Tepha, Inc.

Kai Guo

David P Martin

Simon F Williams

Said Rizk

Skander Limem

Amit Ganatra

German Oswaldo Hohl Lopez

Fabio Felix

Kicherl Ho

Ryan Cahil

David Martin

Resorbable implants, coverings and receptacles comprising poly(butylene succinate) and copolymers thereof have been developed. The implants are preferably sterilized, and contain less than 20 endotoxin units per device as determined by the limulus amebocyte lysate (LAL) assay, and are particularly suitable for use in procedures where prolonged strength retention is necessary, and can include one or more bioactive agents. The implants may be made from fibers and meshes of poly(butylene succinate) and copolymers thereof, or by 3d printing molding, pultrusion or other melt or solvent processing method. The implants, or the fibers preset therein, may be oriented. These coverings and receptacles may be used to hold, or partially/fully cover, devices such as pacemakers and neurostimulators. The coverings, receptacles and implants described herein, may be made from meshes, webs, lattices, non-wovens, films, fibers, foams, molded, pultruded, machined and 3D printed forms.

Medical devices containing compositions of poly(butylene succinate) and copolymers thereof

Articles of poly(butylene succinate) and copolymers thereof

Compositions of P4HB with high purity have been developed. The compositions are prepared by washing P4HB biomass prior to solvent extraction, and precipitating P4HB from solution. The same solvent is preferably used to wash the P4HB biomass, and as a non-solvent to precipitate the polymer from a P4HB solvent solution. The highly pure P4HB compositions are suitable for preparing implants. The implants may be used for the repair of soft and hard tissues.

Compositions and devices of poly-4-hydroxybutyrate

Continuous processing methods for making absorbable polymeric dry spun non-wovens with one or more of the following properties: high burst strength, fine fibers of average diameter from 0.01 &#x3bc;m to 50 &#x3bc;m, and thickness from 10 &#x3bc;m to 10 mm, have been developed. Improved fiber cohesion is made possible by controlling the tackiness of the fibers of the non-woven during web collection. The polymer is preferably a polyhydroxyalkanoate, more preferably, a 4-hydroxybutyrate polymer or copolymer. A non-woven of poly-4-hydroxybutyrate is most preferred. The non-wovens have fine fibers with average diameters ranging from 0.01 &#x3bc;m to 50 &#x3bc;m, and are derived by dry spun processing, during which a solution of polymer(s) is injected into a stream of high velocity air with a pressure of 1 to 500 psi for solvent stripping and polymer strand attenuation. The non-wovens can be used for a variety of purposes including fabrication of medical devices.

Medical devices containing dry spun non-wovens of poly-4-hydroxybutyrate and copolymers

Methods to produce structures containing ultrafine fibers with average diameters from 10 nm to 10 &#x3bc;m and more preferably from 50 nm to 5 &#x3bc;m, have been developed. These methods produce ultrafine fibers without substantial loss of the polymer's weight average molecular weight. The ultrafine electrospun fibers have an unexpectedly higher degree of molecular orientation, and higher melt temperature than fibers derived by dry spinning. In the preferred embodiment, the polymer comprises 4-hydroxybutyrate. The ultrafine fibers are preferably derived by electrospinning. A solution of the polymer is dissolved in a solvent, pumped through a spinneret, subjected to an electric field, and ultrafine fibers with a high degree of molecular orientation are collected. These structures of ultrafine fibers can be used for a variety of purposes including fabrication of medical devices.

Ultrafine electrospun fibers of poly-4-hydroxybutyrate and copolymers thereof

Continuous processing methods are used for making absorbable polymeric non-wovens, with anisotropic properties, improved mechanical properties and without substantial loss of polymer molecular weight during processing. The method includes producing dry spun-non wovens from a polymer, and collecting the fibers using a rotating collector plate, preferably a rotating cylinder, to collect the non-woven instead of a fiberglass stationary collector plate. The non-wovens can be used for a variety of purposes including fabrication of medical devices.

Medical devices containing dry spun non-wovens of poly-4-hydroxybutyrate and copolymers with anisotropic properties

Methods for making P4HB polymers and copolymers thereof that are useful for preparing controlled release systems, medical devices and as intermediates in chemical synthesis, have been developed. These methods avoid the use of organic solvents, and basic conditions that can cause transesterification reactions with polymer terminal end groups or elimination reactions. A preferred embodiment is a method for producing polymers of P4HB with weight average molecular weight less than 250,000, and more preferably, less than 100,000, and a Pd of less than 3, which are useful in controlled release. A particularly preferred embodiment utilizes aqueous acetic acid to hydrolyze pellets of P4HB polymers and copolymers while in suspension.

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Waltham, MA, United States of America

Kai Guo