Abstract: The invention features a gastrointestinal device and methods of use thereof for the treatment of metabolic disorders. The gastrointestinal device features disintegrable sleeve configured to fit within a patient's duodenum and to carry fluid (e.g., liquid or semisolid material, for example, chyme and digestive secretions) from its proximal end to its distal end.

Abstract: A gastrointestinal device and methods of use thereof for the treatment of metabolic disorders is provided. The gastrointestinal device features disintegrable sleeve configured to fit within a patient's duodenum and to carry fluid (e.g., liquid or semisolid material, for example, chyme and digestive secretions) from its proximal end to its distal end.

Abstract: The present invention provides delivery systems for positioning a gastrointestinal implant in a patient, for example, for treatment of a metabolic disease. Also provided are methods for assembling the delivery systems, methods of positioning a gastrointestinal implant, and methods of treatment of metabolic diseases, such as type 2 diabetes, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), obesity, and related comorbidities thereof.

Abstract: The present invention provides combination therapies for treating a metabolic disorder, such as type 2 diabetes, obesity, and related comorbidities (e.g., NASH or NAFLD)) in an individual undergoing treatment with a gastrointestinal implant. The combination therapies described herein include methods for treating an individual with a gastrointestinal implant with a metabolic agent, a bariatric procedure, and/or a microbiota modulator.

Abstract: The present invention provides delivery systems for positioning a gastrointestinal implant in a patient, for example, for treatment of a metabolic disease. Also provided are methods for assembling the delivery systems, methods of positioning a gastrointestinal implant, and methods of treatment of metabolic diseases, such as type 2 diabetes, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), obesity, and related comorbidities thereof.

Abstract: The present invention provides gastrointestinal devices for limiting transfer and contact of material across luminal walls along a segment of the gastrointestinal tract (e.g., at the duodenum and/or upper jejunum). Devices of the invention include a gastrointestinal sleeve, an anchor, and a flange for attachment to a luminal wall proximal to the pyloric orifice. The invention also provides methods of use associated with such gastrointestinal devices, including methods for delivery, removal, and treatment of metabolic disorders, such as type 2 diabetes, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, obesity, and related comorbidities thereof by implanting gastrointestinal devices.

Abstract: The present invention provides combination therapies for treating a metabolic disorder, such as type 2 diabetes, obesity, and related comorbidities (e.g., NASH or NAFLD)) in an individual undergoing treatment with a gastrointestinal implant. The combination therapies described herein include methods for treating an individual with a gastrointestinal implant with a metabolic agent, a bariatric procedure, and/or a microbiota modulator.

Abstract: The present invention provides delivery systems for positioning a gastrointestinal implant in a patient, for example, for treatment of a metabolic disease. Also provided are methods for assembling the delivery systems, methods of positioning a gastrointestinal implant, and methods of treatment of metabolic diseases, such as type 2 diabetes, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), obesity, and related comorbidities thereof.

Abstract: The present invention provides gastrointestinal devices for limiting transfer and contact of material across luminal walls along a segment of the gastrointestinal tract (e.g., at the duodenum and/or upper jejunum). Devices of the invention include a gastrointestinal sleeve, an anchor, and a flange for attachment to a luminal wall proximal to the pyloric orifice. The invention also provides methods of use associated with such gastrointestinal devices, including methods for delivery, removal, and treatment of metabolic disorders, such as type 2 diabetes, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, obesity, and related comorbidities thereof by implanting gastrointestinal devices.

Abstract: The invention features delivery systems for delivering a gastrointestinal device into the gastrointestinal tract of a patient and anchoring the gastrointestinal device with an anchor (e.g., a disintegrable anchor). Also provided are methods of delivering such gastrointestinal devices using the delivery systems described herein. The methods and delivery systems of the invention can be used for treatment of metabolic diseases, such as type 2 diabetes, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), obesity, and related comorbidities thereof.

Abstract: The invention features a gastrointestinal device and methods of use thereof for the treatment of metabolic disorders. The gastrointestinal device features disintegrable sleeve configured to fit within a patient's duodenum and to carry fluid (e.g., liquid or semisolid material, for example, chyme and digestive secretions) from its proximal end to its distal end.

Abstract: The invention features a gastrointestinal anchoring system for securing a gastrointestinal device within the gastrointestinal tract of a patient. Further provided are methods of using the anchoring system to secure a gastrointestinal device within the gastrointestinal tract of a patient and methods of treatment using the anchoring system of the invention to secure a gastrointestinal device of the invention to a luminal wall within a patient's gastrointestinal tract.

Abstract: The present invention provides methods of predicting and monitoring treatment with a gastrointestinal implant (e.g., a gastrointestinal sleeve), including efficacy and complications associated therewith (e.g., complications attributed to the gastrointestinal implant or occurring concurrently with, but independent from, the gastrointestinal implant). Further provided are methods of determining a time point for removing a gastrointestinal implant (e.g., based on one or more biomarkers, e.g., biomarkers associated with safety and efficacy).

Abstract: The present invention provides combination therapies for treating a metabolic disorder, such as type 2 diabetes, obesity, and related comorbidities (e.g., NASH or NAFLD)) in an individual undergoing treatment with a gastrointestinal implant. The combination therapies described herein include methods for treating an individual with a gastrointestinal implant with a metabolic agent, a bariatric procedure, and/or a microbiota modulator.

Abstract: The present invention provides gastrointestinal devices for limiting transfer and contact of material across luminal walls along a segment of the gastrointestinal tract (e.g., at the duodenum and/or upper jejunum). Devices of the invention include a gastrointestinal sleeve, an anchor, and a flange for attachment to a luminal wall proximal to the pyloric orifice. The invention also provides methods of use associated with such gastrointestinal devices, including methods for delivery, removal, and treatment of metabolic disorders, such as type 2 diabetes, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, obesity, and related comorbidities thereof by implanting gastrointestinal devices.

Abstract: The invention involves a mouthguard to optimize breathing while providing protection from physical blows. A mouthguard can include a plurality of conduits running substantially anterior-to-posterior therethrough.

Abstract: There is disclosed a system and method for dynamic stabilization which provides for distraction of the inter-vertebral space while still allowing a patient a substantial range of motion. In one embodiment, an inter-vertebral dynamic brace is used to maintain proper distraction. The dynamic brace is designed to allow the vertebrae to which it is attached to move through their natural arc, maintaining the correct instantaneous center of rotation. An adjustable tensioning device is used to maintain the proper distraction and compression forces to restore and maintain proper kinematics, while allowing the dynamic brace to move through an arc centered with respect to the center of rotation of the portion of the spine between the vertebrae. In one embodiment, a method is provided for adjusting the dynamic brace both with respect to the center of rotation of the vertebrae in both the flexion/extension axis and in the superior/inferior axis.

Abstract: There is disclosed a system and method for dynamic stabilization which provides for distraction of the inter-vertebral space while still allowing a patient a substantial range of motion. In one embodiment, an inter-vertebral dynamic brace is used to maintain proper distraction. The dynamic brace is designed to allow the vertebrae to which it is attached to move through their natural arc, maintaining the correct instantaneous center of rotation. An adjustable tensioning device is used to maintain the proper distraction and compression forces to restore and maintain proper kinematics, while allowing the dynamic brace to move through an arc centered with respect to the center of rotation of the portion of the spine between the vertebrae. In one embodiment, a method is provided for adjusting the dynamic brace both with respect to the center of rotation of the vertebrae in both the flexion/extension axis and in the superior/inferior axis.

Abstract: An assembly for use in spinal stabilization procedures having first and second bone anchor assemblies. Embodiments of the first bone anchor assembly may include an anchor, a poly-axial head, including a cavity, mated with the anchor such that the anchor is movable relative to the poly-axial head. Embodiments of the second bone anchor assembly may include an anchor, a poly-axial head mated with the second anchor such that the anchor is movable relative to the poly-axial head, a slide ring rotatably mated in the second poly-axial head, and a connector slideably mated in the slide ring along a distal end, and having a proximal end having an enlarged portion. The connector may be movable from a first position axially inline with the second bone anchor to a second position wherein the enlarged portion of the connector rests in the cavity of the first poly-axial head.