Abstract: A pharyngeal retractor device and implantation methods are provided for use in the treatment of obstructive sleep apnea. The device includes a retracting element and a tissue engaging element that promotes tissue ingrowth around or onto the retracting element. The device is implanted in tissue space beneath the pharyngeal wall to alter the shape of the wall. The device may be implanted through the oral cavity alone or by using a trocar or a hand-held delivery system to deliver the device through the pharyngeal wall. Alternatively, the device may be implanted using an open, direct visualization approach from the side of a patient's neck.

Abstract: Tissue securement fibers of reduced cross sectional area and methods of making them are disclosed. The fibers comprising reduced cross sectional areas provide higher degrees of flexibility by providing discrete bending zones most useful in applications when the fiber is bent at an included angle less than 180°, more particularly when the included angle is less than 90°.

Abstract: An insertion device and method of use for treating obstructive sleep apnea. The device includes an outer tubular element with a tissue penetrating end and a side opening, an inner tubular element positioned partially within the outer member and movable longitudinally relative to it, a grasping device fixedly coupled to the inner element, and a central shaft extending through the inner tubular element and movable longitudinally relative to the inner and outer tubular elements. The central shaft is slidably coupled with the grasping device. The inner tubular element is further movable between a retracted position wherein the grasping device is positioned entirely within the outer tubular element, and an extended position wherein it extends outwardly therefrom through the side opening. In the extended position, the grasping device is adapted to grasp a filamentary element positioned external of the outer tubular element and in proximity thereto.

Abstract: An implantable tissue suspension device and its method for use. The device includes first and second filamentary elements bonded together only at a central connection region such that first and second leading and trailing legs of the respective first and second filamentary elements extend outwardly from the central connection region. The method includes implanting the device such that the central connection region extends laterally across a patient's tongue and the first and second leading and trailing legs of the first and second filamentary elements extend through the tongue such that ends thereof are positioned external to the genioglossus muscle.

Abstract: Magnetic devices and implantation methods are provided for use in the treatment of obstructive sleep apnea. The devices include a sheet-like element having ferromagnetic qualities. The device may also include a permanent magnet attached to the sheet-like element by magnetic forces. The devices are implanted in soft tissue surrounding the airway and in tissue space beneath the pharyngeal wall to exert forces on and/or change the shape of the soft tissue. The magnetic devices may also include a bladder containing a magnetorheological fluid that stiffens soft tissue when exposed to a magnetic field.

Abstract: A tissue supporting device is provided and method of use. The device includes an anchor element having a plate-like element and first and second side walls extending upwardly therefrom. The plate-like element is defined by front and rear edges, and first and second side edges, with the rear edge being longer than the front edge. The first and second side walls are aligned substantially along at least a portion of the first and second side edges of the plate-like element such that a distance between the first and second side walls at a front side is less than a distance between the first and second side walls at a rear side. The device also includes a soft tissue supporting element adapted for engaging and supporting soft tissue. The soft tissue supporting element is coupled to the plate-like element and extends outwardly from the anchor element.

Abstract: A pharyngeal retractor device and implantation methods are provided for use in the treatment of obstructive sleep apnea. The device includes a retracting element and a tissue engaging element that promotes tissue ingrowth around or onto the retracting element. The device is implanted in tissue space beneath the pharyngeal wall to alter the shape of the wall. The device may be implanted through the oral cavity alone or by using a trocar or a hand-held delivery system to deliver the device through the pharyngeal wall. Alternatively, the device may be implanted using an open, direct visualization approach from the side of a patient's neck.

Abstract: A system and method are disclosed for the securement of tissue and in particular for placement of a tongue base suspension fiber for the treatment of obstructive sleep apnea. The system incorporates disposable connectors with releasable needles to facilitate the placement of fibers with minimal increase in suture site dilation or trauma.

Abstract: An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.

Abstract: Magnetic devices and implantation methods are provided for use in the treatment of obstructive sleep apnea. The devices include a sheet-like element having ferromagnetic qualities. The device may also include a permanent magnet attached to the sheet-like element by magnetic forces. The devices are implanted in soft tissue surrounding the airway and in tissue space beneath the pharyngeal wall to exert forces on and/or change the shape of the soft tissue. The magnetic devices may also include a bladder containing a magnetorheological fluid that stiffens soft tissue when exposed to a magnetic field.

Abstract: A system for treating obstructive sleep apnea includes a body implantable in a soft palate, and a fastening element at a proximal end of the body for connecting the body with a hard palate. In one embodiment, the body is curved and has a convex top surface and a concave bottom surface. The curved body is adapted to support and/or change the shape of the soft palate for minimizing the likelihood of airway obstructions during sleep. The fastening element, secureable to the hard palate, includes at least one barb adapted to engage the hard palate for anchoring the body to the hard palate. In one embodiment, the body has a surface adapted to promote tissue in-growth. The implant body may be made of materials including nitinol, stainless steel, biocompatible polymers, temperature-sensitive materials, and shape memory materials.

Abstract: A surgical wound closure device comprising multiple layers joined at only one edge of each layer in a book-like arrangement and having opposite unjoined edges, including a substrate having a proximal surface and a distal surface; a drape having a proximal surface and a distal surface, and being disposed proximally to said substrate; and an adhesive layer having a proximal surface and a distal surface; said drape being disposed releasably adherently to said distal surface of said adhesive layer. Also provided is a surgical procedure employing a surgical wound closure device.

Abstract: The present invention provides a composition and method for treating tissue defects. The composition includes thrombin and fibrinogen, or sodium alginate and calcium chloride, and also a surfactant, and non-resorbable polymer microparticles dispersed within the composition.

Abstract: A surgical suture includes a shaft having a leading end, a trailing end, and an outer surface extending between the leading and trailing ends. The surgical suture includes a plurality of flexible protrusions extending from the shaft, and a lumen extending between the leading and trailing ends of the shaft. The shaft includes a plurality of openings formed in the outer surface thereof that are in communication with the lumen. The shaft includes a first axial opening at the leading end thereof in communication with the lumen and a second axial opening at the trailing end thereof in communication with the lumen. A flowable material may be disposed in the lumen. After the surgical suture is implanted, the flowable material is adapted to pass from the lumen and through the plurality of openings in the outer surface of the shaft for contacting tissue surrounding the suture.

Abstract: A method of making a composite prosthetic device, such as a hernia repair device, includes providing a support layer, juxtaposing a layer of an absorbable material with the support layer, and disposing an absorbable adhesive between the support layer and the layer of an absorbable material. The method includes heating the layers for melting the absorbable adhesive so as to bond the support layer with the layer of the absorbable material. Before the heating step, the moisture content of at least one of the layers is increased for improving thermal conductivity between the layers so as to enhance the strength of the bonds formed between the layers. The moisture content may be increased by exposing at least one of the layers to an environment having elevated relative humidity. In one embodiment, the support layer is polypropylene mesh, the layer of the absorbable material is oxidized regenerated cellulose, and the absorbable adhesive is polydioxanone.

Abstract: A composition for reducing pain at a surgical wound site or trauma site comprising oxidized regenerated cellulose and a non-steroidal anti-inflammatory drug or pharmaceutically acceptable salt or ester thereof, where the non-steroidal anti-inflammatory drug is an acid having a secondary amine group; and a method of reducing localized pain at a surgical wound site or trauma site.

Abstract: A barbed suture includes a flexible thread having a leading end and a trailing end, and a plurality of barbs projecting from the flexible thread. The flexible thread has a plurality of web-like openings formed therein, whereby each of the openings is disposed adjacent one of the barbs. The openings enhance the flexibility of the barbs and provide space for the barbs to collapse inwardly as the leading end of the flexible thread is pulled through a medium such as tissue. When the barbs are collapsed, the diameter of the barbed sections is preferably no greater than the diameter of the non-barbed sections. In one embodiment, a support element interconnects at least one of the barbs and the flexible thread for reinforcing the at least one barb and resisting flexure of the at least one barb toward the leading end of the flexible thread.

Abstract: An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.

Abstract: An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.

Abstract: An implant for treating medical disorders includes a first chamber having a flexible outer layer that surrounds a flexible inner layer, a second chamber in communication with the first chamber, and a fluid transfer assembly adapted for transferring fluid between the second chamber and the first chamber for selectively modifying the rigidity of the first chamber. The implant includes at least one restraining element in contact with the flexible outer and inner layers for at least partially restricting volume expansion of the first chamber as the fluid is transferred into the first chamber. The first chamber is adapted to become more rigid as the fluid is transferred into the first chamber and more flexible as the fluid is removed from the first chamber. The first chamber is implantable within the soft tissue of a patient such as a tongue, soft palate, pharyngeal wall, urinary tract, rectum, trachea, or stomach.