WO1998005266A1

WO1998005266A1 - Device for preventing male urinary incontinence

Info

Publication number: WO1998005266A1
Application number: PCT/FR1997/001438
Authority: WO
Inventors: Jean-Claude Woimbee; Jean-Claude Henry
Original assignee: Bau, Georges
Priority date: 1996-08-02
Filing date: 1997-07-31
Publication date: 1998-02-12
Also published as: FR2751866A1; FR2751866B1

Abstract

A device comprising a tubular member (10, 20) for insertion into the distal end of the urethra (4), and manually operated sealing means in an external end portion (11, 21) of the tubular member which remains outside the penis. The tubular member includes an intermediate portion forming a flexible balloon (13, 23) spaced from the external end portion so that it may be placed and retained in the navicular fossa (2) when said external end portion is in abutment with the tip of the penis. The device is useful for treating male urinary incontinence.

Description

DEVICE FOR PREVENTING MALE URINARY INCONTINENCE

The present invention relates to a urinary continence device for easily controlling male urinary incontinence.

Urinary incontinence in adults is currently a real public health problem. This problem mainly concerns women but also men, for around 20% of cases. In humans, in addition to the various means making it possible to collect and absorb the urine emitted, such as absorbent layers or the like, use is also made of permanently implanted probes, penis cases or penis clips.

The permanently implanted probes provide good continence, but the drained urine must be collected in an external bag. These devices are commonly causes of infections, and the wearing of the collection bag is uncomfortable and constitutes a notable gene during everyday activities. The use of the penis sheath is analogous to that of an indwelling catheter. The risks of infections are greatly reduced, but there are many more possibilities of leakage in the active subject. The use of the penis case is therefore limited to bedridden subjects without overflow incontinence. Practically, in the majority of cases, male urinary incontinence is treated by wearing rods which ensures greater autonomy for its user. Although being the most effective device for the active man, this device is far from ideal because its user must find a compromise between an energetic tightening required to ensure true continence and a compression which can be supported by the penis but which risks to let some leaks remain.

The object of the present invention is to provide a new device making it possible to remedy the various drawbacks presented by the devices described above, and is particularly aimed at ensuring effective continence without causing discomfort or pain to the user. It also aims to facilitate voluntary urination by a very simple manipulation, while allowing the user to live in society without particular constraints due to his incontinence.

With these objectives in view, the invention relates to a male urinary continence device characterized in that it comprises a tubular element intended to be introduced into the distal end of the urethra, and closing means which can be actuated manually , located in an outer end part of the tubular element intended to remain outside the penis, and in that the tubular element comprises a middle part forming a deformable balloon located at a short distance from the part of external end so as to be able to be placed in the navicular dimple when said external end part is in abutment against the end of the penis.

The deformable balloon ensures the positioning and maintenance of the device on the penis, the closure means ensuring urinary continence in the closed position and unimpeded urination in the open position.

As will be seen more clearly from the description which will be given below of three exemplary embodiments, the device according to the invention uses, to ensure its maintenance in position, the existence of an anatomical formation of the distal urethra called the dimple navicular. This navicular fossa is a tapered enlargement of the terminal urethra located a very short distance from the urinary meatus. The urinary continence device is locked in position by the inflation of the balloon whose wall comes apply against that of the navicular dimple by molding in some way in the latter. It follows that the maintenance in position is ensured without significant distension of the wall of the urethra, the balloon once inflated can however not come out of its housing in the said navicular dimple due to the narrowing of the urethra at the level urinary meatus. In addition, the contact of the wall of the balloon with the wall of the navicular dimple ensures the seal between the tube and the penis, in addition to the seal obtained by the contact of the internal end of the tubular element with the 'urethra.

The device according to the invention does not require, unlike certain known continence devices, to place a probe introduced into the bladder and, by its small size, at most provides only a gene limited to its user. Furthermore, the manipulation of the closure means for their opening or closing can be carried out easily, practically under conditions similar to that of urination carried out by a normally continent person.

According to a first embodiment, the tubular element is a cylindrical tube and the balloon is an inflatable balloon surrounding said tube and held axially thereon at a distance from said external end portion, for example by being bonded to the outer surface of the tube or being held there between an annular lip formed from the wall of the tube and a shoulder formed by said outer end portion of the tube.

According to a second embodiment, in which the tubular element is also a cylindrical tube, the inflatable balloon has a wall formed in one piece with the tube, and folded around the tube and fixed on the external end part.

According to a third embodiment, the balloon is formed by the wall of the middle part of the tubular element, said wall being made of an elastically deformable material. In this variant, the tubular element is shaped so that its middle part has a bulge, which constitutes the balloon. Thanks to the deformability and the elasticity of the material of which it is made, the balloon can retract, so that its wall is then substantially cylindrical and of diameter substantially equal to that of the parts of the tubular element located on either side. 'other of the balloon, to allow the passage of said balloon in the urinary meatus. Once in position in the navicular dimple, the balloon resumes its initial shape elastically and is pressed against the wall of said dimple, thus ensuring that the device is kept in position. It will also be noted that, when the device is in the closed position, the pressure of the urine in the tubular element contributes to pressing the balloon even better against the wall of the anatomical cavity.

Preferably ent, the wall of the balloon comprises in its thickness a plurality of elastic reinforcement elements extending longitudinally and distributed circumferentially. These reinforcing elements are therefore normally bent to match the curvature of the balloon, are deformed to be substantially rectilinear when the balloon is put in place, and resiliently resume their curved shape when the balloon is in position in the navicular dimple. Also preferably, the tubular element comprises towards its internal end part a ring forming a shoulder. This shoulder serves as a stop for a positioning mandrel, as will be better understood later. The ring also serves as a reinforcement to keep the circular shape of the internal end portion of the device, and in addition, all the elements reinforcements of the balloon can be connected by one end to said ring, to form a single piece of reinforcement, for example made of plastic, on which the constituent material of the device, for example latex, is overmolded.

According to yet other arrangements: the internal end of the tubular element is formed of an elastically deformable annular lip, to be applied against the wall of the urethra and to ensure sealing, the device comprises a setting mandrel in place, inserted into the tubular element and comprising abutment means cooperating with the internal end of said tubular element, to retain said internal end and allow the balloon to be deformed by elongation by stretching the tubular element,

- The mandrel has an internal chamber and orifices connecting this chamber and the periphery of the mandrel at the level of the end lip of the tubular element, so that a depression created in said chamber makes it possible to keep the lip pressed by suction on the mandrel when the device is put in place, preferably, the chamber extends to an external end of the mandrel, where it is closed by a breakable end, the lip being held pressed against the mandrel and closing off the said orifices under the effect of a depression created in the room. This arrangement makes it possible to provide a set consisting of the device and the mandrel pre-assembled and ready for installation. The breaking of the nozzle once the device is put in place puts the chamber at atmospheric pressure and thus releases the lip which comes to resiliently press against the wall of the urethra. Whatever the embodiment, the sealing means are preferably integrated in the said outer end portion. According to a particular embodiment, this external end part forms a housing and the closure means comprise a cylindrical part pivotally mounted in the housing and pierced with a transverse hole which can be brought into alignment with the tube in a position d opening and transverse to the tube in a closed position. In order to facilitate handling of the device during urination, the pivoting of the cylindrical part can for example be controlled by a rack and pinion system with automatic return to the closed position.

According to another embodiment, the external end part is made of a material which can be easily deformed, and the closure means comprise a clamping element integrated in said external end part. This clamping element is constituted for example by an elastic clip around which the outer end of the tubular element is molded. This clip is shaped so as to crush the internal wall of the duct of the tubular element in the closed position, and so that a diametrical pressure exerted from the outside on said external end causes the opening of said duct. Other characteristics and advantages will appear in the description which will be given of three alternative embodiments of the device according to the invention.

Reference will be made to the appended drawings in which: FIG. 1 is a sectional view of a device according to the invention according to a first variant, in the position of use on the end of the user's rod,

FIG. 2 is a similar view of a second alternative embodiment,

- Figure 3 is a detail view illustrating the control means of the closure device used in this second variant, in the open position, FIG. 4 illustrates the positioning of the device according to the invention using a mandrel, - FIG. 5 is a view in section of a third variant, the device being in place on the penis, FIG. 6 is a sectional view showing the device and its mandrel during insertion into the urethral orifice, - FIG. 7 is a view of enlarged scale of detail A in FIG. 6, FIG. 8 is a view in half cross-section of the device, along line VIII -VIII of FIG. 7 - FIG. 9 illustrates a second embodiment of the closure means, in the closed position,

- Figure 10 is a view corresponding to Figure 9, with the closure means in the open position.

The drawing of Figure 1 shows a device according to the invention placed on the end 1 of the penis. The device consists of a tube 10 made of biocompatible material, for example latex, ending on the outside with an external end part forming a bulge 11 of larger diameter than the tube 10 itself. Sealing means placed in this bulge and shown diagrammatically by the reference 12, make it possible to seal the tube. These closure means can for example be kept closed at rest under the action of a prestressed spring and open for urination by simply rotating an end portion of the tube for example a quarter turn, this rotation can be easily performed with only two fingers.

An inflatable balloon 13 surrounds the tube 10 and is extends towards the bulge 11 in the form of a channel 14 of small cross-section opening into an annular flange 15 pressing against a shoulder 16 of the bulge 11 and provided with inflation means 17. The balloon is placed at a predetermined distance from the bulge 11 , as it is located just at the level of the navicular fossa 2 when the flange 15 bears just against the wall 3 of the urinary meatus.

The wall of the balloon located against the tube 10 is preferably bonded to the outer surface of the latter. In addition, on the side axially opposite the external bulge 11, the tube has an annular lip 18, formed directly from the material of the tube, which extends just against the internal edge of the balloon and participates in the axial positioning and in the maintenance of this on the tube 10. In addition, this lip extends obliquely, as can be seen in the drawing, to facilitate the introduction of the device into the urethra 4.

The balloon 13 is made for example of latex or any other biocompatible and extensible material. It is inflated, after fitting the device, by an incompressible fluid, for example physiological saline, introduced via the inflation means 17 equipped with a valve and the channel 14. The valve allows, if necessary, to deflate the balloon and therefore to easily remove the entire device.

In the second variant embodiment, the device, shown in FIG. 2 in the normal position at rest, that is to say the shutter means being closed, consists of a tubular part 20 made in one piece with the part d 'outer end 21 forming a housing comprising the closure means 22. The deformable wall 24 of the balloon 23 is formed directly by stretching from the material of the tube 20 to reduce the thickness and give it flexibility and elasticity required. This wall 24 is folded towards the outside, around the tube 20, and its edge 25 is welded or glued to the external end part 21, on the one hand forming an annular chamber 26 and on the other hand a narrowing 27 between said chamber 26 and the elastically deformable part of the balloon.

It will be noted that the internal end 28 of the tube 20, where the deformable wall 24 of the balloon is connected to the tube 20, has a conical shape to facilitate the introduction of the device into the urethra. To inflate the balloon after its installation, a flap valve 29 is placed on the housing 21, in communication with the annular chamber 26. The inflation of the balloon is carried out by physiological saline injected by means of a syringe and a needle through said valve valve 29. The amount of physiological saline injected will be determined so that the balloon is sufficiently inflated to hold the device by applying its wall 24 against the wall of the navicular fossa, without compressing it excessively. The shutter 22 consists for example of a cylindrical piece 31, of about 6.5 mm in diameter, pierced with a transverse hole 32 having a diameter equal to the internal diameter of the tube 20. This cylindrical piece 31 is pivotally mounted in a bore of the housing 21, with an axis perpendicular to the axis of the tube 20. On at least one end of the cylindrical part 31 is produced a gear portion 33 which cooperates with a rack of a pusher 34 sliding in a housing 35 of the housing 21. A spring 36 or similar elastic element is placed between the pusher and the bottom of the housing 35.

A flexible membrane 37, linked to the housing 21, is in contact with the other end of the pusher 34. By pressing on the membrane 37, the rack is moved, for example by 3 mm, against the force exerted by the spring 36, which is enough to rotate the cylindrical part 31 by approximately 90 ° (see FIG. 3), so that the hole 32 of the cylindrical piece 31 is aligned with the tube 20 and allows urination. It will be noted that it suffices with one finger to press on the membrane, the shutter returning to its normally closed rest position as soon as the pressure on the membrane ceases.

As shown in Figure 4, the establishment of the device is facilitated by the use of a semi-rigid mandrel 40 having a cylindrical part 41 inserted into the tube 20 (the shutter being in the open position) and having a rounded end protruding from the side of the internal end of said tube.

Figures 5 to 8 illustrate a third alternative embodiment of the device. The device consists of a tubular element 50 made of an easily deformable material, for example latex. It comprises an external end part 51, shaped so as to be applied against the end of the penis 1 and in which are placed closure means 12, only shown diagrammatically in FIG. 5. The balloon 53 is constituted by the wall, preformed for this purpose in the form of an olive, of the middle part of the tubular element and is connected to the external end part by a neck 52 of diameter adapted to the orifice of the urinary meatus. At the opposite end, on the internal side, the tubular element ends in an annular lip 54 preformed so as to disturb the urine flow as little as possible during urination. In the position shown in FIG. 5, the device being in the use position, the wall of the balloon 53 is pressed against the wall of the navicular dimple on the one hand because of the shape given to the balloon by manufacture and on the other hand by the pressure exerted by the urine filling the device. Also, the lip 54 is applied against the wall of the urethra 4, thus ensuring, in addition to the balloon, the seal between the device and the urinary tract. Preferably, as seen in FIGS. 7 and 8, elastically flexible reinforcing elements, constituted for example by plastic strips 55, are integrated into the wall of the balloon and extend longitudinally along the curvature of the balloon to stiffen its wall while allowing the deformation thereof. These strips 55 are distributed circumferentially, for example six in number as shown in FIG. 8. Furthermore, these strips are all connected at one end to a ring 56 flush with the internal surface of the tubular element and axially located between the balloon 53 and the lip 54. By way of example, the wall of the balloon may be of the order of 0.5 to 1.5 mm, for a diameter of the tubular element of approximately 5 mm; the section of the reinforcing strips 55 being for example 1.5 mm wide by 2 to 3/10 mm thick.

Figures 9 and 10 illustrate an alternative embodiment of the sealing means. In this variant, the external end part 51 comprises a sort of staple, formed of an elastic thread, which comprises two lobes 71, 72 which each surround the orifice 73 of the device. In the closed position shown in Figure 9, the initial conformation of the clip and the elasticity of the connection 74 between the lobes tend to separate the two lobes from each other, ensuring the pinching of the wall of the orifice and its obturation. For urination, it suffices to press said end portion 51 diametrically, as shown by the arrows F2, which brings the lobes 71, 72 back to the position shown in FIG. 10, and causes the opening of the orifice 73. The release of the pressure brings the shutter back to the position in FIG. 9, under the effect of elastic return of the clip 70. The very simple operation and construction of this shutter is made possible thanks to the great flexibility of the material used for the device. In relation to FIG. 6, we will now describe the positioning of the device, by means of a mandrel 60. As shown in the figure, the device forms with the mandrel as a whole prepared, marketable as it is. The device is placed on the mandrel 60 in rigid or semi-rigid material. The mandrel 60 has a shoulder 61 adapted to abut against the ring 56 and its end 62, which projects slightly beyond the lip 54, is rounded to facilitate its introduction into the urethra. It has a chamber 63 which extends axially and ends on the outside, on the right in the figure, in a frangible part 65 connected to the body of the mandrel by a rupture initiator 66. At the other end, orifices 64 distributed circumferentially open on the one hand into said chamber and on the other hand at the periphery of the mandrel at the level of the lip 54. A depression is created in the chamber 63 during manufacture, this depression being sufficient to keep the lip 54 pressed around the mandrel as shown in FIGS. 6 and 7. It will be noted that in this position, the external surface of the lip forms a curved cone substantially in the extension of the rounding of the end 62 of the mandrel, so as to facilitate the introduction into the urethra without injuring the lining of the urinary tract.

For the introduction, the device is stretched axially on the mandrel, according to the arrow FI, the ring 56 abutting against the shoulder 61 of the mandrel, this tension being able to be maintained simply by wedging the external end 51 on the mandrel thanks the sealing means. The balloon is thus brought back by stretching to a cylindrical shape of reduced diameter. The tubular element 50 can thus pass without difficulty into the urinary meatus 3. When the external end part 51 arrives against the end of the penis, the tension exerted on the device is released, which allows the deployment of the balloon in the navicular dimple. Then the end 65 of the mandrel is then broken, which puts the chamber 63 in the open air. The lip 54, which is no longer held pressed against the wall of the mandrel, deploys elastically radially to come to press against the wall of the urethra, as shown in FIG. 5.

Note that the mandrel can be reused to remove the device. It suffices to reintroduce it into the device, to tension the latter on the mandrel to erase the balloon in the position of FIG. 6, and to remove the assembly. On the other hand, the mandrel can no longer be normally used for the installation of another device, since it is then no longer possible to create the depression required therein to press the lip 54. This embodiment thus participates in better hygiene by leading to the use of a new mandrel each time a new device is installed. Note also the practicality for the user of such a system, comprising the device pre-installed on its mandrel. The third embodiment of the device is not however limited to the system which has just been described, and it is also possible to provide a reusable mandrel provided with suction means making it possible to create the vacuum required for maintaining the lip 54.

The invention is not limited to the embodiments which have been described above only by way of example. In particular, other closure systems may be used, as well as other embodiments of the balloon, without departing from the scope of the present invention as defined by the claims.

Claims

1. Male urinary continence device characterized in that it comprises a tubular element (10, 20, 50) intended to be introduced into the distal end of the urethra (4), and shutter means which can be actuated manually, situated in an external end part (11, 21, 51) of the tubular element intended to remain outside the penis, and in that the tubular element comprises a middle part forming a deformable balloon (13, 23 , 53)) located a short distance from the external end part so that it can be placed in the navicular dimple (2) when said external end part abuts against the end of the penis (1).

2. Device according to claim 1, characterized in that the tubular element is a cylindrical tube and the balloon is an inflatable balloon surrounding said tube, and in that it comprises inflation means (15, 17, 29) for inflating the balloon (13, 23), located near said outer end portion.

3. Device according to claim 2, characterized in that the balloon (13) is glued to the outer surface of the tube (10).

4. Device according to one of claims 2 or 3, characterized in that the balloon (13) is held axially on the tube (10) between an annular lip (18) formed from the wall of the tube and a shoulder ( 16) formed by said outer end portion of the tube comprising said shutter means.

5. Device according to claim 2, characterized in that the inflatable balloon (23) has a wall

(24) formed integrally with the tube (20) and folded around the tube and fixed on the outer end part (21).

6. Device according to claim 1, characterized in that the balloon (53) is formed by the wall of the middle part of the tubular element, said wall being made of an elastically deformable material.

7. Device according to claim 6, characterized in that the wall of the balloon (53) has in its thickness a plurality of elastic reinforcement elements (55) extending longitudinally and distributed circumferentially.

8. Device according to claim 6, characterized in that the tubular element comprises in its internal end part a ring (56) forming a shoulder.

9. Device according to claim 6, characterized in that the internal end of the tubular element is formed of an annular lip (54) elastically deformable.

10. Device according to claim 6, characterized in that it comprises a mandrel (60) for positioning, introduced into the tubular element (50) and comprising stop means (61) cooperating with the internal end of the said tubular element, to retain said inner end and allow the balloon (53) to be deformed by elongation by stretching the tubular element.

11. Device according to claim 10 in combination with claim 9, characterized in that the mandrel (60) comprises an internal chamber (63) and orifices (64) connecting this chamber and the periphery of the mandrel at the level of the lip ( 54), so that a depression created in said chamber makes it possible to maintain the lip pressed against the mandrel by suction.

12. Device according to claim 11, characterized in that the chamber (63) extends to an external end of the mandrel, where it is closed by a frangible end piece (65), the lip (54) being kept pressed against the mandrel and closing off said orifices under the effect of a vacuum created in the chamber.

13. Device according to any one of the preceding claims, characterized in that said external end part constitutes a housing (21) in which are placed the closure means (22) which comprise a cylindrical part (31) mounted pivoting in the housing and pierced with a transverse hole (32) which can be brought into alignment with the tubular element (20) in an open position and transversely to the tube in a closed position.

14. Device according to any one of the preceding claims, characterized in that the external end part (51) is made of a material which can be easily deformed, and the closure means comprise an integrated gripping element (70) in said external end portion.

15. Device according to claim 14, characterized in that the clamping element is constituted by an elastic clip (70) around which the outer end of the tubular element is molded, said clip being shaped so as to crush the inner wall of the conduit (73) of the tubular element in the closed position, and so that a diametrical pressure exerted from the outside on said external end causes the opening of said conduit.