Implantable graft to close a fistula

Abstract

Abstract of the DisclosureAn implantable graft, which may be inserted into a fistula tract to occlude the primary opening of the fistula, is provided. The graft may have a curved, generally conical shape with a trumpet-like head end that continuously tapers to a smaller tail end. The graft may be an integral unit made of a single material, such as a heterograft material. Methods of closing single and multiple fistulae are also provided.

Description

Detailed Description of the InventionRELATED APPLICATIONS[0001] The present patent document claims the benefit of the filing date under 35 U.S.C. §119(e) of Provisional U.S. Patent Application Serial No. 60 / 538,365, filed January 21, 2004, which is hereby incorporated by reference.FIELD OF THE INVENTION[0002] A graft for occluding a fistula is provided. The graft may be pulled, tail first, into the fistula to completely occlude the fistula, thereby avoiding a surgical fistulotomy and its attendant complications.BACKGROUND OF THE INVENTION[0003] Fistulae occur commonly in man. Such fistulae may be congenital or may be caused by infection, inflammatory bowel disease (Crohn’s disease), irradiation, trauma, childbirth, or surgery, for example.[0004] Some fistulae occur between the vagina and the bladder (vesico-vaginal fistulae) or between the vagina and the urethra (urethro-vaginal fistulae). These fistulae may be caused by trauma during childbirth. Traditional surgery for these ty...

AI Technical Summary

Benefits of technology

[0014] One object of the present invention is to provide a new technique of minimally invasive fistula closure. Another object is to provide a technique that obviates the need for surgical fistulotomy and avoids surgical pain and the attendant complications of the procedure. Still another object of the invention is to provide an accurate and complete closure of a fistula, thereby preventing a recurrent or persistent fistula. Yet another object of the present invention is to provide a technique that involves no cutting of tissue, sphincter damage, or incontinence.

[0017] The graft of the present invention may be made of any suitable biological or synthetic materials. Desirably, the head and the tail are one continuous piece made of the same material. Suitable biological materials include, but are not limited to, cadaveric allografts from human donors or heterografts from animal tissues. Suitable synthetic materials include, but are not limited to, polygalactin, polydioxanone and polyglycolic acid. Desirably, the biological and / or synthetic material used in the graft of the present invention elicits little immunological reaction, has some inherent resistance to infection, and promotes tissue reconstruction (rather than complete absorption of the graft into the surrounding tissue), thereby occluding the fistula.

[0018] The graft of the present invention may be pulled into the fistula, tail first, through the primary opening, toward the secondary opening. In one embodiment, the graft is drawn into the fistula and the trumpet-like head end of the graft is gradually “wedged” into the primary opening in a manner similar to that of inserting a plug in a hole. The head and / or tail may be further secured by sutures or other suitable means, which may be formed as an integral part of the graft. A trumpet-like head allows the graft to be used for any diameter of primary opening. By applying adequate force to the graft during its insertion, the head of the graft fits snugly into the primary opening and conforms to the size of the primary opening. Multiple or composite grafts may be used for multiple or complex fistulae.

Problems solved by technology

Traditional surgery for these types of fistulae is complex and not very successful.

These paths vary in complexity.

Because a variable amount of sphincter muscle is divided during the procedure, fistulotomy may result in impaired sphincter control or even incontinence.

The main drawback with these methods is that the glues have a liquid consistency and tend to run out of the fistula tract once the patient becomes ambulatory.

In addition, failure rates of these methods are high (up to 86% failure).

Injecting sealant or sclerosant into an unprepared or infected fistula as a one-stage procedure may cause a flare-up of the infection and even further abscess formation.

This procedure (the endo-anal flap procedure) closes the primary opening, but is technically difficult to perform, is painful for the patient, and is associated with a high fistula recurrence rate.

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