Surgical instrument for treating female pelvic prolapse

• US 8,128,552 B2
• Filed: 08/22/2005
• Issued: 03/06/2012
• Est. Priority Date: 08/22/2005
• Status: Active Grant

• Current Assignee: O'Donnell, Pat D.
• Original Assignee: O'Donnell, Pat D.
• Inventors: O'Donnell, Pat D.
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US11/209,021
• Publication Number:
  US 20070043255A1
• Time in Patent Office: 2,388 Days
• Field of Search: 128/885, 128/898, 600 29- 30, 600/32, 600/37, 623/11.11, 623 13- 14, 623 16- 17, 623/23
• 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 first and second tip portions having a plurality of integrated fascia tissue anchoring pins; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein a portion of the plurality of integrated fascia tissue anchoring pins pass through the mesh material portions of the sling.

2. The system of claim 1 wherein the durable fascia is selected from a group further comprising a pelvis, a pelvic fascia, ligaments attached to the pelvis, ligaments overlying the pelvis, and an urethropelvic ligament.

3. 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 first and second tip portions having a plurality of integrated fascia tissue anchoring pins; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein the sling'"'"'s mesh portion is a multilayered mesh portion, wherein a portion of the plurality of integrated fascia tissue anchoring pins pass through the mesh material portion of the sling.

4. 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 anchoring pins; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein each of the sling'"'"'s anchoring pins portions are structured as essentially S-shaped structures.

5. 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 first and second tip portions having a plurality of integrated fascia tissue anchoring pins; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein the sling'"'"'s tip portions comprise an inwardly slanted distal end, wherein the sling'"'"'s tip portions further comprise a suture placed at the distal end of the sling'"'"'s tip portions, wherein a portion of the plurality of integrated fascia tissue anchoring pins pass through the mesh material portion of the sling.

6. 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 first and second tip portions having a plurality of integrated fascia tissue anchoring pins; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein the sling'"'"'s tip portions further comprise a suture and a sling transfer hook, wherein a portion of the plurality of integrated fascia tissue anchoring pins pass through the mesh material portion of the sling.

7. 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 an underlying anterior vaginal wall supporting fascia via lateral injection of saline to a pubic bone and into fascia attached to the pubic bone;

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

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

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

,

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

8. The method for treating female pelvic prolapse according to claim 7 wherein the sling deployment tool is used to place the sling into the durable fascia of the pelvis medial to the pelvis.

9. 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 first and second tip portions having a plurality of integrated fascia tissue anchors; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein a portion of the plurality of integrated fascia tissue anchors pass through the mesh material of the sling.

10. 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 first and second tip portions having a plurality of integrated fascia tissue anchors; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein the sling'"'"'s mesh portion is a multilayered mesh portion, wherein a portion of the plurality of integrated fascia tissue anchors pass through the mesh material portion of the sling.

11. 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; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein each of the sling'"'"'s anchoring pins portions are structured as essentially S-shaped structures.

12. 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 first and second tip portions having a plurality of integrated fascia tissue anchors; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein the sling'"'"'s tip portions comprise an inwardly slanted distal end, wherein the sling'"'"'s tip portions further comprise a suture placed at the distal end of the sling'"'"'s tip portions, wherein a portion of the plurality of integrated fascia tissue anchors pass through the mesh material portion of the sling.

13. 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 first and second tip portions having a plurality of integrated fascia tissue anchors; and

a sling deployment tool in removable communication with the sling, wherein the sling deployment tool is utilized 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;

wherein the sling'"'"'s tip portions further comprise a suture and a sling transfer hook, wherein a portion of the plurality of integrated fascia tissue anchors pass through the mesh material portion of the sling.