Suture-less tissue fixation for implantable device
View Patent ↗A suture-less pelvic implant system and method is provided for treating pelvic conditions, such as incontinence or vaginal prolapse. The implant can include a fixation portion, rectangular or suture line, having a plurality of fixation elements, e.g., barbs, extending therefrom to fixate within target pelvic tissue, such as the vaginal apex. In a sacralcolpopexy, an opposing end or anchor of the implant is fixated within the sacrum or like structure to stabilize, raise, support or reposition the vaginal apex.
1. A method of performing a sacralcolpopexy procedure in a patient, comprising:
providing a generally flexible implant having an implant thickness and a generally planar first surface having a plurality of spaced fixation elements extending transversely and longitudinally from the generally planar first surface, each of the spaced fixation elements oriented generally parallel to one another,
wherein the plurality of fixation elements are generally arrow-shaped barb members,
wherein providing an implant includes providing an implant having first and second fixation portions defining a generally Y-shaped implant having the plurality of fixation elements extending from the first and second fixation portions; and
wherein an end anchor is provided distal to and operably coupled with the implant; providing a fixation tool having first and second jaw portions;
inserting the fixation tool within a pelvic cavity of the patient;
positioning the vaginal tissue intermediate the plurality of fixation elements and the first jaw portion of the fixation tool by positioning the fixation tool;
bringing the first and second jaw portions toward each other to force the plurality of fixation elements into the vaginal tissue by engaging the fixation tool; and
engaging the end anchor of the implant in pelvic region tissue distinct from the vaginal tissue.
2. The method of claim 1 , wherein forcing the plurality of fixation elements into the vaginal tissue includes forcing the plurality of fixation elements into an apex portion of the vagina.
3. The method of claim 1 , further including incising a vaginal wall portion to provide access for at least one of the first and second jaw portions of the fixation tool outside the vaginal wall.
4. The method of claim 1 , wherein the first and second jaw portions of the fixation tool are hingably connected.
5. The method of claim 1 , wherein forcing the plurality of fixation elements into the vaginal tissue includes forcing the plurality of fixation elements into the vaginal tissue without completely penetrating through the vaginal tissue.
6. The method of claim 1 , wherein engaging the end anchor of the implant in tissue other than the vaginal tissue includes engaging the end anchor of the implant in the sacrum.
7. The method of claim 1 , wherein providing an implant includes providing an implant constructed at least in part of a suture line.
8. The method of claim 1 , wherein the plurality of fixation elements are angled barb members.
9. The method of claim 1 , wherein the plurality of fixation elements are curved barb members.