Methods and Apparatus for Securing and Tensioning a Urethral Sling to Pubic Bone

Abstract

Improved methods and apparatus to secure a urethral sling to pubic bone in a sub-urethral location to support the urethra and alleviate incontinence are disclosed. The urethral sling is preferably formed of a flexible sheet material extending between opposed first and second sling ends and bounded by opposed first and second sling sides. The urethral sling is selectively tensioned in a central portion intermediate the first and second sling ends and / or in one or both of end portions bracketing the central portion. In one embodiment, pre-positioned plicating lines in the central portion are selectively drawn and tied to slacken the central portion and tension the end portions. In further embodiments, bone anchor lines passed through locations displaced from the sling ends are drawn and fixed to tension the central portion between the displaced locations and slacken the end portions.

Description

RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application Ser. No. 60 / 677,456 filed May 4, 2005, the entire content of which is incorporated herein by reference.FIELD OF THE INVENTION [0002] The present invention pertains to surgical procedures, kits, and implants to alleviate human incontinence, and particularly to improved methods and apparatus to secure a urethral sling to pubic bone in a sub-urethral location and tensioning the urethral sling to support the urethra and alleviate incontinence. BACKGROUND OF THE INVENTION [0003] Incontinence is a condition characterized by involuntary loss of urine, beyond the individual's control, that results in the loss or diminution of the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) occurs when the patient is physically or emotionally stressed. [0004] One cause for this condition is damage to the urethral sphincter or loss...

AI Technical Summary

Benefits of technology

[0040] In one preferred embodiment, a line retainer is provided that can be selectively advanced over the bone anchor line extending through the mesh and against the urethral sling to maintain the tension. In preferred embodiments, the line retainer is resilient and has a retainer bore sized and shaped to be expanded to pass over the bone anchor line (including any outwardly extending line fixation elements) as the retainer is advanced toward the bone anchor and that resists retraction over the bone anchor away from the bone anchor. Retainer-dispensing tools may be provided that facilitate application of the retainers over the anchor lines.

[0041] After adequate tension is achieved with or without use of line retainers, the anchor lines may be tied off with fewer or smaller knots to reduce suturing time, and the final exposed line trimmed.

[0043] Advantageously, the procedure for attaching the urethral sling to bone anchors is simplified to shorten the surgical time, the tensioning and fixation are made more reliable, and any line knots that are employed are reduced in size.

Problems solved by technology

One cause for this condition is damage to the urethral sphincter or loss of support of the urethral sphincter, such as can occur in males after prostatectomy or following radiation treatment, or that can occur due to pelvic accidents and aging related deterioration of muscle and connective tissue supporting the urethra.

Other causes of male incontinence include bladder instability, over-flowing incontinence and fistulas.

Weakening and elongation of the pubourethral ligaments and the arcus tendineus fascia pelvis, weakening of the endopelvic fascia and pubourethral prolapse of the anterior vaginal wall, and their complex interaction with intraabdominal forces are all suspected to play a role in the loss of pelvic support for the urethra and subsequent hypermobility to an unnaturally low non-anatomic position, leading to urinary incontinence.

Moreover, it is sometimes difficult to achieve the tension in the urethral sling that is sufficient to constrict the urethral sphincter to provide urethral resistance to leakage at the selected water bag height, e.g. at 60 cm.

Tying, untying and retying the suture knots consumes further time.

Applying tension through and retying the trimmed sutures may be difficult to accomplish.

Images