Abstract:
A urinary incontinence device includes an occluding member, such as a tampon or plug that is retained by magnetic forces acting between a support and magnetic inserts located adjacent the urethra. The insets may be implanted or injected and hold the occluding member in place.

Description:
This application is a division of U.S. Ser. No. 08/860,265 filed Aug. 18, 1997 which is a U.S. national completion of International Application PCT/CA95/00717 filed Dec. 19, 1995; which U.S. application is hereby incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to a urinary incontinence device. 
     Urinary incontinence in the aged population is an enormous problem. Approximately 50% of the patients residing in nursing homes were placed there because of problems with urinary incontinence. It is estimated that there are 20 million incontinent patients in the United States alone, and that only 10% of these people ever seek medical assistance. Sufferers from this condition can become social hermits because of the fear of accidents due to sudden loss of urine and the embarrassment associated with urine odours. Most patients have been convinced that incontinence is a natural aging phenomenon and many wear protective padding. This arrangement is extremely primitive and demeaning for the patients. 
     The majority of urinary incontinence occurs in the female. Recently there has been an increase in post prostatectomy incontinence, since radical prostate surgery has increased dramatically in the last five years. 
     A distinction must be made as to whether the problem occurs in an active healthy person or in someone who is institutionalized in either a chronic care facility or in a nursing home. The treatment approaches will necessarily be different. In the case of the institutionalized person suffering from urinary incontinence, they are often unable to have any surgical procedure to correct their condition so that non-invasive (non-surgical) approaches are required. The common practice in most nursing homes at present is to have the patients fitted with an absorbent diaper-like material. These antiquated arrangements account for the malodorous environment found in nursing homes as well as the high incidence of local skin problems due to the constant exposure to urine. For various reasons, most nursing homes will not accept patients with catheters. 
     Many devices have been designed to deal with the problem of urinary leakage and the various difficulties associated with the use of these devices are well known. The basic problem found in many of the females with urinary incontinence is that there is a descent of the bladder neck and an associated wide open bladder neck and upper third of urethra, the so-called funnel-shaped urethra. To correct the incontinence without surgery, one must have a device which either occludes the urethra or elevates the bladder neck and occludes the upper ½ of the urethra. Many of the proposed devices are designed to be placed in the vagina but retaining the device has been one of the main problems associated with their use. In an effort to increase the obstruction to the flow of urine, various other techniques have been used. More recently periurethral injections with various compounds have been used. The purpose of these injections is to obliterate the lumen of the urethra and thus reduce the urinary incontinence. Some of the substances injected include periurethral Teflon, injections of collagen and more recently periurethral injections of autogous fat. In some instances, urethral catheterization has been used to control incontinence. This carries a risk of significant infection. More recently, there have been various urethral plugs designed for inserting in the urethra to occlude the lumen. These plugs are disposable and have to be re-inserted after each voiding. Some of the plugs are retained by means of a balloon arrangements and these all carry the risk of urethral irritation and infection. 
     In summary, females are incontinent of urine for several reasons and there are various classifications of the problem. As a general observation, the condition can be controlled by several non-surgical approaches. One can insert a urethral plug to retain the urine or a device can be used to elevate the bladder neck and occlude the upper half of the urethra. This will restore continence in most instances. 
     In German Patent Application No. 3139811, there is described a device in which a magnetic plate is surgically attached to the pubic bone. A tampon containing a magnet is inserted into the vagina and it is intended that the magnetic force between the plate and magnet will occlude the urethra. Test results indicate that this procedure has not been successful in all instances, possibly because of the spacing between the plate and magnet. Moreover, it is clearly desirable for the tampon to be disposable so that the inclusion of the magnet renders the procedure prohibitively expensive. 
     There have been other proposals to utilize magnetic attraction to retain a medical device, such as that shown in U.S. Pat. No. 4,154,226 or U.S. Pat. No. 3,952,726, both to Hennig, and U.S. Pat. No. 4,258,705 to Sorenson but these have not specifically addressed devices that are intended to overcome the practical problems associated with incontinence. 
     U.S. Pat. No. 3,926,175 shows a mechanical device intended to supplement bladder control but requires surgical implantation about the neck of the bladder and the application of an external mechanism to open or close the device. As such, its installation and operation is unduly complicated. 
     A further device is shown in U.S. Pat. No. 2,649,086 which includes a resilient ring with a radial protrusion that is inserted in the vagina and bears against the urethra. However, the careful placement of this device is critical to its successful operation and its retention is dependent purely upon the resilience of the ring. 
     There are several basic requirements that must be satisfied in the design of these incontinent devices. The device must be held in place and this applies whether the urethra is occluded internally or the bladder neck and upper urethra are occluded by a vaginal device. In either instance of the device, provision must be made for the bladder to be emptied on a regular basis. In some circumstances it is preferable that this should be done without having to remove the appliance. The devices presently available do not meet such requirements satisfactorily and it is therefore an object of the present invention to obviate or mitigate the disadvantages present in such devices. 
     SUMMARY OF THE INVENTION 
     In general terms, the present invention provides an incontinence device which may be positioned to occlude the urethra and is retained in position by magnetic forces. 
     Although magnetic materials have had widespread industrial and domestic applications. They have had limited application in the design of biomedical devices principally because they lost magnetic power when implanted. The discovery of rare earth magnets has opened up a new area for biomedical research. These magnets containing neodymium boron and other compounds are readily available. Their attractiveness lies in the fact that they are up to 50 times stronger than the strongest ferrite or alnico magnets. The rare earth magnets are non-toxic and can be coated with biocompatible materials. This will allow them to be placed in the body and they do not lose their magnetic properties when coated. 
     The preferred embodiment of devices to be described utilize the power of the neodymium magnets and the numerous biocompatible materials which are available to design effective anti-incontinence devices. To complete the magnetic attachment, metallic depots can be established in various areas in the tissues of the female pelvis by injecting metallic material coated with biocompatible compounds. During the last 10 years, there are many reports of Teflon, collagen or fat being injected around the bladder neck and upper urethra in the female in an attempt to correct urinary incontinence. It is now possible to create metallic depots which will serve as anchoring stations for magnetic attachments of the incontinence devices. It is also possible to establish metallic depots in the vagina without injection by means of a pasted or incorporated into a small tampon. 
     In one preferred embodiment, a malleable support is provided to retain a tampon within the vagina. The support is retained by deposits of magnetic material injected into the vaginal wall and co-operating with magnets carried by the support. Accordingly, the support can be configured to suit individual needs but is retained securely by the magnets. Preferably the tampon is disposable. 
     In an alternative embodiment, an incontinence device includes an outer sheath to be secured within the urethra. A core is provided within the sleeve and is retained by magnetic forces between the sleeve and core. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which 
     FIG. 1 is an elevation of a first embodiment of an incontinence device; 
     FIG. 2 is a side elevation of the device of FIG. 1; 
     FIG. 3 is a view showing the device of FIG. 1 installed in a female; 
     FIG. 4 is a side view of FIG. 3; 
     FIG. 5 is a view similar to FIG. 3 showing a second embodiment of the device installed in a male; 
     FIG. 6 is a side elevation of a further embodiment of an incontinence device; 
     FIG. 7 is an end view of the device of FIG. 6; 
     FIG. 8 is a side sectional view of a male urinary incontinence device; 
     FIG. 9 is a side view of an alternative embodiment of incontinence device for female use; 
     FIG. 10 is a view on the line X—X of FIG. 9; and 
     FIG. 11 is a side view similar to FIG. 9 of an alternative device. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring therefore to FIG. 1, an incontinence device  10  comprises a band  11  which has opposite ends folded back upon itself to define upper and lower arms  12 , 14  respectively that are interconnected at opposite ends as indicated at  16 . Each of the arms  12 , 14  is formed from a flexible material that is rendered magnetic, either by a magnetic coating or by selection of the material used to manufacture the arms. Preferably the band  11  is malleable to permit “fitting” of the device  10 . The arms  12 , 14  are covered by a biocompatible material, typically a polymer. 
     An occluding tampon  20  is located between opposed ends of upper arm  12  and is supported by the central portion of lower arm  14 . Notches  18  may be formed in the side of the tampon  20  to locate the ends of arms  12 . The tampon  20  has a convex upper surface  21  in section and is formed of Teflon or other synthetic or natural material that is soft enough to conform to the urethra. 
     The tampon  20  is elongate, as seen in FIG. 2, and has a predefined curvature along its longitudinal axis to conform to the vaginal/urethral wall. Typically the curvature presents a concave upper generatrix. The tampon  20  is resilient so as to provide a gentle lifting force at the distal end when inserted. The resilience is provided either from the material of the tampon itself that is molded or formed with a predefined curvature or from a resilient insert, indicated at  23 , that is covered by the material of the tampon. The tampon  20  terminates in a bulbous tip  25  that elevates the bladder neck when in position. 
     The device  10  is inserted into the vagina  22  to be located adjacent the intersection of the vaginal wall  24  and urethra  26 . Magnetic inserts  28  are located in the periurethral tissues on the opposite side of the vaginal wall  24 . One of the inserts  28  or arms  12 , 14  is magnetized and the other is magnetizable so that there is a magnetic attraction between the arms  12 , 14  and the inserts  28 . Assuming the inserts  28  are magnetized, they apply sufficient force on the arms  12 , 14  to retain the device  10  in the vagina. The tampon  20  is positioned adjacent the urethra  26  so that the convex upper face  21  occludes the urethra. The distal end of the tampon  20  engages the upper wall of the vagina  22  and its resilience and curvature elevates the bladder neck and thereby inhibits fluid flow through the urethra. 
     To vent the bladder, it is simply necessary to remove device  10  by overcoming the magnetic forces between inserts  28  and arms  12 , 14  and thereby open the urethra. Alternatively, the tampon may be manipulated to a position in which the urethra is not occluded and the tip  25  allows the bladder neck to fall to void the bladder. 
     The entire device  10  may be disposable or the band  11  may be reusable with a replacement tampon  20 . 
     The magnetic inserts  28  may be discrete implants of magnetized material or may be localized deposits that are injected or otherwise placed in the periurethral tissues including the adjacent soft tissues, urethral lumen, urethral wall or adjacent bony structures. 
     Naturally the inserts  28  could be magnetizable material and the arms formed from magnetized material, although it is believed that permanently magnetized implants are preferable. Rare earth magnets, such as neodymium, are preferred for their enhanced magnetic properties. Magnetizable deposits may be provided by iron carbonyl powder dispersed in an injectable carrier. 
     Tampon  20  is effective not only to occlude the urethra but also to elevate the bladder neck which should be particularly effective to connect urinary incontinence in females. 
     Notches  18  in the tampon ensure an accurate orientation of the tampon although alternative indicators or orienting arrangements may be utilized. 
     The device  10  may be modified for use in a male as shown in FIG. 5 in which like reference numerals will identify like components with a suffix ‘a’ added for clarity. 
     In FIG. 5, the inserts  28   a  are located in the scrotal and perineal skin at a location where the urethral lumen is essentially subcutaneous. The arms  12   a ,  14   a  are dimensioned to cause the insert  20   a  to compress the urethral lumen  30 . Tampon  20   a  is similar to that described above although not elongate and is dimensioned to occlude the urethral lumen  30  when applied and retained by inserts  28 . Venting of the bladder is accomplished as before by removal of the insert  10 . 
     An alternative embodiment is shown in FIG. 6 with a suffix ‘b’ added for clarity to denote like components. In the embodiment of FIGS.  1 - 4 , the magnetic inserts  28  are located in the vaginal wall adjacent the urethra. As an alternative, as shown in FIG. 6, the inserts  28   b  are created on a surface of the inferior ischiopublic ramus  40  of the pelvis  42 . 
     As seen in FIGS. 6 and 7, the device  10   b  includes a pair of arms  12   b,  each of which terminates in a foot  44 . The foot  44  carries a permanent magnet  46  which co-operates with respective metallic inserts  28   b  to retain the device  10   b  within the vagina. 
     The arms  12   b , are malleable and may be made of lightweight metallic materials such as alloys of magnesium or the like or may be made from non-metallic polymer substances and coated with biocompatible material as necessary. 
     The arms  12   b  are joined to one another by a bridge  48  that supports a tampon  20   b  similar to that described above with reference to FIG.  2 . The tampon  20  may be secured releasably to the bridge  48  in a manner similar to that shown in FIG. 2 or may utilize a magnetic connection where a suitable magnetic insert is included in the tampon  20 . 
     Device  10   b  may therefore be inserted in the vagina and retained by the inserts  28   b  so that the tampon  20  occludes the urethra and elevates the bladder neck. 
     Device  10   b  is removable as above for emptying the bladder but preferably tampon  20   b  will include an opening device that allows the bladder to be emptied without removal of the entire device. 
     The magnetic retention of an urethral plug is shown in FIG. 8 where like reference numerals are used to denote like components with a suffix ‘c’ added for clarity. 
     Device  10   c  is formed as a plug  32  of foam expandable material that is dimensioned to fit the urethral lumen. A retraction cord  34  is secured to one end of the plug  32  and its opposite end is coated with a circumferential metal band  36 . The band  36  may be magnetized or magnetizable. 
     The plug  32  is retained by magnetic inserts  28   c  disposed in the urethral wall either by discrete insertion or injection as preferred. Where the band is magnetized, the inserts are magnetizable and, conversely, when the inserts are magnetized, the band is magnetizable. 
     A urethral plug suitable for female use is shown in FIGS. 9 and 10 where like reference numerals denote like components with a suffix ‘d’ added for clarity. 
     The device  10   d  includes an outer sheath  50  intended to be inserted in the urethra and typically 4.5 cm to 5 cm long. The length and diameter will vary with the age group and condition of the patient. The sheath  50  is formed from elastomeric or polymeric materials that are biocompatible or have a biocompatible coating. The outer surface of sheath  50  may also be treated with biological agents that inhibit production of bacterial biofilm. Magnetic strips  52  are incorporated into the sheath  50  that are at circumferentially spaced locations and are positioned to co-operate with inserts  28   d  provided in the periurethral wall or vaginal wall. 
     A core  54  is dimensioned to be insertable in and occlude the sheath  50 . A flange  56  is provided at the vaginal end of the core  54  to permit rotation of the core  54  in the sheath. The core  54  is of course effective to seal the sheath and inhibit egress from the bladder. 
     The core  54  may be retained by a mechanical locking device that is locked or unlocked by rotation of the core or may utilize magnetic forces for retention as shown in FIGS. 9 and 10. 
     A magnetic strip  58  is incorporated into the outer surface of core  54  and co-operates with the strips  52  in the sheath. Alignment of the strips  52 , 54  provides a magnetic attraction to retain the core  54  and rotation of the core  54  moves the strips out of alignment to release the core. 
     In the device  10   d,  the character of the strips  52 , 58  and inserts  28   d  are selected to that effective magnetic interaction is obtained. Typically, the strips  52  will be magnetized and the inserts  28   d  and strips  58  will be magnetizable. The converse may be selected although care should be taken with the polarity of the magnets. 
     The provision of the sheath  50  avoids the irritation that might otherwise occur with repeated insertion and removal of the core in the urethra. 
     An alternative manner of retaining the sheath is shown in FIG. 11 where a suffix ‘e’ is used to denote like components. 
     In the device  10   e,  the sheath  50   e  is retained by a folding tie bar  60  hinged at one end of the sheath  50   e.  The tie bar  60  is relatively narrow so as not to occlude significantly the sheath and has living hinge points indicated at  62 . Hinge points  62  bias the tie bar to lie flat perpendicular to the urethra so as to engage the bladder neck and inhibit removal of the sheath  50   e.  The tie bar  60  may be extended in the direction of the sheath during insertion by application of a suitable tool along the axis of the sheath and upon release will return to the flat perpendicular orientation. 
     The core  54   e  is retained in the sheath  50   e  in a manner similar to that noted above allowing repeated removal and insertion.