Surgical instrument for treating female pelvic prolapse

• US 20070043255A1
• Filed: 08/22/2005
• Published: 02/22/2007
• Est. Priority Date: 08/22/2005
• Status: Active Grant

• Current Assignee: Pat O'Donnell
• Original Assignee: Pat O'Donnell
• Inventors: O'Donnell, Pat
• Granted Patent: US 8,128,552 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• 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 2017/0412 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 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

A surgical instrument for treating female pelvic prolapse comprising a mesh sling for implanting into the pelvis of a female, which provides support to the urethra, the anterior vaginal wall, and the posterior vaginal wall with the sling defining a tissue-anchoring segment attached to opposite ends of the mesh sling. The mesh sling is surgically positioned using a tissue anchor applier instrument. The tissue anchor segment is positioned to attach to durable fascia that is located anatomically to support the sling. The durable fascia anchored vaginal wall support sling is positioned to provide support to the urethra for surgical management of female urinary incontinence, support to the anterior vaginal wall for surgical management of female cystocele, and support to the posterior vaginal wall for surgical management of female rectocele.

Claims

1. A system for treating female pelvic prolapse comprising:

a sling comprised of a mesh material portion in non-displaceable communication with first and second tip portions positioned at opposite ends of the sling, the sling having a plurality of integrated fascia tissue anchors;

a sling deployment tool in removable communication with the sling; and

utilizing the sling deployment tool to position and insert the integrated fascia tissue anchors into durable fascia resulting in the sling'"'"'s mesh material portion supporting mid and proximal urethral and bladder neck continence sites.

2. The system of claim 1 wherein the sling deployment tool is utilized to position and insert the integrated fasia anchors into durable fascia resulting in the sling'"'"'s material portion supporting the mid-uretheral continence site.

3. The system of claim 1 wherein the plurality of integrated fascia tissue are positioned exclusively on the first and second tip portions of the sling.

4. The system of claim 1 wherein the plurality of integrated fascia tissue anchors are positioned on both mesh material and first and second tip portions of the sling.

5. The system of claim 1 wherein the durable fascia is selected from the group of fascia including pubocervical fascia, periurethral fascia, and obturator internus fascia.

6. The system of claim 4 wherein the durable fascia is selected from the group further comprising the pelvis, the pelvic fascia, ligaments attached to the pelvis, ligaments overlying the pelvis, and the urethropelvic ligament.

7. The system of claim 1 wherein the sling'"'"'s mesh portion is a single layer mesh portion.

8. The system of claim 1 wherein the sling'"'"'s mesh portion is a tubular sling mesh portion.

9. The system of claim 1 wherein the sling'"'"'s mesh portion is a multilayered mesh portion.

10. The system of claim 1 wherein the sling'"'"'s mesh and anchor portions are comprised of biodegradable material.

11. The system of claim 1 wherein the sling'"'"'s mesh and anchor portions are comprised of non-biodegradable material.

12. The system of claim 1 wherein the sling'"'"'s mesh or anchor portions are comprised of biodegradable material.

13. The system of claim 1 wherein the sling'"'"'s mesh or anchor portions are comprised of non-biodegradable material.

14. The system of claim 1 wherein the sling'"'"'s anchor portions are structured as essentially S-shaped structures.

15. The system of claim 1 wherein the sling'"'"'s anchor portions are structured essentially triangular shaped structures.

16. The system of claim 1 wherein the sling'"'"'s tip portions further comprise a suture.

17. The system of claim 1 wherein the sling'"'"'s tip portions further comprise a suture and a sling transfer hook.

18. A method for treating female pelvic prolapse comprising:

(a) providing a sling comprised of a mesh material portion in non-displaceable communication with first and second tip portions positioned at opposite ends of the sling, the sling having a plurality of integrated fascia tissue anchors;

(b) providing a sling deployment tool in removable communication with the sling;

(c) anatomically separating vaginal mucosa from the underlying anterior vaginal wall supporting fascia via lateral injection of saline to the pubic bone and into fascia attached to the pubic bone;

(d) making a midline anterior vaginal incision along the area of planned placement of the vaginal support sling extending from the mid-urethral area to the bladder neck;

(e) separating the vaginal mucosa from the underlying anterior vaginal wall fascia for a distance varying between one centimeter and six centimeters;

(f) utilizing the sling deployment tool positioning the sling between the separated layers of the vaginal mucosa and the underlying vaginal fascia by inserting a tip of the tissue anchor into the durable fascia of the pelvis medial to the pubic bone; and

,

(g) closing the vaginal mucosa subsequent to placement of each anchored vaginal sling using absorbable sutures.

19. The method for treating female pelvic prolapse according to claim 18 wherein the sling deployment tool is used to place the sling into the durable fascia of the pelvis medial to the bony pelvis.

20. A sling for treating female pelvic prolapse comprising:

a sling comprised of a mesh material portion in non-displaceable communication with first and second tip portions positioned at opposite ends of the sling, the sling having a plurality of integrated fascia tissue anchors;

a sling deployment tool in removable communication with the sling; and

utilizing the sling deployment tool to position and insert the integrated fascia tissue anchors into durable fascia resulting in the sling'"'"'s mesh material portion simultaneously supporting mid and proximal urethral and bladder neck continence sites.

21. The sling of claim 20 wherein the plurality of integrated fascia tissue are positioned exclusively on the first and second tip portions of the sling.

22. The sling of claim 20 wherein the plurality of integrated fascia tissue anchors are positioned on both mesh material and first and second tip portions of the sling.

23. The sling of claim 20 wherein the sling'"'"'s mesh portion is a single layer mesh portion.

24. The sling of claim 20 wherein the sling'"'"'s mesh portion is a tubular sling mesh portion.

25. The sling of claim 20 wherein the sling'"'"'s mesh portion is a multilayered mesh portion.

26. The sling of claim 20 wherein the sling'"'"'s mesh and anchor portions are comprised of biodegradable material.

27. The sling of claim 20 wherein the sling'"'"'s mesh and anchor portions are comprised of non-biodegradable material.

28. The sling of claim 20 wherein the sling'"'"'s mesh or anchor portions are comprised of biodegradable material.

29. The sling of claim 20 wherein the sling'"'"'s mesh or anchor portions are comprised of non-biodegradable material.

30. The sling of claim 20 wherein the sling'"'"'s anchor portions are structured as essentially S-shaped structures.

31. The sling of claim 20 wherein the sling'"'"'s anchor portions are structured essentially triangular shaped structures.

32. The sling of claim 20 wherein the sling'"'"'s tip portions further comprise a suture.

33. The sling of claim 20 wherein the sling'"'"'s tip portions further comprise a suture and a sling transfer hook.