Implantable article and method

• US 20020028980A1
• Filed: 08/24/2001
• Published: 03/07/2002
• Est. Priority Date: 09/07/2000
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: American Medical Systems, Inc.
• Inventors: Westrum, John W. Jr., Thierfelder, Christopher A.
• Granted Patent: US 6,592,515 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. 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 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 sacrum to the 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 2 wherein the minor strip has a straight end and the minor strip is bonded to the major strip along substantially all of the end of the minor strip.

4. 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.

5. A surgical article according to claim 1 wherein the major and minor strips comprises a backing with a coating.

6. A surgical article according to claim 5 wherein the backing comprises a polymeric material and the coating comprises a silicone.

7. An implantable surgical article for treating a pelvic floor disorder, such as for a sacral colpopexy procedure, the article comprising:

a base portion,

a head portion comprising two tissue engagement portions extending from the base portion, and

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.

8. An implantable article according to claim 7 wherein the separation force distribution means comprises a bonding composition.

9. An implantable article according to claim 8 wherein the bonding composition comprises an elastomeric material.

10. An implantable article according to claim 7 wherein the separation force distribution means comprises an ultrasonic weld.

11. An implantable article according to claim 7 wherein the article comprises a backing and a coating that is porous.

12. An implantable article according to claim 7 wherein the separation force distribution means comprises a mechanical fastener.

13. An implantable article according to claim 12 wherein the mechanical fastener comprises a polymeric clip.

14. An implantable article according to claim 7 wherein the base portion comprises at least one suture and the implantable article further comprises means for adjusting the tension of the implantable article.

15. An implantable article according to claim 14 wherein the means for adjusting the tension of the implantable article comprises a movable wheel for taking up length of the suture or providing a length of the suture, and means for indexing the wheel in different positions to tighten and/or relax the tension in the implantable article.

16. An implantable article according to claim 7 wherein the base portion comprises a major strip, and the implantable article further comprising adjustment means for adjusting the tension of the implantable 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 position to tighten and/or relax the tension of the implantable article.

18. A surgical kit according to claim 17 wherein the securement means comprises sutures suitable for implantation into bone.

19. A surgical kit according to claim 17 wherein the preassembled implantable article is preassembled in a Y-shape that is sterile packaged.

20. A surgical kit according to claim 17, 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.

21. A surgical kit according to claim 19 wherein the Y-shaped article is sized and shaped to treat vaginal vault prolapse during a sacral colpopexy procedure.

22. A surgical kit according to claim 17 wherein the securement means comprise bone anchors.

23. A surgical kit according to claim 22 where in the bone anchors comprise self-tapping bone screws.

24. A surgical kit according to claim 23 wherein each bone screw has a suture attached thereto.

25. A surgical kit according to claim 24 wherein the suture is a braided suture.

26. A surgical kit according to claim 24 wherein the suture is a polypropylene monofilament.

27. A surgical kit according to claim 17 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.

28. A kit according to claim 27 wherein the kit includes a tissue adhesive or a tissue sealant.

29. A kit according to claim 27 wherein the shaft has a length of at least 28 cm.

30. A kit according to 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.

31. A surgical kit according to claim 17 wherein the surgical article comprises a needle capable of placing a suture in bone.

17. 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.

32. A method of making an implantable surgical article comprising the steps of:

providing a thin, first strip with first and second ends, major surfaces, and a length between the first and second ends;

providing a thin, second strip with first and second ends, major surfaces, and a length between the first and second ends;

the length of the second strip being less than that of the first strip;

placing a major surface of the first strip against a major surface of the second strip; and

bonding the first strip to the second strip.

33. A method of making an implantable surgical article according to claim 32:

wherein the step of bonding the first strip to the second strip includes the step of bonding the first strip to the second strip with a silicone elastomer.

34. A method of making an implantable surgical article according to claim 32 further including providing a fixture with a recessed portion, the step of placing a major surface of the first strip against a major surface of the second strip includes the step of placing at least a portion of the first and second strips in the recessed portion of the fixture;

and the step of bonding includes the step of bonding the portion of the first strip within the recessed portion to the portion of the second strip within the recessed portion.

35. A method of making an implantable surgical article according to claim 32 further including the step of providing a fixture with a recessed portion,

the step of placing a major surface of the first strip against a major surface of the second strip includes the step of placing at least a portion of the first and second strips in the recessed portion of the fixture;

and

the bonding step includes the step of injecting a liquid silicone into the recessed portion of the fixture.

36. A method according to claim 35 further including the step of curing the silicone with heating means.

37. A method of making an implantable surgical article according to claim 32 wherein the step of bonding the first strip to the second strip includes the step of bonding the first strip to the second strip with an adhesive.