting

into the urethra the needed length of spiral stretch 14 which will then get shortened while still remaining suitable to perform the function reαuired to it.

The third advantage is the fact that, in case the catheter is subjected to any accidental pull, no more damages nor traumas are caused to the bladder or to the urethra since the elastic deformation of spiral stretch 14 enables tubular duct 10 to come out freely without the patient suffering any traumatizing effect. A further important advantage achievable by means of the

inventive catheter is the fact that it can be used in

general, also in those cases when the so called "vesical exercise" is needed. In fact, the subject catheter

allows the bladder to fill up freely and then to get empty when the patient feels the miction stimulus. There

is then completely preserved the contractile and releas¬

ing functionality of the bladder.

A further advantage of the subject catheter is the fact

that it may be used in all cases of urine retention, thanks in particular to the spiral portion 12 received within the bladder. The catheter of this invention has a further advantage that it can be set in place with out-

patient procedures, without anaesthesia, and may remain in place for an extended period of time. According to tests, it can be left in place even for more than forty

consecutive days.

A further advantage of the catheter of this invention is the fact that it is completely endourethral, without any extensions visible from outside, which makes it possible to achieve an optimum aestethical effect for the patient.

The presence cf the capsule for slow release of dis¬ infectant and antibacterial agents within the bladder is a further advantageous feature of the invent-

ive catheter, in that said organ of the patient is kept

in the best hygienic conditions, which was impossible with the conventional catheters, therefore no requirem¬

ents being set for daily vesical washouts, nor for the

use of a urine collector, which drawbacks strongly

affect the patient.

Eventually, it should be apparent that variations and/or

modifications may be made to the endourethral valve oper¬

ated catheter according to this invention without

exceeding the scope of protection thereof.

Claims

C L-A I M S 1. A catheter for urinary incontinence or retention, characterized in that it is essentially comprised of a

substantially tubular duct adapted to be inserted, into

the patient's urethra by means of a mandrel and made of

an elastically deformable material, in that an end port¬

ion thereof adapted to be received within the patient's

bladder essentially comprises a substantially spiral

shaped as well as elastically deformable portion of said

tubular duct, said substantially spiral shaped portion

being provided, along the length thereof, with a continuou slit to allow the urines to enter into the

catheter, at the distal end of said substantially tub¬

ular duct there being internally provided a valve having

a longitudinal passage which is closed in a rest

condition and can be opened by the patient himself

through a compressive action on the portion of tubular

duct within which said valve is provided.

2. The catheter of Claim 1, characterized in that the

valve adapted to allow evacuation of the urines is made

of an elastically deformable material.

3. The catheter of Claim 1, characterized in that the

catheter end portion received within the bladder is

provided internally with a capsule of disinfectant and/or antibacterial materials, adapted to release said mater¬ ials within the bladder at a rate delayed in time.

4. The catheter of Claim 1, characterized in that the end of the substantially tubular duct has a rearward folded portion which is left outside the urethra, adapt¬ ed to prevent the catheter to slide inside the patient's

urethra.

5. The catheter of Claim 4, characterized in that said rearward folded portion at the end of the tubular duct is provided with a contoured projection adapted to be used by the patient as a reference member concerning the direction of the pressure he has to apply to control the opening of the valve for urine evacuation.

■ 6. A valve operated endourethral catheter for urinary incontinence and retention, substantially as described

above and as shown in the attached drawing.