Snap fit sling anchor system and related methods

• US 20070015953A1
• Filed: 07/13/2005
• Published: 01/18/2007
• Est. Priority Date: 07/13/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: MacLean, Brian
• Granted Patent: US 8,043,205 B2
• Time in Patent Office: Days
• US Class Current: 600/31
• 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 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/0823 Modular anchors comprising a plurality of separate parts
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

The invention provides, in various embodiments, systems, devices and methods relating to employing soft tissue anchors in combination with an implantable sling to treat urinary incontinence.

Claims

1. A soft tissue anchor comprising,

a tissue engaging portion including a plurality of radially projecting features, and

a sling engaging body portion formed integrally with the tissue engaging portion and located axially adjacent and proximal to the tissue engaging portion, the sling engaging body portion including first and second sections, each section including a sling contacting side, the sling contacting side of the first section including a plurality of apertures and the sling contacting side of the second section including a corresponding plurality of protuberances for passing through a sling and matingly interfitting with the plurality of apertures in the first section.

2. The soft tissue anchor of claim 1, wherein at least one of the contacting sides of the first and second sections is textured to engage with the sling.

3. The soft tissue anchor of claim 1, wherein the apertures are through apertures.

4. The soft tissue anchor of claim 1, wherein the apertures and the protuberances are sized and shape for snap fitting together.

5. The soft tissue anchor of claim 1, wherein the apertures and the protuberances are sized and shaped for reversibly and reusably interfitting together.

6. The soft tissue anchor of claim 1 formed at least in part from a bioabsorbable material.

7. A soft tissue anchor comprising,

a tissue engaging portion including features sized and shaped for impeding removal of the soft tissue anchor from tissues of a patient, and

a sling engaging body portion formed integrally with and extending axially from the tissue engaging portion in a proximal direction, the sling engaging body being split into first and second sections separated from each other along a plane extending axially through both the tissue engaging portion and the sling engaging body portion, the first section including a plurality of apertures and the second section including a corresponding plurality of protuberances for passing through a sling and matingly interfitting with the plurality of apertures in the first section to secure the sling between the first and second sections.

8. The soft tissue anchor of claim 7, wherein at least one of the contacting sides of the first and second sections is textured to engage with the sling.

9. The soft tissue anchor of claim 7, wherein the apertures are through apertures.

10. The soft tissue anchor of claim 7, wherein the apertures and the protuberances are sized and shape for snap fitting together.

11. The soft tissue anchor of claim 7, wherein the apertures and the protuberances are sized and shaped for reversibly and reusably interfitting together.

12. A soft tissue anchor comprising,

a tissue engaging end including features sized and shaped for impeding removal of the anchor from tissues of a patient, and

a sling engaging end formed integrally with and extending axially from the tissue engaging portion in a proximal direction,

the soft tissue anchor being split into first and second sections along a plane extending axially through both the tissue engaging end and the sling engaging end, the first and second sections each including a portion of the tissue engaging end and a portion of the sling engaging end, the portions of the sling engaging end having cooperative sling contacting surfaces for cooperating to attach to a sling.

13. The soft tissue anchor of claim 12, wherein the first and second sections are connected via a hinge disposed along at least a portion of a first axially extending edge.

14. The soft tissue anchor of claim 13 including a latch having a first latch portion located on a second axially extending edge of the first section and a second latch portion sized and shaped for matingly interfitting with the first latch portion and located on a second axially extending edge of the second section.

15. The soft tissue anchor of claim 14, wherein the first and second latch portions are sized and shaped for reversibly and reusably interfitting together.

16. The soft tissue anchor of claim 12 formed from a biodegradable material.

17. The soft tissue anchor of claim 12, wherein at least one of the sling contacting surfaces is textured to engage with the sling.

18. A system for implanting a sling for treating urinary incontinence comprising,

a sling assembly including an implantable sling sized and shaped for providing a urethral support, and

a soft tissue anchor including,

a tissue engaging end sized and shaped for impeding removal of the anchor from tissues of a patient,

a sling engaging end formed integrally with the tissue engaging end and extending axially from in a proximal direction to the tissue engaging end, the sling engaging end including first and second sections, each of the first and second sections including a sling contacting side for interoperating to attach to a sling, and

an axially extending channel, and

a delivery device including a shaft having a distal end sized and shaped for fitting into the axially extending channel of the soft tissue anchor.

19. The soft tissue anchor of claim 18, wherein the first and second sections are connected via a hinge disposed along at least a portion of a first axially extending edge.

20. The soft tissue anchor of claim 19 including a latch having a first latch portion located on a second axially extending edge of the first section and a second latch portion sized and shaped for matingly interfitting with the first latch portion and located on a second axially extending edge of the second section.

21. The soft tissue anchor of claim 20, wherein the first and second latch portions are sized and shaped for reversibly and reusably interfitting together.

22. The soft tissue anchor of claim 18 formed from a biodissolvable material.

23. The soft tissue anchor of claim 18, wherein at least one of the sling contacting surfaces is textured to engage with the sling.

24. The soft tissue anchor of claim 18, wherein the first section includes a plurality of apertures and the second section includes a corresponding plurality of protuberances for passing through a sling and matingly interfitting with the plurality of apertures in the first section to secure the sling between the first and second sections.

25. The soft tissue anchor of claim 24, wherein the apertures are through apertures.

26. The soft tissue anchor of claim 24, wherein the apertures and the protuberances are sized and shape for snap fitting together.

27. The soft tissue anchor of claim 24, wherein the apertures and the protuberances are sized and shaped for reversibly and reusably interfitting together.

28. The soft tissue anchor of claim 18, wherein the sling includes length indicating markings.

29. A method for implanting a sling in the periurethral tissues of a patient comprising,

attaching a first location on the sling to a first soft tissue anchor by sandwiching the first location between first and second sections of the first soft tissue anchor to extend a tissue engaging portion of the first soft tissue anchor along an axis of the sling,

interfitting a proximal end of the first soft tissue anchor over a distal end of a sling delivery device shaft, and

inserting the distal end of the shaft with the first soft tissue anchor interfitted into the body of the patient to implant the sling in the periurethral tissues of the patient.

30. The method of claim 29 comprising inserting the distal end of the shaft and the first soft tissue anchor into the body of the patient via an incision in the vaginal wall of the patient.

31. The method of claim 30 comprising delivering the first soft tissue anchor to the space of Retzius.

32. The method of claim 30 comprising delivering the first soft tissue anchor at least partially through a first transobtural membrane.

33. The method of claim 30 comprising,

attaching a second location on the sling to a second soft tissue anchor by sandwiching the second location between first and second sections of the second soft tissue anchor to extend a tissue engaging portion of the second soft tissue anchor along an axis of the sling,

interfitting a proximal end of the second soft tissue anchor over a distal end of the sling delivery device shaft, and

inserting the distal end of the shaft with the second soft tissue anchor interfitted into the body of the patient to implant the sling in the periurethral tissues of the patient.

34. The method of claim 33 comprising inserting the distal end of the shaft and the first soft tissue anchor into the body of the patient via an incision in the vaginal wall of the patient.

35. The method of claim 34 comprising delivering the second soft tissue anchor to the space of Retzius.

36. The method of claim 34 comprising delivering the second soft tissue anchor at least partially through a second transobtural membrane on a contralateral side of the body from the first transobtural membrane.

37. The method of claim 30 comprising,

attaching a second location on the sling to a second soft tissue anchor by sandwiching the second location between first and second sections of the second soft tissue anchor to extend a tissue engaging portion of the second soft tissue anchor along an axis of the sling,

interfitting a proximal end of the second soft tissue anchor over a distal end of a second sling delivery device shaft, and

inserting the distal end of the second shaft with the second soft tissue anchor interfitted into the body of the patient to implant the sling in the periurethral tissues of the patient.