System for securing sutures, grafts and soft tissue to bone and periosteum

• US 7,410,460 B2
• Filed: 10/03/2003
• Issued: 08/12/2008
• Est. Priority Date: 11/23/1998
• Status: Expired due to Fees

• Current Assignee: Springboard Medical Ventures LLC
• Original Assignee: Springboard Medical Ventures LLC
• Inventors: Benderev, Theodore V.
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US10/679,131
• Publication Number:
  US 20040106847A1
• Time in Patent Office: 1,775 Days
• Field of Search: 600 29- 30, 600/37, 606/75, 606/151, 606/152, 606/213, 606215-216, 606219-220, 606/228, 606/232, 128897-898
• US Class Current: 600/30
• 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 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks

Abstract

Self-anchoring slings and deployment mechanisms for use therewith in selectively positioning a sling into position within the body. According to a preferred embodiment, the sling comprises an elongate sling portion having opposed ends. Formed upon each respective opposed end is an anchor member operative to be advanced through soft tissue at a selected target site in a first direction but resist movement in an opposed direction. Such anchor members are operative to extend in opposed directions to thus enable a sling to be securely affixed into position and resist sag or otherwise lose its ability to support a given structure. The deployment system is operative to selectively anchor the respective anchor members into position within a tissue mass. Although suitable for a wide variety of applications, it is believed that the system and sling of the present invention are particularly well suited for the deployment of suburethral slings via a trans-obturator route.

Claims

1. An implant for providing support to an anatomical structure comprising:

a) an elongate segment of material having first and second opposed ends, said segment of material being operatively positionable adjacent said anatomical structure to be supported; and

b) at least one anchor mechanism integrally formed upon a respective one of said ends of said segment of material, said anchor mechanism being operatively configured to be advanceable into a soft tissue mass at a target site in a first direction and resistant to movement in an opposite direction in the soft tissue, the anchor mechanism being configured to become permanently fixed in position within the soft tissue.

2. The implant of claim 1 wherein said implant includes two anchor mechanisms attached to said segment of material, each anchor mechanism being formed on a respective one of said opposed ends of said segment of material.

3. The implant of claim 2 wherein said first and second anchor mechanisms are operatively positioned to be advanced through a mass of soft tissue in generally opposed or generally parallel directions relative one another.

4. The implant of claim 1 wherein said segment of material comprises a sling.

5. The implant of claim 4 wherein said sling is fabricated from a material selected from the group consisting of synthetic material, natural material, tissue harvested from a host, and combinations thereof.

6. The implant of claim 3 wherein each anchor mechanism comprises at least one generally Y-shaped prong having a cord extending therethrough.

7. The implant of claim 6 wherein said anchor mechanism comprises a plurality of linearly arranged Y-shaped prongs, each respective one of said plurality of prongs having a cord extending medially therethrough.

8. The implant of claim 3 wherein each anchor mechanism comprises at least one generally chevron-shaped prong having a cord extending therethrough.

9. The implant of claim 8 wherein said anchor mechanism comprises a plurality of linearly arranged chevron-shaped prongs, each respective one of said plurality of prongs having a cord extending medially therethrough.

10. The implant of claim 3 wherein each respective anchor mechanism comprises a spiral-shaped screw.

11. A method for surgically implanting a sling to provide support to an anatomical structure within a patient comprising the steps:

a) providing an implantable sling comprising an elongate segment of material having first and second opposed ends, each respective opposed end having an anchor mechanism formed thereon such that each respective anchor mechanism is advanceable through said soft tissue at a selected target site in a first direction and resistant to movement in an opposite direction;

b) providing a deployment mechanism for positioning said anchor mechanisms of said implantable sling within said target site of said soft tissue, said deployment mechanism comprising a manually operable handle having a deployment member extending distally therefrom, said deployment member being detachably fastenable to a respective one of said anchor mechanisms of said implantable sling;

c) mounting a respective one of said anchor mechanisms of said implantable sling upon said distal end of said deployment member of said deployment mechanism;

d) advancing said anchor mechanism mounted upon said distal end of said deployment member in step c) toward a site selected from the group consisting of a first target site about a first side of the obturator foramen, a first target site about the rectus fascia and a first target site about the pubocervical fascia of said patient and selectively detaching said anchor mechanism from said deployment member such that said anchor mechanism becomes embedded within a first mass of soft tissue;

e) mounting the respective other anchor mechanism of said implantable sling upon said distal end of said deployment member and advancing said respective other anchor mechanism toward a site selected from the group consisting of a second target site about the respective other side of said obturator foramen, a second target site about the rectus fascia and a second target site about the pubocervical fascia, said second target sites being dissimilar to said first target sites, such that said segment of material is positioned to support the anatomical structure of said patient; and

f) detaching said respective other anchor mechanism from said deployment member and embedding said anchor mechanism within a second mass of soft tissue such that said anchor mechanisms resist movement in the opposite direction and securely position said sling to support the anatomical structure of said patient.

12. The method of claim 11 wherein said anatomical structure is selected from the group consisting of the urethra and the vaginal wall of said patient and in steps (d) and (e) said anchor mechanisms are advanced toward said sites via a single incision made in a vagina.

13. The method of claim 11 wherein in step (a), each respective one of said anchor mechanisms of said implantable sling comprise a plurality of linearly arranged Y-shaped prongs, each respective one of said plurality of prongs having a cord extending medially therethrough;

and

wherein in steps (d) and (e), said anchor mechanisms are advanced by extending said cord with said generally Y-shaped anchor members formed thereon through said soft tissue.

14. The method of claim 11 wherein in step (a) said anchor mechanism comprises a plurality of generally chevron-shaped anchor mechanisms having a cord extending medially therethrough;

and wherein in steps (d) and (e) said anchor mechanisms are advanced by extending said cord with said generally chevron-shaped anchor mechanisms formed thereon through said soft tissue.

15. The method of claim 11 wherein in step (a), each anchor mechanism on the implantable sling comprises a cord having at least one outwardly extending barbed portion disposed adjacent a distal end of the cord, and wherein the implantable sling comprises a mesh material extending axially aftwardly from the barbed portion in general axial alignment with the barbed portion.

16. The method of claim 15 wherein in step (a), the cord is configured as a cable having reinforcing material therein to provide structural rigidity to the anchor mechanism.

17. The method of claim 15 wherein in step (a), each anchor mechanism comprises a pair of the barbed portions extending outwardly from radially opposed sides of the cord to form a dual-prong configuration and wherein the implantable sling has mesh material extending axially aftwardly from each one of the barbed portions.

18. The method of claim 15 wherein in step (a), the mesh material is oriented such that frayed fiber ends of the mesh material extend in a generally outward direction to resist rearward movement of the anchor mechanisms once implanted within the soft tissue.

19. The method of claim 11 wherein in step (a), each anchor mechanism comprises a cord having at least one outwardly extending barbed portion disposed adjacent a distal end of the cord and wherein the implantable sling has mesh material extending axially aftwardly from the barbed portion in general axial alignment with the barbed portion.

20. The method of claim 19 wherein in step (a), the cord is configured as a cable having reinforcing material therein to provide structural rigidity to the anchor mechanism.

21. The method of claim 19 wherein in step (a), each anchor mechanism comprises a pair of the barbed portions extending outwardly from radially opposed sides of the cord to form a dual-prong configuration and wherein the implantable sling has mesh material extending axially aftwardly from each one of the barbed portions.

22. The method of claim 19 wherein in step (a), the mesh material is oriented such that frayed fiber ends of the mesh material extend in a generally outward direction to resist rearward movement of the anchor mechanisms once implanted within the soft tissue.

23. The method of claim 11 wherein the first and second target sites are about the obturator foramen, and steps (d) and (f) comprise embedding the anchor mechanism within first and second soft tissue masses that include muscle tissue about the obturator foramen.