Non-foldable pouch for forming an implantable artificial organ
Inventors
Bou Aoun, Richard • Burcez, Charles-Thibault • Magisson, Jordan • Sigrist, Séverine
Assignees
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Publication Number
US-11813157-B2
Publication Date
2023-11-14
Expiration Date
Abstract
The present invention relates to an implantable pouch which contains a rigid plate in its inner volume, thereby preventing said pouch to be folded.
Core Innovation
Describes a pouch for forming an implantable artificial organ/device as a closed envelope made from two sealed semi-permeable membranes that are sealed all over the perimeter of the pouch, defining an inner volume and an outer volume. The pouch contains a substantially planar rigid plate positioned in the inner volume, sized to remain parallel and resist folding, thereby maintaining the pouch shape with a non-foldable pouch geometry.
The rigid plate is made from a material selected from biocompatible metal and biocompatible alloy, with titanium or an alloy containing titanium, including titanium/titanium alloys such as nitinol. The plate can be implemented as porous titanium, a lattice/mesh form, include rounded edges, and include surface features such as protuberances and channels to maintain space for cells.
The pouch additionally includes semi-permeability achieved via porous biocompatible polymer layers and non-woven reinforcement, with membrane pore density, pore size, and membrane thickness defined for the semi-permeable membranes. The rigid plate may be coated with an elastomer and an optional anti-adhesive hydrophilic surface treatment to prevent cell adhesion, and connectors are provided for communication between volumes.
Claims Coverage
The independent claim defines an implantable artificial-organ pouch featuring two sealed semi-permeable membranes forming an inner and outer volume, and a substantially planar rigid plate inside the inner volume made of biocompatible titanium or a titanium-containing alloy. Dependent claims further refine plate geometry, plate thickness, plate material options such as porous titanium, and plate surface treatments configured to prevent cell adhesion.
Closed envelope two-semi-permeable-membrane pouch with sealed perimeter
A pouch for forming an implantable artificial organ/device as a closed envelope made from two semi-permeable membranes that are sealed all over the perimeter of the pouch, defining an inner volume and an outer volume of the pouch.
Substantially planar rigid plate in the inner volume
A pouch in which the inner volume contains a substantially planar rigid plate, with the plate being configured to remain planar rather than fold.
Titanium rigid plate material selection
The rigid plate is made from a material selected from biocompatible metal and biocompatible alloy, where the rigid plate is made of titanium or of an alloy containing titanium.
Plate matched surface area fraction
The rigid plate matches the pouch shape and has a surface area at least 60% of the pouch surface area.
Higher plate matched surface area fraction
The rigid plate matches the pouch shape and has a surface area at least 80% of the pouch surface area.
Specified rigid plate thickness range
The rigid plate has a plate thickness within 0.1 mm to 0.6 mm.
Porous titanium plate option
The pouch is made so that the rigid plate is formed from a porous biocompatible material that is porous titanium.
Anti-adhesive cell-avoidance surface treatment on plate
A pouch in which the plate surface is covered with a surface treatment to prevent cell adhesion on the plate surface.
The claim set centers on maintaining pouch shape and spatial accommodation for cells by integrating a substantially planar rigid plate within a closed envelope formed by two sealed semi-permeable membranes, using a titanium/titanium-alloy plate and refining the plate’s surface area relationship to the pouch, plate thickness, porous titanium material options, and anti-adhesive surface treatment.
Stated Advantages
Maintains pouch shape and resists folding by using a substantially planar rigid plate in the inner volume.
Improves reinforcement and cycle resistance of the pouch structure as documented by comparison testing.
Helps prevent cell adhesion on the plate surface via an anti-adhesive surface treatment.
Documented Applications
Implantation scenario is documented using pig implantation to demonstrate that the plate preserves pouch shape versus tearing without it, with verification described as X-ray/scanner verification.
Application described for encapsulation includes islets for diabetes within the pouch chamber.
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