Surgical articles and methods for treating pelvic conditions
View Patent ↗Described are pelvic implants and methods of surgically placing pelvic implants, the implants optionally including the ability to engage a spreader tool for spreading the implant within the patient, also optionally including a stiffening frame ( 306 ), exemplary implants being capable of being used to treat pelvic floor disorders, for example by supporting of levator tissue.
1. A method of supporting tissue of a pelvic region, the method comprising:
creating a posterior incision that allows access to tissue of a pelvic region located inferior to levator muscle;
providing a pelvic implant comprising:
a tissue support portion;
an extension portion extending from the tissue support portion;
a self-fixating tip comprising a base and an internal channel within the base, the self-fixating tip located at an end of the extension portion;
a first bearing disposed at a first location on the tissue support portion; and
a second bearing disposed at a second location on the tissue support portion;
providing an insertion tool configured to engage the internal channel of the self-fixating tip at a distal end of the insertion tool;
passing the implant through the incision;
positioning a portion of the tissue support portion at a medial location to support tissue selected from: an anus, an anal sphincter, a rectum, and perineal muscle;
extending the extension portion in an anterior direction toward an obturator foramen, with placement of the self-fixating tip at tissue of the obturator foramen or at tissue of an arcus tendineus;
positioning a portion of the pelvic implant at a location inferior to the levator muscle to cause the tissue support portion to contact tissue of the levator muscle;
providing a spreader tool comprising a shaft and a spreader at a distal end of the shaft, the spreader including a first jaw and a second jaw, the first jaw movably coupled to the second jaw, the first jaw and the second jaw being independently movably with respect to each other, the first jaw engaging the first bearing at the first location, the second jaw engaging the second bearing at the second location, the first jaw and the second jaw being disposed proximate to each other when the implant is in an un-spread configuration, the first jaw and the second jaw being disposed away from each other when the implant is in a spread configuration; and
inserting the spreader tool through the incision, engaging the first bearing and the second bearing with the first jaw and the second jaw, respectively, and moving at least one of the first jaw and the second jaw to configure the implant into the spread configuration.
2. A method according to claim 1 , comprising placing the support portion inferior to a superficial transverse perineal muscle.
3. A method according to claim 1 , comprising extending the extension portion to contact tissue of the levator muscle, at a location inferior to the levator muscle, to cause the extension portion to support the tissue support portion and the tissue support portion to support levator tissue.
4. A method according to claim 1 , comprising extending the portion of the pelvic implant through a tissue path between levator ani muscle and obturator internus muscle and attaching the extension portion at the arcus tendineus.
5. The method of claim 1 , comprising placing the tissue support portion inferior to the anal sphincter.
6. The method of claim 1 , comprising creating the incision at a region of perirectal or perianal tissue and wherein the incision allows access to tissue inferior to the levator muscle.
7. The method of claim 1 , comprising dissecting tissue to access an inferior surface of the levator muscle.
8. The method of claim 1 , wherein the implant comprises the tissue support portion, the extension portion, the self-fixating tip, a second tissue support portion, a second extension portion extending from the second tissue support portion, and a second self-fixating tip at an end of the second extension portion, the method comprising:
positioning a portion of the second tissue support portion at the medial location;
extending the extension portion in an anterior direction toward an obturator foramen on a right side of the patient;
positioning a portion of the second tissue support portion at a location inferior to a levator muscle on the left side of the patient to cause the tissue support portion to contact tissue of the levator muscle; and
extending the second extension portion in an anterior direction toward an obturator foramen on a left side of the patient, with placement of the second self-fixating tip at tissue of the obturator foramen or at tissue of an arcus tendineus on the left side of the patient.
9. The method of claim 8 comprising:
extending the extension portion in an anterior direction with placement of the self-fixating tip at tissue of the obturator foramen on a right side of the patient; and
extending the second extension portion in an anterior direction with placement of the self-fixating tip at tissue of the obturator foramen on a left side of the patient.
10. The method of claim 1 , wherein the implant is a first implant, the method further comprising providing a second implant, the second implant being separate from the first implant, wherein the tissue support portion is a first tissue support portion, the extension portion is a first extension portion, and the self-fixating tip is a first self-fixating tip, the second implant including a second tissue support portion, a second extension portion, and a second self-fixating tip, the method comprising:
positioning the portion of the first tissue support portion at the medial location;
extending the first extension portion in the anterior direction toward the obturator foramen on a right side of the patient;
positioning a portion of the first implant at a location inferior to the levator muscle on the right side of the patient to cause the first tissue support portion to contact tissue of the levator muscle on the right side of the patient;
positioning a portion of the second tissue support portion at the medial location;
extending the second extension portion in an anterior direction toward an obturator foramen on a left side of the patient; and
positioning a portion of the second implant at a location inferior to levator muscle on the left side of the patient to cause the second tissue support portion to contact tissue of levator muscle on the left side of the patient.
11. The method of claim 10 , comprising:
extending the first extension portion in an anterior direction with placement of the first self fixating tip at tissue of the obturator foramen on a right side of the patient; and
extending the second extension portion in an anterior direction with placement of the second self-fixating tip at tissue of the obturator foramen on a left side of the patient.
12. The method of claim 1 , wherein the self-fixating tip comprises one or more lateral extension that increase a force required to pull the self-fixating tip out of the tissue of the obturator foramen or at the tissue of the arcus tendineus.
13. The method of claim 1 , wherein the base is tapered.
14. The method of claim 1 , wherein the self-fixating tip comprises the base having a proximal base end and a distal base end, the proximal base end connected to the extension portion.
15. The method of claim 14 , wherein the base is tapered, the base placement of having a larger diameter at the proximal base end and a smaller diameter at the distal base end.
16. The method of claim 1 , wherein the self-fixating tip comprises deployable barbs, wherein the deployable barbs are in a closed configuration during insertion and an open configuration when implanted.
17. A method of supporting tissue of a pelvic region, the method comprising:
creating a posterior incision that allows access to tissue of a pelvic region located inferior to levator muscle;
providing a pelvic implant comprising:
a tissue support portion;
an extension portion extending from the tissue support portion;
a self-fixating tip comprising a base and an internal channel within the base, the self-fixating tip located at an end of the extension portion;
a first bearing disposed at a first location on the tissue support portion; and
a second bearing disposed at a second location on the tissue support portion;
providing an insertion tool configured to engage the internal channel of the self-fixating tip at a distal end of the insertion tool;
passing the implant through the incision;
positioning a portion of the tissue support portion at a medial location to support tissue selected from: an anus, an anal sphincter, a rectum, and perineal muscle;
extending the extension portion in an anterior direction toward an obturator foramen, with placement of the self-fixating tip at tissue of the obturator foramen or at tissue of an arcus tendineus;
positioning a portion of the pelvic implant at a location inferior to the levator muscle to cause the tissue support portion to contact tissue of the levator muscle;
providing a spreader tool comprising a shaft and a spreader at a distal end of the shaft, the spreader including a first jaw and a second jaw, the first jaw movably coupled to the second jaw, the first jaw engaging the first bearing at the first location, the second jaw engaging the second bearing at the second location, the first jaw and the second jaw being disposed proximate to each other when the implant is in an un-spread configuration, the first jaw and the second jaw being disposed away from each other when the implant is in a spread configuration; and
inserting the spreader tool through the incision, engaging the first bearing and the second bearing with the first jaw and the second jaw, respectively, and moving at least one of the first jaw and the second jaw to configure the implant into the spread configuration,
wherein the first bearing is a first pocket sewn into the pelvic implant at the first location, and the second bearing is a second pocket sewn into the pelvic implant at the second location.