Implantable article and method

• US 20040230092A1
• Filed: 06/22/2004
• Published: 11/18/2004
• Est. Priority Date: 09/07/2000
• Status: Active Grant

• Current Assignee: David Staskin
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Westrum, John W. Jr., Thierfelder, Christopher A.
• Granted Patent: US 7,517,313 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2230/006 Y-shaped
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0078 Gender-specific, e.g. different for male and female patients

Abstract

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.

Claims

1. A surgical kit for use in a procedure for addressing a pelvic floor disorder, the surgical kit comprising:

a preassembled implantable article having a base portion, securement means for securing the base portion of the implantable article to tissue, and

a surgical article for inserting the securement means into tissue.

2. A surgical kit according to claim 1 wherein the securement means comprises sutures suitable for implantation into bone.

3. A surgical kit according to claim 1 wherein the preassembled implantable article is preassembled in a Y-shape that is sterile packaged.

4. A surgical kit according to claim 1, wherein the implantable article is sized and shaped to loosely extend from the patient'"'"'s sacrum to the patient'"'"'s vagina with at least some slack.

5. A surgical kit according to claim 3 wherein the Y-shaped article is sized and shaped to treat vaginal vault prolapse during a sacral colpopexy procedure.

6. A surgical kit according to claim 1 wherein the securement means comprise bone anchors.

7. A surgical kit according to claim 6 where in the bone anchors comprise self-tapping bone screws.

8. A surgical kit according to claim 7 wherein each bone screw has a suture attached thereto.

9. A surgical kit according to claim 8 wherein the suture is a braided suture.

10. A surgical kit according to claim 8 wherein the suture is a polypropylene monofilament.

11. A surgical kit according to claim 1 wherein the surgical article comprises a motorized surgical driver having a shaft, and

the shaft is sized and shaped to extend from the abdomen of a patient to the sacrum.

12. A kit according to claim 11 wherein the kit includes a tissue adhesive or a tissue sealant.

13. A kit according to claim 11 wherein the shaft has a length of at least 28 cm.

14. A kit according to claim 1 wherein the preassembled implantable article comprises a polymer backing coated with a silicone, wherein the coated polymer backing is porous to afford tissue ingrowth into the pores.

15. A surgical kit according to claim 1 wherein the surgical article comprises a needle capable of placing a suture in bone.

16. A method of implanting an implantable article in addressing a pelvic floor disorder, the method comprising

providing a preassembled implantable, Y-shaped article,

providing self-tapping bone screws, and

providing a motorized surgical driver,

installing the Y-shaped article, to treat the pelvic floor disorder, by securing the article to bone using the bone screws and the motorized surgical driver.

17. The method of claim 16, wherein the preassembled Y-shaped article is sterile packaged.

18. The method of claim 17, wherein the preassembled implantable article comprises a polymer backing coated with a silicone, wherein the coated polymer backing is porous to afford tissue ingrowth into the pores.

19. The method of claim 16, comprising a method of treating vaginal vault prolapse during a sacral colpopexy procedure.

20. The method of claim 16, wherein the motorized surgical driver comprises a shaft sized and shaped to extend from the abdomen of a patient to the sacrum, and wherein the bone screws are installed in the sacrum.