Systems and Methods for Producing Gastrointestinal Tissues at an Anstomosis or Other Physiological Location
OwnerSaverio La Francesca, Sherif Soliman +2inventors
InventorsSaverio La Francesca, Sherif Soliman, David C. Rice, Ara A. Vaporciyan
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Abstract
Aspects of the disclosure relate methods and synthetic scaffolds for regenerating gastrointestinal tissue (e.g., esophageal tissue).
Claims25
A method, comprising the steps of:
- resecting a portion of a tubular organ in a subject, the tubular organ being proximate to the stomach region of the subject, the resection step producing a resected organ portion located primarily in the esophageal region, the resected organ portion remaining in the subject;
- implanting a synthetic scaffold at the site of resection, the synthetic scaffold including a body member, the body member having a tubular region having a first end and a second end opposed to the first end and an outwardly flared region contiguously connected to the tubular region of the body member at a location proximate to one of the first end or second end, an outer polymeric surface and a cellularized sheath layer overlying at least a portion of the outer polymeric surface, wherein the flared region is connected to the stomach and the tubular region is connected to the resected organ portion;
- maintaining the synthetic scaffold at the resection site for a period of time sufficient to achieve guided tissue growth along the synthetic scaffold, the guided tissue growth derived from and in contact with the tissue present in the resected organ portion remaining in the subject;
- and
- after achieving guided tissue growth, removing the synthetic scaffold from the implantation site, the removing step occurring in a manner such that the guided tissue growth remains in the contact with the resected portion of the tubular organ remaining in the subject.
A method comprising:
- resecting a portion of a tubular organ proximate to the stomach in a subject, the resection step producing a resected organ portion, the resected organ portion remaining in the subject and having at least one resection edge, wherein the resected tubular organ includes a tubular organ resection edge and the stomach includes a resected edge,
- implanting a synthetic scaffold at the site of resection, the synthetic scaffold having a body member, the body member having a tubular region having a first end and a second end opposed to the first end and an outwardly flared region contiguously connected to the tubular region of the body member at a location proximate to one of the first end or second end, an outer polymeric surface positioned between the first end and the second end and a cellularized sheath layer overlying at least a portion of the outer polymeric surface, wherein at least a portion to the celluralized sheath layer is proximate to at least one resected,
- maintaining contact between the synthetic scaffold and the at least one resected edge for an intervals sufficient to achieve guided tissue growth along the synthetic scaffold,
- wherein at least a portion of the synthetic scaffold is absorbed at the site of resection within a period of time sufficient to achieve guided tissue growth along the synthetic scaffold.
A synthetic scaffold comprising:
- a body section, the body section having a first end and a second end opposed to the first end, the body section further having a least one portion configured as a tubular member and at least one portion configured as a flared member, the flared member contiguously connected to the tubular member and located proximate to either the first end or the second end of the body section, the body section comprising an outwardly oriented surface, the outwardly oriented surface having at least one region composed of spun polymeric fibers, the spun polymeric fibers having an average fiber diameter between 15 nm and 10 microns, at least a portion of the spun polymeric fibers interlinked to form pores having an average diameter less than 50 microns.
The synthetic scaffold of claim 19 wherein the spun polymeric fibers are electropsun, are interconnected and form an outer layer of the body section and the body section further comprises at least one inner layer, the inner layer composed of at least one of a polymeric mesh, a polymeric braided support material, a solid polymeric member, an electrospun layer, the outer layer in overlying contact with the inner layer.
Dependencies are inferred from the claim text.