Adjustable Sling and Method of Treating Pelvic Conditions

Abstract

Systems for providing support within the pelvic region of a patient. The systems can include an elongated incontinence sling having a central support portion adapted to be positioned to support any one of the urethra or anus, and a sling tension adjustment mechanism operatively attached to the elongated sling. The sling tension adjustment mechanism can include a plunger device adapted for traversal within an interior of the housing, and an inflatable bladder provided within the housing to selectively control traversal of the plunger. Alternatively, the adjustment mechanism can include a bobbin device within the housing and one or more retention devices to selectively restrict unwinding of a suture from the bobbin device.

Description

RELATED APPLICATIONS[0001]This application is a Continuation-In-Part of U.S. patent application Ser. No. 12 / 305,874 filed Dec. 19, 2008, which claims priority to PCT Application No. PCT / US2007 / 014533 filed Jun. 22, 2007, which in turn claims priority to U.S. Provisional Application Ser. No. 60 / 805,544 filed Jun. 22, 2006 and U.S. Provisional Application Ser. No. 60 / 806,664 filed Jul. 6, 2006; this application also claims priority to and the benefit of U.S. Provisional Application Ser. No. 61 / 054,011 filed May 16, 2008 and U.S. Provisional Application Ser. No. 61 / 054,050 filed May 16, 2008; whereby the entire contents of each of the above-identified applications and disclosures are incorporated herein by reference.TECHNICAL FIELD OF THE INVENTION[0002]The present invention pertains to improved methods and apparatus providing support to a portion of the urethra, rectum or anus to alleviate urinary or fecal incontinence and, particularly, to elongated slings having mechanisms for selec...

AI Technical Summary

Benefits of technology

[0022]In one embodiment, sutures are threaded back and forth through mesh pores adjacent the intermediate ends and across the respective adjustment spacings of each sling end portion. The suture ends are adapted to be extended through the skin incisions to function as adjustment actuators in the manner of draw strings for later adjustment of the adjustment spacings during the acute healing phase. The suture ends may be grasped and pulled to pull the sling intermediate ends closer together to decrease the adjustment spacing and thereby decrease the sling length and increase tension applied by the center support portion to the urethra or anus.

[0025]In still another embodiment, the external adjustment actuator is inserted percutaneously (penetrating the skin) to engage and operate the sling tension adjustment mechanism to increase or decrease the adjustment spacing. Various sling tension adjustment mechanisms are provided that can be rotated by the external adjustment actuator in one direction to draw the sling intermediate ends together to increase sling tension and that can be rotated in the other direction to allow the sling intermediate ends to separate apart to decrease sling tension.

[0028]In these embodiments, the fluid chambers are preferably empty of fluid when the sterile sling is supplied in the sterile package from the manufacturer. Implantation of the sling through body pathways may be simpler and easier with the fluid chambers empty. The fluid, e.g., a sterile saline or other biocompatible hydraulic fluid, may be introduced through the fluid delivery port(s) while the port(s) are still accessible. The amount of fluid necessary to effect blockage of the urethral tract may be checked by draining and filling the patient's bladder through the urethral tract, determining efficacy, and adding or withdrawing fluid to adjust the applied urethral pressures in the pressurized and ambient pressure fluid distribution states. Similar procedures may be employed to effect constriction of the anal canal.

[0030]Optionally, sling end tissue anchors may be provided on sling ends to engage tissues, e.g., the rectus fascia or the obturator membrane to fix the sling ends and aid in tension adjustment of the sling end portions.

[0033]In another embodiment, the adjustment mechanism can include a bobbin device or spool within the housing and one or more retention devices to selectively restrict unwinding of a suture from the bobbin device. The suture is operatively connected to the sling such that adjustment of the retention device selectively controls the length of the suture extending from the spool or bobbin device and, in turn, the length of the sling.

Problems solved by technology

Such patients may also experience urge incontinence.

One tension adjustment complication arises from the fact that the loose weave sling mesh inherently stretches and elongates when tension is applied at the ends or central support portion to overcome resistance of the tissue bearing against the sling mesh along the tissue pathway.

It is difficult to judge just how much tension to apply to achieve adequate tightening or loosening in the central support portion.

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