Abstract:
A method of treating incontinence includes implanting the incontinence treatment device having a sling connected between first and second anchors into a patient, and moving an adjustment device through a channel from a first position to a second position that locates the second anchor between the adjustment device and the sling, thus tightening the sling by shortening an effective distance of the device between the first and second anchors.

Description:
BACKGROUND 
     Devices for treating urinary incontinence include slings, supports, artificial urinary sphincters and other devices that are implanted in a user to support and/or coapt the urethra. 
     A sling is a device that is surgically implanted to support the urethra and inhibit urine from undesirably leaking from the urethra. Slings are typically fabricated from mesh and are implanted through one or more incisions. The sling is secured to supporting tissue(s) and the tissue eventually grows through the mesh to support the urethra. The surgeon will peri-operatively determine and achieve the appropriate level of tension in the sling relative to the urethra that will post-operatively provide the user with a continent state. 
     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 non-porous sub-urethral sling provided with an adjustment device. The device includes a first extension member attached to a first end of the sling, a first anchor attached to the first extension member, and a first line attached to the first end of the sling and inserted through a bore formed through the first anchor. The first line includes a stop device fixed to the first line with the first anchor positioned between the stop device and the sling. The device also includes a second extension member attached to a second end of the sling, a second anchor attached to the second extension member, and a second line attached to the second end of the sling. The second anchor includes a channel formed through the second anchor and a restrictor segment provided in the channel. The adjustment device is attached to the second line and is movable through the channel formed through the second anchor. The resistor segment is configured to resist movement of the adjustment device through the channel. 
    
    
     
       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 provided with an anchor and an adjustment device. 
         FIG. 2  is a perspective view of the anchor and the adjustment device illustrated in  FIG. 1 . 
         FIG. 3  is a cross-sectional view of the anchor and the adjustment device illustrated in  FIG. 1 . 
         FIG. 4A  is a schematic view of an incontinence treatment device implanted in the user and configured to allow the passage of urine. 
         FIG. 4B  is a schematic view of the incontinence treatment device illustrated in  FIG. 4A  adjusted to coapt a urethra of the user. 
         FIG. 5A  and  FIG. 5B  illustrate various adjustment states for the incontinence treatment device illustrated in  FIG. 4B . 
         FIG. 6  is a schematic view of one embodiment of an incontinence treatment device implanted in a user. 
         FIG. 7  is a schematic view of one embodiment of an incontinence treatment device planted in a user. 
     
    
    
     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 urethra means to substantially yet reversibly close the urethra to impede the passage of urine and provide a person with a continent state. 
     In this specification a “user” is one into whom an incontinence treatment device has been implanted. 
     In this specification “non-porous” means a material with no through-holes. For example, while the non-porous material might include divots and/or recesses in a surface of the material, the material does not have holes that extend through the material from one surface to the other surface. Non-porous, as employed in this specification, thus means a material that is configured to prevent tissue growth through the implanted material. 
     Embodiments provide an incontinence treatment device provided with a non-porous support and an adjustment mechanism attached to the support. The non-porous support discourages or does not allow tissue to growth through the support such that the support will be able to move relative to the tissue long after having been implanted. The adjustment mechanism operates to adjust and move the non-porous support. The adjustment mechanism moves the support between a first position that allows the passage of urine and a second position that coapts the urethra. The adjustment mechanism is provided as an adjustment device that frictionally engages with a restrictor segment provided inside of a channel of an anchor. The adjustment device is adapted to be forced past the restrictor segment into the second position that is configured to tension the support and coapt the urethra. 
       FIG. 1  is a perspective view of one embodiment of an incontinence treatment device  20 . The incontinence treatment device  20  (device  20 ) includes a sling  22  or a support  22  provided with tissue anchors  40 ,  42  and an adjustment mechanism  70 . The tissue anchors  40 ,  42  fix the sling  22  into place within the pelvis and the adjustment mechanism  70  is accessible by the user/patient to adjust a position of the sling  22 . The sling  22  is provided as a non-porous material that prevents body tissue from growing into or through the sling  22  after implantation. The adjustment mechanism  70  is operable to move the sling  22  relative to tissue to move the sling  22  between a first position that allows the passage of urine through the urethra and a second position that coapts the urethra. 
     The sling  22  includes a first end  24  and a second end  26 . The device  20  includes a first extension member  30  attached to the first end  24  and a second extension member  32  attached to the second end  26  of the support  22 , a first anchor  40  attached to the first extension member  30  and a second anchor  42  attached to the second extension member  32 , with a first line  50  inserted through the first anchor  40  and a second line  52  inserted through the second anchor  42 . The first line  50  is attached to the first end  24  of the sling  22  and is provided with a stop device  60 . The first anchor  40  is positioned between the stop device  60  and the sling  22 . The second line  52  is attached to the second end  26  of the sling  22  and is provided with an adjustment device  62 . The adjustment device  62  is movable through a channel that is formed in the second anchor  42  such that the adjustment device  62  and the second anchor  40  combine to provide the adjustment mechanism  70 . 
     The sling  22  is configured to be implanted into a user to support the urethra and treat incontinence. In one embodiment of the sling  22  is a sub-urethral sling  22  that is implanted under or inferior relative to the urethra. In one embodiment, each of the first and second anchors  40 ,  42  is fixed in position relative to the sling  22 , for example by fixing a length of the first and second extension members  30 ,  32  and then connecting the anchors  40 ,  42  to a respective one of the members  30 ,  32 . Adjustment of the device  20  is provided by the adjustment mechanism  70 . 
     The adjustment mechanism  70  is operable to move the sling  22  between a first configuration that allows the user to pass urine and a second configuration that supports and coapts the urethra to provide the user with a continent state. In one embodiment, the adjustment mechanism  70  is user-operable long after the sling  22  has been implanted and the surgical site has healed. With this in mind, in one embodiment the sub-urethral sling  22  is provided as a non-porous film that is adapted to reduce or prevent tissue growth through the sling  22 , which allows the sling  22  to move or slide relative to the tissue after implantation. 
     The sling  22  is suitably fabricated from polymer materials. For example, in one embodiment the sling  22  is a synthetic material fabricated from rubber, silicone, thermoplastic polymers, thermoset polymers, or blends or copolymers of suitable polymers. One suitable sling  22  is molded from silicone polymer. 
     The extension members  30 ,  32  are secured to the anchors  40 ,  42 , respectively. The extension members  30 ,  32  and the anchors  40 ,  42  are fabricated from material that is suited for implantation into the human body. Preferably, the extension members  30 ,  32  and the anchors  40 ,  42  do not bio-absorb after implantation. As one example, the extension members  30 ,  32  and the anchors  40 ,  42  are suitably fabricated from polypropylene. 
     Each of the anchors  40 ,  42  is configured to be inserted into and engaged with tissue. In one embodiment, each anchor is provided with at least one projection  80  that extends away from a central axis of the anchor and is so configured to engage with tissue. In the illustrated embodiment, each of the anchors  40 ,  42  includes multiple projections  80 —or wings—that configure each anchor  40 ,  42  to engage with tissue when implanted. 
       FIG. 2  is a perspective view and  FIG. 3  is a cross-sectional view of one embodiment of the adjustment mechanism  70 . One of the anchors  40 ,  42 , for example in this embodiment the second anchor  42 , is provided with a channel  90  that extends between a first end  92  and a second end  94  of the anchor  42 . The channel  90  is formed to include a restrictor segment  96  between the first and second ends  92 ,  94 . 
     In one embodiment, the second extension member  32  is attached to an exterior surface of the second anchor  42 . In one embodiment, the second extension member  32  is overmolded into a polymer wall of the second anchor  42 . 
     The second line  52  is inserted through the channel  90  of the second anchor  42 . The adjustment device  62  is sized to have a lateral dimension that is larger than a lateral dimension of the restrictor segment  96 . In this manner, the adjustment device  62  is retained at the first end  92  of the anchor  42  when the adjustment mechanism  70  is in a first position that allows the user to urinate. The adjustment device  62  is adapted to be pulled through the restrictor segment  96  when force is applied to the second line  52 , which pulls the adjustment device  62  from the first end  92  to the second end  94  of the anchor  42 . The restrictor segment  96  is provided to maintain the adjustment device  62  adjacent to the second end  94  of the anchor  42  until the user applies a restoring force to the second line  52 , at which point the adjustment device  62  moves back through the channel  90  to the first end  92  of the anchor  42 . The selective placement of the adjustment device  62  adjacent to the second end  94  of the anchor  42  reduces an effective length of the sling  22 , which operates to close down the urethra and provide the user with a continent state. 
     In one embodiment, the first and second extension members  30 ,  32  are secured to each of the respective anchors  40 ,  42  and these elements combine to provide the device  20  with a fixation mechanism that is configured to secure the sling  22  into tissue when implanted. The sling  22 , when implanted, is thus suspended on a path having a path length that extends between the anchors  40 ,  42 . The first and second lines  50 ,  52  are movable relative to the anchors  40 ,  42 , respectively. In one embodiment, at least second line  52  is movable through the second anchor  42  to shorten the path length of the sling  22 , which allows compression to be applied to the urethra to achieve a continent state as illustrated and described in  FIGS. 4A and 4B  below. 
     The lines  50 ,  52  are fabricated from material that is suited for implantation into the human body. Preferably, the lines  50 ,  52  do not bio-absorb after implantation. As one example, the lines are suitably fabricated from polypropylene. 
       FIG. 4A  is a schematic view of the device  20  as implanted. When implanted, the non-porous structure of the sling  22  will resist and prevent tissue from growing through or attaching to the sling  22 . Eventually, a protective pocket of epithelial tissue will grow around the device  20 . The non-porous nature of the sling  22  allows portions of the device  20  to move within the pocket of tissue that surrounds the sling  22 . 
     During implantation, the first and second anchors  40 ,  42  are fixed into tissue and the sling  22  is suspended along a path length PL 1  that extends between the anchors  40 ,  42  under the urethra U. Although the anchors  40 ,  42  are fixed in the tissue, the non-porous sling  22  is free to move relative to the tissue. The adjustment mechanism  70  occupies a first position where the adjustment device  62  is located between the sling  22  and the second anchor  42 . In the illustrated first position, the sling  22  is under the urethra U and the urethra U is not coapted, which allows the user to pass urine. The adjustment mechanism  70  operates to move the sling  22 , which shortens the path length PL 1 , which tensions the sling  22  to coapt the urethra U as shown in  FIG. 4B . 
       FIG. 4B  is a schematic view of the device  20  with a force F applied to the second line  52  that is sufficient to draw the adjustment device  62  through the anchor  42 . With additional reference to  FIG. 3 , the force F applied to the second line  52  pulls the adjustment device  62  through the restrictor segment  96  until the adjustment device  62  is seated on the second end  94  of the anchor  42 . The selective placement of the adjustment device  62  through the anchor  42  to position the anchor  42  between the adjustment device  62  and the sling  22  moves the adjustment mechanism  70  into a second position that shortens the path length from PL 1  to a shorter path length PL 2 . The shorter path length PL 2  allows the sling  22  to compress and coapt the urethra U. In the illustrated second position, the sling  22  is tightened and effectively shortens a distance of the device  20  between the first and second anchors  40 ,  42 , which coapts the urethra U to provide the user with a continent state. 
       FIGS. 5A and 5B  are schematic views of the device  20  with a force F applied to the first line  50  ( FIG. 5A ) to move the adjustment mechanism  70  from the second position back to the first position ( FIG. 5B ) to allow the user to pass urine. For example, the force F applied to the first line  50  draws the stop device  60  away from the first anchor  40  and pulls the adjustment device  62  back through the channel  90  ( FIG. 3 ) formed in the anchor  42 . In this manner, the adjustment device  62  is once again located between the sling  22  and the anchor  42 , which loosens the sling  22 . Placement of the adjustment device  62  between the sling  22  and anchor  42  effectively increases the distance of the device  20  between the anchors  40 ,  42 . Increasing the effective distance of the device  20  relieves the tension in the sling  22 , which relieves the constriction of the sling  22  against the urethra U to allow the urethra U to open and pass urine. 
     The incontinence treatment device  20  is implantable into the pelvis of the user. The adjustment mechanism  70  operates to allow the user to select a first configuration of the device  20  that allows urination or a second configuration that provides the user with a continent state. 
     In one embodiment, the first line  50  and the second line  52  are directed to a location outside the patient&#39;s body (for example through the abdominal wall or through the groin) to allow the user to access and selectively move the adjustment mechanism  70 . 
     In one embodiment, the first line  50  and the second line  52  are directed to a location within the patient&#39;s body (for example within the scrotum or the labia) and also operate to provide the user with access to the adjustment mechanism  70 . 
       FIG. 6  is a schematic view of the device  20  implanted within a pelvis P of a user. In one embodiment, each of the anchors  40 ,  42  is suitably implanted into a membrane of the obturator foramen OF to position the sling  22  under the urethra U. Each of the first and second lines  50 ,  52  are directed through the skin of the patient to a location outside the body that permits the user to adjust the adjustment mechanism  70  and move the urethra U between open and closed positions. A suitable antibiotic or barrier at the skin is employed to prevent the migration of bacteria along the lines  50 ,  52  into the patient&#39;s body. 
     The device  20  is configured to be implanted into the patient through a single incision. In one exemplary approach, a single incision is made near the urethra and tissue is dissected to expose the urethra U. A suitable introducer tool is employed to direct the first anchor  40  into the membrane covering the first obturator foramen OF and to permit the first line  50  to trail through the skin to a location outside of the body. A similar introducer tool is employed on the contralateral side of the body to place the second anchor  42  into the membrane covering the second obturator foramen OF and pass the second line  52  through the skin to a location outside of the body. In one suitable implantation procedure, the incision is made to expose the urethra (a vaginal incision for a female or a perineal incision for a male) and the introducer tool is moved from an “outside in” path from the groin, through the membrane over the obturator foramen OF, around the descending pubic ramus PR, and out of the incision for engagement with the first line  50  and the first anchor  40 . The introducer tool that is now attached to the first line  50  and the first anchor  40  is pulled back along its pathway around the descending pubic ramus PR, through the obturator foramen OF, and out of the skin. A similar “outside in” path is employed on the contralateral side of the body to place the second line  52  and the second anchor  42 . 
       FIG. 7  is a perspective view of the device  20  implanted in a pelvis P of the user with the first and second lines  50 ,  52  implanted under the skin and in the body of the user. In one embodiment, the anchors  40 ,  42  are secured within the tissue covering the obturator foramen OF to suspend the sling  22  under the urethra U. In one embodiment, each of the first and second lines  50 ,  52  is suitably tunneled to a location inside the body such as within the skin of the scrotum or within the labia of a female user. It is desirable that the user is able to apply a force the both the first line  50  and the second line  52 . With this in mind, a grasping device  98  is attached to an end of each of the lines  50 ,  52  to allow the user to apply a pulling force along the lines  50 ,  52  to move the adjustment mechanism  70  and open/close the urethra U. 
     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.