Abstract: A barrier system is provided for use in reducing infections associated with post-operative surgical incision and/or a percutaneous medical device, such as a catheter, that is disposed within the surgical incision. Such a barrier system may include: a barrier device having a skin-contacting surface and a catheter-receiving surface; and an adhesive composition configured for adhering to skin, the barrier device, and/or the catheter so as to form a barrier at or adjacent to an incision in the skin where the catheter is percutaneously inserted through the skin. A tensioning anchor and associated system of two or more tensioning anchors is provided for post-operative wound closure. A method for applying and removing the barrier device and tensioning anchors is also provided.

Abstract: Nasal implant obtained by additive manufacturing, comprising a main portion and a return portion connected by an intermediate portion, the main and return portions forming an angle of between 25° and 90°, said implant is made from a biocompatible ceramic of synthetic origin; said implant has an average macroporosity characterized by: a density of material of between 20% and 95% by volume, said density of material being higher in said intermediate portion than in said main portion; cavities defining sections of cavities, said sections of cavities each having a diameter of between 0.3 mm and 1 mm; said sections of cavities each having an area and a form substantially equal over the entire implant.

Abstract: Gluteal implants and gluteal implant systems are described herein, as are methods of manufacturing and implanting the same. In certain embodiments, the gluteal implant includes a body having a convex upper surface, a concave lower surface, and an edge, the edge being formed by the intersection between the convex upper surface and the concave lower surface. The body can take on various shapes, including a truncated ovoid shape, a truncated approximate ovoid shape, a truncated substantially ovoid shape, a truncated ellipsoid shape, a truncated approximate ellipsoid shape, or a truncated substantially ellipsoid shape, among others. In certain embodiments, the gluteal implant system includes first and second gluteal implants that have the same or different shaped bodies. In certain, the gluteal implants and gluteal implant systems are implanted in a buttock.

Abstract: A facial implant device includes a support structure adapted to be coupled to a bone surface within a facial region, an outer structure adapted to contour to a predefined anatomy associated with the facial region, and an intermediary bladder structure located between the support structure and the outer structure. The intermediary bladder structure includes an internal volume that is adjusted in response to adapting the outer structure to contour to the predefined anatomy associated with the facial region.

Abstract: One aspect of the present disclosure relates to a system for treating obstructive sleep apnea in a subject. The system can include a power source and a neuromuscular stimulator in electrical communications with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. The at least one electrode can be configured to deliver the therapy signal to a target tissue associated with control of a posterior base of the tongue of the subject.

Abstract: The present disclosure discloses a bone stabilization device (also referred to as a bone tape), which includes a composite flexible construct including a rigidifiable biocompatible sheet structure having first and second opposed surfaces. A biocompatible cement is located on the first surface. In use the composite flexible construct is applied to a bone with the cement contacted directly to the bone. The cement is made of a material that, once adhered to the bone, is curable to mechanically and/or ionically bond to the sheet structure and to chemically bond to the bone to achieve a permanent bond. The bone tape allows simultaneous alignment and stabilization of multiple articulated fragments for successful 3D reconstruction of shattered bones. Initial flexibility and translucency provided by the bone tape can facilitate the temporary stabilization and alignment adjustment of multiple fragments, prior to permanent rigid bonding.

Abstract: Disclosed herein are patient-specific craniofacial implants structured for filling bone voids in the cranium as well as for simultaneously providing soft tissue reconstruction and/or augmentation for improved aesthetic symmetry and appearance. Pterional voids or defects generally result from a chromic skull deformity along with a compromised temporalis muscle or soft tissue distortion from previous surgery. When muscle atrophy occurs in the pterion, temporal hollowing generally results where there would be soft tissue but for the atrophy. The patient-specific temporal implants herein are configured to have an augmented region adjacent the temporal region of the cranium in order to account for and correct any such temporal hollowing.

Abstract: The present disclosure discloses a bone stabilization device (also referred to as a bone tape), which includes a composite flexible construct including a rigidifiable biocompatible sheet structure having first and second opposed surfaces. A biocompatible cement is located on the first surface. In use the composite flexible construct is applied to a bone with the cement contacted directly to the bone. The cement is made of a material that, once adhered to the bone, is curable to mechanically and/or ionically bond to the sheet structure and to chemically bond to the bone to achieve a permanent bond. The bone tape allows simultaneous alignment and stabilization of multiple articulated fragments for successful 3D reconstruction of shattered bones. Initial flexibility and translucency provided by the bone tape can facilitate the temporary stabilization and alignment adjustment of multiple fragments, prior to permanent rigid bonding.

Abstract: A method for selecting modular neck components for hip implants based on independent variables associated with physical characteristics of the implant, including leg length, offset, and anteversion. During surgery, the surgeon may be confronted with a need to change a preoperatively-chosen modular neck. For example, the surgeon may desire a change in at least one of the variables, e.g., leg length, offset, and/or anteversion. The present method allows the surgeon to quickly and easily select a different modular neck based on an evaluation of one of the variables without requiring reevaluation of the other variables. The method may include preoperative planning in which a template including a grid coordinate system is used.

Abstract: A malar implant for mid-face lifts and reconstructions is disclosed. The malar implant is designed to be attached to both bone and soft tissue, and provides both volume and soft tissue lift. A depending tab or lip on the superior edge of the implant attaches to the inferior orbital rim. The implant has a central plateau, which may be gently curved, that includes a number of soft tissue spikes. In one embodiment, the soft tissue spikes have the general shapes of bent isosceles triangular pyramids, thicker at the base than at the tip. The soft tissue spikes may be angled upwardly, toward the superior edge, to reposition and suspend the soft tissues of the mid-face.

Abstract: A device for covering and/or reconstructing a bone defect site and a method for producing a cap of a covering device for a bone defect site, wherein the device for covering and/or reconstructing a bone defect site consists of a cap (moulded shell, rigid shell, shaped body) and of at least one fixing means for fixing the cap on a bone. The cap is distinguished by having a dimensionally stable (rigid) nature, and a wall of the cap directed towards the bone defect or a wall of the cap directed away from the bone defect corresponds to the shape of the regenerated bone.

Abstract: Methods and apparatus are provided for forming a patient-specific surgical implant based on mold system. The apparatus comprises a forming tool and a mold that may be generated using imaging and processing techniques and rapid prototyping methods. The mold apparatus includes at least two non-adjacent surface features for securing an implant forming material (such as a titanium mesh) during the forming process, enabling the implant forming material to be stretched beyond its elastic and thus permanently deformed with the correct patient-specific curvature. The implant may include one or more anatomic surface features for guidance and registration when transferring the implant to a patient.

Abstract: Disclosed herein are patient-specific craniofacial implants structured for filling bone voids in the cranium as well as for simultaneously providing soft tissue reconstruction and/or augmentation for improved aesthetic symmetry and appearance. Pterional voids or defects generally result from a chromic skull deformity along with a compromised temporalis muscle or soft tissue distortion from previous surgery. When muscle atrophy occurs in the pterion, temporal hollowing generally results where there would be soft tissue but for the atrophy. The patient-specific temporal implants herein are configured to have an augmented region adjacent the temporal region of the cranium in order to account for and correct any such temporal hollowing.

Abstract: A porous metal augment is sized for use in mandibular or maxillar bone. The porous metal material of the augment facilitates and promotes ingrowth of the surrounding bone into the porous metal structure, thereby rebuilding a suitable foundation for affixation of dental implants. A non-porous core or insert can be embedded within the porous metal body of the augment, and can be made of a material suitable for firm threaded fixation of dental implants thereto. For example, the metal core can be formed of a titanium structure that has sufficient strength and resiliency to form a firm and long lasting threaded connection with a threaded stem of a dental implant.

Abstract: Embodiments relate to systems and methods for a cranial implant assembly adapted for insertion during a craniectomy procedure. In aspects, the inventive cranial implant assembly can contain a peripheral attachment member for attachment to the edge of a skull opening, as well as an articulated spanning member that over-arches and holds a cover in place over the opening. The articulated spanning member contains a central implant fastened or connected to a swollen dura in the skull opening. As swelling of the dura subsides, tension is exerted on guidewires in both the spanning member and cover to draw those constructs into a rigid state. The tips of the spanning member can gradually approach the peripheral attachment member, and register into place using a locking mechanism, such as a pair of opposing magnets. As a result, only one surgical operation or procedure Is required to both perform a craniectomy and implant a supporting assembly for eventual skull regeneration.

Abstract: A porous surgical implant constructed of a nonbiodegradable polymer that is molded to form an omnidirectional vascularization frame. The frame defines a porous external surface and a plurality of internal longitudinally extending capillaries of a substantially constant porosity throughout the implant. The internal capillaries are in fluid communication with the external porous surface and thereby configured to absorb a fluid adjacent the implant.

Abstract: The present invention relates to mosaic implant (15) comprising a plurality of mosaic plates (17) connected by a wire or mesh anchoring arrangement (9). Methods for forming such implants and methods for using said implants for correction of bone and soft tissue defects are described.

Abstract: The present application describes, inter alia, methods, devices, and systems for modeling and fabricating corrective appliances and methods of treating cleft palate using same.

Abstract: A method of cranial repair and the cranial implant molding device used therein, the device having a frame or base that receives a bottom or convex molding plate and a top or concave molding plate in a manner whereby the two plates are separated a distance to receive a settable or curable implant forming material therebetween. The plates are separated by a compressible member such that by the use of threaded mechanical fasteners or similar members the distance between the two plates can be adjusted by tightening or loosening the mechanical members. The thickness of the implant is varied by varying the separation distance on different sides of the frame.

Abstract: A bone augmentation device includes at least one axial member defining a longitudinal axis and a plurality of transverse members. Each transverse member extends from a first end, or removably connected to the at least one axial member to a second end configured for fixation with bone. The transverse members are spaced apart and disposed along the longitudinal axis. The at least one axial member and the transverse members are disposed in a configuration to define a bone graft cavity. Methods of use are also disclosed.

Abstract: A composite surgical implant that is made of a planar sheet of a thermoplastic resin that includes a top surface (400), a bottom surface (410), and a surgical grade metal mesh (405) contained therein. The implant may be bent by hand, wherein upon the displacement of the implant, the implant will generally maintain the shape to which it has been displaced.

Abstract: A dental bone implant that comprises a first fitted bone graft sized and shaped to fit tightly to a buccal surface of a periodontal alveolar bone around at least one tooth and to reconstruct at least a portion of one or more periodontal bone defect and a second fitted bone graft sized and shaped to fit tightly to a lingual/palatal surface of a periodontal alveolar bone around at least one tooth and to reconstruct at least an additional portion of at least one periodontal bone defect. The portion and the other portion complementary cover the one or more periodontal bone defects.

Abstract: Various embodiments of craniofacial implants, surgical instruments, and techniques are described to provide improved surgical results.

Abstract: The Instant Face-Lifter is an intra-scalp beautifying device that stretches the face's skin creating a younger appearance with minimum scarring. It consists of an oval-shaped device made of solid medical grade silicone, typically measuring 5 12/16? long×4 12/16? wide, with sloping edges and an ever increasing thickness in the direction from border to center, starting at a negligible thickness at the borders and increasing to a varying maximum thickness (i.e. ½?, ¾?, 1?, 1 ½?, etc.) at its center as to be able to provide the user the desired amount of skin-stretching effect. The upper design of the invention follows a curve which parallels the shape of the skull so that it remains unnoticed from the outside. The invention is slided in the space between the scalp and the galea aponeurotica through a 3? to 4? incision on the parietal area using local anesthesia.

Abstract: An airway implant device for maintaining and/or creating an opening in air passageways is disclosed. Methods and devices for removing, the device are also disclosed. Methods of treating airway disorders such as sleep apnea and snoring with the airway implant device are disclosed herein.

Abstract: The present invention provides composite implants for the replacement or augmentation of non-load bearing or load bearing soft tissues, and methods of making and using these implant compositions. In one embodiment, a composite implant of the present invention comprises a soft polymeric component coupled to a porous polymeric substrate.

Abstract: A bendable polymer tissue fixation device suitable to be implanted into a living body, comprising a highly porous body, the porous body comprising a polymer, the porous body comprising a plurality of pores, the porous body being capable of being smoothly bent, wherein the bending collapses a portion of the pores to form a radius curve, the polymer fixation device being rigid enough to protect a tissue from shifting. In a preferred embodiment the polymer fixation device may be capable of being gradually resorbed by said living body. In one embodiment, the polymer fixation device comprises a plurality of layers distinguishable by various characteristics, such as structural or chemical properties. In another embodiment, the polymer fixation device may comprise additional materials; the additional materials serving to reinforce or otherwise alter the structure or physical characteristics of the device, or alternatively as a method of delivering therapy or other agents to the system of a living being.

Abstract: The present invention generally relates to mandibular prostheses. More particularly, the invention relates to a condylar-head replacement for reconstruction of the temporomandibular joint after resection of the condyloid process. The present invention provides a condylar-head replacement comprising a condylar-head attachment that may be adjustably positioned on a reconstruction plate to achieve various condylar-head heights. The condylar-head height adjustment allows the condylar-head replacement to be fit to a particular patient. The condylar-head replacement of the present invention obviates the need for custom fabrication of a condylar-head replacement for a patient.

Abstract: The present invention relates to improved biomedical implantable material comprising a plurality of pores, of which one or more of the pores are interconnected below the surface of the material. The improved biomedical implantable material may be used in biomedical implant devices such as orthopedic implants, spinal implants, neurocranial implants, maxillofacial implants, and joint replacement implants. The present invention also relates to a method of preparing an improved biomedical implantable material, comprising subjecting an implantable material to a pore-forming treatment and optionally further subjecting the material to a surface-modifying treatment. The biomedical implantable material may be used in other applications, which as applications where two surfaces are contacted and bonding between the surfaces is required.

Abstract: A coating for an orbital implant has an anterior portion having a different bioabsorbability than a posterior portion. This allows the implant to have an insertion surface, to reduce irritation, to prevent implant exposure, and to anchor muscles. The coating has a visual indicator to facilitate orientation. Shell materials are further selected to allow for sterile packaging, to secure therapeutic agents thereon, and to secure the coating to the core. Passageways enhance fluid flow to and from the core, and expose the core surface to muscles. The passageways are sized and shaped to reduce irritation. In an alternate embodiment, the anterior coating portion has a vaulted zone creating a gap between the undersurface of the coating and the outer surface of the core through which a suture can easily pass. Perforations through the coating provide targets for passage of the suture through the coating.

Abstract: A biocompatible prosthetic device comprising a thin low friction spacer for location to overlie a bone member in an interpositional location between opposed bone joint articular surfaces. The prosthesis is preferably a thin spacer with at least one low friction surface, the spacer being adapted for location about a bone member in an interpositional location between opposed bone joint articular surfaces preferably about a margin of articular cartilage of a bone member's condyle, preferably without any modification of the articular surface of the condyle. One preferred use of a prosthesis is in a human temporomandibular joint as a thin cap-like member fitted closely over the mandibular condyle to be disposed intermediate of the mandibular condyle and the mandibular fossa of the temporomandibular joint.

Abstract: The implant according to the invention is intended to be used as a replacement for an orbita bottom and optionally also for the medial orbita wall. The implant comprises the form of a single-piece preformed plate or grid which comprises a first segment, a second segment and a third segment. The first segment is designed in accordance with the form of the orbita bottom and the second segment is designed according to the form of the medial side-wall. The first and second segments adjoin each other along a first preset breaking line. The third segment adjoins the first segment and is arranged for fixing the implant to the lateral orbita edge.

Abstract: A composite surgical implant that is made of a planar sheet of a thermoplastic resin that includes a top surface (400), a bottom surface (410), and a surgical grade metal mesh (405) contained therein. The implant may be bent by hand, wherein upon the displacement of the implant, the implant will generally maintain the shape to which it has been displaced.

Abstract: The present invention provides composite implants for the replacement or augmentation of non-load bearing or load bearing soft tissues, and methods of making and using these implant compositions.

Abstract: The present invention generally relates to mandibular prostheses. More particularly, the invention relates to a condylar-head replacement for reconstruction of the temporomandibular joint after resection of the condyloid process. The present invention provides a condylar-head replacement comprising a condylar-head attachment that may be adjustably positioned on a reconstruction plate to achieve various condylar-head heights. The condylar-head height adjustment allows the condylar-head replacement to be fit to a particular patient. The condylar-head replacement of the present invention obviates the need for custom fabrication of a condylar-head replacement for a patient.

Abstract: Various methods and devices are provided for a facet replacement device. In one embodiment of the invention, a facet replacement device is provided and includes an elongate member matable to a first vertebra and a housing. The housing can have a connector formed thereon and matable to an adjacent second vertebra and an inner lumen formed therein. The housing can also include a deformable member disposed within the inner lumen and having an opening formed therein for slidably receiving at least a portion of the elongate member such that the elongate member can be angularly oriented relative to a longitudinal axis of the lumen.

Abstract: A cranio-maxillofacial implant material that is made of a macroporous (greater than 100 microns in diameter) interconnecting porous polyethylene structure with bioactive glass particles dispersed throughout the porous polyethylene structure, is disclosed. The Implant provides augmentation or replacement of cranio-maxillofacial tissues when implanted subperiosteally or within cranio-maxillofacial soft tissue. The addition of the bioactive glass particles to the porous polyethylene implant structure provides for faster fibrovascular ingrowth into the implant material.

Abstract: A biocompatible form and a method for fabricating the implant are provided. The biocompatible form may be used to support bone graft material such as that used to reconstruct missing bone in a patient's oral cavity. The implant is fabricated from a biocompatible mesh, which may be made of titanium, a titanium alloy or fiber and is permanently implantable in the patient's oral cavity. The biocompatible form has an anatomical configuration which includes one or more portions conforming substantially to various alveolar bone contours which may include predetermined, human interproximal bone contours, root prominence bone contours and mylohyoid ridge bone contours. The biocompatible form may include a palatal section. The biocompatible form may also include one or more apertures for receiving a corresponding number of dental prostheses therethrough.

Abstract: An orthopedic surgical implant of one or more components having a surface which is to be contacted by body tissue and/or fluid. The surface contains an inorganic antimicrobial agent either incorporated in the material forming a component having the surface or incorporated in a coating, such as of the adhesive or powder spray type, applied to the surface.

Abstract: An alveolar bone extension apparatus consisting of three parts, which are a plate with screw holes, an extension screw, and fixing screws, wherein the plate is fixed onto an alveolar bone basis and a movable bone fragment with fixing screws, and alveolar bone extension is enabled by rotating an extension screw through a cylinder. This apparatus has the form and structure of making the tip end of the extension screw so as to prevent the end from digging into the alveolar bone basis. Also the thread cutting pitch of the extension screw is set to match with one day's quantity of desired bone extension volume. The holes on the plate are arranged in two rows, one row for odd number holes and the other for even number holes, the two rows lined alternately so as to make the distance between the two rows as short as possible to enable the size of the plate to be small and compact.

Abstract: A biocompatible form and a method for fabricating the implant are provided. The biocompatible form may be used to support bone graft material such as that used to reconstruct missing bone in a patient's oral cavity. The implant is fabricated from a biocompatible mesh, which may be made of titanium, a titanium alloy or fiber and is permanently implantable in the patient's oral cavity. The biocompatible form has an anatomical configuration which includes one or more portions conforming substantially to various alveolar bone contours which may include predetermined, human interproximal bone contours, root prominence bone contours and mylohyoid ridge bone contours. The biocompatible form may include a palatal section. The biocompatible form may also include one or more apertures for receiving a corresponding number of dental prostheses therethrough.

Abstract: A process for making bone implants from calcium phosphate powders is disclosed. This process involves selectively fusing layers of calcium powders that have been coated or mixed with polymer binders. The calcium powder mixture may be formed into layers and the polymer fused with a laser. Complex three-dimensional geometrical shapes can be automatically replicated or modified using this approach.

Abstract: An intra-oral article that is user-customized from a contoured, thermoplastic pre-form stretches and reconfigures cheek skin, thereby diminishing the appearance of cheek lines, wrinkles, folds, and depressions. After heating a pre-form to its softening point, it is pressed against the buccal surface of the gums and teeth in a posterior quadrant of the maxilla or mandible. The pre-form is removed from the mouth after hardening, which yields a customized impression on the interior surface of the pre-form. The customized article can subsequently be applied and removed as desired by the user.

Abstract: A three dimensional facial space-filling implant adapted for filling space subcutaneously, said space being located primarily at the interface of a soft tissue surface and a bone surface. The article has a length, width and thickness wherein the thickness is oriented substantially orthogonal to first and second substantially opposing surfaces of the article. The thickness varies according to location along the length and width. The first surface is adapted to be substantially in contact with the soft tissue surface when implanted. This first surface is substantially porous having void spaces of size adequate to allow tissue ingrowth into at least a portion of the void spaces. The second surface is adapted to be substantially in contact with the bone surface when implanted and is substantially non-porous to substantially prevent ingrowth of bony tissue into the second surface. The first surface is preferably porous polytetrafluoroethylene and the thickness and second surface are preferably silicone.