MXPA98008325A - Device to relieve urine incontinence - Google Patents

Abstract

A device for treating leaks from an external orifice in the body of a patient, consisting of a first member having a first contact surface with the body and a second opposing surface around an opening, said first surface being addable to the patient with said opening located above said hole, and a second integral member with said second surface, said second member consisting of a valve mounted on the opening (4), said valve having a closed position that prevents leakage of fluid through the device and a Open position that allows fluid to flow through said opening when desired. The open and closed positions are achievable without removing the device from the patient's body

Description

- DEVICE FOR RELIEVING URINARY INCONTINENCE FIELD OF THE INVENTION The invention relates to a device for relieving urinary incontinence. More particularly, the invention refers to a device that facilitates the control of urination by preventing unwanted leakage of urine and yet allow urination when required without removing the device from the patient's body. A more pre-ferred modality of the device is to relieve urinary incontinence »particularly stress incontinence» in a female-sex patient. A modality to be used with male patients is also included. An additional modality to treat leaks of a body stoma is also contemplated.

BACKGROUND OF THE INVENTION Urinary incontinence, which is a disease that involves the involuntary loss of urine, is a problem with many patients, particularly in female patients, throughout the world. Sometimes the problem is treated with surgery. However, when the patient can not receive surgery or suffers only from a partial loss of urine, the problem can be treated non-surgically through the use of an internal device (intrauret or intravaginal) or external. A number of female external devices have been proposed in the art. For example »the patent of the United States No. »074» 855 discloses a device for controlling urinary incontinence in a female patient »consisting of an elastic pad configured to seal against the urethral meatus of the user and occlude it. A similar device is described in the United States Patent IMo. 5,33S.20S. In both devices, an adhesive is provided to seal the body of the device against the urethral meatus. Ternary applications No 9S / 39989. 96/39990 and 96/39991 each describe a female urinary incontinence device in the form of a urethral plug with a partially deformable body portion "and a holding portion and a body contact surface. The body portion defines a chamber that allows a vacuum seal when applied to the patient's body. Each of the aforementioned devices prevents urinary leakage by occluding the external urethral orifice and each must be removed by the patient to allow urination. It is desirable to have a device that successfully prevents leakage and also facilitates urination without the need to remove the device from the patient's body. It has now been discovered that this can be achieved by a device incorporating an easily operable valve that prevents leakage when closed and allows flow when opened.

BRIEF DESCRIPTION OF THE INVENTION According to the invention, a device is provided for treating leaks from an external orifice in the body of a patient. This device consists of a first member having a first contact surface with the body and a second opposing surface around an opening. »Said first surface being addable to the patient's body with the opening placed over the hole, and a second integral member with the second surface. the second member consists of a valve mounted on said opening »whose valve has a closed position which prevents leakage of fluid through the device and an open position which allows the flow from the orifice to flow through said opening when desired» being able to achieve the open and closed positions without removing the device from the patient's body. When the external orifice is a urethral orifice »the fluid is urine and in accordance with the invention a" device for relieving urinary incontinence in a patient having an external urethral orifice "is provided as a preferred embodiment" whose device consists of a first member that has a first contact surface with the body and a second opposite surface around an opening »whose first surface is addable to the patient with said opening positioned above said urethral orifice» and a second integral member with said second surface »whose second member consists of a valve mounted on said opening» the valve having a position closed that prevents leakage of urine through the device and an open position that allows the urine said urethral orifice to flow through said opening in voiding »the open and closed positions are achievable without removing the device from the patient. In another preferred embodiment, at least a portion of said first surface is coated with a biologically compatible adhesive, ie a medical adhesive, to facilitate adhesion of the surface to the body, eg, the floor of the labial vestibule around the body. urethral meatus »of the patient. A particularly preferred embodiment of the invention is a device as described above for alleviating urinary incontinence in a female patient, wherein said first member is a substantially circular or oval shaped tab having a first surface where at least a portion thereof is coated with a biologically compatible adhesive such that said first surface is adherable to the floor of the labial vestibule , and said valve is defined by a folding extension of the flange »whose extension forms two folding fins having a closed position wherein the fins are folded inwardly to form a lock over the opening and an open position wherein the fins extend out to define a flow path from the opening to the outside. The valve of the invention can have any number of different configurations. In each preferred version of the valve, the opening is preferably funnel-shaped and the wall of the funnel is defined by the first surface of the flange. In any case, the location of the portions of the tabs that act on the folding flaps to effect the valve lock "each of which is here designated as" clamps "in relation to the other portions» differ in the different versions . The configuration of the portions forming the valve and the folding flaps thereof and the spatial relationship of those portions with respect to each other are described in detail hereinafter with reference to the embodiments illustrated in the accompanying drawings. the present. Each foldable wing of the valve is preferably made of a material that is sufficiently elastic to be bent and compressed or clamped a number of times without deterioration and the preferred material is a biologically compatible elastomer. Typically, all the components of the device are integral with each other and made of the same elastomeric material.

A suitable device for a male patient is also included within the invention "and in this embodiment the first member will be in the form of a short condom instead of a tab. Furthermore, the invention also includes a modality that can be used to control leaks by stoma and allow drainage thereof when desired. The components of such a modality are analogous to those of the modalities described herein for relieving urinary incontinence.

BRIEF DESCRIPTION OF THE DRAWINGS The device of the invention will be described particularly with reference to the preferred embodiments illustrated in the accompanying drawings, in which: Figure 1 is a side schematic elevational view of a first embodiment of the invention showing the valve in the closed position. Figure 2 is a sectional view through the line II-II of Figure 1; Figure 3 is a sectional view through the closed duct of the valve; Figure 4 is a side schematic elevation view of the first embodiment showing the valve in the open position; Figure 5 is a sectional view through the open duct of the valve; Figure 6 is a schematic side elevational view of a second embodiment of the invention showing the valve in the closed position; Figure 7 is a top plan view through line VII of Figure S; Figure 8 is a side schematic elevation view of the second embodiment showing the valve in the open position; Figure 9 is a side schematic elevation view of a third embodiment of the invention showing the valve in the closed position; Fig. 10 is a top plan view through line X of Fig. 9 »and Fig. 11 is a side schematic elevation view of the third embodiment showing the valve in the open position.

DETAILED DESCRIPTION OF THE INVENTION The device illustrated in Figure 1-5 of the accompanying drawings is a first preferred embodiment for the relief of urinary incontinence in a female patient. The device consists of a first member 1 having < a first contact surface with the body 2 and a second opposing surface 3. In the illustrated embodiment, the first member is a substantially circular flange, wherein at least a portion of the first surface 2 is covered with a medical adhesive. Alternatively, the first member may have a substantially oval configuration or any other configuration that will facilitate placing it on the urethral meatus with minimal discomfort. The tab defines an opening 4 that will be located over the urethral orifice when the first surface is adhered to the patient's body with the aid of the adhesive. The opening has a channel-shaped wall 5 which narrows to a neck 6 which acts as a clamp for closing the valve as described hereinafter. The device further comprises a second member 7 which is a valve mounted on the opening. The valve is defined by a foldable extension of the flange consisting of two folding fins each consisting of a dome portion 8 and a duct portion 9. As shown in Figure 3 and Figure 4 the duct portion is defined by side walls 10. In the closed position »as shown in figure 1» the fins are folded inwards and the side walls of the duct portion are taken by the clamps to close the duct and form a closure that prevents the flow of liquid (urine) out through the opening. Each foldable extension or fin terminates in an end piece that is held inwardly by the patient to close the valve as shown in FIG. 1 and can be pulled out to open the valve as shown in FIG. 3. is illustrated in Figure 3 »when the duct portion is pulled out» the valve is in the open position and a flow channel or lumen 12 is provided to allow urination. A second embodiment of the invention is illustrated in Figures 6, 7 and 8. This embodiment also uses a valve defined by folding fins, but the configuration thereof differs somewhat from the configuration of Figure 1, 2 and 3. In this second mode »the reference numbers 1» 2 »3» 4, 5 »9» 10 »11 and 12 have meanings analogous to the reference numbers that identify the characteristics of the first modality. However, in the second embodiment, the configuration of the clamps 16 and of the folding flaps that make up the valve 17 is in some way different. Each clamp is still an integral extension of the flange 1 »but in the second embodiment each clamp terminates in a snap-fit element 22 which is snapped into an indented portion or slot 23 (see figure 8) in the side wall 10 of the duct when the valve is closed. The dome IB of each fin is projected into the funnel of the aperture in contrast to the external configuration of the first mode. When the valve is pressed inward »each adjustment element by means of a jump is adjusted by means of a jump inside the slot 23 and the combination of adjustment elements by means of IO jump-clamp closes the lumen 12. When the valve is opened as shown in figure 8, each adjustment element by jump is removed from each slot and the lumen is opened to allow urination. A further variation of the invention is a third embodiment as illustrated in figures 9, 10 and 11. Here again, the reference numbers 1, 2 »3» A, 5, 910 and 12 have meanings analogous to the reference numbers used in the previous figures. However, in the third embodiment, the dome 28 has a profile different from those of the first and second embodiments and also the grippers 26. In the third embodiment, each gripper 26 comprises a portion in the shape of a wing that includes a jump adjusting element 32. The closed position of the valve as shown in Figure 9 is achieved by pressing the wing portions such that each jump adjustment element 32 is snapped into slot 33 in the dome and the clips close the duct portion 9. The open position is achieved by pressing the wing portions outward. In each of the modalities described above »the size of the flange is such that it can be releasably adhered to the labial vestibule without discomfort to the patient. The opening should be long enough so that when it is placed over the urethral orifice there is enough space to facilitate urination when desired. Typically »the flange should have an external diameter of almost 2 to 3 cm. depending on the size of the patient's body. The protruding dimension of the device should be no more than 1.5 to 2 cm. between the open and closed positions of the valve. The incorporation of a valve as described above in a device according to any of the three preferred embodiments described above provides a valuable means for the relief of urinary incontinence »particularly stress incontinence» in women »which prevents leakage and yet allows urination when desired »with minimum discomfort and maximum ease of operation. By allowing urination without the need to remove the device, the patient is provided with a device that is clearly advantageous over the various plugs and pads hitherto available. The device according to the invention can be used by the patient for as much as a full day or even longer if the patient's condition so permits. It is intended that the preferred device be disposable. The device can be made from any type of valve other than the valve described here. However, valves with a more complex mechanism would be more expensive to produce and any valve that involves a complicated opening and closing procedure, particularly a procedure that requires more than a few seconds of time, should be avoided. Moreover, it is important that the operation of the valve does not significantly affect the adhesion of the device to the patient's body. In addition, the structure described herein can be made in one piece of the same elastomeric material, apart from the adhesive. Thus, for reasons of ease of operation, ease of manufacture. low cost and availability "at least" a device incorporating a valve "as described herein" is the preferred embodiment of the invention.

Claims (9)

NOVELTY OF THE INVENTION CLAIMS

1. - A device for treating leaks by an external orifice of a patient's body »such device consisting of a first member (1) having a first body contact surface (2) and a second opposing surface (3) around an opening (4) »said first surface (2) being addable to the body of the patient with the opening (4) located above said hole, and a second member (7) integral with said second surface (3). said second member (7) consisting of a valve (17) mounted on the opening (4) »said valve (17) having a closed position that prevents leakage of fluid through the device and an open position that allows the flow from said orifice flows through said opening (4) when desired »the open and closed positions being attainable without removing the device from the patient's body.

2. A device for relieving urinary incontinence in a patient having an external urethral orifice, said device consisting of a first member (1) having a first contact surface with the body (2) and a second opposing surface (3) ) around an opening (4), the first surface (2) being addable to the patient with said opening (4) located above said urethral orifice »and a second member (7) integral with said second surface (3)» said second member (7) consisting of a valve (17) mounted on said opening (4) »the valve (17) having a closed position that prevents leakage of urine through the device and an open position that allows urine from said urethral orifice flow through the opening (4) in urination »open and closed positions being achievable without removing the device from the patient.

3. A device according to claim 2 »further characterized in that at least a portion of said first surface (2) is coated with a biologically compatible adhesive to facilitate its adhesion to the surface of the patient's body.

4. A device according to claim 2"for alleviating urinary incontinence in a female patient" further characterized in that said first member (1) is a substantially circular or oval-shaped tab (1) having a first adhesive-coated surface (2) that is bondable to the floor of the labial vestibule »and said valve (17) being defined by a foldable extension of the flange (1) whose extension consists of two folding fins having a closed position in which the tabs are bent inwards to form a lock over the opening (4) and an open position wherein the tabs extend outward to define a flow path from the opening (4) to the outside.

5. - A device according to claim 4 »further characterized in that the foldable wings of the valve (17) are made of a biologically compatible elastomer.

6. A device according to claim 5 »further characterized in that the flange (1) and the fins are integral with each other and are made of the same elastomer.

7. A device according to claim 4 »further characterized in that the opening has a funnel-shaped wall (5) that narrows to a neck (6) having two sides» each of which acts as a clamp (16, 26) to close the valve (17) and the valve (17) is defined by a folding extension of the flange (1) consisting of two folding fins each consisting of a dome portion (8) and a portion of duct (9) »said portion of duct (9) being defined by side walls (10>) wherein the fins are bent inwardly and said side walls (10) are held by the clamps (16, 26) for closing the duct and to form a lock that prevents the flow of urine outward through the opening 4.

A device according to claim 7 further characterized in that each folding fin terminates in a final clamping piece. 11) that is pushed inward by the patient to close the valve (17) and pulled out to open the valve (17) and provide a flow channel through the duct to allow urination.

9. - A modification of the device according to claim 7. further characterized in that each clamp (16 »26) terminates in a snap adjustment element (22, 32) which is adjusted by jumping to a slot (23» 33) in the side wall (10) of the duct when the valve (17) is closed and each jump adjustment element (22, 32) is removed from each slot (23, 33) to open the valve (17) and allow micturition. IO.- A modification of the device according to claim 9, further characterized in that each clamp (16, 26) consists of a wing-shaped portion that includes a jump adjustment element (22, 32) wherein the closed position of the valve (17) is achieved by pressing the wing-shaped portions such that each jump adjustment element (22, 32) fits within a slot (23, 33) in the dome portion (8) and the clamps (16, 26) close the duct portion (9). and the open position is achieved by pressing the wing portions outward.