Stabilization sling for use in minimally invasive pelvic surgery

• US 6,042,534 A
• Filed: 02/13/1998
• Issued: 03/28/2000
• Est. Priority Date: 02/13/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Martin, William, Gellman, Barry N., Rackley, Raymond
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/023,398
• Time in Patent Office: 774 Days
• Field of Search: 600/300, 600/30, 600/29, 600/37, 606/151, 128/898, 128/897
• US Class Current: 600/30
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention relates to prefabricated urethral suspension slings, methods of making the slings, methods of attaching suture to the slings, kits comprising the slings, and methods of using the slings to treat urinary incontinence. The slings comprise a biocompatible material having an elongate shape adapted for urethral suspension. The material has a central portion extending longitudinally between a first end portion and a second end portion. Each end portion of the sling contains at least one suture receiving site. The suture receiving sites are formed prior to surgery and may be reinforced through a variety of means. Sutures may be attached to the suture receiving sites during the manufacturing process or by the physician prior to or during surgery. Additionally, the end portions of the sling containing the suture receiving sites may be thicker than the central portion of the sling.

Claims

1. A sling for improving urinary continence comprising:

a length of biocompatible material, having central portion positioned between a first end portion and a second end portion, and a longitudinal central axis extending between said first and second end portions;

at least one pair of preformed suture receiving sites, wherein each pair of suture receiving sites comprises a first suture receiving site disposed in said first end portion of said material and a second suture receiving site disposed in said second end portion of said material; and

a visual indicator extending across the central portion of said material.

2. A sling as in claim 1, having an odd number of suture receiving site pairs, greater than one, wherein one of said suture receiving site pairs is disposed along said longitudinal central axis extending between said first and second end portions;

and the remainder of said suture receiving site pairs are disposed symmetrically about said longitudinal central axis extending between said first and second end portions.

3. A sling as in claim 1, having an even number of suture receiving site pairs in each end portion, wherein all of said suture receiving site pairs are disposed symmetrically about said longitudinal central axis extending between said first and second end portions.

4. A sling as in claim 1, wherein said visual indicator comprises a radiopague material.

5. A sling as in claim 1, wherein said biocompatible material comprises directionally ordered filaments, grains, striations, or polymeric chains.

6. A sling as in claim 5, wherein said suture receiving sites are disposed in a cross grain section which is produced by folding over the edges of said first and second end portions of said directionally ordered biocompatible material.

7. A sling as in claim 6, wherein the folded edges of said end portions are secured by a technique selected from the group consisting of sewing, heat sealing, ultrasonic sealing, stapling, and gluing.

8. A sling as in claim 7, wherein said biocompatible material is woven.

9. A sling as in claim 8, further comprising at least one attachment member extending laterally from said end potion, said attachment member being formed from trailing fibers of the woven biocompatible material.

10. A sling as in claim 1, wherein said biocompatible material is derived from animal tissue.

11. A sling as in claim 1, wherein said biocompatible material derived from animal tissue is selected from the group consisting of striated muscle, fascia lata, rectus fascia, dura, pericardium, and processed collagen.

12. A sling as in claim 1, wherein said biocompatible material is bioabsorbable.

13. A sling as in claim 1, wherein said biocompatible material is covered with a bioabsorbable coating.

14. A sling as in claim 13, wherein said bioabsorbable coating is selected from the group consisting of collagen, gelatin, polyvinyl alcohol, polyvinyl pyrrolidine, polyglycolic acid, and polylactic acid.

15. A sling as in claim 1, wherein said biocompatible material is impregnated with an antibiotic.

16. A sling as in claim 1, further comprising a stabilizer for strengthening and reducing bucking of said sling, said stabilizer being disposed in said at least one of said first and second end portions of said sling.

17. A sling as in claim 1, wherein said suture receiving sites are reinforced.

18. A sling of as in claim 17, wherein said suture receiving sites are reinforced by ultrasonic sealing or heat sealing.

19. A sling of as in claim 17, wherein said suture receiving sites are reinforced with an eyelet.