Surgical articles and methods for treating pelvic conditions
Described are devices, implants, insertion tools, combinations, and associated methods, that involve placement of a self-fixating tip at tissue of the pelvic region, wherein an insertion tool includes one or more of an aperture for engaging a guide and an extension guard, the method optionally allowing for initial placement of a self-fixating tip at tissue of the pelvic region and adjustment of the location of the self-fixating tip.
1. In combination, a pelvic implant and insertion tool,
the implant comprising a support portion, an extension portion, and a self-fixating tip fixedly connected to an end of the extension portion,
the self-fixating tip comprising
a base comprising a proximal base end and a distal base end, the proximal base end being connected to the extension portion, and
a lateral extension extending from the base along a length of the base between the proximal base end and the distal base end, and comprising a trailing surface extending from the base to a tip of the trailing surface spaced from the base,
the insertion tool comprising
a handle,
a needle extending from the handle,
the needle comprising
a proximal end attached to the handle and
a distal end that includes a needle tip configured to engage the self-fixating tip, and
the insertion tool comprising an extension guard comprising a distal surface extending from the needle to a tip of the distal surface spaced from the needle such that when the needle tip engages the self-fixating tip to allow the needle to push the self-fixating tip for surgical installation, the distal surface is located on a proximal side of the lateral extension to reduce the force required to move the self-fixating tip in a proximal direction through muscle tissue.
2. A combination according to claim 1 wherein the distal surface corresponds to the trailing surface of the lateral extension.
3. A method of treating a pelvic condition in a patient, the method comprising
providing a combination according to claim 1 ,
engaging the self-fixating tip with the needle tip,
inserting the needle tip and self-fixating tip through an incision in a patient into a pelvic region,
using the needle to insert the self-fixating tip into tissue in the pelvic region,
with the needle tip engaging the self-fixating tip located in the pelvic tissue, using the needle to reduce the amount of penetration of the self-fixating tip into the tissue.
4. A combination as recited at claim 1 wherein the trailing surface extends from the base to a width dimension of about 0.5 to 3 millimeters.
5. A combination as recited at claim 1 wherein the implant comprises the support portion, the extension portion extending from a first side of the support portion, a second extension portion extending from a second side of the support portion, and a second self-fixating tip fixedly connected to a distal end of the second extension portion.
6. A combination as recited at claim 5 wherein the support portion, extension portion, and second extension portion, are an integral mesh strip.
7. A combination as recited at claim 1 wherein a cross sectional profile of the distal surface corresponds to a cross sectional profile of the trailing surface of the lateral extension.
8. A combination as recited at claim 7 wherein at least a portion of the distal surface abuts a portion of the trailing surface as the needle tip engages the self-fixating tip.
9. A combination as recited at claim 1 wherein at least a portion of the distal surface abuts a portion of the trailing surface as the needle tip engages the self-fixating tip.
10. A combination according to claim 1 wherein the extension guard is removable from the insertion tool.
11. A combination according to claim 1 wherein the implant is selected from the group consisting of:
a urinary incontinence sling,
two, four, or six-legged implant useful to treat vaginal prolapse, and
an implant useful for treating a condition of the pelvic floor.
12. A method according to claim 3 wherein the implant is a urethral sling comprising
the support portion,
the extension portion extending from a first side of the support portion,
a second extension portion extending from a second side of the support portion, and
a second self-fixating tip fixedly connected to a distal end of the second extension portion,
wherein the method comprises:
placing the support portion below a urethra of the patient,
using the insertion tool to place the self-fixating tip at tissue of a right obturator foramen, and
placing the second self-fixating tip at tissue of a left obturator foramen.
13. A method according to claim 12 wherein the support portion, extension portion, and second extension portion, are constructed of an integral mesh.
14. A method as recited at claim 3 wherein at least a portion of the distal surface abuts a portion of the trailing surface as the needle tip engages the self-fixating tip.
15. A method according to claim 3 wherein the pelvic condition is selected from the group consisting of: urinary incontinence, fecal incontinence, enterocele, cystocele, rectocele, vaginal vault prolapse, a condition of the perineal body, a condition of the pelvic floor, and a condition of the levator hiatus.
16. A method according to claim 3 wherein the pelvic condition is urinary incontinence.
17. A method according to claim 3 comprising supporting tissue selected from vaginal tissue, a urethra, a rectum, coccygeous, levator ani, iliococcygeus, pubococcygeous, perineal body, and levator hiatus.
18. A method according to claim 3 wherein the pelvic condition is a condition of the pelvic floor, and the method comprises supporting tissue of the pelvic floor.
19. In combination a pelvic implant and insertion tool,
the implant comprising a support portion, an extension portion, and a self-fixating tip fixedly connected to an end of the extension portion,
the self-fixating tip comprising
a base comprising a proximal base end and a distal base end, the proximal base end being connected to the extension portion and an aperture extending longitudinally along a length between the proximal base end and the distal base end, and
a lateral extension extending from the base and comprising a trailing surface extending from the base to a tip of the trailing surface spaced from the base,
the insertion tool comprising
a handle,
a needle extending from the handle,
the needle comprising
a proximal end attached to the handle and
a distal end that includes a needle tip configured to engage the self-fixating tip, the needle tip comprising a pin extending distally from the distal end tip and adapted to engage the aperture as the distal end engages the self-fixating tip, and
the insertion tool comprising an extension guard comprising a distal surface extending from the needle to a tip of surface spaced from the needle such that when the needle tip engages the self-fixating tip to allow the needle to push the self-fixating tip for surgical installation, the distal surface is located on a proximal side of the lateral extension to reduce the force required to move the self-fixating tip in a proximal direction through muscle tissue.
20. The combination according to claim 19 wherein the distal surface corresponds to the trailing surface of the lateral extension.