Tepha, Inc.

Albany International Corporation

Amit Ganatra

Said Rizk

David P Martin

Simon F Williams

Bhavin Shah

Skander Limem

Fabio Felix

Matthew Bernasconi

Kai Guo

German Oswaldo Hohl Lopez

Antonio Fosco

Dana Eagles

Joseph Gerald O'Connor

Maurice R Paquin

Jeffrey Scott Denton

Maryann C Kenney

Lynn Faye Kroll

Jennifer L Bowden

John Michael Dempsey

Joseph G O'connor

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

Resorbable three-dimensional implants that can be temporarily deformed, implanted by minimally invasive means, and resume their original shape in vivo, have been developed. These implants are particularly suitable for use in minimally invasive procedures for tissue reinforcement, repair of hernias, and applications where it is desirable for the implant to contour in vivo to an anatomical shape, such as the inguinofemoral region. In the preferred embodiment, the implants are made from meshes of poly-4-hydroxybutyrate monofilament that have reinforced outlying borders that allow the meshes to form three-dimensional shapes that can be temporarily deformed. These implants can resume three-dimensional shapes after being temporarily deformed that contour to the host's tissue or an anatomical shape, for example, in the repair of a hernia, and particularly a hernia in the inguinofemoral region. The implants can contour to the host's tissue for example, of the inguinofemoral region, without the implants wrinkling, bunching or folding.

Three-dimensional resorbable implants for tissue reinforcement and hernia repair

Articles of poly(butylene succinate) and copolymers thereof

Resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yarns have tenacities higher than 8.1 grams per denier, and in vivo, retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo. The monofilament fibers have tensile strengths higher than 500 MPa. These yarns and fibers may be used to make various medical devices for various applications.

Methods of orienting multifilament yarn and monofilaments of poly-4-hydroxybutyrate and copolymers thereof

Resorbable implants comprising poly(butylene succinate) and copolymers thereof have been developed. The implants 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, and the fibers may be oriented. Coverings and receptacles made from forms of poly(butylene succinate) and copolymers thereof have also been developed for use with cardiac rhythm management devices and other implantable devices. These coverings and receptacles may be used to hold, or partially/fully cover, devices such as pacemakers and neurostimulators. The coverings and receptacles are made from meshes, webs, lattices, non-wovens, films, fibers, and foams, and contain antibiotics such as rifampin and minocycline.

Hernia repair, breast reconstruction and sling devices containing poly(butylene succinate) and copolymers thereof

Methods have been discovered that make it possible to continuously extrude tubes of P4HB and copolymers thereof. These methods allow tubes of P4HB and copolymers thereof to be produced without radial deformation of the tubes despite the slow crystallization of the polymer and copolymers. The methods can produce tubes of P4HB and copolymers thereof with tightly defined outside and inside diameters which are required for medical application. These tubes are produced by radial expansion at temperatures above the melting temperature of P4HB and copolymers thereof, and using low tube cooling temperatures and prolonged cooling times. The tubes made from P4HB and copolymers thereof are flexible, and can be prepared with high elongation to break values.

Continuous formation of tubes of poly-4-hydroxybutyrate and copolymers thereof

Resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yarns have tenacities higher than 8.1 grams per denier, and in vivo, retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo. The monofilament fibers have tensile strengths higher than 500 MPa. These yarns and fibers may be used to make various medical devices for various applications, including mesh sutures.

Methods of manufacturing mesh sutures from poly-4-hydroxybutyrate and copolymers thereof

Compositions of P4HB (poly-4-hydroxybutyrate) and copolymers thereof, have been developed for pultrusion, as well as processes to produce profiles from these compositions by pultrusion. These pultrusion processes provide profiles without causing structural damage to the surface of the profile. The profiles may be used in medical applications. These compositions include P4HB, and copolymers thereof, having intrinsic viscosities less than 3.2 dl/g but greater than 0.8 dl/g. The profile may be formed using conditions such as: pull rate of 0.1 to 100 mm/min, die temperature of up to 95&#xb0; C., rod stock temperature up to 95&#xb0; C., draw ratio of up to 100&#xd7;, pulling force of greater than 10 MPa, and clamping pressure at least 10% higher than the pulling force. Preferably, the profile is formed by pulling the rod stock through a series of dies placed at intervals with the hole sizes decreasing in diameter by 0.1 to 10 mm.

Pultrusion of poly-4-hydroxybutyrate and copolymers thereof

The invention discloses herein the use of short wavelength infrared energy to selectively control the locations where thermal fusing or bonding takes place or does not take place in an industrial fabric. Also, the method involves forming a mushroom cap on the tail of a fiber/yarn or monofilament and also creating a surface pattern formation.

Growing community of inventors

Attleboro, MA, United States of America

Amit Ganatra