Methods and Apparatus for Treating Pelvic Floor Prolapse

Abstract

This invention relates to a surgical implant system for repairing pelvic prolapse in a patient. In particular, the present invention relates to an implant, a delivery device and a method for implanting and securing the implant to tissue structures in the pelvic region of the body.

1 . An apparatus for treating pelvic floor disorders comprising:
 an implant having at least one arm extending from the implant that is adapted to secure the implant to a tissue structure,   a delivery device having a housing with a passer disposed inside, said passer configured to penetrate said tissue structure to form a generally circular path when advanced from the housing,   said passer further adapted to couple to the arm and pull the arm through said path when retracted.   
   
   
       2 . The delivery device of  claim 1 , wherein the arm is detachably coupled to the housing and positioned to intersect the expected path of the passer such that a distal end of the passer couples to the arm before the passer is retracted. 
   
   
       3 . The delivery device of  claim 1 , wherein the arm is preloaded to the housing. 
   
   
       4 . The implant of  claim 1  further comprising a mesh that is made from a synthetic material, a biological material or a combination of materials. 
   
   
       5 . The arm of  claim 2 , further comprising a strap, cord, suture or mesh and having an inner and an outer end. 
   
   
       6 . The arm of  claim 5 , wherein the inner end of the arm includes a connector configured to detachably couple the arm to the implant such that the arm may be first secured to the tissue structure then coupled to the implant. 
   
   
       7 . The arm of  claim 6 , further comprising differentiators that can be used to differentiate one arm of the implant from another arm of the implant. 
   
   
       8 . The differentiators of  claim 7 , further comprising the arm color, shape, radiopacity, materials of construction or physical structure. 
   
   
       9 . The connector of  claim 6 , comprising a mechanical fastener, hook and loop type fastener, button, suture, magnetic fastener, adhesive or clamp. 
   
   
       10 . The arm of  claim 5 , wherein the arm is tapered between the ends and further comprises a tapered sleeve, the sleeve adapted to reduce frictional drag as the arm is secured to the tissue structure. 
   
   
       11 . The arm of  claim 5 , further comprising an inner portion and an outer portion, the two portions detachably joined together end to end with a removable cord such that when the cord is removed or cut the distal portion separates from the proximal portion. 
   
   
       12 . A delivery device for securing an arm extending from an implant to a tissue structure comprising:
 a housing with a passer disposed within,   the passer configured to penetrate at least a portion of the tissue to form a generally circular path when advanced from the housing in a plane orthogonal to the longitudinal axis of the housing, said passer having a connector adapted to couple to the arm after penetrating the tissue structure,   and said passer further adapted to pull the arm back through the path when retracted.   
   
   
       13 . The delivery device of  claim 12 , further comprising a pivot and an actuator coupled to the passer, said passer having a circular radius and configured such that as the actuator is advanced, the passer rotates about the pivot in the generally circular path. 
   
   
       14 . The delivery device of  claim 13 , wherein the arm is disposed about the housing such that the generally circular path of the passer intersects a portion of the arm. 
   
   
       15 . The generally circular path of  claim 12 , wherein the path encircles a sacrospinous ligament. 
   
   
       16 . The generally circular path of  claim 12 , wherein the path encircles the arcus tendineus. 
   
   
       17 . The apparatus of  claim 12 , wherein the connector couples to the arm using a magnetic coupler, 
   
   
       18 . The apparatus of  claim 12 , wherein the connector couples to the arm using a mechanical coupler. 
   
   
       19 . The mechanical coupler of  claim 18 , further comprising a barb, a spear, a threaded connector, a snap, a bayonet system, a latch, a clamp or a jaw. 
   
   
       20 . The delivery device of  claim 12 , wherein the housing is flexible and may have a preset or flexible shape. 
   
   
       21 . The passer of  claim 12 , wherein the passer is made from a super elastic alloy having a pre-set radius, the passer being confined to a straightened condition by an outer tube and configured such that as the passer is advanced from the tube in a plane orthogonal to the housing longitudinal axis, a sharpened distal end penetrates tissue in the generally circular path. 
   
   
       22 . The generally circular path of  claim 2   1 , wherein the path encircles a sacrospinous ligament, an arcus tendineus, or other tissue structure. 
   
   
       23 . The delivery device of  claim 12 , further comprising a finger holder configured to retain a finger of an operator such that tactile feel of the operator can guide the delivery device to an anatomical position. 
   
   
       24 . An apparatus for securing an arm of a surgical implant to at least a portion of a tissue structure comprising:
 a tubular housing containing a guide, said guide adapted to penetrate the tissue structure in a substantially circular path when advanced from the open distal end of the housing,   a strap tube connected to the arm and disposed about the guide,   a pusher disposed about the guide in a proximal position to the strap tube,   and said pusher adapted to push the strap tube along the guide.   
   
   
       25 . The guide of  claim 24 , wherein the substantially circular path initially extends away from the housing and then returns to intersect the housing. 
   
   
       26 . The substantially circular path of  claim 19 , wherein the path encircles sacrospinous ligament, arcus tendineus, or other tissue structure. 
   
   
       27 . The housing of  claim 25 , further comprising a catch to retain the strap tube after the strap tube is moved along the guide by the pusher. 
   
   
       28 . The apparatus of  claim 20 , wherein the guide is a guidewire. 
   
   
       29 . A surgical kit for treating pelvic prolapse comprising:
 an implant arm having at least one arm extending therefrom,   a delivery device for securing said arm to a portion of pelvic tissue comprising a passer configured to penetrate at least a portion of the pelvic tissue in a generally circular path when advanced,   said passer having a connector adapted to couple to the arm after penetrating the pelvic tissue,   and said passer adapted to pull the arm through the path when retracted.   
   
   
       30 . The delivery device of  claim 29 , further comprising a pivot and an actuator coupled to the passer, said passer having a circular radius and configured such that as the actuator is advanced, the passer rotates about the pivot in a generally circular path. 
   
   
       31 . The circular path of  claim 29 , wherein the path encircles a sacrospinous ligament, arcus tendineus, or other pelvic tissue structure. 
   
   
       32 . The surgical kit of  claim 29 , further comprising a funnel having a wide and a narrow opening and an attached drape,
 the wide opening forming an opening in the drape and the narrow opening sized for placement into a surgical incision, said funnel further adapted to receive the implant.   
   
   
       33 . The funnel of  claim 32 , further comprising a retention ring formed at the narrow opening that is configured to retain the funnel in the incision, said funnel configured to hold the incision open and to allow the arm to pass through the narrow neck after passing through the portion of the vaginal wall. 
   
   
       34 . The funnel of  claim 32 , wherein said funnel is sized to permit at least partial closure of the incision and is configured to allow the arm to pass through the narrow neck so that the tension of the implant may be adjusted by pulling on the arm against the narrow neck. 
   
   
       35 . A method of securing an implant having at least one arm to the pelvic cavity of a patient comprising:
 making an incision in the vaginal wall,   positioning a delivery device having a housing into the incision, the delivery device also having a passer,   advancing the passer from the housing and penetrating an adjacent tissue structure in a generally circular path,   coupling the passer to the arm,   retracting the passer and pulling the coupled arm back through said path.   
   
   
       36 . The method of  claim 35 , further comprising withdrawing the delivery device and the arm from the incision. 
   
   
       37 . The method of  claim 36 , wherein withdrawing the delivery device and pulling the arm through or around said path secures the arm to the tissue structure. 
   
   
       38 . The method of  claim 35 , further comprising coupling the arm of the implant to the housing prior to the positioning step. 
   
   
       39 . The method of  claim 35 , further comprising adjusting the tension of the arm to position the implant. 
   
   
       40  The method of  claim 36 , further comprising coupling the arm to the implant and adjusting the tension of the arm to position and secure the implant. 
   
   
       41 . The method of  claim 35 , wherein the tissue structure includes a sacrospinous ligament, arcus tendineus, bone or other pelvic structure. 
   
   
       42 . The method of  claim 35 , further comprising positioning the delivery device using a finger coupled to a distal end of the device such that an operator can position a distal end of the delivery device using tactile feedback. 
   
   
       43  The method of  claim 35 , further comprising positioning the delivery device using an endoscope coupled to a distal end of the delivery device. 
   
   
       44 . The method of  claim 35 , further comprising positioning a funnel in the incision, said funnel having a wide and a narrow opening and an attached drape, the wide opening forming an opening in the drape and the narrow opening sized for placement into the incision,
 introducing the implant through the funnel,   pulling a free end of the arm back through the funnel after securing the delivery device to the incision.   
   
   
       45 . The method of  claim 44 , further comprising temporarily securing the funnel in the incision with a retention ring formed at the narrow opening. 
   
   
       46 . The method of  claim 44 , further comprising pulling the free end of the arm against the narrow opening to tension the arm. 
   
   
       47 . A method of securing an implant having at least one arm to the pelvic floor of a patient comprising:
 making an incision in the vaginal wall,   positioning a delivery device having a housing and a guide into the incision,   advancing the guide through at least a portion of a tissue structure, said guide having a proximal end adapted to penetrate tissue structures in a generally circular path,   advancing a strap tube which is connected to the arm and disposed about the guide, along the path of the guide by using a pusher, said pusher being disposed about the guide.   
   
   
       48 . The method of  claim 47 , further comprising extending the guide along a generally circular path that initially extends away from the housing and then returns to intersect the housing. 
   
   
       49 . The method of  claim 48 , further comprising connecting the strap tube to the housing, withdrawing the guide and pusher into the housing and removing the delivery device. 
   
   
       50 . The method of  claim 49  further comprising adjusting the tension of the arm to position the implant. 
   
   
       51 . The method of  claim 50 , further comprising coupling the arm to the implant and adjusting the tension of the arm to position and secure the implant. 
   
   
       52 . The method of  claim 47 , wherein the tissue structure includes a sacrospinous ligament, arcus tendineus, bone or other pelvic structure.