NON-INVASIVE DEVICE AGAINST URINARY INCONTINENCE

Abstract

A non-invasive device against urinary incontinence is described, which is adapted to be applied to the external part of a human penis and which is so shaped as to operationally encircle the penis by compression, the penis internally including a urethral duct in a lower position and two cavernous bodies in lateral positions, the device including a first part adapted to operationally exert an even compression force on the upper part of the penis, and a second part adapted to operationally exert direct compression forces on both cavernous bodies and indirect compression forces on the urethral duct, induced by the direct compression forces exerted on both cavernous bodies, so as to achieve a stable lateral compression for closing the urethral duct.

Claims

1. A non-invasive device against urinary incontinence, adapted to be applied to the external part of a human penis and so shaped as to operationally encircle the penis by compression, said penis internally comprising a urethral duct in a lower position and two cavernous bodies in lateral positions, the device being characterized in that it comprises a first part adapted to operationally exert an even compression force on the upper part of the penis, and a second part adapted to operationally exert direct compression forces on both cavernous bodies and indirect compression forces on the urethral duct, induced by said direct compression forces exerted on both cavernous bodies, so as to achieve a stable lateral compression for closing the urethral duct.

2. The device according to claim 1, wherein said second part comprises a curvilinear inner profile, with two points or areas of relative maximum, with a point or area of relative minimum in between, said points or areas of relative maximum being adapted to exert said direct compression forces on the two cavernous bodies, respectively, said direct compression forces comprising a lateral component.

3. The device according to claim 1, comprising an inner part made of rigid material and an outer part made of soft material, which covers said inner part.

4. The device according to claim 3, wherein said rigid inner part is made of thermoplastic material, or PP, PE, PA11, PA12, PA66, PA6-66, PC, ABS, PEEK, rigid PVC, plasticized PVC, TPU, or blends thereof.

5. The device according to claim 3, wherein said outer part is made by dipping, or spraying, or binding, or deposition, and comprises materials such as EVA polymer foam, SEBS foam, SBS foam, TPU foam, PS foam, polyisoprene, latex, silicone and other thermoplastic or thermosetting polymers, or blends thereof.

6. The device according to claim 1, comprising at least one reclosable opening adapted to allow positioning the device in a manner such that the penis will remain operationally compressed.

7. The device according to claim 6, wherein said at least one reclosable opening comprises closing means adapted to be operationally overlapped for closing and opening the device around the penis.

8. The device according to claim 6, wherein said at least one reclosable opening is implemented by means of Velcro strips, or soft plastic ties for fishbone or saw-tooth or rack-type fastening.

9. The device according to claim 3, wherein, in said inner part, said second part has a curvilinear inner profile comprising bends or broken lines.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Further objects and advantages of the present invention will become apparent from the following detailed description of a preferred embodiment (and variants thereof) referring to the annexed drawings, which are only supplied by way of non-limiting example, wherein:

[0018] FIG. 1 shows a side view of one embodiment of the device according to the invention;

[0019] FIG. 2 shows one embodiment of the inner part of the device;

[0020] FIGS. 3 and 4 show side views of the device of FIG. 1;

[0021] FIG. 5 is a cross-sectional view of a penis;

[0022] FIG. 6 is an explanatory graph showing some examples of the curvilinear profile of the lower inner part of the device;

[0023] FIG. 7 schematically shows how the lines of force developed by the device can compress the penis.

[0024] In the drawings, the same reference numerals and letters identify the same items or components.

DETAILED DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

[0025] Once worn, the device exerts an even pressure on the upper part of the penis; this pressure is then transferred to the lower part of the penis, pressing against the geometry of the lower part of the device.

[0026] The above-mentioned upper and lower parts of the penis and of the device refer to the shape of the penis cross-section as shown in FIG. 5, which highlights the urethral duct UR at the bottom and two cavernous bodies CC1, CC2 at the sides.

[0027] The device 1 is provided in the form of a band encircling the penis in a firm and removable manner, which comprises at least one reclosable opening allowing the device to be arranged in such a way that the penis will remain operationally compressed by it.

[0028] The device comprises an upper part 2 and a lower part 3 opposite to each other. Furthermore, in one embodiment the lower and upper parts are fixedly connected together on one side 4, whereas on the other side they are connected by closing means, e.g. two flaps 5, 5 adapted to be overlapped for closing and opening the device around the penis. Closing can be effected by means of Velcro strips or other systems such as soft plastic ties for fishbone or saw-tooth or rack-type fastening.

[0029] The device preferably comprises a rigid inner layer, e.g. shaped as shown in FIG. 2, coated with a soft foam material part, preferably of antibacterial nature, to adapt itself to the shape of the penis, thus having an overall shape like the one shown by way of example in FIGS. 1, 3, 4.

[0030] One important aspect of the invention is the geometry of the profile of the lower part 3 of the device. It has a curvilinear shape. As shown in FIGS. 6 and 7, an area is defined between two lateral points of absolute minimum a and b, between which two points of relative maximum c and d are defined, with a point of relative minimum e in between. This can be achieved by means of curvatures or broken lines of the rigid inner material, the structure being then effectively modelled by the soft external material.

[0031] The exemplary curves drawn on the x-y axes, where a<x<b, highlight a curvature having points of horizontal tangency (derivative=0), or a broken line with inward points of maximum and minimum. As aforesaid, a and b are points of absolute minimum, e is a point or area of relative minimum in a substantially central position relative to c and d, which are points or areas of relative maximum.

[0032] Point e is a point of stable equilibrium because it is contoured by c and d points, as opposed to prior-art solutions, wherein the central point is a point of unstable equilibrium directly compressing the urethral duct.

[0033] The two lateral protuberances 6, 7 exert a pressure with a lateral force component towards the cavernous bodies (positioned at the sides of the urethral duct), which, being affected by such field of forces orthogonally to the curve surface, close and compress the urethral duct in between. It can be noticed (FIG. 7) that the urethral duct UR is compressed by a vector field of forces that is different from the one achievable with prior-art devices: the upper part of the device exerts an even field of forces on the penis, while the lower part, instead of compressing the urethral duct UR directly from below, compresses it laterally and indirectly, i.e. compression is exerted directly and laterally on the cavernous bodies CC1, CC2 by lateral force components, causing the urethral duct to become deformed between the two cavernous bodies.

[0034] Such field of forces (or pressures) generated by the specific geometry of this device ensures that the urethral duct will stay properly closed even during movements, since the penis will be at a point of stable equilibrium, unlike current anti-incontinence devices, wherein the initial position is a point of unstable equilibrium.

[0035] Therefore, the basic idea is to exert lateral pressure on the cavernous bodies beside the urethral duct, thus creating a point of stable equilibrium to exert pressure on the urethral duct. This provides stability, comfort of use and uninterrupted efficiency.

[0036] The rigid inner body (FIG. 2) is made, for example, of thermoplastic material, preferably Nylon 6 (PA 6).

[0037] As alternatives to Nylon 6, the following materials may be employed: PP, PE, PA11, PA12, PA66, PA6-66, PC, ABS, PEEK, rigid PVC, plasticized PVC, TPU, or any thermoplastic polymeric material having a sufficient modulus of elasticity (>40 MPa of tensile modulus) for creating the inner structure, or blends thereof.

[0038] Said rigid component represents the inner part of the device.

[0039] Said component is manufactured by injection moulding.

[0040] Externally to said rigid component, a layer of soft material is applied by overmoulding or coating; the layer of soft material is preferably made of antibacterial thermoplastic foam material.

[0041] Such soft, elastic and light coating can also be obtained by dipping, spraying, binding, deposition or the like, and its thickness is in the range of 0.5 to 10 mm depending on the mechanical characteristics of the material used for said coating.

[0042] Other materials may also be used for such coating: EVA polymer foam, SEBS foam, SBS foam, TPU foam, PS foam, polyisoprene, latex, silicone and other thermoplastic or thermosetting polymers, or blends thereof.

[0043] Open-cell or closed-cell foam materials are to be preferred for this purpose, due to their lower weight as well as their lower environmental impact (and disposal costs).

[0044] As previously mentioned, the device includes a fastening system that can be modulated and adapted to each user; for example, closure adjustment can be provided by Velcro strips, but other adjustable closing systems can be adopted as well, whether integral with or separate from the coating geometry.

[0045] The above-described non-limiting example of embodiment may be subject to variations without departing from the protection scope of the present invention, including all equivalent designs known to a man skilled in the art.

[0046] The elements and features shown in the various preferred embodiments may be combined together without however departing from the protection scope of the present invention.

[0047] The advantages deriving from the application of the present invention are apparent.

[0048] This device has been developed, tested and validated by means of practical tests to ensure the absence of leaks in individuals suffering from male incontinence. Clear benefits to the user's life style and quality are easily imaginable, since the use of diapers is avoided. The numerous advantages also include a smaller environmental impact of this device as concerns the costs and the pollution related to disposal and production of traditional disposable diapers.

[0049] In fact, due to its innovative antibacterial component and washable materials, this device can be offered as a reusable, as opposed to disposable, device.

[0050] It is important to underline that this solves the problem of the point of unstable equilibrium, which is characteristic of prior-art solutions, and which gives rise to problems, e.g. caused by the person's movements, that can cause the pressure element to shift outside the area of the urethral duct, thus making the device ineffective or even harmful, since it can only be effective in particular conditions, e.g. when the person is still, e.g. sitting in a wheel chair or lying in bed, such effectiveness disappearing if the person moves.

[0051] From the above description, those skilled in the art will be able to produce the object of the invention without introducing any further construction details.