Cell encapsulation devices with controlled cell bed thickness

Inventors

Rusch, Greg • Cully, Edward H.

Assignees

WL Gore and Associates Inc

Abstract

An implantable containment apparatus for receiving and retaining a biological moiety, including a plurality of cells, for insertion into a patient, such as into a tissue bed, is disclosed. The device includes a cell encapsulating pouch that forms and interior volume having a reservoir space for receiving cells, where the reservoir space includes first and second interior surfaces, and a tensioning member to maintain an average distance between the first interior surface and the second interior surface.

Core Innovation

The invention relates to an implantable cell encapsulation device that includes a cell encapsulating pouch defining an interior volume between a first layer and a second layer sealed along portions of their periphery. The interior volume comprises a first interior surface and an opposing second interior surface spaced apart from the first interior surface, and includes a reservoir space for receiving cells between the opposing interior surfaces.

To control the thickness of the cell bed by maintaining an average distance between the opposing interior surfaces, the device includes at least one tensioning member disposed within the interior volume. The tensioning member contacts at least two opposing portions of the cell encapsulating pouch to exert opposing forces that urge the first layer and the second layer apart, preventing the reservoir from collapsing and undesired change in pouch thickness under in vivo/compressive or loading forces.

The pouch and tensioning structures further include configurations for uniform tension and for isolating tensioning members from the reservoir space. In some configurations, the tensioning member is a frame with opposing ends that are non-linear and opposing sides that are linear to provide uniform tension across a length of the cell encapsulating membrane or membrane composite; in other configurations, the first layer is sealed via a seal to the second layer between the tensioning member and the reservoir space to isolate the tensioning member from the reservoir space, or structural spacers within the interior volume inward from the seal define the average distance.

A cell displacing core may also define the average distance, with the reservoir space adjacent to at least a portion of the cell displacing core. The partial content further includes interconnected containment tubes comprising a first end, a second end opposite the first end, and an interior reservoir space, the containment tubes being interconnected by welds, quilting, adhesive, or structural supports, and a tensioning member disposed around at least a portion of a perimeter of the plurality of containment tubes to maintain an average thickness of each of the containment tubes.

Claims Coverage

The partial content includes five independent claims directed to a cell encapsulation device that maintains controlled interior spacing using tensioning structures and a reservoir space for cells; variations include interconnected containment tubes, a frame-based uniform-tension configuration, sealing arrangements that isolate the tensioning member, and a cell displacing core that defines the average distance.

Across the independent claims, the shared inventive concept is a cell encapsulating pouch with opposing interior surfaces and a cell reservoir, where one or more tensioning structures exert opposing forces to urge pouch layers apart and maintain an average internal spacing. The independent claim set further differentiates implementations using interconnected containment tubes with a perimeter tensioning member, a non-linear ended/linear sided frame configured to provide uniform tension, sealing arrangements that isolate the tensioning member from the reservoir, and an embodiment where a cell displacing core defines the average distance.

Stated Advantages

Documented Applications