Implantable Article and Method

Abstract

An implantable article and method of use are disclosed to treat urological disorders. The biocompatible device includes a sling assembly configured to be minimally invasive and provide sufficient support to the target site. In addition, the configuration of the sling assembly also allows the position of the sling to be permanently changed during and/or after implantation.

1 . A sling for treating urinary incontinence in a patient comprising:
 first and second major surfaces,   a pair of end portions,   a support portion for placement in a therapeutically effective position relative to a physiological environment intended to be supported, the support portion having an axially elongate mesh, and a pair of ends, and   repositioning means, associated with the sling, for transferring sling tightening or sling loosening forces along the sling to afford effective, permanent repositioning of the sling without adversely affecting the therapeutic effect of the sling.   
     
     
         2 . A sling according to  claim 1  wherein the sling is constructed for treating female incontinence with a surgical procedure that includes a vaginal incision, and the repositioning means is without any structure that extends through the vaginal incision. 
     
     
         3 . A sling according to  claim 1  wherein the sling includes a removable sheath and the repositioning means affords permanent tightening of the sling when the sling is partially implanted and the sheath is removed, by pulling on the sling and repositioning means at a suprapubic location. 
     
     
         4 . A sling according to  claim 1  wherein the sling is initially placed via an access incision such as a vaginal incision, and the repositioning means affords post operative loosening of the sling after the vaginal incision is closed without any subsequent vaginal incision and without any structure extending through the original vaginal incision. 
     
     
         5 . A sling according to  claim 1  wherein the repositioning means transfers sling tightening or sling loosening forces along the sling while avoiding permanent deformation of the sling. 
     
     
         6 . A sling according to  claim 1 , wherein the repositioning means comprises at least one filament threaded along the mesh. 
     
     
         7 . A sling according to  claim 6 , wherein the filament is attached to the mesh at the ends of the support portion. 
     
     
         8 . A sling according to  claim 1 , wherein the repositioning means comprises at least one filament integrally woven in the mesh. 
     
     
         9 . A sling according to  claim 1 , wherein the mesh has a length, and the repositioning means comprises a plurality of filaments that are each threaded along substantially the entire length of the mesh. 
     
     
         10 . A sling according to  claim 9  wherein the filaments extend from an edge of the support portion to the other edge of the support portion. 
     
     
         11 . A sling according to  claim 1 , wherein the mesh of the support portion is woven and the repositioning means comprises a portion of the support portion that is more tightly woven than another portion of the support portion. 
     
     
         12 . A sling according to  claim 1 , wherein the sling comprises a woven mesh and the repositioning means comprises a portion of the mesh that is more tightly woven than another portion of the sling. 
     
     
         13 . A sling according to  claim 1 , wherein the repositioning means is constructed to afford transfer at least some of a repositioning force applied to the sling to an end of the support portion. 
     
     
         14 . A sling according to  claim 1  wherein the sling includes synthetic material. 
     
     
         15 . A sling according to  claim 1 , wherein the repositioning member includes a coating selected from the group consisting of medicaments, hormones, antibiotics, antimicrobials, dyes, silicone elastomers, polyurethanes, radiopaque substances, anti-bacterial substances, and combinations thereof. 
     
     
         16 . A sling according to  claim 1  wherein the sling includes a coating selected from the group consisting of medicaments, hormones, antibiotics, antimicrobials, dyes, silicone elastomers, polyurethanes, radiopaque substances, anti-bacterial substances, and combinations thereof. 
     
     
         17 . A sling according to  claim 1  wherein at least a portion of the sling is constructed from a bioabsorbable material constructed to retain predetermined properties after implantation for at least a predetermined amount of time. 
     
     
         18 . A sling according to  claim 1  wherein at least a portion of the repositioning member is a resorbable material constructed to retain predetermined properties after implantation for at least a predetermined amount of time. 
     
     
         19 . A sling according to  claim 1  wherein the repositioning member is woven in a weave pattern along the mesh so that the weave pattern affords an indication of proper sling orientation after implantation. 
     
     
         20 . A sling according to  claim 19  wherein a majority of the repositioning member protrudes above the second major side of the support portion of the sling. 
     
     
         21 . A sling according to  claim 1  further including a sheath. 
     
     
         22 . A sling according to  claim 21  wherein the sheath indicia means for assisting the surgeon is properly orienting the sling relative to the urethra. 
     
     
         23 . A sling according to  claim 22  wherein the sheath includes separation means selected from the group consisting of tear scores, perforations or holes. 
     
     
         24 . A sling according to  claim 21  wherein the sheath comprises first and second sections that overlap adjacent the support portion of the sling. 
     
     
         25 . A sling according to  claim 1  wherein the sling and repositioning means are of contrasting colors and each of the sling and the repositioning means are of a color that contrasts with the physiological environment it will be implanted to assist a surgeon in identifying and distinguishing between the sling, the repositioning means and the physiological environment. 
     
     
         26 . A sling according to  claim 1  wherein the sling mesh is braided. 
     
     
         27 . A sling according to  claim 1  wherein the sling mesh is knitted. 
     
     
         28 . A sling according to  claim 1  wherein the sling has a length, the repositioning means comprises a one piece, elongate member threaded in the mesh and extending axially along substantially the entire length of the sling, and wherein the one piece, elongate member is attached to the sling at the ends of the support portion. 
     
     
         29 . A sling according to  claim 28  wherein the sling includes a means for locating and detaching the one piece, elongate member. 
     
     
         30 . A sling according to  claim 29  wherein the means for locating and detaching the one piece, elongate member comprises loops in the elongate, one piece member at the ends of the support portion. 
     
     
         31 . A sling according to  claim 1  wherein the repositioning means comprises a handle situated in the support portion. 
     
     
         32 . A sling for treating urinary incontinence in a patient comprising:
 first and second major surfaces,   a pair of end portions,   a support portion for placement in a therapeutically effective position relative to a physiological environment intended to be supported, the support portion being constructed of autologous material, and having a pair of ends, and   repositioning means, associated with the sling, for transferring sling tightening or sling loosening forces along the sling to afford effective repositioning of the sling without adversely affecting the therapeutic effect of the sling.   
     
     
         33 . A method of treating urinary incontinence in a patient comprising the steps of: establishing a pathway in tissue on both sides of a patient's tissue intended to be supported, the pathways extending between an abdominal wall of the patient and a pubic space of the patient;
 atraumatically dilating the pathways after the establishment of the pathways;   introducing a sling material into the pathways while the pathways are being atraumatically dilated;   positioning the sling material so that in the pathways in a therapeutic relationship relative to the tissue of the patient that is intended to be supported, and so that the sling extends upward toward the abdominal wall; and   repositioning the sling to support the urethra of the patient.   
     
     
         34 . A method according to  claim 33 , wherein the step of positioning the sling comprises the step of positioning the sling proximate the patient's urethra. 
     
     
         35 . A method according to  claim 33  wherein the step of establishing a pathway comprises making an original vaginal incision and the step of repositioning the sling occurs after the vaginal incision is closed and is accomplished without any structure passing through the original vaginal incision. 
     
     
         36 . A method according to  claim 33  wherein the step of repositioning the sling occurs during the surgical procedure. 
     
     
         37 . A method of treating urinary incontinence in a patient comprising:
 providing a sling with repositioning means;   creating a pathway in tissue extending between an abdominal wall of the patient and a pubic region of the patient;   positioning a sling material into the pathways so that the sling material is in a therapeutic relationship relative to the urethra of the patient and so that the sling extends upwards toward the abdominal wall; and   tightening the sling material by using the repositioning means.