Implantable article

• US 6,648,921 B2
• Filed: 10/30/2001
• Issued: 11/18/2003
• Est. Priority Date: 10/03/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Siegel, Steven W., Neisz, Johann J., Anderson, Kimberly A.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/004,185
• Publication Number:
  US 20030065402A1
• Time in Patent Office: 749 Days
• Field of Search: 623/23-4-, 600/29, 600/30, 600/37
• US Class Current: 623/23.64
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

An implantable article is disclosed. The implantable article includes features for tightening or loosening the implantable article. In preferred embodiments, the adjustment may occur post or perioperatively.

Claims

1. An implantable article for urological applications such as a sling procedure, the article comprising:

an elongate biocompatible material having first and second major surfaces, edges and first and second ends defining an overall longitudinal axial length therebetween,

at least one fold about the longitudinal axis so as to reduce the overall axial length, and

releasable holding means for retaining the at least one fold in a folded position and, upon release, for affording unfolding of the at least one fold to reduce the tension of the implantable article,

wherein the releasable holding means comprises a filament element, and

wherein the filament element is sized to extend from the implantable article through a vaginal incision.

2. An implantable article according to claim 1 comprising at least two folds.

3. An implantable article according to claim 1 comprising at least two folds, and at least one fold reduces the overall axial length more than at least one other fold.

4. An article according to claim 3 wherein the releasable holding means comprise filament elements, and

identification means for distinguishing at least one filament element from another filament element to afford a predetermined release of tension.

5. An article according to claim 9 wherein the identification means comprises constructing at least one filament element in a color that is different than a color of at least one other filament element.

6. An article according to claim 1 wherein the biocompatible material comprises a synthetic material.

7. An article according to claim 1 wherein the at least one fold extends substantially transverse to the longitudinal axis.

8. An article according to claim 1 wherein the filament is associated with the biocompatible material in a fashion that affords release by pulling on the filament element.

9. An article according to claim 1 wherein the filament is associated with the biocompatible material by being threaded therethrough without additional structure for associating the filament with the biocompatible material.

10. An article according to claim 1 wherein the filament element is constructed to be palpable through vaginal tissue so that it can be adjusted without requiring an incision through vaginal tissue.

11. An article according to claim 10 wherein the filament includes grasping means.

12. An article according to claim 1 wherein the filament includes locating means capable of being detected through vaginal tissue.

13. An article according to claim 12 wherein the locating means comprises a radioopaque handle.

19. An implantable article according to claim 1 wherein the releasable holding means is free of a permanent connection to the implantable article.

14. An article for urological applications such as a sling procedure, the article comprising:

an elongate biocompatible material having first and second major surfaces, edges and first and second ends defining an overall longitudinal axial length therebetween,

at least one fold about the longitudinal axis so as to reduce the overall axial length, and

releasable holding means for retaining the at least one fold in a folded position and, upon release, for affording unfolding of the at least one fold to reduce the tension of the implantable article, and

wherein the biocompatible material comprises non-synthetic material.

15. An article according to claim 14 wherein the releasable holding means comprises a biocompatible releasable adhesive.

16. An article according to claim 14 wherein the releasable holding means comprises a structured surface.

17. An implantable article according to claim 14 wherein the biocompatible material has a width between its edges,

the at least one fold has a width, and

the width of the at least one fold is less than the width of the biocompatible material.

18. An article for urological applications such as a sling procedure, the article comprising:

an elongate biocompatible material having first and second major surfaces, edges and first and second ends defining an overall longitudinal axial length therebetween,

at least two folds about the longitudinal axis so as to reduce the overall axial length,

releasable holding means for retaining the at least two folds in a folded position and, upon release, for affording unfolding of at least one fold to reduce the tension of the implantable article,

wherein a releasable holding means is associated with each fold and each releasable holding means is adapted to release upon application of a substantially axial force applied to the biocompatible material, and

wherein the amount of axial force required to release one releasable holding means is substantially different than the force required to release another releasable holding means.

20. An implantable article for urological applications such as a sling procedure, the article comprising:

an elongate biocompatible material having first and second major surfaces, edges and first and second ends defining an overall longitudinal axial length therebetween,

at least one fold about the longitudinal axis so as to reduce the overall axial length,

releasable holding means for retaining the at least one fold in a folded position and, upon release, for affording unfolding of the at least one fold to reduce the tension of the implantable article,

wherein the biocompatible material comprises a polypropylene with a plurality of holes, and

the at least one fold is provided by a folded filament connected to discrete, unfolded portions of the biocompatible material.

21. An implantable article for urological applications such as a sling procedure, the article comprising:

an elongate biocompatible material having first and second major surfaces, a pair of edges, first and second ends defining an overall longitudinal axial length therebetween, a mid portion and first and second end portions,

an adjustment filament element axially woven through the biocompatible material so as to alternatively project above one major surface and then another major surface along the first end portion, the adjustment filament being associated with the biocompatiable material to afford a reduction or an increase in the tension of the implantable article, and

wherein the article is constructed and arranged such that the mid portion of the biocompatible material may be placed adjacent to target anatomical tissue such as the urethra without any filament element situated between a major surface of the mid portion of the biocompatible material and the target anatomical tissue.

22. An article according to claim 21 further comprising

a second adjustment filament element axially woven through the biocompatible material so as to alternatively project above one major surface and then another major surface along the second end portion, the second adjustment filament being associated with the biocompatiable material to afford a reduction or an increase in the tension of the implantable article.

23. An article according to claim 21 wherein end portions of the adjustment filament element are sized to extend from the biocompatible material through a vaginal incision.

24. An article according to claim 21 wherein an end portion of the adjustment filament is constructed to be palpable through vaginal tissue without requiring an incision through vaginal tissue.

25. An article according to claim 21 wherein the adjustment filament includes grasping means.

26. An article according to claim 21 wherein the adjustment filament includes locating means capable of being detected through vaginal tissue.

27. An article according to claim 26 wherein the locating means comprises a radioopaque element.

28. A method of treating incontinence comprising the steps of:

providing a sling comprising an elongate biocompatible material having first and second major surfaces, edges, and first and second ends defining an overall longitudinal axial length therebetween, at least one fold about the longitudinal axis so as to reduce the overall axial length of the sling, and releasable holding means for retaining the at least one fold in a folded position and, upon release, for affording unfolding of the at least one fold to increase the overall axial length,

implanting the sling,

releasing the releasable holding means to reduce the tension of the sling,

creating a vaginal incision,

providing a filament element as the releasable holding means,

extending the filament element through the vaginal incision, and

the step of releasing the releasable holding means to reduce the tension of the sling includes the step of pulling on the portion of the filament element that extends through the vaginal incision to separate the filament from the fold.

29. A method of treating incontinence comprising the steps of:

providing a sling comprising an elongate biocompatible material having first and second major surfaces, first and second ends defining an overall longitudinal axial length therebetween, a mid portion and first and second end portions,

axially weaving a first filament element through the biocompatible material so as to alternatively project above one major surface and then another major surface along the first end portion such that the length of the biocompatible material may be adjusted,

implanting the sling such that the mid portion of the biocompatible material is situated adjacent the urethra without any filament element situated between a major surface of the mid portion of the biocompatible material and the urethra; and

manipulating the filament element to increase or decrease the tension of the sling.

30. A method according to claim 29 wherein the step of manipulating the filament element to increase or decrease the tension of the sling includes the step of tying a knot in the filament element just adjacent the mid portion of the biocompatible material.

31. A method according to claim 30 wherein the step of tying a knot includes the step of tying an adjustable knot.