Tepha, Inc.

Medos International Sarl

Dennis Connelly

David P Martin

Said Rizk

Jon I Montcrieff

Simon F Williams

Matthew Bernasconi

David B Spenciner

Fabio Felix

Gregory R Whittaker

Andrew James Carter

Reagan A Theis

Daniel Gamache

Joseph Algeri

Samantha T Johnson

Samantha Johnson

A suture construct that is elongate along a longitudinal direction and configured to change in size from a first configuration to a second configuration includes an outer layer of material that extends along the longitudinal direction and has a plurality of intertwined fibers that comprise a first sub-set of fibers crossed by a second sub-set of fibers at respective intersections, such that the first subset of fibers and the second subset of fibers are configured to reorient relative to each other in a manner causing the outer layer of material to change in one or more of surface texture and visual appearance as the suture construct changes between the first and second configurations.

Suture having adaptable surface characteristics, and related systems and methods

A suture anchor for fixation within an anatomical structure includes an actuation member in contact with an anchor body at a first location thereof. The anchor body is elongate along a direction of elongation and defines a central axis. In a neutral configuration, the anchor body is flat and defines a thickness along a transverse direction and a width along a lateral direction, the width being greater than the thickness. The anchor body has first and second tails that are braided together along a portion of the actuation member from the first location to a second location of the anchor body. The actuation member is configured to apply a force to the braided anchor body so as to actuate the anchor body in a manner increasing its maximum thickness along a second direction that is angularly offset from the direction of elongation.

Fixation members, assemblies, and related systems and methods

Methods to produce substantially closed cell foams with densities less than 0.75 g/cm, and more preferably less than 0.5 g/cm, without substantial loss of the polymer's weight average molecular weight, have been developed. The closed cells foams have an open cell content of generally less than 50%, and more preferably an open cell content of less than 20%, and the cells have a maximum diameter of less than 5 mm. The foam may include poly-4-hydroxybutyrate or a copolymer thereof. Preferably, the foam is derived by heating a foam polymer formula to a temperature above the melt temperature of the polymer to form a melt polymer system, adding a blowing agent to produce a foamable melt, extruding the foamable melt through a die to a lower pressure to cause foaming, cooling of the foam, and solidification of the foam. These foam structures can be used for fabrication of medical products.

Closed cell foams including poly-4-hydroxybutyrate and copolymers thereof

Methods to produce thermoforms from P4HB homopolymer and blends thereof have been developed. These thermoforms are produced from films and sheets including P4HB, wherein the intrinsic viscosity of the P4HB is less than 3.5 dl/g, but greater than 0.35 dl/g, and the thermoforms are produced at a temperature equal to or greater than the softening point of P4HB, and more preferably at a temperature higher than the melting point of P4HB. A preferred embodiment includes a P4HB thermoform wherein a film or sheet including a P4HB polymer is thermoformed at a temperature between its melting point and 150&#xb0; C. In a particularly preferred embodiment the thermoform is a laminate made from a P4HB film and a P4HB mesh.

Thermoformed poly-4-hydroxybutyrate medical implants

Biocompatible coatings and spin finishes that can be applied to polyhydroxyalkanoate (PHA) polymers, and medical devices made from PHA polymers, have been developed. The coatings impart good lubricity to PHA polymers, particularly to fibers and braids made from these materials, making the coatings ideal for use on medical devices such as PHA braided sutures. The spin finishes can be applied to PHA fibers to facilitate their manufacture, and also for their conversion to other products, including medical textiles. The spin finishes serve to protect multifilament fiber bundles, and keep them intact following extrusion, and also to impart lubricity to the fiber bundles and monofilament fibers so that they are not damaged in subsequent processing steps particularly in textile processing. The coating reduces tissue drag of, for example, braided sutures.

Coatings for the manufacture and application of polyhydroxyalkanoate medical devices

Compositions of P4HB and processes to injection mold these compositions have been developed. These compositions are prepared from P4HB polymers and blends having intrinsic viscosities less than 3.2 dl/g but greater than 0.8 dl/g, moisture contents of less than 0.5% by weight, and more preferably less than 0.05% by weight, and using a polymer melt temperature during molding of at least 150&#xb0; C. A preferred embodiment comprises a P4HB molding with an intrinsic viscosity of less than 3.2 dl/g that degrades rapidly in vivo.

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Arlington, MA, United States of America

Dennis Connelly