A METHOD AND DEVICE FOR EXTERNAL URINARY INCONTINENCE TREATMENT FOR WOMEN

Abstract

The invention is an external urinary incontinence treatment method and device for women that assists women or a care giver in locating the orifice of the urethral tract for the connection of a tube for removal of urine. The method and device facilitate a stable and reversibly fixated connection of a urine receiving component with the skin surrounding the orifice of the urethral tract of a treated patient while minimizing the discomfort of the treatment. The device for the treatment in women of urinary incontinence comprises a urine collecting component and a stabilizing component that are reversibly connected in a manner that the distance between the components can easily be altered so as to minimize the discomfort caused to a treated patient.

Claims

1) An external urinary incontinence treatment device for a woman patient comprising: a stabilizing component, a urine collecting component, wherein said stabilizing component comprises: a urine-receiving-component-support-ring, a connection-ring, a body-connection-pad, wherein, said connection ring has an adhesive layer on both its surface-sides, wherein, said body connection pad comprises an elongated sheet of flexible material with a layer of an adhesive material in one of its sides and a hole at its center, wherein, said urine-receiving-component-support-ring has a ring configuration and tube support plate in its center, wherein said tube support plate connects to the rim of said urine-receiving-component-support-ring by at least two spokes, wherein said tube support plate has at in it at least one hole with slits running from the rim of the hole, wherein, said connection-ring of said stabilizing component connects to urine-receiving-component-support-ring and to said body-connection-pad, wherein said urine collecting component comprises: a urine receiving component, a tube, a vaginal stabilizing component, wherein, said tube has least one circumferential slit along its external wall and an entry port at its tip. wherein, said vaginal stabilizing component comprises a plate having an elongated configuration, wherein, said vaginal stabilizing component and said tube are connected to said a urine receiving component and said tube communicates freely with said urine receiving component, wherein, said tube inserts into said hole in said tube support plate in said urine-receiving-component-support-ring, said tube moves freely inside said hole until said slit in said tube reversibly interlocks with the rim of said hole in said tube support plate, wherein, said vaginal stabilizing component is inserted into vagina of said treated patient and the rim of said urine receiving component reversibly tightly connects to the skin surrounding the urethral orifice of said treated patient, wherein, said body-connection-pad reversibly connects to the skin in the genital region of said treated patient.

2) The stabilizing component of external urinary incontinence treatment device of claim 1, wherein the stabilizing component is produced as a single entity component.

3) The urine collecting component, of external urinary incontinence treatment device of claim 1, wherein the urine collecting component is produced as a single entity component.

4) The stabilizing urine-receiving-component-support-ring of stabilizing component of external urinary incontinence treatment device of claim 1 wherein the stabilizing urine-receiving-component-support-ring is made of semi-rigid materials.

5) The body-connection-pad of stabilizing component of external urinary incontinence treatment device of claim 1 wherein the body-connection-pad is made of a material having a flexible sheet configuration.

6) The body-connection-pad of stabilizing component of external urinary incontinence treatment device of claim 1 wherein the body-connection-pad is reversibly connected to a body-connection-pad protective cover.

7) The urine collecting component of external urinary incontinence treatment device of claim 1 wherein the urine collecting component is made of semi-rigid materials.

8) The urine receiving component of urine collecting component of external urinary incontinence treatment device of claim 1, wherein the urine receiving component has a spatial configuration that facilitates a reversible urine leak-tight connection with the skin surrounding the orifice of a treated patient.

9) The vaginal stabilizing component of the urine collecting component of external urinary incontinence treatment device of claim 1 wherein the vaginal stabilizing component has an elongated plate spatial configuration.

10) The vaginal stabilizing component of claim 9 wherein the vaginal stabilizing component has a spatial configuration that prevents the spontaneous expulsion from within the vagina of a treated patient.

11) The vaginal stabilizing component of claim 9 wherein the vaginal stabilizing component has a spatial configuration that facilitates a tight reversible yet comfortable connection with the wall of the vagina of a treated patient.

12) The urine receiving component of urine collecting component of external urinary incontinence treatment device of claim 1, wherein the urine receiving component has an air inlet hole running through the wall of the urine receiving component.

13) The tube of urine collecting component of external urinary incontinence treatment device of claim 1, wherein the tube has an air inlet hole running through the wall of the tube.

14) A method for the treatment of urinary incontinence treatment of a women by deploying a external urinary incontinence treatment device, the device comprising: a stabilizing component and urine collecting component, wherein said stabilizing component comprises: a urine-receiving-component-support-ring, a connection-ring, a body-connection-pad, wherein, said connection ring has an adhesive layer on both its surface-sides, wherein, said body connection pad comprises an elongated sheet of flexible material with a layer of an adhesive material in one of its sides and a hole at its center, wherein, said urine-receiving-component-support-ring has a ring configuration and tube support plate in its center, wherein said tube support plate connects to the rim of said urine-receiving-component-support-ring by at least two spokes, wherein said tube support plate has at in it at least one hole with slits running from the rim of the hole, wherein, said connection-ring of said stabilizing component connects to urine-receiving-component-support-ring and to said body-connection-pad, wherein said urine collecting component comprises: a urine receiving component, a tube, a vaginal stabilizing component, wherein, said tube has least one circumferential slit along its external wall and an entry port at its tip. wherein, said vaginal stabilizing component comprises a plate having an elongated configuration, wherein, said vaginal stabilizing component and said tube are connected to said a urine receiving component and said tube communicates freely with said urine receiving component, wherein, said tube inserts into said hole in said tube support plate in said urine-receiving-component-support-ring, said tube moves freely inside said hole until said slit in said tube reversibly interlocks with the rim of said hole in said tube support plate, wherein, said vaginal stabilizing component is inserted into vagina of said treated patient and the rim of said urine receiving component reversibly tightly connects to the skin surrounding the urethral orifice of said treated patient, wherein, said body-connection-pad reversibly connects to the skin in the genital region of said treated patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to better understand the present invention, and appreciate its practical applications, the following Figures are provided and referenced hereafter. It should be noted that the Figures are given as examples only and in no way limit the scope of the invention. Like components are denoted by like reference numerals.

[0037] FIG. 1 is an isometric from-above-and-side view of an illustration of an external urinary incontinence treatment device of the present invention, with the components of the device disassembled and disconnected.

[0038] FIG. 2 is an isometric from-above-and-side view of an illustration of an external urinary incontinence treatment device of the present invention in an assembled and connected configuration.

[0039] FIG. 3 is an isometric from-above-and-side view of an illustration of a urine-receiving-component-support-ring (URCSR) and a urine-collecting component (UCC) of the present invention, in a disconnected configuration, without the body connection pad, and the connection ring.

[0040] FIG. 4 is an isometric from-above-and-side view of an illustration of the URCSR and the UCC shown in FIG. 3, in a connected configuration.

[0041] FIG. 5A up to and including FIG. 5F, are illustrations of consecutive stages of deploying the external urinary incontinence treatment device of the present invention, illustrated in FIG. 2.

[0042] FIG. 6 is a cross cut illustration of the external urinary incontinence treatment device of the present invention deployed in a treated patient.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

[0043] It should be clear that the description of the embodiment and attached Figures set forth in this specification serves only for a better understanding of the invention, without limiting its scope.

[0044] The external urinary incontinence treatment device of the present invention (10) is composed of: a stabilizing component (12) referred to interchangeably as SC, and a urine collecting component (26), referred to interchangeably as UCC.

[0045] FIG. 1 shows an isometric from-above-and-side view illustration of an external urinary incontinence treatment device (10) of the present invention, with the components that construct SC (12) disassembled and in a configuration in which SC (12) is apart from the UCC (26), and the SC (12) is illustrated in disassembled configuration, illustrating connection pad (22) and connection ring (20).

[0046] FIG. 2 shows an isometric from-above-and-side view illustration of the external urinary incontinence treatment device illustrated in FIG. 1, in a configuration in which the SC (12) components are assembled and the SC (12) reversibly connected to the UCC (26).

[0047] FIG. 3 is an isometric from-above-and-side view of an illustration of a urine-receiving-component-support-ring, referred to interchangeably as URCSR (13), which is a component of SC (12), and a urine-collecting component (UCC) (26), illustrated in FIG. 1.

[0048] FIG. 4 is an isometric from-above-and-side view of an illustration of the URCSR (13) and UCC (26), shown in FIG. 1, in a reversible connected configuration.

[0049] Reference is presently made to stabilizing component (12) of the present invention shown in a disassembled configuration in FIG. 1 and in an assembled configuration in FIG. 2.

SC (12) is constructed of a URCSR (13), a connection-ring (20), a body-connection-pad, referred to interchangeably as BCP (22) and a BCP protective cover, referred to interchangeably as BCPPC (24). URCSR (13) is constructed of a flat-ring (14) which has inner spoke-bars (16) that support at the center, or near the center, of the ring a plate-structure (18) that has in its center at list one hole (15). URCRS (13), optionally has a flat elliptical configuration, In the illustrate embodiment 4 spoke-bars (16) are illustrated. At least two slits (15A) extend from the rims of hole (15). URCSR (13) is constructed of a rigid or semi-rigid material, such as, but not limited to, silicon, plastic or rubber. The slits (15A) extending from hole (15) in plate (18) provide the rim of the hole elasticity that enables the penetration of a tube having a diameter that fits into hole (15) while slightly bending the rim of the hole. The bent rim of the hole interlock into circumference slits (30) along tube (28). By squeezing the longitudinal sides of plate structure (18) towards each other with tube (28) interlocked, the configurational change along slits (15A) releases tube (28) from the interlocked state, and tube (28) can (again) moved inside hole (15). If plate (18) is not squeezed, tube ((28) can be moved till another slit (30) interlocks with the tube. Connection-ring (20) is a flat ring constructed of a rigid or semi-rigid material, such as, but not limited to, silicon, plastic or rubber, or thin sheet of glue. Connection ring (20) has an adhesive layer on both its surface-sides. The adhesive layers are composed of a thin spread of sticky glue material, or, alternatively, composed of sheets made of, but not limited to, thin-paper or thin plastic material, that are connected to the surface-sides and have a layer of adhesive material. Connection ring (20) connects to ring (14) in one side and around hole (21) in the top, none sticky side, of body connection pad (22). BCP (22) is an elongated pad made of a sheet of flexible material such as, but not limited to, cloth or plastic material or paper, and has a hole (21), typically at its center, or near the center. Typically, hole (21) has an elliptical configuration. The side of BCP (22) that connects to connection-ring (20) is plain (not sticky) and the other side is coated by a human-skin contact-suitable adhesive sticky layer, that connects BCP (22) firmly yet reversibly, to a treated patient. The sticky layer can be formed by a glue layer on the surface of the pad, or alternatively, by a thin film with a fixated side connected to the BCP and a sticky side left free. BCP protective cover (24) is reversible connected to the sticky side of BCP (22) and BCPPC (24) is removed when the device (10) of the present invention is deployed. BCPPC (24) is divided into two parts, (24A) and (24B), which encircle a hole (23) that aligns with hole (21) when the two parts are connected to BCP (22). The partition to two parts enables the peeling off and removal of BCPPC (24) from BCP (22) without the necessity of changing the placement of BCP (22) when device (10) is deployed. The rim of hole (23) is reversibly connected to the rim of hole (21).

[0050] Reference is presently made to the urine-collecting component (26), illustrated in detail in FIG. 1 and FIG. 3.

[0051] UCC (26) is typically produced as, but not limited to, a component having a single entity made of rigid and semi-rigid material or materials such as, but not limited to, silicon and/or plastic and/or rubber. UCC is constructed of a urine-receiving component (32), referred interchangeably as URC, that has a tube-entry hole at one of its sides and an air-inlet hole (34) at its opposite side. Air-inlet-hole (34) is a hole that runs through the wall of urine-receiving component (32) and has a diameter of approximate between 0.3 and 0.6 millimeter. The diameter of hole (34) enables the free passage of air and restricts the passage of urine. A tube (28) connects to the tube entry hole in URC (32) and communicates freely with the enclosed volume of the urine receiving component (32). Tube (28) has at the tip not connected to the URC (32), a rigid, or semi rigid, ring tube entry port (29) for the connection to a urine removal tube (51) (shown in FIG. 5F) that flows the urine to a collection vessel. In addition, tube (28) has along its external wall at least one, typically two or more, circumference slits (30). A vaginal stabilizing component (36), referred to interchangeably as VSC, is connected to the rim of urine-receiving component (32) on the far side from air-inlet hole (34). VSC (36) can have any spatial configuration that facilitates easy insertion of the component into the vagina and prevents its spontaneous expulsion from its placement-position within the vagina. Typically VSC (36) has a spatial configuration of an elongated plate with the shape of, but is not limited to, a flat guitar, or, a flat rowing-paddle, or flat tennis racket. Optionally, air-inlet hole is not limited to the far side of component (32) and can be in other locations in the component or in the tube (28).

[0052] Typically, but not limited to, the urine receiving component is made in an elongated dome configuration that fits the spatial configuration of the genital region where the receiving component is deployed. In describing the embodiment of the present invention illustrated in the figures the term “urine-receiving component” is interchangeably used in the text as the “urine-receiving dome”.

[0053] Reference is presently made to explaining the reversible connection of URCSR (13) of SC (12) to tube (28) of UCC (26), illustrated in FIG. 3 and FIG. 4. Tube (28) is inserted into hole (15 in plate structure (18) of urine-receiving-component-support-ring (13). The tube is slid in the hole and is reversibly fixated in place by the rim of hole (15), interlocking with the slit (30) of choice along the length of the tube (28). The choice of the slit is determined by the patient and can be altered in the course of the treatment.

[0054] Reference is presently made to explaining the procedural stages of deploying the urinary incontinence treatment device (10) shown in FIG. 2, illustrated in FIG. 5A up to and including FIG. 5F.

[0055] FIG. 5A illustrates a stabilizing component (12) held by one hand (52) of a patient and a urine collecting component (26), held by the other hand (50). Hole (18) in SC (12) is aligned with entry port (29) of tube (28) in UCC (26).

[0056] FIG. 5B illustrates the insertion of tube (28) of UCC (26) illustrated in 5A, into hole (15) in URCSR (13). Slit (30), shown in FIG. 5A, interlocks reversibly with the rim of hole (15) in URCSR (13). The choice of the slit (30) used is made by the patient (or care giver) and can be easily changed if another slit is more suitable for fixating the movement of tube (30) inside hole (15). The length of tube (28) extending from the URC (32) towards the URCSR (13) determines the fastness of the connection between the urine receiving component (32) and the surrounding skin of the orifice of the uretheral tract of the treated patient. The fastness is applied to the extent that causes minimum discomfort to the treated patient.

[0057] FIG. 5C illustrates the patient using her hand (50) to part the lips of the labia minora (not shown in the Fig.) and inserting vaginal stabilizing component (36) of the UCC (26), into the vagina ((38), (shown in FIG. 6)). The insertion is done by holding tube (28) with her other hand (52) and pushing the VSC (36) into the vagina. Ring (14) of SC (12) is shown connected to body connection pad (22). By pushing the VSC (36) towards the wall of the vagina and towards the symphysis pubis (40), as illustrated in FIG. 6, the rim of urine receiving dome (32) is positioned over and around the orifice of the uretheral tract of the patient. By continuing to push UCC (26) urine receiving dome is fastened to the skin surrounding the orifice. By movements of the UCC (26) toward the body, while the VSC (36) is in the vagina, the connection, adjustment and fastening of the urine receiving dome (32) are achieved. The fixating of the urine receiving dome (32) around the orifice of the uretheral tract is achieved by connecting BCP to the body of the treated patient, as illustrated in FIG. 5D and FIG. 5E.

[0058] FIG. 5D illustrates the patient peeling BCP protective cover (24) from body connection pad (22) while vaginal stabilizing component (36) is in place in her vagina, and the URC (32) is surrounding the urethra hall. The patient is shown pressing BCP (22) towards her body with one hand (50) while pulling and peeling BCPPC (24) from BCP (22) with the other hand (52).

[0059] FIG. 5E illustrates the patient pressing with her hand (52) BCP (22), towards her body. With BCPPC (24) removed, the adhesive layer on BCP (22) reversibly connects to the skin of the patient, thus, stabilizing device (10) in its placement from outside the body. The inserted vagina stabilizing component (36) stabilizes device (10) in its placement from inside the body of the patient.

[0060] By squeezing simultaneously towards each other the longitudinal sides of plate-structure (18) (shown in FIG. 1) tube (28) can be freed from being interlocked in a given position with the rim of hole (15) and another interlocked position along the length of tube (28) can be easily established by moving tube (28) inside hole (15) either towards or from the body of the treated patient.

[0061] FIG. 5F illustrates device (10) stabilized in the body of the patient and a urine removal tube (51) connected to tube entry port (29) of tube (28).

[0062] By releasing the interlock slit (30) of tube (28) from the rim of hole (15) in plate structure (18) the tight connection between the urine receiving dome (32) and the surrounding of the orifice of the urethral tract (43), (shown in FIG. 6) is terminated. By disconnecting the BCP from the body and slightly swirling the VSC (36) inside the vagina the UCC can be withdrawn from the body of the treated patient and device 10 completely removed.

[0063] FIG. 6 is a cross cut illustration of the external urinary incontinence treatment device (10) of the present invention deployed in a treated patient. The illustration in FIG. 5E is the view from outside of the body of the patient of the deployment-state of device (10) shown in FIG. 6. The illustration shows plate of VSC (36) of the UCC (26) inside the vagina (38) of a treated patient and pressed the wall of the vagina towards the symphysis pubis (40). With plate (36) pressed towards the symphysis pubis (40), urine-receiving dome (32) is pressed towards the body of the patient by pressing on tube (28), thus forming a reversible urine leak-free connection between the rim of urine-receiving dome (32) and the skin surrounding the external ureteral orifice (43) of the treated patient. Plate (36) pressed inside the vagina together with body-connection-pad (22) reversibly connected to the external skin surrounding the genital region of the treated patient secure the reversible fixating of the urine receiving dome (32) in place.

[0064] It should also be clear that a person skilled in the art, after reading the present specification could make adjustments or amendments to the attached Figures and above described embodiments that would still be covered by the present invention