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Implantable sling having bladder support

Implantable sling having bladder support description/claims

Not Applicable

Not Applicable

Concomitant cystocele repair and placement of a pubovaginal sling for the treatment of urinary incontinence by means of a transvaginal approach is known in the art. In this regard, a high correlation exists between such medical conditions and it is frequently desirable to address both via a single surgical procedure. Specifically, such procedure seeks to accomplish both goals of lifting and tightening the tissue around the bladder so that it no longer pushes against weakened tissue in the front wall of the vagina (i.e., cystocele) and positioning a sling beneath the urethra in order to provide structural support thereto such that accidental leakage of urine is eliminated or substantially reduced, particularly during provocative events such as coughing and the like.

The specifics regarding suburethral sling surgical procedures are described in detail in the references of Blaivas, Jerry G., Successful Pubovaginal Sling Surgery, Contemporary Urology, July, 1993; Blaivas, Jerry, G. Treatment of Female Incontinence Secondary To Urethral Damage Or Loss, Urologic Clinics of North America, Vol. 18, No. 2, May, 1991; Raz, Schlomo, Surgical Therapy For Urinary Incontinence, Atlas Of Transvaginal Surgery, W. B. Saunders, 1992, Loughlin, K. R., The Endoscopic Fascial Sling Treatment of Female Urinary Stress Incontinence, J. Urol, 1996, A.P.R.; 155 (4): 1265-7; and Staskin, D. R., et al., The Gore-Tex Sling Procedure For Female Sphincteric Incontinence: Indications, Technique And Results, J. Urol, 1997; 15(5): 295-9, the teachings of which are expressly incorporated herein by reference.

With respect to the simultaneous repair of the cystocele and placement of a pubovaginal sling, such procedure is disclosed by Kobashi et al., in the reference A New Technique for Cystocele Repair and Transvaginal Sling: the Cadaveric Prolapse Repair and Sling (CaPS), Urology, 2000 December 4:56 (Suppl. 1): 9-14 and by Chung et al., in the reference Technique of Combined Pubovaginal Sling and Cystocele Repair Using a Single Piece of Cadaveric Dermal Graft, Urology. 2002 April; 59 (4): 538-41, the teachings of each of which are expressly incorporated herein by reference.

Despite the optimal opportunity to concurrently perform cystocele repair and pubovaginal sling surgery via a transvaginal approach, there has not to date been any type of implantable support material/tissue that is readily sized and configured to be surgically affixed into position such that both the bladder is properly supported (i.e., so that it no longer pushes against the vagina), and that the urethra is provided with a suburethral sling optimally positioned to treat the related condition of incontinence. In this respect, to the extent concurrent cystocele repair and pubovaginal sling surgery are performed, the prior art teaches the use of a harvested piece of tissue derived from a cadaver that must be surgically fashioned for implantation within a particular patient. To derive such implantable material, however, is exceptionally problematic due to the requirement that cadaveric tissue be available. Moreover, even to the extent a source of cadaveric tissue is available, the same must necessarily be excised to near precise dimensions and thereafter implanted with great care. In this respect, to the extent the harvested tissue is improperly sized or is otherwise torn or damaged during implantation, such supportive material will be rendered useless and require that at least one additional segment of material be harvested. As a consequence, substantial time, expense, and potential patient discomfort associated with such surgical procedure can frequently occur.

Accordingly, there is a substantial need in the art for a surgical implant operative to serve both as a suburethral sling for the treatment of incontinence, as well as provide structural support necessary to effectuate cystocele repair. There is additionally a need in the art for such an implant that can be readily fabricated from known implantable materials, and specifically sized and configured for immediate surgical implantation in procedures involving both the placement of a suburethral sling and supportive tissue to effectuate cystocele repair. There is still a further need in the art for such an implant that may be fabricated from materials possessing desirable properties, such as biocompatibility, material strength, and adaptability for use in surgical procedures. There is yet a further need in the art for such an implant that is of exceedingly simple construction, low cost to manufacture, and is capable of being readily deployed using known surgical techniques.

The present invention specifically addresses and alleviates the above-identified deficiencies in the art. In this regard, the present invention is direct to an implant operative to simultaneously function as a suburethral sling for the treatment of incontinence, as well as provide lift and support about the bladder so that it no longer pushes against the vagina and thus effectuate cystocele repair. According to a preferred embodiment, the implant comprises a first sling portion sized and configured as per conventional suburethral slings for positioning and placement beneath the urethra to provide a sufficient degree of urethral support. Such implant includes a second bladder support portion affixed to or formed as part of the sling portion that is operative to be surgically interconnected about a portion of the bladder to enable the latter to be lifted and supported to a degree necessary to effectuate cystocele repair. Preferably, the implant will possess a generally T-shape with the first sling portion defining an elongate strip having opposed ends, a front portion and a rear portion. The second implant portion will be affixed medially about a portion of the rear peripheral edge of the first sling portion and extend rearwardly therefrom. The implant may be fabricated such that both sling and bladder support portions are integrally formed from a single piece of harvested tissue. Alternatively, the sling and bladder support portions will be integrally formed from a unitary piece of synthetic material. Still further, the implant may be fabricated such that a respective one of the sling portion or bladder support portion is fabricated from a synthetic material with the respective other portion being fabricated from a piece of harvested tissue and coupled to the respective other piece via stitching or any other means known in the art to couple the two implant portions to one another. In a most highly preferred embodiment, the sling portion of the implant will be comprised from a synthetic material, which may be selected from a variety of well-known materials in the art, and the bladder support portion will comprise a graft harvested from a donor, which may comprise a cadaver, another human subject, an animal, such as a pig, and even the patient herself.

Advantageously, by providing a pre-formed implant operative to provide both suburethral support concomitantly with the bladder support necessary to perform cystocele repair, both conditions (i.e., incontinence and cystocele) can be treated via a single surgical procedure. Moreover, by providing a readily-fabricated implant, there is thus eliminated the need to surgically fashion such a support from cadaverous tissue, thus tremendously reducing the time necessary to perform such procedure, as well as eliminating the need to have a source of cadaverous tissue available. Furthermore, in those embodiments where the implant is comprised of a sling portion fabricated from a synthetic material and a bladder support portion formed from a graft or harvested tissue, such embodiment allows for rapid fabrication that further enables the implant to possess exceptional durability with respect to the sling component thereof and optimal biocompatibility with respect to the bladder support portion thereof.

With respect to the surgical implantation of the implants of the present invention, the same may be deployed through any known procedure in the art. Along these lines, such implant may be secured in position pursuant to those procedures disclosed by Kobashi et al., in the reference A New Technique for Cystocele Repair and Transvaginal Sling: the Cadaveric Prolapse Repair and Sling, referred to above.

It is therefore an object of the present invention to provide an implantable sling having bladder support that enables pubovaginal sling surgery and cystocele repair to be performed via a single surgical procedure.

Another object of the present invention is to provide an implantable sling having bladder support that enables pubovaginal sling surgery and cystocele repair to be performed in a manner that eliminates the need to surgically fashion an implant operative to simultaneously impart suburethral support for the treatment of incontinence and also impart a sufficient degree of support to the bladder to effectuate cystocele repair.

Another object of the present invention is to provide an implantable sling having bladder support that enables pubovaginal sling surgery and cystocele repair to be performed in a manner that eliminates any dependency on a readily accessible source of cadaverous tissue during such surgical procedure.

Another object of the present invention is to provide an implantable sling having bladder support that may be easily and readily fabricated from known implantable materials, is of simple construction, is easy to surgically manipulate, is exceptional durable in functioning as an implant, and is of relatively low cost.

Still further objects of the present invention are to provide methods for using the implants of the present invention to thus simultaneously effectuate cystocele repair and urinary incontinence that is substantially more time efficient, easier to perform, and more cost effective than prior art techniques.

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• Utility Patent

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