Implant with fillable reservoir

Inventors

Limem, Skander • Felix, Fabio • Rizk, Said • Martin, David P. • Williams, Simon F.

Assignees

Tepha Inc

Abstract

Implants with fillable reservoirs have been developed that are suitable for rhinoplasty, breast reconstruction, ear reconstruction, and replacement, reconstruction or repair of other soft tissues. The implants can be filled with graft material prior to implantation. The implants are preferably made from resorbable polymers, can be tailored to provide different geometries, mechanical properties and resorption rates in order to provide more consistent surgical outcomes. The implants preferably have an interconnected network of unit cells with microporous outer layers and optionally some or all of the unit cells having at least one macropore in their outer layers. The implants can be loaded by injection with microfat, collagen, DCF, cells, bioactive agents, and other augmentation materials, prior to implantation.

Core Innovation

The invention relates to an implant having a fillable reservoir with a microporous outer layer including a plurality of micropores. The microporous outer layer further includes a macropore, where the macropore has a size between 0.0045 mm2 and 5 mm2 and the plurality of micropores have an average diameter of less than 10 μm.

In described embodiments, the microporous outer layer is formed from a microporous polymer architecture such as a nonwoven microporous layer, with either an interconnected unit-cell network or sealed edges to establish the fillable reservoir. The structure may include macropores and/or macroporous internal fiber filler, providing a wick-like uptake and retention of graft materials and enabling tissue ingrowth within the implant architecture.

The implant is described as resorbable and engineered for geometry and degradation rate, with poly-4-hydroxybutyrate (P4HB) and P4HB copolymers identified as preferred degradable polymer materials. The implant is described as fillable pre-implantation with graft materials that include microfat, fat/fat extracts, DCF, cells/stem cells, collagen, gels/hydrogels, and bioactive agents.

Claims Coverage

Independent claim clm-00001 defines 3 inventive features centered on a fillable reservoir implant architecture with a microporous outer layer, a macropore, and size constraints on the macropore and micropores. Dependent claims further refine structure, placement, and materials, including nonwoven microporous membranes, unit-cell networks, sealed edges, thermal bonding point relationships, and optional internal macroporous fiber filler and stacked microporous layers.

Overall, the claim coverage centers on a fillable reservoir implant where a microporous outer layer includes both micropores and a macropore with explicit size bounds, and where dependent refinements specify nonwoven membrane construction, unit-cell or sealed-edge reservoir structures, positional separation from thermal bonding points, edge-sealed stacked microporous layers, and resorbable polymer material selection.

Stated Advantages

Documented Applications