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US 12,201,748 B2Granted
Biopolymer scaffold implants and methods for their production
AssigneeEmbody, Inc.
InventorsMichael P. Francis, Yas Maghdouri-White, Hilary Wriggers, Nardos Sori, Stella Petrova, Seth Polk, Nicholas Thayer
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Abstract
Compositions and blends of biopolymers and bio-acceptable polymers are described, along with the use of benign solvent systems to prepare biocompatible scaffolds and surgically implantable devices for use in supporting and facilitating the repair of soft tissue injuries.
Claims23
A method for producing an implantable biopolymer scaffold comprising the steps of:
- dissolving a biopolymer, and optionally a bio-acceptable polymer, in a DMSO solvent system comprising about 40 to 100% by volume of dimethylsulfoxide (DMSO) and about 0 to 60% by volume of a solvent selected from the group consisting of ethanol, tetrahydrofuran and acetic acid to form a biopolymer solution that is not chemically cross-linked;
- generating biopolymer fibers from the biopolymer solution;
- and
- collecting the biopolymer fibers to form a biopolymer scaffold,
- wherein the biopolymer fibers comprise:
- about 10 to 90% by weight of collagen,
- about 10 to 90% by weight of a bio-acceptable polymer selected from the group consisting of PDLA, PDLLA, and mixtures thereof, and
- a wt:wt ratio of the collagen to bio-acceptable polymer ranges from 10:90 to 50:50.
5 more elements
An implantable biopolymer scaffold for supporting the repair of a soft tissue injury comprising at least one biopolymer sheet comprising biopolymer fibers,
- wherein the biopolymer fibers comprise:
- about 10 to 90% by weight of collagen, and
- about 10 to 90% by weight of a bio-acceptable polymer selected from the group consisting of PDLA, PDLLA, and mixtures thereof;
- a wt:wt ratio of the collagen to bio-acceptable polymer ranges from 10:90 to 50:50, and
- wherein the biopolymer scaffold has one or more of the following characteristics:
- (i) an average porosity of about 50 to 150 microns as determined by mercury porosimetry;
- (ii) an absorbance of about its weight in blood in about 5 min and an absorbance of about twice its weight in blood in about 20 minutes when measured in vitro;
- (iii) an average fiber diameter in the range of about 150-4,500 nm;
- (iv) substantial in vivo cell infiltration into the scaffold within about two weeks following implantation, and
- (v) average configuration of the pores is substantially in the shape of a slit relative to other configurations including elliptical or random pore configurations
- wherein the biopolymer scaffold is produced from a DMSO solvent system comprising about 40 to 100% by volume of dimethylsulfoxide (DMSO) and about 0 to 60% by volume of a solvent selected from the group consisting of ethanol, tetrahydrofuran and acetic acid that is not chemically cross-linked.
8 more elements
Dependencies are inferred from the claim text.