Implantable article and method

• US 7,517,313 B2
• Filed: 06/22/2004
• Issued: 04/14/2009
• 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.
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US10/873,472
• Publication Number:
  US 20040230092A1
• Time in Patent Office: 1,757 Days
• Field of Search: 600 29- 32, 128/DIG.25, 128897-898, 606/232, 606144-145, 606222-225, 606/102, 606/119, 606/148, 606 65- 67, 606 72- 75, 623 1111- 1512
• US Class Current: 600/30
• 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. 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.

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.

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.

18. A method according to claim 12 wherein the implantable article is installed transabdominally or transvaginally.

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.

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.

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.

19. A method according to claim 15 wherein the implantable article is installed transabdominally or transvaginally.