Volumetric grafts for treatment of fistulae and related methods and systems

摘要

Described are devices, methods, and systems useful in the treatment of fistulae, and in certain embodiments those having openings extending into the alimentary canal, such as anorectal fistulae. Illustratively, an anorectal fistula can be treated by placing a volumetric construct within the primary opening of the fistula. In certain embodiments, the volumetric construct can include a rolled remodelable material processed to form a substantially unitary body. Advantageous such remodelable materials can include collagenous extracellular matrix materials, such as small intestine submucosa.

主权项

1. A method for treating a fistula having a primary fistula opening, comprising:
delivering to the fistula a molded graft construct that comprises one or more pieces of sheet-form collagenous extracellular matrix material, wherein the one or more pieces of sheet-form collagenous extracellular matrix material are in a rolled or layered configuration defining contacting layer portions, wherein said contacting layer portions of the rolled or layered configuration are sufficiently dehydrothermally bonded to each adjacent layer portion to provide said molded graft construct as a substantially unitary structure, wherein said molded graft construct includes a generally conical longitudinal segment for lodging within and filling the primary opening with remodelable extracellular matrix material, wherein said one or more pieces of sheet-form collagenous extracellular matrix material include lyophilized collagenous material, wherein said molded graft construct prior to delivering to the fistula has a plurality of passages formed therein with each formed passage including a generally coherent passage wall that extends from an exterior surface of the molded graft construct through contacting layer portions defined by the rolled or layered configuration and into interior regions of the molded graft construct, wherein said plurality of passages are formed in the molded graft construct prior to said contacting layer portions being dehydrothermally bonded to one another so as to enhance uniformity of the matrix structure of said bonded layer portions and said lyophilized collagenous material; wherein the plurality of passages have a diameter from about 0.1 mm to about 1.0 mm; and wherein said plurality of passages remain intact after delivering said molded graft construct to the fistula so as to have a coherent passage wall comprising said contacting layer portions.