METHODS AND APPARATUS FOR SECURING A URETHRAL SLING TO A PUBIC BONE

• US 20100168505A1
• Filed: 06/20/2006
• Published: 07/01/2010
• Est. Priority Date: 06/21/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Lechner-Riehle, Jeffrey A., Inman, Mona J., Watschke, Eric S., Monarski, Matthew J., Arnal, Kevin R., Roychowdhury, Suranjan, Rykhus, Robert L. JR.
• Granted Patent: US 8,864,650 B2
• Time in Patent Office: Days
• 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 17/0487 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 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 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• 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 to pubic bone in a sub-urethral location to support the urethra and alleviate incontinence are disclosed. Bone anchors, e.g., bone screws, are driven into pubic bones with exposed bone anchor heads and necks configured to receive and support a urethral sling applied to the bone anchors with and without retainers applied against the urethral sling to retain portions of the urethral sling between the bone anchor heads and the pubic bones.

Claims

1. A surgical kit comprising:

a urethral sling having opposed sling sides and extending between a first sling end adapted to be coupled to a first pubic bone and a second sling end adapted to be coupled to a second pubic bone to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence, the urethral sling having or capable of having a sling opening formed through the sling adjacent the first and second sling ends;

at least one bone anchor comprising an anchor body having an anchor body axis and extending between a distal bone fixation mechanism adapted to attached to pubic bone through an anchor neck having a neck dimension lateral to the anchor body axis to a proximal anchor head having a head dimension lateral to the anchor body axis exceeding the neck dimension, whereby the urethral sling is adapted to be applied against the anchor head to insert the anchor head through the sling opening and engage the sling with the anchor neck; and

at least one sling retainer having a retainer dimension exceeding the head dimension adapted to be engaged by one of the anchor head and the anchor neck and applied against the urethral sling, whereby the sling retainer is adapted to be interposed between the urethral sling and the anchor head to retain the sling attached to the bone anchor.

2. The surgical kit of claim 1, wherein the sling retainer comprises a retainer bore having a bore dimension less than the head dimension and sized to receive the bone anchor neck to dispose the sling retainer between the anchor head and the urethral sling.

3. The surgical kit of claim 2, wherein the retainer bore extends through the sling retainer and has a bore dimension selected with respect to the head dimension to enable advancement of the sling retainer over the anchor head into engagement with a portion of the urethral sling.

4. The surgical kit of claim 3, wherein the sling retainer is formed of a resilient material enabling expansion of the retainer bore sufficiently to pass over the anchor head when axially advanced over the anchor head, and slits are formed extending away from the retainer bore toward a peripheral edge of the sling retainer to form flaps that facilitate expansion of the retainer bore as the retainer is passed over the anchor head.

8. The surgical kit of claim 3, further comprising a sling retainer dispenser comprising:

an elongated dispenser shaft having a shaft axis and extending from a shaft proximal end to a shaft distal end and adapted to be manually grasped, the shaft distal end shaped to engage the bone anchor head to enable axial alignment of the shaft axis with the bone anchor axis; and

at least one sling retainer supported along the length of the dispenser shaft with the retainer bore axially aligned with the shaft axis,

whereby a sling retainer may be moved distally along the shaft and from the shaft distal end over a bone anchor head engaged by the shaft distal end.

9. The surgical kit of claim 3, wherein the anchor head comprises a driver engagement element adapted to be engaged to drive the bone fixation mechanism into bone and further comprising an anchor driver that engages the driver engagement element to drive the bone fixation mechanism into bone.

10. The surgical kit of claim 9, wherein the anchor driver further comprises:

a drive motor adapted to be manually grasped;

an elongated drive shaft having a shaft axis and extending from a shaft proximal end coupled to the drive motor and a drive shaft distal end shaped to engage the bone anchor head to enable axial alignment of the shaft axis with the bone anchor axis, the drive motor adapted to drive the drive shaft and impart bone penetrating force to the bone fixation mechanism; and

a sling retainer dispenser supported by the drive shaft that in turn supports at least one sling retainer to be applied over an anchor head engaged by the drive shaft distal end.

11. The surgical kit of claim 10, wherein:

the sling retainer dispenser further comprises;

an elongated dispenser sheath having a sheath axis and sheath lumen extending between a sheath proximal end and a sheath distal end; and

at least one sling retainer supported along the length of the dispenser shaft with the retainer bore axially aligned with the shaft axis; and

the drive shaft is extended through the sheath lumen, whereby a sling retainer may be moved distally along the sheath and from the drive shaft distal end over a bone anchor head engaged by the shaft distal end.

12. The surgical kit of claim 11, wherein:

the elongated drive shaft comprises a shaft lumen; and

the bone anchor further comprises a suture extending from the anchor head adapted to be extended through the shaft lumen to facilitate engagement of the drive shaft distal end with the driver engagement element.

13. The surgical kit of claim 12, wherein the retainer further comprises a slot extending from a retainer body edge to a retainer bore dimensioned to receive the anchor neck and enable lateral advancement of the sling retainer with respect to the anchor neck to dispose the anchor neck in the retainer bore and to dispose the sling retainer between the sling and the anchor head.

14. The surgical kit claim 1, wherein the anchor head extends laterally to the anchor neck a generally constant dimension exceeding the anchor neck dimension through 360°

rotation about the axis of the anchor body, and the sling retainer bores are dimensioned to fit over the bone screw head to engage the bone screw neck or to be extended laterally around the bone screw neck to fit between the bone screw head and the urethral sling.

16. The surgical kit of claim 1, wherein the anchor head comprises at least one hook extending substantially laterally away from the anchor neck and the anchor body axis a dimension exceeding the lateral dimension of the anchor neck.

18. The surgical kit of claim 1, wherein the anchor head comprises a spiral wire having at least one spiral turn extending substantially laterally to the anchor neck and the anchor body axis a dimension exceeding the lateral dimension of the anchor neck.

5-7. -7. (canceled)

15. (canceled)

17. (canceled)

19-32. -32. (canceled)

33. Sling retention apparatus for securing a urethral sling at a plurality of locations to pubic bone to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence, the urethral sling having a sling opening, the apparatus comprising:

at least one bone anchor adapted to attached to pubic bone having an anchor neck and an anchor head having a head dimension enabling passage through the sling opening, and

at least one sling retainer having a retainer dimension exceeding the head dimension and a neck receiving port,

wherein the urethral sling is adapted to be applied against the anchor head to insert the anchor head through the sling opening and apply the sling against the anchor neck, and the sling retainer is adapted to be interposed between the sling and the anchor head with the anchor neck extending through the neck receiving port to retain the sling against the anchor neck and to inhibit passage of the sling over the anchor head.

34. The sling retention apparatus of claim 33, wherein the anchor head comprises a spiral wire having at least one spiral turn extending substantially laterally to the anchor neck and an anchor body axis a dimension exceeding the lateral dimension of the anchor neck.

35. The sling retention apparatus of claim 33 further comprising a driver engagement element adapted to be engaged to drive a bone fixation mechanism adapted to attach to pubic bone, whereby the driver engagement element is adapted to be engaged by a driver to drive the bone anchor into bone, and the urethral sling is adapted to be applied against the anchor head to insert the anchor head through the sling opening and engage the sling with the anchor neck.

36. The bone anchor of claim 35, further comprising an elongated suture affixed to the anchor head and extending to a suture free end adapted to guide a driver head into engagement with a driver engagement element.

37. The bone anchor of claim 35, wherein the anchor head extends laterally from the anchor body axis to a plurality of head lobes providing a head dimension exceeding the anchor neck dimension, the head lobes spaced from one another through a 360°

rotation about the axis of the anchor body providing sling engaging points and a driver engagement element adapted to be engaged to drive the bone fixation mechanism into bone.

38. The bone anchor of claim 35, wherein the anchor head comprises at least one hook extending substantially laterally away from the anchor neck and the anchor body axis a dimension exceeding the lateral dimension of the anchor neck.

39. A method of securing a urethral sling at a plurality of locations to pubic bone to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence, the urethral sling having a sling opening, the method comprising:

providing a bone anchor having an anchor body with an anchor body axis and extending between a distal bone fixation mechanism adapted to attached to pubic bone through an anchor neck having a neck dimension lateral to the anchor body axis to a proximal anchor head having a head dimension lateral to the anchor body axis exceeding the neck dimension, and a driver engagement element adapted to be engaged to drive the bone fixation mechanism into bone,

providing a driver having a drive shaft and a driving element at the drive shaft distal end;

engaging the driver engagement element with the driving element;

operating the driver to drive the bone anchor into pubic bone,

applying the opening of the urethral sling around the anchor neck;

providing a sling retainer having a retainer dimension exceeding the head dimension and a neck receiving bore; and

interposing the sling retainer between the sling and the anchor head with the anchor neck extending through the neck receiving port to retain the sling against the anchor neck and to inhibit passage of the sling over the anchor head.

40. The method of claim 39, wherein:

the sling retainer providing step comprises supporting the sling retainer on a retainer dispenser;

and the interposing step comprises;

aligning the retainer dispenser with an anchor head; and

dispensing the sling retainer from the retainer dispenser between the sling and the anchor head.

41. The method of claim 39, wherein:

the driver providing step comprises providing a retainer dispenser on the drive shaft;

the sling retainer providing step comprises supporting the sling retainer on the retainer dispenser;

and the interposing step comprises;

engaging the driver engagement element with the driving element to align the retainer dispenser with an anchor head; and

dispensing the sling retainer from the retainer dispenser between the sling and the anchor head.