Systems and methods for producing gastrointestinal tissues at an anastomosis or other physiological location
Inventors
La Francesca, Saverio • Soliman, Sherif • Hu, Shunfu • Meng, Linghui
Assignees
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Publication Number
US-12048619-B2
Publication Date
2024-07-30
Expiration Date
Abstract
Aspects of the disclosure relate methods and synthetic scaffolds for regenerating gastrointestinal tissue (e.g., esophageal tissue).
Core Innovation
The invention provides engineered regeneration of gastrointestinal tissue using a synthetic scaffold that guides new tissue growth. The scaffold includes a body section with a tubular member and a flared member contiguously connected near an end, and an outwardly oriented surface that includes regions composed of spun polymeric fibers that form interlinked pores with an average diameter less than 50 microns.
The scaffold further includes an inner tubular member that is coaxially disposed with the tubular region. In a use position, the tubular member extends in contact defined with an interior surface defined in the flared region and projects into a region defined in the stomach, and the structural relationships define how the tubular and flared regions are positioned relative to a stomach region at the gastroesophageal junction.
In addition, the scaffold includes at least one sheath layer composed of cellular material. The cellular material includes mesenchymal cells and stem cells present in a defined layer between 1 and 100 cells thick, and the cellular material excretes extracellular matrix components on the scaffold, supporting formation of multilayer regenerated tissue, including esophageal regeneration and gastroesophageal junction regeneration.
Claims Coverage
The independent claims describe a synthetic scaffold and its structural and functional components, including a tubular member with a contiguous flared member, an outward surface composed of spun polymeric fibers with defined fiber diameter and pore diameter constraints, a coaxial inner tubular member configured for stomach-region projection in a use position, and a sheath layer of mesenchymal cells and stem cells that excrete extracellular matrix components. One independent claim is explicitly provided (clm-00001).
Tubular and flared scaffold body section
A synthetic scaffold comprising a body section with a first end and a second end, the body section having at 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, wherein the body section comprises an outwardly oriented surface.
Spun polymeric fibers forming interlinked pores
An outwardly oriented surface having at least one region composed of spun polymeric fibers, where the spun polymeric fibers have an average fiber diameter between 15 nm and 10 microns and at least a portion of the spun polymeric fibers are interlinked to form pores having an average diameter less than 50 microns.
Coaxial inner tubular member projecting into stomach region
An inner tubular member coaxially disposed with the tubular region, wherein the tubular member extends in contact defined with an interior surface defined in the flared region of the synthetic scaffold and the tubular member projects into a region defined in the stomach when the synthetic scaffold is in a use position.
Cellular sheath layer that secretes extracellular matrix
At least one sheath layer composed of cellular material, the cellular material composed of mesenchymal cells and stem cells present in a defined layer between 1 and 100 cells thick, wherein the cellular material excreting extracellular matrix components on the scaffold.
The provided independent claim defines a synthetic, tubular-and-flared scaffold architecture with a fiber-based outer surface forming pores, a coaxial inner tubular member configured to project into a stomach region in a use position, and a defined-thickness cellular sheath layer of mesenchymal cells and stem cells that excrete extracellular matrix components.
Stated Advantages
Guides gastrointestinal tissue regeneration, including esophageal regeneration and gastroesophageal junction regeneration, using the scaffold during a guided growth process.
Provides a structural configuration in which the tubular and flared regions are positioned relative to a stomach region in a use position to support the described regeneration outcomes.
Uses cellular material present as a defined layer between 1 and 100 cells thick that excretes extracellular matrix components on the scaffold to support tissue formation.
Documented Applications
Engineered esophageal tissue regeneration, including in vivo evidence in pigs with endoscopic and histological regeneration described for multilayer esophageal tissue.
Gastroesophageal junction regeneration, including regenerated tissue extending over an enlarged end described in the provided content.
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