Implant inserted without bone anchors

• US 20020161382A1
• Filed: 03/25/2002
• Published: 10/31/2002
• Est. Priority Date: 03/29/2001
• Status: Abandoned Application

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Neisz, Johann J., Watschke, Brian P., Anderson, Kimberly A., Lund, Robert E., Gohman, James A.
• Application Number:
  US10/106,086
• Publication Number:
  US 20020161382A1
• Time in Patent Office: Days
• US Class Current: 606/151
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0438 slotted, i.e. having a longitudinal slot for enhancing their elasticity
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

The present invention discloses an implant for placement in the retropubic space of a patient. Novel methods and assemblies for use in conjunction with the implant are also described.

Claims

1. A method of treating incontinence in a patient comprising the steps of:

providing an implantable material capable of eliciting a foreign body response, the implantable material being sized and shaped to be placed in the patient'"'"'s retropubic space without extending through the patient'"'"'s rectus fascia,

placing the implantable material in the retropubic space without securing the implant to substantially fixed anatomical structures such as the patient'"'"'s pubic bone, periosteum of the pubic bone, Cooper'"'"'s ligament and rectus fascia; and

eliciting a foreign body response with the implantable material.

2. A method according to claim 1 wherein the step of eliciting a foreign body response with the implantable material causes the patient'"'"'s retropubic space to more closely mimic the retropubic space of a continent individual.

3. A method according to claim 1 wherein the step of placing the implantable material in the retropubic space includes the step of anchoring the implantable material to endopelvic fascia with a mechanical fastener.

4. A method of treating incontinence in a patient comprising the steps of:

providing an implantable material that is sized and shaped be implanted in the patient'"'"'s retropubic space and that is capable of eliciting a foreign body response;

placing the implantable material in the retropubic space in a therapeutically effective position relative to the patient'"'"'s urethra without extending the implantable material to the patient'"'"'s rectus fascia, without suturing the implant to the patient'"'"'s Cooper'"'"'s ligament, and without using bone anchors.

5. A method according to claim 4 wherein the step of providing an implantable material includes the step of providing an implantable material with first and second ends, and

the step of placing the implantable material includes the step of associating the first end of the implantable material with endopelvic fascia on one side of the patient'"'"'s urethra and associating the second end of the implantable material with endopelvic fascia on the other side of the patient'"'"'s urethra.

6. A method according to claim 4 wherein the step of placing the implantable material includes the step of placing the implant mid-urethra.

7. A method according to claim 4 wherein the step of placing the implantable material includes the steps of:

passing a deployable anchoring member with an associated suture through endopelvic fascia;

deploying the anchoring member after the anchoring member has substantially passed through endopelvic fascia, and

securing the implantable material to the suture associated with the anchoring member.

8. A method according to claim 4 wherein the step of placing the implantable material includes the step of extending the implantable material from the endopelvic fascia on one side of the patient'"'"'s urethra, underneath approximately the mid-urethra, and to the endopelvic fascia on the other side of the patient'"'"'s urethra.

9. A method according to claim 4 wherein the step of placing the implantable material includes the step of at least temporarily adhering the implantable material to endopelvic fascia with a tissue adhesive.

10. A method according to claim 9 further including the step of using a foam material.

11. An assembly for placing an implant in a patient'"'"'s retropubic space during a surgical procedure for treating incontinence, the assembly comprising:

at least one deployable member for associating the implant with endopelvic fascia of a retropubic space; and

an inserter that is sized and shaped to associate the deployable member with endopelvic fascia.

12. An assembly according to claim 11 wherein the inserter includes a sheath with a distal end, and a movable member within the sheath,

the movable member being operatively associated with the deployable member to move the deployable member between i) a retracted position with the deployable member at least partially received within the sheath of the inserter, and ii) an extended position spaced more distally to the distal end of the sheath than in the retracted position, and

wherein movement of the movable member causes the deployable member to move from the retracted position toward the extended position.

13. An assembly according to claim 11 wherein the deployable member is capable of assuming a first orientation that affords at least partial receipt of the deployable member within a sheath of the inserter, and a second orientation that affords secure association between the deployable member and endopelvic fascia.

14. An assembly according to claim 13 wherein the deployable member has a first profile in the first orientation and a second profile in the second orientation, and

wherein the first profile is less than the second profile.

15. An assembly according to claim 11 wherein the deployable member comprises a flexible, substantially disc shape.

16. An assembly according to claim 11 wherein the inserter comprises a tissue adhesive dispenser and the deployable members comprises components of a tissue adhesive.

17. An assembly according to claim 13 wherein the deployable member comprises a substantially clover shaped top portion substantially situated in a first plane, and a stem substantially adapted to be situated in a second plane, and

in the first orientation, the first plane is nearly parallel to the second plane, and

in the second orientation, the first plane is substantially perpendicular to the second plane.

18. An assembly according to claim 11 wherein the inserter includes a tissue stop for blocking insertion of a distal end of the inserter past preselected endopelvic fascia.

19. An assembly according to claim 13 wherein the movable member is rotatable.

20. An assembly according to claim 13 wherein the movable member is linearly movable relative to the sheath.

21. An assembly according to claim 11 wherein the deployable member comprises a conical spring.

22. An assembly according to claim 11 wherein the deployable member comprises a plurality of anchoring fingers.

23. An assembly according to claim 11 wherein the deployable member comprises an expandable tube that affords movement into tissue in one direction, but that resists movement though tissue in an opposite direction.

26. An implant according to claim 25 wherein the sheet is capable of eliciting a foreign body response.

27. An implant according to claim 26 wherein the sheet comprises a synthetic mesh material having a plurality of holes, the holes being sized and shaped to afford tissue ingrowth to anchor the implant in the retropubic space.

28. An implant according to claim 25 wherein the implant is sized and shaped to anchor in the patient'"'"'s endopelvic fascia.

24. A kit for a surgical procedure to treat incontinence comprising:

an implant that is sized and shaped to be implanted in a patient'"'"'s retropubic space;

at least two deployable members for associating the implant with endopelvic fascia of a retropubic space; and

an inserter that is sized and shaped to associate the deployable members with endopelvic fascia.

25. An implant for treating incontinence in a patient comprising:

a substantially thin, flexible sheet that has a geometry, size and shape suitable for implanting in the patient'"'"'s retropubic space without extending through the patient'"'"'s rectus fascia and without requiring the implant to be secured to substantially fixed anatomical structures such as the patient'"'"'s pubic bone, periosteum of the pubic bone, Cooper'"'"'s ligament and rectus fascia.

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

providing an implantable material capable of eliciting a foreign body response, the implantable material being sized and shaped to be placed in the patient'"'"'s retropubic space without extending through the patient'"'"'s rectus fascia,

placing the implantable material in the retropubic space without securing the implant to substantially fixed anatomical structures such as the patient'"'"'s pubic bone, periosteum of the pubic bone, Cooper'"'"'s ligament and rectus fascia; and

looping the implantable material underneath the rectum to correct the patient'"'"'s ano-rectal angle.

30. A method of treating incontinence in a patient comprising the steps of:

providing an implantable material capable of eliciting a foreign body response, the implantable material being sized and shaped to be placed in the patient'"'"'s retropubic space without extending through the patient'"'"'s rectus fascia, and

securing the implantable material in the retropubic space with a sponge-like substance without securing the implant to substantially fixed anatomical structures such as the patient'"'"'s pubic bone, periosteum of the pubic bone, Cooper'"'"'s ligament and rectus fascia.