Surgical articles and methods for treating pelvic conditions
View Patent ↗Described are pelvic implants (e.g., urinary incontinence sling, hammock, etc.) and method of inserting a pelvic implant that provide treatment for pelvic floor disorders such as incontinence or stress urinary incontinence.
1. A pelvic implant assembly comprising:
a support portion;
a first mesh extension portion extending from the support portion; and
a second mesh extension portion extending from the support portion;
a first self-fixating tip directly connected to the first mesh extension portion, the first self-fixating tip including a base having a proximal base end, a distal base end, and a length between the proximal base end and the distal base end defining a longitudinal axis, the proximal base end configured to be coupled to the first mesh extension portion, the base including an internal channel extending from the proximal base end to the distal base end, the base including a first lateral fin extending from the base in a first direction, and a second lateral fin extending from the base in a second direction, the first lateral fin has a first length dimension, where the first lateral fin meets the base, and a second length dimension, opposite the first length dimension, where the first lateral fin extends away from the base, the first length dimension being larger than the second length dimension, and each of the first length dimension and the second length dimension extending in a direction parallel to the longitudinal axis; and
a second self-fixating tip directly connected to the second mesh extension portion.
2. The pelvic implant assembly according to claim 1 , wherein the first lateral fin includes a leading edge that extends away from a first location on the base and extends proximally to a point, and the first lateral fin includes a trailing edge that extends away from a second location on the base to the point.
3. The pelvic implant assembly according to claim 2 , wherein the leading edge includes a sharpened edge.
4. The pelvic implant assembly according to claim 2 , wherein the trailing edge includes a portion having a thickness in a range from 0.2 to 1.5 millimeters.
5. The pelvic implant assembly according to claim 1 , wherein the first lateral fin includes a width dimension in a range from 0.5 to 3 millimeters, and a thickness dimension in a range from 0.2 to 1.5 millimeter.
6. The pelvic implant assembly according to claim 1 , wherein the first length dimension of the first lateral fin is in a range from 0.5 to 5 millimeters.
7. The pelvic implant assembly according to claim 1 , wherein the first length dimension of the first lateral fin is in a range from 1 to 4 millimeters.
8. The pelvic implant assembly according to claim 1 , wherein a length of the first mesh extension portion is adjustable.
9. The pelvic implant assembly according to claim 1 , wherein the length between the proximal base end and the distal base end is in a range from 0.4-1.0 centimeter.
10. A medical apparatus comprising:
a pelvic implant including a support portion, a mesh extension portion extending from the support portion, and a self-fixating tip directly connected to the mesh extension portion, the self-fixating tip including a base having a proximal base end and a distal base end, the proximal base end configured to be coupled to the mesh extension portion, the base including an internal channel extending from the proximal base end to the distal base end, the internal channel includes a flat surface, the base including a first lateral fin extending from the base in a first direction, and a second lateral fin extending from the base in a second direction; and
an insertion tool having a handle and a needle extending from the handle, the needle including a proximal end attached to the handle and a distal end, the distal end including a tip configured to engage the self-fixating tip, the tip having a diameter that is smaller than a diameter of a shaft of the needle, the needle including an exterior surface that is configured to engage the flat surface of the internal channel of the base.
11. The medical apparatus of claim 10 , wherein the needle includes a curved needle portion, the self-fixating tip maintains an orientation relative to the insertion tool with the first lateral fin and the second lateral fin aligned for implantation into fibrous tissue the first lateral fin and the second lateral fin configured to penetrate the fibrous tissue in an orientation that is non-parallel to a direction of fibers of the fibrous tissue.
12. The medical apparatus of claim 11 , wherein the self-fixating tip maintains an orientation relative to the insertion tool in which the first lateral fin and the second lateral fin are aligned at an angle in a range from 70 to 100 degrees relative to fibers of obturator internus muscle tissue.
13. A method of treating a pelvic condition, the method comprising:
providing the medical apparatus of claim 10 ;
engaging the distal end of the needle with the self-fixating tip in a manner that allows the needle to push the self-fixating tip into tissue;
inserting the distal end of the needle and the self-fixating tip through a perineal or vaginal incision in a patient; and
using the needle to push the self-fixating tip to insert the self-fixating tip into the tissue in the pelvic region.
14. The method of claim 13 , wherein the pelvic condition is selected from the group consisting of: urinary incontinence, fecal incontinence, enterocele, cystocele, rectocele, and vaginal vault prolapse.
15. The method of claim 13 , wherein the incision is selected from a vaginal incision of a female patient and a perineal incision of a male patient.
16. The method according to claim 13 , wherein the method includes placing the self-fixating tip in fibrous tissue, with the first lateral fin and the second lateral fin of the self-fixating tip being oriented in a direction that is non-parallel to fibers of the fibrous tissue.
17. The method according to claim 13 , wherein the method includes inserting the self-fixating tip into fibrous tissue with the first lateral fin and the second lateral fin aligned at an angle in a range from 70 to 100 degrees relative to fibers of the fibrous tissue.
18. The medical apparatus according to claim 10 , wherein the implant includes a mesh strip and two self-fixating tips, one self-fixating tip at each end of the mesh strip.
19. The medical apparatus according to claim 10 , wherein the implant includes a tissue support portion, two posterior extension portions, the self-fixating tip being disposed at a distal end of each posterior extension portion, and with the tissue support portion placed at posterior vaginal tissue, the self-fixating tip configured to be placed at tissue of the sacrospinous ligament.
20. The medical apparatus according to claim 10 , wherein the first lateral fin includes a leading edge and a trailing edge, the leading edge extending away from a first location on the base and extending proximally to a point, the trailing edge extending away from a second location on the base to the point.
21. The medical apparatus according to claim 20 , wherein the leading edge includes a sharpened edge.