Apparatus and method for laparoscopic urethropexy

• US 5,591,163 A
• Filed: 06/14/1995
• Issued: 01/07/1997
• Est. Priority Date: 06/14/1995
• Status: Expired due to Fees

• Current Assignee: Dexterity Surgical, Inc. (Wave Sync Corp.)
• Original Assignee: Incont, LLC
• Inventors: Thompson, Ronald J.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): LEONARDO, MARK
• Application Number:
  US08/490,463
• Time in Patent Office: 573 Days
• Field of Search: 606/72, 606/75, 606/113, 606/144, 606/139, 606/219, 606/220, 606/232, 600/30, 128/898, 128/D23, 128/D25
• US Class Current: 606/29
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A template for guiding at least one suture through the periurethral fascia and vaginal mucosa adjacent a patient'"'"'s urethra during a urethropexy procedure, wherein the at least one suture is attached to an anchor secured within the body of the patient above the patient'"'"'s urethra, is provided. The template comprises first and second wing members extending laterally from opposite sides of the template; and at least one suture guide aperture positioned in each of the wing members at a predetermined location; the template configured to be alignable within the vagina of a patient such that one of the wing members will be positioned adjacent either side of the urethra with the at least one guide aperture in each wing member positioned such that a suture may be retrieved from within the patient'"'"'s body through the at least one aperture. A method for performing a urethropexy procedure employing this template is also provided.

Claims

1. A template for guiding at least one suture through the periurethral fascia and vaginal mucosa adjacent a patient'"'"'s urethra during a urethropexy procedure, wherein said at least one suture is attached to an anchor secured within the body of said patient above the patient'"'"'s urethra, said template comprising:

(a) first and second wing members extending laterally from opposite sides of the template; and

(b) at least one suture guide aperture positioned in each of said wing members at a predetermined location;

said template configured to be alignable within the vagina of a patient such that one of said wing members will be positioned adjacent either side of said urethra with said at least one guide aperture in each wing member positioned such that a suture may be retrieved from within the patient'"'"'s body through said at least one aperture.

2. The template of claim 1, wherein said template further comprises a trough of arcuate cross-section, said trough having a length and first and second ends, said first and second wing members extending away from opposite sides of said trough along said length.

3. The template of claim 2, wherein said second end of said trough comprises an end wall, and wherein said trough is sized such that a patient'"'"'s urethra may be positioned within said trough with said end wall adjacent to the end of the patient'"'"'s urethra, to thereby locate said apertures on either side of the patient'"'"'s urethra.

4. The template of claim 2, further comprising an alignment member extending away from the end wall of said trough, said alignment member having a longitudinal axis, said alignment member extending parallel to said trough with the longitudinal axis of said alignment member parallel and aligned with the centerline of said trough.

5. The template of claim 4, wherein said alignment member is arcuate in cross-section and extends away from said trough, and wherein said alignment member is sized such that the alignment member may be positioned about the circumference of a catheter inserted in a patient'"'"'s urethra to thereby position said template in the desired location.

6. The template of claim 4, wherein said alignment member is arcuate in cross-section and extends from said end wall towards said first end of said trough above the interior surface of said trough, and wherein said alignment member is insertable in a patient'"'"'s urethra in order to align said template.

7. The template of claim 1, wherein each of said wing members has first and second guide apertures, said first and second guide apertures in each wing member spaced from one another by a predetermined amount.

14. A surgical method for performing urethropexy on a female patient, said surgical method comprising the steps of:

(a) providing first and second anchors, each of said anchors having a suture extending therefrom, each of said sutures having a pair of tails;

(b) securing said anchors within the abdominal cavity of said patient;

(c) positioning the surgical template of claim 7 within the vagina of the patient such that one of said wing members extends laterally away from either side of the patient'"'"'s urethra adjacent the vaginal mucosa;

(d) passing a tail of one of said sutures through the periurethral fascia, the vaginal mucosa, and one of said guide apertures into the vagina;

(e) repeating step (d) for the remaining three tails and guide apertures, such that a single tail is pulled through each guide aperture;

(f) tying the two tails of each suture to each other within the vagina such that said sutures will elevate the urethra to the desired angle.

15. The surgical method of claim 14, wherein the two tails of the suture extending from said first anchor are passed through the periurethral fascia and vaginal mucosa on one side of the patient'"'"'s urethra, and two tails of the suture extending from said second anchor are passed through the periurethral fascia and vaginal mucosa on the opposite side of the patient'"'"'s urethra, such that after said tying step each suture will provide an upward force on the tissue on opposite sides of the patient'"'"'s urethra.

16. The surgical method of claim 15, wherein said surgical template further comprises a trough of arcuate cross-section, said trough having a length and first and second ends, and wherein said wing members extend away from opposite sides of said trough along its length, and wherein said positioning step comprises placing the template within the patient'"'"'s vagina such that the urethra will be positioned within said trough to thereby align said wing members adjacent the vaginal mucosa on either side of the urethra.

17. The surgical method of claim 16, further comprising the step of inserting a catheter into the patient'"'"'s urethra to the bladder, and wherein said second end of said trough comprises an end wall, and said template further comprises an alignment member extending away from said end wall and said trough, said alignment member having an arcuate cross-section, and wherein said positioning step further comprises securing said alignment member about at least a portion of the circumference of the portion of said catheter positioned immediately outside of the urethra, thereby securing said template in the proper location.

18. The surgical method of claim 17, further comprising the step of determining the length of the patient'"'"'s urethra, and wherein said template is sized so as to correspond with the length of the urethra, and wherein said template is positioned within the vagina such that said said wall will abut against the end of the patient'"'"'s urethra.

19. The surgical method of claim 16, wherein the step of passing the tails of said sutures through the periurethral fascia, the vaginal mucosa, and one of said guide apertures into the vagina comprises:

(a) inserting a portion of a suture retriever into the vagina, through one of said guide apertures, through the vaginal mucosa and periurethral tissue above said aperture, and into the abdominal cavity of the patient in the region wherein said anchors are positioned;

(b) grasping a tail of a suture with said suture retriever;

(f) pulling said tail grasped by said retriever back through the periurethral fascia, vaginal mucosa and guide aperture by means of said retriever so that said tail extends from said anchor into the patient'"'"'s vagina.

8. A template for guiding suture tails through the periurethral tissue on either side of a patient'"'"'s urethra during a urethropexy procedure, wherein at least one of said sutures is attached to an anchor secured within the body of said patient above the patient'"'"'s urethra, said template comprising:

(a) a trough of arcuate cross-section, said trough having a length and first and second ends;

(a) first and second wing members extending substantially horizontally away from opposite sides of said trough; and

(b) at least one suture guide aperture positioned in each of said wing members at a predetermined location;

said template configured so as to be alignable within the vagina of a patient such that the patient'"'"'s urethra will be positioned within said trough, and such that one of said wing members will be positioned adjacent either side of said urethra with said guide aperture in each wing member positioned a predetermined distance from the urethra and the UVJ.

9. The template of claim 8, further comprising a vertical end wall secured to the first end of said trough, and an alignment member attached to and extending away from said end wall, said alignment member having an arcuate cross-section, and wherein the longitudinal axis of said alignment member is parallel to the longitudinal axis of said trough.

10. The template of claim 9, wherein said alignment member is of a resilient material such that said alignment member may be secured about a catheter, thereby providing a means for alignably positioning said template within a patient'"'"'s vagina when a catheter has been inserted into the patient'"'"'s urethra.

11. The template of claim 10, wherein each of said wing members has first and second guide apertures, each of said first apertures positioned adjacent said trough, and each of said second apertures positioned at least about one centimeter from the first aperture in the same wing member.

12. The template of claim 11, wherein the distance between said end wall and each of said first guide apertures is between about 2.5 and about 3.2 centimeters.

13. The template of claim 11, wherein said first and second guide apertures in each wing member are aligned along an imaginary line extending perpendicularly away from said trough.

20. A surgical method for performing a urethropexy procedure, said surgical method comprising the steps of:

(a) providing a template for guiding sutures through the periurethral fascia and vaginal mucosa adjacent the urethra, said template having at least first and second suture guide apertures;

(b) providing at least One anchor, said anchor having a suture extending therefrom, said suture having first and second tails;

(c) securing said anchor within the abdominal cavity of a patient;

(d) positioning said template within the vagina of the patient such that said first guide aperture is positioned against the vaginal mucosa adjacent the urethra;

(d) pulling said first tail of said suture through the periurethral fascia, the vaginal mucosa, and said first guide aperture into the vagina;

(e) pulling said second tail of said suture through the periurethral fascia, the vaginal mucosa, and said second guide aperture into the vagina; and

(f) tying said first and second tails to one another within the vagina.

21. The surgical method of claim 20, wherein said template has first and second wing members extending from opposite sides of said template, wherein each of said wing members has first and second guide apertures, and wherein said positioning step positions said wing members adjacent the vaginal mucosa on either side of the urethra, further comprising the steps of:

(a) providing a second anchor having a second suture extending therefrom, said suture having first and second tails;

(b) securing said anchor within the abdominal cavity of the patient;

(c) pulling said first tail of said second suture through the periurethral fascia, the vaginal mucosa, and a first guide aperture into the vagina;

(e) pulling said second rail of said second suture through the periurethral fascia, the vaginal mucosa, and a second guide aperture into the vagina; and

(f) tying said first and second tails of said second suture to one another within the vagina;

wherein the tails of said suture of said at least one anchor are pulled through the first and second guide apertures of said first wing member, and wherein the tails of said second suture are pulled through the first and second guide apertures of said second wing member.

22. The method of claim 21, wherein said template further comprises a trough of arcuate cross-section, said trough having a length and first and second ends, and wherein said wing members extend away from opposite sides of said trough along its length, and wherein said positioning step comprises placing the template within the patient'"'"'s vagina such that the urethra will be positioned within said trough to thereby align said wing members adjacent the vaginal mucosa on either side of the urethra.

23. The method of claim 22, further comprising the step of inserting a catheter into the patient'"'"'s urethra to the bladder, and wherein said second end of said trough comprises an end wall, and said template further comprises an alignment member extending away from said end wall and said trough, said alignment member having an arcuate cross-section, and wherein said positioning step further comprises securing said alignment member about at least a portion of the circumference of the portion of said catheter positioned immediately outside of the urethra, thereby securing said template in the proper location.

24. The method of claim 21, wherein said anchors are secured in the pubic bone of the patient on either side of the pubic symphysis.

25. The surgical method of claim 20, wherein the step of pulling said tails of said suture through the periurethral fascia, the vaginal mucosa, and said guide apertures into the vagina comprises:

(a) inserting a portion of a suture retriever into the vagina, through one of said guide apertures, through the vaginal mucosa and periurethral tissue above said aperture, and into the abdominal cavity of the patient in the region wherein said anchor is positioned;

(b) grasping a tail of said suture with said suture retriever;

(f) pulling said tail grasped by said retriever back through the periurethral fascia, vaginal mucosa and guide aperture by means of said retriever so that said tail extends from said anchor into the patient'"'"'s vagina.