Systems, methods and devices relating to implantable supportive slings

• US 20060089525A1
• Filed: 06/14/2005
• Published: 04/27/2006
• Est. Priority Date: 06/14/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Weiser, Michael F., Mamo, George
• Granted Patent: US 8,628,465 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 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• 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 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0459 Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• 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 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0007 : for adjusting length

Abstract

The invention provides, in various embodiments, aspects of soft tissue anchors, adjustable length/tension slings, interconnects between slings and soft tissue anchors, delivery devices and systems for implanting supportive slings, and methods relating to anchoring, adjusting and implanting supportive slings.

Claims

1. An implantable sling for treating urinary incontinence comprising,

an elongated sling having first and second terminal ends,

the first end having a first portion folded over onto a portion of a length of the sling to form a first pocket in the first end, and

the second end having a second portion folded over onto a portion of the length of the sling to form a pocket in the second end.

2. The implantable sling of claim 1, wherein the first and second pockets are sized and shaped for receiving a distal end of a delivery device shaft.

3. The implantable sling of claim 1, wherein the first portion has first and second long edges affixed to first portions of corresponding long edges of the sling, and the second portion has first and second long edges affixed to second portions of the corresponding long edges to form the first and second pockets.

4. A soft tissue anchor comprising an elongated body having an aperture in a proximal end and a passage extending axially in a distal direction at least part way to a distal end of the elongated body, and a plurality of barbs projecting radially from an external surface of the elongated body, wherein the elongated body is between about 2.5 and 3.5 cm long.

5. The soft tissue anchor of claim 4, wherein the barbs are between about 2 mm and about 5 mm in length.

6. The soft tissue anchor of claim 4, wherein the barbs are between about 1 mm and about 2 mm in width at a maximum width location.

7. The soft tissue anchor of claim 4, wherein the barbs have a maximum width of less than about 1 mm.

8. The soft tissue anchor of claim 4, wherein the barbs are arranged in one or more substantially radially aligned rows.

9. The soft tissue anchor of claim 4, wherein the barbs are arranged in one or more substantially axially aligned rows.

10. The soft tissue anchor of claim 4, wherein not of the barbs align radially or axially.

11. The soft tissue anchor of claim 4, wherein the barbs are cut into and pealed back from an outer surface of the elongated body.

12. The soft tissue anchor of claim 4, wherein the axially extending passage is a through passage extending between the proximal and distal ends of the elongated body.

13. The soft tissue anchor of claim 4 having a maximum outside diameter, not including the barbs of less than about 4 mm.

14. The soft tissue anchor of claim 4 having a maximum outside diameter, not including the barbs of between about 2mm and about 4 mm.

15. The soft tissue anchor of claim 4 including a slot extending distally from the proximal end of the anchor along a cross-sectional radius of the anchor, the slot being sized and shaped for receiving a sling end.

16. The soft tissue anchor of claim 4 having a loop extending from the proximal end of the anchor, the loop being sized and shaped for slidably receiving a sling.

17. The soft tissue anchor of claim 16, wherein the loop includes radially inwardly oriented projections sized and shaped to allow a sling to pass in a first direction and for inhibiting the sling from passing back in an opposite direction.

18. The soft tissue anchor of claim 4 including first and second radially oriented elongaged through apertures in a side wall of the anchor, the apertures being in communication with the chamber, being separated by a cross member, and being sized for receiving a sling.

19. The soft tissue anchor of claim 18 including projections extending into at least one of the first and second apertures sized, shaped and oriented to pass a sling in a first direction and to resist passing back in an opposite direction.

20. The soft tissue anchor of claim 4 including a bar located within the chamber of the anchor and extending across the chamber between first and second locations on an internal wall defining the chamber, the bar being sized and shaped for passing a sling around it.

21. The soft tissue anchor of claim 20, wherein the bar includes projections sized, shaped and oriented for passing a sling around it in a first direction and for inhibiting the sling from passing back in an opposite direction.

22. The soft tissue anchor of claim 20, wherein the internal wall includes projections sized, shaped and oriented for passing a sling around the bar in a first direction and for inhibiting the sling from passing back in an opposite direction.

23. The soft tissue anchor of claim 4, wherein at least two of the barbs are smaller as compared to others of the barbs, are located near the distal end of the anchor, and are sized and shaped for interlocking with mating structures on an internal wall near a proximal end of another anchor.

24. The soft tissue anchor of claim 24 comprising indentations near the proximal end of the anchor on an internal wall defining the chamber, the indentations be sized, shaped and oriented for interlocking with mating projections on a distal end of the other anchor.

25. The soft tissue anchor of claim 24, wherein the indentations are through apertures extending between the internal wall of the chamber and an external surface of the anchor.

26. A soft tissue anchoring system comprising,

a plurality of anchors, each of the anchors including proximal and distal ends, internal and external surfaces, and an internal chamber defined by the internal surface and extending from the proximal end of the anchor at least part way to the distal end, each of the anchors also including one or more radial projections located on the external surface near a distal end of the anchor, and indentations located on the internal surface near the proximal end of the anchor, the radial projections of each of the plurality of anchors being sized, shaped and oriented to matingly snap fit with the indentations of others of the plurality of anchors to enable stacking of the plurality of anchors to form anchors of increased length.

27. The soft tissue anchor system of claim 26, wherein the indentations for through apertures extending between the internal and external surfaces if the anchors.

28. A soft tissue anchoring system comprising,

an anchor including proximal and distal ends, internal and external surfaces, an internal chamber defined by the internal surface and extending from the proximal end of the anchor at least part way to the distal end of the anchor, and a loop extending from the proximal end of the anchor, the loop being sized and shaped for slidably receiving a sling, and

means separate from the anchor for prohibiting the anchor from sliding off the sling.

29. A soft tissue anchor system comprising,

an anchor including proximal and distal ends, internal and external surfaces, an internal chamber defined by the internal surface and extending from the proximal end of the anchor at least part way to the distal end of the anchor, and a bar located within the chamber of the anchor and extending across the chamber between the first and second locations on the internal wall, the bar being sized and shaped for passing a sling around it, and

means separate from the anchor for prohibiting the anchor from sliding off the sling.

30. A sling assembly comprising,

an implantable sling having first and second ends and a aperture located near the first end,

at least one tissue anchor having proximal and distal ends, a passage extending axially in a distal direction from the proximal end of the tissue anchor at least part way to the distal end of the tissue anchor, and an aperture in a side wall, and

a filament having first and second ends, the first end of the filament threading through the aperture in the side wall of the tissue anchor, the second end of the filament threading through the aperture in a sling end, the first and second ends of the filament being secured together by a slidable mechanism.

31. The sling assembly of claim 30, wherein the slidable mechanism is a one-way slip knot.

32. A sling assembly comprising,

an implantable sling having first and second ends and first and second apertures located near the first end,

a tissue anchor having proximal and distal ends with the proximal end attached to the first end of the implantable sling, and

a filament having first and second ends, the first end passing through the first aperture in the sling and the second end passing through the second aperture in the sling, the first end of the filament also being interwoven with the sling along a portion of a first long edge of the sling, and the second end of the filament also being interwoven with the sling along a portion of a second long edge of the sling, the first and second filament ends being drawable to accordion the portion of the sling with which they interweave to shorten a length of the sling.

33. A sling assembly comprising,

a first sling assembly section including a first sling section having a first end attached to a first tissue anchor and a second free end,

a second sling assembly section including a second sling section having a first end attached to a second tissue anchor and a second free end, and

the first free ends of the first and second sling assembly sections being attachable together to form a custom length sling assembly.

34. The sling assembly of claim 33 comprising a clip for clipping the first free ends of the first and second sling assembly sections together.

35. The sling assembly of claim 33 including an aperture near the first free end of the first sling assembly section, and projections along a portion of the second sling section, the aperture begin sized and shaped for passing the second tissue anchor and the second sling in a first direction and for engaging with the projections to resist passing at least the portion of the second sling section back in an opposite direction.

36. A sling assembly comprising,

an anchor including proximal and distal ends, and a loop extending from the proximal end of the anchor,

an implantable supportive sling,

an elongated element having radial projections extending from an end of the supportive sling, and

the loop and the elongated element being sized and shaped for allowing the elongated element to pass through the loop in a first direction but inhibit the elongated element from passing back in an opposite direction to attach the anchor to the implantable supportive sling.

37. A sling assembly comprising,

an anchor including proximal and distal ends, internal and external sides, an internal chamber defined by the internal side and extending from the proximal end of the anchor at least part way to the distal end of the anchor, and

an implantable supportive sling attached to a location on the external side of the anchor about midway between the proximal and distal ends of the anchor.

38. The sling assembly of claim 37, wherein the sling is attached directly to the anchor.

39. The sling assembly of claim 37, wherein the sling is attached indirectly to the anchor.

40. The sling assembly of claim 39, wherein the indirect attachment is via a suture.

41. A sling delivery device comprising,

a handle, and

a shaft extending distally from a distal end of the handle, the shaft having first and second sections, the first section having a greater outside diameter than the second section to form a radially extending shoulder between the first and second sections, the second section having a length of at least about 3 cm.

42. The delivery device of claim 41, wherein the second section has a length of at least about 4 cm.

43. The delivery device of claim 41, wherein the second section has an outside diameter of between about 0.03 inch and about 0.05 inch.

44. The delivery device of claim 41, wherein the first section has an outside diameter of between about 0.07 inch and about 0.1 inch.

48. The delivery device of claim 42, wherein the exposed distal portion has a length of at least about 4 cm.

45. A delivery device comprising,

a handle,

a shaft extending distally from the handle, and

a pusher assembly including a cannula slidably interfitted over the shaft and a user actuator attached to the cannula for enabling a user to slide the cannula back and forth over the shaft, wherein with the cannula fully retracted, the shaft has an exposed distal portion having a length of at least about 3 cm.

46. The delivery device of claim 45, wherein the exposed distal portion has a length of at least about 4 cm.

47. A delivery device comprising,

a handle,

a cannula extending distally from the handle, and

a shaft slidably interfitted within the cannula and mechanically coupled to a slider on the handle for sliding the shaft back and forth within the cannula, wherein with the shaft in a fully extended position, the shaft has an exposed distal portion having a length of at least about 3 cm.

49. A delivery device comprising,

a dilator having an elongated body with apertures at proximal and distal ends and a through lumen extending axially therebetween,

an elongated guide member longer than the dilator and sized and shaped for slidably interfitting and axially passing through the through lumen of the dilator, and

a pusher having a handle with distal and proximal ends and a through lumen extending axially there between, and a cannula extending axially from the distal end of the handle and including a through lumen, the through lumen of the handle being axially aligned with the through lumen of the cannula, and both being sized for slidably interfitting over the elongated guide member to advance an anchor distally along the guide member.

51. The method of claim 49, wherein the anatomical site is within an obturator membrane of the patient.

52. The method of claim 49, wherein the anatomical site is through the obturator membrane into the obturator formamen of the patient.

50. A method for implanting a tissue anchor attached to a supportive sling to an anatomical site within the body of a patient, the method comprising,

inserting an elongated dilator having proximal and distal ends and a through lumen extending there between distal end first into a body of a patient via an incision in a vaginal wall,

advancing the dilator until the distal end of the dilator is near the anatomical site,

advancing an elongated guide member through the lumen of the dilator at least until a distal tip of the elongated guide member is exposed through the distal end of the dilator,

sliding the dilator proximally over the guide member to remove the dilator from the body of the patient,

advancing a hollow anchor attached to a sling proximally over the guide member until the anchor is at the anatomical site, and

removing the guide member to leave the anchor implanted within the body of the patient at the anatomical site.

53. The method of claim 50, wherein the anatomical site is between about 1 cm and about 2.5 cm into the obturator foramen, as measured from an obturator foramen side of the obturator membrane.