Implantable article and method
View Patent ↗An implantable article and method are disclosed for treating pelvic floor disorders such as vaginal vault prolase. A surgical kit useful for performing a surgical procedure such as a sacral colpopexy is also described.
1. An implantable surgical article comprising:
a thin, substantially flat major strip having proximal and distal ends, and a length and a width along first and second orthogonal axes;
a thin, substantially flat minor strip having a length less than that of the major strip, and a pair of ends;
the minor strip being bonded to the major strip along an end of the minor portion with a flowable bonding agent such that a substantial portion of the minor strip can extend along an axis that is perpendicular to both the first and second axes;
the location of the bond is selected such that a portion of the major strip near its distal end and the minor strip may be sutured to a vaginal cuff of a patient; and,
the distance between the proximal end of the major strip and the bond is at least sufficient to extend from the patient's sacrospinous ligament to the patient's vaginal cuff.
2. A surgical article according to claim 1 wherein the major and minor strips each have a perimeter with substantially straight edges, and the straight edges of the major and minor strips are substantially aligned to provide a surgical article with a substantially constant width.
3. A surgical article according to claim 1 wherein the minor strip has a distal end and the distal ends of the major and minor strips are substantially aligned.
4. A surgical article according to claim 1 wherein the major and minor strips comprise a backing with a coating.
5. An implantable surgical article for treating a pelvic floor disorder, the article comprising:
a base portion;
a head portion comprising two tissue engagement portions extending from the base portion; and,
a separation force distribution means for attaching at least one of the tissue engagement portions to the base portion in a fashion that distributes a force that would tend to separate a tissue engagement portion from the base portion across an area greater than that occupied by a suture;
the article being sized and shaped to extend from the patient's sacrospinous ligament to the patient's vagina; and
wherein the separation force distribution means is selected from a group consisting of a bonding composition, an ultrasonic weld, a mechanical fastener, and a polymeric clip.
6. A surgical article according to claim 5 wherein the base portion comprises at least one suture and the surgical article further comprises means for adjusting the tension of the implantable article.
7. A surgical article according to claim 5 wherein the base portion comprises a major strip, and the surgical article further comprises adjustment means for adjusting the tension of the surgical article, the adjustment means comprising a movable wheel for taking up length of the major strip or providing a length of major strip, and means for indexing the wheel in different positions to tighten and/or relax the tension of the surgical article.
8. A surgical kit for use in a procedure addressing a pelvic floor disorder, the surgical kit comprising:
a preassembled implantable article of claim 1 ,
securement means for securing the base portion of the implantable article to tissue, and
a surgical article for inserting the at least one soft tissue anchor into tissue.
9. A surgical kit according to claim 8 wherein the implantable article is preassembled in a Y-shape that is sterile packaged.
10. A surgical kit for use in a procedure addressing a pelvic floor disorder, the surgical kit comprising:
a preassembled implantable article of claim 5 ,
securement means for securing the base portion of the implantable article to tissue, and
a surgical article for inserting the at least one soft tissue anchor into tissue.
11. A surgical kit according to claim 10 wherein the implantable article is preassembled in a Y-shape that is sterile packaged.
12. A method of implanting an implantable article in addressing a pelvic floor disorder, the method comprising the steps of:
providing a preassembled implantable article of claim 1 , and
installing the implantable article to treat pelvic floor disorder, by securing the implantable article to tissue.
13. A method according to claim 12 wherein the implantable article is secured to the sacrospinous ligament.
14. A method according to claim 12 wherein the implantable article is secured using at least one suture.
15. A method of implanting an implantable article in addressing a pelvic floor disorder, the method comprising the steps of:
providing a preassembled implantable article of claim 5 , and
installing the implantable article to treat pelvic floor disorder, by securing the implantable article to tissue.
16. A method according to claim 15 wherein the implantable article is secured to the sacrospinous ligament.
17. A method according to claim 15 wherein the implantable article is secured using at least one suture.
18. A method according to claim 12 wherein the implantable article is installed transabdominally or transvaginally.
19. A method according to claim 15 wherein the implantable article is installed transabdominally or transvaginally.