Urinary drainage device with non-adhesive attachment to the penis

Abstract

The present disclosure relates to the field of urinary drainage devices that are attached to the penis of a patient, particularly a patient suffering from urinary incontinence, without the use of medical glue or adhesives, the device comprising a glans penis sheath and an attachment system (100), the glans penis sheath comprising a proximal portion, the proximal portion of the glans penis sheath having a frustoconical inner and outer surface, each of the inner and outer surfaces comprising a distal end having a small diameter (Dd) and a proximal end having a large diameter (Dp), the attachment system (100) configured to hold a retracted foreskin on the outer surface of the proximal portion, the glans penis sheath comprising a distal portion extending to the proximal portion, the distal portion having an outer surface with a protuberance (B), such that the retracted foreskin is held by the attachment system (100) between the proximal and distal portions.

Description

[Technical field]

[0001] The present disclosure relates to the field of urine drainage devices for fixation to the penis of a patient, such as a patient suffering from urinary incontinence, without the use of adhesives or medical glues. [Background technology]

[0002] Urinary incontinence is characterized by the involuntary loss of urine through the urethra. There are several types of urinary incontinence depending on their pathophysiological cause. However, whatever the cause, the impact on the patient's daily life is significant and can result in great social discomfort.

[0003] Many therapeutic solutions, with or without drugs, are available to improve the lives of patients suffering from urinary incontinence.

[0004] Among the drug-free solutions, a distinction is made in particular between non-absorbent devices and absorbent devices, such as diapers. - an adhesive or non-adhesive penile sheath, which is an external urine collection device. Penile sheaths traditionally have a shape similar to that of a condom, and generally comprise an assembly consisting of a sheath that is placed on the penis and an endpiece to which a tube is attached, which tube is connected to a collection bag. - A urethral catheter, a tube introduced into the urethral opening into the bladder for the purpose of collecting urine.

[0005] Although urinary catheters have proven effective, they can be uncomfortable and painful for patients and can interfere with certain daily activities. They are also a potential source of infection.

[0006] Urinary devices including penile sheaths that use adhesive or medical glue to secure the penile sheath to the penis or glans of the patient's penis have several disadvantages. Adhesive tape attached to the delicate skin of the patient's penis or directly to the glans of the patient's penis can cause irritation. Removing the sheath can be painful, and getting the sheath in place can be tedious, as once the sheath is affixed to the skin it is difficult to adjust the position of the sheath on the penis. Furthermore, it is sometimes recommended to leave the penile sheath in place for several days, in which case the quality of the adhesive may deteriorate and fixation of the sheath is no longer guaranteed.

[0007] To overcome these problems, penile sheaths have been provided which are mechanically secured to the patient's penis by "pinching," "clamping," or similarly "applying pressure" to the patient's foreskin.

[0008] U.S. Patent No. 4,388,923 describes a urination device in the form of a condom that is stretched only over the glans of the patient's penis. Once the device is placed over the glans, the patient stretches his foreskin over the device. The device also includes an elastic sheath that can be stretched from one side of the condom or the other, like an umbrella that folds in one direction or another. Thus, the sheath can be stretched over the foreskin to encase it, holding the device firmly against the patient's foreskin. The device terminates in a tube that collects the patient's urine in a bag.

[0009] Other patent applications disclose improvements to the device of US 4,388,923. For example, US 2001 / 0005782 describes the placement of an elastic connection between the tube and the end of the condom placed on the glans. This relieves the device from the weight of the bag and prevents the patient's foreskin from being pinched too tightly when the bag fills with urine and gravity pulls the end of the device downwards, which could be in danger of "pinching" the foreskin tighter. US 2004 / 0087921 discloses that the membrane covering the foreskin is made of a breathable material that allows gas exchange but not liquid exchange.

[0010] The above mentioned devices have the following drawbacks: They are difficult to adapt to the different morphologies of the glans and penis of the patient. In fact, the dimensions of the device are limited by the size of the elastic sheath that stretches over the foreskin. The elasticity of the sheath decreases over time and the fixation of the device is no longer guaranteed. The patient cannot adjust the tightness of the device. Finally, when removing the device, the elastic effect may cause the sheath to suddenly retract, which may cause splashing that is unpleasant for the patient.

[0011] The device of the present invention is a urinary device that improves the above-mentioned situation and solves the problems. Moreover, the device of the present invention may be used by subjects who do not necessarily suffer from urinary incontinence, but who need a urinary device due to being unable to use a toilet for long periods of time, such as, for example, aviators or glider pilots. Summary of the Invention

[0012] According to a first aspect, the invention is a urination device comprising a non-adhesive balanic sheath (balanic being an adjective meaning "pertaining to the glans of the penis") and a fastening system, the balanic sheath comprising a proximal portion for receiving the exposed glans of a patient, the proximal portion of the balanic sheath having frusto-conical inner and outer surfaces, each of the inner and outer surfaces of the proximal portion of the sheath comprising a distal end having a smaller diameter and a proximal end having a larger diameter, the fastening system configured to hold the patient's foreskin spread over the outer surface of the proximal portion of the balanic sheath, the balanic sheath comprising a distal portion contiguous with the proximal portion, the distal portion having an outer surface with protuberances such that when the foreskin is spread, the foreskin is held by the fastening system in a region spanning the proximal and distal portions, upstream of the protuberances.

[0013] In the remainder of this description, "sheath" and "glans sheath" are used equivalently to designate the same shape.

[0014] The particular shape of the glans penis sheath combined with the protrusions allows the glans penis sheath to be effectively held in place on the patient's penis by a fastening system that spans the proximal and distal portions of the glans penis sheath and fastens the foreskin upstream of the protrusions. The particular location and shape of the protrusions allows for easy placement of the sheath on the penis. The protrusions also allow for effective fastening of the fastening system on the sheath.

[0015] According to one embodiment of the present invention, the projection is a continuous or discontinuous circular bead arranged on a disk that perpendicularly intersects the distal portion of the glans penis sheath when the glans penis sheath is viewed from the side where the axis of the frustoconical proximal portion is collinear with the vertical axis.

[0016] The continuous or discontinuous bead arrangement as protrusions creates continuous or discontinuous depressions on the exterior surface of the sheath across the proximal and distal portions of the sheath, which effectively holds the foreskin in place and prevents the fastening system from slipping.

[0017] According to one embodiment of the present invention, the fastening system is a non-rigid fastening collar. The non-rigid collar is preferably adaptable to the thickness and length of the foreskin. The non-rigid fastening collar is, for example, a touch-and-close band (which may be elastic or not), or a cord fastened by a fastening button of the cord-lock type, or a cord closed by a push button (particularly elastic), or a stretchable circular band, or a flexible magnet in the form of a band, or a cord closed by a magnet (particularly elastic).

[0018] During the day, the size of the penis may change and the patient may need to adapt the fixation of the device to the penis. The use of a non-rigid, adaptable tightening collar allows the patient to very easily adjust the tightening of the foreskin over the exterior of the glans sheath.

[0019] According to another embodiment of the invention, the fastening system is a rigid fastening collar. The rigid collar may include, for example, two articulated parts that are closed around the foreskin by a touch-and-close fastener, a magnetic fastener, or a pin-type closure system. The pin-type closure system includes a first part having at least one hole that receives a pin of the second part of the system. This type of closure is conventionally used to fasten and close watch straps.

[0020] According to another embodiment, the fastening system is a clip system, the clip spans the proximal and distal parts of the sheath and fastens the foreskin on the glans penis sheath upstream of the protrusion, and the actuation mechanism of the clip is located downstream of the protrusion at the distal part of the sheath. The actuation mechanism of the clip is, for example, a spring actuation system. In other cases, the end of the clip that contacts the foreskin to fasten the foreskin on the sheath may include a magnet that magnetically locks with another magnet in or on the sheath. Furthermore, the actuation mechanism of the clip may be a ring that threads onto a thread on the distal part of the sheath or clips into a notch on the distal part of the sheath, so that when the ring is threaded or clipped downstream of the protrusion, the clip fastens the patient's foreskin upstream of the protrusion. The clip may also be held around the foreskin by surrounding and fastening the foreskin with a non-rigid fastening collar as described above.

[0021] The clip system allows the patient to more conveniently fasten the glans penis sheath to the patient's foreskin and allows the sheath to be removed by simply loosening the clip. Additionally, the clip system can be modified to tighten or loosen the clip to the foreskin, for example, by adjusting the elasticity of the spring.

[0022] According to another embodiment, the fastening system is a "skirt" type fastening system including a first circular elastic band downstream of the protrusion and a non-rigid fastening collar as described above arranged to span the distal and proximal parts of the glans penis sheath and fasten the patient's foreskin upstream of the protrusion. The first elastic band and the non-rigid fastening collar are connected to each other by a fine fabric such as silk or cotton or silicone woven fabric.

[0023] The "skirt" type fastening system ensures, on the one hand, the fixation of the foreskin to the glans sheath and, on the other hand, the fixation of the fastening system to the sheath.

[0024] The inner surface of the glans penis sheath may be made of a different material than its outer surface.

[0025] The possibility may be given to modify the material of the sheath so that the contact between the inner surface of the sheath and the glans is as comfortable as possible for the user while at the same time minimizing irritation.

[0026] The glans penis sheath may also be made integrally from a single material.

[0027] The glans penis sheath may be made of a material or combination of materials selected from the families of, for example, polyolefins, styrenes, vinyls, polyamides, polyesters, polyketides, polysulfides, polysulfones, polyacetals, thermoplastic elastomers, polycarbonates, fluorinated polymers. Preferably, the material is selected from thermoplastic polymers and silicones. More preferably, the material is selected from polyvinyl chloride, silicones, polyethylenes, polystyrenes, polypropylenes, polyethylene terephthalates, polyacrylates, and polymethylacrylates, and polyurethanes.

[0028] Examples of materials from the above mentioned families are presented according to their acronyms used in the bibliographical studies, and therefore the scientific names corresponding to these acronyms are presented in English.

[0029] For example, the family of polyolefins includes LDPE (low density polyethylene), HDPE (high density polyethylene), LLDPE (linear low density polyethylene), PP (polypropylene), and EVA (ethylene vinyl acetate).

[0030] For example, the styrene family includes PS (polystyrene), SAN (styrene acrylonitrile), ABS (acrylonitrile butadiene styrene), and HIPS (high impact polystyrene).

[0031] For example, the vinyl family includes PVC (poly(vinyl chloride)), PVDC (PVDC).

[0032] For example, the family of polyamides includes nylon 6, 6 / 6, 6 / 10, 6 / 12, 11, and 12.

[0033] For example, the family of polyesters includes PET (polyethylene terephthalate), PBT (poly(butylene terephthalate)), PETG (polyethylene terephthalate glycol) and PLA (polylactide), PGA (polyglycolide), PLGA (poly(lactide-coglycolide), PCL (polycaprolactone), PBL (poly-butyrolactone), PHA (polyhydroxyalkanoates), and copolymers thereof.

[0034] For example, the polyketide family includes PEEK (polyetheretherketone).

[0035] For example, the polysulfide family includes PPS (polyphenylene sulfide).

[0036] For example, the polysulfone family includes PSU and PES (polyethersulfone).

[0037] For example, the polyacetal family includes POM (polyoxymethylene).

[0038] For example, the family of thermoplastic elastomers includes PU (polyurethane), PEBA (polyether block amide), COPE (polyether-ester block copolymer thermoplastic elastomer (COPE / TEEE)), TPO (blends of polyolefins), EPDM (ethylene propylene diene modified rubber), EPR (ethylene propylene rubber), FPO (flexible polyolefin), POE (polyolefin elastomer), SBC (styrenic block copolymer), SBS (styrene-butadiene-styrene), SEBS (styrene-ethylene-butylene-styrene) and SIS (styrene-isoprene-styrene), TPV (thermoplastic vulcanizate), TPU (thermoplastic polyurethane), flexible block segments of polyether or polyester bonded to hard blocks of aromatic or aliphatic isocyanates, COPE (copolyesters), PEBA (polyether block amide and copolyamide elastomers).

[0039] For example, the polycarbonate family includes polycarbonate.

[0040] For example, the family of fluoropolymers includes PVDF (polyvinylidene fluoride), ETFE (ethylene-tetrafluoroethylene), and PTFE (polytetrafluoroethylene).

[0041] The glans penis sheath, like the fastening system, may be washable and sterilizable, so the device may be reused by the user.

[0042] The length of the proximal portion of the sheath may be 5 to 25 mm, preferably 13 to 20 mm, and more preferably 17 mm.

[0043] The ratio of the major diameter of the inner surface of the proximal portion of the sheath to the smallest diameter at the distal end of the proximal portion of the sheath may be 1-3, more preferably 2.

[0044] Such a ratio allows easy placement of the glans penis sheath on the glans penis and also allows optimal flow of urine, so that there is no risk of urine droplets stagnating on the glans penis of the patient, thus avoiding the risk of infection.

[0045] The projection may be in the shape of a hemisphere or a section of a ball. If the sheath is then viewed from a side with its longitudinal axis collinear with the vertical axis, the projection viewed from that side is a semicircle or an arc of a circle that forms the outer surface of the distal portion of the sheath at the projection, and is characterized by a diameter if the projection is a hemisphere, or by a length of the arc if it is a section of a sphere, and also by a thickness, which is the maximum distance between the inner and outer surfaces of the distal portion of the sheath at the projection, and the distance between the center of the hemisphere and the larger diameter proximal end of the proximal portion of the sheath.

[0046] The diameter or arc length may be 5-15 mm, preferably 7-16 mm, more preferably 9 mm. The thickness may be 3-20 mm, preferably 5-15 mm, more preferably 7 mm. If the protrusion is a hemisphere, the thickness of the protrusion is substantially equal to the diameter of the sphere. If the protrusion is a portion of a sphere, viewed from the side, the thickness of the protrusion is the chord height, preferably less than the diameter of the sphere. The distance between the center of the hemisphere and the proximal end of the larger diameter may be 15-25 mm, preferably 21 mm.

[0047] If the protrusions are beads, the beads, viewed from the side when the longitudinal axis of the glans sheath is collinear with the vertical axis, may have a shape according to a bell curve or a Gaussian curve, and the beads may be characterized by a height of 5-20 mm, preferably 5-15 mm, more preferably 9 mm. The thickness of the beads between the inner and outer surfaces may be 3-20 mm, preferably 5-15 mm, more preferably 7 mm.

[0048] Thus, the shape of the beads is a little more characteristic than a hemisphere. Moreover, while the beads go around the sheath in a continuous or discontinuous manner, the protrusions in the form of hemispheres or portions of spheres are merely "humps" that appear on one side of the sheath.

[0049] These dimensions make it possible to ensure effective fixation of the fastening system on the device without the risk of the device "slipping" relative to the foreskin.

[0050] According to another aspect, the present invention relates to a kit comprising the urinary diversion device of the present invention, a tube, and a urine collection bag.

[0051] The glans penis sheath of the urinary device may be manufactured, for example, by 3D printing, injection or extrusion. [Brief description of the drawings]

[0052] Other features, details and advantages will become apparent from reading the following detailed description and from examining the accompanying drawings in which the protrusions are shown as beads.

[0053] [Figure 1] FIG. 1 illustrates a side view of a glans penis sheath when the longitudinal axis is collinear with the vertical axis, according to one embodiment. [Diagram 2] 1 illustrates a cross-sectional view of a glans penis sheath when the longitudinal axis is collinear with the vertical axis, according to one embodiment. [Diagram 3] 1 shows a perspective view of a glans penis sheath according to one embodiment of the present invention. [Figure 4] FIG. 1 shows a front view through the distal end of the distal portion of the glans penis sheath of a urinary device according to one embodiment of the present invention, where the fastening system is a non-rigid fastening collar in the form of a cord that is fastened using a cord-lock type fastening button. [Diagram 5]FIG. 1 shows a side view of a urination apparatus when the longitudinal axis of the glans penis sheath is collinear with the vertical axis, according to one embodiment, where the fastening system is a rigid fastening collar including two articulating parts that close around the foreskin by a pin-type fastening system. [Figure 6] FIG. 1 shows a side view of the device when the longitudinal axis of the glans penis sheath is collinear with the vertical axis, according to one embodiment, where the fastening system is a clip system, the clip fastening the foreskin on the glans penis sheath upstream of the bead, and the clip actuation mechanism is located downstream of the bead and the fastening system is open. [Figure 7] A process diagram is shown in which the clip actuation mechanism is a ring that screws onto threads downstream of a bead on the distal portion of the glans penis sheath, such that when the ring is screwed, the clip clamps the patient's foreskin upstream of the bead. [Figure 8] FIG. 1 shows a side view of a urination device when the longitudinal axis of the glans penis sheath is collinear with the vertical axis, according to one embodiment, where the fastening system is a clip system, the clip spanning the proximal and distal portions and fastening the foreskin on the sheath, the clip actuation mechanism being located downstream of the beads, and the fastening system fastening the foreskin by a non-rigid fastening collar. [Figure 9] FIG. 1 shows a side view of a urinary diversion device when the longitudinal axis of the glans penis sheath is collinear with the vertical axis, where the fastening system is open and the fastening system is of the "skirt" type, according to one embodiment. [Figure 10] 11 shows a side view of FIG. 10 with the clamping system closed. [Figure 11] 11 shows a side view at the top and a top view at the bottom of a urination device when the longitudinal axis of the glans penis sheath is collinear with the horizontal, the fastening system including a fastening band coupled to a lever fixed for rotation to a distal portion of the glans penis sheath, in FIG. 11 the lever is in an open position. [Figure 12] 12 shows the same side view and the same top view as in FIG. 11, with the lever in the closed position. [Figure 13]12 shows the same side view and the same top view as FIG. 11, with the tightening band tightening around the glans penis sheath in the area spanning the proximal and distal portions. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0054] The urinary diversion device of the present invention includes a non-adhesive glans penis sheath 10. In this application, "non-adhesive" is understood to mean that the glans penis sheath is not attached to the patient's penis or glans penis by adhesive or medical glue.

[0055] Since the glans penis sheath 10 of the urination device of the present invention does not use adhesives or medical glue, the inventors needed to manufacture the glans penis sheath 10 with a specific shape and dimensions that allow the sheath to be optimally held on the patient's penis. To this end, the inventors devised an ingenious urination device that includes the glans penis sheath 10 and a fastening system that allows the patient's foreskin to be fastened onto the sheath.

[0056] [Glans penis sheath] The glans penis sheath 10 of the urination device comprises a proximal portion 11 and a distal portion 12. The proximal portion 11 of the glans penis sheath 10 is intended to be placed on the glans penis of a patient. The distal portion 12 of the glans penis sheath 10 is contiguous with the proximal portion 11. The distal portion 12 of the glans penis sheath is in material continuity with the proximal portion 11 and is intended to collect and drain urine towards a tube connected, for example, to a bag. The distal portion 12 therefore terminates in a connection portion 13 for attachment to such a tube.

[0057] The glans penis sheath 10 has a longitudinal axis that is an axis that is collinear with the height of the truncated cone on the inner surface of the proximal portion 11 of the glans penis sheath 10. In the remainder of this application, "vertical axis" is understood to mean an axis that is perpendicular to the ground and points upward. Thus, when the large diameter proximal end of the glans penis sheath 10 is resting on a flat surface, the longitudinal axis of the glans penis sheath 10 is collinear with the vertical axis.

[0058] Please refer to FIG. 1, which shows a side view of the glans penis sheath 10 when its longitudinal axis is collinear with the vertical axis. The glans penis sheath 10 may be characterized by different lengths. The total length L (proximal part + distal part) of the glans penis sheath, considered along its longitudinal axis, may be 15-60 mm, preferably 30-40 mm, more preferably 35 mm.

[0059] However, if the glans penis sheath 10 has a tube that is materially continuous with the distal part 12 of the sheath, in particular by being fixed to the connecting part 13, the total length L of the sheath can be much larger, for example up to 1 m.

[0060] Please refer to FIG. 2 which shows a glans penis sheath 10 including a proximal portion 11 and a distal portion 12, separated by a dashed line in the figure. The proximal portion 11 includes two surfaces, the inner surface being frusto-conical in shape and the outer surface forming slight ripples. The inner surface of the distal portion 12 has an advantageous inner surface with several narrowed regions. In particular, the inner surface of the distal portion 12 has an area of ​​approximately constant width forming a reservoir, immediately after the proximal portion 11 of the sheath, followed by an area that narrows to allow the drainage of urine from the reservoir.

[0061] Between its inner surface and its outer surface, the glans penis sheath 10 therefore has a thickness delimited, on the one hand, by the variation of the inner surface, and, on the other hand, by the variation of the outer surface. The thickness of the sheath 10 is therefore not necessarily constant. Since the inner surface follows a more or less complex shape, the outer surface of the sheath 10 also follows a certain shape. For example, the thickness of the sheath 10 can vary, at least in parts, for example to form small waves upstream of the bead B. Moreover, the thickness of the sheath 10 can be constant, except for the protrusions.

[0062] The proximal portion 11 may be made of a different material than the distal portion 12, or they may be made of the same material.

[0063] [Proximal part] When the patient places the inner surface of the proximal portion 11 of the glans penis sheath 10 over the patient's glans, the patient must first roll the patient's foreskin toward the pubic area. Once the proximal portion 11 of the sheath 10 is placed over the patient's glans, the patient unrolls the foreskin over the outer surface of the proximal portion 11 of the sheath 10.

[0064] The inner surface of the proximal portion 11 of the sheath 10 has a frustoconical shape characterized by a major diameter Dp, a minor diameter Dd at its distal end, and a height h. The major diameter Dp is at the proximal end of the proximal portion 11 of the sheath, while the minor diameter Dd is now at the distal end of the proximal portion 11 of the sheath. The frustoconical shape can be adapted to a multitude of glans shapes and can be easily adjusted to best suit the patient's morphology.

[0065] The major diameter Dp may be 7 to 25 mm, preferably 10 to 20 mm, and more preferably 20 mm.

[0066] The minor diameter Dd may be 5 to 10 mm, preferably 7 mm.

[0067] The height h of the truncated cone forming the proximal portion 11 of the sheath may be 5 to 25 mm, preferably 13 to 20 mm, and more preferably 17 mm.

[0068] The ratio of the maximum diameter Dp to the minimum diameter Dd of the truncated cone of the proximal part 11 of the sheath may be 1-3, more preferably 2.

[0069] The outer surface of the proximal portion 11 of the glans penis sheath may be of the same shape as the inner surface of the proximal portion 11 of the sheath, in which case the thickness between these two surfaces is constant.

[0070] In other cases, the thickness between the two surfaces can vary. In this case, the outer surface of the proximal portion 11 of the sheath may have variations, for example in the form of ripples. On the other hand, the outer surface, as well as the inner surface, includes a larger diameter at the proximal end of the proximal portion 11 of the urinary device and a smaller diameter at the distal end of the proximal portion 11, such that the proximal portion 11 of the sheath has approximately the shape of a truncated cone.

[0071] [Distal part] The inner and outer surfaces of the proximal portion 11 of the glans penis sheath are materially continuous with the inner and outer surfaces of the distal portion 12 of the sheath.

[0072] The inner surface of the distal portion 12 of the sheath is preferably funnel-shaped. The outer surface has a protrusion B, which is described in more detail below, on a portion of the outer surface.

[0073] The inner surface of the distal section 12 may also have some areas of narrowing at the distal end of the distal section 12, down to a minimal narrowing of 0.5-3 mm, preferably 1-4 mm, more preferably 3 mm.

[0074] The distal end of the distal part 12 of the glans penis sheath is intended to collect urine and direct it to the outside of the sheath, for example by being connected to a tube and then to a bag, in particular via a connection part 13. This connection part 13 can be a tube integrally formed with the distal part 12 or it can be a tube added to the distal part 12. The outer diameter of the tube can be 4-8 mm, in particular 5-7 mm, for example 6 mm. The inner diameter of the tube can be 1.5-3.5 mm, in particular 2-3 mm, for example 2.5 mm.

[0075] [Protrusion] The glans penis sheath 10 of the urination device of the present invention is characterized in that the outer surface of the distal portion 12 of the sheath has an outward projection B located a predetermined distance d from the proximal end of the larger diameter Dp of the sheath, whereby the fastening system fastens the patient's foreskin upstream of the projection B on a portion C spanning the proximal and distal portions 12, the upstream being the portion closest to the larger diameter proximal end and the downstream being the portion closest to the smaller diameter end of the sheath.

[0076] The protrusion B makes it possible for the clamping system to clamp the foreskin upstream of the protrusion B. The protrusion B makes it possible, for example, to ensure that the clamping system does not slide along the sheath. Depending on the predetermined distance d, it makes it possible for the patient to have a glans penis sheath 10 that is perfectly adapted to his morphology. Thus, a patient with a longer than average foreskin can choose a sheath in which the predetermined distance d is longer than average.

[0077] The protrusion B is, for example, a "hump" located on the outer surface of the distal part of the sheath. The hump is a hemisphere-like volume characterized by a center and a diameter. In this case, the predetermined distance d is the distance between the center of the hemisphere and the proximal end of the sheath, projected onto the height of the truncated cone of the sheath (and thus follows the longitudinal axis of the truncated cone). In addition to the predetermined distance d, the diameter I of the hemisphere can also be adjusted, for example, depending on the tightening system implemented.

[0078] According to one embodiment of the present invention, the protrusion is a continuous or discontinuous circular bead B, which is arranged on a disk that perpendicularly intersects the distal part of the glans penis sheath when the glans penis sheath is viewed from the side where the longitudinal axis of the cone is collinear with the vertical axis.

[0079] A discontinuous bead B can for example increase the breathability of the foreskin. A continuous bead B can optimize the fixation of the sheath to the foreskin by the fastening system. A compromise between these two effects can be chosen.

[0080] Reference is now made to FIG. 2, which shows a cross-sectional view of a urinary diversion device according to the invention, in an embodiment in which the projections B are continuous beads, where the longitudinal axis of the glans penis sheath is collinear with the vertical axis.

[0081] Viewed in cross section, the bead B can correspond, for example, to a so-called bell curve or a Gaussian curve or a parabola. The skilled person is able to select the curve that allows optimal fixation of the fastening system upstream of the bead.

[0082] The bead B is defined by its thickness e, its height I, and its predetermined distance d from the proximal end of the larger diameter of the glans penis sheath. Thus, the bead may be characterized by a height I of 5-20 mm, preferably 5-15 mm, more preferably 9 mm, a thickness e of the bead between the inner and outer surfaces which may be 3-20 mm, preferably 5-15 mm, more preferably 7 mm, and a distance d from the proximal end of the larger diameter of the glans penis sheath of 15-25 mm, preferably 21 mm.

[0083] The thickness e is the thickness between the inner and outer surfaces of the distal part of the glans penis sheath forming the bead. This thickness can be solid (e.g. a single material forming the sheath) or this thickness can be filled with air, for example to lighten the weight of the sheath. Furthermore, the outer surface of the bead can be rigid or non-rigid. If the bead is non-rigid, the user can deform it, for example by pressing it. This can make it easier to adapt to a particular fastening system, for example.

[0084] Reference is now made to FIG. 3, which shows a perspective view of a sheath according to an embodiment of the present invention, in which the protrusions B are continuous beads. FIG. 3 shows a proximal end of a larger diameter Dp, intended to be placed on the glans penis of a patient, and a bead B placed at a predetermined distance from the proximal end Dp. Between the bead B and the proximal end Dp, the glans penis sheath has a recess C spanning the proximal and distal portions. When placed on the glans penis, the patient's foreskin rolls onto the outer surface of the proximal portion of the sheath (upstream of the protrusions B, which in this embodiment are beads). The foreskin is then received in the recess C formed upstream of the bead B.

[0085] The recess C is a result of the frusto-conical shape of the inner surface of the proximal portion 11 of the glans penis sheath, and the location of the protrusions spanning the proximal portion 11 and the distal portion 12. The foreskin is received in this recess and a tightening system holds the glans penis sheath 10 onto the glans of the patient's penis.

[0086] [Tightening system] Several fastening systems have been devised by the inventors to hold the patient's foreskin to the glans penis sheath of the urinary diversion device of the present invention.

[0087] [Non-rigid fastening collar] Referring to FIG. 4, which shows a front view through the small-diameter distal end of the glans penis sheath of a urinary device according to an embodiment of the present invention, the fastening system 100 is a non-rigid fastening collar in the form of a cord that is fastened using a cord-lock type fastening button 110. However, the non-rigid fastening collar may also be, for example, a touch-and-close band, or a cord that closes using a push button, or an elastic circular band, or a flexible magnet in the form of a band, or a cord that closes by magnets (especially elastic). In the case of a cord that closes by a push button, to ensure adaptability, the cord may be elastic or may have multiple female push button portions along the cord and a single male push button portion at the end of the cord, or multiple male push button portions along the cord and a single female push button portion at the end of the cord.

[0088] Once the patient's foreskin is spread over the exterior surface of the glans penis sheath, upstream of the protrusion, the user places the cord upstream of the protrusion and tightens the foreskin using the cord-lock type 110 tightening button. The cord-lock type tightening button allows for easy adjustment of tightness throughout the day to accommodate different morphologies of the patient's penis.

[0089] The cord 100 is fully visible in Figure 4 for ease of understanding the invention. In reality, the portion of the cord that tightens around the foreskin will be at least partially hidden by the protrusions when the glans penis sheath is viewed from the front through the smaller diameter distal end.

[0090] [Rigidity tightening collar] Referring now to FIG. 5, which is a side view of the urinary diversion device of the present invention when the longitudinal axis of the glans penis sheath is collinear with the vertical axis, according to one embodiment, the fastening system is a rigid fastening collar including two articulating portions 210 and 220 that are closed around the foreskin by a hook-and-loop band or a pin-type fastening system.

[0091] The fastening system is practical to implement, can be easily cleaned or sterilized, and has a long life.

[0092] [Clip system] Referring now to FIG. 6, which shows a side view of a urinary diversion device when the longitudinal axis of the glans penis sheath is collinear with the vertical axis, according to one embodiment, the fastening system is a clip system, the clip 310 of which fastens the foreskin on the sheath upstream of the beads, and the actuation mechanism 320 of the clip is located downstream of the beads and the fastening system is open.

[0093] FIG. 6 shows an embodiment in which the actuation mechanism 320 of the clip is a spring actuation system. The fastening system may further include two prongs 330, which allow the user to open the clip by applying pressure to the prongs 330. When the pressure is released, the elastic force of the spring fastens the foreskin at the recess C, upstream of the bead B, where the unfolded foreskin is located on the sheath. By adjusting the elastic force of the spring, the fastening of the patient's foreskin on the sheath can be adjusted. The fastening system may be integral with the sheath, or it may be possible to replace the fastening system. For example, the fastening system is glued, clipped or even screwed to the glans penis sheath by a ring 340 arranged downstream of the bead B.

[0094] The end of the clip 310 that contacts the foreskin to clamp it over the glans penis sheath may include a magnet for magnetically locking with another magnet later provided in or on the sheath. The magnet may replace or augment the clip's actuation mechanism, which uses, for example, a spring 320.

[0095] 7, which shows another embodiment, the actuation mechanism of the clip is no longer a spring-activated mechanism or one that includes a protrusion that the user can press, but a ring 420 that screws onto a thread downstream of the bead or clips into a notch downstream of the bead, such that when the ring is screwed or clipped onto the bead, the clip 310 clamps the patient's foreskin upstream of bead B. Again, the clip clamps the foreskin upstream of bead B, spanning the proximal and distal portions, at a recess C present on the sheath.

[0096] The two embodiments shown in Figures 6 and 7 can be combined with the embodiment defined above and shown in Figure 8, in which the clip 310 is held tightly around the foreskin by a non-rigid tightening collar 100.

[0097] ["Skirt" type system] 9 and 10, which show one embodiment of the present invention, the fastening system is of the so-called "skirt" type and includes a first circular elastic band 510 positioned downstream of the bead B, and a non-rigid fastening collar 100 positioned to fasten the patient's foreskin upstream of the bead B, the first elastic band 510 and the non-rigid fastening collar 100 being interconnected by a fine fabric 530, such as silk or cotton or silicone woven fabric.

[0098] The user fits the fastening system into place by sliding it over the glans sheath, pulling the elastic band to enlarge, and positioning the first circular elastic band 510 over the sheath so that it tightens the sheath downstream of bead B and the non-rigid fastening collar 100 tightens the foreskin upstream of bead B.

[0099] [Non-rigid clamp collar coupled to lever] 11-13, which illustrate one embodiment, tightening system 600 is a non-rigid tightening collar 620, such as a tightening band, coupled to lever 610.

[0100] The lever 610 is rotatably attached to the glans penis sheath, in particular to the distal end of the glans penis sheath, such that the rotation axis 611 is perpendicular to the longitudinal axis of the glans penis sheath. Thus, the lever 610 extends from the surface of the glans penis sheath, for example from the distal end of the glans penis sheath to a free end. The rotation axis 611 is typically located below the connection part 13 for connecting to the liquid discharge tube of the glans penis sheath 10.

[0101] The lever 610 comprises a closed position (or further lowered position, see Figs. 12, 13, 15 and 16) in which it is adjacent to and extends along the glans penis sheath. In particular, it is in this position that its free end is closest to the surface of the glans penis sheath. The shape of the lever is selected such that in this closed position, the lever is as close as possible to the surface of the glans penis sheath. Thus, the lever comprises, along its extent from its attachment point 611, a projecting portion 612 (corresponding to a protruding portion) that deviates from the longitudinal axis of the glans penis sheath, and a recess 613 (corresponding to a region spanning the proximal and distal portions) that is close to the longitudinal axis of the glans penis sheath.

[0102] Furthermore, in this position, the recess 613 forms a gap across the span C, preferably 0.5-5 mm. This gap corresponds to the thickness of the foreskin. Typically, the lever 610 and the glans penis sheath together form a gap of 0.5-5 mm along the entire length of the glans penis sheath. Preferably, this gap is constant all along the glans penis sheath.

[0103] The lever 610 also has a maximum open position (or fully raised position, see Figures 11 and 14) in which its free end is furthest from the surface of the glans penis sheath. Maximum openness can be obtained when the intermediate axis 61A of the lever 610 and the longitudinal axis of the glans penis sheath form an angle of 10 to 80°.

[0104] The material of the lever 610 can be one of the above-mentioned materials of the glans penis sheath. Preferably, the material of the lever and the material of the glans penis sheath are the same.

[0105] The non-rigid fastening collar 620 is fixed at one end to the lever 610, in particular to the recess 613 thereof, and is free at its other end. The non-rigid fastening collar 620 may be elastic or non-elastic. The non-rigid fastening collar 620 is adapted to close on itself after encircling the glans penis sheath (see Figures 13 and 16).

[0106] Preferably, the non-rigid tightening collar 620 has the shape of a band, in particular with a length to width ratio of greater than 5. The width is preferably between 2 and 10 mm.

[0107] In use, after placing the tip of the glans penis on the proximal portion of the glans penis sheath and spreading the foreskin over the exterior surface of the proximal portion to the extent of the region C spanning the proximal and distal portions, the user lowers the lever 610 to the closed position, then grasps the non-rigid fastening collar 620 located opposite the spanning region C and circles it around the spanning region C of the glans penis sheath, securing the free end of the non-rigid fastening collar 620.

[0108] Fastening can be done in several ways: by fastening the non-rigid fastening collar 620 to itself, or by fastening the non-rigid clamp collar 620 to the lever 610. If the non-rigid fastening collar 620 fastens to itself, it may include a touch-and-close system or a push button. If the non-rigid fastening collar 620 fastens with the lever 610, the fastening may be a hook-loop or hook-hook system, in which case the non-rigid fastening collar is preferably elastic.

[0109] When the user wishes to remove the system, they release the non-rigid clamping collar 620 and then raise the lever 610. It is not necessary to raise the lever 610 to its maximum open position, a few rotations may be sufficient to release the foreskin.

[0110] 〔kit〕 According to a final aspect, the present invention relates to a kit comprising the above-mentioned urinary diversion device, a tube and a urine collection bag. The tube can be fixed to the small-diameter distal end of the glans penis sheath by screwing, gluing or embedding. Moreover, the tube and the glans penis sheath can be integrated and made in the same mould.

Claims

1. A urination device comprising a non-adhesive glans penis sheath for urination and a fastening system, the glans penis sheath includes a proximal portion for receiving the patient's exposed glans penis, the proximal portion of the glans penis sheath having frusto-conical inner and outer surfaces, each of the inner and outer surfaces including a distal end having a smaller diameter and a proximal end having a larger diameter; the fastening system is configured to hold the patient's foreskin spread over the exterior surface of the proximal portion of the glans penis sheath; The glans penis sheath includes a distal portion contiguous with the proximal portion, the distal portion having an outer surface with protrusions such that when the foreskin is spread, the foreskin is retained by the fastening system in a region spanning the proximal and distal portions.

2. 2. The urinary diversion device of claim 1, wherein the protrusions are continuous or discontinuous circular beads arranged on a disk that perpendicularly intersects the distal portion of the sheath when the sheath is viewed from a side where the axis of the cone is collinear with the vertical axis.

3. 3. A urinary diversion device according to claim 1 or 2, wherein the fastening system is a non-rigid, in particular an adaptable fastening collar, for example a touch-and-close band, or a cord which is fastened by a fastening button of the cord-lock type, or a cord which is closed by a push button, or an elastic circular band, or a flexible magnet in the form of a band, or a cord which is closed by a magnet (in particular elastic).

4. 3. The urinary diversion device of claim 1 or 2, wherein the fastening system is a rigid fastening collar including two articulating parts that close around the foreskin, for example by a touch-and-close fastener, a magnetic fastener, or a pin-type fastening system.

5. 3. The urination device according to claim 1, wherein the fastening system is a clip system, the clip spanning the proximal and distal portions of the sheath and fastening the foreskin over the glans penis sheath upstream of the protrusion, and an actuation mechanism of the clip is located downstream of the protrusion in the distal portion of the sheath.

6. The urinary diversion device of claim 5 , wherein the actuation mechanism of the clip is a spring actuation system.

7. 6. The urinary diversion device of claim 5, wherein the end of the clip that contacts the foreskin to fasten the foreskin over the glans penis sheath includes a magnet that magnetically engages with another magnet provided in or on the sheath.

8. 6. The urination device of claim 5, wherein the actuation mechanism of the clip is a ring that screws onto a thread on the distal portion of the glans penis sheath or clips into a notch on the distal portion of the glans penis sheath, such that when the ring is screwed or clipped downstream of the protrusion, the clip clamps the patient's foreskin upstream of the protrusion.

9. 7. A urinary diversion device as claimed in claim 5 or 6 in combination with claim 3, wherein the clip is tightened and held around the foreskin by a non-rigid tightening collar as claimed in claim 3.

10. The urination device according to claim 1 or 2 in combination with claim 3, wherein the fastening system is of a "skirt" type including a first circular elastic band downstream of the protrusion and a non-rigid fastening collar according to claim 3 arranged to span the distal and proximal portions of the glans penis sheath and fasten the patient's foreskin upstream of the protrusion, and the first elastic band and the non-rigid fastening collar are connected to each other by a fine fabric such as silk or cotton or silicone woven fabric.

11. a lever rotatably attached to the glans penis sheath such that an axis of rotation is perpendicular to a longitudinal axis of the glans penis sheath and having a closed position extending along the glans penis sheath; The urinary diversion device of claim 3 , wherein the non-rigid tightening collar is secured to the lever and adapted to close on itself to encircle the glans penis sheath.

12. 12. The urination device of claim 11, wherein the lever includes, along an extent of the lever from a point of attachment of the lever to the glans penis sheath, a protruding portion that deviates from the longitudinal axis of the glans penis sheath and corresponds to the protrusion, and a recess that approaches the longitudinal axis of the glans penis sheath and corresponds to the region spanning the proximal portion and the distal portion.

13. The urinary diversion device of claim 12, wherein the non-rigid tightening collar is secured to the recess in the lever.

14. The urination device according to any one of claims 1 to 13, wherein the glans penis sheath is made from a material selected from polyvinyl chloride, silicone, polyethylene, polystyrene, polypropylene, polyethylene terephthalate, polyacrylate, polymethylacrylate, and polyurethane, and the outer surface of the glans penis sheath is made from a material selected from polyvinyl chloride, silicone, polyethylene, polystyrene, polypropylene, polyethylene terephthalate, polyacrylate, polymethylacrylate, and polyurethane.

15. The urinary diversion device according to any one of claims 1 to 14, wherein the glans penis sheath is washable and sterilizable.

16. The urination device according to any one of claims 2 to 15, wherein the protrusions are beads having a shape that follows a bell curve or a Gaussian curve when viewed from a side when the longitudinal axis of the glans penis sheath is collinear with a vertical axis, and the beads have a height of 5 to 20 mm, preferably 5 to 15 mm, more preferably 9 mm, and a thickness between the inner and outer surfaces of 3 to 20 mm, preferably 5 to 15 mm, more preferably 7 mm.

17. The urination device according to any one of claims 1 to 16, wherein the length of the proximal portion of the glans penis sheath having a frustum-shaped inner surface may be 5 to 25 mm, preferably 13 to 20 mm, more preferably 17 mm, and the ratio of the major diameter of the inner surface of the proximal portion of the glans penis sheath to the minor diameter of the distal end of the proximal portion of the glans penis sheath is 1 to 3, more preferably 2.

18. A kit comprising the urination device according to any one of claims 1 to 17, a tube, and a urine collection bag.

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