Systems and methods for producing gastrointestinal tissues

Inventors

La Francesca, Saverio • Soliman, Sherif • Marsh, Matthew • Hu, Shunfu • Meng, Linghui

Assignees

Harvard Apparatus Regenerative Technology Inc

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Publication Number

US-12029638-B2

Patent

Publication Date

2024-07-09

Expiration Date


Abstract

Aspects of the disclosure relate methods and synthetic scaffolds for regenerating gastrointestinal tissue (e.g., esophageal tissue).

Core Innovation

The disclosed invention relates to guided tissue growth and guided regeneration of gastrointestinal hollow tissue by implanting a synthetic polymeric scaffold at a resection site and later removing the scaffold intrascopically. A portion of a tubular organ is resected in a subject, leaving resection-edge tissue at a resection site, and the scaffold is maintained at the implantation site for a period of time sufficient to achieve guided tissue growth along the scaffold derived from and in contact with the resection-edge tissue.

The synthetic polymeric scaffold includes a body section having an outer polymeric surface with spun polymeric fibers and a cellularized sheath layer overlying at least a portion of the outer polymeric surface. The guided tissue growth achieved comprises multilayered muscle tissue and epithelia configured as a lumen, with the new tissue remaining in contact with the resected tubular organ portion after scaffold removal.

In one implementation, the cellularized sheath layer is positioned proximate to the resection edge, and the scaffold includes a first end and a second end with the outer polymeric surface positioned between the ends. The scaffold is maintained in contact with the resection edge for a period of time sufficient to achieve guided tissue growth along the synthetic polymeric scaffold, and the scaffold is intrascopically removed after the guided tissue growth is achieved.

Claims Coverage

The document includes two independent method claims. Across these claims, the core inventive features are scaffold-guided regeneration after resection, a cellularized sheath overlying a spun-fiber outer surface positioned at or proximate to resection-edge tissue, guided tissue growth that includes multilayered muscle tissue and epithelia configured as a lumen, and intrascopic removal of the scaffold while preserving contact between the new tissue and the resected organ portion remaining in the subject.

Resection-edge scaffold-guided regeneration of tubular organ

Resecting a portion of a tubular organ in a subject to produce a resected organ portion with at least one resection edge remaining in the subject at a resection site, implanting a synthetic polymeric scaffold at the resection site, and maintaining the scaffold at the implantation site for a period of time sufficient to achieve guided tissue growth along the synthetic polymeric scaffold derived from and in contact with the tissue at the at least one resection edge present in the resected organ portion remaining in the subject at the resection site.

Cellularized sheath overlying spun-fiber outer surface

Implanting a synthetic polymeric scaffold including a body section having an outer polymeric surface in which the outer polymeric surface includes spun polymeric fibers and a cellularized sheath layer overlying at least a portion of the outer polymeric surface of the body section.

Intrascopic scaffold removal while preserving tissue-organ contact

After achieving the guided tissue growth, intrascopically removing the synthetic polymeric scaffold from the implantation site in a manner such that the guided tissue growth remains in contact with the resected organ portion of the tubular organ remaining in the subject.

Multilayered muscle tissue and lumen epithelia as guided tissue growth

Wherein the guided tissue growth achieved comprises multilayered muscle tissue and epithelia configured as a lumen.

Proximate resection-edge cellularized sheath on scaffold ends

Resecting a portion of a tubular organ in a subject, implanting a synthetic polymeric scaffold having an outer polymeric surface including a first end and a second end opposed to the first end, a cellularized sheath layer overlying at least a portion of the outer polymeric surface, wherein at least a portion of the cellularized sheath layer is proximate to the resection edge of the resected tubular organ portion, maintaining contact between the synthetic polymeric scaffold and the resection edge for a period of time sufficient to achieve guided tissue growth along the synthetic polymeric scaffold.

Scaffold removal after lumen-forming guided tissue growth

Intrascopically removing the synthetic polymeric scaffold after the guided tissue growth is achieved.

Both independent claims cover a method where a synthetic polymeric scaffold with a cellularized sheath layer overlying an outer polymeric surface with spun fibers is maintained at a resection site in contact with resection-edge tissue to achieve guided tissue growth comprising multilayered muscle tissue and epithelia configured as a lumen, followed by intrascopic removal of the scaffold while preserving contact of the guided tissue growth with the remaining resected organ portion.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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