Lexington, MA, United States
Lexington, MA, United States

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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.


Implantable fasteners that can be repositioned after implantation, and implants including these repositionable implantable fasteners, have been developed. The fasteners are designed to fixate medical devices and other implantable components in the body, and can be adjusted after initial fixation in tissue to reposition the implanted medical device. The fasteners include a plurality of tissue retainers emanating from a supportive backing, wherein the tissue retainers can swivel from the plane of the supportive backing to engage tissue. The fasteners are fixated in tissue by movement in a first direction, and can be removed when pulled in a direction opposite to the first direction. The fasteners may be attached to medical devices before or after implantation. In one embodiment, the implant is a mastopexy device in the form of a mesh and the repositionable fastener.


Methods to produce micro-fiber webs containing fibers of 4- hydroxybutyrate or copolymers thereof with average diameters from 0.01 to 100 m, have been developed. The micro-fiber webs are produced by centrifugal spinning. These methods allow the micro-fiber webs to be produced without substantial loss of the polymer weight average molecular weight. Webs containing micro-fibers of poly-4-hydroxybutyrate or copolymer thereof, are made by centrifugal spinning. The micro-fibers have average diameters ranging from 0.01 to 100 m and contain crimped fibers with a higher elongation at break fibers when compared to fibers derived by melt-blown extrusion, dry spinning and electrospinning. The fibers of the micro-fiber webs have a high degree of orientation. These micro-fiber webs can be used for a variety of purposes including fabrication of medical devices.


Methods to produce perforated collagen coated meshes for use as implants have been developed. The method involves positioning needles through the pores of the mesh, coating the mesh with a collagen solution, freezing the coated mesh, removing the needles from the frozen coated mesh, drying the collagen coated mesh, and optionally cross-linking the coated mesh. The method allows perforated collagen coated meshes to be prepared with variable thickness, and without damage to the surface of the mesh. The perforations of the collagen coated meshes may be designed to prevent the formation of fluid pockets when the coated meshes are implanted, and to permit rapid incorporation into host tissue. The perforated collagen coated meshes may be used for soft tissue repair, regeneration or remodeling including, for example, hernia repair, mastopexy, treatment of urinary incontinence, pelvic floor reconstruction, and ligament and tendon repair.


Patent
Tepha Inc | Date: 2017-02-09

A mastopexy implant for maintaining the breast in an elevated and aesthetically pleasing position includes a lower pole support comprising end portions which may be affixed to the chest wall or to a previously installed upper suspension strut. The implant is loaded in an insertion device. The insertion device is inserted through a small incision and into a subcutaneous pocket created in an inferior half of the breast. The lower pole support may have various constructs and in one embodiment includes a unitary conformable mesh having a plurality of arm or band members which are attached across the breast parenchyma and to the chest wall.


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. Methods for producing absorbable self-retaining sutures that have high tensile strengths and pronounced sheath-core structures wherein the sheath is harder than the core are also provided. The self-retaining sutures may be made by spinning and orienting a monofilament fiber of poly-4- hydroxybutyrate or copolymer thereof and inserting retainers in monofilament fibers.


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.


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 hosts 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 hosts tissue for example, of the inguinofemoral region, without the implants wrinkling, bunching or folding.


Patent
Tepha Inc | Date: 2016-08-22

Toughened compositions of PLA and PLA copolymers are disclosed, which also have low tensile modulus values and greater elongation to break. These toughened compositions are prepared by blending PLA and PLA copolymers with poly-4-hydroxybutyrate, and copolymers thereof. Blending of poly-4-hydroxybutyrate with PLA and its copolymers has been found to impart advantageous properties to the resulting blend. These compositions, and objects formed from these compositions, have improved toughness and lower stiffness than polylactic acid polymers or copolymers alone.


Patent
Tepha Inc | Date: 2016-08-22

Toughened compositions of PLA and PLA copolymers are disclosed, which also have low tensile modulus values and greater elongation to break. These toughened compositions are prepared by blending PLA and PLA copolymers with poly-4-hydroxybutyrate, and copolymers thereof. Blending of poly-4-hydroxybutyrate with PLA and its copolymers has been found to impart advantageous properties to the resulting blend. These compositions, and objects formed from these compositions, have improved toughness and lower stiffness than polylactic acid polymers or copolymers alone.

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