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

• US 20040106847A1
• Filed: 10/03/2003
• Published: 06/03/2004
• Est. Priority Date: 11/23/1998
• Status: Active Grant

• Current Assignee: Springboard Medical Ventures LLC
• Original Assignee: Springboard Medical Ventures LLC
• Inventors: Benderev, Theodore V.
• Granted Patent: US 7,410,460 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 formed upon a respective one of said ends of said segment of material, said anchor mechanism being operatively configured such that said anchor mechanism is advanceable through a soft tissue mass in a first direction and selectively positionable at a target site therewithin and resistant to movement in an opposite direction.

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 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 system for securing a sling into affixed position within a target site of soft tissue within the body comprising:

a) an implantable sling comprised of 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 said selected target site in a first direction and resistant to movement in a direction dissimilar from said first direction; and

b) 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, said mechanism further comprising an actuator for selectively detaching said anchor member from said deployment member of said mechanism.

12. The system of claim 11 wherein said actuator is disposed within said deployment member and operative to advance said anchor member through said soft tissue.

13. The system of claim 11 wherein said deployment member has a sharpened distal-most end for cutting through soft tissue.

14. The system of claim 11 wherein said actuator comprises a manually depressable button coupled to a shaft extending within said deployment member and operative to push said anchor mechanism through said soft tissue.

15. The system of claim 11 wherein said segment of material is selected from the group consisting of synthetic material, natural material, tissue harvested from a host, or combinations thereof.

21. The system of claim 11 wherein said deployment member comprises an elongate sheath having a lumen extending therethrough, said respective one of said anchor mechanisms being selectively positionable within said lumen and selectively deployable therefrom.

22. The system of claim 21 wherein said anchor mechanism comprises a plurality of linearly-arranged anchor bodies, each respective one of said plurality of said anchor bodies being selectively positionable within and selectively deployable from said sheath.

23. The system of claim 22 wherein each respective one of said anchor bodies is operatively transitional between a first insertion configuration wherein said anchor bodies are disposed within the lumen of said sheath and a second operative configuration wherein said anchor bodies are operatively embedded within a target site of tissue and remain substantially retained in position.

16. A method for surgically implanting a sling beneath an anatomical structure within a patient comprising the steps:

a) providing an implantable sling comprised of 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 said 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, said mechanism further comprising an actuator for selectively detaching said anchor member from said deployment member of said mechanism;

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 side of the obturator foramen, a first target site of rectus fascia and a first target site of 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 member toward a site selected from the group consisting of respective other side of said obturator foramen, a second target site of rectus fascia and a second target site of pubocervical fascia, said second target sites being dissimilar to said first target sites of rectus fascia and pubocervical fascia, such that said respective other anchor member extends in a direction dissimilar to said first anchor member and said segment of material is positioned beneath 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 toward one another and securely position said sling beneath the anatomical structure of said patient.

17. The method of claim 16 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 sides via a single incision made in a vagina.

18. The method of claim 16 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.

19. The method of claim 16 wherein in step (a) said anchor mechanism comprises a plurality of linearly-arranged Y-shaped members 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 members formed thereon through said soft tissue.

20. The method of claim 16 wherein in step a), each anchor mechanism comprises a screw-shaped mechanism;

and steps (d) and (e) further comprise screwing said anchor mechanism into said target site within said soft tissue.

24. A method of performing vaginofixation of a prolapsed or partially prolapsed vagina comprising the steps:

a) reverting said prolapsed or partially prolapsed vagina; and

b) anchoring a portion of the vaginal wall of the reverted vagina in step (a) to soft tissue positioned within the obturator foramen of said patient.

25. The method of claim 24 wherein step (b) comprises the steps:

a) providing a fixation device, said fixation device having an anchor portion operative to be anchored within said soft tissue situated about said obturator foramen and a head portion operative to compress and be retained against said vaginal wall; and

b) positioning said fixation device such that said anchor portion is caused to extent through said vaginal wall and into said soft tissue situated about said obturator foramen and said anchor portion is operative to remain compressed against a portion of the vaginal wall.

26. A method of performing colporrhphy comprising the step of anchoring a portion of the torn vaginal wall to soft tissue positioned within the obturator foramen of said patient.