Tepha, Inc.

Metabolix, Inc.

Other

Simon F Williams

David P Martin

Said Rizk

Skander Limem

Fabio Felix

Amit Ganatra

Arikha Moses

Frank Anthony Skraly

Antonio Fosco

Bhavin Shah

Matthew Bernasconi

Bruce Van Natta

Ajay Ahuja

Kai Guo

Tillman U Gerngross

Daniel M Horowitz

Klaus-Peter Schmitz

Detlef Behrend

Katrin Sternberg

Dennis Connelly

German Oswaldo Hohl Lopez

Oliver P Peoples

Kicherl Ho

Niels Grabow

Emily Stires

Jon I Montcrieff

Rebecca Holmes

Andrew James Carter

Thomas Lenarz

Struan H Coleman

Luhua Zhong

Matthew Dubois

Timothy John Butler

Kristin Crescenzi

Kemal Sariibrahimoglu

Ryan Cahil

David Martin

Dennis W Connelly

Jon Montcrieff

Struan Coleman

Nonwoven resorbable pouches that at least partially enclose implantable medical devices and improved methods for producing the implantable medical device pouches are described. The nonwoven pouches may comprise one or more drugs. Implantable medical devices that are placed in the pouches prior to implantation are prevented from migrating from the site of implantation by tissue ingrowth into the pouch. Antibiotics may be incorporated into the pouches to prevent post-operative infections. The pouches may be formed in fewer steps than conventional pouches, and without polymer coatings. Nonwoven pouches can be formed in one step by dry spinning instead of using multiple processing steps. In embodiments, the nonwoven pouches are smoother on the inside than the outside to tightly fit the implantable medical devices internally while encouraging external tissue ingrowth. In embodiments, the nonwoven pouches eliminate the use of knitted or woven multifilament fibers that can trap bacteria and result in post-operative infection.

Resorbable nonwoven pouches for medical device implants

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.

Implant with fillable reservoir

Absorbable implants for breast surgery that conform to the breast parenchyma and surrounding chest wall have been developed. These implants support newly lifted breast parenchyma, and/or a breast implant. The implants have mechanical properties sufficient to support a reconstructed breast, and allow the in-growth of tissue into the implant as it degrades. The implants have a strength retention profile allowing the support of the breast to be transitioned from the implant to regenerated host tissue, without significant loss of support. Three-dimensional implants for use in minimally invasive mastopexy/breast reconstruction procedures are also described, that confer shape to a patient's breast. These implants are self-reinforced, can be temporarily deformed, implanted in a suitably dissected tissue plane, and resume their preformed three-dimensional shape. The implants are preferably made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof. The implants have suture pullout strengths that can resist the mechanical loads exerted on the reconstructed breast.

Absorbable implants for plastic surgery

Absorbable implants can be used to create volume and shape in the breast of a patient with regenerated tissue. The implants comprise scaffolds formed from layers of parallel filaments. The layers of filaments can be stacked and bonded together to form scaffolds with porous crisscross arrangements of filaments. The implant's scaffolds may be coated or filled with cells and tissues, including autologous fat graft, and/or a vascular pedicle may be inserted into the implant. The implants are particularly suitable for use in plastic surgery procedures, for example, to regenerate or augment breast tissue following mastectomy or in mastopexy procedures, and can provide an alternative to the use of permanent breast implants in these procedures.

Breast reconstruction implant

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

Three dimensional mastopexy implant

Absorbable monofilament fibers and self-retaining sutures with high tensile strengths have been developed. The straight pull tensile strengths of the absorbable self-retaining sutures closely approximate, equal or exceed the average minimum knot-pull tensile standards set by the United States Pharmacopeia (USP). These higher strength absorbable self-retaining sutures can therefore be used either without needing to oversize the suture for a given procedure, or by oversizing the self-retaining suture by no more than 0.1 mm in diameter. In one embodiment, the absorbable self-retaining sutures are made from poly-4-hydroxybutyrate or copolymers thereof.

Self-retaining sutures of poly-4-hydroxybutyrate and copolymers thereof

Full contour absorbable implants for breast surgery redistribute breast volume between the breast's upper and lower poles in exact and desirable ratios. The implants preferably redistribute breast volume so that the upper pole breast volume is 20-40% of the total volume, and the lower pole breast volume is 60-80% of the total volume. The implants are also designed to provide specific curvatures to the poles of the breast, and to angulate the nipple areolar complex slightly skyward so that the patient's nipple is positioned at an angle above the nipple meridian reference line. The implants are designed to be transitory, with sufficient strength retention to allow transition from support of the breast by the implant to support by regenerated host tissue growing in and around the implants, without any significant loss of support during or subsequent to remodeling. The implants may optionally be used with permanent breast implants.

Full contour breast implant

Absorbable implants can be used to create volume and shape in soft tissues with regenerated tissue. The implants comprise lattices formed from multiple unit cells. Unit cells can be coils or springs, skeletal polyhedrons, foams, or structures derived from mesh and fiber. The implants may be coated or filled with cells and tissues, and preferably with autologous fat graft. The implants are particularly suitable for use in plastic surgery procedures, for example, to regenerate or augment breast tissue following mastectomy or in mastopexy procedures, and can provide an alternative to the use of permanent breast implants in these procedures.

Implants assembled from skeletal polyhedron unit cells, coiled unit cells or mesh unit cells

Resorbable implants 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, 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.

Surgical mesh implants containing poly(butylene succinate) 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.

Oriented implants containing poly(butylene succinate) and copolymer, and methods of use thereof

Articles of poly(butylene succinate) and copolymers thereof

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Sherborn, MA, United States of America

Simon F Williams