Abstract:
An implantable device arranged to contact the urethral sphincter allows for manipulation of the device from outside the body by the patient.

Description:
FIELD OF THE INVENTION 
     The present application relates generally to patient-manipulable devices for ameliorating incontinence. 
     BACKGROUND OF THE INVENTION 
     Urinary incontinence can have a variety of causes. Such incontinence results when the urethral sphincter does not close sufficiently to block urine flow through the urethra. A second urinary sphincter malady is urinary retention, which can be caused by spinal cord injury. Urinary retention is the outcome of the urethral sphincter not voluntarily relaxing and opening to allow the urethra to open, causing a state of permanent urinary retention. Particularly in the case of males, there is not much real estate with which to work on the urethra since the prostate surrounds a portion of the urethra, dividing the sphincter muscle into two, whereas for females the sphincter extends along the urethra from the bladder to near where it opens to the outside of the body. 
     A common treatment for incontinence is simply inserting a catheter into the urethra. Not only is this an uncomfortable nuisance for the patient, it entails the risk is that of urinary tract infections (UTI), which increase in frequency with the number of catheterizations required. 
     Another treatment which is useful for males only is the use of a so-called artificial urinary sphincter/urethral cuff, in which a working fluid can inflate a cuff that is implanted around the urethra. The working fluid is infused and removed from the cuff pumped by squeezing a pump surgically located in the scrotum. Not only can this device not be used in females, it entails the risk of injury to the scrotum, and patients find it a nuisance to feel for the pump in the scrotum. Moreover, fine tuning the relatively cumbersome cuff to the patient is not possible. 
     For females, pubovaginal slings made of tissue have been provided in which titanium screws are placed in the pelvic bone on both the sides of the urethra. These screws are attached to sutures that support a strip of tissue that is passed beneath the urethra to support the urethra and the bladder, so that the leakage does not occur during coughing, sneezing, laughing or other physical activities. This procedure does not allow for patient control, and entails a risk of perforation of the urethra or bladder neck due to elevated pressure. A similar approach with similar problems is the use of tension-free vaginal tape in which a “hammock” is wrapped around a portion of the abdominal muscle instead of held in place by screws. There is a risk of perforation of the urethra or bladder neck due to elevated pressure, and the device does not compensate for change due to movement of the abdominal muscles due to weight loss or gain, which could lead to stresses that could cause serious damage. Or, ligaments can be attached to a sagging bladder neck and urethra that have dropped abnormally low in the pelvic area, but as understood herein, this procedure caries many of the risks noted above, and also the risk of tearing/bleeding at the sutures attached to the vaginal wall. 
     SUMMARY OF THE INVENTION 
     Accordingly, a device includes a pressure element formed with a pressure surface juxtaposable with the urethral sphincter of a patient. An actuator extends away from the pressure element and is engaged therewith. The actuator can be manipulable by the patient from outside the body of the patient to move the pressure element between a retracted position, in which the pressure surface exerts no more than a first pressure on the urethral sphincter, and an advanced position, in which the pressure surface exerts at least a second pressure on the urethral sphincter. The second pressure is greater than the first pressure, such that in the advanced position incontinence is ameliorated. 
     In an example embodiment, the actuator includes a magnet and a coupler coupling the magnet to the pressure element. In this embodiment, the magnet is movable within the patient by a patient-held actuator magnet moved by the patient outside the patient&#39;s body. The pressure surface is established by a distal end of the pressure element for contacting the urethral sphincter, and if desired the pressure surface can be a continuous curved surface. If desired, a spring may be coupled to the pressure element to bias the pressure element toward the advanced position, and an adjustment mechanism can be coupled to the spring to establish a compression of the spring. 
     As set forth further below, a distal urethra closure establishes, along with the pressure surface, an enclosure in which the urethra can be received. The distal urethra closure may be detachable from the device to permit a surgeon to position the pressure surface next to the urethral sphincter. The distal urethra closure can then be engaged with the device to hold the urethra within the enclosure. Or, the distal urethra closure may hinge on the device between an open configuration, in which the urethra may pass into the enclosure, and a closed configuration, in which the urethra may not pass into the enclosure. 
     In alternate examples, the pressure surface is established by opposed arms each defining a distal end with at least one arm being hinged on the device. The distal ends are distanced from each other in an open configuration to permit the urethra to pass between the arms. Also, the distal ends can be juxtaposed with other in a closed configuration to prevent the urethra from passing between the arms. In this embodiment, the arms can terminate at the respective distal ends. On the other hand, in a sub-embodiment each arm loops back on itself at the respective distal end such that each arm forms a slot into which a portion of the urethral sphincter can be received, such that the urethral sphincter is urged to open the urethra in the open configuration to alleviate urinary retention and such that the urethral sphincter is urged to close in the closed configuration to alleviate incontinence. 
     In yet another non-limiting example the pressure element includes first and second curved arms that criss-cross each other to form a bight into which the urethral sphincter can be positioned. The pressure surface is defined by portions of inner surfaces of the arms bordering the bight. Distal ends of the pressure actuator are engageable with bone structure in the patient. In this embodiment, the actuator includes a manipulator tab positionable under the skin of the patient to permit the patient to urge the arms against the bone structure, thereby enlarging the bight. The manipulator tab is releasable by the patient to permit the arms under material bias to move to shrink the bight around the urethra. 
     In another aspect, a method includes implanting a device in the retropubic space of a patient, with a manipulator member of the device juxtaposed with the top of the pubic symphysis and with the device extending between the pubis and the bladder toward the urethra. The method includes engaging a pressure element of the device with the urethral sphincter. The device has a configuration in which the device applies pressure to the urethral sphincter to alleviate incontinence. 
     In another aspect, an assembly includes an implantable device configured to contact the urethral sphincter. The device includes a reciprocatingly arranged slidable pressure element to selective apply pressure to the urethral sphincter responsive to manipulation from outside the body to alleviate incontinence, with no portions of the device extending outside the body. 
     In another aspect, an implantable device is configured to contact the urethral sphincter. The device includes a C-shaped inflatable cuff defining a longitudinally open slit and central channel. The cuff has a deflated configuration, in which the slit is large enough to accept the urethra of a patient therethrough into the central channel, and an inflated configuration in which the slit is not large enough to allow the urethra to pass therethrough and the cuff exerts surrounding pressure on the urethral sphincter to ameliorate the effects of incontinence. A movable actuator selectively urges the cuff toward the inflated configuration. 
     The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which: 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view showing a first embodiment of the device engaged with a male&#39;s urethral just below the prostate gland; 
         FIG. 2  is a perspective view of a first embodiment with the outer surface transparent to illustrate interior components, with the distal urethra closure in the closed configuration and the pressure element midway between the advanced position and retracted position; 
         FIG. 3  is a perspective view of the first embodiment with the distal urethra closure in the open configuration and the pressure element in the retracted position; 
         FIG. 4  is a perspective view of the distal part of a second embodiment with the outer surface transparent to illustrate interior components, showing a distal urethra closure that is detachable from the device to permit a surgeon to position the pressure surface next to the urethral sphincter, with the distal urethra closure then being engageable with the device as shown to hold the urethra within the enclosure; 
         FIG. 5  is a perspective view of a third embodiment showing a pressure element established by opposed curved arms; 
         FIG. 6  is a perspective view of a fourth embodiment showing a pressure element established by opposed curved arms each of which loops back on itself at the respective distal end such that each arm forms a slot into which a portion of the urethral sphincter can be received, such that the urethral sphincter is urged to open the urethra in the open configuration to alleviate urinary retention and such that the urethral sphincter is urged to close in the closed configuration to alleviate incontinence; 
         FIG. 7  is a perspective view of a fifth embodiment in which the pressure element includes first and second curved arms that criss-cross each other to form a bight into which the urethral sphincter can be positioned; 
         FIG. 8  is a perspective view of the fifth embodiment showing the distal ends of the pressure actuator engaged with the pelvis of the patient such that when the patient presses the manipulator tab, which is positioned under the skin of the patient, the arms are urged against the pelvis, thereby enlarging the bight, with the manipulator tab being releasable by the patient to permit the arms under material bias to move to shrink the bight around the urethra; 
         FIG. 9  is a perspective of a sixth embodiment of a pressure element established by an inflatable cuff; 
         FIG. 10  is a front elevational view of the embodiment shown in  FIG. 9  in the inflated configuration; 
         FIG. 11  is a side elevational view of the embodiment shown in  FIG. 9 ; and 
         FIG. 12  is a front elevational view of the embodiment shown in  FIG. 9  in the deflated configuration. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring initially to  FIG. 1 , a device  10  includes a fluidless pressure element assembly  12  engaged with the urethral sphincter  14  of a patient, just below the prostate gland  16 . An actuator  18  of the device  10  extends away from the pressure element assembly  12  to form an elongated, relatively thin device  10 , and as described further below, the actuator  18  can be manipulated by the patient from outside the body of the patient to move the pressure element assembly  12  between a retracted position, in which a pressure surface of the pressure element assembly  12  exerts no more than a first pressure on the urethral sphincter and preferably exerts no pressure at all on the sphincter, and an advanced position, in which the pressure surface exerts pressure on the urethral sphincter such that in the advanced position incontinence is ameliorated. 
     In the example shown, when implanted the device  10  occupies the retropubic space, extending from the top of the pubic symphysis through the space between the pubis  20  and the bladder  22 , down towards the urethra. Present principles recognize that the retropubic space has certain advantages. It is relatively ‘open’, being occupied by only soft tissue. Also, the pelvis protects the device  10  from accidental damage due to force exerted on the outside of the body near to it. The retropubic space can be accessed surgically either from above (over top of pubis) or below (up through the perineum). 
     In an embodiment described below, in which the actuator  18  includes a magnet, the magnet resides in the end above the pubic symphysis, near the abdominal wall, and is located such that if a magnet with sufficiently large ‘pull’ is held up to the abdomen outside the body in the vicinity of the device magnet, sufficient force is exerted by the exterior magnet to attract the device magnet and actuate the device. If desired, the actuator end of the device with the internal magnet may be fixed to the back of the pubis (e.g., by suturing) to prevent damage to the urethra due to undesired movement of the device body caused by movement or pull of internal magnet. 
     A minimally invasive implantation procedure can be employed when placing and tuning the device  10 . The slim profile of the device would allow the device to pass through a relatively small opening. The exterior housing of the device  10  can be made of a biocompatible material such as but not limited to Salubria. 
       FIG. 2  shows details of an example embodiment of the device  10 . As shown, the actuator  18  includes a biocompatible housing  24  with a magnet enclosure  26  configured to closely receive a permanent magnet  28  therein. The magnet  28  can slide within the enclosure  26  under the influence of a magnetic force from a patient-holdable actuator magnet  30  located outside the body. 
     In the example shown, the permanent magnet  28  is parallelepiped-shaped as is the enclosure  26 , and the magnet  28  can slide from a rear wall  32  of the enclosure  26  to a front wall  34 . The width and depth of the enclosure  26  may be slightly larger than the width and depth of the magnet  28 . If desired, a magnetic or non-magnetic extension  36  can be provided on a front face of the magnet  28  and can slide in an extension enclosure  38  that is contiguous to the enclosure  26  which holds the permanent magnet  28 . As was the case with the magnet  28 /enclosure  26 , the extension enclosure  38  is but marginally larger in width and thickness than the extension  36 , so that the enclosures  26 ,  38  closely bear the respective magnet  28 /extension  36  as the magnet  28  and extension  36  slide together along the longitudinal axis of the device  10  between the retracted and extended positions under the influence of the actuator magnet  30 . 
     A coupler couples the magnet  28  to the pressure element assembly  12 . In the embodiment shown, the coupler is established by two elongated axially stiff wires, lines, or rods  40  that extend through an elongated connector segment  42  of the housing  26  from the extension  36  to a slidable pressure element  44  of the pressure element assembly  12 . A distal end  46  (which may be a continuous curved surface such as concave as shown) of the pressure element  44  establishes a pressure surface that faces the urethral sphincter surrounding the urethra when the device  10  is implanted as shown in  FIG. 1 . 
     In the example shown, a leaf or more preferably coil spring  48  is disposed in the housing  24  in compressive contact with the pressure element  44  to bias the pressure element  44  toward an advanced position, in which the pressure element  44  exerts a pressure on the urethral sphincter which is greater than the pressure exerted by the pressure element  44  on the sphincter when the pressure element  44  is in a retracted position away from the sphincter. Note that in the retracted position, the pressure element  44  may exert little or no pressure on the sphincter and urethra. In any case, it may now be readily appreciated that when a person moves the actuator magnet  30  outside the body and relatively closely spaced from the permanent magnet  28  (typically separated only by a few centimeters of soft tissue), the magnetic coupling between the magnets enables a person to move the permanent magnet and, hence, the pressure element  44  between the advanced and retracted positions to respectively close off the urethra to ameliorate incontinence, and to permit the urethra to open to pass urine. 
     If desired, an adjustment mechanism  50  may be coupled to the spring  48  to establish a compression of the spring and hence a preloading of the compressive force exerted by the pressure element  44  on the urethra, to “fine tune” the operation of the device to the particular physiology of the patient. In the example shown, the adjustment mechanism  50  is a set screw threadably engaged with the housing  24  in contact with the spring  48 . A surgeon may advance or retract the set screw by rotating it as appropriate to establish a clinically appropriate compression preload on the pressure element  44 . 
     In non-limiting examples, a catheter-borne pressure sensor can be used to measure pressure within the urethra while a tool such as an Allen wrench is used to adjust the screw depth until the desired pressure was attained. This ensures that the device did not exert over-pressure, which could cause damage to the sphincter and/or urethra, or under-pressure, defined as pressure too low to reliably maintain continence. In embodiments in which permanent retention is an issue, the spring  48  may be dispensed with. 
     In cross-reference to  FIGS. 2 and 3 , a distal urethra closure establishes, along with the pressure surface  46  of the pressure element  44 , an enclosure  54  in which the urethra can be received. In one example, the distal urethra closure includes first and second curved closure arms  56  that are hingedly engaged with the housing  24  between an open configuration ( FIG. 3 ), in which the urethra may pass into the enclosure  54 , and a closed configuration ( FIG. 2 ), in which the urethra may not pass into (or out of) the enclosure  54 . The surgeon manually moves the arms  56  to the open configuration, advances the device  10  to the urethra until the urethra is positioned in the enclosure  54 , and then closes the arms. The arms may be held closed by a friction fit between the arms and the housing, solvent bonding applied by the surgeon, sutures, a clip structure on one arm engaging a recess in the other arm, or other suitable closure methods. 
     Alternatively,  FIG. 4  illustrates a unitary closure element  58  that is detachable from the device to permit a surgeon to position the pressure surface next to the urethral sphincter, with the distal urethra closure then being engageable with the device to hold the urethra within the enclosure. In the embodiment shown, channels in the closure element  58  can be engaged with complementarily-shaped and -sized pins  60  in the housing, with two pins on each side as shown in the example embodiment of  FIG. 4 . A friction fit between the closure element  58  and pins  60  (or other appropriate fixation structure) can be used to hold the closure element  58  onto the housing of the device as shown in  FIG. 4 . 
     Refer now to  FIGS. 5 and 6 , which show respective alternate embodiments that in all essential respects are identical to that shown in  FIGS. 2 and 3  with the following exceptions. In  FIG. 5 , a pressure element of a device  100  is established by opposed curved arms  102  each defining a respective distal end  104 , with at least one arm and preferably both arms  102  being hinged on a housing  106  of the device  100 . When the permanent magnet in a magnet housing  108  of the device  100  is retracted (away from the urethra), the arms  102  are retracted into a distal opening  110  of the housing  106  with the outer surfaces of the arms  102  riding against the periphery of the opening  110 , which urges the arms  102  to pivot so that the distal ends  104  move toward each other to establish a closed configuration to trap the urethra between the arms. On the other hand, when the magnet is moved toward the urethra the arms  102  move outward, pivoting under, e.g., the influence of material bias as they clear the opening  110  to an open configuration in which the distal ends  104  are distanced from each other to establish an open configuration to permit the urethra to pass between the arms. In  FIG. 5 , the arms  102  terminate at the respective distal ends  104 . 
     In contrast,  FIG. 6  shows a device  200  which is substantially identical to the device  100  shown in  FIG. 5  except that each of two arms  202  loops back on itself at a respective distal end  204  such that each arm  202  forms a respective slot  206 . A portion of the urethral sphincter can be received in the slots  206  with the urethra itself remaining in a central enclosure  108 . This is possible because the urethral sphincter is horseshoe-shaped and does not completely surround the urethra. With the device  200 , the urethral sphincter can be urged to open the urethra by moving the permanent magnet toward the urethra to cause the arms  202  to pivot open, pulling the sphincter outwardly from the urethra. This alleviates urinary retention. Also, the urethral sphincter is urged to close when the arms are pulled away from the urethra to alleviate incontinence. 
       FIGS. 7 and 8  illustrate yet another alternate incontinence relief device  400  that can be engaged with the urethral sphincter to close it off. In the device  400 , which may be made of a single unitary piece of biocompatible plastic, a pressure element is established by first and second curved flexible arms  402  that criss-cross each other to form a bight  404  into which the urethral sphincter can be positioned. A pressure surface is defined by portions  406  of inner surfaces of the arms bordering the bight. 
     Distal free ends  408  of the arms  402  can be engaged with bone structure in the patient such as the pelvis. Opposite the free ends  408 , a solid, preferably rectilinear manipulator tab  410  is coupled to the arms  402  and may be positioned under the skin of the patient to permit the patient to urge the arms  402  against the bone structure, thereby enlarging the bight  408 . The manipulator tab can then be released by the patient to permit the arms  402  under material bias to move to shrink the bight  408  around the urethra to alleviate incontinence. 
     In the specific example shown, the arms  402  are coupled to opposed outer edges of the tab  410 . The arms  402  extend inwardly from the tab, crossing each other at  412 , then curve in respective convex segments  414  to establish the bight  404 , crossing each other again at  416  and continuing to extend away from each other along distal segments  418  to the distal ends  408 . Because they are flexible, a surgeon can pull the distal segments  418  of the arms  402  away from each other sufficiently to pass the urethra between the arms into the bight  404 , at which point the arms are released to move back toward each other, closing the bight and trapping the urethra therein. The tab  410  is surgically located above the pubic symphysis, similar to the previous embodiments, such that pressure with a finger or palm on the lower abdomen exerts pressure on the tab  410 . The resulting mechanical deflection causes the arms  402  bow outwards, relaxing the pressure on the urethra and allowing for normal voiding. 
     It may now be appreciated that the devices herein require no mechanical or electrical connections outside the patient while avoiding infections that can be caused by catheters. Not only do the devices assist in alleviating incontinence, but they also do not destroy anything in the body. Beneficially, implantation may be done clinically without the need for the patient to spend the night at a hospital, and the chance for infection is much lower because nothing crosses the boundary between the inside and outside of the body since there is no way for infection to get in. The implanted device has an adjustability quality because it assists the sphincter as set when implanted, so it will provide the appropriate pressure required to prevent incontinence. 
       FIGS. 9-12  show an alternate device  500  that is established by a C-shaped inflatable cuff  502  defining a longitudinally open slit  504  and central channel  506 . The cuff  502  has a deflated configuration ( FIG. 12 ), in which the slit  504  is large enough to accept the urethra of a patient therethrough into the central channel  506 . Also, the cuff  502  has an inflated configuration ( FIGS. 9 and 10 ) in which the slit  504  is not large enough to allow the urethra to pass therethrough and the cuff  502  exerts an even, surrounding pressure on the urethral sphincter to ameliorate the effects of incontinence. A reciprocatingly arranged actuator  507  such as a magnet can be moved to selectively urge the cuff  502  toward the inflated configuration. As was the case with the previous embodiments, the actuator is manipulable by the patient from outside the body of the patient to move the cuff  502 . 
     As shown, a rigid plastic or metal C-shaped support  508  surrounds the cuff  502  in contact with the cuff such that inflation of the cuff does not change the outer diameter of the cuff, being constrained by the support  508 , but only causes the inner diameter of the cuff to decrease. A cylindrical or rectilinear inflatable tube  510  may be in fluid communication with the cuff  502 , extending away from the cuff through an opening in the support  508  as shown. The actuator  507  bears against the tube  510  to urge fluid in the tube into the cuff and thereby urge the cuff toward the inflated configuration. 
     In operation, the surgeon advances the cuff in the deflated configuration around the urethral sphincter through the slot  504 . The cuff  502  and tube  510  are then inflated with a working fluid such as a flowable silicone used in breast implants or saline. The amount of inflation is as clinically necessary to close the urethra of the particular patient. Subsequent movement of the actuator  507  (e.g., by moving a magnet outside the body to move a magnetic-based actuator  507 ) against the tube  510  squeezes the tube, urging fluid from the tube into the cuff  502  to cause it to clamp down on the urethral sphincter. In alternate structural cooperation the actuator  507  may be moved to relieve pressure on the tube and, hence, on the cuff to facilitate voiding by the patient. 
     While the particular PATIENT-MANIPULABLE DEVICE FOR AMELIORATING INCONTINENCE is herein shown and described in detail, it is to be understood that the subject matter which is encompassed by the present invention is limited only by the claims.