WO2013075723A1

WO2013075723A1 - Incontinence device

Info

Publication number: WO2013075723A1
Application number: PCT/DK2012/050430
Authority: WO
Inventors: Niels Erikstrup; Henrik Harboe
Original assignee: Magcath Aps
Priority date: 2011-11-23
Filing date: 2012-11-23
Publication date: 2013-05-30

Abstract

The present invention relates to an incontinence device that may comprise a flexible body having a first end and an opposite, second end, the flexible body defining an oblong geometry, a urine outlet being formed at the first end of the flexible body, a urine inlet being formed at the second end of the flexible body, a channel connecting the urine inlet and the urine outlet allowing fluid to flow between the urine inlet and the urine outlet, a closure device configured for selectively either allowing fluid to flow through the urine outlet or to hinder fluid to flow through the urine outlet, a first member and a second member being mutually magnetically attractive, the first member being connected to the flexible body and the second member being connected to the closure device so that when the closure device is to hinder fluid to flow through the urine outlet the magnetic force between the first member and the second member provides sufficient force for sealing.

Description

Incontinence device

FIELD OF THE INVENTION

The present invention relates to a device for use by persons suffering from incontinence, especially women suffering from incontinence. The device according to the present invention is suited for flow control in the urethra.

BACKGROUND OF THE INVENTION

Incontinence is the inability of any of the physical organs to restrain discharges of their contents; in the presence context incontinence is considered the involuntary discharge or evacuation of urine. This could e.g. be during movement, such as jumping, or when sneezing or laughing that persons suffering from incontinence experience problems. Persons suffering from incontinence are often compelled to wear a pad for collecting urine being discharged from the urethra. Also persons suffering from incontinence may experience that the discharge of urine causes unwanted odours, which may cause the person to feel uncomfortable and embarrassed. Therefore there is a need for a device hindering uncontrolled discharge of urine.

It is a further object of the present invention to provide an alternative to the prior art.

SUMMARY OF THE INVENTION

Thus, the above described object and several other objects are intended to be obtained in a first aspect of the invention by providing an incontinence device comprising a flexible body having a first end and an opposite, second end, the flexible body defining an oblong geometry, a urine outlet being formed at the first end of the flexible body, a urine inlet being formed at the second end of the flexible body, a channel connecting the urine inlet and the urine outlet allowing fluid to flow between the urine inlet and the urine outlet, a closure device configured for selectively either allowing fluid to flow through the urine outlet or to hinder fluid to flow through the urine outlet, a first member and a second member being mutually magnetically attractive, the first member being connected to the flexible body and the second member being connected to the closure device so that when the closure device is to hinder fluid to flow through the urine outlet, the magnetic force between the first member and the second member provides sufficient force for sealing. Further the magnetic force between the first member and the second member may help to hold the closure device in position. The closure device may be attached to the flexible body by at least one attachment member. When the closure device allows fluid to flow through the urine outlet, the closure is said to be in an open state. When the closure device hinders fluid to flow through the urine outlet, the closure device is said to be in a closed state.

The incontinence device is to be inserted in the urethra, thereby the device will block the urethra and no urine will be uncontrollably discharged. It would be inconvenient for a user of the incontinence device to remove the entire

incontinence device when the person wishes to discharge the urine in the bladder. Therefore a channel is provided in the body of the incontinence device. The channel is in communication with an inlet, to be positioned so as to receive urine from the bladder, and the channel is also in communication with a urine outlet to be positioned at the outer part of the urethra . Further a closure device is provided so that the user may selectively choose if the closure device hinders urine to flow or not.

The closure device may be adapted or configured so that when the closure device is to hinder fluid to flow through the urine outlet, the magnetic force between the first member and the second member secures the sealing. Either the first member or the second member may be magnetic. Alternatively both the first member and the second member may be magnetic. Advantageously the mutual attraction between the first and second member may be achieved by one or both of the members having permanent magnet properties in at least part of their volume. Generally a permanent magnet is a material that is magnetized and creates its own persistent magnetic field. Permanent magnets may be manufactured from materials, such as alnico and ferrite that are subjected to special processing in a magnetic field during manufacture, so as to align their internal microcrystalline structure, making them very hard to demagnetize. Other potential permanent magnet materials include rare-earth magnets like samarium-cobalt and neodymium-iron-boron magnets. The alnico magnets resist corrosion but other aspects and trade-offs might make the alternatives more attractive.

The shaping of the magnets may be made by casting, sintering or injection- moulding. Sintering offers superior mechanical characteristics, whereas casting delivers higher magnetic field strengths and allows for the design of intricate shapes. Another way to shape the magnets is by injection-moulding. Injection- moulded magnets may be a composite of various types of resin and magnetic powders, allowing parts of complex shapes, e.g. the closure device, to be manufactured by injection moulding. The physical and magnetic properties of an injection moulded product depend on the raw materials, but generally offer lower magnetic strength and may resemble plastic materials in their physical properties. It is also possible to produce flexible magnets if so desired . Flexible magnets may be considered similar to injection-moulded magnets, using a flexible resin or binder such as polyurethane or medical grade silicone. These types of magnets have lower magnetic field strength but may be very flexible, depending on the binder used.

The choice of the permanent magnet design for the members may depend on factors such as manufacturability, cost, appearance, corrosion and user comfort.

Advantageously the incontinence device may include a protrusion at the outlet and a mating part on the closure device so as to hold the closure device in position. This provides a mechanical force to keep the closure device in the closed state when the incontinence device is in use. Further advantageously, the magnetic force and the mechanical force provides a secure sealing of the outlet.

The flexible body allows for the incontinence device to adapt to any changes in the urethra. Further, the flexibility of the flexible body allows for a comfortable insertion of the device compared to a rigid device. Still further, the urethra may not be entirely straight.

Advantageously the flexible body comprises a protruding part at the second end configured for engaging the inner wall of a bladder or urethra when the incontinence device is positioned in a urethra. This is contemplated to provide a grip force so that the device is kept in place. As will be discussed later, the flexible body may be lengthened so as to reduce the width or diameter of the device, especially at the protruding part, so as to allow the device to pass through the urethra in the process of positioning the device.

Advantageously the opening, or urine inlet, at the second end is formed either in the protruding part or in an area closer to the second end .. This allows the device to be kept in place as discussed above and provides an inlet that is not, or at least less likely, to be blocked by the wall of the bladder.

Advantageously the flexible body has a cylindrical-shaped outer surface located between the urine outlet and the urine inlet. The cylindrical-shaped section or outer surface preferably includes the majority of the channel. The cylind rical- shaped section is contemplated to be the most comfortable geometry of the device, alternatively an elliptical cross-section or outer surface may be used. Further, a conically shaped geometry may be used . A flexible body having a conical geometry may be more confortable for some persons, e.g. women, as their uthera often have a slightly conical shape. By providing a device having a matching conical, or nearly matching, geometry it is contemplated that discomfort is reduced and risk of the device of loosening or falling out is reduced.

Advantageously the protruding part is flexible so that when the flexible body is stretched lengthwise, the maximum width of the protruding part is reduced. This allows a more comfortable insertion and/or removal of the device in the urethra. It has been shown that the length from the urethra opening to the inner rim of the bladder is typically in the range 1,3 cm to 5,5 cm with a median length of 3,0 cm . Thus the incontinence device may advantageously be supplied to fit in urethras having these lengths. A set of incontinence devices having a range of lengths may be supplied in one package so that medical staff may chose the most appropriate size having the best fit to a specific patient.

Advantageously the flexible body has an overall length so that the first end of the flexible body extends from the external wall of the urethra when the incontinence device is mounted in a urethra. As discussed above, a number of devices having different lengths may be provided to e.g. a urologist so that an appropriate size device may be provided to a specific patient.

The circumference of the device intended to be located in the urethra may be measured according to the French scale or French gauge system which is commonly used to measure the size (outside circumference) of a catheter. It is most often abbreviated as Fr. It may also be abbreviated as CH or Ch (for Charriere, its inventor) in French speaking countries. 1 Fr = 1/3 mm . Catheters for females generally come in French sizes 8Fr-24Fr, where 10-14Fr is the most common.

Advantageously a coating may be applied to the outer surface of the incontinence device. The coating may be a bacterial reducing agent so as to reduce the risk of e.g. urinary tract infection (UTI). A urinary tract infection is a bacterial infection that may affect any part of the urinary tract. Symptoms include frequent feeling and/or need to urinate, pain during urination, and cloudy, foul smelling urine. The main causal agent is Escherichia coli. Although urine contains a variety of fluids, salts, and waste products, it does not usually have bacteria in it, but when bacteria get into the bladder or kidney and multiply in the urine, they may cause a UTI.

The most common type of UTI is acute cystitis often referred to as a bladder infection. An infection of the upper urinary tract or kidney is known as

pyelonephritis, and is potentially more serious. Although they cause discomfort, urinary tract infections can usually be easily treated with a short course of antibiotics with no significant difference between the classes of antibiotics commonly used.

Advantageously the closure device is attached to the flexible body by at least one flexible part. This may e.g . be in the form of a string or band. The flexible part may be formed integrally with the flexible body. The flexible part may ensure that the closure device is not lost when the user opens or removes the closure device from the closed position. The attachment member may be formed by at least one flexible part being integrally formed with the flexible body. The attachement member may comprise parts with different flexibility, e.g. some parts may be more rigid than others. The attachment member may be formed by severals pa rts.

Advantageously the flexible body comprises a rim at the first end for engaging the closure device so as to establish a seal when no fluid is to flow through the urine outlet. This rim constitutes a contact surface for the closure device.

Advantageously the first member is attached at the second end of the flexible body so that a lengthwise displacement of the first member causes elongation or shortening of the flexible body so that the maximum width, i.e. diameter, of the protruding part is reduced or enlarged. This is useful when the incontinence device is to be inserted in the urethra. When the incontinence device has a reduced cross-section, i.e. diameter, it is easier to position the device in the urethra. When the maximum diameter of the device is to be reduced, the displacement is preferably along the length of the device and preferably a force on or via the first member is applied in the direction from the urine outlet towards the urine inlet. When the force is no longer applied the flexible body returns to the original shape, provided the urethra does not deform it. Advantageously the first member may be positioned in the channel of the flexible body, the first member has an elongated geometry having a first end and a second end, the second end of the first member being attached at the second end of the flexible body, and the first end of the first member being positioned at the urine outlet. In one form the first member has a pin-shaped geometry, the first member may alternatively have a circular or elliptical or square or rectangular cross-section or even a helical geometry and/or be hollow, or a cylindrical/tubular geometry. The fastening or mounting of the second end of the first member to the flexible body provides the possibility to apply a force to the first end of the flexible body from the outside of the urethra, so that the flexible device elongates, the protruding part's diameter is reduced and so that the insertion is made easier.

Advantageously the second member may be embedded in the flexible body at the first end in the rim . This allows a close, secure and firm contact between the two members, using the magnetic force. Advantageously the second member may have the form of a metal ball or metal cylinder or metal sphere or metal box. The use of the metal allow for one of the members to be magnetic or magnetisable and thus uses magnetic force to keep the closure device in position. Advantageously the second member may have the form of a magnetic ball or magnetic cylinder or magnetic sphere or magnetic cube or magnetic box.

Advantageously the closure device comprises a coating layer for reducing corrosion of the closure device and/or for reducing deposits and/or biofilms and/or for improving cleaning and/or for improving biocompatibility. As the closure device is exposed to a range of things, e.g. urine may be either acidic or alkaline, where e.g. persistent alkaline urine (pH 7 - 8) suggests urinary tract infection. If a metallic material is used this may corrode the closure device, which the user is not likely to find attractive and may further lead to agglomeration of material which again may lead to increased risk of infection.

Advantageously the coating layer may be a layer of polymer coat, e.g. silicone or Teflon or a metal coat including a non-corroding metal, such as silver or gold. The layer may be relatively thin compared to the size of the closure device.

Advantageously the flexible body is made from medical grade silicone or poly urethane. The specific choice of material may depend on a number of factors such as manufacturing methods, biocompatibility etc.

The invention is particularly, but not exclusively, advantageous for obtaining a device that reduces the inconvenience or nuisance of a device being placed in the urinary tract, and which at the same time provides a secure seal so as to efficiently reduce the amount of urine unintentionally discharged.

These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE FIGURES The incontinence device according to the invention will now be described in more detail with regard to the accompanying figures. The figures show one way of implementing the present invention and is not to be construed as being limiting to other possible embodiments falling within the scope of the attached claim set.

Fig. 1 is a schematic illustration of an incontinence device,

Fig. 2 is a schematic illustration of a step of placing an incontinence device into a urethra,

Fig. 3 is a schematic illustration of a last step of placing an incontinence device into a urethra,

Fig. 4 is a schematic illustration of an incontinence device in a discharge state, Fig. 5 is a schematic illustration of an incontinence device in a sealed state, Fig. 6 is a schematic illustration of an incontinence device in a discharge state, Figs. 7-15 are schematic illustrations of outlet portions of incontinence devices, Figs. 16- 18 are schematic illustrations of inlet portions of incontinence devices, Figs. 19-24 are schematic illustrations of embodiments of variations in the outer geometry of incontinence devices,

Fig. 25 schematically illustrates a step in removing an incontinence device from a urethra,

Fig. 26 is a schematic view of an inlet portion of an incontinence device in a sealed state,

Fig. 27 is a schematic view of an inlet portion of an incontinence device in a sealed state,

Fig. 28 is a schematic view of an inlet portion of an incontinence device in a sealed state,

Fig. 29 is a schematic view of an incontinence device in a bend state,

Fig. 30 is a schematic view of an incontinence device in a bend state,

Fig. 31 is a schematic view of an inlet portion of an incontinence device in a sealed state,

Fig. 32 is a schematic view of an incontinence device in a sealed state,

Fig. 33 is a schematic view of an incontinence device in an open state,

Fig. 34 is a schematic view of an outlet portion of an incontinence device, Fig. 35 is a schematic view of an incontinence device in an open state,

Fig. 36 is a schematic view of an inlet portion of an incontinence device in a sealed state, and Fig. 37 is a schematic view of an inlet portion of an incontinence device in an open state.

DETAILED DESCRIPTION OF EMBODIMENTS

Fig. 1 is a schematic illustration of an incontinence device 10. The incontinence device 10 comprises a flexible body having a first end 12 and an opposite, second end 14. The flexible body has an overall oblong geometry. The incontinence device 10 comprises a urine outlet 16 being formed at the first end 12 of the flexible body. The incontinence device 10 comprises a urine inlet 18 being formed at the second end 14 of the flexible body. The incontinence device 10 comprises a channel 20 connecting the urine inlet 18 and the urine outlet 16 allowing fluid, i.e. mainly urine, to flow between, or from, the urine inlet 18 and to the urine outlet 16. The incontinence device 10 comprises a closure device 22 configured for selectively either allowing fluid to flow through the urine outlet 16 or to hinder fluid to flow through the urine outlet 16. The incontinence device 10 comprises a first member 24 and a second member 26 being mutually magnetically attractive, the first member 24 being connected to the flexible body and the second member 26 being connected to the closure device 22 so that when the closure device 22 is to hinder fluid to flow through the urine outlet 16, the magnetic force between the first member 24 and the second member 26 holds the closure device 22 in position.

Using the magnetic force to keep the closure device 22 in place is advantageous in that it is easy for the user to seal the incontinence device 10, e.g . compared to solutions where the closure device 22 includes a thread for establishing a seal. The embodiments described herein also have the advantage that the closure device 22 may be relatively easily opened and/or closed by the user when the incontinence device 10 is placed in the urethra.

In the embodiment illustrated in Fig. 1 the flexible body is made from one piece. This is contemplated to be advantageous compared to a more complex assembly if the flexible body comprised a number of parts. It is, however, possible to produce a flexible body in two or more parts if desired. The flexible body may advantageously be produced in one operation of an injection moulding station or using similar techniques.

The incontinence device 10 comprises a protruding part 28 at the second end 14. 5 The protruding part 28 is configured for engaging the inner wall of a bladder, see later figures 3, 4, 5 or 6, when the incontinence device 10 is positioned in a urethra. The protruding part 28 comprises a first sidewall 30 and a second sidewall 32. The second sidewall 32 is in this embodiment the part that for the most part abuts the inner wall of a bladder, see Fig. 3 or 4. The diameter of the 10 protruding part 28 is larger than the expected diameter of the urethra of the

patient when the incontinence device 10 is in a relaxed state or when positioned in the urethra of the patient.

As the body of the incontinence device 10 is flexible, the diameter of the

15 protruding part 28 may be reduced. As is seen in Fig. 2 the overall length of the incontinence device 10 may be increased, thereby reducing the diameter or cross- section of the device, especially interesting is the reduction in the cross-section of the protruding part 28 as this reduction allows the device 10 to pass through the urethra 34. Thus the protruding part 28 is flexible so that when the flexible body 20 is stretched, the maximum width of the protruding part 28 is reduced.

In general the opening, i.e. the urine inlet, at the second end 14 may be formed at one distance from the second end of the incontinence device 10 and the protruding part 28 may be formed at another, larger, distance from the second 25 end of the incontinence device 28, i.e. so that the urine inlet will be at a distance from the bladder wall 36 such as illustrated in e.g. Fig. 3.

In Fig. 1 it is seen that the flexible body has a cylindrical-shaped section 38 between the urine outlet 16 and the urine inlet 18. The cylindrical-shaped section 30 38 has in this embodiment a circular cross-section, but may in other embodiments have e.g. an elliptical cross-section.

Generally the incontinence device 10 has an overall length so that first end of the flexible body extends from the external wall 40 of the urethra when the incontinence device 10 is mounted in a urethra 34. This is seen e.g. in Figs. 3 and 4.

Fig. 2 schematically illustrates a step in the process of inserting or positioning the incontinence device 10 in the urethra 34. A support device 42 having a handle 44 is used. The closure device has been omitted for simplifying the view and is thus not visible in Figs. 2 and 3. The support device 42 engages the first member 24. This causes elongation of the flexible body so as to reduce the cross-section of the incontinence device 10, which eases the inserting of the device 10. The

incontinence device 10 may be removed from the position in the urethra by pulling the closure device 22, as illustrated and discussed in relation to Fig. 25.

In Fig. 1, and other figures, it may be seen that the first member 24 is attached at the second end of the flexible body so that displacement of the first member 24 towards the second end causes elongation of the flexible body so that the maximum width of the flexible body is reduced. The first member 24 is positioned in the channel 20 of the flexible body. The first member 24 has an elongated geometry having a first end and a second end. The second end of the first member 24 is attached at the second end of the flexible body, and the first end of the first member is positioned at the urine outlet.

The first member 24 is retained centred in the channel by the centrering device 25. The centrering device 25 supports a part of the first member 24 so that it is substantially centred and thereby the likelihood for the second member 24 and the closure device 22 to engage is maximized. In other embodiments a spiral- or helix-shaped device may be used. The device 25 for centrering the second member 24 should not hinder flow of urine too much. The device 25, and other corresponding devices for this use, must be shaped so that it introduces a minimal pressure drop, i.e. has a low flow resistance.

In other embodiments the centrering of the first member 24 may be achieved by protrusions on the inner wall of the channel 20, such as a helical support or multiple, relatively short, protrusions keeping the first member 24 in the intended position relative to the channel 20. Fig. 3 schematically illustrates a step in the process of inserting or positioning the incontinence device 10 in the urethra 34. Here the incontinence device 10 is in the intended position in the urethra 34. The length of the cylindrical-shaped section 38 matches the length of the urethra 34. When the incontinence device 10 is in position the support device 42 is removed, i.e. withdrawn.

Fig. 4 schematically illustrates the incontinence device 10 in the urethra 34. The closure device 22 is in a state where urine is allowed to flow from the urine inlet 18 through the channel 20 to the urine outlet 16.

The closure device 22 is attached to the flexible body by a flexible part 46. This ensures that the closure device 22 does not e.g. fall into the toilet bowl when the user desires to empty her bladder. Also, the flexibility of the flexible part 46 allows the closure device 22 to be moved from the closed position to the open position, the open position is illustrated in Fig. 4, and the closed position is illustrated in Fig. 1. In the embodiment, the flexible part 46 is formed integrally with the flexible body.

A coating is applied to the outer surface of the incontinence device 10. In other embodiments the coating may be omitted. The coating includes a bacterial reducing agent so as to reduce the risk of Urinary tract infection. The introduction of foreign matter in the human body almost inevitably increases the risk of introducing bacteria . Therefore it is an advantage to provide a coating or layer of bacterial reducing agent. In other embodiments this may be omitted. Further lubrication easing the insertion of the incontinence device may be added. Still further a mild sedative may be applied to the outer surface of the incontinence device.

The incontinence device 10 comprises a rim 48 at the first end 12 of the flexible body for engaging or abutting the closure device 22 so as to establish a seal when no fluid is to flow through the urine outlet 16. The rim also ensures that the device cannot be displaced further into the urethra than intended, e.g. all the way into the bladder. Fig. 5 schematically illustrates the incontinence device positioned in a urethra in a sealed state. The closure device 22 is attached and abuts the second member 24 so as to create a liquid tight seal. The closure device 22 is held in place due to the magnetic force.

Fig. 6 schematically illustrates the incontinence device positioned in a urethra in an open or discharge state. The closure device 22 is distanced from the flexible body so as to allow fluid flow out of the outlet 16. The closure device 22 is attached to the flexible body via the part 46 as described above, and thus is not at risk of being lost. The second end 14 has a geometry that will be discussed in more detail later.

Fig. 7 schematically illustrates that a supplemental metal member 50 may be embedded in the flexible body at the first end in the rim 48, for adding further magnetic force to increase the strength of the seal.

Fig. 8 schematically illustrates an embodiment where the first member 24 has a substantially flat surface abutting the second member 26. Fig. 9 schematically illustrates an embodiment where the second member 26 is engulfed by the layer 52. The layer 52 is formed integrally with the part 46 and the flexible body.

Generally the rim may have a circular cross-section in a non-loaded state.

In Figs. 10- 15 further various embodiments of the closure device 22 are illustrated. Specifically it is illustrated that the closure device 22 may include a metal ball or metal cylinder or metal sphere. The coating layer 52 also serves the purpose of fixating the second member 26 inside the closure device 22.

Also in Figs. 10- 15 it is illustrated that the closure device 22 may comprise a coating layer, e.g. the layer 52, for reducing corrosion of the closure device and/or for reducing deposits and/or for improving cleaning. In Fig. 12 the coating layer 52 nearly encloses the second member 26 leaving a small opening 54 for receiving and centrering the first member 24. In Fig. 11 the first member 24 is illustrated as having a helical geometry, i.e. a spring-like geometry, whereas in e.g. Fig. 10 and 12 the first member 24 is pin- shaped.

Fig. 13 schematically illustrates that the first member 24 may be hollow, e.g. have a tube-like geometry. This may be advantageous in providing a larger area for engaging the second member 26 so as to better stabilise the second member 26 when the two are in contact.

Fig. 14 schematically illustrates that the second member 26 may be in the form of a cylinder. There may be production considerations that encourage the use of a cylindrical second member 26. Fig. 15 schematically illustrates sealing surface rim 48 which includes one or more ribs 50 for increasing leak tightness of the device. Here it is illustrated that the rim 48 includes four ribs 50.

Figs. 16- 18 schematically illustrate various embodiments of fastening of the first member 24 to the flexible body. Figs. 16- 18 also illustrate various embodiments of the sealing surfaces at the urine inlet.

In Fig. 16 the first member 24 is embedded in a part 54 having barbs 56. The part 54 is made from a rigid material.

Common for all embodiments the part 54 transfers force or movement from the first member 24 to the flexible body. The part 54 may be formed integrally with the first member 24, as illustrated in Fig. 18, or may be attached to the first member 24, as illustrated in Figs. 16 and 17.

The part 54 also serves as an aid for holding the first member in place and ensuring that the first member cannot escape the incontinence device 10, with the risk of it travelling into the bladder of the user or through the urine outlet. When the incontinence device 10 is to be sealed, the second member 24 is moved in the direction of the arrow 62 and as the flexible body of the incontinence device 10 is fixated in the urethra, the surfaces 64 and 66 are brought into contact thereby creating a seal blocking any urine flow from the volume 68. At the same 5 time the protruding part 28 will bulge out, so that the maximum width is enlarged or increased. This is illustrated in Figs. 26 and 27.

In Fig. 17 the surface 70 has the same function as the surface 66 in Fig . 16. Here the surfaces 70 and 72 are brought into contact when the device is to be sealed 10 when the first member 24 is pulled in the direction of the arrow 78.

In Fig. 16 a sealing surface is formed differently than in the embodiments of Figs. 17 and 18. The difference lies in that both sealing surfaces are part of the flexible body.

15

Fig. 19 schematically illustrates the incontinence device 10. The section including the channel is in this embodiment provided with enlarged portions 58 and 60. The enlarged portions or ribs 58 and 60 may serve at least two purposes, namely providing extra retention force by providing enlarged contact surface towards the 20 urethra. Further the enlarged portions 58 and 60 may provide enhanced liquid barrier as the urethra may not fit tightly around the flexible body to provide a leak-tight closure of the urethra.

Fig. 20 schematically illustrates the incontinence device 10 where the urine inlet is 25 formed at the surface 30 of the protruding part facing away from the bladder wall when the incontinence device is positioned in the urethra.

Fig. 21 schematically illustrates the incontinence device 10 where the urine inlet is formed on the surface of the protruding part between the two sidewalls 30 and 30 32.

Fig. 22 schematically illustrates the incontinence device 10 where the urine inlet is formed both at the surface 30 of the protruding part facing away from the bladder wall when the incontinence device is positioned in the urethra, and on the surface 35 of the protruding part between the two sidewalls 30 and 32. As is also seen in Figs. 21 and 22 the number of openings forming the urine inlet may be varied. The number of openings forming the urine inlet may be chosen dependent on the strength and flexibility of the material used for the device or other considerations.

Figs. 23 and 24 schematically illustrate the incontinence device 10 where the urine inlet is formed by slit openings extending between the first sidewall 30 and the second sidewall 32. As with the openings in Figs. 21 and 22, the size and numbers of slits may be varied.

Fig. 25 schematically illustrates a person removing an incontinence device 10 from urethra. The person has gripped the closure device 22 which is now in a non- engaged state. The person pulls the closure device 22 in the direction of the arrow 78. The pull from the closure device 22 via the flexible part 46 causes an elongation of the flexible body, and especially a width reduction of the protruding part 28. As the maximum width of the protruding part 28 is reduced, the protruding part 28 escapes the position bearing against the inner wall of the bladder and the incontinence device may be extracted from the urethra.

The width of the incontinence device 10 is indicated by the line 76. The incontinence device illustrated in Fig. 25 is in a state where the width is smaller than the width of the incontinence device illustrated in the state in e.g. Fig. 4. Fig. 26 is a schematic view of a urine inlet portion of an incontinence device in a sealed state. As explained above a force is transferred via the part 54 to the flexible body causing it to be displaced in the direction of the arrow 62 in Fig. 16. In Fig. 26 the two surfaces 64 and 66 are in contact. As urine enters the inlet openings 74 the urine flow is blocked and cannot enter the channel 20 due to the closure formed by the walls 64 and 66.

Fig. 27 is a schematic view of a urine inlet portion of an incontinence device in a sealed state. Here the seal is created as the two walls 70 and 72 abut, i.e. bear against each other. Fig. 28 schematically illustrates a device where the first member 24 is a helical spring.

Figs. 29 and 30 schematically illustrate a device where the first member 24 is in a state where it is bent so as to conform to the shape of the urethra, which will be more or less rectilinear depending on the user. In Fig . 29 the first member 24 is in the form of a spring member. In the present context the term spring is used for a helical spring. In Fig. 30 the first member 24 is pin-shaped. The pin-shaped first member 24 allows the device to be bent to a certain degree, the pin-shaped first member 24, after being removed from the urethra, will return to a relaxed state where it is substantially straight.

Fig. 31 schematically illustrates a device including a flange or collar 78 so as to increase the diameter of the device which reduces the risk of the device of slipping through the urethra into the bladder.

Fig. 32 schematically illustrates a device where the first member 24 is a spring having a helical shape with a variable pitch. Further, the first member has sections with high density, i.e. low pitch, at either end 80 so as to allow a better fastening to the flexible body and an increased strength of the magnetic force. The flexible body has a cavity 82 wherein the first member 24 extends at the urine inlet part. Herein the first member can be fastened to the flexible member.

Further, the increased number of coils at the opening increases the attraction between the first member and the second member as the magnetic force from the second member has more material to engage.

Fig. 33 schematically illustrates a view of a device where the closure device is in a state where urine is allowed to flow out through the channel via the outlet. The closure device is securely attached to the flexible body via attachment member 86. This means that the person using the device does not run the risk of the closure device falling off and into the toilet or floor. The closure device is further protected from unwanted material, such as hair, via a wall or cup 84 surrounding the closure device when it is in a closed state, as illustrated in fig. 32. As seen in Fig. 32 the wall 84 forms a receptacle or protective part so that in use the risk of loosening the closure device when the device is positioned in the urethera is reduced. The thickness of the wall 84 is comparable to the thickness of the other walls of the device.

Fig. 34 is a schematic zoomed view of the inlet part of the device in Fig. 32 and 33.

Fig. 35 is a schematic perspective view of the device of Fig. 32 and 33. The wall 84 protecting the closure device here has a horseshoe-shaped geometry. The closure device is attached via attachment member at the lower part of the horseshoe-shaped geometry. The attachment member attatching the closure device to the flexible body has a width comparable to or slightly larger than the width of closure device. In this embodiment the attachment member is formed from a single piece of material and integrally formed with the flexible body. In other embodiments the attachment member may be formed from several pieces. The attachment member may comprise parts of different ridigity. The attachment member may be formed by one or more relatively rigid parts.

Fig. 36 is a schematic zoomed view of an outlet portion of a flexible device. Here the wall 84 comprises a protrusion 86 and the closure device comprises a mating portion 88 so as to establish an increased retension force. This means that a larger force is needed for operating the closure device from the closed state to the open state. This reduces the risk of the device of opening accidentally when the device is positioned in the urethra.

The device comprises a lip 90. The lip part in the flexible body is positioned so that when the closure device is in a closed state the lip part is between the closure device and the first member. This is seen in Fig. 36.

Fig. 37 is a schematic view of the outlet illustrated in Fig. 36 in an open state. Here the mating portion 88 of the closure device is seen more clearly. The protrusion 86 at the wall 84 is in this cross-sectional view only seen at a part of the wall. The protrusion does not need to extend along the entire length of the wall 84. The lip 90 is seen in this view also.

Although the present invention has been described in connection with the

5 specified embodiments, it should not be construed as being in any way limited to the presented examples. The scope of the present invention is set out by the accompanying claim set. In the context of the claims, the terms "comprising" and "comprises" do not exclude other possible elements or steps. Also, the mentioning of references such as "a" or "an" etc. should not be construed as excluding a

10 plurality. Any use of reference signs in the claims with respect to elements

indicated in the figures shall also not be construed as limiting the scope of the invention. Furthermore, individual features mentioned in different claims, may possibly be advantageously combined, and the mentioning of these features in different claims does not exclude that a combination of features is not possible

15 and advantageous.

In the above illustrations not all elements are numbered in all views to increase visibility of the individual features discussed in relation to each figure.

With reference to the drawings the following reference numerals are used :

20

10 incontinence device

12 first end

14 second end

16 urine outlet

25 18 urine inlet

20 channel

22 closure device

24 first member

25 centering device

30 26 second member

28 protruding part

30 first sidewall

32 second sidewall

34 urethra

35 36 bladder wall

38 cylindrical-shaped section

40 external wall of the urethra

42 support device

44 handle

40 46 flexible part

48 rim

50 supplemental member

52 layer / coating layer

54 part 56 barb

58 enlarged portion

60 enlarged portion

62 arrow

5 64 surface

66 surface

68 volume

70 surface

72 surface

10 74 inlet opening

76 line

78 collar or flange

80 end

82 cavity

15 84 wall

86 protrusion

88 mating portion

90 lip

20 The present invention may be characterised by the following points:

1. An incontinence device comprising :

a flexible body having a first end and an opposite, second end, the flexible body defining an oblong geometry,

25 a urine outlet being formed at the first end of the flexible body,

a urine inlet being formed at the second end of the flexible body, a channel connecting the urine inlet and the urine outlet allowing fluid to flow between the urine inlet and the urine outlet,

a closure device configured for selectively either allowing fluid to flow 30 through the urine outlet or to hinder fluid to flow through the urine outlet,

a first member and a second member being mutually magnetically attractive, the first member being connected to the flexible body and the second member being connected to the closure device so that when the closure device is to hinder fluid to flow through the urine outlet the magnetic force between the 35 first member and the second member holds the closure device in position.

2. The incontinence device according to point 1, wherein the flexible body comprises a protruding part at the second end configured for engaging the inner wall of a bladder when the incontinence device is positioned in a urethra.

40

3. The incontinence device according to point 2, wherein the opening at the second end is formed at one distance from the end of the incontinence device and the protruding part is formed at another, larger, distance from the end of the incontinence device.

4. The incontinence device according to any one of the points 1-3, wherein the flexible body has a cylindrical-shaped section between the urine outlet and the urine inlet.

5. The incontinence device according to any one of the points 3 or 4, wherein the protruding part is flexible so that when the flexible body is stretched, the maximum width of the protruding part is reduced.

6. The incontinence device according to any one of the points 1-5, wherein the flexible body has an overall length so that first end of the flexible body extends from the external wall of the urethra when the incontinence device is mounted in a urethra.

7. The incontinence device according to any one of the points 1-6, wherein a coating is applied to the outer surface of the incontinence device, the coating is a bacterial reducing agent so as to reduce the risk of Urinary tract infection.

8. The incontinence device according to any one of the points 1-7, wherein the closure device is attached to the flexible body by at least one flexible part.

9. The incontinence device according to any one of the points 1-8, wherein the flexible body comprises a rim at the first end for engaging the closure device so as to establish a seal when no fluid is to flow through the urine outlet.

10. The incontinence device according to any one of the points 1-9, wherein the first member is attached at the second end of the flexible body so that lengthwise displacement of the first member causes elongation of the flexible body so that the maximum width of the flexible body is reduced.

11. The incontinence device according to any one of the points 1- 10, wherein the first member being positioned in the channel of the flexible body, the first member having an elongated geometry having a first end of the first member and a second end of the first member,

the second end of the first member being attached at the second end of the flexible body, and

the first end of the first member being positioned at the urine outlet.

12. The incontinence device according to any one of the points 1- 10, wherein the second member is embedded in the flexible body at the first end in the rim. 13. The incontinence device according to point 12, wherein the rim has a circular cross-section in a non-loaded state.

14. The incontinence device according to any one of the points 1- 13, wherein the closure device includes a metallic ball or metallic cylinder or metallic sphere or metallic cube or metallic box.

15. The incontinence device according to point 14, wherein the closure device comprises a coating layer for reducing corrosion of the closure device and/or for reducing deposits and/or for improving cleaning.

Claims

Claims 1. An incontinence device comprising :

a urine outlet being formed at the first end of the flexible body,

a closure device configured for selectively either allowing fluid to flow through the urine outlet or to hinder fluid to flow through the urine outlet, wherein the closure device is attached to the flexible body by at least one attachment member,

a first member and a second member being mutually magnetically attractive, the first member being connected to the flexible body and the second member being connected to the closure device so that when the closure device is positioned to hinder fluid to flow through the urine outlet the magnetic force between the first member and the second member provides sufficient force for sealing.

2. The incontinence device according to claim 1, wherein the attachment member comprises a flexible part.

3. The incontinence device according to claim 1 or 2, wherein the magnetic force between the first member and the second member holds the closure device in position.

4. The incontinence device according to any one of the claims 1-3, wherein a protrusion at the outlet and a mating part on the closure device holds the closure device in position.

5. The incontinence device according to any one of the claims 1-4, wherein the flexible body comprises a protruding part at the second end configured for engaging the inner wall of a bladder when the incontinence device is positioned in a urethra and/or the inner wall of a urethra.

6. The incontinence device according to claim 5, wherein the opening at the second end is formed either in the protruding part or in an area closer to the second end.

7. The incontinence device according to any one of the claims 1-6, wherein the flexible body has a cylindrical-shaped section between the urine outlet and the urine inlet and/or the flexible body has a conically-shaped section between the urine outlet and the urine inlet.

8. The incontinence device according to any one of the claims 6 or 7, wherein the protruding part is flexible so that when the flexible body is stretched thereby increasing the distance between the first end and the second end, the maximum width of the protruding part is reduced.

9. The incontinence device according to any one of the claims 1-6, wherein the flexible body has an overall length so that first end of the flexible body extends from the external wall of the urethra when the incontinence device is mounted in a urethra.

10. The incontinence device according to any one of the claims 1-9, wherein a coating is applied to the outer surface of the incontinence device, the coating is a bacterial reducing agent so as to reduce the risk of Urinary tract infection.

11. The incontinence device according to any one of the claims 1- 10, wherein the attachment member is at least one flexible part being integrally formed with the flexible body.

12. The incontinence device according to any one of the claims 1- 11, wherein the first member is a spring having a variable pitch part and/or a fixed pitch part.

13. The incontinence device according to any one of the claims 1- 12, further comprising a lip part in the flexible body positioned so that when the closure device is in a closed state, the lip part is between the closure device and the first member.

5

14. The incontinence device according to any one of the claims 1- 13, wherein the flexible body comprises a rim at the first end for engaging the closure device so as to establish a seal when no fluid is to flow through the urine outlet.

10 15. The incontinence device according to any one of the claims 1- 14, wherein the first member is attached at the second end of the flexible body so that lengthwise displacement of the first member causes elongation of the flexible body so that the maximum width of the flexible body is reduced or increased.

15 16. The incontinence device according to any one of the claims 1- 15, wherein the first member being positioned in the channel of the flexible body, the first member having an elongated geometry having a first end of the first member and a second end of the first member,

the second end of the first member being attached at the second end of the

20 flexible body, and

the first end of the first member being positioned at the urine outlet.

17. The incontinence device according to any one of the claims 14-16, wherein the second member is embedded in the flexible body at the first end in the rim.

25

18. The incontinence device according to claim 17, wherein the rim has a circular cross-section in a non-loaded state.

19. The incontinence device according to any one of the claims 1- 18, wherein 30 the closure device includes a metallic ball or metallic cylinder or metallic sphere or metallic cube or metallic box.

20. The incontinence device according to any one of the claims 1- 19, wherein the second member is a magnetic ball or magnetic cylinder or magnetic sphere or

35 magnetic cube or magnetic box.

21. The incontinence device according to claim 19 or 20, wherein the closure device comprises a coating layer for reducing corrosion of the closure device and/or for reducing deposits and/or for improving cleaning and/or for improving biocompablility.