Systems, devices and methods for treating pelvic floor disorders

Abstract

Disclosed are implants for pelvic floor repair and related uses, and devices, kits, and methods which can be used to deliver the implants. In certain embodiments, the devices are used to deliver extensions of a surgical implant to respective target tissue regions of the levator ani muscle and the sacrospinous ligament.

1 . A device for delivering an implantable sling to an anatomical location within a patient, comprising
 a shaft having a distal end and a proximal end,   a head having a curved region, a tip disposed at a distal end of the curved region, and a substantially linear region at a proximal end of the curved region, and   a curved junction connecting the proximal end of the curved region and the distal end of the shaft, wherein an axis of the substantially linear region is perpendicular to a longitudinal axis of the shaft.   
     
     
         2 . The device of  claim 1 , wherein an end of the tip is equiplanar with the longitudinal axis of the shaft portion. 
     
     
         3 . The device of  claim 1 , wherein the head lies in a plane, and the longitudinal axis of the shaft portion is normal to the plane. 
     
     
         4 . The device of  claim 3 , wherein the head extends in a counterclockwise path from the distal end of the shaft. 
     
     
         5 . The device of  claim 3 , wherein the head extends in a clockwise path from the distal end of the shaft. 
     
     
         6 . The device of  claim 1 , wherein the head lies in a plane, and the longitudinal axis of the shaft has a non-normal incidence with the plane. 
     
     
         7 . The device of  claim 1 , wherein the tip includes a stopping mechanism configured to prevent passage of an implant associator in a proximal direction along the device. 
     
     
         8 . The device of  claim 7 , wherein
 the stopping mechanism includes a shoulder with a cross-sectional area, and   the cross-sectional area is greater than a cross-sectional area of a portion of the tip distal to the shoulder.   
     
     
         9 . The device of  claim 7 , wherein the implant associator comprises a ring. 
     
     
         10 . The device of  claim 7 , wherein
 the implant associator includes two linear flexible wings extending radially from the ring.   
     
     
         11 . The device of  claim 1 , further comprising an implantable sling including a central region and three or more extensions extending from the central region. 
     
     
         12 . The device of  claim 1 , wherein the curved region is semi-circular. 
     
     
         13 . A device for delivering an implantable sling to an anatomical location within a patient, comprising
 a shaft including a distal end and a proximal end,   a rotatable head distal to the shaft including a tip at a distal end of the head, and   a pivotable junction connecting the head and the shaft.   
     
     
         14 . The device of  claim 13 , wherein the rotatable head includes a curved region. 
     
     
         15 . The device of  claim 13 , wherein the curved region is semi-circular. 
     
     
         16 . The device of  claim 13 , wherein the rotatable head is rotatable about the distal end of the shaft. 
     
     
         17 . The device of  claim 13 , wherein the shaft portion includes a stop surface to prevent rotation of the rotatable head portion beyond a predetermined angle of rotation. 
     
     
         18 . The device of  claim 13 , further comprising a cannula disposed about the shaft and operably coupled with the rotatable head to control a rotation of the rotatable head. 
     
     
         19 . The device of  claim 13 , wherein the tip includes a stopping mechanism configured to prevent passage of an implant associator in a proximal direction along the device. 
     
     
         20 . The device of  claim 19 , wherein the implant associator comprises a ring. 
     
     
         21 . The device of  claim 20 , wherein the implant associator includes two linear flexible wings extending radially from the ring. 
     
     
         22 . The device of  claim 19 , wherein
 the stopping mechanism includes a shoulder with a cross-sectional area, and   the cross-sectional area is greater than a cross-sectional area of a portion of the tip distal to the shoulder.   
     
     
         23 . A method for delivering to a patient an implant with a central region and at least four extensions, comprising
 securing a first extension of the implant to at least one of a sacrospinous ligament and a levator ani muscle on a first side of a patient,   securing a second extension of the implant to at least one of a sacrospinous ligament and a levator ani muscle on a contralateral side of the patient,   delivering a third extension of the implant through an obturator foramen on the first side of the patient, and   delivering a fourth extension of the implant through an obturator foramen on the contralateral side of the patient.   
     
     
         24 . The method of  claim 23 , further comprising
 securing the first extension with a first delivery device,   securing the second extension with a second delivery device different from the first delivery device, and   delivering the third extension with a third delivery device different from the first delivery device and different from the second delivery device.   
     
     
         25 . The method of  claim 23 , further comprising
 securing a fifth extension to at least one of a sacrospinous ligament and a levator ani muscle on the first side of a patient, and   securing a sixth extension to at least one of a sacrospinous ligament and a levator ani muscle on the contralateral side of the patient.   
     
     
         26 . The method of  claim 25 , comprising
 securing the fifth extension with a delivery device different from the first delivery device, different from the second delivery device, and different from the third delivery device.   
     
     
         27 . The method of  claim 25 , wherein at least one of securing the first extension and securing the second extension includes
 associating the respective first or second extensions with a delivery device including a head, the head portion including a tip, and   driving the tip of the delivery device through the respective sacrospinous ligament or levator ani muscle.   
     
     
         28 . The method of  claim 27 , wherein driving the tip of the delivery device through the respective sacrospinous ligament or levator ani muscle includes
 placing the tip against the respective sacrospinous ligament or levator ani muscle, and applying pressure directly on the head.   
     
     
         29 . The method of  claim 23 , wherein
 at least one of securing the first extension and securing the second extension includes suturing the respective first or second extension to the respective sacrospinous ligament or levator ani muscle.   
     
     
         30 . A surgical kit for use in delivering an implant within a patient, including
 a first delivery device having a first shaft for delivering a first implant region, and   a second delivery device having a second shaft for delivering a second implant region, wherein   the first shaft is longer than the second shaft.   
     
     
         31 . The kit of  claim 30 , wherein
 the first shaft is more than about 20% longer than the second shaft.   
     
     
         32 . The kit of  claim 30 , further comprising
 a third delivery device having a third shaft for delivering a third implant region.   
     
     
         33 . The kit of  claim 32 , wherein
 the second delivery device includes a second head extending in a counterclockwise path from the distal end of the second shaft, and   the third delivery device includes a third head extending in a clockwise path from the distal end of the third shaft.   
     
     
         34 . The kit of  claim 30 , further including an implantable sling having a central region and three or more extension regions. 
     
     
         35 . A surgical kit for use in delivering an implant within a patient, including
 a first delivery device having a first shaft and a first head for delivering a first implant region,   a second delivery device having a second shaft and a second head for delivering a second implant region, and   a third delivery device having a third shaft and a third head for delivering a third implant region, wherein   the second head extends in a counterclockwise path from the distal end of the second shaft, and   the third head extends in a clockwise path from the distal end of the third shaft.   
     
     
         36 . The surgical kit of  claim 35 , wherein the first shaft is longer than the second shaft. 
     
     
         37 . The kit of  claim 35 , further including an implantable sling having a central region and three or more extension regions. 
     
     
         38 . The kit of  claim 37 , further including an implant associator configured to inter-fit with a tip of at least one of the delivery devices and configured to attach to an extension of the sling.