Abstract:
An incontinence treatment device and method of treating urinary incontinence in a person includes fabricating an artificial urethra to have a flow diameter formed inside of a circumferential wall and a closure device attached directly to a portion of an outer surface of the circumferential wall of the artificial urethra. The artificial urethra is sized to be spliced to a natural urethra for alignment of the flow diameter of the artificial urethra with a lumen of the natural urethra. A pump is provided for moving liquid out of a reservoir and into the closure device to push the outer surface of the circumferential wall into the flow diameter of the artificial urethra, which operates to close the flow diameter of the artificial urethra.

Description:
BACKGROUND 
     Devices for treating urinary incontinence include slings, supports, artificial urinary sphincters and other devices that are implanted in a patient&#39;s body to support and/or coapt the urethra. 
     A sling is a device that is surgically implanted under the urethra to support the urethra and inhibit urine from leaking out of the urethra during a provocative event such as coughing or sneezing. Slings are typically implanted through one or more incisions and anatomically secured to supporting tissue(s). 
     An artificial urinary sphincter is generally provided as an inflatable ring or cylinder that is surgically implanted around a portion of the urethra. Some people become incontinent after having some or the entire prostate removed, which can result in a loss of some or all of the function of the prostatic urinary sphincter. An artificial urinary sphincter implanted around the compromised prostatic urinary sphincter can provide the patient with improved control of urinary function. However, the placement of an artificial urinary sphincter around a section of natural urethra can lead to undesirable erosion of the tissue of the urethra, which has the potential to reduce the efficacy of the artificial sphincter. 
     Improved incontinence treatment devices would be welcomed by both the patient and the surgical staff. 
     SUMMARY 
     One aspect provides an incontinence treatment device including a synthetic urethra and a closure device for the synthetic urethra. The synthetic urethra provides a flow diameter that is configured to be spliced into a natural urethra such that the flow diameter is aligned with a lumen of the natural urethra for passage of urine. The closure device includes a pump communicating between a reservoir and a manifold. The manifold is attached to a wall of the synthetic urethra. The pump is operable to move a liquid from the reservoir to the manifold to displace the wall and substantially close the flow diameter of the synthetic urethra. 
     One aspect provides an incontinence treatment device including a synthetic urethra and a closure device for the synthetic urethra. The synthetic urethra provides a flow diameter that is configured to be spliced into a natural urethra such that the flow diameter is aligned with a lumen of the natural urethra for passage of urine. The closure device includes a pump communicating between a reservoir and a cuff. The cuff is separate from the synthetic urethra and attachable around an outer circumference of the synthetic urethra. The pump is operable to move a liquid from the reservoir to inflate the cuff, and the inflated cuff is adapted to circumferentially compress and constrict the flow diameter of the synthetic urethra. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
         FIG. 1  is a perspective view of one embodiment of an incontinence treatment device including a closure device attached to a synthetic urethra. 
         FIG. 2  is a cross-sectional view of a pump of the closure device illustrated in  FIG. 1 . 
         FIG. 3A  is a cross-sectional view of the incontinence treatment device illustrated in  FIG. 1  showing an open flow diameter through the synthetic urethra sized for the passage of urine. 
         FIG. 3B  is a cross-sectional view of the incontinence treatment device illustrated in  FIG. 1  showing a coapted flow diameter of the synthetic urethra that impedes the passage of urine to provide the user with a continent state. 
         FIG. 3C  is a cross-sectional view of one embodiment of a synthetic urethra having an open flow diameter for the passage of urine. 
         FIG. 3D  is a cross-sectional view of the synthetic urethra illustrated in  FIG. 3C  with a coapted flow diameter that impedes the passage of urine to provide the user with a continent state. 
         FIG. 4  is a schematic view of the incontinence treatment device illustrated in  FIG. 1  implanted in a male user. 
         FIG. 5  is a perspective view of the synthetic urethra of the incontinence treatment device illustrated in  FIG. 4  spliced between the prostatic urethra and the membranous urethra. 
         FIG. 6  is a perspective view of one embodiment of a synthetic urethra of an incontinence treatment device as illustrated in  FIG. 1  spliced between sections of a natural urethra of a female. 
         FIG. 7  is a perspective view of one embodiment of an incontinence treatment device including an artificial urinary sphincter closure device attachable to a section of synthetic urethra. 
         FIG. 8  is a perspective view of one embodiment of the section of synthetic urethra illustrated in  FIG. 7 . 
         FIG. 9  is a perspective view of one embodiment of an incontinence treatment device including a pair of artificial urinary sphincter closure devices attachable to a section of synthetic urethra. 
     
    
    
     DETAILED DESCRIPTION 
     In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. 
     It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise. 
     Tissue includes soft tissue, which includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes. As employed in this specification, the term “tissue” does not include bone. 
     In this specification the word “coapt” means to close or to substantially close. To coapt an opening is to bring two surfaces together in close approximation such that the gap between the two surfaces is reduced or eliminated. To coapt a flow diameter means to substantially close the flow diameter to impede the passage of fluid flow through the flow diameter, which when the fluid is urine provides a person with a continent state. 
     In this specification a synthetic urethra is a urethra that is not the patient&#39;s natural urethra. A synthetic urethra is an artificial urethra. A synthetic urethra or a section of synthetic urethra replaces a portion of the patient&#39;s natural urethra to provide a flow diameter for urine between the bladder and the distal exit of the urethra. A synthetic urethra is not a catheter that is inserted into a urethra. 
     Embodiments provide an incontinence treatment device that addresses the issue of erosion of the urethra by providing a section of synthetic urethra and a closure device that is attachable to the section of synthetic urethra. The section of synthetic urethra is configured to be more compliant and more resistant to erosion the natural urethra. The closure device is attachable to the section of synthetic urethra to allow the user to selectively close the flow path through the synthetic urethra to achieve a continent state. The section of synthetic urethra is adapted to be spliced between portions of the natural urethra. 
       FIG. 1  is a perspective view of one embodiment of an incontinence treatment device  20  (device  20 ). The device  20  includes a section  22  of synthetic urethra and a closure device  24  attached to the section  22  of synthetic urethra. The section  22  of synthetic urethra provides a flow diameter  26  sized to be spliced into a portion of a natural urethra to accommodate urine flow. The closure device  24  is operable to selectively close the flow diameter  26  to provide the user with a continent state. 
     In one embodiment, the closure device  24  includes a pump  30  that communicates between a reservoir  32  and a manifold  34  that is attached to the section  22  of synthetic urethra. For example, in one embodiment a tube  36  is connected between the reservoir  32  and the pump  30  and a separate tube  38  is connected between the pump  30  and the manifold  34 . The tubes  36 ,  38  generally provide pathways for liquid that is transported through the action of the pump  30  between the reservoir  32  and the manifold  34 . The tubes  36 ,  38  can optionally include quick-connect and quick-disconnect attachment features that allow the surgeon to connect the tubes  36 ,  38  after implanting the section  22  of synthetic urethra, the pump  30 , and the reservoir  32 . 
     The section  22  of synthetic urethra is sized to be spliced between sections of natural urethra and in one embodiment has an outside diameter of between about 2-10 mm, preferably between about 4-8 mm. In one embodiment, the wall thickness W of the section  22  of synthetic urethra is between about 0.25-1 mm. The length of the section  22  of synthetic urethra is based on the anatomy of the user. For a male user the length of the section  22  of synthetic urethra is between about 2-16 cm, and for a female user the length of the section  22  of synthetic urethra is between approximately 1-4 cm. The above dimensions are provided as suitable examples, although one of ordinary skill in the art will recognize that other dimensions are acceptable based on the size of the anatomy of the end-user. 
     In one embodiment, the section  22  of synthetic urethra is sized to be spliced between sections of a natural prostatic urethra, between sections of a natural membranous urethra, between sections of a natural bulbar urethra, or between sections of a natural penile urethra, or between two of these urethral sections. 
     The section  22  of synthetic urethra is suitably fabricated from natural materials or polymer materials. For example, in one embodiment the section  22  of synthetic urethra is fabricated from autograft material (the patient&#39;s own tissue), allograft material (tissue from a cadaver), xenograft material (tissue from another species), decellularized tissue such as decellularized allograft tissue, or synthetic materials such as rubber, silicone, thermoplastic polymers, thermoset polymers, or blends or copolymers of suitable polymers. 
       FIG. 2  is a cross-sectional view of one embodiment of the pump  30 . The pump  30  includes a bulb  40  having with a bulb volume V and a valve assembly  42  communicating with the tubes  36 ,  38 . In one embodiment, the valve assembly  42  includes an inlet valve  44  biased by a spring  46  and an outlet valve  54  biased by a spring  56 . The bulb  40  is compressible to eject a portion of the bulb volume V past the outlet valve  54  and through the tube  38  to the manifold  34  ( FIG. 1 ). The compression of the bulb  40  creates a vacuum that sucks or siphons fluid through the tube  36  and across the inlet valve  44  into the expanding bulb  40 , which configures the bulb  40  to again eject the fluid from the bulb through the tube  38  to the manifold  34 . The valve assembly  42  is illustrated with ball valves  44 ,  54 , although one of ordinary skill in the art will understand that other valves configured to allow liquid to be drawn from the reservoir  32  and ejected to the manifold  34  are also acceptable. 
       FIG. 3A  is a cross-sectional view of the manifold  34  attached to an exterior wall of the section  22  of synthetic urethra with the flow diameter  26  in an open position.  FIG. 3B  is a cross-sectional view of liquid filling the manifold  34  to close the flow diameter  26 . 
     In one embodiment, the section  22  of synthetic urethra is provided as a tubular segment having an outer perimeter P that is provided by a first portion  60  attached to a second portion  62 , where the first portion  60  is more flexible than the second portion  62 . In this regard, the tubular section  22  of synthetic urethra has a first material property in the first portion  60  that is different than a material property of the second portion  62 . For example, the first portion  60  is supplied with a lower durometer material or a more elastic material than the second portion  62 . In this manner, the first portion  60  is more easily deformed than the second portion  62  (e.g., the first portion  60  stretches more than the second portion  62 ) and will respond to a greater extent for a given force is applied to the section  22  of synthetic urethra. In one embodiment, the manifold  34  extends around less than about one-half of the perimeter P of the section  22  of the synthetic urethra. In one embodiment, the manifold  34  extends around approximately one-half of the perimeter P of the section  22  of the synthetic urethra. 
     In one embodiment, the first portion  60  is fabricated from a rubber having a durometer of between about 20-40 Shore A and the second portion  62  is fabricated from a rubber having a durometer of between about 40-60 Shore A. It is desirable that the manifold  34  is more rigid or firmer than the section  22  of synthetic urethra. In one embodiment, the manifold  34  is fabricated from a rubber or polymer material having a hardness of about 45-70 Shore A such that it is more rigid and less flexible than the section  22  of synthetic urethra. 
       FIG. 3B  illustrates a fluid force acting on the first portion  60  of the tubular section  22  of synthetic urethra. The fluid force presses against the first portion  60  and expands or deforms the first portion  60  inwardly into contact with the second portion  62 . In this manner, the pump  30  operates to move liquid from the reservoir  32  to the manifold  34  to move a wall of the first portion  60  of synthetic urethra inward to substantially close the flow diameter  26  to the passage of urine, which coapts or closes the section  22  of synthetic urethra to provide the user with a continent state. 
     With additional reference to  FIG. 1 , in one embodiment the fluid force is provided by the pump  30  moving a liquid such as saline from the reservoir  32  into the manifold  34 . Alternatively, the fluid force is provided by the pump  30  moving a gas such as air from the reservoir  32  to the manifold  34 . 
     The manifold  34  and the section  22  of synthetic urethra are configured to function over many cycles in a lifetime of use. In one embodiment, the section  22  of synthetic urethra is attached to the manifold  34  such that the section  22  does not slip when the manifold  34  compresses the section  22 . The section  22  of synthetic urethra is fabricated to have a response to deformation such that erosion of the synthetic urethra during use is substantially eliminated. In contrast, when an artificial urinary sphincter is placed over a section of natural urethra the natural urethra will tend to erode and become damaged. The manifold  34  of the closure device  24  cooperates with the section  22  of synthetic urethra to reduce or eliminate erosion in the section  22  of synthetic urethra. 
       FIG. 3C  is a cross-sectional view of a manifold  34 ′ attached to a section  22 ′ of synthetic urethra with the flow diameter  26  in an open position, and  FIG. 3D  is a cross-sectional view of liquid filling the manifold  34 ′ to close the flow diameter  26 . 
     In one embodiment, the section  22 ′ of synthetic urethra has substantially uniform properties throughout its cross-section and the manifold  34 ′ is attached around most (more than one-half) of the outer perimeter P of the section  22 ′ of synthetic urethra. In this regard, the portions of the wall of the section  22 ′ are equally flexible and elastic and it is desirable to compress a sufficient radial amount of the wall of the section  22 ′ to ensure that the flow diameter  26  can be closed. 
       FIG. 3D  is a cross-sectional view illustrating a fluid force pressing against one wall of the section  22 ′ of synthetic urethra to force the wall to close against an opposing wall of the section  22 ′ synthetic urethra to close the flow diameter  26 . 
       FIG. 4  is a schematic view of the incontinence treatment device  20  implanted in a male user. The pump  30  is implanted in the scrotum and communicates between the reservoir  32  and the manifold  34  that is attached to the section  22  of synthetic urethra. The section  22  of synthetic urethra is placed between portions of the natural urethra, for example in a location of the prostatic urethra descending from the bladder. The reservoir  32  is implanted within the patient, for example in the space of Retzius posterior to the pubic symphysis, or alternatively, in a space that is anterior the pubic symphysis. 
       FIG. 5  is a perspective view of the section  22  of synthetic urethra that is spliced between portions of the natural urethra. In one embodiment, the section  22  of synthetic urethra is spliced between the prostatic urethra and the membranous urethra, for example after removal of the prostate gland. The section  22  of synthetic urethra may be suitably spliced to the natural urethra through the use of micro-suturing, welding, adhesive attachment, through the use of bio-adhesive attachment, or through tissue in-growth between the natural urethra and the synthetic urethra. 
     The section  22  of synthetic urethra is configured to replace a section of damaged urethra, for example as sometimes occurs when the prostate is removed. In other embodiments, the section  22  of synthetic urethra is spliced distal to the membranous urethra, for example in a location of the bulbar urethra, or the section  22  of synthetic urethra is spliced into the pendulous urethra. In one embodiment, a length of the section  22  of synthetic urethra is configured to replace substantially all of the male urethra and has a length of about 20 cm. 
     Specific aspects of one suitable surgical procedure for placement of the device  20  are described in the following paragraphs. The patient is typically placed in a dorsal lithotomy position with the legs positioned at about 90 degrees and held in place by stirrups. The patient is catheterized, for example with a 14 French catheter to drain the bladder. The surgeon may elect to leave the catheter in place within the urethra until the urethra is severed for placement of the synthetic urethra  22 . The surgeon makes a vertical perineal incision in the midline and dissects tissue to eventually isolate the ventral bulbous urethra and the prostatic urethra. The surgeon will subsequently expose the bulbospongiosus muscle and dissect further to expose the natural urethra(s). 
     In one example, the prostate has been removed and the surgeon dissects down to expose the urethra posterior the bulbous urethra. A portion of the prostatic urethra is appropriately dissected, and at the surgeon&#39;s preference, a portion of the prostatic urethra is removed to make place for the synthetic urethra  22 . One end of the synthetic urethra is suitably attached to an exposed end the prostatic urethra, for example by micro-suturing or another suitable attachment method that provides a leak resistant attachment of the synthetic urethra  22  to the prostatic urethra. Similarly, an opposing end of the synthetic urethra  22  is attached to an opposing end of the severed prostatic urethra and the flow diameter of the synthetic urethra  22  is aligned with a lumen of the natural urethra. 
     With additional reference to  FIG. 1 , the pump  30  is implanted within the scrotum and reservoir  32  is implanted within the abdomen, for example in the space of Retzius. The reservoir  32  is filled with a liquid and attached to the pump  30 . The pump  30  is attached to synthetic urethra  22  by the tube  38  and the pump  30  is attached to the reservoir  32  by the tube  36 . The surgeon evaluates the function of the pump  30  by moving a liquid from the reservoir  32  into the manifold  34  to coapt the synthetic urethra  22 . 
     The surgical site is closed. The patient is typically catheterized for the duration of the healing process, after which the device  20  is ready for use. 
       FIG. 6  is a schematic view of the section  22  of synthetic urethra implanted in a female. There urethra of the female is substantially shorter than the urethra of the male and has a length of between about 2-4 cm. With this in mind, the section  22  of synthetic urethra is sized to replace a portion or all of the urethra of the female user and is implanted distal the bladder. In one embodiment, the section  22  synthetic urethra is spliced into the natural urethra of the female user between the trigon of the exit of the bladder and a distal exit of the urethra. 
     The reservoir  32  is implanted in a suitable location, for example posterior the pubic symphysis. The pump is likewise implanted in a suitable location of the female anatomy, and in one embodiment is sized to be implanted in the labia majora. With this in mind, one suitable pump  70  is provided for implantation into the labia having a length that is greater than its with and includes a valve assembly  72  that operates in a manner similar to the valve assembly  42  described above. 
       FIG. 7  is a perspective view of one embodiment of an incontinence treatment device  100  (device  100 ). The device  100  includes a section  102  of synthetic urethra and a closure device  104  that is provided to close a flow diameter  106  in the section  102  of synthetic urethra. 
     In one embodiment, the closure device  104  is provided as an artificial urinary sphincter  104  and includes a pump  110  connected between a reservoir  112  and an inflatable cuff  114 . For example, the pump  110  is connected to the reservoir  112  by a tube  116  and is connected to the cuff  114  by a separate tube  118 . The pump  110  is configured to draw a fluid from the reservoir  112  and use the fluid to inflate the cuff  114 . In one embodiment, the fluid is liquid and the pump  110  includes a valve assembly similar to the valve assembly  42  described above. In one embodiment, the fluid is a gas and the pump  110  is an electronic pump configured to compress the gas and use the compressed gas to inflate the cuff  114 . In any regard, the cuff  114  is configured to inflate and compress a wall W of the section  102  of synthetic urethra to close the flow diameter  106  and provide the user with a continent state. 
     In one embodiment, the section  102  of synthetic urethra is provided separately from the cuff  114 . In one embodiment, the cuff  114  is attached to the synthetic urethra  102 , and the synthetic urethra  102  and the cuff  114  are fabricated as a single, monolithic integral unit. 
     The closure device  104  and the section  102  of synthetic urethra are configured to function over many cycles in a lifetime of use. In one embodiment, the section  102  of synthetic urethra and the closure device  104  are fabricated to have approximately equal response to deformation such that erosion of the synthetic urethra during use is substantially eliminated. In contrast, when an artificial urinary sphincter (AUS) is placed over a section of natural urethra, the natural urethra will tend to erode and become damaged because the AUS is more durable than the natural urethra. The closure device  104  cooperates with the section  102  of synthetic urethra to reduce or eliminate erosion in the synthetic urethra. 
       FIG. 8  is a perspective view of the section  102  of synthetic urethra. In one embodiment, the section  102  of synthetic urethra includes at least a portion that is more flexible or more elastic than the remaining portion of the section  102  of synthetic urethra. For example, in one embodiment the section  102  of synthetic urethra is provided as tube having an annular ring with a first portion  122  that is more flexible than a remaining portion  120  of the tube. In this manner, the first portion  122  that is more flexible is more easily deformed and is configured to be activated with a lower pressure delivered from the pump  110  ( FIG. 7 ). 
       FIG. 9  is a perspective view of one embodiment of an incontinence treatment device  200  (device  200 ). The device  200  includes the section  102  of synthetic urethra described above and a closure device  204  that is provided to close the flow diameter  106  in the section  102  of synthetic urethra. 
     In one embodiment, the closure device  204  is provided with the pump  110  that is connected between the reservoir  112  and a pair of inflatable cuffs  214   a ,  214   b . For example, the pump  110  is connected to the reservoir  112  by the tube  116  and the pump  110  is connected to the first cuff  214   a  by a first tube  118   a  and to the second cuff  214   b  by a second tube  118   b . The pump  110  is configured to draw a fluid from the reservoir  112  and use the fluid to inflate the both of the cuffs  214   a ,  214   b  to ensure that a sufficient compression is delivered to the section  102  of synthetic urethra to close the flow diameter  106 . 
     The above-described closure devices  24 ,  104 ,  204  provide means for coapting the flow diameter of a synthetic urethra to allow a user to selectively impede the passage of urine through the synthetic urethra to control continence. 
     Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.