Abstract:
The invention relates to a urine flow control system ( 50 ) including a catheter device ( 10, 100 ) for insertion into a urethra, the catheter device ( 10, 100 ) having: a proximal end portion ( 14 ) and an opposite distal end portion ( 16, 102 ), a conduit (C) between said proximal end portion ( 14 ) and said distal end portion ( 16 ) having a urine inlet opening ( 2 ) at said proximal end portion ( 14 ) and a urine outlet opening ( 4,  P) at said distal end portion ( 16, 102 ), and a magnetically actuatable valve located at said distal end portion ( 16, 102 ) for controlled discharge of urine from said catheter device ( 10, 100 ) through said outlet opening ( 4,  P), and a magnetic actuator device with an actuator magnet ( 201 ), separate from said catheter device ( 10, 100 ), for operating said valve, characterized in said magnetic actuator device ( 200 ) comprising a housing ( 205 ) for receiving urine discharged from said catheter device ( 10, 100 ), said housing ( 205 ) having a first open end ( 202 ) configured for receiving said distal end portion ( 16, 102 ) with said magnetically actuatable valve and said outlet opening ( 4,  P), and a second end, said housing ( 205 ) having at said first end ( 202 ) said actuator magnet ( 201 ).

Description:
[0001]    The present invention relates to an improved urine flow control system of the type involving the use of a magnetic valve body and magnetic actuator device, and to a magnetic actuator device for use in said system. 
         [0002]    Incontinence is the inability of any of the physical organs to restrain discharges of their contents; in the present 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 where persons suffering from incontinence experience problems. 
         [0003]    Persons suffering from incontinence are often compelled to wear a pad for collecting urine being discharged from the urethra. In addition, 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. 
         [0004]    Some persons, on the other hand, have problems emptying their bladder. This may be due to low detrusor activity, which is associated to neurological or myogenic conditions. It may also be due to patient age factors, medication or bladder outlet obstruction. Such patients insert catheters when emptying the bladder. Either they catheterize themselves, have nurses perform the catheterization, or they carry a catheter permanently. 
         [0005]    Such patients may be helped by wearing a urine flow control system with a valve catheter, as this can eliminate the need for catheterization every time the bladder needs emptying. 
         [0006]    US patent application 2001/0034470 and U.S. Pat. No. 5,030,199 show examples of prior art urine flow control systems or incontinence device, both involving a conduit for urethral installment as well as a magnetic actuator device allowing a user to control urine discharge. A user may control discharge of urine by manually holding the actuator device in the form of an actuator magnet close to the distal end of the conduit outside the urethra. In the prior art the actuator magnet is also referred to as a “portable activating magnet” which is configured to be placed in a pocket, a pocket book, or which can be formed in a decorative shape to be worn on a necklace or bracelet for convenient access. It may even be formed for retention in a key chain or as part of a ring. 
         [0007]    One aspect of general importance to a user of an incontinence device is that discharge of urine should be possible to carry out in a highly hygienic manner. The fact that the prior art actuator magnet is hand held involves the risk that the user will soil herself as the actuator magnet is held close to the valve body, and this may be seen as a problem with those prior art catheter devices that have a magnetically actuatable drainage control valve. 
         [0008]    The present invention aims at solving this problem and, hence, to increase the user-convenience experienced with the particular type of urine flow control systems referred to above which for many reasons would be expected to be more popular than non-magnetic catheter devices, such as those having a urine discharge conduits with a valve that must be squeezed manually to open it. 
         [0009]    Broadly, the aforementioned problems are solved with a system and a magnetic actuator device as claimed. Preferred embodiments are defined in the dependent claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    In the following an embodiment of the invention will be described in more detail with reference to the drawings, wherein: 
           [0011]      FIG. 1  is a simplified anatomical view showing the general location of an incontinence device in the urethra, 
           [0012]      FIG. 2  is a sectional view showing a prior art incontinence device as shown in  FIG. 1 , located in the urethra, 
           [0013]      FIG. 3  shows a perspectival partial view of another incontinence device, 
           [0014]      FIG. 4  shows the novel urine flow system according to the invention, including a magnetically activated catheter device and a magnetic actuator device, 
           [0015]      FIGS. 5 a  and 5 b    show, respectively, a sectional view of the magnetic actuator device and various types of actuator magnets for the magnetic actuator device, 
           [0016]      FIGS. 6 a  and 6 b    show perspective views of an embodiment incorporating a horseshoe magnet, 
           [0017]      FIGS. 7 a  and 7 b    show field lines when using magnets of the two types shown in  FIG. 5   b,    
           [0018]      FIG. 8 a    is a perspective cross-sectional view showing a further embodiment of the present urine flow control system, and 
           [0019]      FIG. 8 b    is a cross/sectional view showing the encircled area in  FIG. 8   a.    
       
    
    
     DETAILED DESCRIPTION 
       [0020]    It is emphasized that the urine flow control system discussed in the following may equally be used by an incontinent as well as a person suffering from problems emptying their bladder. For convenience, however, the urine flow control system of the invention will in the following be described in the context of incontinence devices. 
         [0021]      FIG. 1  shows an example of a prior art female incontinence control device in the form of a catheter device  10  with a urine discharge conduit C, the conduit C having an inlet opening  2  at the proximal end portion nearest bladder B of the catheter device  10  and an outlet opening  4  at the distal end portion thereof. To maintain the correct position of the catheter device  10  in the urethra use is made of a bladder engaging section  8  located at the proximal end portion of the catheter device  10 . The bladder engaging section  8  may, as shown, be an inflatable balloon. 
         [0022]    The prior art catheter device  10  shown in  FIG. 1  is illustrative of the general type of incontinence devices, or urine flow control devices, to which the present invention is related, namely where a magnetically actuatable drainage control valve is included to seal off the urine discharge conduit C, as discussed below. In this way, a user may control discharge of urine by manually holding an actuator close to the distal end of the conduit C outside the urethra. This operation is shown in  FIG. 2  where the actuator in the form of an actuator magnet is referenced by numeral  27 . The magnetically actuatable drainage control valve includes a valve body  14  of a magnetically attractive or magnetized material, arranged in a chamber  16 ; in  FIG. 2  the valve body  14  is biased by a spring  18  towards a closed position (not shown) resting against a valve seat  19  and preventing outflow of urine through the sideways oriented outlet opening  4  at the distal end portion. It will be understood that the magnetic force by actuator magnet  27  is such that the valve body  14  is drawn against the spring  18  towards its open position away from the valve seat  19 , allowing sideways outflow of urine through the outlet opening  4  located at the distal end portion. When the actuator magnet  27  is removed, the valve closes again. 
         [0023]    In the prior art the actuator magnet  27  shown in  FIG. 2  is also referred to as a “portable activating magnet” which can be placed in a pocket, a pocket book, or which can be formed in a decorative shape to be worn on a necklace or bracelet for convenient access. It may even be formed for retention in a key chain or as part of a ring. 
         [0024]    One aspect of general importance to a user of an incontinence device is that discharge of urine should be possible to carry out in a highly hygienic manner. The fact that the prior art actuator magnet  27  is hand held involves the risk that the user will soil herself as the actuator magnet  27  is held close to the valve body  14 , and this may be seen as a problem with those prior art catheter devices that have a magnetically actuatable drainage control valve. 
         [0025]    The present invention aims at solving this problem and, hence, to increase the user-convenience experienced with the particular type of magnetic catheter devices referred to above which for many reasons would be expected to be more popular than non-magnetic catheter devices, such as those having a urine discharge conduits with a valve that must be squeezed manually to open it. 
         [0026]    The invention will in the following be discussed in connection with a novel catheter device  100  subject of a parallel patent application by the present inventor and which is shown partially in  FIG. 3 ; however, it is stressed that any type of incontinence catheter device having a magnetically actuatable drainage control valve, such as that shown in  FIG. 2 , may normally form part of the present novel incontinence flow control system and be used in connection with the novel magnetic actuator device discussed in the following. 
         [0027]    Shown in  FIG. 3  is an incontinence device  100  having a urine discharge conduit C and a metal coil  121  which provides for stability of the device  100  and which also is magnetically attractive to attract a magnet acting as a valve body  126  towards a valve seat  134  near the end of the coil  121 . The valve body  126  is mounted to be axially displaceable within a chamber  142  in the distal end portion  102  and defines, together with the valve seat  134  and metal coil  121 , a magnetically actuatable valve. As an alternative, a spring located in the chamber  142  may be used to hold the valve body  126  against the valve seat  134 . 
         [0028]    In  FIG. 3 , for discharging urine a user has approached the valve body  126  with an actuator comprising an actuator magnet  201  held in her hand close to the distal end portion of the catheter device  100 , which distal end portion  102  is located outside the urethra. The magnetic force from actuator magnet  201  is of such strength as to pull or displace the aforementioned magnet acting as valve body  126  away from the valve seat  134  to allow for an axial outflow of urine, as shown by the arrow P. By “axial outflow” is meant herein a flow of urine directed parallel with, substantially parallel with, the conduit C, in contrast to the “sideways outflow” discussed in relation to  FIG. 2 . As an alternative, the actuator may comprise a body of a magnetically attractive material, the overall object being to displace the magnet acting as valve body  126  by magnetic attraction. When the actuator is removed the valve recloses by the magnetic attraction driving the valve body  126  towards the valve seat  134 . 
         [0029]      FIG. 4  shows the catheter device  100  of  FIG. 3  approximately in the position it would be in in the urethra, as shown in  FIG. 1 , and with its distal end portion  102  being received within the open end  202  of an embodiment of the novel magnetic actuator device  200  of the present invention, which comprises a tubular or essentially tubular housing  205  or funnel and a centrally located raised housing subportion  207  wherein an actuator as discussed above, be it a magnet  201  or a body  201 ′ of a magnetically attractive material, is lodged. 
         [0030]      FIG. 4  as such shows the novel urine flow system  50  according to the invention being the novel combination of a magnetically activated catheter device  100  with the novel magnetic actuator device  200 . The raised subportion  207  defines a passage  230  on either side thereof, each passage  230  being delimited to the other side opposite the raised subportion  207  by a portion of the wall  206  of the housing  205 . 
         [0031]    The housing  205  is preferably molded of a plastics material and is easy to rinse, and the actuator comprising a magnet  201  or a body  201 ′ of a magnetically attractive material, may be embedded in the material forming the housing subportion  207  during the molding operation. Alternatively, the actuator comprising actuator magnet  201  or body  201  may be arranged, still centrally along the central axis X of the housing  205 , with its surface directly exposed.  FIG. 5 a    is a sectional view of the magnetic actuator device  200  and  FIG. 5 b    shows various types of actuator magnets  201  for lodging in the housing subportion  207 . In another embodiment the housing  205  is made of a biodegradable material and intended for single use. 
         [0032]    Referring again to  FIG. 4 , when a female using the catheter device  100  wishes to discharge urine she will hold on to the outside gripping portion  210  of the magnetic actuator device  200  and move it towards the distal end portion  102  of the catheter device  100  which projects from the urethra. The magnetic actuator device  200  is configured to receive the distal end portion  102  of the catheter device  100  by simply moving it into the inside of the housing  205  through the open end  202 , with or without contacting the housing wall  206  and without necessarily establishing any mechanical coupling between the catheter device  100  and the magnetic actuator device  200 . 
         [0033]    Common to the use of the present magnetic actuator device  200  with the general type catheter devices shown in  FIGS. 2 and 3  is that as soon as the distal end portion with the urine outlet opening  4 , P is received within the tubular housing  205  the catheter device valve opens as the valve body  14 ,  126 , which is a magnet, is attracted by actuator magnet  201  or to body  201 ′ of a magnetically attractive material, such that urine discharge into the interior of housing  205  through passage P,  4 , respectively, is permitted. The skilled person will understand that the properties of the body  201 ′ are selected such that there is a greater attractive force between the valve body  14 ,  126  and the body  201 ′ than between the valve body  14 ,  126  and the valve seat  134 , such that the valve body  14 ,  126  will seek towards the body  201 ′of the magnetically attractive material. 
         [0034]    In this connection, it may sometimes be advantageous when the catheter device is of the type providing for an axial outflow, as in  FIG. 3 , but clearly the catheter device of  FIG. 2  offering a sideways outflow may also be used as the housing wall  206  will prevent spillage of urine due to the location of the actuator  201 ,  201 ′ centrally within the housing  205  in the embodiment of  FIG. 4 . As the skilled person will realize, in some combinations it may be desirable to position the actuator  201 ,  201 ′ spaced a relatively large distance from the open end  202 . This may be the case where there is a desire to insert the distal end portion  16 ,  102  deeper into the housing  205 . 
         [0035]    In some applications it may alternatively be preferred to embed or arrange the actuator, be it magnet  201  or body  201 ′, in the peripheral wall  206  of the housing  205 , with the actuator  201 ,  201 ′ being shielded such that the magnetic field outside the housing  205  is of such low strength that the valve body  14 ,  126  will not be affected if the housing  205  is incorrectly held close to the catheter device  100  without the distal end portion thereof being received within the housing  205 .  FIGS. 6 a  and 6 b    show such an embodiment incorporating a horseshoe magnet embedded or otherwise arranged at the first open end  202 ; the magnetic field lines are such that the valve will more likely open for urine discharge when the distal end portion is received inside the housing  205  than outside. 
         [0036]    Preferably, the magnetic field lines and strength of the actuator magnet  201  are/is selected such that the valve will only open when the distal end portion of the catheter device, which projects from the urethra, is substantially or fully received in the housing  205  such that there is a high certainty that urine will be discharged into the elongated magnetic actuator housing  205  and flow along the length thereof. This means that the magnetically activatable drainage control valve will preferably not open if the magnetic actuator device  100  is merely brought close to the catheter device; only when the distal end portion of the catheter device is located within the housing  205  of the magnetic actuator device  200  will the valve open.  FIGS. 7 a  and 7 b    show field lines when using magnets  201  of the two types shown in  FIG. 5 b   . The embodiment of  FIG. 7 b    may in some cases be preferred since the distal end portion  102  of the catheter device  10  will be drawn towards the projecting or raised subportion  207 , leading to a higher degree of guidance of the housing  205  relative to the distal end portion  102 , as the magnetic actuator device  200  is moved towards the catheter device  10 , i.e. towards the distal end portion  102  thereof. 
         [0037]    It is possible to form the housing  205  with a closed end opposite the open end  202 , so that urine may be collected in a chamber in the housing  205 , or alternatively to form the housing  205  with an aperture  217  opposite the open end  202  to allow urine to be immediately discharged into a toilet. 
         [0038]    Preferably, the elongated housing  205  has a length in the order of 5 cm-15 cm and a width or diameter in the order of 0.4 cm-3 cm. A shorter housing  205  may also find use, such as where the user prefers to attach a flexible collection bag to the end of the housing  205  at aperture  217 ; such a bag may be of the type having a narrow opening that may be pulled over the housing wall  206  and attached thereto, such as by a rubber band or similar. 
         [0039]      FIG. 8 a    shows yet another embodiment wherein the wall  206  of the housing  205  is of a flexible material and of an elongated tubular configuration, allowing the housing  205  to be bent as required to permit a directional control of the urine discharge. In this embodiment the housing  205  has open opposite first and second ends, with the aforementioned body  201 ′ of a magnetically attractive material located centrally at the first end  202  in a central support structure  206 ′ connected to peripheral wall  206 ; urine flowing along the length of the housing  205  inside thereof is discharged at the second end shown to the left in  FIG. 8 a   . As seen best in  FIG. 8 b   , the peripheral wall  206  of the housing  205  may be shaped at the first end  202  with an end face F 2  configured to mate with another face F 1  on the distal end portion  102  of the catheter device  100 , thus establishing an interface which in the shown example extends perpendicular to the direction of flow of urine; direct inflow of urine into the housing  205  via passage P occurs as the magnetic valve body  126  is drawn towards the body  201 ′, away from the valve seat  134  and the metal coil  121 , which—by the properties, such as mass, of the body  201 ′ applies the smallest attractive force onto the magnetic valve body  126 . In  FIG. 8 b    the distal end portion  102  of the catheter device  100  is configured to receive the first open end  202 , thereby providing lateral support to the housing  205 ; faces F 1 , F 2  need not contact.