Adjustable tissue support member
The present disclosure relates to implants having two arms and a support portion configured to support a body tissue, such as a urethra. The implants are anchored in soft tissue with tissue anchors having a plurality of barbs. The tissue anchors contain an aperture through which a portion of arm is maintained. A locking member is disposed within at least one of the arms to facilitate fixation of the arm to at least one of the anchors.
1. A tissue support system including an implantable tissue support member, comprising:
a tissue support portion;
a first arm having a first end joined to a first end of the tissue support portion;
a second arm constructed of mesh including a lumen formed by a tubular knit construction of the mesh, the second arm having a first end joined to a second end of the tissue support portion;
a first tissue anchor fixed to a second end of the first arm;
a second tissue anchor having an aperture therein, the aperture at least partially enclosing a portion of the second arm; and
a locking member disposed in the lumen of the second arm between the second tissue anchor and a second end of the second arm.
2. The tissue support system according to claim 1 , wherein the aperture is configured to resist unconstrained movement of the second arm therethrough.
3. The tissue support system according to claim 1 , wherein the locking member is configured to be urged in the direction of the second anchor, and to resist movement in the direction of the second end of the second arm.
4. The tissue support system according to claim 1 , further comprising a stylet configured for introduction into the lumen from the second end of the second arm, and for urging the locking member in the direction of the second anchor.
5. The tissue support system according to claim 1 , further comprising an introducer needle configured to releasably secure a tissue anchor.
6. The tissue support system according to claim 5 , wherein the introducer needle comprises a shaft and a handle.
7. The tissue support system according to claim 6 , wherein the shaft has a curved portion.
8. The tissue support system according to claim 7 , wherein the shaft has a substantially helical shape.
9. The tissue support system according to claim 6 , wherein the introducer needle comprises a collet at the distal end of the shaft.
10. The tissue support system according to claim 6 , wherein the handle comprises a manually operable mechanism for releasing the anchor from the distal end of the shaft.
11. The tissue support system according to claim 1 , wherein the tissue support portion comprises orientating indicia.
12. The tissue support system according to claim 11 , wherein the orientating indicia comprises a colored feature in the center of the tissue support portion.
13. A method for providing support to body tissue, comprising:
making an incision in the vaginal wall;
inserting an introducer needle having a first tissue anchor at the distal end thereof into the incision in the direction of the obturator membrane, wherein the first introducer needle is connected to an implant;
ejecting the first tissue anchor from the introducer needle;
withdrawing the introducer needle from the incision, and inserting a second tissue anchor in the distal end thereof, wherein the second tissue anchor is connected to the implant, the implant including a lumen that passes through an aperture in the second tissue anchor, and wherein a locking feature is disposed in the lumen for urging in a first direction, the locking feature resisting movement in a second direction opposite of the first direction;
re-inserting the introducer needle into the incision in the direction of the contra-lateral obturator membrane;
ejecting the second tissue anchor from the introducer needle; and
applying traction to the implant until the desired amount of tissue support is obtained.
14. The method according to claim 13 , further comprising locking the implant to the second tissue anchor by urging the locking feature through the lumen of the implant and into the aperture of the second tissue anchor.
15. The method according to claim 14 , wherein the implant is locked to the second tissue anchor via a frictional fit of the locking feature in the aperture.
16. The method according to claim 14 , wherein the step of locking the implant to the second tissue anchor is performed immediately after the applying traction step.
17. The method according to claim 14 , wherein the step of locking the implant to the second tissue anchor is performed from 12-72 hours after the applying traction step.
18. The method according to claim 13 , wherein the body tissue is the urethra.
19. The method according to claim 13 , wherein the body tissue is the bladder.
20. A method for providing support to body tissue, comprising:
making an incision in the vaginal wall;
inserting an introducer needle having a first tissue anchor at the distal end thereof into the incision in the direction of the obturator membrane, wherein the first introducer needle is connected to an implant;
ejecting the first tissue anchor from the introducer needle;
withdrawing the introducer needle from the incision, and inserting a second tissue anchor in the distal end thereof, wherein the second tissue anchor is connected to the implant, the implant including a lumen that passes through an aperture in the second tissue anchor;
re-inserting the introducer needle into the incision in the direction of the contra-lateral obturator membrane;
ejecting the second tissue anchor from the introducer needle;
applying traction to the implant until the desired amount of tissue support is obtained; and
locking the implant to the second tissue anchor by urging an anchor stop disposed in the implant lumen toward the second tissue anchor and into the second tissue anchor aperture.