Surgical kit for securing an implantable sling in a pubic region

• US 9,549,799 B2
• Filed: 07/03/2013
• Issued: 01/24/2017
• Est. Priority Date: 06/21/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Inman, Mona J., Arnal, Kevin R., Monarski, Matthew J., Rykhus, Robert L. Jr., Roychowdhury, Suranjan, Lechner-Riehle, Jeffrey A., Watschke, Eric S.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): COX, THADDEUS B
• Application Number:
  US13/934,739
• Publication Number:
  US 20130296641A1
• Time in Patent Office: 1,301 Days
• Field of Search: 600 29- 30, 600/37
• US Class Current: 1/1
• 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 17/0487 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 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Surgical procedures, kits and implants for alleviating human incontinence, and particularly providing improved methods and apparatus to secure a urethral sling (30) to pubic bone (24, 26) to support the urethra and alleviate incontinence are disclosed. Bone anchors (64) are driven into pubic bones with elongated bone anchor sutures (84) configured to be passed through openings of a urethral sling. Suture retainers are applied to the sutures to apply retentive force to the urethral sling to maintain the fixation of the urethral sling proximate to the pubic bone.

Claims

1. A surgical kit comprising:

an implantable sling having opposed sling sides and extending between a first sling end and a second sling end, the sling comprising a sling opening formed through the sling adjacent the first sling end;

an anchor;

a first elongated anchor suture having a first end attached to the anchor and a second free end, wherein the first suture is passable through the sling opening to allow for movement of the sling along a length of the first suture relative to the anchor;

a second elongated anchor suture having a first end attached to the anchor and a second free end, wherein the second suture is passable through the sling opening to allow for movement of the sling along a length of the second suture relative to the anchor;

at least one single-piece suture retainer having a retainer body and at least first and second retainer bores through the retainer body, the first and second retainer bores positioned adjacent to each other across a width of the suture retainer, and sized and shaped to receive and frictionally engage the first and second sutures, respectively, adjacent the implantable sling to inhibit slippage of the first and second sutures, respectively, relative to the first and second retainer bores and to apply retentive force through the retainer body against the implantable sling to retain a portion of the implantable sling proximate a target location,

wherein the retainer body further comprises first and second fixed slots extending from a retainer body edge to each of the first and second retainer bores, respectively, and dimensioned to enable lateral advancement of the suture retainer with respect to the first and second sutures to pass the first and second sutures through the first and second slots into the first and second retainer bores and to dispose the retainer into engagement with a portion of the sling,

the retainer body defining a first recess defined on the retainer body edge at a first location, and a second recess defined on the retainer body edge at a second location; and

a retainer installation and dispensing tool having a clamp having a first projection and a second projection, the first projection configured to engage with the first recess, the second projection configured to engage with the second recess.

2. The surgical kit of claim 1, wherein the first and second retainer bores are shaped to enable axial advancement of the retainer over the first and second sutures and into engagement with a portion of the implantable sling and to resist axial retraction of the retainer from engagement with the portion of the implantable sling.

3. The surgical kit of claim 1, wherein at least one of the first and second sutures has a variable suture cross-sectional area and comprises a suture body extending from the suture anchor to a suture free end, the suture body having a retention element extending outwardly from the suture body.

4. The surgical kit of claim 3, wherein the first and second slots are dimensioned to enable lateral advancement of the retainer with respect to the first and second sutures to pass the first and second sutures through the first and second slots into the first and second retainer bores and to dispose the retainer into engagement with and between the retention element and the portion of the implantable sling.

5. The surgical kit of claim 3, wherein the first and second retainer bores extend through the retainer body and are dimensioned to enable axial advancement of the retainer over the first and second sutures into engagement with the portion of the implantable sling.

6. The surgical kit of claim 3, wherein the retainer body extends from a first body end to a second body end, wherein each of the first and second retainer bores extend from a first bore diameter at the first body end sufficient to receive the retention element to a second bore diameter at the second body end smaller than the first bore diameter, and wherein the retainer body is expandable at the second body end to expand the second bore diameter to pass the retention element through the retainer bore.

7. The surgical kit of claim 6, wherein the retention element is shaped to expand the second bore diameter as the retainer body is advanced over the retention element and to allow contraction of the second bore diameter upon passage of the retainer body over the retention element.

8. The surgical kit of claim 3, wherein the retention element is tapered down in cross-sectional area from a location spaced from the first end of the first and second sutures toward the suture free ends.

9. The surgical kit of claim 8, wherein the retention element includes a conical shape.

10. The surgical kit of claim 8, wherein the retention element is a first retention element, and the suture body includes a second retention element, the first retention element and the second retention element being spaced from each other along the length of the suture by a first distance, wherein the first distance is at least as large as a combination of a thickness of the sling and a thickness of the suture retainer.

11. The surgical kit of claim 1, wherein the retainer installation and dispensing tool includes a tab extending from the clamp, the tab configured to be gripped by an operator, the tab having a width smaller than a width of the clamp.

12. A surgical kit comprising:

an implantable sling having opposed sling sides and extending between a first sling end portion and a second sling end portion, the sling comprising a first set of sling openings disposed on the first sling end portion and a second set of sling openings disposed on the second sling end portion;

a plurality of anchors;

a plurality of pairs of sutures, each pair of sutures includes first ends attached to a different anchor of the plurality of anchors and suture free ends, wherein each suture is passable through one of the sling openings to allow for movement of the sling along a length of the suture relative to the anchor to which it is attached;

a first suture retainer including a first retainer body and a first retainer cover, the first retainer body including a plurality of pairs of retainer bores, each pair of retainer bores being sized and shaped to receive a different pair of sutures that extend from the first set of openings, the first retainer body configured to be coupled to the first retainer cover to entrap the sutures that extend from the first set of openings;

a second suture retainer including a second retainer body, and a second retainer cover, the second retainer body including a plurality of pairs of retainer bores, each pair of retainer bores of the second retainer body being sized and shaped to receive a different pair of sutures that extend from the second set of openings, second retainer body configured to be coupled to the second retainer cover to entrap the sutures that extend from the second set of openings.

13. The surgical kit of claim 12, wherein the first retainer body is coupled to the first retainer cover based on a snap fit.

14. The surgical kit of claim 12, wherein the first retainer body is movably coupled to the first retainer cover.